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| Publications of Kevin P. Weinfurt :chronological alphabetical combined listing:
%% Journal Articles
@article{fds370293,
Author = {Coles, TM and Lin, L and Weinfurt, K and Reeve, BB and Spertus, JA and Mentz, RJ and Piña, IL and Bocell, FD and Tarver, ME and Saha, A and Caldwell, B},
Title = {Investigating Potential Gender-Based Differential Item
Functioning for Items in the Kansas City Cardiomyopathy
Questionnaire (KCCQ) Physical Limitations
Domain},
Journal = {Applied Research in Quality of Life},
Volume = {18},
Number = {4},
Pages = {1785-1798},
Year = {2023},
Month = {August},
url = {http://dx.doi.org/10.1007/s11482-023-10162-3},
Abstract = {Women with heart failure report worse health-related quality
of life on average, than men. This may result from actual
differences in care or differing interpretations of and
responses to survey questions. We investigated potential
gender-based differential item functioning on the Kansas
City Cardiomyopathy Questionnaire (KCCQ) Physical
Limitations domain. Using data from the HF-ACTION trial, a
multicenter, randomized controlled trial of exercise
training in patients with chronic heart failure with reduced
ejection fraction (661 women, 1670 men), we assessed
gender-based differential item functioning using a Wald test
based on item response theory and ordinal logistic
regression. Both methods evaluated how men and women
responded to each KCCQ item after adjusting for physical
limitation status. No item exhibited statistically
significant differential item functioning using the Wald
method. Two items exhibited differential item functioning
using the ordinal logistic regression method (KCCQ1e:
Climbing a flight of stairs without stopping; KCCQ1f:
Hurrying or jogging) (P < 0.01), but the magnitude of
differential item functioning was negligible. To accurately
measure patient-reported outcomes, it is important to
evaluate potential biases that may influence the ability to
compare patient subgroups. The magnitude of differential
item functioning on a 5-item KCCQ Physical Limitation domain
was negligible.},
Doi = {10.1007/s11482-023-10162-3},
Key = {fds370293}
}
@article{fds362116,
Author = {Fridman, I and Chan, L and Thomas, J and Fish, LJ and Falkovic, M and Brioux, J and Hunter, N and Ryser, DH and Hwang, ES and Pollak, KI and Weinfurt, KP and Ryser, MD},
Title = {A web-based personalized decision support tool for patients
diagnosed with ductal carcinoma in situ: development,
content evaluation, and usability testing.},
Journal = {Breast Cancer Res Treat},
Volume = {192},
Number = {3},
Pages = {517-527},
Year = {2022},
Month = {April},
url = {http://dx.doi.org/10.1007/s10549-022-06512-8},
Abstract = {PURPOSE: Patients diagnosed with ductal carcinoma in situ
(DCIS) face trade-offs when deciding among different
treatments, including surgery, radiation, and endocrine
therapy. A less chosen option is active monitoring. While
evidence from clinical trials is not yet available,
observational studies show comparable results for active
monitoring and immediate treatment on cancer outcomes in
select subgroups of patients. We developed and tested a
web-based decision support tool (DST) to help patients
explore current knowledge about DCIS and make an informed
choice. METHODS: The DST, an interactive web application,
was informed by literature reviews and formative work with
patients, breast surgeons, and health communication experts.
We conducted iterative interviews to evaluate the DST
content among women with and without a history of breast
cancer, as well as breast cancer experts. For usability
testing, we conducted an online survey among women with and
without a history of breast cancer. RESULTS: For content
evaluation, 5 women with and 10 women without a history of
DCIS were interviewed. The sample included 11 White and 4
non-White women, with a mean age of 64 years. The expert
sample consisted of 5 attendings and a physician assistant.
The feedback was used to add, clarify, or reorganize
information in the DST. For usability testing, 22
participants with a mean age of 61 years were recruited
including 15 White and 7 Black women and 6 women with a
history of DCIS. The mean usability score was 3.7 out of 5.
Most participants (86%) found that the DST provided unbiased
information about treatments. To improve usability, we
reduced the per-page content and added navigation cues.
CONCLUSION: Content and usability evaluation showed that the
DST helps patients explore trade-offs of active monitoring
and immediate treatment. By adopting a personalized
approach, the tool will enable informed decisions aligned
with patients' values and expectations.},
Doi = {10.1007/s10549-022-06512-8},
Key = {fds362116}
}
@article{fds370547,
Author = {Flynn, KE and Mansfield, SA and Smith, AR and Gillespie, BW and Bradley,
CS and Cella, D and Helmuth, ME and Lai, HH and Kirkali, Z and Talaty, P and Weinfurt, KP},
Title = {PERSONAL CHARACTERISTICS ASSOCIATED WITH 30-DAY RECALL OF
SELF-REPORTED LOWER URINARY TRACT SYMPTOMS},
Journal = {JOURNAL OF UROLOGY},
Volume = {203},
Pages = {E409-E410},
Year = {2020},
Key = {fds370547}
}
@article{fds369238,
Author = {Flynn, KE and Weinfurt, KP and Lin, L and Radich, JP and Schiffer, CA and Mauro, MJ and Pinilla Ibarz and J and Moore, JO and Larson, RA and Oehler,
VG and Deininger, MW and Thompson, JE and Shah, NP and Wadleigh, M and Ritchie, EK and Silver, RT and Cortes, JE and Kota, V and Atallah,
EL},
Title = {Patient-Reported Outcome Results from the U.S. Life after
Stopping TKIs (LAST) Study in Patients with Chronic Myeloid
Leukemia},
Journal = {Blood},
Volume = {134},
Number = {Supplement_1},
Pages = {705-705},
Publisher = {American Society of Hematology},
Year = {2019},
Month = {November},
url = {http://dx.doi.org/10.1182/blood-2019-126002},
Abstract = {<jats:p>Background: Treatment of chronic myeloid leukemia
(CML) with a tyrosine kinase inhibitor (TKI) offers
significant improvements over previous treatments in terms
of survival and toxicity yet has been associated with
reduced health-related quality of life and very high cost.
Discontinuing TKIs with regular monitoring is safe, but
little is known about the impact of discontinuation on
patient-reported outcomes (PROs). In the largest U.S. study
to date, we evaluated molecular recurrence of CML and PROs
after TKI discontinuation.</jats:p> <jats:p>Methods: The
Life After Stopping TKIs (LAST) study was a prospective
single-group longitudinal study. Key inclusion criteria were
age &gt; 18 years, patient on TKI therapy (imatinib,
dasatinib, nilotinib, or bosutinib) for &gt; 3 years
with documented BCR-ABL &lt; 0.01% by PCR for &gt; 2
years, and no previous TKI resistance. We monitored disease
outcome (PCRs by central lab) and PROs (PROMIS computerized
adaptive tests via REDCap) monthly for the first 6 months,
every 2 months until 24 months, then every 3 months until 36
months. Molecular recurrence was defined as &gt; 0.1%
BCR-ABL IS by central lab (loss of major molecular response
[MMR]). We considered 3 points to be clinically meaningful
and hypothesized that by 6 months after TKI discontinuation,
fatigue, depression, sleep disturbance, and diarrhea would
improve by at least 3 points each, corresponding to a
standardized effect size of 0.3. Given reports of a
withdrawal syndrome of musculoskeletal pain in some patients
after discontinuation, pain was an additional outcome of
particular interest. For each PRO domain, we estimated a
polynomial piecewise linear mixed effects model that
specified one nonlinear trajectory after TKI discontinuation
and, for those with molecular recurrence, another trajectory
after TKI restart. The models included patient-level random
effects for the intercepts and linear slopes.</jats:p>
<jats:p>Results: From 12/2014 to 12/2016, 172 patients
enrolled from 14 U.S. sites. Median age was 60 years (range
21-86) and 89 (52%) were female. The median time on TKI
prior to enrollment was 81 months (IQR 54-123). With a
minimum follow-up of 24 months, 107 (62%) patients remained
in a treatment free remission (TFR). Reasons for restarting
therapy were: loss of MMR by central (n=56) or local (n=2)
lab, patient decision (n=4), and withdrawal syndrome (n=3).
Missing PRO data was minimal (&lt; 5%) with &gt;
2000 assessments completed. For patients in TFR at 6 months,
the average estimated improvement in fatigue was 2.6 points
(95% CI 2.5-2.7), depression was 1.9 points (95% CI
1.8-1.9), sleep disturbance was 0.9 points (95% CI 0.8-1.0),
and diarrhea was 2.7 points (95% CI 2.6-2.7). The average
estimated worsening in pain interference (i.e., the extent
to which pain affects daily life) was 0.4 points (95% CI
0.3-0.5). The figure shows the distribution of estimated
change for each domain at 6 months. All patients showed
improvements in depression, diarrhea, and fatigue. About 1
in 6 patients (17%) experienced a clinically meaningful
(i.e., at least 3 points) improvement in fatigue and/or
diarrhea at 6 months.</jats:p> <jats:p>Conclusion: The LAST
study is the largest US TKI discontinuation study to date,
and the first to include comprehensive PRO measurement. For
patients in TFR at 6 months, TKI discontinuation conferred
modest benefits in fatigue and diarrhea on average, with a
negligible increase in pain interference. Some patients
experienced more notable improvements in fatigue and
diarrhea. Planned secondary analyses will include change
over time up to 3 years and evaluation of additional PRO
domains, including anxiety, physical function, social
function, and sexual function. Our results provide important
new evidence to support shared patient-provider clinical
decision making regarding TKI discontinuation for patients
with CML.</jats:p> <jats:p>Figure.</jats:p> <jats:sec>
<jats:title>Disclosures</jats:title> <jats:p>Radich:
Novartis: Other: RNA Sequencing; TwinStrand Biosciences:
Research Funding. Mauro:Pfizer: Consultancy; Takeda:
Consultancy; Novartis Oncology: Consultancy, Research
Funding; Bristol-Myers Squibb: Consultancy. Pinilla
Ibarz:Sanofi: Speakers Bureau; Abbvie: Consultancy, Speakers
Bureau; Teva: Consultancy; Janssen: Consultancy, Speakers
Bureau; Novartis: Consultancy; Takeda: Consultancy, Speakers
Bureau; Bayer: Speakers Bureau; TG Therapeutics:
Consultancy; Bristol-Myers Squibb: Consultancy.
Larson:Celgene: Consultancy; Novartis: Honoraria, Other:
Contracts for clinical trials; Agios: Consultancy.
Oehler:Blueprint Medicines: Consultancy; NCCN: Consultancy;
Pfizer Inc.: Research Funding. Deininger:Humana: Honoraria;
Incyte: Honoraria; Blueprint: Consultancy, Honoraria,
Membership on an entity's Board of Directors or advisory
committees; Pfizer: Consultancy, Honoraria, Research
Funding; Ascentage Pharma: Consultancy, Honoraria; TRM:
Consultancy; Sangoma: Consultancy; Fusion Pharma:
Consultancy; Adelphi: Consultancy; Takeda: Honoraria,
Membership on an entity's Board of Directors or advisory
committees; Novartis: Honoraria; Sangamo: Consultancy.
Shah:Bristol-Myers Squibb: Research Funding. Ritchie:Tolero:
Other: Advisory board; Celgene: Other: Advisory board;
Celgene, Novartis: Other: travel support; Jazz
Pharmaceuticals: Research Funding; Celgene, Incyte,
Novartis, Pfizer: Consultancy; AStella, Bristol-Myers
Squibb, Novartis, NS Pharma, Pfizer: Research Funding;
Ariad, Celgene, Incyte, Novartis: Speakers Bureau;
Genentech: Other: Advisory board; Pfizer: Other: Advisory
board, travel support; agios: Other: Advisory board.
Silver:PharmEssentia: Consultancy, Honoraria, Membership on
an entity's Board of Directors or advisory committees.
Cortes:Sun Pharma: Research Funding; Pfizer: Consultancy,
Honoraria, Research Funding; Forma Therapeutics:
Consultancy, Honoraria, Research Funding; BiolineRx:
Consultancy; Bristol-Myers Squibb: Consultancy, Research
Funding; Takeda: Consultancy, Research Funding; Novartis:
Consultancy, Honoraria, Research Funding; Daiichi Sankyo:
Consultancy, Honoraria, Research Funding; Jazz
Pharmaceuticals: Consultancy, Research Funding; Biopath
Holdings: Consultancy, Honoraria; Immunogen: Consultancy,
Honoraria, Research Funding; Merus: Consultancy, Honoraria,
Research Funding; Astellas Pharma: Consultancy, Honoraria,
Research Funding. Atallah:Jazz: Consultancy; Helsinn:
Consultancy; Pfizer: Consultancy; Takeda: Consultancy,
Research Funding; Jazz: Consultancy; Helsinn: Consultancy;
Novartis: Consultancy.</jats:p> </jats:sec>},
Doi = {10.1182/blood-2019-126002},
Key = {fds369238}
}
@article{fds348585,
Author = {Amundsen, CL and Helmuth, ME and Smith, AR and DeLancey, JOL and Bradley, CS and Flynn, KE and Kenton, KS and Lai, HH and Cella, D and Griffith, JW and Andreev, VP and Yang, CC and Jelovsek, JE and Weinfurt,
KP and Liu, AB and Fraser, MO and Kirkali, Z},
Title = {LONGITUDINAL CHANGES IN SYMPTOM-BASED FEMALE AND MALE LUTS
CLUSTER CHARACTERISTICS AND FACTORS ASSOCIATED WITH
CHANGE},
Journal = {JOURNAL OF UROLOGY},
Volume = {201},
Number = {4},
Pages = {E568-E569},
Publisher = {LIPPINCOTT WILLIAMS & WILKINS},
Year = {2019},
Month = {April},
Key = {fds348585}
}
@article{fds340792,
Author = {Bloom, DL and Chapman, BM and Wheeler, SB and McGuire, KP and Lee, CN and Weinfurt, K and Rosenstein, DL and Plichta, JK and Jacobson Vann and JC and Hwang, ES},
Title = {Reframing the conversation about contralateral prophylactic
mastectomy: Preparing women for postsurgical
realities.},
Journal = {Psychooncology},
Volume = {28},
Number = {2},
Pages = {394-400},
Year = {2019},
Month = {February},
url = {http://dx.doi.org/10.1002/pon.4955},
Abstract = {OBJECTIVE: Women with unilateral, early-stage breast cancer
and low genetic risk are increasingly opting for
contralateral prophylactic mastectomy (CPM), a concerning
trend because CPM offers few clinical benefits while
increasing risks of surgical complications. Few qualitative
studies have analyzed factors motivating this irreversible
decision. Using qualitative methods, this study sought to
understand women's decision making and the impact of CPM on
self-confidence, sense of femininity, sexual intimacy, and
peace of mind. METHODS: Women who had CPM within the last
10 years were recruited to participate in the study. We
conducted a thematic analysis of the data. RESULTS:
Forty-five women were interviewed. When making the decision
for CPM, most had incomplete knowledge of potential negative
outcomes. However, all believed CPM had more benefits than
harms and would confer the most peace of mind and the fewest
regrets should cancer return. They knew their contralateral
breast cancer risk was low but were not persuaded by
statistics. They wanted to do everything possible to reduce
their risk of another breast cancer, even by a minimal
amount, but most reported paying an unexpectedly high price
for this small reduction in risk. Nevertheless, 41 of 45
reported that they would make the same decision again.
CONCLUSIONS: These findings highlight an opportunity for
physicians to reframe the conversation to focus on the
patient experience of the tradeoffs of CPM rather than
statistical odds of future cancers. Our findings suggest
that more data may not dissuade women from CPM but may
better prepare them for its outcomes.},
Doi = {10.1002/pon.4955},
Key = {fds340792}
}
@article{fds348586,
Author = {Amundsen, CL and Helmuth, ME and Smith, AR and DeLancey, JOL and Bradley, CS and Flynn, KE and Kenton, KS and Lai, HH and Cella, D and Griffith, JW and Andreev, VP and Yang, CC and Jelovsek, JE and Weinfurt,
KP and Liu, AB and Fraser, MO and Kirkal, Z},
Title = {Longitudinal changes in symptom-based female and male luts
cluster characteristics and factors associated with
change},
Journal = {NEUROUROLOGY AND URODYNAMICS},
Volume = {38},
Pages = {S85-S86},
Publisher = {WILEY},
Year = {2019},
Month = {February},
Key = {fds348586}
}
@article{fds348587,
Author = {Agochukwu, NQ and Wiseman, JB and Smith, AR and Helmuth, ME and Weinfurt, KP and Sarma, AV and Griffith, JW and Cella, D and Cameron,
AP and Flynn, KE and Erickson, BA and Kirkali, Z and Amundsen, CL and Lai,
HH and Tavathia, M and Clemens, JQ},
Title = {Correlation of symptom severity and bother in individuals
seeking care for lower urinary tract symptoms},
Journal = {NEUROUROLOGY AND URODYNAMICS},
Volume = {38},
Pages = {S120-S121},
Publisher = {WILEY},
Year = {2019},
Month = {February},
Key = {fds348587}
}
@article{fds348588,
Author = {Agochukwu, NQ and Wiseman, JB and Smith, AR and Helmuth, ME and Weinfurt, KP and Sarma, AV and Griffith, JW and Cella, D and Cameron,
AP and Flynn, KE and Erickson, BA and Kirkali, Z and Amundsen, CL and Lai,
HH and Tavathia, M and Clemens, JQ},
Title = {Relationship between symptom bother and severity in
individuals seeking care for lower urinary tract symptoms
(LUTS)},
Journal = {NEUROUROLOGY AND URODYNAMICS},
Volume = {38},
Pages = {S86-S87},
Publisher = {WILEY},
Year = {2019},
Month = {February},
Key = {fds348588}
}
@article{fds370548,
Author = {Flynn, KE and Mansfield, SA and Smith, AR and Gillespie, BW and Bradley,
CS and Clemens, JQ and Helmuth, ME and Talaty, P and Lai, HH and Kirkali,
Z and Weinfurt, KP},
Title = {ACCURACY OF 7-AND 30-DAY RECALL FOR SELF-REPORTED LOWER
URINARY TRACT SYMPTOMS},
Journal = {JOURNAL OF UROLOGY},
Volume = {201},
Number = {4},
Pages = {E416-E416},
Year = {2019},
Key = {fds370548}
}
@article{fds370549,
Author = {Agochukwu, NQ and Wiseman, JB and Smith, AR and Helmuth, ME and Weinfurt, KP and Sarma, AV and Griffith, JW and Cella, D and Cameron,
AP and Flynn, KE and Erickson, BA and Kirkali, Z and Amundsen, CL and Lai,
HH and Tavathia, M and Clemens, JQ},
Title = {CORRELATION OF SYMPTOM SEVERITY AND BOTHER IN INDIVIDUALS
SEEKING CARE FOR LOWER URINARY TRACT SYMPTOMS},
Journal = {JOURNAL OF UROLOGY},
Volume = {201},
Number = {4},
Pages = {E569-E569},
Year = {2019},
Key = {fds370549}
}
@article{fds370550,
Author = {Agochukwu, NQ and Wiseman, JB and Smith, AR and Helmuth, ME and Weinfurt, KP and Tavathia, M and Sarma, AV and Griffith, JW and Cella,
D and Cameron, AP and Flynn, KE and Erickson, BA and Kirkali, Z and Amundsen, CL and Lai, HH and Clemens, JQ},
Title = {CHARACTERISTICS OF HIGH LOWER URINARY TRACT SYMPTOM (LUTS)
BOTHER IN INDIVIDUALS SEEKING CARE FOR LUTS},
Journal = {JOURNAL OF UROLOGY},
Volume = {201},
Number = {4},
Pages = {E458-E458},
Year = {2019},
Key = {fds370550}
}
@article{fds370551,
Author = {Cella, D and Smith, AR and Griffith, JW and Flynn, KE and Gillespie, BW and Bradley, CS and Helmuth, ME and Talaty, P and Merion, RM and Weinfurt,
KP and Kirkali, Z},
Title = {A NEW BRIEF LOWER URINARY TRACT SYMPTOMS CLINICAL ASSESSMENT
TOOL FOR WOMEN AND MEN: THE LURN SYMPTOM
INDEX},
Journal = {JOURNAL OF UROLOGY},
Volume = {201},
Number = {4},
Pages = {E568-E568},
Year = {2019},
Key = {fds370551}
}
@article{fds339674,
Author = {Reeve, BB and Wang, M and Weinfurt, K and Flynn, KE and Usinger, DS and Chen, RC},
Title = {Psychometric Evaluation of PROMIS Sexual Function and
Satisfaction Measures in a Longitudinal Population-Based
Cohort of Men With Localized Prostate Cancer.},
Journal = {J Sex Med},
Volume = {15},
Number = {12},
Pages = {1792-1810},
Year = {2018},
Month = {December},
url = {http://dx.doi.org/10.1016/j.jsxm.2018.09.015},
Abstract = {BACKGROUND: There are multiple treatment options for men
with localized prostate cancer that provide similar curative
efficacy but differ in their impact on sexual functioning.
AIM: To evaluate the psychometric properties of the
Patient-Reported Outcomes Measurement Information System
(PROMIS) Sexual Function and Satisfaction (SexFS) measures,
including items from versions 1 and 2 of the short forms.
METHODS: A population-based cohort of men across North
Carolina completed surveys via phone interviews at baseline
(prior to treatment) and at 3, 12, and 24 months after
cancer treatment initiation. Surveys included the PROMIS
SexFS domains of interest in sexual activity, erectile
function, orgasm, and satisfaction and the Prostate Cancer
Symptom Indices. Analyses included descriptive statistics,
assessment of structural validity using confirmatory factor
analysis and item response theory, tests for differential
item functioning, assessment of convergent validity using
correlations, and evaluation of responsiveness of the PROMIS
SexFS measures over time. We hypothesized that men
undergoing surgery (prostatectomy) would report the poorest
sexual function at the 3-month survey. RESULTS: Sample size
varied by assessment point and ranged from 332‒939 men,
consisting of 30% non-white men, and 30% of the sample had a
high school degree or less. The items within the PROMIS
orgasm domain did not form a unidimensional scale. PROMIS
measures of interest in sexual activity, erectile function,
and satisfaction were unidimensional and highly correlated
with related Prostate Cancer Symptom Indices measures
(eg, erectile function, r = 0.84‒0.95). Erectile
function in the surgery group declined more at 3 months
compared to the no-surgery group (2 points); this
difference narrowed at 12 and 24 months after surgery, as
the surgery group recovered over time. Results were similar
for PROMIS Interest in Sexual Activity and PROMIS
Satisfaction scales. CLINICAL IMPLICATIONS: The PROMIS SexFS
measures may be used to identify effective interventions to
treat sexual dysfunction and monitor sexual functioning in
men with prostate cancer over time. STRENGTH & LIMITATIONS:
This study was limited to men living in North Carolina who
could self-report their health-related quality of life in
English. However, this study was able to include more men
from vulnerable populations by allowing them to self-report
over the phone. CONCLUSION: This study provided strong
support for use of the PROMIS SexFS (version 2) measures in
men with localized prostate cancer to assess sexual
interest, erectile function, and satisfaction over time.
Reeve BB, Wang M, Weinfurt K, et al. Psychometric
Evaluation of PROMIS Sexual Function and Satisfaction
Measures in a Longitudinal Population-Based Cohort of Men
With Localized Prostate Cancer. J Sex Med
2018;15:1792-1810.},
Doi = {10.1016/j.jsxm.2018.09.015},
Key = {fds339674}
}
@article{fds348589,
Author = {Andreev, VP and Liu, G and Yang, CC and Smith, AR and Helmuth, ME and Wiseman, JB and Merion, RM and Weinfurt, KP and Lai, HH and Cella, D and Helfand, BT and Griffith, JW and DeLancey, JOL and Fraser, MO and Kirkali, Z},
Title = {SYMPTOM-BASED CLUSTERING OF FEMALE LUTS PARTICIPANTS IN THE
SYMPTOMS OF LOWER URINARY TRACT DYSFUNCTION RESEARCH NETWORK
(LURN) STUDY},
Journal = {NEUROUROLOGY AND URODYNAMICS},
Volume = {37},
Pages = {S622-S622},
Publisher = {WILEY},
Year = {2018},
Month = {February},
Key = {fds348589}
}
@article{fds348590,
Author = {Flynn, KE and Lin, L and Weinfurt, KP},
Title = {Recent sexual function and satisfaction by sexual
orientation in US adults},
Journal = {QUALITY OF LIFE RESEARCH},
Volume = {25},
Pages = {52-52},
Publisher = {SPRINGER},
Year = {2016},
Month = {October},
Key = {fds348590}
}
@article{fds348591,
Author = {Teng, T-HK and Tay, NLW-T and Schulman, KA and Weinfurt, KP and Flynn,
KE and Whellan, DJ and Kraus, WE and Pina, IL and O'Connor, C and Anand, I and Zhang, S and Shimizu, W and Narasimhan, C and Park, S-W and Yu, C-M and Ngarmukos, T and Omar, R and Reyes, E and Siswanto, B and Hung, C-L and Ling, L-H and Richards, AM and Mentz, RJ and Lam,
CSP},
Title = {Multinational ethnic variations in self-reported health
status in chronic heart failure patients},
Journal = {EUROPEAN HEART JOURNAL},
Volume = {37},
Pages = {534-535},
Publisher = {OXFORD UNIV PRESS},
Year = {2016},
Month = {August},
Key = {fds348591}
}
@article{fds348595,
Author = {Czajkowski, SM and Riley, W and Pilkonis, PA and Weinfurt,
KP},
Title = {PATIENT-REPORTED OUTCOMES MEASUREMENT INFORMATION SYSTEM
(PROMIS): USING NEW THEORY AND TECHNOLOGY TO IMPROVE
MEASUREMENT OF PATIENT-REPORTED OUTCOMES IN CLINICAL
RESEARCH},
Journal = {ANNALS OF BEHAVIORAL MEDICINE},
Volume = {41},
Pages = {S145-S145},
Publisher = {SPRINGER},
Year = {2011},
Month = {April},
Key = {fds348595}
}
@article{fds348597,
Author = {Sulmasy, DP and Astrow, AB and He, MK and Seils, DM and Meropol, NJ and Weinfurt, KP},
Title = {THE CULTURE OF FAITH AND HOPE: SUBJECTS' JUSTIFICATIONS FOR
THEIR HIGH ESTIMATIONS OF EXPECTED BENEFIT IN EARLY PHASE
ONCOLOGY TRIALS.},
Journal = {JOURNAL OF GENERAL INTERNAL MEDICINE},
Volume = {24},
Pages = {181-181},
Publisher = {SPRINGER},
Year = {2009},
Month = {April},
Key = {fds348597}
}
@article{fds348598,
Author = {Weinfurt, KP and Hall, MA and Hardy, C and Friedman, JY and Schulman,
KA and Sugarman, J},
Title = {CONFLICT OF INTEREST OVERSIGHT IN NON-ACADEMIC RESEARCH
SETTINGS},
Journal = {JOURNAL OF GENERAL INTERNAL MEDICINE},
Volume = {24},
Pages = {47-47},
Publisher = {SPRINGER},
Year = {2009},
Month = {April},
Key = {fds348598}
}
@article{fds348599,
Author = {Flynn, KE and Shelby, R and Krystal, A and Reeve, BB and Mitchell, S and Buysse, D and Keefe, F and Weinfurt, KP},
Title = {Sleep/wake functioning during and following
cancer},
Journal = {SLEEP},
Volume = {31},
Pages = {A298-A298},
Publisher = {OXFORD UNIV PRESS INC},
Year = {2008},
Month = {January},
Key = {fds348599}
}
@article{fds348600,
Author = {Lewis, E and Li, Y and Reed, SD and Weinfurt, KP and Solomon, SD and Pfeffer, MA},
Title = {Impact of non-fatal cardiovascular events on change in
health-related quality of life in patients who survive
myocardial infarction},
Journal = {CIRCULATION},
Volume = {116},
Number = {16},
Pages = {859-859},
Publisher = {LIPPINCOTT WILLIAMS & WILKINS},
Year = {2007},
Month = {October},
Key = {fds348600}
}
@article{fds348601,
Author = {Flynn, KE and Tzeng, J and Jeffery, DD and Reeve, BB and Weinfurt,
KP},
Title = {Conceptualizations of sexual functioning and intimacy among
cancer sufferers and survivors},
Journal = {PSYCHO-ONCOLOGY},
Volume = {16},
Number = {9},
Pages = {S135-S136},
Publisher = {JOHN WILEY & SONS LTD},
Year = {2007},
Month = {September},
Key = {fds348601}
}
@article{fds348602,
Author = {Flynn, KE and Weinfurt, KP and Sils, DM and Burnett, CB and Schulman,
KA and Meropol, NJ},
Title = {Decisional conflict among patients who accept or decline
participation in phase I cancer clinical
trials},
Journal = {PSYCHO-ONCOLOGY},
Volume = {16},
Number = {9},
Pages = {S166-S167},
Publisher = {JOHN WILEY & SONS LTD},
Year = {2007},
Month = {September},
Key = {fds348602}
}
@article{fds369239,
Author = {Weinfurt, KP and Seils, DM and Tzeng, JP and Compton, KL and Sulmasy,
DP and Astrow, AB and Schulman, KA and Meropol, NJ},
Title = {Understanding patient expectations in early-phase clinical
trials},
Journal = {JOURNAL OF CLINICAL ONCOLOGY},
Volume = {25},
Number = {18},
Pages = {1 pages},
Publisher = {AMER SOC CLINICAL ONCOLOGY},
Year = {2007},
Month = {June},
Key = {fds369239}
}
@article{fds369240,
Author = {Flynn, KE and Weinfurt, KP and Seils, DM and Burnett, CB and Schulman,
KA and Meropol, NJ},
Title = {Decisional conflict among patients who accept or decline
participation in phase I cancer clinical
trials},
Journal = {JOURNAL OF GENERAL INTERNAL MEDICINE},
Volume = {22},
Pages = {38-38},
Publisher = {SPRINGER},
Year = {2007},
Month = {April},
Key = {fds369240}
}
@article{fds369241,
Author = {Flynn, KE and Dombeck, CB and Dewitt, EM and Diener, LW and Schulman,
KA and Weinfurt, KP},
Title = {Incorporating item banks into clinical trials: Investigator
perceptions},
Journal = {JOURNAL OF GENERAL INTERNAL MEDICINE},
Volume = {22},
Pages = {114-114},
Publisher = {SPRINGER},
Year = {2007},
Month = {April},
Key = {fds369241}
}
@article{fds369242,
Author = {Weinfurt, KP and Seils, DM and Tzeng, JP and Compton, KL and Sulmasy,
DP and Astrow, AB and Schulman, KA and Meropol, NJ},
Title = {Understanding patient expectations in early-phase clinical
oncology trials},
Journal = {JOURNAL OF GENERAL INTERNAL MEDICINE},
Volume = {22},
Pages = {98-98},
Publisher = {SPRINGER},
Year = {2007},
Month = {April},
Key = {fds369242}
}
@article{fds369244,
Author = {Weinfurt, KP and Anstrom, KJ and Castel, LD and Brandman, J and Schulman, KA},
Title = {Effect of zoledronic acid on clinically meaningful changes
in pain associated with metastatic prostate
cancer.},
Journal = {JOURNAL OF CLINICAL ONCOLOGY},
Volume = {22},
Number = {14},
Pages = {426S-426S},
Publisher = {AMER SOC CLINICAL ONCOLOGY},
Year = {2004},
Month = {July},
Key = {fds369244}
}
@article{fds348604,
Author = {Rathore, SS and Weinfurt, KP and Gross, CP and Krumholz,
HM},
Title = {Validity of a simple ST-elevation myocardial infarction risk
index: Are RCT-derived prognostic estimates generalizable to
elderly patients?},
Journal = {CIRCULATION},
Volume = {106},
Number = {16},
Pages = {E79-E79},
Publisher = {LIPPINCOTT WILLIAMS & WILKINS},
Year = {2002},
Month = {October},
Key = {fds348604}
}
@article{fds348605,
Author = {Rathore, SS and Gersh, BJ and Weinfurt, KP and Oetgen, WJ and Schulman,
KA and Solomon, AJ},
Title = {Effectiveness of reperfusion therapy among elderly acute
myocardial infarction patients presenting with left bundle
branch block},
Journal = {CIRCULATION},
Volume = {102},
Number = {18},
Pages = {385-385},
Publisher = {LIPPINCOTT WILLIAMS & WILKINS},
Year = {2000},
Month = {October},
Key = {fds348605}
}
@article{fds348606,
Author = {Rathore, SS and Epstein, AJ and Weinfurt, KP and Berger, AK and Oetgen,
WJ and Gersh, BJ and Schulman, KA},
Title = {Hospital characteristics and treatment of acute myocardial
infarction: Role of ownership and teaching
status},
Journal = {JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY},
Volume = {35},
Number = {2},
Pages = {267A-267A},
Publisher = {ELSEVIER SCIENCE INC},
Year = {2000},
Month = {February},
Key = {fds348606}
}
@article{fds348607,
Author = {Rathore, SS and Weinfurt, KP and Gersh, BJ and Oetgen, WJ and Schulman,
KA and Solomon, AJ},
Title = {Reperfusion therapy among paced patients with acute
myocardial infarction},
Journal = {JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY},
Volume = {35},
Number = {2},
Pages = {396A-396A},
Publisher = {ELSEVIER SCIENCE INC},
Year = {2000},
Month = {February},
Key = {fds348607}
}
@article{fds348608,
Author = {Rathore, SS and Weinfurt, KP and Gersh, BJ and Oetgen, WJ and Schulman,
KA and Solomon, AJ},
Title = {Treatment of paced patients with acute myocardial
infarction},
Journal = {JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY},
Volume = {35},
Number = {2},
Pages = {143A-143A},
Publisher = {ELSEVIER SCIENCE INC},
Year = {2000},
Month = {February},
Key = {fds348608}
}
@article{fds348609,
Author = {Rathore, SS and Berger, AK and Weinfurt, KP and Felnleib, M and Oetgen,
WJ and Gersh, BJ and Schulman, KA},
Title = {Race, gender, community socioeconomic characteristics and
the medical treatment of acute myocardial infarction in the
elderly},
Journal = {CIRCULATION},
Volume = {100},
Number = {18},
Pages = {805-805},
Publisher = {LIPPINCOTT WILLIAMS & WILKINS},
Year = {1999},
Month = {November},
Key = {fds348609}
}
@article{fds348610,
Author = {Sheifer, SE and Rathore, SS and Gersh, BJ and Weinfurt, KP and Oetgen,
WJ and Breall, JA and Schulman, KA},
Title = {Time to presentation with acute myocardial infarction in the
elderly: Associations with race, gender, and
poverty},
Journal = {CIRCULATION},
Volume = {100},
Number = {18},
Pages = {805-805},
Publisher = {LIPPINCOTT WILLIAMS & WILKINS},
Year = {1999},
Month = {November},
Key = {fds348610}
}
@article{fds348611,
Author = {Rathore, SS and Weinfurt, KP and Schulman, KA and Oetgen, WJ and Gersh,
BJ and Solomon, AJ},
Title = {Acute myocardial infarction complicated by advanced heart
block in the elderly: Patient characteristics and
outcomes},
Journal = {CIRCULATION},
Volume = {100},
Number = {18},
Pages = {806-806},
Publisher = {LIPPINCOTT WILLIAMS & WILKINS},
Year = {1999},
Month = {November},
Key = {fds348611}
}
%% Papers Published
@article{fds376698,
Author = {Arizmendi, C and Wang, S and Kaplan, S and Weinfurt,
K},
Title = {Evaluating Recall Periods for Patient-Reported Outcome
Measures: A Systematic Review of Quantitative
Methods.},
Journal = {Value Health},
Volume = {27},
Number = {4},
Pages = {518-526},
Year = {2024},
Month = {April},
url = {http://dx.doi.org/10.1016/j.jval.2024.01.016},
Abstract = {OBJECTIVES: The current guidance for selection of recall
periods recommends considering the design of the study,
nature of the condition, patient's burden and ability to
recall, and intent of the outcome measure. Empirical study
of the accuracy of recall periods is recommended; however,
there is not consensus on how to quantitatively evaluate the
consistency of results from patient-reported outcome
measures (PROMs) with different recall periods. We conducted
a systematic review to describe quantitative methods for
evaluating results obtained from PROMs with differing recall
periods to lay the groundwork for establishing consensus.
METHODS: We searched MEDLINE, Embase, Scopus, and American
Psychological Association PsycINFO for studies where
participants are given the same health-related measure (eg,
quality of life, well-being, functioning, and pain) with
differing recall periods. RESULTS: A total of 7174 abstracts
were screened. The 30 included studies reflected a wide
range of domains, including pain, fatigue, and sexual
behavior and function. The recall periods ranged from
momentary to 6 months. The analytic approaches varied,
including different methods for assessing relative
agreement, absolute agreement, and for assessing combined
relative and absolute agreement. CONCLUSIONS: We found
variability in how PROM recall periods were evaluated,
suggesting an opportunity for greater consensus on
methodological approach. As a starting point, we provide
recommendations for which methods are preferred for which
contexts.},
Doi = {10.1016/j.jval.2024.01.016},
Key = {fds376698}
}
@article{fds375248,
Author = {Weinfurt, KP and Flynn, K},
Title = {Some Clarifications Regarding the PROMIS© SexFS: Commentary
on Clements et al. (2023).},
Journal = {Arch Sex Behav},
Volume = {53},
Number = {3},
Pages = {869-870},
Year = {2024},
Month = {March},
url = {http://dx.doi.org/10.1007/s10508-023-02789-y},
Doi = {10.1007/s10508-023-02789-y},
Key = {fds375248}
}
@article{fds375347,
Author = {Green, T and Bosworth, HB and Coronado, GD and DeBar, L and Green, BB and Huang, SS and Jarvik, JG and Mor, V and Zatzick, D and Weinfurt, KP and Check, DK},
Title = {Factors Affecting Post-trial Sustainment or
De-implementation of Study Interventions: A Narrative
Review.},
Journal = {J Gen Intern Med},
Year = {2024},
Month = {January},
url = {http://dx.doi.org/10.1007/s11606-023-08593-7},
Abstract = {In contrast to traditional randomized controlled trials,
embedded pragmatic clinical trials (ePCTs) are conducted
within healthcare settings with real-world patient
populations. ePCTs are intentionally designed to align with
health system priorities leveraging existing healthcare
system infrastructure and resources to ease intervention
implementation and increase the likelihood that effective
interventions translate into routine practice following the
trial. The NIH Pragmatic Trials Collaboratory, funded by the
National Institutes of Health (NIH), supports the conduct of
large-scale ePCT Demonstration Projects that address major
public health issues within healthcare systems. The
Collaboratory has a unique opportunity to draw on the
Demonstration Project experiences to generate lessons
learned related to ePCTs and the dissemination and
implementation of interventions tested in ePCTs. In this
article, we use case studies from six completed
Demonstration Projects to summarize the Collaboratory's
experience with post-trial interpretation of results, and
implications for sustainment (or de-implementation) of
tested interventions. We highlight three key lessons
learned. First, ineffective interventions (i.e., ePCT is
null for the primary outcome) may be sustained if they have
other measured benefits (e.g., secondary outcome or
subgroup) or even perceived benefits (e.g., staff like the
intervention). Second, effective interventions-even those
solicited by the health system and/or designed with
significant health system partner buy-in-may not be
sustained if they require significant resources. Third,
alignment with policy incentives is essential for achieving
sustainment and scale-up of effective interventions. Our
experiences point to several recommendations to aid in
considering post-trial sustainment or de-implementation of
interventions tested in ePCTs: (1) include secondary outcome
measures that are salient to health system partners; (2)
collect all appropriate data to allow for post hoc analysis
of subgroups; (3) collect experience data from clinicians
and staff; (4) engage policy-makers before starting the
trial.},
Doi = {10.1007/s11606-023-08593-7},
Key = {fds375347}
}
@article{fds370913,
Author = {Morain, SR and Bollinger, J and Weinfurt, K and Sugarman,
J},
Title = {Stakeholder perspectives on data sharing from pragmatic
clinical trials: Unanticipated challenges for meeting
emerging requirements},
Journal = {Learning Health Systems},
Volume = {8},
Number = {1},
Year = {2024},
Month = {January},
url = {http://dx.doi.org/10.1002/lrh2.10366},
Abstract = {Introduction: Numerous arguments have been advanced for
broadly sharing de-identified, participant-level clinical
trial data. However, data sharing in pragmatic clinical
trials (PCTs) presents ethical challenges. While prior
scholarship has described aspects of PCTs that raise
distinct considerations for data sharing, there have been no
reports of the experiences of those at the leading edge of
data-sharing efforts for PCTs, including how these
particular challenges have been navigated. To address this
gap, we conducted interviews with key stakeholders, with a
focus on the ethical issues presented by sharing data from
PCTs. Methods: We recruited respondents using purposive
sampling to reflect the range of stakeholder groups affected
by efforts to expand PCT data sharing. Through
semi-structured interviews, we explored respondents'
experiences and perceptions about sharing de-identified,
individual-level data from PCTs. An integrated approach was
used to identify and describe key themes. Results: We
conducted 40 interviews between April and September 2022.
Five overarching themes emerged through analysis: (1)
challenges in sharing data collected under a waiver or
alteration of consent; (2) conflicting views regarding PCT
patient-subject preferences for data sharing; (3)
identification of respect-promoting practices beyond
consent; (4) concerns about elevated risks or burdens from
sharing PCT data; and (5) diverse views about the likely
benefits resulting from sharing PCT data. Conclusion: Our
data indicate unresolved tensions in how to fulfill the
expectation to broadly share de-identified, individual-level
data from PCTs, and suggest that those promulgating and
implementing data-sharing policies must be sensitive to
PCT-specific considerations. Future work could inform
efforts to tailor data-sharing policy and practice to
reflect the challenges presented by PCTs, including sharing
experiences from trials that have successfully navigated
these tensions.},
Doi = {10.1002/lrh2.10366},
Key = {fds370913}
}
@article{fds372842,
Author = {Bernstein, SM and Barks, MC and Ubel, PA and Weinfurt, K and Barlet, MH and Farley, S and Jiao, MG and Bansal, S and Fisher, K and Lemmon,
ME},
Title = {Prognostic Discordance Among Parents and Physicians Caring
for Infants with Neurologic Conditions.},
Journal = {J Pediatr},
Volume = {263},
Pages = {113677},
Year = {2023},
Month = {December},
url = {http://dx.doi.org/10.1016/j.jpeds.2023.113677},
Abstract = {OBJECTIVE: To determine the frequency, degree, and nature of
prognostic discordance between parents and physicians caring
for infants with neurologic conditions. STUDY DESIGN: In
this observational cohort study, we enrolled parents and
physicians caring for infants with neurologic conditions in
advance of a family conference. Parent-physician dyads
completed a postconference survey targeting expected
neurologic outcomes across 3 domains (motor, speech, and
cognition) using a 6-point scale. Prognostic discordance was
defined as a difference of ≥2 response options and was
considered moderate (difference of 2-3 response options) or
high (difference of 4-5 response options). Responses were
categorized as differences in belief and/or differences in
understanding using an existing paradigm. RESULTS: Forty
parent-physician dyads of 28 infants completed surveys.
Parent-physician discordance about prognosis occurred in
≥1 domain in the majority of dyads (n = 28/40, 70%).
Discordance was generally moderate in degree (n = 23/28,
82%) and occurred with similar frequency across all domains.
Of parent-physician dyads with discordance, the majority
contained a difference in understanding in at least 1 domain
(n = 25/28, 89%), while a minority contained a difference
of belief (n = 6/28, 21%). When discordance was present,
parents were typically more optimistic in their predictions
compared with physicians (n = 25/28, 89%). CONCLUSIONS:
Differing perceptions about the prognosis of critically ill
infants are common and due to differences in both
understanding and belief. These findings can be used to
develop targeted interventions to improve prognostic
communication.},
Doi = {10.1016/j.jpeds.2023.113677},
Key = {fds372842}
}
@article{fds374241,
Author = {Nash, AL and Bloom, DL and Chapman, BM and Wheeler, SB and McGuire, KP and Lee, CN and Weinfurt, K and Rosenstein, DL and Plichta, JK and Vann,
JCJ and Hwang, ES},
Title = {ASO Visual Abstract: Contralateral Prophylactic Mastectomy
Decision Making-The Partners' Perspective.},
Journal = {Ann Surg Oncol},
Volume = {30},
Number = {13},
Pages = {8481-8482},
Year = {2023},
Month = {December},
url = {http://dx.doi.org/10.1245/s10434-023-14184-x},
Doi = {10.1245/s10434-023-14184-x},
Key = {fds374241}
}
@article{fds372425,
Author = {Nash, AL and Bloom, DL and Chapman, BM and Wheeler, SB and McGuire, KP and Lee, CN and Weinfurt, K and Rosenstein, DL and Plichta, JK and Vann,
JCJ and Hwang, ES},
Title = {Contralateral Prophylactic Mastectomy Decision-Making: The
Partners' Perspective.},
Journal = {Ann Surg Oncol},
Volume = {30},
Number = {10},
Pages = {6268-6274},
Year = {2023},
Month = {October},
url = {http://dx.doi.org/10.1245/s10434-023-14022-0},
Abstract = {BACKGROUND: The rate of contralateral prophylactic
mastectomy (CPM) continues to rise despite no improvement in
survival, an increased risk of surgical complications, and
negative effects on quality of life. This study explored the
experiences of the partners of women who undergo CPM.
METHODS: This study was part of an investigation into the
factors motivating women with early-stage unilateral breast
cancer and low genetic risk to opt for contralateral
prophylactic mastectomy (CPM). Participating women were
asked for permission to invite their partners to take part
in interviews. In-depth interviews with partners were
conducted using a semi-structured topic guide. A thematic
analysis of the data was performed RESULTS: Of 35 partners,
all men, 15 agreed to be interviewed. Most perceived their
role to be strong and logical. Some hoped their wives would
choose a bilateral mastectomy. All felt strongly that the
final decision was up to their partners. The partners often
framed the decision for CPM as one of life or death. Thus,
any aesthetic effects were unimportant by comparison. The
male partners had difficulty grasping the physical and
emotional changes inherent in mastectomy, which made
communicating about sexuality and intimacy very challenging
for the couples. In the early recovery period, some noted
the stress of managing home life. CONCLUSIONS: The
experiences of the male partners provide insight into how
couples navigate complex treatment decision-making, both
together and separately. There may be a benefit to including
partners in pre- and post-surgical counseling to mitigate
miscommunication regarding the expected oncologic and
emotional outcomes related to CPM.},
Doi = {10.1245/s10434-023-14022-0},
Key = {fds372425}
}
@article{fds372841,
Author = {Nayak, A and Alkaitis, MS and Nayak, K and Nikolov, M and Weinfurt, KP and Schulman, K},
Title = {Comparison of History of Present Illness Summaries Generated
by a Chatbot and Senior Internal Medicine
Residents.},
Journal = {JAMA Intern Med},
Volume = {183},
Number = {9},
Pages = {1026-1027},
Year = {2023},
Month = {September},
url = {http://dx.doi.org/10.1001/jamainternmed.2023.2561},
Doi = {10.1001/jamainternmed.2023.2561},
Key = {fds372841}
}
@article{fds370912,
Author = {Weinfurt, KP},
Title = {Developing, Selecting, and Modifying Performance Outcome
Assessments.},
Journal = {Value Health},
Volume = {26},
Number = {7},
Pages = {957-958},
Year = {2023},
Month = {July},
url = {http://dx.doi.org/10.1016/j.jval.2023.04.011},
Doi = {10.1016/j.jval.2023.04.011},
Key = {fds370912}
}
@article{fds371137,
Author = {Oehrlein, EM and US Food and Drug Administration
Interviewees},
Title = {An Interview With the Food and Drug Administration About
Draft Patient-Focused Drug Development Guidance 3:
Selecting, Developing, or Modifying Fit-for-Purpose Clinical
Outcome Assessments.},
Journal = {Value Health},
Volume = {26},
Number = {6},
Pages = {791-795},
Year = {2023},
Month = {June},
url = {http://dx.doi.org/10.1016/j.jval.2023.04.006},
Doi = {10.1016/j.jval.2023.04.006},
Key = {fds371137}
}
@article{fds370390,
Author = {Harper, JD and Desai, AC and Maalouf, NM and Yang, H and Antonelli, JA and Tasian, GE and Lai, HH and Reese, PP and Curatolo, M and Kirkali, Z and Al-Khalidi, HR and Wessells, H and Scales, CD},
Title = {Risk Factors for Increased Stent-associated Symptoms
Following Ureteroscopy for Urinary Stones: Results From
STENTS.},
Journal = {J Urol},
Volume = {209},
Number = {5},
Pages = {971-980},
Year = {2023},
Month = {May},
url = {http://dx.doi.org/10.1097/JU.0000000000003183},
Abstract = {PURPOSE: The STudy to Enhance uNderstanding of
sTent-associated Symptoms sought to identify risk factors
for pain and urinary symptoms, as well as how these symptoms
interfere with daily activities after ureteroscopy for stone
treatment. MATERIALS AND METHODS: This prospective
observational cohort study enrolled patients aged ≥12
years undergoing ureteroscopy with ureteral stent for stone
treatment at 4 clinical centers. Participants reported
symptoms at baseline; on postoperative days 1, 3, 5; at
stent removal; and day 30 post-stent removal. Outcomes of
pain intensity, pain interference, urinary symptoms, and
bother were captured with multiple instruments.
Multivariable analyses using mixed-effects linear regression
models were identified characteristics associated with
increased stent-associated symptoms. RESULTS: A total of 424
participants were enrolled. Mean age was 49 years (SD 17);
47% were female. Participants experienced a marked increase
in stent-associated symptoms on postoperative day 1. While
pain intensity decreased ∼50% from postoperative day 1 to
postoperative day 5, interference due to pain remained
persistently elevated. In multivariable analysis, older age
was associated with lower pain intensity (P = .004). Having
chronic pain conditions (P < .001), prior severe stent pain
(P = .021), and depressive symptoms at baseline (P < .001)
were each associated with higher pain intensity. Neither
sex, stone location, ureteral access sheath use, nor stent
characteristics were drivers of stent-associated symptoms.
CONCLUSIONS: In this multicenter cohort, interference
persisted even as pain intensity decreased. Patient factors
(eg, age, depression) rather than surgical factors were
associated with symptom intensity. These findings provide a
foundation for patient-centered care and highlight potential
targets for efforts to mitigate the burden of
stent-associated symptoms.},
Doi = {10.1097/JU.0000000000003183},
Key = {fds370390}
}
@article{fds367788,
Author = {Coles, TM and Lucas, N and McFatrich, M and Henke, D and Ridgeway, JL and Behnken, EM and Weinfurt, K and Reeve, BB and Corneli, A and Dunlay, SM and Spertus, JA and Lin, L and Piña, IL and Bocell, FD and Tarver, ME and Dohse, H and Saha, A and Caldwell, B},
Title = {Investigating gender-based differential item functioning on
the Kansas City Cardiomyopathy Questionnaire (KCCQ) using
qualitative content analysis.},
Journal = {Qual Life Res},
Volume = {32},
Number = {3},
Pages = {841-852},
Year = {2023},
Month = {March},
url = {http://dx.doi.org/10.1007/s11136-022-03276-y},
Abstract = {PURPOSE: The purpose of this study is to evaluate potential
gender-based differences in interpreting the Kansas City
Cardiomyopathy Questionnaire (KCCQ-23) and to explore if
there are aspects of health-related quality of life (HRQOL)
not captured by the KCCQ-23 that are important to assess in
men and/or women with heart failure (HF). METHODS:
Patients ≥ 22 years of age with clinician-diagnosed
HF and left ventricular ejection fraction ≤ 40% were
recruited from two academic medical centers to participate
in semi-structured concept elicitation and cognitive
debriefing interviews. Enrollment was stratified by
patient-identified gender (half women/half men). All
interviews were conducted over the phone/web and audio
recorded. Interviews were transcribed and descriptive
qualitative content analysis was used to summarize findings
overall and by gender. RESULTS: Twenty-five adults (56%
women) diagnosed with HF participated. The average age was
67 years (range: 25-88). Women attributed a wider variety
of symptoms to HF than men. Some participants had difficulty
differentiating whether their experiences were due to HF,
side effects of their medications, or age. We found very
little evidence that participants interpreted KCCQ-23 items
differently based on gender. CONCLUSIONS: Overall, our
findings indicate that interpretation of the KCCQ-23 items
were similar in men and women. However, some modifications
to items may improve clarity of interpretation for a wide
range of patients.},
Doi = {10.1007/s11136-022-03276-y},
Key = {fds367788}
}
@article{fds369096,
Author = {Marsolo, KA and Weinfurt, KP and Staman, KL and Hammill,
BG},
Title = {Moving From Idealism to Realism With Data
Sharing.},
Journal = {Ann Intern Med},
Volume = {176},
Number = {3},
Pages = {402-403},
Year = {2023},
Month = {March},
url = {http://dx.doi.org/10.7326/M22-2973},
Doi = {10.7326/M22-2973},
Key = {fds369096}
}
@article{fds369236,
Author = {Staman, KL and Check, DK and Zatzick, D and Mor, V and Fritz, JM and Sluka,
K and DeBar, LL and Jarvik, JG and Volandes, A and Coronado, GD and Chambers, DA and Weinfurt, KP and George, SZ},
Title = {Intervention delivery for embedded pragmatic clinical
trials: Development of a tool to measure
complexity.},
Journal = {Contemp Clin Trials},
Volume = {126},
Pages = {107105},
Year = {2023},
Month = {March},
url = {http://dx.doi.org/10.1016/j.cct.2023.107105},
Abstract = {BACKGROUND: Conducting an embedded pragmatic clinical trial
in the workflow of a healthcare system is a complex
endeavor. The complexity of the intervention delivery can
have implications for study planning, ability to maintain
fidelity to the intervention during the trial, and/or
ability to detect meaningful differences in outcomes.
METHODS: We conducted a literature review, developed a tool,
and conducted two rounds of phone calls with NIH Pragmatic
Trials Collaboratory Demonstration Project principal
investigators to develop the Intervention Delivery
Complexity Tool. After refining the tool, we piloted it with
Collaboratory demonstration projects and developed an online
version of the tool using the R Shiny application
(https://duke-som.shinyapps.io/ICT-ePCT/). RESULTS: The
6-item tool consists of internal and external factors.
Internal factors pertain to the intervention itself and
include workflow, training, and the number of intervention
components. External factors are related to intervention
delivery at the system level including differences in
healthcare systems, the dependency on setting for
implementation, and the number of steps between the
intervention and the outcome. CONCLUSION: The Intervention
Delivery Complexity Tool was developed as a standard way to
overcome communication challenges of intervention delivery
within an embedded pragmatic trial. This version of the tool
is most likely to be useful to the trial team and its health
system partners during trial planning and conduct. We expect
further evolution of the tool as more pragmatic trials are
conducted and feedback is received on its performance
outside of the NIH Pragmatic Trials Collaboratory.},
Doi = {10.1016/j.cct.2023.107105},
Key = {fds369236}
}
@article{fds363744,
Author = {Coles, TM and Lin, L and Weinfurt, K and Reeve, BB and Spertus, JA and Mentz, RJ and Piña, IL and Bocell, FD and Tarver, ME and Henke, DM and Saha, A and Caldwell, B and Spring, S},
Title = {Do PRO Measures Function the Same Way for all Individuals
With Heart Failure?},
Journal = {J Card Fail},
Volume = {29},
Number = {2},
Pages = {210-216},
Year = {2023},
Month = {February},
url = {http://dx.doi.org/10.1016/j.cardfail.2022.05.017},
Abstract = {Women diagnosed with heart failure report worse quality of
life than men on patient-reported outcome (PRO) measures. An
inherent assumption of PRO measures in heart failure is that
women and men interpret questions about quality of life the
same way. If this is not the case, the risk then becomes
that the PRO scores cannot be used for valid comparison or
to combine outcomes by subgroups of the population.
Inability to compare subgroups validly is a broad issue and
has implications for clinical trials, and it also has
specific and important implications for identifying and
beginning to address health inequities. We describe this
threat to validity (the psychometric term is differential
item functioning), why it is so important in heart-failure
outcomes, the research that has been conducted thus far in
this area, the gaps that remain, and what we can do to avoid
this threat to validity. PROs bring unique information to
clinical decision making, and the validity of PRO measures
is key to interpreting differences in heart failure
outcomes.},
Doi = {10.1016/j.cardfail.2022.05.017},
Key = {fds363744}
}
@article{fds370546,
Author = {Hovén, E and Flynn, KE and Weinfurt, KP and Eriksson, LE and Wettergren, L},
Title = {Psychometric evaluation of the Swedish version of the PROMIS
Sexual Function and Satisfaction Measures in clinical and
nonclinical young adult populations.},
Journal = {Sexual medicine},
Volume = {11},
Number = {1},
Pages = {qfac006},
Year = {2023},
Month = {February},
url = {http://dx.doi.org/10.1093/sexmed/qfac006},
Abstract = {<h4>Background</h4>The Patient-Reported Outcomes Measurement
Information System (PROMIS®) Sexual Function and
Satisfaction (SexFS) version 2.0 measurement tool was
developed to assess sexual functioning and satisfaction in
the general population regardless of health condition and
sexual orientation.<h4>Aim</h4>The study aimed to evaluate
the psychometric properties of the Swedish version of the
PROMIS SexFS measure in clinical and nonclinical populations
of young adults (aged <40 years).<h4>Methods</h4>The SexFS
was answered by a clinical population of young adult women
(<i>n</i> = 180) and men (<i>n</i> = 110) with
breast cancer and testicular cancer, respectively, and a
nonclinical population of young adult women
(<i>n</i> = 511) and men (<i>n</i> = 324) from the
general population. Psychometric properties were evaluated
by examining data quality (score distribution, floor and
ceiling effects, proportion of missing data), construct
validity (corrected item, total correlation, scaling
success), and reliability (Cronbach α).<h4>Outcomes</h4>The
following domains of the SexFS 2.0 were investigated:
Vaginal Lubrication, Vaginal Discomfort, Vulvar Discomfort-
Clitoral, Vulvar Discomfort- Labial, Erectile Function,
Interest in Sexual Activity, Satisfaction With Sex Life,
Orgasm- Ability, and Orgasm- Pleasure.<h4>Results</h4>The
Swedish version of the SexFS 2.0 generated data of
acceptable quality. Some noteworthy floor or ceiling effects
were identified across domains and respondent groups.
Corrected item totals were used to express the coherence
between an item and the other items in the domain. The
correlation coefficients were above 0.40 for all items,
except for 1 of the items within the Vaginal Discomfort
domain and for the items in the Erectile Function domain in
the nonclinical group of men. High proportions of scaling
success were noted across domains (96%-100%). Reliability
was satisfactory (α = 0.74-0.92) for all domains, expect
for Erectile Function of the nonclinical group (α = 0.53),
due to low variability in item responses, which was improved
somewhat (α = 0.65) when combined with the clinical
group.<h4>Clinical implications</h4>A flexible tool to
measure self-reported sexual function and satisfaction in
young men and women is available for researchers and
clinicians in Sweden.<h4>Strengths and limitations</h4>The
nationwide population-based sample of patients with cancer,
identified from national quality registers, minimized
selection bias. However, men in the general population had a
lower response rate (34%) compared to the other groups,
which introduced a risk of bias in estimates. The
psychometric evaluation was limited to young adults (aged
19-40 years).<h4>Conclusion</h4>The results provide
evidence for the validity and reliability of the Swedish
version of the SexFS measure for the assessment of sexual
functioning and satisfaction in young adults from both
clinical and nonclinical populations.},
Doi = {10.1093/sexmed/qfac006},
Key = {fds370546}
}
@article{fds367787,
Author = {Locklear, T and Lewis, R and Calhoun, F and Li, A and Dickerson, KC and McMillan, A and Davis, L and Dzirasa, K and Weinfurt, KP and Grambow,
SC},
Title = {Advancing workforce diversity by leveraging the Clinical and
Translational Science Awards (CTSA) program.},
Journal = {J Clin Transl Sci},
Volume = {7},
Number = {1},
Pages = {e30},
Publisher = {Cambridge University Press (CUP)},
Year = {2023},
url = {http://dx.doi.org/10.1017/cts.2022.489},
Abstract = {Clinical trials continue to disproportionately
underrepresent people of color. Increasing representation of
diverse backgrounds among clinical research personnel has
the potential to yield greater representation in clinical
trials and more efficacious medical interventions by
addressing medical mistrust. In 2019, North Carolina Central
University (NCCU), a Historically Black College and
University with a more than 80% underrepresented student
population, established the Clinical Research Sciences
Program with support from the Clinical and Translational
Science Awards (CTSA) program at neighboring Duke
University. This program was designed to increase exposure
of students from diverse educational, racial, and ethnic
backgrounds to the field of clinical research, with a
special focus on health equity education. In the first year,
the program graduated 11 students from the two-semester
certificate program, eight of whom now hold positions as
clinical research professionals. This article describes how
leveraging the CTSA program helped NCCU build a framework
for producing a highly trained, competent, and diverse
workforce in clinical research responsive to the call for
increased diversity in clinical trial participation.},
Doi = {10.1017/cts.2022.489},
Key = {fds367787}
}
@article{fds365923,
Author = {Morain, SR and Bollinger, J and Weinfurt, K and Sugarman,
J},
Title = {Ethics challenges in sharing data from pragmatic clinical
trials.},
Journal = {Clin Trials},
Volume = {19},
Number = {6},
Pages = {681-689},
Year = {2022},
Month = {December},
url = {http://dx.doi.org/10.1177/17407745221110881},
Abstract = {Numerous arguments have been advanced for broadly sharing
de-identified, participant-level clinical trials data, and
trial sponsors and journals are increasingly requiring it.
However, data sharing in pragmatic clinical trials presents
ethical challenges related to the use of waivers or
alterations of informed consent for some pragmatic clinical
trials and corresponding limitations of informed consent to
guide sharing decisions; the potential for data sharing in
pragmatic clinical trials to present risks not only for
individual patient-subjects, but also for health systems and
the clinicians within them; sharing of data from electronic
health records instead of data newly collected for research
purposes; and researchers' limited capacity to control
sensitive data within an electronic health record and
potential implications of such limits for meeting
obligations inherent to Certificates of Confidentiality.
These challenges raise questions about the extent to which
traditional research ethics governance structures are
capable of guiding decisions about pragmatic clinical trial
data sharing. This article identifies and examines these
ethical challenges for pragmatic clinical trial data
sharing. We suggest several areas for future empirical
scholarship, including the need to identify patient and
public attitudes regarding pragmatic clinical trial data
sharing as well as to assess the demand for pragmatic
clinical trial data and the correspondingly likely benefit
of such sharing. Further conceptual work is also needed to
explore how requirements to respect patient-subjects about
whom data are shared in the context of pragmatic clinical
trials should be understood, particularly in the absence of
informed consent for initial research activities, and the
appropriate balance between promoting the generation of
socially valuable knowledge and respecting
autonomy.},
Doi = {10.1177/17407745221110881},
Key = {fds365923}
}
@article{fds367239,
Author = {Flynn, KE and Wiseman, JB and Helmuth, ME and Smith, AR and Bradley, CS and Cameron, AP and Henry Lai and H and Kirkali, Z and Kreder, KJ and Geynisman-Tan, J and Merion, RM and Weinfurt, KP and LURN Study
Group},
Title = {Comparing clinical bladder diaries and recalled patient
reports for measuring lower urinary tract symptoms in the
symptoms of Lower Urinary Tract Dysfunction Research Network
(LURN).},
Journal = {Neurourol Urodyn},
Volume = {41},
Number = {8},
Pages = {1711-1721},
Year = {2022},
Month = {November},
url = {http://dx.doi.org/10.1002/nau.25030},
Abstract = {PURPOSE: Bladder diaries are a key source of information
about lower urinary tract symptoms (LUTS); however, many
patients do not complete them as instructed.
Questionnaire-based patient-reported outcome measures
(PROMs) are another option for reporting LUTS but may have
recall bias. We assessed the strength of the associations
between PROMs and a 3-day bladder diary. MATERIALS AND
METHODS: Symptomatic adults from 6 tertiary care sites
completed a 3-day paper bladder diary and 3-, 7-, and 30-day
electronic PROMs. We assessed the linear associations
between mapped pairs of diary variables and responses to
PROM items using biserial and polyserial correlation
coefficients with 95% confidence intervals. RESULTS: Of 290
enrolled participants, 175 (60%) completed the bladder diary
as instructed and at least one corresponding PROM. Linear
associations were strongest between the diary and 3-day
recall of daytime frequency (r = 0.75) and nighttime
frequency (r = 0.69), followed by voids with urgency
sensations (r = 0.62), and an item reporting any
incontinence (r = 0.56). Linear associations between
bladder diary and specific incontinence variables (e.g.,
stress, urgency) were low to negligible (ranging from
r = 0.16-0.39). Linear associations were consistent
across the 3-, 7-, and 30-day recall periods. CONCLUSIONS:
Missing and unusable bladder diary data were common,
highlighting the patient burden associated with this method
of data collection. A questionnaire-based PROM is a
reasonable alternative to a diary for reporting voiding
frequency and may offer an easier option for reporting some
symptoms.},
Doi = {10.1002/nau.25030},
Key = {fds367239}
}
@article{fds367789,
Author = {Flynn, KE and Atallah, E and Lin, L and Shah, NP and Silver, RT and Larson,
RA and Panilla-Ibarz, J and Thompson, JE and Oehler, VG and Radich, JP and Kota, V and Mauro, MJ and Schiffer, CA and Cortes, J and Weinfurt,
KP},
Title = {Patient- and physician-reported pain after tyrosine kinase
inhibitor discontinuation among patients with chronic
myeloid leukemia.},
Journal = {Haematologica},
Volume = {107},
Number = {11},
Pages = {2641-2649},
Year = {2022},
Month = {November},
url = {http://dx.doi.org/10.3324/haematol.2021.280377},
Abstract = {For patients with optimally treated chronic myeloid leukemia
(CML), discontinuation of tyrosine kinase inhibitor (TKI)
therapy can lead to treatment-free remission. In previous
trials, TKI discontinuation has been associated with
increased musculoskeletal pain in some patients ("withdrawal
syndrome"), based on physician-reported adverse events (AE).
Patient-reported pain has not been described. The Life After
Stopping TKI study was a 14-site prospective, non-randomized
clinical trial of TKI discontinuation. We defined increased
pain after discontinuation as: (i) a physician-reported pain
AE, (ii) a 2-level increase in self-reported musculoskeletal
pain (4-level single item), or (iii) initiation of a
medication for pain. We plotted the trajectory of
patient-reported pain over time using a piecewise
mixed-effects ordinal logistic model. Within 3 months of
discontinuation, 35 of 172 patients (20.3%) had a
physician-reported pain AE, 22 of 172 (12.8%) had an
increase in self-reported pain, and 18 of 154 (11.7%)
initiated a pain medication. Agreement among these measures
was limited; overall, 60 of 172 patients (34.9%) had
increased pain. Three patients (1.7%) restarted a TKI
because of pain. The modelpredicted trajectory showed an
increase in pain in the first 3 months followed by a
decrease, returning to baseline levels by 6 months and
further decreasing after that. This trajectory was similar
among patients who did and did not restart TKI, suggesting
that resuming a TKI for withdrawal syndrome may be necessary
for some, but other approaches to manage pain should be
tried so that patients can remain in treatment-free
remission when possible.},
Doi = {10.3324/haematol.2021.280377},
Key = {fds367789}
}
@article{fds367445,
Author = {Barlet, MH and Barks, MC and Ubel, PA and Davis, JK and Pollak, KI and Kaye, EC and Weinfurt, KP and Lemmon, ME},
Title = {Characterizing the Language Used to Discuss Death in Family
Meetings for Critically Ill Infants.},
Journal = {JAMA Netw Open},
Volume = {5},
Number = {10},
Pages = {e2233722},
Year = {2022},
Month = {October},
url = {http://dx.doi.org/10.1001/jamanetworkopen.2022.33722},
Abstract = {IMPORTANCE: Communication during conversations about death
is critical; however, little is known about the language
clinicians and families use to discuss death. OBJECTIVE: To
characterize (1) the way death is discussed in family
meetings between parents of critically ill infants and the
clinical team and (2) how discussion of death differs
between clinicians and family members. DESIGN, SETTING, AND
PARTICIPANTS: This longitudinal qualitative study took place
at a single academic hospital in the southeast US. Patients
were enrolled from September 2018 to September 2020, and
infants were followed up longitudinally throughout their
hospitalization. Participants included families of infants
with neurologic conditions who were hospitalized in the
intensive care unit and had a planned family meeting to
discuss neurologic prognosis or starting, not starting, or
discontinuing life-sustaining treatment. Family meetings
were recorded, transcribed, and deidentified before being
screened for discussion of death. MAIN OUTCOMES AND
MEASURES: The main outcome was the language used to
reference death during family meetings between parents and
clinicians. Conventional content analysis was used to
analyze data. RESULTS: A total of 68 family meetings
involving 36 parents of 24 infants were screened; 33 family
meetings (49%) involving 20 parents (56%) and 13 infants
(54%) included discussion of death. Most parents involved in
discussion of death identified as the infant's mother (13
[65%]) and as Black (12 [60%]). Death was referenced 406
times throughout the family meetings (275 times by
clinicians and 131 times by family members); the words die,
death, dying, or stillborn were used 5% of the time by
clinicians (13 of 275 references) and 15% of the time by
family members (19 of 131 references). Four types of
euphemisms used in place of die, death, dying, or stillborn
were identified: (1) survival framing (eg, not live), (2)
colloquialisms (eg, pass away), (3) medical jargon,
including obscure technical terms (eg, code event) or
talking around death with physiologic terms (eg,
irrecoverable heart rate drop), and (4) pronouns without an
antecedent (eg, it). The most common type of euphemism used
by clinicians was medical jargon (118 of 275 references
[43%]). The most common type of euphemism used by family
members was colloquialism (44 of 131 references [34%]).
CONCLUSIONS AND RELEVANCE: In this qualitative study, the
words die, death, dying, or stillborn were rarely used to
refer to death in family meetings with clinicians. Families
most often used colloquialisms to reference death, and
clinicians most often used medical jargon. Future work
should evaluate the effects of euphemisms on mutual
understanding, shared decision-making, and clinician-family
relationships.},
Doi = {10.1001/jamanetworkopen.2022.33722},
Key = {fds367445}
}
@article{fds364316,
Author = {Weinfurt, KP and Reeve, BB},
Title = {Patient-Reported Outcome Measures in Clinical
Research.},
Journal = {JAMA},
Volume = {328},
Number = {5},
Pages = {472-473},
Year = {2022},
Month = {August},
url = {http://dx.doi.org/10.1001/jama.2022.11238},
Doi = {10.1001/jama.2022.11238},
Key = {fds364316}
}
@article{fds365924,
Author = {O'Shea, M and Boyles, S and Bradley, CS and Jacobs, K and McFatrich, M and Sung, V and Weinfurt, K and Siddiqui, NY},
Title = {AUGS-PERFORM: A New Patient-Reported Outcome Measure to
Assess Quality of Prolapse Care.},
Journal = {Female Pelvic Med Reconstr Surg},
Volume = {28},
Number = {8},
Pages = {468-478},
Year = {2022},
Month = {August},
url = {http://dx.doi.org/10.1097/SPV.0000000000001225},
Abstract = {UNLABELLED: Patient-reported outcomes (PRO) are important
for measuring quality of care, particularly for
interventions aimed at improving symptom bother such as
procedures for pelvic organ prolapse. We aimed to create a
concise yet comprehensive PRO measurement tool to assess
pelvic organ prolapse care in high-volume clinical
environments. METHODS: The relevant concepts to measure
prolapse treatment quality were first established through
literature review, qualitative interviews, and a patient and
provider-driven consensus-building process. Extant items
mapping to these concepts, or domains, were identified from
an existing pool of patient-reported symptoms and
condition-specific and generic health-related quality of
life measures. Item classification was performed to group
items assessing similar concepts while eliminating items
that were redundant, inconsistent with domains, or overly
complex. A consensus meeting was held in March 2020 where
patient and provider working groups ranked the remaining
candidate items in order of relevance to measure prolapse
treatment quality. After subsequent expert review, the
revised candidate items underwent cognitive interview
testing and were further refined. RESULTS: Fifteen relevant
PRO instruments were initially identified, and 358 items
were considered for inclusion. After 2 iterative consensus
reviews and 4 rounds of cognitive interviewing with 19
patients, 11 final candidate items were identified. These
items map 5 consensus-based domains that include awareness
and bother from prolapse, physical function, physical
discomfort during sexual activity, pain, and
urinary/defecatory symptoms. CONCLUSIONS: We present a
concise set of candidate items that were developed using
rigorous patient-centered methodology and a national
consensus process, including urogynecologic patients and
providers.},
Doi = {10.1097/SPV.0000000000001225},
Key = {fds365924}
}
@article{fds363396,
Author = {Kamat, S and Yaworsky, A and Guillemin, I and Krohe, M and Litcher-Kelly, L and McLafferty, M and Lamoureux, RE and Lowe, C and Chehade, M and Spergel, JM and Weinfurt, K and Turner-Bowker,
DM},
Title = {Novel Questionnaires for Assessing Signs and Symptoms of
Eosinophilic Esophagitis in Children.},
Journal = {J Allergy Clin Immunol Pract},
Volume = {10},
Number = {7},
Pages = {1856-1863.e3},
Year = {2022},
Month = {July},
url = {http://dx.doi.org/10.1016/j.jaip.2022.02.049},
Abstract = {BACKGROUND: Pediatric patients with eosinophilic esophagitis
(EoE) experience heterogeneous symptoms and the patient's
age may preclude reliable self-report of symptoms.
OBJECTIVE: The goal of this study was to develop a
patient-reported outcome and an observer-reported outcome
questionnaire to evaluate the signs and symptoms of EoE in
pediatric patients (≥1 to <12 y of age) in a clinical
trial setting. METHODS: A concept-focused literature review,
expert advice meetings, and concept elicitation interviews
with pediatric EoE patients and their caregivers were
conducted to identify disease-related signs and symptoms.
Instructions, items, and response options were drafted.
Cognitive debriefing interviews were conducted to evaluate
children's and caregivers' ability to understand and respond
to the questionnaires and to evaluate the comprehensiveness
of the concepts measured. RESULTS: Results from the
literature review, expert advice meetings (n = 6), and
concept elicitation interviews (n = 24) informed the
development of the Pediatric Eosinophilic Esophagitis
Sign/Symptom Questionnaire intended for use by patients
(PESQ-P) with EoE 8 years or older to younger than 12 years
and an observer-reported outcome questionnaire planned for
use by caregivers of patients (PESQ-C) 1 year old or older
to younger than 12 years. Both questionnaires measure the
same concepts; the PESQ-P assesses the frequency, duration,
and/or severity of symptoms and the PESQ-C assesses the
presence/absence of the signs/symptoms. The cognitive
debriefing interviews (n = 17) demonstrated that
participants were able to comprehend and complete the
questionnaires as intended. CONCLUSIONS: This study provides
evidence of the content validity of 2 novel questionnaires,
PESQ-P and PESQ-C, designed to evaluate the symptom
experience of pediatric EoE patients in a clinical trial
setting.},
Doi = {10.1016/j.jaip.2022.02.049},
Key = {fds363396}
}
@article{fds362715,
Author = {Barlet, MH and Ubel, PA and Weinfurt, KP and Glass, HC and Pollak, KI and Brandon, DH and Lemmon, ME},
Title = {Decisional Satisfaction, Regret, and Conflict Among Parents
of Infants with Neurologic Conditions.},
Journal = {J Pediatr},
Volume = {245},
Pages = {81-88.e3},
Year = {2022},
Month = {June},
url = {http://dx.doi.org/10.1016/j.jpeds.2022.02.043},
Abstract = {OBJECTIVE: To characterize decisional satisfaction, regret,
and conflict among parents of critically ill infants with
neurologic conditions. STUDY DESIGN: In this prospective
cohort study, we enrolled parents of infants with neurologic
conditions in the intensive care unit (ICU). Hospital
discharge surveys included the validated Family Satisfaction
with the ICU (FS-ICU) decision making subscale, Decision
Regret Scale (DRS), and Decisional Conflict Scale (DCS). We
defined high satisfaction with decision making as an FS-ICU
score ≥75, high decisional regret/conflict as DRS/DCS
score >25, and within-couple disagreement as a difference of
at least 25 points between scores. RESULTS: We enrolled 61
parents of 40 infants (n = 40 mothers, n = 21 fathers);
35 mothers and 15 fathers completed surveys. Most mothers
reported high satisfaction with decision making (27 of 35;
77%) and low decision regret (28 of 35; 80%); 40% (14 of 35)
reported high decisional conflict. Mothers and fathers
reported higher decisional conflict in the domains of
uncertainty and values clarity compared with the domain of
effective decision making (Bonferroni-corrected P < .05).
There were no differences in decision outcomes between
paired mothers and fathers; however, within any given
couple, there were numerous instances of disagreement (7 of
15 for decision regret and 5 of 15 for decisional conflict).
CONCLUSIONS: Many parents experience decisional conflict
even if they ultimately have high satisfaction and low
regret, underscoring the need for decision aids targeting
uncertainty and values clarity. Couples frequently
experience different levels of decisional regret and
conflict.},
Doi = {10.1016/j.jpeds.2022.02.043},
Key = {fds362715}
}
@article{fds364014,
Author = {O'Brien, EC and Sugarman, J and Weinfurt, KP and Larson, EB and Heagerty, PJ and Hernandez, AF and Curtis, LH},
Title = {The impact of COVID-19 on pragmatic clinical trials: lessons
learned from the NIH Health Care Systems Research
Collaboratory.},
Journal = {Trials},
Volume = {23},
Number = {1},
Pages = {424},
Year = {2022},
Month = {May},
url = {http://dx.doi.org/10.1186/s13063-022-06385-8},
Abstract = {BACKGROUND: The COVID-19 pandemic has considerably disrupted
nearly all aspects of daily life, including healthcare
delivery and clinical research. Because pragmatic clinical
trials are often embedded within healthcare delivery
systems, they may be at high risk of disruption due to the
dual impacts on the conduct of both care and research.
METHODS: We collected qualitative data using multiple
methods to characterize the impact of COVID-19 on the
research activities of 14 active pragmatic clinical trials
in the National Institutes of Health (NIH) Health Care
Systems Research Collaboratory. A COVID-19 impact
questionnaire was administered electronically to principal
investigators in June 2020. Text responses were analyzed
thematically, and qualitative summaries were subsequently
reviewed by five independent reviewers, who made iterative
revisions. Additional COVID-19-related impacts were
identified during virtual meetings with trial teams during
April-July 2020 and combined with questionnaire responses
for analysis. RESULTS: Impacts of the pandemic were broadly
classified into two main types: healthcare operations and
social distancing. In some instances, trial delays created
statistical challenges, particularly with trials using
stepped-wedge designs, and necessitated changing data
collection strategies or modifying interventions. The
majority of projects used existing stakeholder-driven
approaches to adapt interventions. Several benefits of these
adaptions were identified, including expanded outreach
capabilities and ability to study virtual intervention
delivery. All trial teams were able to adapt to
pandemic-related modifications. CONCLUSION: In a group of 14
ongoing pragmatic clinical trials, there was significant
impact of COVID-19 on trial activities. Engaging appropriate
stakeholders was critical to designing and implementing
trial modifications and making continued safe progress
toward meeting research objectives.},
Doi = {10.1186/s13063-022-06385-8},
Key = {fds364014}
}
@article{fds358787,
Author = {Weinfurt, KP and Bollinger, JM and May, E and Geller, G and Mathews,
DJH and Morain, SR and Schmid, L and Bloom, DL and Sugarman,
J},
Title = {Patients' Reactions to Letters Communicating Collateral
Findings of Pragmatic Clinical Trials: a National Web-Based
Survey.},
Journal = {J Gen Intern Med},
Volume = {37},
Number = {7},
Pages = {1658-1664},
Year = {2022},
Month = {May},
url = {http://dx.doi.org/10.1007/s11606-021-07087-8},
Abstract = {BACKGROUND: Collateral findings in pragmatic clinical trials
are findings that may have implications for patients' health
but were not generated to address a trial's primary research
questions. It is uncertain how best to communicate these
collateral findings to patients. OBJECTIVES: To determine
how reactions to a letter communicating collateral findings
relate to who signed the letter, the type of finding, or
whether the letter specified that the finding arose from a
pragmatic clinical trial. RESEARCH DESIGN: Web-based survey
experiment using a between-subjects design in which
respondents were randomly assigned within education strata
to view and respond to 1 of 16 hypothetical scenarios.
SUBJECTS: Adults recruited from an online panel constructed
from a probability sample of US-based postal addresses.
MEASURES: The primary outcomes were the action the
respondent would take next (i.e., contact a doctor
immediately or something else) and the respondent's
emotional reactions (i.e., all positive, all negative,
mixed, or none). RESULTS: A total of 4080 respondents had
analyzable data. Although some effects were statistically
significant (P < .05), none exceeded a prespecified
threshold for policy relevance (15 or more percentage
points). Ratings of letter clarity and level of
understanding were lower for letters that included a
description of the clinical trial. CONCLUSIONS: Signatory
and level of detail about collateral findings did not
substantially affect people's intentions to take the
recommended action of contacting their doctor. Deciding
whether to include a description of the pragmatic clinical
trial requires a trade-off between transparency and more
difficulty understanding the contents of the
letter.},
Doi = {10.1007/s11606-021-07087-8},
Key = {fds358787}
}
@article{fds362848,
Author = {Amtmann, D and Bamer, AM and Salem, R and McMullen, K and Beier, M and Flynn, KE and Foley, FW and Weinfurt, KP and Wilkie, D and Alschuler,
KN},
Title = {Extension and Evaluation of the PROMIS Sexual Function and
Satisfaction Measures for Use in Adults Living With Multiple
Sclerosis.},
Journal = {J Sex Med},
Volume = {19},
Number = {5},
Pages = {719-728},
Year = {2022},
Month = {May},
url = {http://dx.doi.org/10.1016/j.jsxm.2022.01.523},
Abstract = {BACKGROUND: Sexual dysfunction is a common symptom of
multiple sclerosis (MS). Clinically meaningful and
psychometrically sound measures of sexual function validated
in people with MS are necessary to identify people with MS
who experience problems with sexual function. AIM: To
evaluate the Patient-Reported Outcomes Measurement
Information System (PROMIS) Sexual Function and Satisfaction
(SexFS) v2.0 measure in people with MS and to extend the
PROMIS SexFS Brief and Full Profiles to include additional
aspects of sexual function relevant to people living with
MS. METHODS: A convenience sample of MS clinicians and
sexually active individuals with MS ranked relevance of 26
items that listed specific factors that interfere with
sexual function. Rankings were used to select items to
include in the modified SexFS for Multiple Sclerosis
(SexFS-MS) profiles. Sex-FS Brief and Full profiles along
with the top 22 ranked interfering factor items underwent
cognitive interviews (CI) to assess whether the items were
understandable and meaningful. OUTCOMES: The SexFS as
originally published functioned well in people with MS after
minor modifications. RESULTS: Twelve MS clinicians and 26
people with MS ranked items. The 10 highest ranked questions
about factors that interfere with sexual function most
relevant to people with MS were added to the SexFS-MS Brief
profiles and 18 to the Full profiles. Ten men and 12 women
with MS participated in CIs and found most items to be clear
and meaningful. However, important changes were made to the
profile instructions, some response sets, and to some items
to improve clarity and function. New items to assess
numbness and reasons why sexually active people choose at
times not to engage in sexual activity were added. CLINICAL
IMPLICATIONS: Brief and Full profiles are freely available
and are recommended for research and clinical practice that
include people with MS. STRENGTHS & LIMITATIONS: This study
is the first to provide validity evidence for the PROMIS
SexFS in people living with MS. Though the PROMIS SexFS was
tested in people who identify as lesbian, gay, or bisexual,
only individuals who identified as heterosexual participated
in this study. Results may not represent views of people
with MS who identify as other sexual orientations who may
have different concerns and priorities related to sexual
function. CONCLUSION: This study extended the PROMIS SexFS
Brief and Full profiles to create the SexFS-MS by adding
items that measure most relevant issues related to sexual
function in individuals living with MS. Amtmann D, Bamer AM,
Salem R, et al. Extension and Evaluation of the PROMIS
Sexual Function and Satisfaction Measures for Use in Adults
Living With Multiple Sclerosis. J Sex Med
2022;19:719-728.},
Doi = {10.1016/j.jsxm.2022.01.523},
Key = {fds362848}
}
@article{fds371308,
Author = {Amtmann, D and Bamer, AM and Salem, R and McMullen, K and Beier, M and Flynn, KE and Foley, FW and Weinfurt, KP and Wilkie, D and Alschuler,
KN},
Title = {Extension and Evaluation of the PROMIS Sexual Function and
Satisfaction Measures for Use in Adults Living with Multiple
Sclerosis.},
Journal = {J Sex Med},
Volume = {19},
Number = {5},
Pages = {719-728},
Year = {2022},
Month = {May},
url = {http://dx.doi.org/10.1016/j.jsxm.2022.01.523},
Abstract = {BACKGROUND: Sexual dysfunction is a common symptom of
multiple sclerosis (MS). Clinically meaningful and
psychometrically sound measures of sexual function validated
in people with MS are necessary to identify people with MS
who experience problems with sexual function. AIM: To
evaluate the Patient-Reported Outcomes Measurement
Information System (PROMIS) Sexual Function and Satisfaction
(SexFS) v2.0 measure in people with MS and to extend the
PROMIS SexFS Brief and Full Profiles to include additional
aspects of sexual function relevant to people living with
MS. METHODS: A convenience sample of MS clinicians and
sexually active individuals with MS ranked relevance of 26
items that listed specific factors that interfere with
sexual function. Rankings were used to select items to
include in the modified SexFS for Multiple Sclerosis
(SexFS-MS) profiles. Sex-FS Brief and Full profiles along
with the top 22 ranked interfering factor items underwent
cognitive interviews (CI) to assess whether the items were
understandable and meaningful. OUTCOMES: The SexFS as
originally published functioned well in people with MS after
minor modifications. RESULTS: Twelve MS clinicians and 26
people with MS ranked items. The 10 highest ranked questions
about factors that interfere with sexual function most
relevant to people with MS were added to the SexFS-MS Brief
profiles and 18 to the Full profiles. Ten men and 12 women
with MS participated in CIs and found most items to be clear
and meaningful. However, important changes were made to the
profile instructions, some response sets, and to some items
to improve clarity and function. New items to assess
numbness and reasons why sexually active people choose at
times not to engage in sexual activity were added. CLINICAL
IMPLICATIONS: Brief and Full profiles are freely available
and are recommended for research and clinical practice that
include people with MS. STRENGTHS & LIMITATIONS: This study
is the first to provide validity evidence for the PROMIS
SexFS in people living with MS. Though the PROMIS SexFS was
tested in people who identify as lesbian, gay, or bisexual,
only individuals who identified as heterosexual participated
in this study. Results may not represent views of people
with MS who identify as other sexual orientations who may
have different concerns and priorities related to sexual
function. CONCLUSION: This study extended the PROMIS SexFS
Brief and Full profiles to create the SexFS-MS by adding
items that measure most relevant issues related to sexual
function in individuals living with MS.},
Doi = {10.1016/j.jsxm.2022.01.523},
Key = {fds371308}
}
@article{fds362407,
Author = {Federico, CA and Heagerty, PJ and Lantos, J and O'Rourke, P and Rahimzadeh, V and Sugarman, J and Weinfurt, K and Wendler, D and Wilfond, BS and Magnus, D},
Title = {Ethical and epistemic issues in the design and conduct of
pragmatic stepped-wedge cluster randomized clinical
trials.},
Journal = {Contemp Clin Trials},
Volume = {115},
Pages = {106703},
Year = {2022},
Month = {April},
url = {http://dx.doi.org/10.1016/j.cct.2022.106703},
Abstract = {Stepped-wedge cluster randomized trial (SW-CRT) designs are
increasingly employed in pragmatic research; they differ
from traditional parallel cluster randomized trials in which
an intervention is delivered to a subset of clusters, but
not to all. In a SW-CRT, all clusters receive the
intervention under investigation by the end of the study.
This approach is thought to avoid ethical concerns about the
denial of a desired intervention to participants in control
groups. Such concerns have been cited in the literature as a
primary motivation for choosing SW-CRT design, however
SW-CRTs raise additional ethical concerns related to the
delayed implementation of an intervention and consent. Yet,
PCT investigators may choose SW-CRT designs simply because
they are concerned that other study designs are infeasible.
In this paper, we examine justifications for the use of
SW-CRT study design, over other designs, by drawing on the
experience of the National Institutes of Health's Health
Care Systems Research Collaboratory (NIH Collaboratory) with
five pragmatic SW-CRTs. We found that decisions to use
SW-CRT design were justified by practical and epistemic
reasons rather than ethical ones. These include concerns
about feasibility, the heterogeneity of cluster
characteristics, and the desire for simultaneous clinical
evaluation and implementation. In this paper we compare the
potential benefits of SW-CRTs against the ethical and
epistemic challenges brought forth by the design and suggest
that the choice of SW-CRT design must balance epistemic,
feasibility and ethical justifications. Moreover, given
their complexity, such studies need rigorous and informed
ethical oversight.},
Doi = {10.1016/j.cct.2022.106703},
Key = {fds362407}
}
@article{fds362214,
Author = {Weinfurt, KP},
Title = {Constructing and evaluating a validity argument for a
performance outcome measure for clinical trials: An example
using the Multi-luminance Mobility Test.},
Journal = {Clin Trials},
Volume = {19},
Number = {2},
Pages = {184-193},
Year = {2022},
Month = {April},
url = {http://dx.doi.org/10.1177/17407745211073609},
Abstract = {BACKGROUND: Clinical trials that evaluate new medical
products often use clinical outcome assessments to measure
how patients feel or function. Determining the evidentiary
support needed for clinical outcome assessments is
challenging but necessary to ensure scores from a clinical
outcome assessment reflect the relevant aspects of patients'
health. Modern validity theory-from educational and
psychological testing-addresses the challenge by requiring
that investigators state key assumptions underlying the
proposed use of a clinical outcome assessment and collect
evidence for or against those assumptions. METHODS: This
article describes the argument-based approach to validity
using an example of a performance outcome measure-the
Multi-luminance Mobility Test-designed to assess patients
with inherited retinal dystrophy that causes progressive
loss of night vision. For the proposed interpretation and
use of a performance outcome measure to be reasonable,
several key assumptions need to be plausible. I describe the
assumptions along with examples of supporting evidence from
the published literature to evaluate each assumption within
the rationale. RESULTS: This article provides an example of
a validity rationale to evaluate a clinical outcome
assessment using the Multi-luminance Mobility Test as an
example. CONCLUSION: The demonstration illustrates the use
of the argument-based approach to validity evaluation and
the challenges in supporting parts of a validity rationale
for clinical outcome assessments that measure how patients
feel and function in a more indirect way. By making clinical
outcome assessment validation practices consistent with
modern validity theory, investigators, sponsors, and
regulators should be able to communicate more clearly and
direct resources more efficiently to support the creation of
patient-centered endpoints in clinical trials.},
Doi = {10.1177/17407745211073609},
Key = {fds362214}
}
@article{fds361833,
Author = {Ali, J and Morain, SR and O'Rourke, PP and Wilfond, B and O'Brien, EC and Zigler, CK and Staman, KL and Weinfurt, KP and Sugarman,
J},
Title = {Responding to signals of mental and behavioral health risk
in pragmatic clinical trials: Ethical obligations in a
healthcare ecosystem.},
Journal = {Contemp Clin Trials},
Volume = {113},
Pages = {106651},
Year = {2022},
Month = {February},
url = {http://dx.doi.org/10.1016/j.cct.2021.106651},
Abstract = {BACKGROUND: Ethical responsibilities for monitoring and
responding to signals of behavioral and mental health risk
(such as suicidal ideation, opioid use disorder, or
depression) in general clinical research have been
described; however, pragmatic clinical trials (PCTs) raise
new contextual challenges. METHODS: We use our experience
with the PRISM (Pragmatic and Implementation Studies for the
Management of Pain to Reduce Opioid Prescribing) program,
which is a component of the Helping End Addiction Long-Term
(HEAL) Initiative, to provide examples of research studying
nonpharmacologic interventions for pain that collect
sensitive data. Members of the PRISM Ethics and Regulatory
Core and Patient-Centered Outcome Core Working Group
discussed and refined considerations and recommendations.
RESULTS: PCT researchers can help identify the extent of
their ethical obligations to monitor and respond to signals
of potential behavioral and mental health risks by
understanding and aligning stakeholder expectations;
considering characteristics of the trial and study
population; defining triggers, thresholds, and
responsibilities for action; identifying appropriate
response mechanisms and capabilities; integrating responses
with health systems; and addressing privacy. Based on such
an assessment, researchers should proactively identify if,
when, and how a response will be triggered. Doing so
necessitates that stakeholders understand their roles in
managing such risks. Finally, consent forms and other study
disclosures should clearly state what if any responses might
be taken. CONCLUSION: Early and ongoing bi-directional
communication with relevant stakeholders is critical to
identifying and meeting the ethical challenges for PCTs when
managing and responding to behavioral and mental health data
that potentially signal elevated risk to
individuals.},
Doi = {10.1016/j.cct.2021.106651},
Key = {fds361833}
}
@article{fds362117,
Author = {Schoenbeck, KL and Atallah, E and Lin, L and Weinfurt, KP and Cortes, J and Deininger, MWN and Kota, V and Larson, RA and Mauro, MJ and Oehler, VG and Pinilla-Ibarz, J and Radich, JP and Schiffer, CA and Shah, NP and Silver, RT and Thompson, JE and Flynn, KE},
Title = {Patient-Reported Functional Outcomes in Patients With
Chronic Myeloid Leukemia After Stopping Tyrosine Kinase
Inhibitors.},
Journal = {J Natl Cancer Inst},
Volume = {114},
Number = {1},
Pages = {160-164},
Year = {2022},
Month = {January},
url = {http://dx.doi.org/10.1093/jnci/djab184},
Abstract = {Treatment-free remission (TFR) is a goal for patients with
chronic myeloid leukemia (CML). Functional outcomes after
discontinuing tyrosine kinase inhibitor (TKI) treatment have
not been described. Patient-Reported Outcomes Measurement
Information System (PROMIS) measures of social, physical,
cognitive, and sexual function were assessed over
36 months in 172 adult patients with chronic phase CML
from 14 sites at baseline (on TKI) and after
discontinuation. Linear mixed-effects models described the
average trajectories for each patient-reported outcome
measure after discontinuation and in those who restarted
TKI. Of 112 patients in TFR at 12 months, 103 (92.0%) had
a 3-point or greater improvement in social function, 80
(71.4%) in social isolation, 11 (9.8%) in satisfaction with
sex life, 4 (3.6%) in physical function, and no patients had
a 3-point or greater improvement in cognitive function or
interest in sexual activity. Patients' scores worsened after
restarting TKI. This novel information on functional
outcomes in TFR can help guide patient and clinician
decision making.},
Doi = {10.1093/jnci/djab184},
Key = {fds362117}
}
@article{fds363043,
Author = {Anderson, DI and Balog, V and Bansal, S and Barbu-Roth, M and Barks, MC and Barlet, M and Barrera Resendiz and JE and Bernstein, S and Biran, V and Blennow, M and Brandon, D and Canfora, M and Craig, A and Cutler, A and Deerwester, K and Dumuids, M-V and El-Dib, M and Erdei, C and Eriksson
Westblad, M and Forde, M and Forma, V and Fox, L and Glass, H and Harmony,
T and Inder, T and Jermendy, Á and Kaneko-Tarui, T and Kapadia, J and Kátai, LK and Kumar, A and Lemmon, M and Lindström, K and Maron, J and Pilon, B and Pollak, K and Provasi, J and Grossmann, KR and Sunwoo, J and Szabó, M and Ubel, P and Vakharia, B and Vatai, B and Vatsavai, S and Weinfurt, K},
Title = {Proceedings of the 13th International Newborn Brain
Conference: Long-term outcome studies, Developmental care,
Palliative care, Ethical dilemmas, and Challenging clinical
scenarios.},
Journal = {J Neonatal Perinatal Med},
Volume = {15},
Number = {2},
Pages = {441-452},
Year = {2022},
url = {http://dx.doi.org/10.3233/NPM-229004},
Doi = {10.3233/NPM-229004},
Key = {fds363043}
}
@article{fds361415,
Author = {Sandy, LC and Glorioso, TJ and Weinfurt, K and Sugarman, J and Peterson,
PN and Glasgow, RE and Ho, PM},
Title = {Leave me out: Patients' characteristics and reasons for
opting out of a pragmatic clinical trial involving
medication adherence.},
Journal = {Medicine (Baltimore)},
Volume = {100},
Number = {51},
Pages = {e28136},
Year = {2021},
Month = {December},
url = {http://dx.doi.org/10.1097/MD.0000000000028136},
Abstract = {Opt-out procedures are sometimes used instead of standard
consent practices to enable patients to exercise their
autonomous preferences regarding research participation
while reducing patient and researcher burden. However,
little is known about the characteristics of patients who
opt-out of research and their reasons for doing so. We
gathered such information in a large pragmatic clinical
trial (PCT) evaluating the effect of theory informed text
messages on medication adherence.Eligible patients,
identified through electronic health records, were sent
information about the study and provided with an opportunity
to opt-out. Those opting out were asked to complete a
voluntary survey regarding their reasons for doing so.
Demographic data were compared among patients opting-out vs
those included in the study using chi-squared tests and a
log binomial regression model.Of 9046 patients receiving
study packets, 906 (10.0%) patients returned opt-out forms.
Of those, 451 (49.8%) returned the opt-out survey. Patients
who opted out were more likely to be older, white, and
nonHispanic than those who were included in the PCT. Survey
respondents expressed high levels of trust in their health
care providers, research, and system. Nearly half (46.6%)
reported concerns about time as a reason to opt-out.In this
PCT, 10% of patients receiving packets opted out, with
significant differences in age, race, gender, and ethnicity
compared to those included. Future trials should further
investigate representativeness and reasons patients choose
to opt-out of participating in research.},
Doi = {10.1097/MD.0000000000028136},
Key = {fds361415}
}
@article{fds360091,
Author = {Garland, A and Weinfurt, K and Sugarman, J},
Title = {Incentives and payments in pragmatic clinical trials:
Scientific, ethical, and policy considerations.},
Journal = {Clin Trials},
Volume = {18},
Number = {6},
Pages = {699-705},
Year = {2021},
Month = {December},
url = {http://dx.doi.org/10.1177/17407745211048178},
Abstract = {Pragmatic clinical trials are increasingly used to generate
knowledge about real-world clinical interventions. However,
they involve some distinctive ethical and regulatory
challenges. In this article, we examine a set of issues
related to incentives and other payments to patients in
pragmatic clinical trials. Although many of the ethical
concerns related to incentives and payments in explanatory
trials pertain to pragmatic clinical trials, the pragmatic
features may introduce additional challenges. These include
those related to the risk of incentives and payments
undermining the scientific validity and social value of
pragmatic clinical trials, the sources of data used in
pragmatic clinical trials, and when the pragmatic clinical
trials are conducted under waivers of consent. Based on our
examination of these matters, we offer some preliminary
recommendations regarding incentives and payments in
pragmatic clinical trials, recognizing that additional data
and experiences are needed to refine them.},
Doi = {10.1177/17407745211048178},
Key = {fds360091}
}
@article{fds358786,
Author = {Weinfurt, KP},
Title = {Analyzing and interpreting patient-reported outcome measures
in clinical trials: comment on Collister
et al.},
Journal = {J Clin Epidemiol},
Volume = {140},
Pages = {202},
Year = {2021},
Month = {December},
url = {http://dx.doi.org/10.1016/j.jclinepi.2021.08.016},
Doi = {10.1016/j.jclinepi.2021.08.016},
Key = {fds358786}
}
@article{fds359928,
Author = {Morain, SR and Mathews, DJH and Geller, G and Bollinger, J and Weinfurt,
K and Jarvik, JG and May, E and Sugarman, J},
Title = {Identification and management of pragmatic clinical trial
collateral findings: A current understanding and directions
for future research.},
Journal = {Healthc (Amst)},
Volume = {9},
Number = {4},
Pages = {100586},
Year = {2021},
Month = {December},
url = {http://dx.doi.org/10.1016/j.hjdsi.2021.100586},
Abstract = {While the embedded nature of pragmatic clinical trials
(PCTs) can improve the efficiency and relevance of research
for multiple stakeholders, embedding research into ongoing
clinical care can also involve ethical and regulatory
challenges. An emergent challenge is the management of
pragmatic clinical trial collateral findings (PCT-CFs).
While PCT-CFs share some features with incidental or
secondary findings that are encountered in conventional
clinical trials and clinical care, the PCT context differs
in ethically relevant ways that complicate PCT-CF
identification and management. We report on the results of a
two-year multi-method investigation of PCT-CFs. Overall,
five core themes emerged: 1) the liminal nature of PCTs and
the implications of this for PCT-CFs; 2) the
context-specific nature of PCT-CF management; 3) the
centrality of institutions; 4) the importance of prospective
planning; and 5) patient expectations. Among the central
lessons of this work are that prior ethics guidance from
other settings cannot easily be adapted to address PCT-CFs,
nor can a single approach readily accommodate all PCT-CFs.
Moving forward, stakeholders, including researchers,
institutions, ethics oversight bodies, and funders, should
anticipate and plan for PCT-CFs in the design, conduct, and
analysis of PCTs. Future scholarship is needed to examine
experiences with PCT-CFs, and the practical and conceptual
issues they raise for the future conduct of
PCTs.},
Doi = {10.1016/j.hjdsi.2021.100586},
Key = {fds359928}
}
@article{fds359065,
Author = {Flynn, KE and Lin, L and Carter, J and Baser, RE and Goldfarb, S and Saban,
S and Weinfurt, KP},
Title = {Correspondence Between Clinician Ratings of Vulvovaginal
Health and Patient-Reported Sexual Function After
Cancer.},
Journal = {J Sex Med},
Volume = {18},
Number = {10},
Pages = {1768-1774},
Year = {2021},
Month = {October},
url = {http://dx.doi.org/10.1016/j.jsxm.2021.07.011},
Abstract = {BACKGROUND: Tools for diagnosing sexual dysfunction and for
tracking outcomes of interest include clinician interviews,
physical exam, and patient self-report. Limited work has
described relationships among these three sources of
information regarding female sexual dysfunction and
vulvovaginal health. AIM: We describe correlations among
data collected from clinician interviews, clinical
gynecological examination, and patient self-report. METHODS:
Data are from a single-site, single-arm, prospective trial
in 100 postmenopausal patients with a history of breast or
endometrial cancer who sought treatment for vulvovaginal
symptoms. The trial collected a standardized clinical
gynecologic exam, clinician-reported outcome (ClinRO)
measures of vulvovaginal dryness and pain, and
patient-reported outcome (PRO) measures of sexual function,
including PROMIS Sexual Function and Satisfaction (SexFS)
lubrication, vaginal discomfort, labial discomfort, and
clitoral discomfort and Female Sexual Function Index (FSFI)
lubrication and pain. We examined polyserial correlations
between measures with bootstrapped 95% confidence intervals
from the baseline and 12-14-week timepoints. RESULTS: All of
the relationships between the ClinRO variables and the PRO
variables were in the expected direction (ie, positive), but
the strength of the relationships varied substantially. At
12-14 weeks, there were medium-to-large correlations between
ClinRO vaginal dryness and SexFS Lubrication (0.64), ClinRO
vulvar dryness and SexFS Lubrication (0.46), ClinRO vulvar
discomfort and SexFS Labial Discomfort (0.70), and ClinRO
vulvar discomfort and SexFS Clitoral Discomfort (0.43). With
one exception, the correlations between the exam variables
and the corresponding PRO scores were small (range
0.01-0.27). STRENGTHS & LIMITATIONS: Our study included a
comprehensive, standardized gynecologic exam designed
specifically to evaluate sexual dysfunction as well as
established PRO measures with significant evidence for
validity. A limitation of our findings is that the sample
size was relatively small, and our sample was restricted to
women who received cancer treatments known to have dramatic
effects on vulvovaginal tissue quality. CONCLUSION: Patient-
and clinician-reported vulvovaginal dryness and discomfort
were moderately correlated with each other but not with
clinical gynecologic exam findings. Understanding the
relationships among these different types of data highlights
the distinct contributions of each to understand
vulvovaginal tissue quality and patient sexual function
after cancer.},
Doi = {10.1016/j.jsxm.2021.07.011},
Key = {fds359065}
}
@article{fds352268,
Author = {Morain, SR and Mathews, DJH and Weinfurt, K and May, E and Bollinger,
JM and Geller, G and Sugarman, J},
Title = {Stakeholder perspectives regarding pragmatic clinical trial
collateral findings},
Journal = {Learning Health Systems},
Volume = {5},
Number = {4},
Year = {2021},
Month = {October},
url = {http://dx.doi.org/10.1002/lrh2.10245},
Abstract = {Context: Pragmatic clinical trials (PCTs), which are
becoming widespread since they are relatively inexpensive
and offer important benefits for healthcare decision-making,
can also present practical, ethical, and legal challenges.
One such challenge involves managing “pragmatic clinical
trial collateral findings” (PCT-CFs), or information
emerging in a PCT that is unrelated to the primary research
question(s), yet may have implications for individual
patients, clinicians, or health care systems from whom or
within which data were collected. The expansion of PCTs
makes it likely healthcare systems will increasingly
encounter PCT-CFs, yet little guidance exists regarding
their appropriate management. Methods: We conducted
semi-structured interviews with key stakeholders experienced
in the conduct or oversight of PCTs and those in health
system leadership. Interviews explored respondents'
experience with PCTs and PCT-CFs, and actual or hypothetical
reactions to PCT-CF management. We used standard methods of
qualitative analysis to identify key themes. Findings:
Forty-one stakeholders participated. Four key themes
emerged. First, discussions of PCT-CFs are complicated by
layers of ambiguity related to both the nature of PCTs
themselves, and unanticipated results that emanate from
them. Second, management of PCT-CFs is context-specific, and
not amenable to a “one-size-fits-all” approach. Third,
there was a wide diversity of attitudes regarding the scope
of researcher responsibilities in PCTs. Fourth, PCT-CFs had
generally not been previously considered by respondents, but
there was widespread belief in the importance of prospective
planning to anticipate such issues in future PCTs.
Conclusions: PCT-CFs are likely to increase, yet those
charged with PCT-CF decision-making and their disclosure are
unlikely to have experience with these issues. Further
deliberation about the ethical obligations and
implementation processes regarding PCT-CFs is needed. To
enhance the likelihood of developing sound policies and
practices, such deliberations should include the input and
perspectives of key stakeholders in PCTs, including
professionals, policy makers, and patients.},
Doi = {10.1002/lrh2.10245},
Key = {fds352268}
}
@article{fds357278,
Author = {Coles, TM and Hernandez, AF and Reeve, BB and Cook, K and Edwards, MC and Boutin, M and Bush, E and Degboe, A and Roessig, L and Rudolph, A and McNulty, P and Patel, N and Kay-Mugford, T and Vernon, M and Woloschak,
M and Buchele, G and Spertus, JA and Roe, MT and Bury, D and Weinfurt,
K},
Title = {Enabling patient-reported outcome measures in clinical
trials, exemplified by cardiovascular trials.},
Journal = {Health Qual Life Outcomes},
Volume = {19},
Number = {1},
Pages = {164},
Year = {2021},
Month = {June},
url = {http://dx.doi.org/10.1186/s12955-021-01800-1},
Abstract = {OBJECTIVES: There has been limited success in achieving
integration of patient-reported outcomes (PROs) in clinical
trials. We describe how stakeholders envision a solution to
this challenge. METHODS: Stakeholders from academia,
industry, non-profits, insurers, clinicians, and the Food
and Drug Administration convened at a Think Tank meeting
funded by the Duke Clinical Research Institute to discuss
the challenges of incorporating PROs into clinical trials
and how to address those challenges. Using examples from
cardiovascular trials, this article describes a potential
path forward with a focus on applications in the United
States. RESULTS: Think Tank members identified one key
challenge: a common understanding of the level of evidence
that is necessary to support patient-reported outcome
measures (PROMs) in trials. Think Tank participants
discussed the possibility of creating general evidentiary
standards depending upon contextual factors, but such
guidelines could not be feasibly developed because many
contextual factors are at play. The attendees posited that a
more informative approach to PROM evidentiary standards
would be to develop validity arguments akin to courtroom
briefs, which would emphasize a compelling rationale
(interpretation/use argument) to support a PROM within a
specific context. Participants envisioned a future in which
validity arguments would be publicly available via a
repository, which would be indexed by contextual factors,
clinical populations, and types of claims. CONCLUSIONS: A
publicly available repository would help stakeholders better
understand what a community believes constitutes compelling
support for a specific PROM in a trial. Our proposed
strategy is expected to facilitate the incorporation of
PROMs into cardiovascular clinical trials and trials in
general.},
Doi = {10.1186/s12955-021-01800-1},
Key = {fds357278}
}
@article{fds352833,
Author = {Scales, CD and Lai, HH and Desai, AC and Antonelli, JA and Maalouf, NM and Tasian, GE and Reese, PP and Curatolo, M and Weinfurt, K and Al-Khalidi,
HR and Wessells, H and Kirkali, Z and Harper, JD},
Title = {Study to Enhance Understanding of Stent-Associated Symptoms:
Rationale and Study Design.},
Journal = {J Endourol},
Volume = {35},
Number = {6},
Pages = {761-768},
Year = {2021},
Month = {June},
url = {http://dx.doi.org/10.1089/end.2020.0776},
Abstract = {Background: Ureteral stents are commonly employed after
ureteroscopy to treat urinary stone disease, but the devices
impose a substantial burden of stent-associated symptoms
(SAS), including pain and urinary side effects. The NIDDK
(National Institute of Diabetes and Digestive and Kidney
Diseases) Urinary Stone Disease Research Network sought to
develop greater understanding of SAS causes and severity
among individuals treated ureteroscopically for ureteral or
renal stones. Materials and Methods: We designed a
prospective, observational cohort study comprising
adolescents and adults undergoing ureteroscopic intervention
for ureteral or renal stones. Participants will undergo
detailed symptom assessment using validated questionnaires,
a psychosocial assessment, and detailed collection of
clinical and operative data. Quantitative sensory testing
will be utilized to assess pain sensitization. In addition,
a small cohort (∼40 individuals) will participate in
semi-structured interviews to develop more granular
information regarding their stent symptoms and experience.
Biospecimens (blood and urine) will be collected for future
research. Results: The Study to Enhance Understanding of
sTent-associated Symptoms (STENTS) enrolled its first
participant in March 2019 and completed nested qualitative
cohort follow-up in August 2019. After a planned pause,
enrollment for the main study cohort resumed in September
2019 and is expected to be completed in 2021. Conclusion:
STENTS is expected to provide important insights into the
mechanisms and risk factors for severe ureteral SAS after
ureteroscopy. These insights will generate future
investigations to mitigate the burden of SAS among
individuals with urinary stone disease.},
Doi = {10.1089/end.2020.0776},
Key = {fds352833}
}
@article{fds355462,
Author = {Weinfurt, KP},
Title = {Constructing arguments for the interpretation and use of
patient-reported outcome measures in research: an
application of modern validity theory.},
Journal = {Qual Life Res},
Volume = {30},
Number = {6},
Pages = {1715-1722},
Year = {2021},
Month = {June},
url = {http://dx.doi.org/10.1007/s11136-021-02776-7},
Abstract = {The past 100 years have witnessed an evolution of the
meaning of validity and validation within the fields of
education and psychology. Validity was once viewed as a
property of tests and scales, but is now viewed as the
extent to which theory and evidence support proposed
interpretations and uses of test scores. Uncertainty about
what types of validity evidence were needed motivated the
current "argument-based" approach, as reflected in the 2014
Standards for Educational and Psychological Testing.
According to this approach, investigators should delineate
the assumptions required in order for a proposed
interpretation or use to be plausible and then seek evidence
that supports or refutes those assumptions. Though
validation practices within the field of patient-reported
outcome measurement have implicitly included many elements
of the argument-based approach, the approach has yet to be
explicitly adopted. To facilitate adoption, this article
proposes an initial set of assumptions that might be
included in most arguments for research-related
interpretations and uses of scores from patient-reported
outcome measures. The article also includes brief
descriptions of the types of evidence that would be best
suited for evaluating each assumption. It is hoped that
these generic assumptions will stimulate further discussion
and debate among quality of life researchers regarding how
best to adopt modern validity theory to patient-reported
outcome measures.},
Doi = {10.1007/s11136-021-02776-7},
Key = {fds355462}
}
@article{fds355577,
Author = {Scales, CD and Desai, AC and Harper, JD and Lai, HH and Maalouf, NM and Reese, PP and Tasian, GE and Al-Khalidi, HR and Kirkali, Z and Wessells,
H and Urinary Stone Disease Research Network},
Title = {Prevention of Urinary Stones With Hydration (PUSH): Design
and Rationale of a Clinical Trial.},
Journal = {Am J Kidney Dis},
Volume = {77},
Number = {6},
Pages = {898-906.e1},
Year = {2021},
Month = {June},
url = {http://dx.doi.org/10.1053/j.ajkd.2020.09.016},
Abstract = {RATIONALE & OBJECTIVE: Although maintaining high fluid
intake is an effective low-risk intervention for the
secondary prevention of urinary stone disease, many patients
with stones do not increase their fluid intake. STUDY
DESIGN: We describe the rationale and design of the
Prevention of Urinary Stones With Hydration (PUSH) Study, a
randomized trial of a multicomponent behavioral intervention
program to increase and maintain high fluid intake.
Participants are randomly assigned (1:1 ratio) to the
intervention or control arm. The target sample size is 1,642
participants. SETTING & PARTICIPANTS: Adults and adolescents
12 years and older with a symptomatic stone history and low
urine volume are eligible. Exclusion criteria include
infectious or monogenic causes of urinary stone disease and
comorbid conditions precluding increased fluid intake.
INTERVENTIONS: All participants receive usual care and a
smart water bottle with smartphone application. Participants
in the intervention arm receive a fluid intake prescription
and an adaptive program of behavioral interventions,
including financial incentives, structured problem solving,
and other automated adherence interventions. Control arm
participants receive guideline-based fluid instructions.
OUTCOMES: The primary end point is recurrence of a
symptomatic stone during 24 months of follow-up. Secondary
end points include changes in radiographic stone burden,
24-hour urine output, and urinary symptoms. LIMITATIONS:
Periodic 24-hour urine volumes may not fully reflect daily
behavior. CONCLUSIONS: With its highly novel features, the
PUSH Study will address an important health care problem.
FUNDING: National Institute of Diabetes and Digestive and
Kidney Diseases. TRIAL REGISTRATION: Registered at
ClinicalTrials.gov with study number NCT03244189.},
Doi = {10.1053/j.ajkd.2020.09.016},
Key = {fds355577}
}
@article{fds352416,
Author = {Burgio, KL and James, AS and LaCoursiere, DY and Mueller, ER and Newman,
DK and Low, LK and Weinfurt, KP and Wyman, JF and Cunningham, SD and Vargo,
K and Connett, J and Williams, BR and Prevention of Lower Urinary
Tract Symptoms (PLUS) Research Consortium},
Title = {Views of Normal Bladder Function Among Women Experiencing
Lower Urinary Tract Symptoms.},
Journal = {Urology},
Volume = {150},
Pages = {103-109},
Year = {2021},
Month = {April},
url = {http://dx.doi.org/10.1016/j.urology.2020.08.021},
Abstract = {OBJECTIVE: To explore the perspectives of normal bladder
function among women with lower urinary tract symptoms.
METHODS: This was a secondary analysis of qualitative data
from structured interviews with 50 adult women with lower
urinary tract symptoms. A directed content analysis of the
transcripts explored women's perspectives on normal bladder
function. RESULTS: Participants' descriptions of "normal"
took many forms and were based on several aspects of bladder
function. A prominent feature of normal was that voiding
occurred as a seamless process, beginning with an urge
sensation, followed by voiding with ease and to completion,
and then "being done." Descriptions of normal were based
largely on concepts of voiding regularity, including voiding
frequency, intervals, and patterns during the day and night.
Another aspect of normal bladder function was the notion of
having control in terms of not leaking urine, as well as the
ability to hold urine and defer urination. Views of normal
bladder function extended to the absence of symptoms and the
impact of being symptom-free on day-to-day life, including
not having to think about or worry about the bladder or
limit daily activities. CONCLUSION: Women's perspectives on
normal bladder function are multifaceted, reflecting
attributes most salient to each individual and likely
informed by their personal experience with symptoms and
their influence on daily life. This work has implications
for how clinicians might engage women in discussing bladder
symptoms and can inform future research and public health
messaging about normal bladder function.},
Doi = {10.1016/j.urology.2020.08.021},
Key = {fds352416}
}
@article{fds361241,
Author = {Weinfurt, KP},
Title = {Generalizing From Qualitative Data as a Moral Activity: An
Example From Regulatory Decision Making for Medical
Products},
Journal = {Qualitative Psychology},
Volume = {8},
Number = {1},
Pages = {119-124},
Year = {2021},
Month = {January},
url = {http://dx.doi.org/10.1037/qup0000180},
Abstract = {The generalizability of quality research is discussed in
terms of the generalizing actions of scientists and
policymakers. Using decision making in regulatory drug
trials as a case study, I illustrate how questions of
generalizability arise when specifying outcome measures to
use in clinical trials. Specifically, qualitative concept
elicitation interviews are required to infer the relevant
symptoms and functional impacts of a particular disease (the
Source). Whether such qualitative data and the measure
developed from them can be extended to a different disease
(the Target) is an important question faced often by
researchers and makers of medical products. I suggest that
the logical steps in considering such inferences are (1)
identifying the salient attributes of the settings that
should be compared between the Source and Target; (2)
assessing the fit between the Source and the Target with
respect to the salient characteristics; and (3) deciding
whether the degree of fit is sufficient to justify making an
inference about the Target using data from the Source. I
underscore the importance of moral considerations when
deciding to engage in a generalization from a Target to a
Source and call for greater transparency regarding the
values upon which people’s generalizations are
based.},
Doi = {10.1037/qup0000180},
Key = {fds361241}
}
@article{fds353295,
Author = {Atallah, E and Schiffer, CA and Radich, JP and Weinfurt, KP and Zhang,
M-J and Pinilla-Ibarz, J and Kota, V and Larson, RA and Moore, JO and Mauro, MJ and Deininger, MWN and Thompson, JE and Oehler, VG and Wadleigh, M and Shah, NP and Ritchie, EK and Silver, RT and Cortes, J and Lin, L and Visotcky, A and Baim, A and Harrell, J and Helton, B and Horowitz, M and Flynn, KE},
Title = {Assessment of Outcomes After Stopping Tyrosine Kinase
Inhibitors Among Patients With Chronic Myeloid Leukemia: A
Nonrandomized Clinical Trial.},
Journal = {JAMA Oncol},
Volume = {7},
Number = {1},
Pages = {42-50},
Year = {2021},
Month = {January},
url = {http://dx.doi.org/10.1001/jamaoncol.2020.5774},
Abstract = {IMPORTANCE: Tyrosine kinase inhibitors (TKIs) have been
associated with improved survival of patients with chronic
myeloid leukemia (CML) but are also associated with adverse
effects, especially fatigue and diarrhea. Discontinuation of
TKIs is safe and is associated with the successful
achievement of treatment-free remission (TFR) for some
patients. OBJECTIVE: To evaluate molecular recurrence (MRec)
and patient-reported outcomes (PROs) after TKI
discontinuation for US patients with CML. DESIGN, SETTING,
AND PARTICIPANTS: The Life After Stopping TKIs (LAST) study
was a prospective single-group nonrandomized clinical trial
that enrolled 172 patients from 14 US academic medical
centers from December 18, 2014, to December 12, 2016, with a
minimum follow-up of 3 years. Participants were adults with
chronic-phase CML whose disease was well controlled with
imatinib, dasatinib, nilotinib, or bosutinib. Statistical
analysis was performed from August 13, 2019, to March 23,
2020. INTERVENTION: Discontinuation of TKIs. MAIN OUTCOMES
AND MEASURES: Molecular recurrence, defined as loss of major
molecular response (BCR-ABL1 International Scale ratio
>0.1%) by central laboratory testing, and PROs
(Patient-Reported Outcomes Measurement Information System
computerized adaptive tests) were monitored. Droplet digital
polymerase chain reaction (ddPCR) was performed on samples
with undetectable BCR-ABL1 by standard real-time
quantitative polymerase chain reaction (RQ-PCR). RESULTS: Of
172 patients, 89 were women (51.7%), and the median age was
60 years (range, 21-86 years). Of 171 patients evaluable for
molecular analysis, 112 (65.5%) stayed in major molecular
response, and 104 (60.8%) achieved TFR. Undetectable
BCR-ABL1 by either ddPCR or RQ-PCR at the time of TKI
discontinuation (hazard ratio, 3.60; 95% CI, 1.99-6.50;
P < .001) and at 3 months (hazard ratio, 5.86; 95% CI,
3.07-11.1; P < .001) was independently associated with
MRec. Molecular recurrence for patients with detectable
BCR-ABL1 by RQ-PCR was 50.0% (14 of 28), undetectable
BCR-ABL1 by RQ-PCR but detectable by ddPCR was 64.3% (36 of
56), and undetectable BCR-ABL1 by both ddPCR and RQ-PCR was
10.3% (9 of 87) (P ≤ .001). Of the 112 patients in TFR
at 12 months, 90 (80.4%) had a clinically meaningful
improvement in fatigue, 39 (34.8%) had a clinically
meaningful improvement in depression, 98 (87.5%) had a
clinically meaningful improvement in diarrhea, 24 (21.4%)
had a clinically meaningful improvement in sleep
disturbance, and 5 (4.5%) had a clinically meaningful
improvement in pain interference. Restarting a TKI resulted
in worsening of PROs. CONCLUSIONS AND RELEVANCE: In this
study, TKI discontinuation was safe, and 60.8% of patients
remained in TFR. Discontinuation of TKIs was associated with
improvements in PROs. These findings should assist patients
and physicians in their decision-making regarding
discontinuation of TKIs. Detectable BCR-ABL1 by RQ-PCR or
ddPCR at the time of TKI discontinuation was associated with
higher risk of MRec; clinical application of this finding
should be confirmed in other studies. TRIAL REGISTRATION:
ClinicalTrials.gov Identifier: NCT02269267.},
Doi = {10.1001/jamaoncol.2020.5774},
Key = {fds353295}
}
@article{fds351498,
Author = {Bollinger, JM and Geller, G and Weinfurt, K and May, E and Morain, SR and Mathews, DJH and Sugarman, J},
Title = {Patients' Views About the Disclosure of Collateral Findings
in Pragmatic Clinical Trials: a Focus Group
Study.},
Journal = {J Gen Intern Med},
Volume = {35},
Number = {12},
Pages = {3436-3442},
Year = {2020},
Month = {December},
url = {http://dx.doi.org/10.1007/s11606-020-06113-5},
Abstract = {BACKGROUND: Pragmatic clinical trials (PCTs) are
increasingly being conducted to efficiently generate
evidence to inform healthcare decision-making. Despite their
growing acceptance, PCTs may involve a variety of ethical
issues, including the management of pragmatic clinical
trial-collateral findings (PCT-CFs), that is, information
that emerges in PCTs that is unrelated to the primary
research questions but may have implications for patients,
clinicians, and health systems. OBJECTIVE: We sought to
understand patients' views about PCT-CF disclosure,
including how, by whom, and the nature and extent of
information provided. DESIGN: Prospective, qualitative focus
group study. PARTICIPANTS: Focus groups were conducted in
Baltimore, MD; Houston, TX; and Seattle, WA (overall N =
66), during July and August 2019. APPROACH: All groups
discussed a hypothetical scenario involving the detection of
a PCT-CF of contraindicated medications. Participants were
asked about their reactions to the PCT-CF and issues related
to its disclosure. KEY RESULTS: Reactions to learning about
the PCT-CF were mixed, ranging from fear of a significant
health problem, anger that the contraindicated medications
had gone unnoticed and/or for being included in research
without their permission, to gratitude for the information.
Preferences for how such disclosures are made varied but
were driven by several consistent desires, namely minimizing
patient harm and anxiety and demonstrating trust and
respect. Many wanted their treating clinician to be informed
of the PCT-CF so that they would be prepared to answer
patients' questions and to discuss treatment options.
CONCLUSIONS: The detection of PCT-CFs is likely to increase
with further expansion of PCTs. As such, clinicians will
undoubtedly become involved in the management of PCT-CFs.
Our data illustrate some of the challenges clinicians may
face when their patients are informed of a PCT-CF and the
need to develop guidance for disclosing PCT-CFs in ways that
align with patients' preferences and values.},
Doi = {10.1007/s11606-020-06113-5},
Key = {fds351498}
}
@article{fds351170,
Author = {Agochukwu-Mmonu, N and Wiseman, JB and Smith, AR and Helmuth, ME and Sarma, AV and Cameron, AP and Amundsen, CL and Flynn, KE and Cella, D and Weinfurt, KP and Kirkali, Z and Clemens, JQ},
Title = {Relationship of symptom severity and bother in individuals
seeking care for lower urinary tract symptoms.},
Journal = {Neurourol Urodyn},
Volume = {39},
Number = {8},
Pages = {2161-2170},
Year = {2020},
Month = {November},
url = {http://dx.doi.org/10.1002/nau.24466},
Abstract = {AIMS: Bother attributed to lower urinary tract symptoms
(LUTS) drives care-seeking and treatment aggressiveness. The
longitudinal relationship of LUTS severity and bother in a
care-seeking cohort, however, is not well understood. We aim
to conduct a longitudinal evaluation of LUTS severity and
bother and identify characteristics of patients with
discordant LUTS bother relative to severity. METHODS: Men
and women with LUTS seeking care at six US tertiary care
centers enrolled in the symptoms of lower urinary tract
dysfunction research network study. Patients reporting at
least one urinary symptom based on the LUTS Tool were
prospectively enrolled from June 2015 to January 2017.
Correlations were used to assess the relationship between
LUTS severity and bother. Discordance scores (ie, the
difference between bother and severity) were used to
classify patients with high and low bother. Patients were
classified as having high or low bother phenotypes if scores
were one standard deviation above or below zero,
respectively. Repeated measures multinomial logistic
regression evaluated characteristics associated with high
and low bother phenotypes. RESULTS: LUTS severity and bother
were at least moderately correlated for all symptom items
and highly correlated for 13 out of 21 items. Correlations
were highest for urgency, and lowest for daytime frequency
and urinary incontinence. Odds of being in high bother
phenotype were lowest at 3 and 12 months (3 months vs
baseline odds ratio [OR] = 0.71, 95% confidence
ninterval [CI] = 0.54-0.94; 12 months vs baseline
OR = 0.66, 95% CI = 0.48-0.91), and highest for
those who endorsed all urgency questions (OR = 3.65, 95%
CI = 2.17-6.13). Odds of being in the low bother
phenotype were lowest for patients who endorsed all urgency
items (OR = 0.33, 95% CI = 0.26-0.42), and all
frequency items (OR = 0.68, 95% CI = 0.53-0.88).
CONCLUSIONS: LUTS severity and bother correlate highly and
measurement of both in clinical practice is likely
redundant. There are patient factors associated with
discordance which may justify additional
evaluation.},
Doi = {10.1002/nau.24466},
Key = {fds351170}
}
@article{fds350816,
Author = {Bennett, AV and Jonsson, M and Chen, RC and Al-Khatib, SM and Weinfurt,
KP and Curtis, LH},
Title = {Applying patient-reported outcome methodology to capture
patient-reported health data: Report from an NIH
Collaboratory roundtable.},
Journal = {Healthc (Amst)},
Volume = {8},
Number = {3},
Pages = {100442},
Year = {2020},
Month = {September},
url = {http://dx.doi.org/10.1016/j.hjdsi.2020.100442},
Abstract = {Patient-reported health data provide information for
pragmatic clinical trials that may not be readily available
from electronic health records or administrative claims
data. In this report, we present key considerations for
collecting patient-reported health information in pragmatic
clinical trials, which are informed by best practices from
patient-reported outcome research. We focus on question
design and administration via electronic data collection
platforms with respect to 3 types of patient-reported health
data: medication use, utilization of health care services,
and comorbid conditions. We summarize key scientific
literature on the accuracy of these patient-reported data
compared with electronic health record data. We discuss
question design in detail, specifically defining the concept
to be measured, patient understanding of the concept, recall
periods of the question, and patient willingness to report.
In addition, we discuss approaches for question
administration and data collection platforms, which are key
aspects of successful patient-reported data
collection.},
Doi = {10.1016/j.hjdsi.2020.100442},
Key = {fds350816}
}
@article{fds351171,
Author = {Flynn, KE and Mansfield, SA and Smith, AR and Gillespie, BW and Bradley,
CS and Cella, D and Helmuth, ME and Lai, HH and Kirkali, Z and Talaty, P and Griffith, JW and Weinfurt, KP and LURN Study Group},
Title = {Patient demographic and psychosocial characteristics
associated with 30-day recall of self-reported lower urinary
tract symptoms.},
Journal = {Neurourol Urodyn},
Volume = {39},
Number = {7},
Pages = {1939-1948},
Year = {2020},
Month = {September},
url = {http://dx.doi.org/10.1002/nau.24461},
Abstract = {AIMS: Measurement of self-reported lower urinary tract
symptoms (LUTS) typically uses a recall period, for example,
"In the past 30 days…." Compared to averaged daily
reports, 30-day recall is generally unbiased, but recall
bias varies by item. We examined the associations between
personal characteristics (eg, age, symptom bother) and
30-day recall of LUTS using items from the Symptoms of Lower
Urinary Tract Dysfunction Research Network Comprehensive
Assessment of Self-reported Urinary Symptoms questionnaire.
METHODS: Participants (127 women and 127 men) were recruited
from 6 US tertiary care sites. They completed daily
assessments for 30 days and a 30-day recall assessment at
the end of the study month. For each of the 18 tested items,
representing 10 LUTS, the average of the participant's daily
responses was modeled as a function of their 30-day recall,
the personal characteristic, and the interaction between the
30-day recall and the characteristic in separate general
linear regression models, adjusted for sex. RESULTS: Nine
items representing 7 LUTS exhibited under- or overreporting
(recall bias) for at least 25% of participants. Bias was
associated with personal characteristics for six LUTS.
Underreporting of incontinence was associated with older
age, lower anxiety, and negative affect; overreporting of
other LUTS was associated with, symptom bother, symptom
variability, anxiety, and depression. CONCLUSIONS: We
identified under- or overreporting that was associated with
personal characteristics for six common LUTS. Some cues (eg,
less bother and lower anxiety) were related to recall bias
in an unexpected direction. Thus, providers should exercise
caution when making judgments about the accuracy of a
patient's symptom recall based on patient demographic and
psychosocial characteristics.},
Doi = {10.1002/nau.24461},
Key = {fds351171}
}
@article{fds352415,
Author = {Roberts, MK and Fisher, DM and Parker, LE and Darnell, D and Sugarman,
J and Carrithers, J and Weinfurt, K and Jurkovich, G and Zatzick,
D},
Title = {Ethical and Regulatory Concerns in Pragmatic Clinical Trial
Monitoring and Oversight.},
Journal = {Ethics Hum Res},
Volume = {42},
Number = {5},
Pages = {29-37},
Year = {2020},
Month = {September},
url = {http://dx.doi.org/10.1002/eahr.500066},
Abstract = {The implementation of pragmatic clinical trials (PCTs) can
be accompanied by unique regulatory challenges. In this
paper, we describe the experience and management of
regulatory noncompliance during a 25-site acute care PCT.
During the trial, the study team conducted a comprehensive
audit of all enrollment forms (informed consent and Health
Insurance Portability and Accountability Act authorization
forms) and related study documentation. A review of 997
participants' enrollment forms identified 138 (13.8%) that
required reporting to the institutional review board due to
noncompliance. To prevent subsequent noncompliance, the
study team developed and introduced a revised participant
tracking system, reviewed all enrollment documentation, and
retrained sites regarding study procedures. Based on these
experiences, we developed a set of recommendations for
future PCTs to ensure both operational success and
regulatory compliance.},
Doi = {10.1002/eahr.500066},
Key = {fds352415}
}
@article{fds349678,
Author = {Weinfurt, KP},
Title = {A Model to Be Emulated.},
Journal = {Am J Bioeth},
Volume = {20},
Number = {5},
Pages = {18-20},
Year = {2020},
Month = {June},
url = {http://dx.doi.org/10.1080/15265161.2020.1745949},
Doi = {10.1080/15265161.2020.1745949},
Key = {fds349678}
}
@article{fds369237,
Author = {Weinfurt, KP},
Title = {Vanquishing false idols, then and now},
Journal = {Science},
Volume = {367},
Number = {6484},
Pages = {1312-1312},
Publisher = {American Association for the Advancement of Science
(AAAS)},
Year = {2020},
Month = {March},
url = {http://dx.doi.org/10.1126/science.aba5802},
Abstract = {<jats:p>Francis Bacon's 400-year-old list of scientific
foibles holds lessons for modern scientists</jats:p>},
Doi = {10.1126/science.aba5802},
Key = {fds369237}
}
@article{fds348583,
Author = {Weinfurt, KP and Flynn, KE},
Title = {Assessing Patient-Reported Outcomes: A Negotiated
Process.},
Journal = {J Clin Oncol},
Volume = {38},
Number = {6},
Pages = {652-653},
Year = {2020},
Month = {February},
url = {http://dx.doi.org/10.1200/JCO.19.02114},
Doi = {10.1200/JCO.19.02114},
Key = {fds348583}
}
@article{fds348090,
Author = {Morain, SR and Weinfurt, K and Bollinger, J and Geller, G and Mathews,
DJ and Sugarman, J},
Title = {Ethics and Collateral Findings in Pragmatic Clinical
Trials.},
Journal = {Am J Bioeth},
Volume = {20},
Number = {1},
Pages = {6-18},
Year = {2020},
Month = {January},
url = {http://dx.doi.org/10.1080/15265161.2020.1689031},
Abstract = {Pragmatic clinical trials (PCTs) offer important benefits,
such as generating evidence that is suited to inform
real-world health care decisions and increasing research
efficiency. However, PCTs also present ethical challenges.
One such challenge involves the management of information
that emerges in a PCT that is unrelated to the primary
research question(s), yet may have implications for the
individual patients, clinicians, or health care systems from
whom or within which research data were collected. We term
these findings as ?pragmatic clinical trial collateral
findings,? or ?PCT-CFs?. In this article, we explore the
ethical considerations associated with the identification,
assessment, and management of PCT-CFs, and how these
considerations may vary based upon the attributes of a
specific PCT. Our purpose is to map the terrain of PCT-CFs
to serve as a foundation for future scholarship as well as
policy-making and to facilitate careful deliberation about
actual cases as they occur in practice.},
Doi = {10.1080/15265161.2020.1689031},
Key = {fds348090}
}
@article{fds347610,
Author = {Cella, D and Smith, AR and Griffith, JW and Kirkali, Z and Flynn, KE and Bradley, CS and Jelovsek, JE and Gillespie, BW and Helfand, BT and Talaty, P and Weinfurt, KP and LURN Study Group},
Title = {A New Brief Clinical Assessment of Lower Urinary Tract
Symptoms for Women and Men: LURN SI-10.},
Journal = {J Urol},
Volume = {203},
Number = {1},
Pages = {164-170},
Year = {2020},
Month = {January},
url = {http://dx.doi.org/10.1097/JU.0000000000000465},
Abstract = {PURPOSE: Lower urinary tract symptoms are common in men and
women. Members of the LURN (Lower Urinary Tract Dysfunction
Research Network) sought to create a brief, clinically
relevant tool to improve existing measurements of lower
urinary tract symptoms in men and women. MATERIALS AND
METHODS: Using a modified Delphi methodology during an
expert consensus meeting we reduced the LURN CASUS
(Comprehensive Assessment of Self-Reported Urinary Symptoms)
questionnaire to a brief set of clinically relevant items
measuring lower urinary tract symptoms. The sum score of
these items was evaluated by comparing it to the AUA SI
(American Urological Association Symptom Index), the UDI-6
(Urinary Distress Inventory Short Form) in women only and
the CASUS lower urinary tract symptoms screening questions
using the Pearson correlation, regression analysis and ROC
curves. RESULTS: The LURN SI-10 (10-Item LURN Symptom Index)
assesses urinary frequency, nocturia, urgency, incontinence,
bladder pain, voiding and post-micturition symptoms (score
range 0 to 38). The correlation between LURN SI-10 and AUA
SI scores was 0.77 in men and 0.70 in women. The UDI-6 and
the LURN SI-10 correlated highly in women (r=0.76). The LURN
SI-10 showed good accuracy to predict moderate and severe
lower urinary tract symptoms as defined by the AUA SI (ROC
AUC range 0.82-0.90). Similar accuracy was shown in
predicting different levels of symptom status using the
UDI-6 (AUC range 0.84-0.86). CONCLUSIONS: The LURN SI-10
correlates well with the AUA SI and the UDI-6. It includes
items related to a broader spectrum of lower urinary tract
symptoms, particularly incontinence, bladder pain and
post-micturition symptoms, and it applies to men and
women.},
Doi = {10.1097/JU.0000000000000465},
Key = {fds347610}
}
@article{fds347390,
Author = {Weinfurt, KP},
Title = {Clarifying the Meaning of Clinically Meaningful Benefit in
Clinical Research: Noticeable Change vs Valuable
Change.},
Journal = {JAMA},
Volume = {322},
Number = {24},
Pages = {2381-2382},
Year = {2019},
Month = {December},
url = {http://dx.doi.org/10.1001/jama.2019.18496},
Doi = {10.1001/jama.2019.18496},
Key = {fds347390}
}
@article{fds344885,
Author = {Weinfurt, KP and Lin, L and Sugarman, J},
Title = {Public views regarding the responsibility of patients,
clinicians, and institutions to participate in research in
the United States.},
Journal = {Clin Trials},
Volume = {16},
Number = {6},
Pages = {574-579},
Year = {2019},
Month = {December},
url = {http://dx.doi.org/10.1177/1740774519858917},
Abstract = {BACKGROUND: The need for more and better evidence to inform
clinical decision making among all stakeholders has fueled
calls for creating learning healthcare systems. The
successful realization of a learning healthcare system seems
to assume that various parties have a responsibility to
participate in learning activities, including research. The
objective of this study was to determine whether members of
the general public perceive an ethical responsibility to
participate in pragmatic clinical research that would be
inherent to a learning health system. METHODS: A total of
2994 English-speaking adults completed a nationally
representative online survey. RESULTS: About two-thirds of
respondents were relatively neutral regarding a
responsibility for themselves and others to participate in
research; the remainder felt that they and others did not
have a responsibility to participate in research.
CONCLUSIONS: Efforts to justify and develop a robust
learning health system in an ethically acceptable fashion
need to take these findings into account.},
Doi = {10.1177/1740774519858917},
Key = {fds344885}
}
@article{fds346299,
Author = {Weinfurt, KP},
Title = {Viewing assessments of patient-reported heath status as
conversations: Implications for developing and evaluating
patient-reported outcome measures.},
Journal = {Qual Life Res},
Volume = {28},
Number = {12},
Pages = {3395-3401},
Year = {2019},
Month = {December},
url = {http://dx.doi.org/10.1007/s11136-019-02285-8},
Abstract = {Patient-reported outcome measures (PROMs) are frequently
used in research to reflect the patient's perspective. In
this commentary, I argue that further improvements can be
made in how we develop and evaluate PROMs by viewing
assessment as a type of conversation. Philosophically
speaking, a PROM assessment can be conceptualized as a
formal conversation that serves as a model of an informal,
longer, and more nuanced conversation with a research
participant about their health experience. Psychologically
speaking, evidence from research in survey methodology and
discursive psychology shows that respondents to self-report
measures behave in ways consistent with the idea that they
are doing their best to participate in a conversation,
albeit an unusual one. Several suggestions are offered for
creating a better conversational context through study
materials and PROM instructions, and by improving the yield
of cognitive interviews. It is hoped that this commentary
can stimulate further discussions in our field regarding how
to integrate insights about the conversational nature of
assessment from survey research and discursive psychology to
better reflect the patient's voice in research.},
Doi = {10.1007/s11136-019-02285-8},
Key = {fds346299}
}
@article{fds346300,
Author = {Flynn, KE and Whicker, D and Lin, L and Cusatis, R and Nyitray, A and Weinfurt, KP},
Title = {Sexual Orientation and Patient-Provider Communication About
Sexual Problems or Concerns Among US Adults.},
Journal = {J Gen Intern Med},
Volume = {34},
Number = {11},
Pages = {2505-2511},
Year = {2019},
Month = {November},
url = {http://dx.doi.org/10.1007/s11606-019-05300-3},
Abstract = {BACKGROUND: Limited patient-provider communication about
sexual health is a crucial barrier to patients receiving
treatment for sexual problems, and little is known about how
patient sexual orientation is associated with
patient-provider communication about sexual problems.
OBJECTIVE: To describe the prevalence of patient-provider
communication about sexual problems and the associations
between communication and (1) persistent sexual problems and
(2) whether those who identified as lesbian, gay, or
bisexual had disclosed their sexual orientation to their
clinicians. DESIGN: Cross-sectional, online survey
PARTICIPANTS: 4325 English-speaking US adults from
KnowledgePanel®, a probability-based sample of the
civilian, noninstitutionalized population. MAIN MEASURES:
Sexual orientation, disclosure of sexual orientation (being
"out") to a health care provider, communication with health
care providers regarding sexual problems or concerns, and
persistent sexual problems or concerns. KEY RESULTS: In the
past year, 8-15% of US adults discussed a sexual problem or
concern with a health care provider. Between 23 and 42% of
US adults reported persistent sexual problem(s) in the past
year, and of those, 18% of gay/lesbian women, 20% of
heterosexual women, 22% of bisexual women, 30% of gay men,
31% of heterosexual men, and 37% of bisexual men had
discussed a sexual concern with a clinician. Eighty percent
of gay/lesbian women and 70% of gay men had disclosed their
sexual orientation to their regular health care provider,
versus only 24% of bisexual men and women. Among those who
were "out," 30% had ever talked to a clinician about a
sexual problem compared with 17% of those who were not
"out." A smaller proportion of lesbian women had ever
received care or treatment for a sexual problem, 6% compared
with 14-23% in the other groups. CONCLUSIONS: There are
significant unmet needs among US adults with regard to
patient-provider communication about sexual problems or
concerns. Improving patient-provider communication about
sexual health is critical.},
Doi = {10.1007/s11606-019-05300-3},
Key = {fds346300}
}
@article{fds347317,
Author = {Flynn, KE and Mansfield, SA and Smith, AR and Gillespie, BW and Bradley,
CS and Cella, D and Clemens, JQ and Helmuth, ME and Lai, HH and Kirkali, Z and Talaty, P and Weinfurt, KP and LURN Study Group},
Title = {Can 7 or 30-Day Recall Questions Capture Self-Reported Lower
Urinary Tract Symptoms Accurately?},
Journal = {J Urol},
Volume = {202},
Number = {4},
Pages = {770-778},
Year = {2019},
Month = {October},
url = {http://dx.doi.org/10.1097/JU.0000000000000310},
Abstract = {PURPOSE: Self-reported measurement tools often provide a
recall period, eg "In the past 7 days…" For lower urinary
tract symptoms the concordance of end of day (daily) reports
with 7 and 30-day recalled reports is unknown to our
knowledge. We evaluated how accurately 7 or 30-day recall
questions capture lower urinary tract symptoms. MATERIALS
AND METHODS: The 261 female and 254 male participants were
recruited from a total of 6 United States tertiary care
sites. We evaluated 18 items representing 7 symptoms
covering storage, voiding and post-micturition symptoms.
Item responses on the daily forms were averaged for a 7 or a
30-day period and compared to the corresponding 7 or 30-day
recall version of the item. Analyses were item and gender
specific. Within person concordance was assessed using the
Pearson correlation. Bias (systematic overreporting or
underreporting) was calculated as the difference between the
recalled item and the averaged daily item score, and
reported as a percent of the item scale. RESULTS: All
correlations exceeded 0.60. Correlations between averaged
daily reports and recalled reports ranged from 0.72 to 0.89
for 7 days and from 0.71 to 0.91 for 30 days among women,
and from 0.68 to 0.90 and 0.68 to 0.95, respectively, among
men. Most items did not show systematic bias and the median
percent bias did not exceed 10% for any item. However, bias
exceeding ±10% for some items was observed in a subset of
individuals. CONCLUSIONS: Recalled reports during the 7 and
30 days tracked well with averaged daily reports for men and
women. Systematic bias was minimal, suggesting that 7 and
30-day recall periods for self-reported lower urinary tract
symptoms are reasonable.},
Doi = {10.1097/JU.0000000000000310},
Key = {fds347317}
}
@article{fds345917,
Author = {Liu, AB and Liu, Q and Yang, CC and Griffith, JW and Smith, AR and Helmuth,
ME and Lai, HH and Amundsen, CL and Erickson, BA and Jelovsek, JE and Agochukwu, NQ and Mueller, MG and Andreev, VP and Weinfurt, KP and Kenton, KS and Fraser, MO and Cameron, AP and Kirkali, Z and Gore, JL and LURN Study Group},
Title = {Patient Characteristics Associated with More Bother from
Lower Urinary Tract Symptoms.},
Journal = {J Urol},
Volume = {202},
Number = {3},
Pages = {585-591},
Year = {2019},
Month = {September},
url = {http://dx.doi.org/10.1097/JU.0000000000000324},
Abstract = {PURPOSE: Some patients continue to have bothersome lower
urinary tract symptoms despite treatment. We examined
characteristics associated with bother from lower urinary
tract symptoms in a prospective cohort. MATERIALS AND
METHODS: In this 1-year prospective, observational cohort
study we obtained data on patients with lower urinary tract
symptoms who were seeking care at a total of 6 tertiary care
centers in the United States. Participants answered the
AUA-SI (American Urological Association Symptom Index)
global urinary bother question at study entry and 12 months
later. Multilevel logistic and linear regression was used to
identify factors associated with worsening bother and bother
at 12 months, respectively. RESULTS: Of the 756 participants
121 (16%) had worsened lower urinary tract symptom bother
during the study period. When adjusted for other variables,
worsened lower urinary tract symptom bother was more likely
among men who were nonwhite (OR 1.79, 95% CI 0.94-3.40) or
who had diabetes (OR 1.68, 95% CI 0.86-3.27) and among women
with diabetes (OR 1.77, 95% CI 0.85-3.67), prior treatment
of lower urinary tract symptoms (OR 2.58, 95% CI 1.22-5.46)
or a higher depression level (OR 1.29, 95% CI 1.10-1.52).
Baseline factors associated with more severe bother at 12
months in men included more severe bother at baseline,
nonwhite race, worse urinary frequency and incontinence, and
higher levels of stress (p <0.05). Among women more severe
bother at baseline, urinary urgency and frequency, and worse
physical function were associated with more severe bother at
12 months. CONCLUSIONS: Urinary symptom severity at
baseline, race, depression and psychological stress were
associated with the bother of lower urinary tract symptoms
in a prospective cohort of men and women treated at tertiary
care facilities. These findings may inform the clinical care
of patients with bothersome lower urinary tract symptoms and
direct providers to better prognosticate for patients with
challenging lower urinary tract symptoms
cases.},
Doi = {10.1097/JU.0000000000000324},
Key = {fds345917}
}
@article{fds345326,
Author = {Cella, D and Smith, AR and Griffith, JW and Flynn, KE and Bradley, CS and Gillespie, BW and Kirkali, Z and Talaty, P and Jelovsek, JE and Helfand,
BT and Weinfurt, KP and LURN Study Group},
Title = {A new outcome measure for LUTS: Symptoms of Lower Urinary
Tract Dysfunction Research Network Symptom Index-29 (LURN
SI-29) questionnaire.},
Journal = {Neurourol Urodyn},
Volume = {38},
Number = {6},
Pages = {1751-1759},
Year = {2019},
Month = {August},
url = {http://dx.doi.org/10.1002/nau.24067},
Abstract = {AIMS: To develop a representative, self-report assessment of
lower urinary tract symptoms (LUTS) for men and women, the
symptoms of Lower Urinary Tract Dysfunction Research Network
Symptom Index-29 (LURN SI-29). METHODS: Women and men
seeking treatment for LUTS at one of six academic medical
centers in the US were assessed at baseline, 3-month and
12-month intervals. Twelve-month data on 78 LURN SI-29 items
were analyzed among 353 women and 420 men using exploratory
factor analysis (EFA), with factor structure confirmed using
confirmatory factor analysis (CFA). Internal consistency,
reliability, and validity of the five developed scales were
evaluated by assessing correlations with the American
Urological Association Symptom Index (AUA-SI), the
genitourinary pain index (GUPI), and the Pelvic Floor
Distress Inventory-20 (PFDI-20), and by examining expected
sex differences in scores. RESULTS: EFA results (n = 150
women; 150 men) produced an interpretable eight-factor
solution, with three of the factors comprised of dichotomous
items addressing LUTS-associated sensations. The remaining
five factors, confirmed with CFA in an independent sample of
473 participants, produced five scales: incontinence,
urgency, voiding difficulty, bladder pain, and nocturia.
Subscales and total LURN SI-29 scores were correlated as
expected with AUA-SI, GUPI, and PFDI-20. LURN SI-29 scores
also performed as expected in differentiating men from women
based upon clinically expected differences, with men
reporting more voiding difficulties and nocturia, and women
reporting more urgency and incontinence. CONCLUSIONS: The
LURN SI-29 questionnaire has the potential to improve
research and clinical outcome measurement for both men and
women with LUTS.},
Doi = {10.1002/nau.24067},
Key = {fds345326}
}
@article{fds344720,
Author = {Ljungman, L and Eriksson, LE and Flynn, KE and Gorman, JR and Ståhl, O and Weinfurt, K and Wiklander, M and Lampic, C and Wettergren,
L},
Title = {Sexual Dysfunction and Reproductive Concerns in Young Men
Diagnosed With Testicular Cancer: An Observational
Study.},
Journal = {J Sex Med},
Volume = {16},
Number = {7},
Pages = {1049-1059},
Year = {2019},
Month = {July},
url = {http://dx.doi.org/10.1016/j.jsxm.2019.05.005},
Abstract = {INTRODUCTION: The survival rates for testicular cancer are
excellent; still, there is a lack of knowledge regarding
important survivorship issues, such as sexual dysfunction
and reproductive concerns. AIM: The aim of this study was to
investigate the prevalence and predictors of sexual
dysfunction and reproductive concerns and the potential
association between these issues in young men ∼2 years
after a diagnosis of testicular cancer. METHODS: Data were
collected from 111 men (response rate = 50%) diagnosed with
testicular cancer at age 16-39. Patients were identified via
the Swedish National Quality Registry for Testicular Cancer
and approached with a survey, including standardized
measures of sexual function, reproductive concerns, body
image, and health-related quality of life. The survey was
sent to participants approximately 2 years after their
cancer diagnosis. Clinical variables were collected from the
registry. Predictors were identified by multivariable linear
regression analyses. MAIN OUTCOME MEASURES: The main
outcomes were sexual function, assessed with the
Patient-Reported Outcomes Measurement Information System
Sexual Function and Satisfaction measure version 2.0, and
reproductive concerns, assessed with the Reproductive
Concerns After Cancer scale. RESULTS: Sexual dysfunction was
reported by 26% of men, and a high level of reproductive
concerns was reported by 28%. Lower satisfaction with sex
life was associated with older age (β = -0.41), negative
body image (β = -0.42), not having a partner (β = 4.8),
and dissatisfaction with sex life before cancer (β =
8.31). Negative body image was associated with reproductive
concerns in the dimensions of fertility potential (β =
0.06), partner disclosure (β = 0.08), and child's health
(β = 0.07), whereas having had fertility preservation
predicted higher levels of concerns with regard to personal
health (β = 0.52) and achieving pregnancy (β = 0.53).
Clinical variables did not predict either sexual function or
reproductive concerns. CLINICAL IMPLICATIONS: Our results
show that the majority of young men diagnosed with
testicular cancer do not report sexual dysfunction or
reproductive concerns 2 years after diagnosis. A sizeable
minority, however, does report dysfunction or reproductive
concerns, which should be recognized in the follow-up care
of this population. STRENGTHS & LIMITATIONS: A strength of
the study is the use of high-quality registry data and
validated instruments. The lack of Swedish norms for sexual
function and reproductive concerns is a possible limitation.
CONCLUSION: A subgroup of young men treated for testicular
cancer report sexual dysfunction or reproductive concerns
approximately 2 years after diagnosis. Factors associated
with these issues seem to mainly be psychological, rather
than medical, nature. Ljungman L, Eriksson LE, Flynn KE,
et al. Sexual Dysfunction and Reproductive Concerns in
Young Men Diagnosed With Testicular Cancer: An Observational
Study. J Sex Med 2019;16:1049-1059.},
Doi = {10.1016/j.jsxm.2019.05.005},
Key = {fds344720}
}
@article{fds344886,
Author = {Weinfurt, KP},
Title = {Commentary: Dangerous Disconnections.},
Journal = {Camb Q Healthc Ethics},
Volume = {28},
Number = {3},
Pages = {413-414},
Year = {2019},
Month = {July},
url = {http://dx.doi.org/10.1017/S096318011900032X},
Doi = {10.1017/S096318011900032X},
Key = {fds344886}
}
@article{fds343376,
Author = {Weinfurt, KP and Griffith, JW and Flynn, KE and Cella, D and Bavendam,
T and Wiseman, JB and Andreev, VP and Lai, HH and Liu, AB and Kirkali, Z and Cameron, AP and Bradley, CS and LURN Study Group},
Title = {The Comprehensive Assessment of Self-Reported Urinary
Symptoms: A New Tool for Research on Subtypes of Patients
with Lower Urinary Tract Symptoms.},
Journal = {J Urol},
Volume = {201},
Number = {6},
Pages = {1177-1183},
Year = {2019},
Month = {June},
url = {http://dx.doi.org/10.1097/JU.0000000000000140},
Abstract = {PURPOSE: To improve the potential for finding clinically
important subtypes of patients with lower urinary tract
symptoms we developed the CASUS (Comprehensive Assessment of
Self-reported Urinary Symptoms). We used it to present data
on the experiences of lower urinary tract symptoms in
treatment seeking women and men from a prospective
observational cohort. MATERIALS AND METHODS: We created an
initial list of lower urinary tract symptoms that were
confirmed in 22 qualitative interviews with providers, and
88 qualitative interviews with care seeking and noncare
seeking women and men with lower urinary tract symptoms.
Items from extant measures were adopted and revised, and new
items were developed. All items were evaluated for
understanding in 64 cognitive interviews. Items were
administered to a prospective cohort of female and male
patients with lower urinary tract symptoms who were seeking
care. Analyses were done to describe item response
distributions and correlations among item responses
separately for women and men. RESULTS: A total of 444 males
and 372 females provided responses to the CASUS. Several
sets of items showed different relationships for women
compared to men. In particular the associations between
sensation related items and incontinence related items were
generally positive among females but often negative among
males. CONCLUSIONS: After using an intensive development
process the CASUS addresses a wide range of lower urinary
tract symptoms. It should help identify clinically important
subtypes of patients. Further, item collection can provide
the foundation for shorter measures for use in the clinic
and as trial end points.},
Doi = {10.1097/JU.0000000000000140},
Key = {fds343376}
}
@article{fds348584,
Author = {Weinfurt, KP},
Title = {Managing different intellectual personalities in scientific
teams.},
Journal = {J Clin Transl Sci},
Volume = {3},
Number = {2-3},
Pages = {50-52},
Year = {2019},
Month = {June},
url = {http://dx.doi.org/10.1017/cts.2019.388},
Doi = {10.1017/cts.2019.388},
Key = {fds348584}
}
@article{fds342390,
Author = {Cella, D and Choi, SW and Condon, DM and Schalet, B and Hays, RD and Rothrock, NE and Yount, S and Cook, KF and Gershon, RC and Amtmann, D and DeWalt, DA and Pilkonis, PA and Stone, AA and Weinfurt, K and Reeve,
BB},
Title = {PROMIS® Adult Health Profiles: Efficient Short-Form
Measures of Seven Health Domains.},
Journal = {Value Health},
Volume = {22},
Number = {5},
Pages = {537-544},
Year = {2019},
Month = {May},
url = {http://dx.doi.org/10.1016/j.jval.2019.02.004},
Abstract = {BACKGROUND: There is a need for valid self-report measures
of core health-related quality of life (HRQoL) domains.
OBJECTIVE: To derive brief, reliable and valid health
profile measures from the Patient Reported Outcomes
Measurement Information System® (PROMIS®) item banks.
METHODS: Literature review, investigator consensus process,
item response theory (IRT) analysis, and expert review of
scaling results from multiple PROMIS data sets. We developed
3 profile measures ranging in length from 29 to 57
questions. These profiles assess important HRQoL domains
with highly informative subsets of items from respective
item banks and yield reliable information across
mild-to-severe levels of HRQoL experiences. Each instrument
assesses the domains of pain interference, fatigue,
depression, anxiety, sleep disturbance, physical function,
and social function using 4-, 6-, and 8-item short forms for
each domain, and an average pain intensity domain score,
using a 0-10 numeric rating scale. RESULTS: With few
exceptions, all domain short forms within the profile
measures were highly reliable across at least 3 standard
deviation (30 T-score) units and were strongly correlated
with the full bank scores. Construct validity with ratings
of general health and quality of life was demonstrated.
Information to inform statistical power for clinical and
general population samples is also provided. CONCLUSIONS:
Although these profile measures have been used widely, with
summary scoring routines published, description of their
development, reliability, and initial validity has not been
published until this article. Further evaluation of these
measures and clinical applications are encouraged.},
Doi = {10.1016/j.jval.2019.02.004},
Key = {fds342390}
}
@article{fds343377,
Author = {Beskow, LM and Weinfurt, KP},
Title = {Exploring Understanding of "Understanding": The Paradigm
Case of Biobank Consent Comprehension.},
Journal = {Am J Bioeth},
Volume = {19},
Number = {5},
Pages = {6-18},
Year = {2019},
Month = {May},
url = {http://dx.doi.org/10.1080/15265161.2019.1587031},
Abstract = {Data documenting poor understanding among research
participants and real-time efforts to assess comprehension
in large-scale studies are focusing new attention on
informed consent comprehension. Within the context of
biobanking consent, we previously convened a
multidisciplinary panel to reach consensus about what
information must be understood for a prospective
participant's consent to be considered valid. Subsequently,
we presented them with data from another study showing that
many U.S. adults would fail to comprehend the information
the panel had deemed essential. When asked to evaluate the
importance of the information again, panelists' opinions
shifted dramatically in the direction of requiring that less
information be understood. Follow-up interviews indicated
significant uncertainty about defining a threshold of
understanding and what should happen when prospective
participants are unable to grasp key information. These
findings have important implications for urgently needed
discussion of whether consent comprehension is an ethical
requirement or an ethical aspiration.},
Doi = {10.1080/15265161.2019.1587031},
Key = {fds343377}
}
@article{fds341017,
Author = {Dickert, NW and Scicluna, VM and Adeoye, O and Angiolillo, DJ and Blankenship, JC and Devireddy, CM and Frankel, MR and Goldkind, SF and Kumar, G and Ko, Y-A and Mitchell, AR and Nogueria, RG and Parker, RM and Patel, MR and Riedford, M and Silbergleit, R and Speight, CD and Spokoyny, I and Weinfurt, KP and Pentz, RD},
Title = {Emergency Consent: Patients' and Surrogates' Perspectives on
Consent for Clinical Trials in Acute Stroke and Myocardial
Infarction.},
Journal = {J Am Heart Assoc},
Volume = {8},
Number = {2},
Pages = {e010905},
Year = {2019},
Month = {January},
url = {http://dx.doi.org/10.1161/JAHA.118.010905},
Abstract = {Background Emergent informed consent for clinical trials in
acute myocardial infarction (AMI) and stroke is challenging.
The role and value of consent are controversial, and
insufficient data exist regarding patients' and surrogates'
experiences. Methods and Results We conducted structured
interviews with patients (or surrogates) enrolled in AMI or
acute stroke trials at 6 sites between 2011 and 2016.
Primary domains included trial recall, consent experiences,
and preferences regarding involvement. Descriptive and test
statistics were used to characterize responses and explore
relationships between key domains and characteristics.
Multivariable logistic regression was used to examine
associations between key covariates and consent preferences.
There were 176 (84 stroke, 92 AMI) completed interviews.
Most stroke respondents (82%) were surrogates; all AMI
respondents were patients. Average time from trial
enrollment to interview was 1.9 years (stroke) and
2.8 years (AMI); 89% of stroke and 62% of AMI respondents
remembered being in the trial, and among these respondents,
80% (stroke) and 44% (AMI) remembered reading some of the
consent form. Over 90% reported not feeling pressure to
enroll, being treated in a caring way, and being treated
with dignity. A minority (16% stroke and 26% AMI) reported
they would have preferred not to be asked for consent. Just
over half (61% stroke and 53% AMI) recalled a postenrollment
conversation about the study. Conclusions Most respondents
felt they were treated respectfully and were glad they had
been asked for consent. Trial recall was relatively low, and
many respondents recalled little postenrollment discussion.
Further development of context-sensitive approaches to
consent is important.},
Doi = {10.1161/JAHA.118.010905},
Key = {fds341017}
}
@article{fds340791,
Author = {Simon, GE and Richesson, R and Weinfurt, K and Hernandez, AF and Curtis,
LH},
Title = {Statistical Code for Clinical Research Papers.},
Journal = {Ann Intern Med},
Volume = {170},
Number = {1},
Pages = {80},
Year = {2019},
Month = {January},
url = {http://dx.doi.org/10.7326/L18-0613},
Doi = {10.7326/L18-0613},
Key = {fds340791}
}
@article{fds342794,
Author = {Sugarman, J and Lin, L and Baeten, JM and Palanee-Phillips, T and Brown,
ER and Matovu Kiweewa and F and Mgodi, NM and Nair, G and Siva, S and Seils,
DM and Weinfurt, KP and MTN-020/ASPIRE Study Team},
Title = {Preventive Misconception and Risk Behaviors in a
Multinational HIV Prevention Trial.},
Journal = {AJOB Empir Bioeth},
Volume = {10},
Number = {2},
Pages = {79-87},
Year = {2019},
url = {http://dx.doi.org/10.1080/23294515.2019.1593257},
Abstract = {BACKGROUND: Some HIV prevention research participants may
hold a "preventive misconception" (PM), an overestimate of
the probability or level of personal protection afforded by
trial participation. However, these reports typically rely
upon small, retrospective qualitative assessments that did
not use a standardized approach. METHODS: We administered a
measure of PM called PREMIS, during Microbicide Trials
Network 020-A Study to Prevent Infection with a Ring for
Extended Use, a large, multicenter, placebo-controlled,
phase III trial evaluating the safety and efficacy of a
dapivirine vaginal ring among women at risk for HIV
infection in Malawi, South Africa, Uganda, and Zimbabwe. The
maximum follow-up period was 2.6 years. RESULTS: One
thousand two hundred sixty-one respondents completed PREMIS
at their month 3 visit (M3); 2085 at their month 12 visit
(M12); and 1010 at both visits. Most participants expressed
high expectations of personal benefit (EPB) and that at
least one of the rings used in the trial would reduce the
risk of getting HIV (expectation of maximum aggregate
benefit or EMAB). There was a moderate positive correlation
between EPB and EMAB at M3 (r = .43, 95% CI: .37, .47) and
M12 (r = .44, 95% CI: .40, .48). However, there was
variability among sites in the strength of the relationship.
There was no relationship between either expectation
variable and condom use, adherence, or HIV infection.
CONCLUSIONS: A majority of trial participants expressed some
belief that their risk of HIV infection would be reduced by
using a vaginal ring, which may signal PM. However, such
beliefs were not associated with adherence, condom use, or
subsequent HIV infection, and there was variability across
sites. Further work is needed to understand these
findings.},
Doi = {10.1080/23294515.2019.1593257},
Key = {fds342794}
}
@article{fds338577,
Author = {Ljungman, L and Ahlgren, J and Petersson, L-M and Flynn, KE and Weinfurt, K and Gorman, JR and Wettergren, L and Lampic,
C},
Title = {Sexual dysfunction and reproductive concerns in young women
with breast cancer: Type, prevalence, and predictors of
problems.},
Journal = {Psychooncology},
Volume = {27},
Number = {12},
Pages = {2770-2777},
Year = {2018},
Month = {December},
url = {http://dx.doi.org/10.1002/pon.4886},
Abstract = {OBJECTIVE: A dearth of studies focusing on young women
(<40 years) with breast cancer have hampered the
understanding of the type, prevalence, and predictors of
sexual dysfunction and reproductive concerns in this
population. METHODS: Data were collected from 181 women
(response rate = 60%) diagnosed with breast cancer
approximately 2 years previously (age 21-39) using the
Swedish National Quality Registry for Breast Cancer and a
survey including standardized measures of sexual
dysfunction, reproductive concerns, body image, and
health-related quality of life. Multivariable logistic
binary regression analyses were used to identify predictors
of sexual dysfunction and reproductive concerns. RESULTS:
Sexual dysfunction in at least one domain was reported by
68% of the women, and a high level of reproductive concerns
in at least one dimension was reported by 58%. Model results
showed that current endocrine treatment was a significant
predictor of dysfunction related to lubrication (OR 3.8, 95%
CI 1.2-12.1) and vaginal discomfort (OR 8.7, 95% CI
1.5-51.5). Negative body image was related to satisfaction
with sex life (OR 1.1, 95% CI 1.0-1.2). A high level of
reproductive concerns was predicted by a wish for
(additional) children in the future (OR 3.4, 95% CI
1.1-10.2) and by previous chemotherapy (OR 2.5, 95% CI
1.1-5.9). CONCLUSIONS: Sexual dysfunction and reproductive
concerns are common in young women with breast cancer.
Current endocrine treatment, previous chemotherapy, a
negative body image, and a wish for children in the future
predict higher level of problems.},
Doi = {10.1002/pon.4886},
Key = {fds338577}
}
@article{fds339345,
Author = {Andreev, VP and Liu, G and Yang, CC and Smith, AR and Helmuth, ME and Wiseman, JB and Merion, RM and Weinfurt, KP and Cameron, AP and Lai, HH and Cella, D and Gillespie, BW and Helfand, BT and Griffith, JW and DeLancey, JOL and Fraser, MO and Clemens, JQ and Kirkali, Z and LURN
Study Group},
Title = {Symptom Based Clustering of Women in the LURN Observational
Cohort Study.},
Journal = {J Urol},
Volume = {200},
Number = {6},
Pages = {1323-1331},
Year = {2018},
Month = {December},
url = {http://dx.doi.org/10.1016/j.juro.2018.06.068},
Abstract = {PURPOSE: Women with lower urinary tract symptoms are often
diagnosed based on a predefined symptom complex or a
predominant symptom. There are many limitations to this
paradigm as often patients present with multiple urinary
symptoms which do not perfectly fit the preestablished
diagnoses. We used cluster analysis to identify novel,
symptom based subtypes of women with lower urinary tract
symptoms. MATERIALS AND METHODS: We analyzed baseline
urinary symptom questionnaire data obtained from 545 care
seeking female participants enrolled in the LURN (Symptoms
of Lower Urinary Tract Dysfunction Research Network)
Observational Cohort Study. Symptoms were measured with the
LUTS (lower urinary tract symptoms) Tool and the AUA SI
(American Urological Association Symptom Index), and
analyzed using a probability based consensus clustering
algorithm. RESULTS: Four clusters were identified. The 138
women in cluster F1 did not report incontinence but
experienced post-void dribbling, frequency and voiding
symptoms. The 80 women in cluster F2 reported urgency
incontinence as well as urgency and frequency but minimal
voiding symptoms or stress incontinence. Cluster F3 included
244 women who reported all types of incontinence, urgency,
frequency and mild voiding symptoms. The 83 women in cluster
F4 reported all lower urinary tract symptoms at uniformly
high levels. All but 2 of 44 LUTS Tool and 8 AUA SI
questions significantly differed between at least 2 clusters
(p <0.05). All clusters contained at least 1 member from
each conventional group, including continence, and stress,
urgency, mixed and other incontinence. CONCLUSIONS: Women
seeking care for lower urinary tract symptoms cluster into 4
distinct symptom groups which differ from conventional
clinical diagnostic groups. Further validation is needed to
determine whether management improves using this new
classification.},
Doi = {10.1016/j.juro.2018.06.068},
Key = {fds339345}
}
@article{fds339694,
Author = {Gensheimer, SG and Wu, AW and Snyder, CF and PRO-EHR Users’ Guide
Steering Group, and PRO-EHR Users’ Guide Working
Group},
Title = {Oh, the Places We'll Go: Patient-Reported Outcomes and
Electronic Health Records.},
Journal = {Patient},
Volume = {11},
Number = {6},
Pages = {591-598},
Year = {2018},
Month = {December},
url = {http://dx.doi.org/10.1007/s40271-018-0321-9},
Abstract = {The growing measurement of patient-reported outcomes (PROs)
and adoption of electronic health records (EHRs) presents an
unprecedented opportunity to improve health care for
patients and populations. The integration of PROs into EHRs
can promote patient-centered care and advance quality
improvement initiatives, research, and population health.
Despite these potential benefits, there are few best
practices to help organizations achieve integration. To
integrate PROs into EHRs, organizations should evaluate the
advantages and disadvantages of various approaches within
three themes: Planning, Selection, and Engagement. Planning
considerations for integration include what strategy will be
used, how the integrated system will be governed, ethical
and legal issues, and how data from multiple EHRs can be
pooled across organizations. Selection considerations
involve identifying which patient population to target for
PRO data collection on the basis of the intended use of the
data in the health care system, and then choosing specific
outcomes and their measures. Engagement considerations
include how, where, and with what frequency patients will
respond to PRO measures, how to display PRO data in EHRs,
how clinical teams will act upon PRO data, and how to train,
support and incent clinical teams and patients to
incorporate PRO data into care. There is no most effective
model that will work in all contexts. Organizations wishing
to integrate PROs and EHRs should assemble the
multidisciplinary expertise needed to evaluate the
advantages and disadvantages of the various approaches for
their particular context. We specifically recommend that
organizations think carefully about stakeholder
participation; design their system with data sharing in
mind; develop a framework to aid in PRO selection; create
guidelines to support PRO interpretation and action for
patients and clinicians; and ensure patients have access to
their own PRO data.},
Doi = {10.1007/s40271-018-0321-9},
Key = {fds339694}
}
@article{fds337742,
Author = {Eluri, S and Cross, RK and Martin, C and Weinfurt, KP and Flynn, KE and Long, MD and Chen, W and Anton, K and Sandler, RS and Kappelman,
MD},
Title = {Correction to: Inflammatory Bowel Diseases Can Adversely
Impact Domains of Sexual Function Such as Satisfaction with
Sex Life.},
Journal = {Dig Dis Sci},
Volume = {63},
Number = {10},
Pages = {2816},
Year = {2018},
Month = {October},
url = {http://dx.doi.org/10.1007/s10620-018-5250-x},
Abstract = {The original version of the article unfortunately contained
an error in Results section of Abstract.},
Doi = {10.1007/s10620-018-5250-x},
Key = {fds337742}
}
@article{fds338578,
Author = {Weinfurt, KP},
Title = {Propositions and Pragmatics.},
Journal = {Am J Bioeth},
Volume = {18},
Number = {9},
Pages = {18-20},
Year = {2018},
Month = {September},
url = {http://dx.doi.org/10.1080/15265161.2018.1498943},
Doi = {10.1080/15265161.2018.1498943},
Key = {fds338578}
}
@article{fds336097,
Author = {Helfand, BT and Smith, AR and Lai, HH and Yang, CC and Gore, JL and Erickson, BA and Kreder, KJ and Cameron, AP and Weinfurt, KP and Griffith, JW and Lentz, A and Talaty, P and Andreev, VP and Kirkali, Z and LURN},
Title = {Prevalence and Characteristics of Urinary Incontinence in a
Treatment Seeking Male Prospective Cohort: Results from the
LURN Study.},
Journal = {J Urol},
Volume = {200},
Number = {2},
Pages = {397-404},
Year = {2018},
Month = {August},
url = {http://dx.doi.org/10.1016/j.juro.2018.02.075},
Abstract = {PURPOSE: Male urinary incontinence is thought to be
infrequent. We sought to describe the prevalence of urinary
incontinence in a male treatment seeking cohort enrolled in
the LURN (Symptoms of Lower Urinary Tract Dysfunction
Research Network). MATERIALS AND METHODS: Study inclusion
and exclusion criteria, including men with prostate cancer
or neurogenic bladder, were previously reported. LURN
participants prospectively completed questionnaires
regarding lower urinary tract symptoms and other clinical
variables. Men were grouped based on incontinence type,
including 1) no urinary incontinence, 2) post-void dribbling
only and 3) urinary incontinence. Comparisons were made
using ANOVA and multivariable regression. RESULTS: Of the
477 men 24% reported no urinary incontinence, 44% reported
post-void dribbling only and 32% reported urinary
incontinence. African American men and those with sleep
apnea were more likely to be in the urinary incontinence
group than in the no urinary incontinence group (OR 3.2, p =
0.02 and OR 2.73, p = 0.003, respectively). Urinary
incontinence was associated with significantly higher bother
compared to men without leakage (p <0.001). Compared to men
without urinary incontinence and men with only post-void
dribbling those with urinary incontinence were significantly
more likely to report higher scores (more severe symptoms)
on the PROMIS (Patient-Reported Outcomes Measurement
Information System) questionnaires regarding bowel issues,
depression and anxiety than men without urinary incontinence
(p <0.01). CONCLUSIONS: Urinary incontinence is common among
treatment seeking men. This is concerning because the
guideline recommended questionnaires to assess male lower
urinary tract symptoms do not query for urinary
incontinence. Thus, clinicians may be missing an opportunity
to intervene and improve patient care. This provides a
substantial rationale for a new or updated symptom
questionnaire which provides a more comprehensive symptom
assessment.},
Doi = {10.1016/j.juro.2018.02.075},
Key = {fds336097}
}
@article{fds333790,
Author = {Eluri, S and Cross, RK and Martin, C and Weinfurt, KP and Flynn, KE and Long, MD and Chen, W and Anton, K and Sandler, RS and Kappelman,
MD},
Title = {Inflammatory Bowel Diseases Can Adversely Impact Domains of
Sexual Function Such as Satisfaction with Sex
Life.},
Journal = {Dig Dis Sci},
Volume = {63},
Number = {6},
Pages = {1572-1582},
Year = {2018},
Month = {June},
url = {http://dx.doi.org/10.1007/s10620-018-5021-8},
Abstract = {BACKGROUND: Aspects of sexual health, which can be adversely
affected by chronic disease, have been inadequately explored
in inflammatory bowel disease (IBD). AIMS: We evaluated
patient-reported interest in sexual activity and
satisfaction with sex life in a large cohort of IBD
patients. METHODS: We conducted a cross-sectional study
within the Crohn's and Colitis Foundation Partners Internet
cohort. Sequential participants completed a 6-question
supplemental online survey to examine sexual interest and
satisfaction using the Patient-Reported Outcome Measurement
Information System® (PROMIS®) Sexual Function and
Satisfaction measures. One-sample t tests were used to
compare interest and satisfaction scores to general
population norms. RESULTS: Among 2569 individuals, 1639 had
Crohn's disease (CD), 930 had ulcerative colitis (UC) or
indeterminate colitis, and 71% were women. Mean PROMIS
scores for sexual interest were comparable to the general US
population in men (CD: 49 and UC: 50 vs. population mean 50)
and women (CD: 41 and UC: 40 vs. population mean 42).
However, sexual satisfaction scores were lower than the US
population in men (CD: 48 and UC: 48 vs. 51) and women (CD:
47 and UC: 46 vs. 49), p < 0.01 for both. Older age,
disease activity, depression, anxiety, and pain were
associated with lower interest and satisfaction and lowered
IBD-specific quality of life. CONCLUSIONS: IBD patients in a
large online survey had similar levels of sexual interest
but decreased sexual satisfaction compared to the general
population. Exploring these sexual health domains during
clinical encounters can aid in improving IBD quality of
life.},
Doi = {10.1007/s10620-018-5021-8},
Key = {fds333790}
}
@article{fds333789,
Author = {Atallah, E and Schiffer, CA and Weinfurt, KP and Zhang, M-J and Radich,
JP and Oehler, VG and Pinilla-Ibarz, J and Deininger, MWN and Lin, L and Larson, RA and Mauro, MJ and Moore, JO and Ritchie, EK and Shah, NP and Silver, RT and Wadleigh, M and Cortes, J and Thompson, J and Guhl, J and Horowitz, MM and Flynn, KE},
Title = {Design and rationale for the life after stopping tyrosine
kinase inhibitors (LAST) study, a prospective, single-group
longitudinal study in patients with chronic myeloid
leukemia.},
Journal = {BMC Cancer},
Volume = {18},
Number = {1},
Pages = {359},
Year = {2018},
Month = {April},
url = {http://dx.doi.org/10.1186/s12885-018-4273-1},
Abstract = {BACKGROUND: Treatment of chronic myeloid leukemia with a
tyrosine kinase inhibitor (TKI) offers significant
improvements over previous treatments in terms of survival
and toxicity yet nevertheless is associated with reduced
health-related quality of life and very high cost. Several
small studies from Europe and Australia suggested that
discontinuing TKIs with regular monitoring was safe.
METHODS: The Life After Stopping TKIs (LAST) study is a
large, U.S.-based study that aims to improve the evidence
for clinical decision making regarding TKI discontinuation
with monitoring in patients with chronic myeloid leukemia
who have a deep molecular response to TKI therapy. The LAST
study is a non-randomized, prospective, single-group
longitudinal study of 173 patients. The co-primary
objectives are to determine the proportion of patients who
develop molecular recurrence (> 0.1% BCR-ABLIS) after
discontinuing one of four TKIs (imatinib, dasatinib,
nilotinib, or bosutinib) and to compare the patient-reported
health status of patients before and after stopping TKIs.
Outcomes are assessed at baseline and throughout the
36-month study follow-up period with a central laboratory
used for blood samples. All samples with undetectable
BCR-ABL are also examined using digital polymerase chain
reaction, which is a more sensitive nanofluidic polymerase
chain reaction system. DISCUSSION: Because of their high
cost and side effects, discontinuation of TKIs for patients
with chronic myeloid leukemia who have a deep molecular
response to TKI therapy is a promising approach to
treatment. The LAST study is the largest U.S.-based TKI
discontinuation study. It is the first to allow
participation from patients on any of 4 first- and
second-generation TKIs, includes a robust approach to
measurement of clinical and patient-reported outcomes, and
is using digital polymerase chain reaction to explore better
prediction of safe discontinuation. TRIAL REGISTRATION: This
study was registered prospectively on October 21, 2014 and
assigned trial number NCT02269267 .},
Doi = {10.1186/s12885-018-4273-1},
Key = {fds333789}
}
@article{fds333245,
Author = {Cameron, AP and Lewicky-Gaupp, C and Smith, AR and Helfand, BT and Gore,
JL and Clemens, JQ and Yang, CC and Siddiqui, NY and Lai, HH and Griffith,
JW and Andreev, VP and Liu, G and Weinfurt, K and Amundsen, CL and Bradley,
CS and Kusek, JW and Kirkali, Z and Symptoms of Lower Urinary Tract
Dysfunction Research Network Study Group},
Title = {Baseline Lower Urinary Tract Symptoms in Patients Enrolled
in LURN: A Prospective, Observational Cohort
Study.},
Journal = {J Urol},
Volume = {199},
Number = {4},
Pages = {1023-1031},
Year = {2018},
Month = {April},
url = {http://dx.doi.org/10.1016/j.juro.2017.10.035},
Abstract = {PURPOSE: We described and compared the frequency and type of
lower urinary tract symptoms reported by men and women at
the time that they were recruited from urology and
urogynecology clinics into the Symptoms of Lower Urinary
Tract Dysfunction Research Network multicenter, prospective,
observational cohort study. MATERIALS AND METHODS: At 6
research sites treatment seeking men and women were enrolled
who reported any lower urinary tract symptoms at a frequency
more than rarely during the last month on the LUTS (Lower
Urinary Tract Symptoms) Tool. At baseline the study
participants underwent a standardized clinical evaluation
and completed validated questionnaires. Urological tests
were performed, including pelvic/rectal examination,
post-void residual urine measurement and urinalysis.
RESULTS: A total of 545 women and 519 men were enrolled in
the study. Mean ± SD age was 58.8 ± 14.1 years. At
baseline nocturia, frequency and a sensation of incomplete
emptying were similar in men and women but men experienced
more voiding symptoms (90% vs 85%, p = 0.007) and women
reported more urgency (85% vs 66%, p <0.001). Women also
reported more of any type of urinary incontinence than men
(82% vs 51% p <0.001), which was mixed incontinence in 57%.
Only 1% of men reported stress incontinence but they had
other urinary incontinence, including post-void dribbling in
44% and urgency incontinence in 46%. Older participants had
higher odds of reporting symptoms of nocturia and urgency.
CONCLUSIONS: In this large, treatment seeking cohort of men
and women lower urinary tract symptoms varied widely by
gender and age. Men reported more voiding symptoms and
nonstress or urgency urinary incontinence while women
reported more incontinence overall and urgency. Older
participants had greater odds of urgency and
nocturia.},
Doi = {10.1016/j.juro.2017.10.035},
Key = {fds333245}
}
@article{fds331471,
Author = {Griffith, JW and Messersmith, EE and Gillespie, BW and Wiseman, JB and Flynn, KE and Kirkali, Z and Kusek, JW and Bavendam, T and Cella, D and Kreder, KJ and Nero, JJ and Corona, ME and Bradley, CS and Kenton, KS and Helfand, BT and Merion, RM and Weinfurt, KP and LURN Study
Group},
Title = {Reasons for Seeking Clinical Care for Lower Urinary Tract
Symptoms: A Mixed Methods Study.},
Journal = {J Urol},
Volume = {199},
Number = {2},
Pages = {528-535},
Year = {2018},
Month = {February},
url = {http://dx.doi.org/10.1016/j.juro.2017.07.067},
Abstract = {PURPOSE: The primary objective of this study was to evaluate
reasons for seeking care among men and women with lower
urinary tract symptoms. MATERIALS AND METHODS: Participants
were recruited from urology and urogynecology clinics, and
the community. The sample was enriched with persons expected
to have abnormal or diminished bladder sensations (eg
participants with lower back surgery and participants 65
years old or older). Interviews were performed in person
beginning with an open-ended assessment of urinary symptoms
and associated bother followed by more directed questions,
including reasons for seeking or not seeking treatment. We
also examined the relationship between symptom frequency and
bother using the LUTS (Lower Urinary Tract Symptoms) Tool.
RESULTS: A total of 88 participants, including 38 men and 50
women, with a mean ± SD age of 52.2 ± 14.3 years provided
information about urinary symptoms, including a range of
quality of life consequences and coping behaviors. They
sought treatment mostly because of new, continuing or
bothersome symptoms. Factors associated with not seeking
treatment included low symptom severity and concerns about
the costs vs the benefits of treatment (eg side effects of
medication). Symptom frequency and bother were associated
with each other across symptoms assessed by the LUTS Tool.
CONCLUSIONS: In this large qualitative study we obtained
useful insights into the impact of lower urinary tract
symptoms from the perspective of the person with the
symptoms. Removing barriers and misconceptions about the
treatment of lower urinary tract symptoms may increase the
number of people who seek clinical care and improve the
clinical course of men and women who experience lower
urinary tract symptoms.},
Doi = {10.1016/j.juro.2017.07.067},
Key = {fds331471}
}
@article{fds331316,
Author = {Dickert, NW and Eyal, N and Goldkind, SF and Grady, C and Joffe, S and Lo,
B and Miller, FG and Pentz, RD and Silbergleit, R and Weinfurt, KP and Wendler, D and Kim, SYH},
Title = {Reframing Consent for Clinical Research: A Function-Based
Approach.},
Journal = {Am J Bioeth},
Volume = {17},
Number = {12},
Pages = {3-11},
Year = {2017},
Month = {December},
url = {http://dx.doi.org/10.1080/15265161.2017.1388448},
Abstract = {Although informed consent is important in clinical research,
questions persist regarding when it is necessary, what it
requires, and how it should be obtained. The standard view
in research ethics is that the function of informed consent
is to respect individual autonomy. However, consent
processes are multidimensional and serve other ethical
functions as well. These functions deserve particular
attention when barriers to consent exist. We argue that
consent serves seven ethically important and conceptually
distinct functions. The first four functions pertain
principally to individual participants: (1) providing
transparency; (2) allowing control and authorization; (3)
promoting concordance with participants' values; and (4)
protecting and promoting welfare interests. Three other
functions are systemic or policy focused: (5) promoting
trust; (6) satisfying regulatory requirements; and (7)
promoting integrity in research. Reframing consent around
these functions can guide approaches to consent that are
context sensitive and that maximize achievable
goals.},
Doi = {10.1080/15265161.2017.1388448},
Key = {fds331316}
}
@article{fds329323,
Author = {DeLamater, JD and Weinfurt, KP and Flynn, KE},
Title = {Patients' Conceptions of Terms Related to Sexual Interest,
Desire, and Arousal.},
Journal = {J Sex Med},
Volume = {14},
Number = {11},
Pages = {1327-1335},
Year = {2017},
Month = {November},
url = {http://dx.doi.org/10.1016/j.jsxm.2017.09.009},
Abstract = {BACKGROUND: Measurement of sexual function typically uses
self-report, which, to work as intended, must use language
that is understood consistently by diverse respondents.
Commonly used measures employ multiple terms, primarily
(sexual) interest, desire, and arousal, that might not be
understood in the same way by laypeople and professionals.
AIM: To inform self-reported measurement efforts for
research and clinical settings by examining how US men and
women recruited from a health care setting understand and
interpret different terms. METHODS: We conducted 10 focus
groups in Durham, NC (N = 57). Discussions were
audio-recorded and transcribed, and the content of the
discussions was systematically analyzed in 2 phases of
coding by the research team, facilitated by Nvivo
qualitative analysis software (QSR International, Doncaster,
VIC, Australia). OUTCOMES: Patient focus group discussions
about the meanings and connotations of multiple terms
related to sexual function, especially interest, desire, and
arousal. RESULTS: 5 groups included male participants and 5
included female participants. Participants characterized
(sexual) interest as a cognitive phenomenon and a
situational response to a specific person. Similarly, they
characterized (sexual) desire as a situational
person-specific experience with some support for it as a
cognitive phenomenon but more support for it as a physical
phenomenon. In contrast, participants characterized sexual
arousal as a physical phenomenon occurring in response to
physical or visual stimulation and not related to a specific
person. CLINICAL IMPLICATIONS: These results can help us
understand how laypeople are using and responding to these
terms when they are used in clinical and research settings.
STRENGTHS AND LIMITATIONS: Patient participants in these
groups were diverse in age, gender, sexual orientation, and
health, with the potential to voice diverse perspectives on
sexual functioning; however, the sample was limited to a
single city in the southeastern United States. CONCLUSION:
The meanings of interest, desire, and arousal were defined,
compared, and contrasted in the context of patient focus
groups. Qualitative coding showed that interest was
considered the most "cognitive," arousal the most
"physical," and desire somewhere in between. DeLamater JD,
Weinfurt KP, Flynn KE. Patients' Conceptions of Terms
Related to Sexual Interest, Desire, and Arousal. J Sex Med
2017;14:1327-1335.},
Doi = {10.1016/j.jsxm.2017.09.009},
Key = {fds329323}
}
@article{fds327306,
Author = {Weinfurt, KP and Bollinger, JM and Brelsford, KM and Bresciani, M and Lampron, Z and Lin, L and Topazian, RJ and Sugarman,
J},
Title = {Comparison of Approaches for Notification and Authorization
in Pragmatic Clinical Research Evaluating Commonly Used
Medical Practices.},
Journal = {Med Care},
Volume = {55},
Number = {11},
Pages = {970-978},
Year = {2017},
Month = {November},
url = {http://dx.doi.org/10.1097/MLR.0000000000000762},
Abstract = {BACKGROUND: For pragmatic clinical research comparing
commonly used treatments, questions exist about if and how
to notify participants about it and secure their
authorization for participation. OBJECTIVE: To determine how
patients react when they seek clinical care and encounter
one of several different pragmatic clinical research
studies. RESEARCH DESIGN: In an online survey using a
between-subjects experimental design, respondents read and
responded to 1 of 24 hypothetical research scenarios
reflecting different types of studies and approaches to
notification and authorization (eg, general notification,
oral consent, written consent). SUBJECTS: English-speaking
US adults 18 years and older. MEASURES: Willingness to
participate in the hypothetical study, acceptability of the
notification and authorization approach, understanding of
the study, perceptions of benefit/harm, trust, and
perception of amount of study information received. RESULTS:
Willingness to participate did not differ by notification
and authorization approach. Some (21%-36%) of the patients
randomized to general notification with an explicit opt-out
provision were not aware they would be enrolled by default.
Acceptability was greatest for and similar among
notification and authorization approaches that actively
engaged the patient (eg, oral or written consent) and lower
for approaches with less engagement (eg, general
notification). Problems of understanding were found among
20%-55% of respondents, depending on the particular
scenario. Most respondents (77%-94%) felt that participation
in the hypothetical study posed no risks of harm to their
health or privacy. CONCLUSIONS: Current attitudes about
notification and authorization approaches and difficulties
understanding pragmatic clinical research pose significant
challenges for pragmatic research. Data from this study
provide a starting point to developing solutions to these
surprisingly complex issues.},
Doi = {10.1097/MLR.0000000000000762},
Key = {fds327306}
}
@article{fds328938,
Author = {Weinfurt, KP and Hernandez, AF and Coronado, GD and DeBar, LL and Dember, LM and Green, BB and Heagerty, PJ and Huang, SS and James, KT and Jarvik, JG and Larson, EB and Mor, V and Platt, R and Rosenthal, GE and Septimus, EJ and Simon, GE and Staman, KL and Sugarman, J and Vazquez,
M and Zatzick, D and Curtis, LH},
Title = {Pragmatic clinical trials embedded in healthcare systems:
generalizable lessons from the NIH Collaboratory.},
Journal = {BMC Med Res Methodol},
Volume = {17},
Number = {1},
Pages = {144},
Year = {2017},
Month = {September},
url = {http://dx.doi.org/10.1186/s12874-017-0420-7},
Abstract = {BACKGROUND: The clinical research enterprise is not
producing the evidence decision makers arguably need in a
timely and cost effective manner; research currently
involves the use of labor-intensive parallel systems that
are separate from clinical care. The emergence of pragmatic
clinical trials (PCTs) poses a possible solution: these
large-scale trials are embedded within routine clinical care
and often involve cluster randomization of hospitals,
clinics, primary care providers, etc. Interventions can be
implemented by health system personnel through usual
communication channels and quality improvement
infrastructure, and data collected as part of routine
clinical care. However, experience with these trials is
nascent and best practices regarding design operational,
analytic, and reporting methodologies are undeveloped.
METHODS: To strengthen the national capacity to implement
cost-effective, large-scale PCTs, the Common Fund of the
National Institutes of Health created the Health Care
Systems Research Collaboratory (Collaboratory) to support
the design, execution, and dissemination of a series of
demonstration projects using a pragmatic research design.
RESULTS: In this article, we will describe the
Collaboratory, highlight some of the challenges encountered
and solutions developed thus far, and discuss remaining
barriers and opportunities for large-scale evidence
generation using PCTs. CONCLUSION: A planning phase is
critical, and even with careful planning, new challenges
arise during execution; comparisons between arms can be
complicated by unanticipated changes. Early and ongoing
engagement with both health care system leaders and
front-line clinicians is critical for success. There is also
marked uncertainty when applying existing ethical and
regulatory frameworks to PCTS, and using existing electronic
health records for data capture adds complexity.},
Doi = {10.1186/s12874-017-0420-7},
Key = {fds328938}
}
@article{fds326416,
Author = {Beskow, LM and Lin, L and Dombeck, CB and Gao, E and Weinfurt,
KP},
Title = {Improving biobank consent comprehension: a national
randomized survey to assess the effect of a simplified form
and review/retest intervention.},
Journal = {Genet Med},
Volume = {19},
Number = {5},
Pages = {505-512},
Year = {2017},
Month = {May},
url = {http://dx.doi.org/10.1038/gim.2016.157},
Abstract = {PURPOSE: To determine the individual and combined effects of
a simplified form and a review/retest intervention on
biobanking consent comprehension. METHODS: We conducted a
national online survey in which participants were randomized
within four educational strata to review a simplified or
traditional consent form. Participants then completed a
comprehension quiz; for each item answered incorrectly, they
reviewed the corresponding consent form section and answered
another quiz item on that topic. RESULTS: Consistent with
our first hypothesis, comprehension among those who received
the simplified form was not inferior to that among those who
received the traditional form. Contrary to expectations,
receipt of the simplified form did not result in
significantly better comprehension compared with the
traditional form among those in the lowest educational
group. The review/retest procedure significantly improved
quiz scores in every combination of consent form and
education level. Although improved, comprehension remained a
challenge in the lowest-education group. Higher quiz scores
were significantly associated with willingness to
participate. CONCLUSION: Ensuring consent comprehension
remains a challenge, but simplified forms have virtues
independent of their impact on understanding. A
review/retest intervention may have a significant effect,
but assessing comprehension raises complex questions about
setting thresholds for understanding and consequences of not
meeting them.Genet Med advance online publication 13 October
2016.},
Doi = {10.1038/gim.2016.157},
Key = {fds326416}
}
@article{fds323758,
Author = {Flynn, KE and Carter, J and Lin, L and Lindau, ST and Jeffery, DD and Reese, JB and Schlosser, BJ and Weinfurt, KP},
Title = {Assessment of vulvar discomfort with sexual activity among
women in the United States.},
Journal = {Am J Obstet Gynecol},
Volume = {216},
Number = {4},
Pages = {391.e1-391.e8},
Year = {2017},
Month = {April},
url = {http://dx.doi.org/10.1016/j.ajog.2016.12.006},
Abstract = {BACKGROUND: Multidimensional self-report measures of sexual
function for women do not include the assessment of vulvar
discomfort, limiting our understanding of its prevalence. In
an effort to improve the measurement of patient-reported
health, the National Institutes of Health funded the
creation of the Patient Reported Outcomes Measurement
Information System (PROMIS). This included the development
of the PROMIS Sexual Function and Satisfaction measure, and
version 2.0 of the Sexual Function and Satisfaction measure
included 2 scales to measure vulvar discomfort with sexual
activity. OBJECTIVES: The objectives of the study were to
describe the development of 2 self-reported measures of
vulvar discomfort with sexual activity, describe the
relationships between these scales and scales for
lubrication and vaginal discomfort, and report the
prevalence of vulvar discomfort with sexual activity
in a large, nationally representative sample of US women.
STUDY DESIGN: We followed PROMIS measure development
standards, including qualitative development work with
patients and clinicians and psychometric evaluation of
candidate items based on item response theory, in a
probability sample of 1686 English-speaking US adult women.
We tested 16 candidate items on vulvar discomfort. We
present descriptive statistics for these items, correlation
coefficients among the vulvar and vaginal scales, and mean
PROMIS scores with 95% confidence intervals separately by
menopausal status for the 1046 women who reported sexual
activity in the past 30 days. RESULTS: Based on the
psychometric evaluation of the candidate items, we created 2
separate 4 item scales, one to measure labial discomfort and
pain and one to measure clitoral discomfort and pain.
Additional items not included in the scales assess pain
quality, numbness, and bleeding. The correlations between
the lubrication, vaginal discomfort, and the 2 vulvar
discomfort measures ranged from 0.46 to 0.77, suggesting
that these measures represent related yet distinct concepts.
In our nationally representative sample, 1 in 5 US women
endorsed some degree of vulvar discomfort with sexual
activity in the past 30 days. Menopausal status was
associated with lower lubrication and higher vaginal
discomfort but not with vulvar discomfort. CONCLUSION: The
PROMIS Vulvar Discomfort with Sexual Activity-Labial and
Vulvar Discomfort with Sexual Activity-Clitoral scales are
publicly available for use in research and clinical
settings. There is limited overlap between vulvar discomfort
and lubrication or vaginal discomfort. The importance of
measuring vulvar discomfort as part of a comprehensive
assessment of sexual function is underscored by its
prevalence.},
Doi = {10.1016/j.ajog.2016.12.006},
Key = {fds323758}
}
@article{fds326258,
Author = {Flynn, KE and Lin, L and Weinfurt, KP},
Title = {Sexual function and satisfaction among heterosexual and
sexual minority U.S. adults: A cross-sectional
survey.},
Journal = {PLoS One},
Volume = {12},
Number = {4},
Pages = {e0174981},
Year = {2017},
url = {http://dx.doi.org/10.1371/journal.pone.0174981},
Abstract = {BACKGROUND: Despite known health disparities for sexual
minorities, few studies have described sexual function by
sexual orientation using a robust approach to measurement of
sexual function. We compared recent sexual function and
satisfaction by sexual orientation among English-speaking US
adults. METHODS AND FINDINGS: Cross-sectional surveys were
administered by KnowledgePanel® (GfK), an online panel that
uses address-based probability sampling and is
representative of the civilian, noninstitutionalized US
population. Data were collected in 2013 from the general
population (n = 3314, 35% response rate) and in 2014 from
self-identified lesbian, gay, and bisexual adults (n = 1011,
50% response rate). Sexual function and satisfaction were
measured using the Patient-Reported Outcomes Measurement
Information System® Sexual Function and Satisfaction
measure version 2.0 (PROMIS SexFS v2). The PROMIS SexFS v2
is a comprehensive, customizable measurement system with
evidence for validity in diverse populations. A score of 50
(SD 10) on each domain corresponds to the average for US
adults sexually active in the past 30 days. We adjusted all
statistics for the complex sample designs and report
differences within each sex where the 95% CIs do not
overlap, corresponding to p<0.01. Among US men who reported
any sexual activity in the past 30 days, there were no
differences in erectile function or orgasm-ability. Compared
to heterosexual men, sexual minority men reported higher
oral dryness and lower orgasm-pleasure and satisfaction.
Compared to heterosexual men, gay men reported lower
interest, higher anal discomfort and higher oral discomfort.
Among sexually active women, there were no differences in
the domains of vulvar discomfort-clitoral, orgasm-pleasure,
or satisfaction. Compared to heterosexual women, sexual
minority women reported higher oral dryness. Lesbian women
reported lower vaginal discomfort than other women; lesbian
women reported higher lubrication and orgasm-ability than
heterosexual women. Bisexual women reported higher interest,
higher vulvar discomfort-labial and higher anal discomfort
than other women, as well as higher oral discomfort compared
to heterosexual women. CONCLUSIONS: Recent sexual function
and satisfaction differed by sexual orientation among US
adults. Sexual minority men and women had decrements in
domains of sexual function that have not traditionally been
included in multi-dimensional self-report measures.
Clinicians should make themselves aware of their patients'
sexual concerns and recognize that sexual minority patients
may be more vulnerable to certain sexual difficulties than
heterosexual patients.},
Doi = {10.1371/journal.pone.0174981},
Key = {fds326258}
}
@article{fds322132,
Author = {Flynn, KE and Lin, L and Bruner, DW and Cyranowski, JM and Hahn, EA and Jeffery, DD and Reese, JB and Reeve, BB and Shelby, RA and Weinfurt,
KP},
Title = {Sexual Satisfaction and the Importance of Sexual Health to
Quality of Life Throughout the Life Course of U.S.
Adults.},
Journal = {J Sex Med},
Volume = {13},
Number = {11},
Pages = {1642-1650},
Year = {2016},
Month = {November},
url = {http://dx.doi.org/10.1016/j.jsxm.2016.08.011},
Abstract = {INTRODUCTION: Discussions about sexual health are uncommon
in clinical encounters, despite the sexual dysfunction
associated with many common health conditions. Understanding
of the importance of sexual health and sexual satisfaction
in U.S. adults is limited. AIM: To provide epidemiologic
data on the importance of sexual health for quality of life
and people's satisfaction with their sex lives and to
examine how each is associated with demographic and health
factors. METHODS: Data are from a cross-sectional
self-report questionnaire from a sample of 3,515
English-speaking U.S. adults recruited from an online panel
that uses address-based probability sampling. MAIN OUTCOME
MEASURES: We report ratings of importance of sexual health
to quality of life (single item with five-point response)
and the Patient-Reported Outcomes Measurement Information
System Satisfaction With Sex Life score (five items, each
with five-point responses, scores centered on the U.S.
mean). RESULTS: High importance of sexual health to quality
of life was reported by 62.2% of men (95% CI = 59.4-65.0)
and 42.8% of women (95% CI = 39.6-46.1, P < .001).
Importance of sexual health varied by sex, age, sexual
activity status, and general self-rated health. For the 55%
of men and 45% of women who reported sexual activity in the
previous 30 days, satisfaction with sex life differed by
sex, age, race-ethnicity (among men only), and health. Men
and women in excellent health had significantly higher
satisfaction than participants in fair or poor health. Women
with hypertension reported significantly lower satisfaction
(especially younger women), as did men with depression or
anxiety (especially younger men). CONCLUSION: In this large
study of U.S. adults' ratings of the importance of sexual
health and satisfaction with sex life, sexual health was a
highly important aspect of quality of life for many
participants, including participants in poor health.
Moreover, participants in poorer health reported lower
sexual satisfaction. Accordingly, sexual health should be a
routine part of clinicians' assessments of their patients.
Health care systems that state a commitment to improving
patients' overall health must have resources in place to
address sexual concerns. These resources should be available
for all patients across the lifespan.},
Doi = {10.1016/j.jsxm.2016.08.011},
Key = {fds322132}
}
@article{fds331317,
Author = {Weinfurt, KP},
Title = {The Need to Improve Care and Research on Sexual Functioning
in Cardiology.},
Journal = {JAMA Cardiol},
Volume = {1},
Number = {7},
Pages = {765-766},
Year = {2016},
Month = {October},
url = {http://dx.doi.org/10.1001/jamacardio.2016.2436},
Doi = {10.1001/jamacardio.2016.2436},
Key = {fds331317}
}
@article{fds323346,
Author = {Topazian, R and Bollinger, J and Weinfurt, KP and Dvoskin, R and Mathews, D and Brelsford, K and DeCamp, M and Sugarman,
J},
Title = {Physicians' perspectives regarding pragmatic clinical
trials.},
Journal = {J Comp Eff Res},
Volume = {5},
Number = {5},
Pages = {499-506},
Year = {2016},
Month = {August},
url = {http://dx.doi.org/10.2217/cer-2016-0024},
Abstract = {AIM: Practicing physicians inevitably become involved in
pragmatic clinical trials (PCTs), including comparative
effectiveness research. We sought to identify physicians'
perspectives related to PCTs. METHODS: In-depth
semistructured interviews with 20 physicians in the USA.
RESULTS: Although physicians are generally willing to
participate in PCTs, their support is predicated on several
factors including expected benefits, minimization of time
and workflow burdens and physician engagement. Physicians
communicated a desire to respect patients' rights and
interests while maintaining a high level of care.
CONCLUSION: Future work is needed to systematically assess
the impact of PCTs on clinicians in meeting their ethical
obligations to patients and the burdens clinicians are
willing to accept in exchange for potential
benefits.},
Doi = {10.2217/cer-2016-0024},
Key = {fds323346}
}
@article{fds322133,
Author = {Yang, CC and Weinfurt, KP and Merion, RM and Kirkali, Z and LURN Study
Group},
Title = {Symptoms of Lower Urinary Tract Dysfunction Research
Network.},
Journal = {J Urol},
Volume = {196},
Number = {1},
Pages = {146-152},
Year = {2016},
Month = {July},
url = {http://dx.doi.org/10.1016/j.juro.2016.01.007},
Abstract = {PURPOSE: To address gaps in understanding and treating lower
urinary tract symptoms, the NIDDK created the Symptoms of
Lower Urinary Tract Dysfunction Research Network (LURN). The
goals of LURN are to work collaboratively to 1) identify and
explain the important subtypes of lower urinary tract
symptoms; 2) improve the measurement of patient experiences
of lower urinary tract symptoms; 3) disseminate novel
findings to researchers, clinicians and patients; and 4)
generate data, research tools and biological samples for
future studies. MATERIALS AND METHODS: As a first step in
understanding subtypes of lower urinary tract symptoms, LURN
will focus on disorders of urinary sensation (eg urgency)
and their causes. These are being examined with respect to
patient experience, organism or systemic factors,
genitourinary organs and tissues, and cellular/molecular
factors. This is being achieved via an observational
cohort study that is currently enrolling patients with
lower urinary tract symptoms (target number 1,000) and that
will extensively characterize patients with lower urinary
tract symptoms. Future studies embedded within the
observational cohort study will focus on neuroimaging and
sensory testing, biomarkers and organ based factors. To
advance the science of measurement of lower urinary tract
symptoms, LURN is also developing and evaluating a
comprehensive set of self-report questions to provide more
granular assessments of lower urinary tract symptoms.
RESULTS: LURN has taken its first steps by developing a
framework for studying lower urinary tract symptom subtypes.
CONCLUSIONS: In developing this framework, LURN is choosing
an initial domain on which to focus (sensory experiences),
and creating and executing protocols designed to improve
measurement of self-reported symptoms and identify patient
subtypes.},
Doi = {10.1016/j.juro.2016.01.007},
Key = {fds322133}
}
@article{fds323347,
Author = {Cook, KF and Jensen, SE and Schalet, BD and Beaumont, JL and Amtmann, D and Czajkowski, S and Dewalt, DA and Fries, JF and Pilkonis, PA and Reeve,
BB and Stone, AA and Weinfurt, KP and Cella, D},
Title = {PROMIS measures of pain, fatigue, negative affect, physical
function, and social function demonstrated clinical validity
across a range of chronic conditions.},
Journal = {J Clin Epidemiol},
Volume = {73},
Pages = {89-102},
Year = {2016},
Month = {May},
url = {http://dx.doi.org/10.1016/j.jclinepi.2015.08.038},
Abstract = {OBJECTIVE: To present an overview of a series of studies in
which the clinical validity of the National Institutes of
Health's Patient Reported Outcome Measurement Information
System (NIH; PROMIS) measures was evaluated, by domain,
across six clinical populations. STUDY DESIGN AND SETTING:
Approximately 1,500 individuals at baseline and 1,300 at
follow-up completed PROMIS measures. The analyses reported
in this issue were conducted post hoc, pooling data across
six previous studies, and accommodating the different
designs of the six, within-condition, parent studies.
Changes in T-scores, standardized response means, and effect
sizes were calculated in each study. When a parent study
design allowed, known groups validity was calculated using a
linear mixed model. RESULTS: The results provide substantial
support for the clinical validity of nine PROMIS measures in
a range of chronic conditions. CONCLUSION: The
cross-condition focus of the analyses provided a unique and
multifaceted perspective on how PROMIS measures function in
"real-world" clinical settings and provides external anchors
that can support comparative effectiveness research. The
current body of clinical validity evidence for the nine
PROMIS measures indicates the success of NIH PROMIS in
developing measures that are effective across a range of
chronic conditions.},
Doi = {10.1016/j.jclinepi.2015.08.038},
Key = {fds323347}
}
@article{fds322134,
Author = {Weinfurt, KP and Bollinger, JM and Brelsford, KM and Crayton, TJ and Topazian, RJ and Kass, NE and Beskow, LM and Sugarman,
J},
Title = {Patients' Views Concerning Research on Medical Practices:
Implications for Consent.},
Journal = {AJOB Empir Bioeth},
Volume = {7},
Number = {2},
Pages = {76-91},
Year = {2016},
url = {http://dx.doi.org/10.1080/23294515.2015.1117536},
Abstract = {BACKGROUND: Comparative effectiveness research (CER) and
pragmatic clinical trials commonly test interventions that
are in routine use and pose minimal incremental risk or
burdens to patients who participate in this research. The
objective of this study was to elicit the range of patients'
views and opinions regarding a variety of different types of
research on usual medical practices, especially notification
and authorization for them. METHODS: We conducted twelve
focus groups with adults in five U.S. cities-six focus
groups addressing CER ("CER groups") and six groups
addressing research involving hospital operations and
clinician interventions ("Operations groups"). Participants
discussed hypothetical research studies and potential
methods of notifying patients and obtaining their
authorization to participate. Group discussions were
recorded, transcribed, and coded to identify patients' views
related to research on standard medical practice. RESULTS: A
total of ninety six people participated. Twelve key themes
emerged from participants' discussions of the hypothetical
research studies; these themes were then grouped into four
general categories: clinical care; notification and
authorization; communication; and conduct and design of
research. The desire to be actively notified and asked was
more prominent with regard to CER studies than with regard
to Operations studies. CONCLUSIONS: Our data suggest that
effective policy and guidance will involve balancing
different patients' interests and potentially different sets
of interests for different types of research studies on
usual medical practices.},
Doi = {10.1080/23294515.2015.1117536},
Key = {fds322134}
}
@article{fds323348,
Author = {Sugarman, J and Seils, DM and Watson-Ormond, JK and Weinfurt,
KP},
Title = {Using Cognitive Interviews to Enhance Measurement in
Empirical Bioethics: Developing a Measure of the Preventive
Misconception in Biomedical HIV Prevention
Trials.},
Journal = {AJOB Empir Bioeth},
Volume = {7},
Number = {1},
Pages = {17-23},
Year = {2016},
url = {http://dx.doi.org/10.1080/23294515.2015.1037967},
Abstract = {BACKGROUND: We describe our use of cognitive interviews in
developing a measure of "preventive misconception" to
demonstrate the importance of this approach to researchers
developing surveys in empirical bioethics. The preventive
misconception involves research participants' false beliefs
about a prevention trial, including beliefs that the
interventions being tested will certainly be effective.
METHODS: We developed and refined a measure of the
preventive misconception using qualitative interviews that
focused on cognitive testing of proposed survey items with
HIV prevention trial participants. RESULTS: Two main
problems emerged during initial interviews. First, the
phrase "reduce your risk," used to elicit beliefs about risk
reduction from the use of study medications, was interpreted
as relating to a reduction of risky behaviors. Second, the
phrase "participating in this study," intended to elicit
beliefs about trial group assignment, was interpreted as
relating to personal behavior changes associated with study
participation. Additional interviews using a revised measure
were no longer problematic in these ways, and participants
felt the response options were appropriate for conveying
their answers. CONCLUSIONS: These findings underscore the
importance of cognitive testing in developing surveys for
empirical bioethics.},
Doi = {10.1080/23294515.2015.1037967},
Key = {fds323348}
}
@article{fds276624,
Author = {Flynn, KE and Dew, MA and Lin, L and Fawzy, M and Graham, FL and Hahn, EA and Hays, RD and Kormos, RL and Liu, H and McNulty, M and Weinfurt,
KP},
Title = {Reliability and construct validity of PROMIS® measures for
patients with heart failure who undergo heart
transplant.},
Journal = {Qual Life Res},
Volume = {24},
Number = {11},
Pages = {2591-2599},
Year = {2015},
Month = {November},
ISSN = {0962-9343},
url = {http://dx.doi.org/10.1007/s11136-015-1010-y},
Abstract = {PURPOSE: To evaluate the reliability and construct validity
of measures from the Patient-Reported Outcomes Measurement
Information System(®) (PROMIS(®)) for patients with heart
failure before and after heart transplantation. METHODS: We
assessed reliability of the PROMIS short forms using
Cronbach's alpha and the average marginal reliability. To
assess the construct validity of PROMIS computerized
adaptive tests and short-form measures, we calculated
Pearson product moment correlations between PROMIS measures
of physical function, fatigue, depression, and social
function and existing PRO measures of similar domains (i.e.,
convergent validity) as well as different domains (i.e.,
discriminate validity) in patients with heart failure
awaiting heart transplant. We evaluated the responsiveness
of these measures to change after heart transplant using
effect sizes. RESULTS: Forty-eight patients were included in
the analyses. Across the many domains examined, correlations
between conceptually similar domains were larger than
correlations between different domains of health,
demonstrating construct validity. Health status improved
substantially after heart transplant (standardized effect
sizes, 0.63-1.24), demonstrating the responsiveness of the
PROMIS measures. Scores from the computerized adaptive tests
and the short forms were similar. CONCLUSIONS: This study
provides evidence for the reliability and construct validity
(including responsiveness to change) of four PROMIS domains
in patients with heart failure before and after heart
transplant. PROMIS measures are a reasonable choice in this
context and will facilitate comparisons across studies and
health conditions.},
Doi = {10.1007/s11136-015-1010-y},
Key = {fds276624}
}
@article{fds276623,
Author = {McKinney, RE and Beskow, LM and Ford, DE and Lantos, JD and McCall, J and Patrick-Lake, B and Pletcher, MJ and Rath, B and Schmidt, H and Weinfurt, K},
Title = {Use of altered informed consent in pragmatic clinical
research.},
Journal = {Clin Trials},
Volume = {12},
Number = {5},
Pages = {494-502},
Year = {2015},
Month = {October},
ISSN = {1740-7745},
url = {http://dx.doi.org/10.1177/1740774515597688},
Abstract = {There are situations in which the requirement to obtain
conventional written informed consent can impose significant
or even insurmountable barriers to conducting pragmatic
clinical research, including some comparative effectiveness
studies and cluster-randomized trials. Although certain
federal regulations governing research in the United States
(45 CFR 46) define circumstances in which any of the
required elements may be waived, the same standards apply
regardless of whether any single element is to be waived or
whether consent is to be waived in its entirety. Using the
same threshold for a partial or complete waiver limits the
options available to institutional review boards as they
seek to optimize a consent process. In this article, we
argue that new standards are necessary in order to enable
important pragmatic clinical research while at the same time
protecting patients' rights and interests.},
Doi = {10.1177/1740774515597688},
Key = {fds276623}
}
@article{fds276633,
Author = {Flynn, KE and Lindau, ST and Lin, L and Reese, JB and Jeffery, DD and Carter, J and Baron, SR and Abramsohn, E and Weinfurt,
KP},
Title = {Development and Validation of a Single-Item Screener for
Self-Reporting Sexual Problems in U.S. Adults.},
Journal = {J Gen Intern Med},
Volume = {30},
Number = {10},
Pages = {1468-1475},
Year = {2015},
Month = {October},
ISSN = {0884-8734},
url = {http://dx.doi.org/10.1007/s11606-015-3333-3},
Abstract = {BACKGROUND: Brief self-assessment of sexual problems in a
clinical context has the potential to improve care for
patients through the ability to track trends in sexual
problems over time and facilitate patient-provider
communication about this important topic. However,
instruments designed for research are typically too long to
be practical in clinical practice. OBJECTIVE: To develop and
validate a single-item self-report clinical screener that
would capture common sexual problems and concerns for men
and women. DESIGN: We created three candidate screener
items, refined them through cognitive interviews, and
administered them to a large sample. We compared the
prevalence of responses to each item and explored the
discrepancies between items. We evaluated the construct
validity of the items by comparing them to scores on the
Patient-Reported Outcomes Measurement Information System®
Sexual Function and Satisfaction (PROMIS® SexFS) measure.
PARTICIPANTS: Local patients participated in two rounds of
cognitive interviews (n = 7 and n = 11). A
probability-based random sample of U.S. adults comprised the
item-testing sample (n = 3517). MAIN MEASURES: The items
were as follows: 1) a yes/no item on any sexual problems or
concerns ("general screener"), 2) a yes/no item on problems
experienced for 3 months or more during the past 12 months,
with a list of examples ("long list screener"), and 3) an
item identical to the long list screener except that
examples appeared individually as response options and
respondents could check all that applied ("checklist
screener"). KEY RESULTS: All of the screeners tested showed
evidence for basic validity and had minimal missing data.
Percentages of women and men endorsing the screeners were 10
% and 15 % (general); 20 % and 17 % (long list); and 38 %
and 30 % (checklist), respectively. Participants who
endorsed the screeners had lower function compared to those
who did not endorse them. CONCLUSIONS: We recommend the
checklist screener for its specificity and ability to
identify specific problems associated with decreased sexual
function.},
Doi = {10.1007/s11606-015-3333-3},
Key = {fds276633}
}
@article{fds276625,
Author = {Weinfurt, KP and Lin, L and Bruner, DW and Cyranowski, JM and Dombeck,
CB and Hahn, EA and Jeffery, DD and Luecht, RM and Magasi, S and Porter,
LS and Reese, JB and Reeve, BB and Shelby, RA and Smith, AW and Willse, JT and Flynn, KE},
Title = {Development and Initial Validation of the PROMIS(®) Sexual
Function and Satisfaction Measures Version
2.0.},
Journal = {J Sex Med},
Volume = {12},
Number = {9},
Pages = {1961-1974},
Year = {2015},
Month = {September},
ISSN = {1743-6095},
url = {http://dx.doi.org/10.1111/jsm.12966},
Abstract = {INTRODUCTION: The Patient-Reported Outcomes Measurement
Information System (PROMIS)(®) Sexual Function and
Satisfaction measure (SexFS) version 1.0 was developed with
cancer populations. There is a need to expand the SexFS and
provide evidence of its validity in diverse populations.
AIM: The aim of this study was to describe the development
of the SexFS v2.0 and present preliminary evidence for its
validity. METHODS: Development built on version 1.0, plus
additional review of extant items, discussions with 15
clinical experts, 11 patient focus groups (including
individuals with diabetes, heart disease, anxiety,
depression, and/or are lesbian, gay, bisexual, or aged 65 or
older), 48 cognitive interviews, and psychometric evaluation
in a random sample of U.S. adults plus an oversample for
specific sexual problems (2281 men, 1686 women). We examined
differential item functioning (DIF) by gender and sexual
activity. We examined convergent and known-groups validity.
RESULTS: The final set of domains includes 11 scored scales
(interest in sexual activity, lubrication, vaginal
discomfort, clitoral discomfort, labial discomfort, erectile
function, orgasm ability, orgasm pleasure, oral dryness,
oral discomfort, satisfaction), and six nonscored item pools
(screeners, sexual activities, anal discomfort, therapeutic
aids, factors interfering with sexual satisfaction, bother).
Domains from version 1.0 were reevaluated and improved.
Domains considered applicable across gender and sexual
activity status, namely interest, orgasm, and satisfaction,
were found to have significant DIF. We identified subsets of
items in each domain that provided consistent measurement
across these important respondent groups. Convergent and
known-groups validity was supported. CONCLUSIONS: The SexFS
version 2.0 has several improvements and enhancements over
version 1.0 and other extant measures, including expanded
evidence for validity, scores centered around norms for
sexually active U.S. adults, new domains, and a final set of
items applicable for both men and women and those sexually
active with a partner and without. The SexFS is
customizable, allowing users to select relevant domains and
items for their study.},
Doi = {10.1111/jsm.12966},
Key = {fds276625}
}
@article{fds276634,
Author = {Beskow, LM and Dombeck, CB and Thompson, CP and Watson-Ormond, JK and Weinfurt, KP},
Title = {Informed consent for biobanking: consensus-based guidelines
for adequate comprehension.},
Journal = {Genet Med},
Volume = {17},
Number = {3},
Pages = {226-233},
Year = {2015},
Month = {March},
ISSN = {1098-3600},
url = {http://dx.doi.org/10.1038/gim.2014.102},
Abstract = {PURPOSE: Federal regulations and best practice guidelines
identify categories of information that should be
communicated to prospective biobank participants during the
informed consent process. However, uncertainty remains about
which of this information participants must understand to
provide valid consent. METHODS: We conducted a Delphi
process to define "adequate comprehension" in the context of
biobanking consent. The process involved an iterative series
of three online surveys of a diverse panel of 51 experts,
including genome scientists, biobank managers, ethics and
policy experts, and community and participant
representatives. We sought consensus (>70% agreement)
concerning what specific details participants should know
about 16 biobank consent topics. RESULTS: Consensus was
achieved for 15 of the 16 consent topics. The exception was
the comprehension needed regarding the Genetic Information
Nondiscrimination Act. CONCLUSION: Our Delphi process was
successful in identifying a concise set of key points that
prospective participants must grasp to provide valid consent
for biobanking. Specifying the level of knowledge sufficient
for individuals to make an informed choice provides a basis
for improving consent forms and processes, as well as an
absolute metric for assessing the effectiveness of other
interventions to improve comprehension.Genet Med 17 3,
226-233.},
Doi = {10.1038/gim.2014.102},
Key = {fds276634}
}
@article{fds276638,
Author = {Havrilesky, LJ and Alvarez Secord and A and Ehrisman, JA and Berchuck,
A and Valea, FA and Lee, PS and Gaillard, SL and Samsa, GP and Cella, D and Weinfurt, KP and Abernethy, AP and Reed, SD},
Title = {Patient preferences in advanced or recurrent ovarian
cancer.},
Journal = {Cancer},
Volume = {120},
Number = {23},
Pages = {3651-3659},
Year = {2014},
Month = {December},
ISSN = {0008-543X},
url = {http://dx.doi.org/10.1002/cncr.28940},
Abstract = {BACKGROUND: The objective of this study was to elucidate
relative preferences of women with ovarian cancer for
symptoms, treatment-related side effects, and
progression-free survival (PFS) relevant to choosing a
treatment regimen. METHODS: Women with advanced or recurrent
ovarian cancer participated in a survey that included 3
methods to measure patient preferences (ratings, rankings,
and a discrete-choice experiment) for 7 attributes: mode of
administration, visit frequency, peripheral neuropathy,
nausea and vomiting, fatigue, abdominal discomfort, and PFS.
Participants were asked to choose between 2 unlabeled
treatment scenarios that were characterized using the 7
attributes. Each participant completed 12 choice questions
in which attribute levels were assigned according to an
experimental design and a fixed-choice question representing
2 chemotherapy regimens for ovarian cancer. RESULTS: In
total, 95 women completed the survey. Participants' ratings
and rankings revealed greater concern and importance for PFS
than for any other attribute (P < .0001 for all). The
discrete-choice experiment revealed that the relative odds
that a participant would choose a scenario with 18 months,
21 months, and 24 months of PFS versus 15 months of PFS were
1.5 (P = .01), 3.4 (P < .001), and 7.5
(P < .001), respectively. However, participants' choices
indicated that they were willing to accept a shorter PFS to
avoid severe side effects: 6.7 months to reduce nausea and
vomiting from severe to mild, 5.0 months to reduce
neuropathy from severe to mild, and 3.7 months to reduce
abdominal symptoms from severe to moderate. CONCLUSIONS: PFS
is the predominant driver of patient preferences for
chemotherapy regimens. However, women in the current study
were willing to trade significant PFS time for reductions in
treatment-related toxicity.},
Doi = {10.1002/cncr.28940},
Key = {fds276638}
}
@article{fds276640,
Author = {Alexander, AM and Flynn, KE and Hahn, EA and Jeffery, DD and Keefe, FJ and Reeve, BB and Schultz, W and Reese, JB and Shelby, RA and Weinfurt,
KP},
Title = {Improving patients' understanding of terms and phrases
commonly used in self-reported measures of sexual
function.},
Journal = {J Sex Med},
Volume = {11},
Number = {8},
Pages = {1991-1998},
Year = {2014},
Month = {August},
ISSN = {1743-6095},
url = {http://dx.doi.org/10.1111/jsm.12599},
Abstract = {INTRODUCTION: There is a significant gap in research
regarding the readability and comprehension of existing
sexual function measures. Patient-reported outcome measures
may use terms not well understood by respondents with low
literacy. AIM: This study aims to test comprehension of
words and phrases typically used in sexual function measures
to improve validity for all individuals, including those
with low literacy. METHODS: We recruited 20 men and 28 women
for cognitive interviews on version 2.0 of the
Patient-Reported Outcome Measurement Information System(®)
(PROMIS(®) ) Sexual Function and Satisfaction measures. We
assessed participants' reading level using the word reading
subtest of the Wide Range Achievement Test. Sixteen
participants were classified as having low literacy. MAIN
OUTCOME MEASURES: In the first round of cognitive
interviews, each survey item was reviewed by five or more
people, at least two of whom had lower than a ninth-grade
reading level (low literacy). Patient feedback was
incorporated into a revised version of the items. In the
second round of interviews, an additional three or more
people (at least one with low literacy) reviewed each
revised item. RESULTS: Participants with low literacy had
difficulty comprehending terms such as aroused, orgasm,
erection, ejaculation, incontinence, and vaginal
penetration. Women across a range of literacy levels had
difficulty with clinical terms like labia and clitoris. We
modified unclear terms to include parenthetical descriptors
or slang equivalents, which generally improved
comprehension. CONCLUSIONS: Common words and phrases used
across measures of self-reported sexual function are not
universally understood. Researchers should appreciate these
misunderstandings as a potential source of error in studies
using self-reported measures of sexual function. This study
also provides evidence for the importance of including
individuals with low literacy in cognitive pretesting during
the measure development.},
Doi = {10.1111/jsm.12599},
Key = {fds276640}
}
@article{fds276628,
Author = {Sama, PR and Eapen, ZJ and Weinfurt, KP and Shah, BR and Schulman,
KA},
Title = {An evaluation of mobile health application
tools.},
Journal = {JMIR Mhealth Uhealth},
Volume = {2},
Number = {2},
Pages = {e19},
Year = {2014},
Month = {May},
ISSN = {2291-5222},
url = {http://dx.doi.org/10.2196/mhealth.3088},
Abstract = {BACKGROUND: The rapid growth in the number of mobile health
applications could have profound significance in the
prevention of disease or in the treatment of patients with
chronic disease such as diabetes. OBJECTIVE: The objective
of this study was to describe the characteristics of the
most common mobile health care applications available in the
Apple iTunes marketplace. METHODS: We undertook a
descriptive analysis of a sample of applications in the
"health and wellness" category of the Apple iTunes Store. We
characterized each application in terms of its health factor
and primary method of user engagement. The main outcome
measures of the analysis were price, health factors, and
methods of user engagement. RESULTS: Among the 400
applications that met the inclusion criteria, the mean price
of the most frequently downloaded paid applications was US
$2.24 (SD $1.30), and the mean price of the most currently
available paid applications was US $2.27 (SD $1.60).
Fitness/training applications were the most popular (43.5%,
174/400). The next two most common categories were health
resource (15.0%, 60/400) and diet/caloric intake (14.3%,
57/400). Applications in the health resource category
constituted 5.5% (22/400) of the applications reviewed.
Self-monitoring was the most common primary user engagement
method (74.8%, 299/400). A total of 20.8% (83/400) of the
applications used two or more user engagement approaches,
with self-monitoring and progress tracking being the most
frequent. CONCLUSIONS: Most of the popular mobile health
applications focus on fitness and self-monitoring. The
approaches to user engagement utilized by these applications
are limited and present an opportunity to improve the
effectiveness of the technology.},
Doi = {10.2196/mhealth.3088},
Key = {fds276628}
}
@article{fds276641,
Author = {Lewis, EF and Li, Y and Pfeffer, MA and Solomon, SD and Weinfurt, KP and Velazquez, EJ and Califf, RM and Rouleau, J-L and Kober, L and White,
HD and Schulman, KA and Reed, SD},
Title = {Impact of cardiovascular events on change in quality of life
and utilities in patients after myocardial infarction: a
VALIANT study (valsartan in acute myocardial
infarction).},
Journal = {JACC Heart Fail},
Volume = {2},
Number = {2},
Pages = {159-165},
Year = {2014},
Month = {April},
ISSN = {2213-1779},
url = {http://dx.doi.org/10.1016/j.jchf.2013.12.003},
Abstract = {OBJECTIVES: The objective of this study was to determine the
impact of nonfatal cardiovascular (CV) events on changes in
health-related quality of life (HRQL). BACKGROUND: There is
limited understanding of the impact of nonfatal CV events on
long-term changes in HRQL in survivors of myocardial
infarction (MI). METHODS: The VALIANT (Valsartan In Acute
Myocardial Infarction) trial enrolled 14,703 patients
post-MI complicated by Killip class II or higher (scale
measuring heart failure severity post-MI ranging from class
I to IV) and/or reduced ejection fraction. The HRQL substudy
included 2,556 (17.4%) patients who completed the EQ-5D with
5 questions, with responses mapped to utility weight on a
scale of 0 to 1 and a visual analog scale (VAS) ranging from
0 (worst) to 100 (best) imaginable health state. EQ-5D was
administered at baseline and 6, 12, 20, and 24 months. The
trajectory of EQ-5D scores was developed by using linear
mixed effects regression models with calculation of
deviation from this trajectory after nonfatal CV events.
Patients who died before the next EQ-5D assessment were
excluded. RESULTS: Over a 2-year period, 597 patients
experienced a nonfatal CV event and survived to have another
EQ-5D assessment. Their baseline EQ-5D scores were lower
than patients without a subsequent nonfatal CV event (VAS
61.0 ± 19 vs 68.2 ± 18 [p < 0.001] and US-based utility
score 0.76 ± 0.22 vs 0.83 ± 0.17 [p < 0.001]). These
patients with CV events experienced a trajectory-adjusted
6.6 point decrease (p < 0.001) in VAS scores and a 0.07
decrease (p < 0.001) in utility score after the nonfatal
CV event. CONCLUSIONS: MI survivors suffering a CV event
experienced significantly worse HRQL than their previous
trajectory, suggesting that generic instruments can be
responsive to nonfatal events. Reduction in nonfatal CV
events may affect longitudinal changes in
HRQL.},
Doi = {10.1016/j.jchf.2013.12.003},
Key = {fds276641}
}
@article{fds276650,
Author = {Weinfurt, KP and Lin, L and Dombeck, CB and Broderick, JE and Snyder,
DC and Williams, MS and Fawzy, MR and Flynn, KE},
Title = {Accuracy of 30-day recall for components of sexual function
and the moderating effects of gender and
mood.},
Journal = {J Sex Med},
Volume = {11},
Number = {3},
Pages = {678-696},
Year = {2014},
Month = {March},
url = {http://www.ncbi.nlm.nih.gov/pubmed/23802907},
Abstract = {INTRODUCTION: Despite the ubiquity of 1-month recall periods
for measures of sexual function, there is limited evidence
for how well recalled responses correspond to individuals'
actual daily experiences. AIM: To characterize the
correspondence between daily sexual experiences and 1-month
recall of those experiences. METHODS: Following a baseline
assessment of sexual functioning, health, and demographic
characteristics, 202 adults from the general population (101
women, 101 men) were recruited to complete daily assessments
of their sexual function online for 30 days and a single
recall measure of sexual function at day 30. MAIN OUTCOME
MEASURES: At the baseline and 30-day follow-ups,
participants answered items asking about sexual
satisfaction, sexual activities, interest, interfering
factors, orgasm, sexual functioning, and use of therapeutic
aids during the previous 30 days. Participants also
completed a measure of positive and negative affect at
follow-up. The main outcome measures were agreement between
the daily and 1-month recall versions of the sexual function
items. RESULTS: Accuracy of recall varied depending on the
item and on the gender and mood of the respondent. Recall
was better (low bias and higher correlations) for sexual
activities, vaginal discomfort, erectile function, and more
frequently used therapeutic aids. Recall was poorer for
interest, affectionate behaviors (e.g., kissing), and
orgasm-related items. Men more than women overestimated
frequency of interest and masturbation. Concurrent mood was
related to over- or underreporting for six items addressing
the frequency of masturbation and vaginal intercourse,
erectile function, and orgasm. CONCLUSIONS: A 1-month recall
period seems acceptable for many aspects of sexual function
in this population, but recall for some items was poor.
Researchers should be aware that concurrent mood can have a
powerful biasing effect on reports of sexual
function.},
Doi = {10.1111/jsm.12225},
Key = {fds276650}
}
@article{fds276646,
Author = {Dickert, NW and Mah, VA and Biros, MH and Harney, DM and Silbergleit, R and Sugarman, J and Veledar, E and Weinfurt, KP and Wright, DW and Pentz,
RD},
Title = {Consulting communities when patients cannot consent: a
multicenter study of community consultation for research in
emergency settings.},
Journal = {Crit Care Med},
Volume = {42},
Number = {2},
Pages = {272-280},
Year = {2014},
Month = {February},
url = {http://www.ncbi.nlm.nih.gov/pubmed/24145834},
Abstract = {OBJECTIVES: To assess the range of responses to community
consultation efforts conducted within a large network and
the impact of different consultation methods on acceptance
of exception from informed consent research and
understanding of the proposed study. DESIGN: A cognitively
pretested survey instrument was administered to 2,612
community consultation participants at 12 U.S. centers
participating in a multicenter trial of treatment for acute
traumatic brain injury. SETTING: Survey nested within
community consultation for a phase III randomized controlled
trial of treatment for acute traumatic brain injury
conducted within a multicenter trial network and using
exception from informed consent. SUBJECTS: Adult
participants in community consultation events.
INTERVENTIONS: Community consultation efforts at
participating sites. MEASUREMENTS AND MAIN RESULTS:
Acceptance of exception from informed consent in general,
attitude toward personal exception from informed consent
enrollment, and understanding of the study content were
assessed. Fifty-four percent of participants agreed
exception from informed consent enrollment was acceptable in
general in the proposed study; 71% were accepting of
personal exception from informed consent enrollment.
Participants in interactive versus noninteractive community
consultation events were more accepting of exception from
informed consent in general (63% vs 49%) and personal
exception from informed consent inclusion (77% vs 67%).
Interactive community consultation participants had
high-level recall of study content significantly more often
than noninteractive consultation participants (77% vs 67%).
Participants of interactive consultation were more likely to
recall possible study benefits (61% vs 45%) but less likely
to recall potential risks (56% vs 69%). CONCLUSIONS:
Interactive community consultation methods were associated
with increased acceptance of exception from informed consent
and greater overall recall of study information but lower
recall of risks. There was also significant variability in
exception from informed consent acceptance among different
interactive consultation events. These findings have
important implications for institutional review board and
investigators conducting exception from informed consent
research and for community engagement efforts in research
more generally.},
Doi = {10.1097/CCM.0b013e3182a27759},
Key = {fds276646}
}
@article{fds276643,
Author = {Dickert, NW and Govindarajan, P and Harney, D and Silbergleit, R and Sugarman, J and Weinfurt, KP and Pentz, RD},
Title = {Community consultation for prehospital research: experiences
of study coordinators and principal investigators.},
Journal = {Prehosp Emerg Care},
Volume = {18},
Number = {2},
Pages = {274-281},
Year = {2014},
url = {http://www.ncbi.nlm.nih.gov/pubmed/24401134},
Abstract = {OBJECTIVE: To assess principal investigators' and study
coordinators' views and experiences regarding community
consultation in a multicenter trial of prehospital treatment
for status epilepticus conducted under an exception from
informed consent for research in emergency settings.
METHODS: Principal investigators and study coordinators at
all 17 hubs for the Rapid Anticonvulsant Medication Prior to
Arrival Trial (RAMPART) were invited to complete a web-based
survey regarding community consultation at their site for
RAMPART. Major domains included 1) perceived goals of
community consultation, 2) experiences with and views of
community consultation methods used, 3) interactions with
IRB regarding community consultation, and 4) general
satisfaction and lessons learned. Descriptive statistics
were tabulated for Likert scale data; relevant themes were
reported for text-based data. RESULTS: Twenty-eight
individuals (16 coordinators and 12 investigators)
representing all 17 RAMPART hubs completed the survey.
Respondents considered multiple community consultation goals
to be important, with least support for the role of
community consultation in altering study design. All sites
used multiple methods (median = 5). The most widely used,
and generally favored, method was attending previously
scheduled meetings of existing groups. Respondents expressed
frustration with low attendance and responsiveness at open
public meetings. CONCLUSIONS: Coordinators and investigators
in this trial viewed community consultation efforts as
successful but reported real challenges generating public
interest. Individuals with the condition under study were
found to be more engaged and supportive of the trial.
Respondents endorsed numerous potential goals of the
community consultation process and often combined methods to
achieve these goals.},
Doi = {10.3109/10903127.2013.856503},
Key = {fds276643}
}
@article{fds276627,
Author = {Denicoff, AM and McCaskill-Stevens, W and Grubbs, SS and Bruinooge,
SS and Comis, RL and Devine, P and Dilts, DM and Duff, ME and Ford, JG and Joffe, S and Schapira, L and Weinfurt, KP and Michaels, M and Raghavan,
D and Richmond, ES and Zon, R and Albrecht, TL and Bookman, MA and Dowlati,
A and Enos, RA and Fouad, MN and Good, M and Hicks, WJ and Loehrer, PJ and Lyss, AP and Wolff, SN and Wujcik, DM and Meropol,
NJ},
Title = {The National Cancer Institute-American Society of Clinical
Oncology Cancer Trial Accrual Symposium: summary and
recommendations.},
Journal = {J Oncol Pract},
Volume = {9},
Number = {6},
Pages = {267-276},
Year = {2013},
Month = {November},
url = {http://www.ncbi.nlm.nih.gov/pubmed/24130252},
Abstract = {INTRODUCTION: Many challenges to clinical trial accrual
exist, resulting in studies with inadequate enrollment and
potentially delaying answers to important scientific and
clinical questions. METHODS: The National Cancer Institute
(NCI) and the American Society of Clinical Oncology (ASCO)
cosponsored the Cancer Trial Accrual Symposium: Science and
Solutions on April 29-30, 2010 to examine the state of
accrual science related to patient/community,
physician/provider, and site/organizational influences, and
identify new interventions to facilitate clinical trial
enrollment. The symposium featured breakout sessions,
plenary sessions, and a poster session including 100
abstracts. Among the 358 attendees were clinical
investigators, researchers of accrual strategies, research
administrators, nurses, research coordinators, patient
advocates, and educators. A bibliography of the accrual
literature in these three major areas was provided to
participants in advance of the meeting. After the symposium,
the literature in these areas was revisited to determine if
the symposium recommendations remained relevant within the
context of the current literature. RESULTS: Few rigorously
conducted studies have tested interventions to address
challenges to clinical trials accrual. Attendees developed
recommendations for improving accrual and identified
priority areas for future accrual research at the
patient/community, physician/provider, and
site/organizational levels. Current literature continues to
support the symposium recommendations. CONCLUSIONS: A
combination of approaches addressing both the multifactorial
nature of accrual challenges and the characteristics of the
target population may be needed to improve accrual to cancer
clinical trials. Recommendations for best practices and for
future research developed from the symposium are
provided.},
Doi = {10.1200/JOP.2013.001119},
Key = {fds276627}
}
@article{fds276649,
Author = {Williams, MS and Snyder, DC and Sloane, R and Levens, J and Flynn, KE and Dombeck, CB and Demark-Wahnefried, W and Weinfurt,
KP},
Title = {A comparison of cancer survivors from the PROMIS study
selecting telephone versus online questionnaires.},
Journal = {Psychooncology},
Volume = {22},
Number = {11},
Pages = {2632-2635},
Year = {2013},
Month = {November},
url = {http://www.ncbi.nlm.nih.gov/pubmed/23813785},
Doi = {10.1002/pon.3330},
Key = {fds276649}
}
@article{fds276648,
Author = {Piña, IL and Lin, L and Weinfurt, KP and Isitt, JJ and Whellan, DJ and Schulman, KA and Flynn, KE and HF-ACTION Investigators},
Title = {Hemoglobin, exercise training, and health status in patients
with chronic heart failure (from the HF-ACTION randomized
controlled trial).},
Journal = {Am J Cardiol},
Volume = {112},
Number = {7},
Pages = {971-976},
Year = {2013},
Month = {October},
url = {http://www.ncbi.nlm.nih.gov/pubmed/23809621},
Abstract = {Anemia is common in patients with chronic heart failure
(HF), with a prevalence ranging from 10% to 56%, and may be
a risk factor for poor outcomes. Anemia in HF remains poorly
understood, with significant gaps in its impact on
health-related quality of life (HRQoL), with most studies in
HF being retrospective or from registries. The purpose of
this study was to explore the relation of hemoglobin (Hgb)
with HRQoL and training-induced changes in HRQoL in a cohort
of patients in Heart Failure: A Controlled Trial
Investigating Outcomes of Exercise Training (HF-ACTION).
Using data from HF-ACTION, a randomized controlled trial of
exercise training in patients with HF and low left
ventricular ejection fractions, HRQoL was measured using the
Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline,
3 and 12 months, and annually up to 4 years. Treatment
group effects on HRQoL were estimated using linear mixed
models according to the intention-to-treat principle. It was
hypothesized that baseline Hgb would be correlated with
baseline KCCQ scales and that Hgb would moderate the
beneficial effect of exercise training on HRQoL. Hgb level
was not significantly correlated with baseline HRQoL.
Baseline Hgb did not moderate the beneficial effect of
exercise training on KCCQ overall or subscales relative to
usual care. In conclusion, in the HF-ACTION cohort, there
was no correlation with baseline Hgb and baseline HRQoL as
measured by the KCCQ. In addition, the beneficial effects of
HRQoL from exercise training were not modulated by baseline
Hgb.},
Doi = {10.1016/j.amjcard.2013.05.033},
Key = {fds276648}
}
@article{fds348592,
Author = {Weinfurt, KP and Lin, L and Reese, JB and Bruner, DW and Dombeck, C and Keefe, FJ and Moore, A and Porter, L and Flynn, KE},
Title = {Reasons for sexual inactivity in a US national survey of
adults},
Journal = {QUALITY OF LIFE RESEARCH},
Volume = {22},
Pages = {1 pages},
Publisher = {SPRINGER},
Year = {2013},
Month = {October},
Key = {fds348592}
}
@article{fds348593,
Author = {Flynn, KE and Lin, L and Keefe, FJ and Reese, JB and Weinfurt,
KP},
Title = {The vulvar discomfort domain of the PROMIS (R) sexual
function and satisfaction measure},
Journal = {QUALITY OF LIFE RESEARCH},
Volume = {22},
Pages = {1 pages},
Publisher = {SPRINGER},
Year = {2013},
Month = {October},
Key = {fds348593}
}
@article{fds276651,
Author = {Flynn, KE and Kramer, JM and Dombeck, CB and Weinfurt,
KP},
Title = {Participants' perspectives on safety monitoring in clinical
trials.},
Journal = {Clin Trials},
Volume = {10},
Number = {4},
Pages = {552-559},
Year = {2013},
Month = {August},
url = {http://www.ncbi.nlm.nih.gov/pubmed/23644503},
Abstract = {BACKGROUND: Minimizing the risk to study participants is an
essential requirement of ethical research. Respecting the
rights of subjects is also paramount, which includes
respecting their autonomy by making available important
information about the evolving safety profile of an
investigational product as the trial progresses. Little is
known about what trial participants understand and expect
regarding monitoring and communication of serious adverse
events during the conduct of a trial in which they have
agreed to participate. PURPOSE: To explore understanding and
expectations of potential trial participants concerning
monitoring and communication of serious adverse events
during a clinical trial. METHODS: A professional moderator
led four 90-min, in-person focus groups: two groups with
individuals who had never participated in a clinical trial
and two groups with people who had. After relevant research
terms were defined and existing regulations were explained,
discussion focused on how participants expected safety to be
monitored and communicated during the conduct of a clinical
trial. Group comments were video-recorded and transcribed
and then analyzed by the investigators. RESULTS: The 27
racially diverse focus group members were largely unaware of
existing safeguards and regulations to manage risk in
clinical trials. Many people expressed a desire for
increased transparency about serious adverse events during
the trial as well as shortened reporting deadlines. Focus
group members also spontaneously expressed concerns about
potential financial conflicts of interest in monitoring and
reporting serious adverse events. LIMITATIONS: This was a
single-site, qualitative study and is not meant to establish
the prevalence of beliefs. CONCLUSIONS: Potential trial
participants have limited understanding and a wide range of
expectations about how safety monitoring in clinical trials
should be managed and communicated. The overall tenor of
opinion suggests unease about participant safety and a
desire to have more information conveyed by sponsors to
investigators and, in some cases, by investigators to
participants. Additional study in other regions and settings
may be useful to more broadly explore the range of
participants' beliefs and expectations. In the meantime,
engaging patient advocates in the design of clinical trials
and clearly communicating to trial participants the plan for
oversight of their safety may help ease the types of
concerns expressed in this study.},
Doi = {10.1177/1740774513484394},
Key = {fds276651}
}
@article{fds276652,
Author = {Check, DK and Weinfurt, KP and Dombeck, CB and Kramer, JM and Flynn,
KE},
Title = {Use of central institutional review boards for multicenter
clinical trials in the United States: a review of the
literature.},
Journal = {Clin Trials},
Volume = {10},
Number = {4},
Pages = {560-567},
Year = {2013},
Month = {August},
url = {http://www.ncbi.nlm.nih.gov/pubmed/23666951},
Abstract = {BACKGROUND: To improve the efficiency of conducting
multicenter clinical trials, the Food and Drug
Administration, the Office of Human Research Protections,
and the Department of Health and Human Services have
expressed support for using a centralized institutional
review board (IRB) process. However, research institutions
differ in their willingness to defer to central IRBs.
PURPOSE: We aimed to review and describe peer-reviewed
journal articles on the use of central IRBs for multicenter
clinical trials in the United States in an effort to inform
the policy discussion about central IRBs. METHODS: We used a
PubMed search and consulted IRB experts and the
bibliographies of other reviews to identify relevant
commentaries and empirical studies. RESULTS: Our search
identified 33 articles related to the use of central IRBs
for multicenter trials in the United States. Of these, 22
were commentary pieces and 11 were empirical studies.
LIMITATIONS: Our review was restricted to journal articles
about the use of central IRBs for multicenter clinical
trials in the United States. CONCLUSIONS: There is limited
empirical work on the use of central IRBs for multicenter
trials in the United States. Most published studies focused
on problems in efficiency associated with redundant local
reviews of multicenter studies and the potential benefits of
a centralized system. Because the absence of studies on the
use of central IRBs may be due to their infrequent use,
additional work is needed to generate data on the use of
central IRBs and to elucidate and address the concerns that
research institutions have about deferring ethical review to
a central IRB.},
Doi = {10.1177/1740774513484393},
Key = {fds276652}
}
@article{fds276647,
Author = {Weinfurt, KP},
Title = {Understanding What Participants in Empirical Bioethical
Studies Mean: Historical Cautions From William James and
Ludwig Wittgenstein},
Journal = {AJOB Primary Research},
Volume = {4},
Number = {3},
Pages = {49-54},
Publisher = {Informa UK Limited},
Year = {2013},
Month = {July},
ISSN = {2150-7716},
url = {http://dx.doi.org/10.1080/21507716.2013.807893},
Abstract = {Methods from psychology are informing much empirical
research in bioethics by helping to understand the thoughts,
feelings, and beliefs of people as they relate to a variety
of bioethical issues. This can lead to improvements in
practice or policy only if the subjective mental states
under study have been characterized accurately. In this
article, I describe two cautions from the history of
psychology concerning the accurate characterization of
mental states that have significant implications for how we
elicit and interpret data in empirical bioethical studies.
Both make reference to tendencies of mind that can be
difficult to combat and that are the cause of other more
specific methodological errors. The first historical
caution, William James's "psychologist's fallacy," warns
against substituting the ethicist/researcher's point of view
with that of the person under study. Failure to appreciate
this essentially egocentric bias can result in asking people
to report on things (e.g., probability of benefit from an
experimental therapy) that are not a part of the person's
experience in the same way they are a part of the
researcher's worldview. The responses the person provides in
such cases do not provide good information about his or her
experience and so cannot be used to guide sound policy. The
second historical caution is Wittgenstein's discursive
perspective, which urges us to interpret the meaning of
things said by a person in a research study by examining the
function each utterance serves for the person. For example,
one should avoid assuming that people respond to queries
about understanding by simply describing their
understanding. Instead, research participants might provide
responses to achieve other goals, such as establishing a
desired attitude in themselves. I suggest that both cautions
can be addressed through careful qualitative investigation
at the beginning of a research project. © 2013 Copyright
Taylor and Francis Group, LLC.},
Doi = {10.1080/21507716.2013.807893},
Key = {fds276647}
}
@article{fds276656,
Author = {Meropol, NJ and Egleston, BL and Buzaglo, JS and Balshem, A and Benson,
AB and Cegala, DJ and Cohen, RB and Collins, M and Diefenbach, MA and Miller, SM and Fleisher, L and Millard, JL and Ross, EA and Schulman,
KA and Silver, A and Slater, E and Solarino, N and Sulmasy, DP and Trinastic, J and Weinfurt, KP},
Title = {A Web-based communication aid for patients with cancer: the
CONNECT Study.},
Journal = {Cancer},
Volume = {119},
Number = {7},
Pages = {1437-1445},
Year = {2013},
Month = {April},
url = {http://www.ncbi.nlm.nih.gov/pubmed/23335150},
Abstract = {BACKGROUND: Cancer patients and their oncologists often
report differing perceptions of consultation discussions and
discordant expectations regarding treatment outcomes.
CONNECT, a computer-based communication aid, was developed
to improve communication between patients and oncologists.
METHODS: CONNECT includes assessment of patient values,
goals, and communication preferences; patient communication
skills training; and a preconsultation physician summary
report. CONNECT was tested in a 3-arm, prospective,
randomized clinical trial. Prior to the initial medical
oncology consultation, adult patients with advanced cancer
were randomized to the following arms: 1) control; 2)
CONNECT with physician summary; or 3) CONNECT without
physician summary. Outcomes were assessed with
postconsultation surveys. RESULTS: Of 743 patients
randomized, 629 completed postconsultation surveys. Patients
in the intervention arms (versus control) felt that the
CONNECT program made treatment decisions easier to reach (P
= .003) and helped them to be more satisfied with these
decisions (P < .001). In addition, patients in the
intervention arms reported higher levels of satisfaction
with physician communication format (P = .026) and
discussion regarding support services (P = .029) and quality
of life concerns (P = .042). The physician summary did not
impact outcomes. Patients with higher levels of education
and poorer physical functioning experienced greater benefit
from CONNECT. CONCLUSIONS: This prospective randomized
clinical trial demonstrates that computer-based
communication skills training can positively affect patient
satisfaction with communication and decision-making.
Measurable patient characteristics may be used to identify
subgroups most likely to benefit from an intervention such
as CONNECT.},
Doi = {10.1002/cncr.27874},
Key = {fds276656}
}
@article{fds276653,
Author = {Flynn, KE and Reeve, BB and Lin, L and Cyranowski, JM and Bruner, DW and Weinfurt, KP},
Title = {Construct validity of the PROMIS® sexual function and
satisfaction measures in patients with cancer.},
Journal = {Health Qual Life Outcomes},
Volume = {11},
Pages = {40},
Year = {2013},
Month = {March},
url = {http://www.ncbi.nlm.nih.gov/pubmed/23497200},
Abstract = {BACKGROUND: With data from a diverse sample of patients
either in treatment for cancer or post-treatment for cancer,
we examine inter-domain and cross-domain correlations among
the core domains of the Patient-Reported Outcomes
Measurement Information System Sexual Function and
Satisfaction measures (PROMIS® SexFS) and the corresponding
domains from conceptually-similar measures of sexual
function, the International Index of Erectile Function and
the Female Sexual Function Index. FINDINGS: Men (N=389) and
women (N=430) were recruited from a tumor registry, oncology
clinics, and an internet panel. The PROMIS SexFS,
International Index of Erectile Function, and Female Sexual
Function Index were used to collect participants'
self-reported sexual function. The domains shared among the
measures include desire/interest in sexual activity,
lubrication and vaginal discomfort/pain (women), erectile
function (men), orgasm, and satisfaction. We examined
correlations among different domains within the same
instrument (discriminant validity) and correlations among
similar domains measured by different instruments
(convergent validity). Correlations demonstrating
discriminant validity ranged from 0.38 to 0.73 for men and
0.48 to 0.74 for women, while correlations demonstrating
convergent validity ranged from 0.62 to 0.83 for men and
0.71 to 0.92 for women. As expected, correlations
demonstrating convergent validity were higher than
correlations demonstrating discriminant validity, with one
exception (orgasm for men). CONCLUSIONS: Construct validity
was supported by convergent and discriminant validity in a
diverse sample of patients with cancer. For patients with
cancer who may or may not have sexual dysfunction, the
PROMIS SexFS measures provide a comprehensive assessment of
key domains of sexual function and satisfaction.},
Doi = {10.1186/1477-7525-11-40},
Key = {fds276653}
}
@article{fds276654,
Author = {Flynn, KE and Lin, L and Cyranowski, JM and Reeve, BB and Reese, JB and Jeffery, DD and Smith, AW and Porter, LS and Dombeck, CB and Bruner, DW and Keefe, FJ and Weinfurt, KP},
Title = {Development of the NIH PROMIS ® Sexual Function and
Satisfaction measures in patients with cancer.},
Journal = {J Sex Med},
Volume = {10 Suppl 1},
Number = {0 1},
Pages = {43-52},
Year = {2013},
Month = {February},
url = {http://www.ncbi.nlm.nih.gov/pubmed/23387911},
Abstract = {INTRODUCTION: We describe the development and validation of
the Patient-Reported Outcomes Measurement Information
System(®) Sexual Function and Satisfaction (PROMIS(®)
SexFS; National Institutes of Health) measures, version 1.0,
for cancer populations. AIM: To develop a customizable
self-report measure of sexual function and satisfaction as
part of the U.S. National Institutes of Health PROMIS
Network. METHODS: Our multidisciplinary working group
followed a comprehensive protocol for developing
psychometrically robust patient-reported outcome measures
including qualitative (scale development) and quantitative
(psychometric evaluation) development. We performed an
extensive literature review, conducted 16 focus groups with
cancer patients and multiple discussions with clinicians,
and evaluated candidate items in cognitive testing with
patients. We administered items to 819 cancer patients.
Items were calibrated using item-response theory and
evaluated for reliability and validity. MAIN OUTCOME
MEASURES: The PROMIS SexFS measures, version 1.0, include 81
items in 11 domains: Interest in Sexual Activity,
Lubrication, Vaginal Discomfort, Erectile Function, Global
Satisfaction with Sex Life, Orgasm, Anal Discomfort,
Therapeutic Aids, Sexual Activities, Interfering Factors,
and Screener Questions. RESULTS: In addition to content
validity (patients indicate that items cover important
aspects of their experiences) and face validity (patients
indicate that items measure sexual function and
satisfaction), the measure shows evidence for discriminant
validity (domains discriminate between groups expected to be
different) and convergent validity (strong correlations
between scores on PROMIS and scores on conceptually similar
older measures of sexual function), as well as favorable
test-retest reliability among people not expected to change
(interclass correlations from two administrations of the
instrument, 1 month apart). CONCLUSIONS: The PROMIS SexFS
offers researchers a reliable and valid set of tools to
measure self-reported sexual function and satisfaction among
diverse men and women. The measures are customizable;
researchers can select the relevant domains and items
comprising those domains for their study.},
Doi = {10.1111/j.1743-6109.2012.02995.x},
Key = {fds276654}
}
@article{fds276658,
Author = {Kamble, S and Weinfurt, KP and Schulman, KA and Reed,
SD},
Title = {Patient time costs associated with sensor-augmented insulin
pump therapy for type 1 diabetes: results from the STAR 3
randomized trial.},
Journal = {Med Decis Making},
Volume = {33},
Number = {2},
Pages = {215-224},
Year = {2013},
Month = {February},
url = {http://www.ncbi.nlm.nih.gov/pubmed/23128579},
Abstract = {BACKGROUND: Sensor-augmented pump therapy (SAPT) leads to
lower glycated hemoglobin levels than multiple daily
injections of insulin (MDI) in patients with type 1
diabetes. Patient time and costs associated with SAPT are
not known. OBJECTIVE: We compared time spent on
diabetes-related care, changes in time, and associated
patient time costs between patients randomly assigned to
SAPT or MDI. DESIGN, SETTING, AND PARTICIPANTS. During a
52-week clinical trial, participants aged 7 to 70 years (n =
483) reported total time per week spent on diabetes-related
care. MEASUREMENTS: Patient time, including comparisons
during pump initiation, 52-week patient time costs, and
changes in weekly time estimates after pump initiation.
RESULTS: At baseline, patients in the MDI group reported
spending an average of 4.0 hours per week on
diabetes-related care. During the pump initiation period
(weeks 1-7), SAPT patients spent 1.9 hours more per week
than MDI patients (95% confidence interval [CI], 1.2-2.6).
After the initiation period (weeks 8-52), SAPT patients
spent 1 hour more per week (95% CI, 0.4-1.7) than MDI
patients (i.e., 4.4 v. 3.4 hours); patients in both groups
spent progressively less time on diabetes-related care by
1.2 minutes per week (95% CI, -1.7 to -0.7). Overall, mean
time costs per person were $4600 with the SAPT group and
$3523 with the MDI group (difference, $1077; 95% CI,
$491-$1638). LIMITATIONS: Time spent on specific activities
was not collected, and the estimates do not explicitly
account for caregiver time associated with diabetes care
activities. CONCLUSIONS: Patients receiving SAPT v. MDI
spent approximately 2 hours more per week on
diabetes-related care during pump initiation and 1 hour more
per week thereafter, resulting in higher patient time
costs.},
Doi = {10.1177/0272989X12464824},
Key = {fds276658}
}
@article{fds276657,
Author = {Weinfurt, KP and Kim, SY and Meropol, NJ},
Title = {Talking with patients about dying.},
Journal = {N Engl J Med},
Volume = {368},
Number = {5},
Pages = {479},
Year = {2013},
Month = {January},
url = {http://www.ncbi.nlm.nih.gov/pubmed/23363508},
Doi = {10.1056/NEJMc1214249},
Key = {fds276657}
}
@article{fds276655,
Author = {Flynn, KE and Hahn, CL and Kramer, JM and Check, DK and Dombeck, CB and Bang, S and Perlmutter, J and Khin-Maung-Gyi, FA and Weinfurt,
KP},
Title = {Using central IRBs for multicenter clinical trials in the
United States.},
Journal = {PLoS One},
Volume = {8},
Number = {1},
Pages = {e54999},
Year = {2013},
url = {http://www.ncbi.nlm.nih.gov/pubmed/23383026},
Abstract = {Research institutions differ in their willingness to defer
to a single, central institutional review board (IRB) for
multicenter clinical trials, despite statements from the
FDA, OHRP, and NIH in support of using central IRBs to
improve the efficiency of conducting trials. The Clinical
Trials Transformation Initiative (CTTI) supported this
project to solicit current perceptions of barriers to the
use of central IRBs and to formulate potential solutions. We
held discussions with IRB experts, interviewed
representatives of research institutions, and held an expert
meeting with diverse stakeholder groups and thought leaders.
We found that many perceived barriers relate to conflating
responsibilities of the institution with the ethical review
responsibilities of the IRB. We identified the need for
concrete tools to help research institutions separate
institutional responsibilities from ethical responsibilities
required of the IRB. One such tool is a document we created
that delineates these responsibilities and how they might be
assigned to each entity, or, in some cases, both entities.
This tool and project recommendations will be broadly
disseminated to facilitate the use of central IRBs in
multicenter trials. The ultimate goal is to increase the
nation's capacity to efficiently conduct the large number of
high-quality trials.},
Doi = {10.1371/journal.pone.0054999},
Key = {fds276655}
}
@article{fds276668,
Author = {Weinfurt, KP and Seils, DM and Lin, L and Sulmasy, DP and Astrow, AB and Hurwitz, HI and Cohen, RB and Meropol, NJ},
Title = {Research participants' high expectations of benefit in
early-phase oncology trials: are we asking the right
question?},
Journal = {J Clin Oncol},
Volume = {30},
Number = {35},
Pages = {4396-4400},
Year = {2012},
Month = {December},
url = {http://www.ncbi.nlm.nih.gov/pubmed/23091107},
Abstract = {PURPOSE: To determine whether patients' expectations of
benefit in early-phase oncology trials depend on how
patients are queried and to explore whether expectations are
associated with patient characteristics. PATIENTS AND
METHODS: Participants were 171 patients in phase I or II
oncology trials in the United States. After providing
informed consent for a trial but before receiving the
investigational therapy, participants answered questions
about expectations of benefit. We randomly assigned
participants to one of three groups corresponding to three
queries about expectations: frequency type, belief type, or
both. Main outcomes were differences in expectations by
question type and the extent to which expectations were
associated with demographic characteristics, numeracy,
dispositional optimism, religiousness/spirituality,
understanding of research, and other measures. RESULTS: The
belief-type group had a higher mean expectation of benefit
(64.4 of 100) than the combination group (51.6; P = .01) and
the frequency-type group (43.1; P < .001). Mean expectations
in the combination and frequency groups were not
significantly different (P = .06). Belief-type expectations
were associated with a preference for nonquantitative
information (r = -0.19; 95% CI, -0.19 to -0.36), knowledge
about research (r = -0.21; 95% CI, -0.38 to -0.03),
dispositional optimism (r = 0.20; 95% CI, 0.01 to 0.37), and
spirituality (r = 0.22; 95% CI, 0.03 to 0.38).
Frequency-type expectations were associated with knowledge
about clinical research (r = -0.27; 95% CI, -0.27 to -0.51).
CONCLUSION: In early-phase oncology trials, patients'
reported expectations of benefit differed according to how
patients were queried and were associated with patient
characteristics. These findings have implications for how
informed consent is obtained and assessed.},
Doi = {10.1200/JCO.2011.40.6587},
Key = {fds276668}
}
@article{fds276675,
Author = {Flynn, KE and Reese, JB and Jeffery, DD and Abernethy, AP and Lin, L and Shelby, RA and Porter, LS and Dombeck, CB and Weinfurt,
KP},
Title = {Patient experiences with communication about sex during and
after treatment for cancer.},
Journal = {Psychooncology},
Volume = {21},
Number = {6},
Pages = {594-601},
Year = {2012},
Month = {June},
ISSN = {1099-1611},
url = {http://www.ncbi.nlm.nih.gov/pubmed/21394821},
Keywords = {Adult • Aged • Aged, 80 and over • Coitus
• Communication* • Female • Focus Groups
• Humans • Male • Middle Aged •
Neoplasms • North Carolina • Patient Satisfaction
• Physician-Patient Relations* • Qualitative
Research • Quality of Life • Questionnaires •
Sexual Dysfunction, Physiological • Survivors •
complications* • physiology • physiopathology
• psychology • psychology*},
Abstract = {OBJECTIVE: We studied patients' experiences with oncology
providers regarding communication about sexual issues during
and after treatment for cancer. METHODS: During development
of the Patient-Reported Outcomes Measurement Information
System (PROMIS(®)) Sexual Function measure, we collected
focus group and survey data on communication with oncology
professionals about sexual problems. We conducted 16 focus
groups with patients and survivors (n = 109) and analyzed
the discussions for major themes, including experiences
discussing sex during oncology visits. During testing of the
PROMIS Sexual Function measure, we assessed experiences
discussing sexual problems with oncology professionals (n =
819) and measured bivariate associations between asking for
information from clinicians and sexual function and
satisfaction with sex life. RESULTS: Most patients and
survivors (74%) thought that discussions with oncology
professionals about sexual problems were important, but
whether they had ever received information about sexual
function from a provider varied by cancer type (23% lung,
29% breast, 39% colorectal, and 79% prostate). Those who had
asked an oncology professional about sexual problems had
significantly greater interest in sexual activity as well as
more sexual dysfunction. CONCLUSIONS: Sexual problems are a
widespread concern among patients and survivors, but there
is much variation in experiences of communication about
sexual issues, and many patients do not receive the
information they need from their oncology providers. There
are large differences in sexual function between patients
who do and do not ask providers about sexual problems.
Sexual health has yet to be fully integrated into oncology
care, even for cancers involving sex organs.},
Language = {eng},
Doi = {10.1002/pon.1947},
Key = {fds276675}
}
@article{fds276674,
Author = {Hooper, LM and Epstein, SA and Weinfurt, KP and DeCoster, J and Qu, L and Hannah, NJ},
Title = {Predictors of primary care physicians' self-reported
intention to conduct suicide risk assessments.},
Journal = {J Behav Health Serv Res},
Volume = {39},
Number = {2},
Pages = {103-115},
Year = {2012},
Month = {April},
ISSN = {1094-3412},
url = {http://www.ncbi.nlm.nih.gov/pubmed/22218814},
Abstract = {Primary care physicians play a significant role in
depression care, suicide assessment, and suicide prevention.
However, little is known about what factors relate to and
predict quality of depression care (assessment, diagnosis,
and treatment), including suicide assessment. The authors
explored the extent to which select patient and physician
factors increase the probability of one element of quality
of care: namely, intention to conduct suicide assessment.
Data were collected from 404 randomly selected primary care
physicians after their interaction with CD-ROM vignettes of
actors portraying major depression with moderate levels of
severity. The authors examined which patient factors and
physician factors increase the likelihood of physicians'
intention to conduct a suicide assessment. Data from the
study revealed that physician-participants inquired about
suicide 36% of the time. A random effects logistic model
indicated that several factors were predictive of
physicians' intention to conduct a suicide assessment:
patient's comorbidity status (odds ratio (OR) = 0.61;
95% confidence interval (CI) = 0.37-1.00), physicians'
age (OR = 0.67; 95% CI = 0.49-0.92), physicians'
race (OR = 1.84; 95% CI = 1.08-3.13), and how
depressed the physician perceived the virtual patient to be
(OR = 0.58; 95% CI = 0.39-0.87). A substantial
number of primary care physicians in this study indicated
they would not assess for suicide, even though most
physicians perceived the virtual patient to be depressed or
very depressed. Further study is needed to establish factors
that may be modified and targeted to increase the likelihood
of physicians' providing one element of quality of
care--suicide assessment--for depressed patients.},
Language = {eng},
Doi = {10.1007/s11414-011-9268-5},
Key = {fds276674}
}
@article{fds276673,
Author = {Shelby, RA and Scipio, CD and Somers, TJ and Soo, MS and Weinfurt, KP and Keefe, FJ},
Title = {Prospective study of factors predicting adherence to
surveillance mammography in women treated for breast
cancer.},
Journal = {J Clin Oncol},
Volume = {30},
Number = {8},
Pages = {813-819},
Year = {2012},
Month = {March},
ISSN = {1527-7755},
url = {http://www.ncbi.nlm.nih.gov/pubmed/22331949},
Abstract = {PURPOSE: This prospective study examined the factors that
predicted sustained adherence to surveillance mammography in
women treated for breast cancer. METHODS: Breast cancer
survivors (N = 204) who were undergoing surveillance
mammography completed questionnaires assessing
mammography-related anticipatory anxiety, persistent breast
pain, mammography pain, and catastrophic thoughts about
mammography pain. Adherence to mammography in the following
year was assessed. RESULTS: In the year after study entry,
84.8% of women (n = 173) returned for a subsequent
mammogram. Unadjusted associations showed that younger age,
shorter period of time since surgery, and having upper
extremity lymphedema were associated with lower mammography
adherence. Forty percent of women reported moderate to high
levels of mammography pain (score of ≥ 5 on a 0 to 10
scale). Although mammography pain was not associated with
adherence, higher levels of mammography-related anxiety and
pain catastrophizing were associated with not returning for
a mammogram (P < .05). The impact of anxiety on mammography
use was mediated by pain catastrophizing (indirect effect, P
< .05). CONCLUSION: Findings suggest that women who are
younger, closer to the time of surgery, or have upper
extremity lymphedema may be less likely to undergo repeated
mammograms. It may be important for health professionals to
remind selected patients directly that some women avoid
repeat mammography and to re-emphasize the value of
mammography for women with a history of breast cancer.
Teaching women behavioral techniques (eg, redirecting
attention) or providing medication for reducing anxiety
could be considered for women with high levels of anxiety or
catastrophic thoughts related to mammography.},
Language = {eng},
Doi = {10.1200/JCO.2010.34.4333},
Key = {fds276673}
}
@article{fds276672,
Author = {Flynn, KE and Lin, L and Moe, GW and Howlett, JG and Fine, LJ and Spertus,
JA and McConnell, TR and Piña, IL and Weinfurt, KP},
Title = {Relationships between changes in patient-reported health
status and functional capacity in outpatients with heart
failure.},
Journal = {Am Heart J},
Volume = {163},
Number = {1},
Pages = {88-94.e3},
Year = {2012},
Month = {January},
ISSN = {1097-6744},
url = {http://www.ncbi.nlm.nih.gov/pubmed/22172441},
Keywords = {Aged • Female • Health Status* • Heart
Failure • Humans • Longitudinal Studies •
Male • Middle Aged • Pain Measurement •
Quality of Life* • Randomized Controlled Trials as
Topic • Self Report* • Severity of Illness Index
• Stroke Volume • physiopathology*},
Abstract = {BACKGROUND: Heart failure trials use a variety of measures
of functional capacity and quality of life. Lack of formal
assessments of the relationships between changes in multiple
aspects of patient-reported health status and measures of
functional capacity over time limits the ability to compare
results across studies. METHODS: Using data from HF-ACTION
(N = 2331), we used the Pearson correlation coefficients and
predicted change scores from linear mixed-effects modeling
to demonstrate the associations between changes in
patient-reported health status measured with the EQ-5D
visual analog scale and the Kansas City Cardiomyopathy
Questionnaire (KCCQ) and changes in peak VO(2) and 6-minute
walk distance at 3 and 12 months. We examined a 5-point
change in KCCQ within individuals to provide a framework for
interpreting changes in these measures. RESULTS: After
adjustment for baseline characteristics, correlations
between changes in the visual analog scale and changes in
peak VO(2) and 6-minute walk distance ranged from 0.13 to
0.28, and correlations between changes in the KCCQ overall
and subscale scores and changes in peak VO(2) and 6-minute
walk distance ranged from 0.18 to 0.34. A 5-point change in
KCCQ was associated with a 2.50-mL kg(-1) min(-1) change in
peak VO(2) (95% CI 2.21-2.86) and a 112-m change in 6-minute
walk distance (95% CI 96-134). CONCLUSIONS: Changes in
patient-reported health status are not highly correlated
with changes in functional capacity. Our findings generally
support the current practice of considering a 5-point change
in the KCCQ within individuals to be clinically
meaningful.},
Language = {eng},
Doi = {10.1016/j.ahj.2011.09.027},
Key = {fds276672}
}
@article{fds276671,
Author = {Beskow, LM and Check, DK and Namey, EE and Dame, LA and Lin, L and Cooper,
A and Weinfurt, KP and Wolf, LE},
Title = {Institutional review boards' use and understanding of
certificates of confidentiality.},
Journal = {PLoS One},
Volume = {7},
Number = {9},
Pages = {e44050},
Year = {2012},
url = {http://www.ncbi.nlm.nih.gov/pubmed/22962599},
Abstract = {Certificates of Confidentiality, issued by agencies of the
U.S. government, are regarded as an important tool for
meeting ethical and legal obligations to safeguard research
participants' privacy and confidentiality. By shielding
against forced disclosure of identifying data, Certificates
are intended to facilitate research on sensitive topics
critical to the public's health. Although Certificates are
potentially applicable to an extensive array of research,
their full legal effect is unclear, and little is known
about stakeholders' views of the protections they provide.
To begin addressing this challenge, we conducted a national
survey of institutional review board (IRB) chairs, followed
by telephone interviews with selected chairs, to learn more
about their familiarity with and opinions about
Certificates; their institutions' use of Certificates;
policies and practices concerning when Certificates are
required or recommended; and the role Certificates play in
assessments of research risk. Overall, our results suggest
uncertainty about Certificates among IRB chairs. On most
objective knowledge questions, most respondents chose the
incorrect answer or 'unsure'. Among chairs who reported more
familiarity with Certificates, composite opinion scores
calculated based on five survey questions were evenly
distributed among positive, neutral/middle, and negative
views. Further, respondents expressed a variety of ideas
about the appropriate use of Certificates, what they are
intended to protect, and their effect on research risk.
Nevertheless, chairs who participated in our study commonly
viewed Certificates as a potentially valuable tool,
frequently describing them as an 'extra layer' of
protection. These findings lead to several practical
observations concerning the need for more stakeholder
education about Certificates, consideration of Certificates
for a broader range of studies, the importance of remaining
vigilant and using all tools available to protect
participants' confidentiality, and the need for further
empirical investigation of Certificates' effect on
researchers and research participants.},
Doi = {10.1371/journal.pone.0044050},
Key = {fds276671}
}
@article{fds276683,
Author = {Eisenstein, EL and Diener, LW and Nahm, M and Weinfurt,
KP},
Title = {Impact of the Patient-Reported Outcomes Management
Information System (PROMIS) upon the design and operation of
multi-center clinical trials: a qualitative research
study.},
Journal = {J Med Syst},
Volume = {35},
Number = {6},
Pages = {1521-1530},
Year = {2011},
Month = {December},
ISSN = {0148-5598},
url = {http://www.ncbi.nlm.nih.gov/pubmed/20703765},
Keywords = {Focus Groups • Humans • Information Systems •
Multicenter Studies as Topic* • Outcome Assessment
(Health Care) • Qualitative Research • Systems
Integration • organization & administration*},
Abstract = {New technologies may be required to integrate the National
Institutes of Health's Patient Reported Outcome Management
Information System (PROMIS) into multi-center clinical
trials. To better understand this need, we identified likely
PROMIS reporting formats, developed a multi-center clinical
trial process model, and identified gaps between current
capabilities and those necessary for PROMIS. These results
were evaluated by key trial constituencies. Issues reported
by principal investigators fell into two categories:
acceptance by key regulators and the scientific community,
and usability for researchers and clinicians. Issues
reported by the coordinating center, participating sites,
and study subjects were those faced when integrating new
technologies into existing clinical trial systems. We then
defined elements of a PROMIS Tool Kit required for
integrating PROMIS into a multi-center clinical trial
environment. The requirements identified in this study serve
as a framework for future investigators in the design,
development, implementation, and operation of PROMIS Tool
Kit technologies.},
Language = {eng},
Doi = {10.1007/s10916-010-9429-8},
Key = {fds276683}
}
@article{fds348594,
Author = {Kamble, S and Weinfurt, KP and Perry, BM and Schulman, KA and Reed,
SD},
Title = {PMD29 PATIENT TIME AND INDIRECT COSTS ASSOCIATED WITH
SENSOR-AUGMENTED INSULIN PUMP THERAPY IN TYPE 1
DIABETES},
Journal = {Value in Health},
Volume = {14},
Number = {3},
Pages = {A84-A84},
Publisher = {Elsevier BV},
Year = {2011},
Month = {May},
url = {http://dx.doi.org/10.1016/j.jval.2011.02.468},
Doi = {10.1016/j.jval.2011.02.468},
Key = {fds348594}
}
@article{fds276676,
Author = {Dinan, MA and Compton, KL and Dhillon, JK and Hammill, BG and Dewitt,
EM and Weinfurt, KP and Schulman, KA},
Title = {Use of patient-reported outcomes in randomized,
double-blind, placebo-controlled clinical
trials.},
Journal = {Med Care},
Volume = {49},
Number = {4},
Pages = {415-419},
Year = {2011},
Month = {April},
ISSN = {0025-7079},
url = {http://www.ncbi.nlm.nih.gov/pubmed/21368680},
Keywords = {Data Interpretation, Statistical • Double-Blind Method
• Humans • Outcome Assessment (Health Care) •
Placebos • Quality Indicators, Health Care •
Quality of Life • Randomized Controlled Trials as
Topic* • Research Subjects • methods* •
psychology*},
Abstract = {BACKGROUND: To optimize the use of patient-reported outcomes
(PROs) in clinical research, it is first necessary to review
the current use of these outcomes in clinical trials to
determine under what circumstances they are most useful, and
to reveal current limitations. PURPOSE: To investigate
current patterns of use of PROs in clinical trials. RESEARCH
DESIGN: We conducted a systematic literature review of all
double-blind, placebo-controlled, randomized clinical trials
using one or more PROs as a study outcome from 2004 to 2006.
Data were abstracted and analyzed with descriptive
statistics and logistic regression to characterize the use
of PROs in clinical trials. RESULTS: The 180 clinical trials
that met the study inclusion criteria used 173 unique
instruments to measure a total of 466 PROs. Most PRO
measurements were obtained using relatively few PRO
instruments, with one-third of PRO instruments applied in
more than 1 trial. In multivariable analysis, tests of
statistical significance were more often reported for PROs
used as primary trial outcomes. Statistically significant
PRO outcomes (P<0.05) were more likely among
disease-specific PROs compared with general PROs, PROs with
a discussion of minimally important difference, and larger
trials. CONCLUSIONS: PRO instruments may be improved through
efforts to provide centralized electronic administration,
cross-validation, and standardized interpretation of
clinically relevant outcomes. The majority of PROs used in
current clinical trials come from relatively few, commonly
used disease-specific PRO instruments within major
therapeutic areas.},
Language = {eng},
Doi = {10.1097/MLR.0b013e3182064aa2},
Key = {fds276676}
}
@article{fds276678,
Author = {Flynn, KE and Jeffery, DD and Keefe, FJ and Porter, LS and Shelby, RA and Fawzy, MR and Gosselin, TK and Reeve, BB and Weinfurt,
KP},
Title = {Sexual functioning along the cancer continuum: focus group
results from the Patient-Reported Outcomes Measurement
Information System (PROMIS®).},
Journal = {Psychooncology},
Volume = {20},
Number = {4},
Pages = {378-386},
Year = {2011},
Month = {April},
ISSN = {1099-1611},
url = {http://www.ncbi.nlm.nih.gov/pubmed/20878833},
Keywords = {Adult • Aged • Aged, 80 and over • Female
• Focus Groups • Humans • Information Systems
• Male • Middle Aged • Neoplasms •
Outcome Assessment (Health Care)* • Patient
Satisfaction • Psychometrics* • Qualitative
Research • Quality of Life • Questionnaires •
Research Design • Sexual Behavior • Sexual
Dysfunction, Physiological • complications* •
physiology • physiopathology • psychology •
psychology*},
Abstract = {OBJECTIVE: Cancer and treatments for cancer affect specific
aspects of sexual functioning and intimacy; however, limited
qualitative work has been done in diverse cancer
populations. As part of an effort to improve measurement of
self-reported sexual functioning, we explored the scope and
importance of sexual functioning and intimacy to patients
across cancer sites and along the continuum of care.
METHODS: We conducted 16 diagnosis- and sex-specific focus
groups with patients recruited from the Duke University
tumor registry and oncology/hematology clinics (N=109). A
trained note taker produced field notes summarizing the
discussions. An independent auditor verified field notes
against written transcripts. The content of the discussions
was analyzed for major themes by two independent coders.
RESULTS: Across all cancers, the most commonly discussed
cancer- or treatment-related effects on sexual functioning
and intimacy were fatigue, treatment-related hair loss,
weight gain and organ loss or scarring. Additional barriers
were unique to particular diagnoses, such as shortness of
breath in lung cancer, gastrointestinal problems in
colorectal cancers and incontinence in prostate cancer.
Sexual functioning and intimacy were considered important to
quality of life. While most effects of cancer were
considered negative, many participants identified
improvements to intimacy after cancer. CONCLUSION: Overall
evaluations of satisfaction with sex life did not always
correspond to specific aspects of functioning (e.g. erectile
dysfunction), presenting a challenge to researchers aiming
to measure sexual functioning as an outcome. Health-care
providers should not assume that level of sexual impairment
determines sexual satisfaction and should explore cancer
patients' sexual concerns directly.},
Language = {eng},
Doi = {10.1002/pon.1738},
Key = {fds276678}
}
@article{fds195942,
Author = {MA Kelly and JQ Morse and A Stover and T Hofkens and E Huisman and S
Shulman, SV Eisen and SJ Becker and K Weinfurt and E Boland and PA
Pilkonis},
Title = {Describing depression: congruence between patient
experiences and clinical assessments.},
Journal = {The British journal of clinical psychology / the British
Psychological Society},
Volume = {50},
Number = {1},
Pages = {46-66},
Year = {2011},
Month = {March},
ISSN = {0144-6657},
url = {http://dx.doi.org/10.1348/014466510X493926},
Keywords = {Depressive Disorder • Female • Focus Groups •
Humans • Male • Middle Aged • Psychiatric
Status Rating Scales • Reproducibility of Results
• Self Report* • diagnosis* • psychology*
• statistics & numerical data*},
Abstract = {OBJECTIVE: Efforts to describe depression have relied on
top-down methods in which theory and clinical experience
define depression but may not reflect the individuals'
experiences with depression. We assessed the degree of
overlap between academic descriptions of depression and
patient-reported symptoms as conceptualized in the
Patient-Reported Outcomes Measurement Information System(®)
(PROMIS(®)). By extension, this work assesses the degree of
overlap between current clinical descriptions of depression
and patient-reported symptoms. METHODS: In this content
analysis study, four focus groups were conducted across two
sites to elicit symptoms and the experience of depression
from depressed and medically ill patients. METHODS:
Depressed and medically ill patients were asked to describe
symptoms that characterize depression. Data were transcribed
and then coded using an a priori list of 43 facets of
depression derived from extant depression measures. RESULTS:
Participants described 93% of the symptoms from the a priori
list, supporting the validity of current depression
measures. Interpersonal difficulties were underscored as was
anger. In general, results from the focus groups did not
require the generation of new items for depression and
supported the content validity of the PROMIS hierarchical
framework and item pool created originally. CONCLUSIONS:
This work supports the validity of current depression
assessment, but suggests further investigation of
interpersonal functioning and anger may add to the depth and
breadth of depression assessment.},
Language = {eng},
Doi = {10.1348/014466510X493926},
Key = {fds195942}
}
@article{fds276677,
Author = {Glickman, SW and Ndubuizu, A and Weinfurt, KP and Hamilton, CD and Glickman, LT and Schulman, KA and Cairns, CB},
Title = {Perspective: The case for research justice: inclusion of
patients with limited English proficiency in clinical
research.},
Journal = {Acad Med},
Volume = {86},
Number = {3},
Pages = {389-393},
Year = {2011},
Month = {March},
ISSN = {1938-808X},
url = {http://www.ncbi.nlm.nih.gov/pubmed/21248607},
Keywords = {Biomedical Research • Ethics Committees, Research
• Humans • Informed Consent • Language*
• Organizational Policy* • Patient Selection
• Social Justice • United States • ethics
• ethics* • organization & administration*},
Abstract = {Persons with limited English proficiency (LEP) constitute a
growing portion of the U.S. population, yet they are
underrepresented in clinical research. This inherently
limits the societal benefits of the research and its
generalizability to ethnic populations living in the United
States. To illustrate the complexity associated with
including LEP participants in clinical research, the authors
critically evaluated LEP consent requirements posted on the
Web sites of 134 academic health centers in March 2008. They
found wide variability with regard to consent policies and
striking interinstitutional differences in posted IRB
policies and attitudes toward consent of LEP patients in
research. The authors argue this variation highlights
competing concerns between autonomy and justice.
Outcomes-based justice requires inclusion of LEP patients in
the research, yet the consent process is often
resource-intensive and complex. The authors suggest that
more uniform and specific guidance from federal agencies for
enrollment of LEP patients in clinical research be
established and that this guidance explicitly recalibrate
the current balance between autonomy and justice.
Investigators and institutional review boards should also
develop streamlined best practices to reduce unnecessary
effort and expense associated with recruitment of LEP
individuals. LEP individuals should have fair access to
clinical research in order to fully realize individual and
societal benefits of their participation and to ensure the
generalizability of scientific discovery.},
Language = {eng},
Doi = {10.1097/ACM.0b013e318208289a},
Key = {fds276677}
}
@article{fds276686,
Author = {Kelly, MAR and Morse, JQ and Stover, A and Hofkens, T and Huisman, E and Shulman, S and Eisen, SV and Becker, SJ and Weinfurt, K and Boland, E and Pilkonis, PA},
Title = {Describing depression: congruence between patient
experiences and clinical assessments.},
Journal = {Br J Clin Psychol},
Volume = {50},
Number = {1},
Pages = {46-66},
Year = {2011},
Month = {March},
ISSN = {0144-6657},
url = {http://www.ncbi.nlm.nih.gov/pubmed/21332520},
Abstract = {OBJECTIVES: Efforts to describe depression have relied on
top-down methods in which theory and clinical experience
define depression but may not reflect the individuals'
experiences with depression. We assessed the degree of
overlap between academic descriptions of depression and
patient-reported symptoms as conceptualized in the
Patient-Reported Outcomes Measurement Information System(®)
(PROMIS(®)). By extension, this work assesses the degree of
overlap between current clinical descriptions of depression
and patient-reported symptoms. DESIGN: In this content
analysis study, four focus groups were conducted across two
sites to elicit symptoms and the experience of depression
from depressed and medically ill patients. METHODS:
Depressed and medically ill patients were asked to describe
symptoms that characterize depression. Data were transcribed
and then coded using an a priori list of 43 facets of
depression derived from extant depression measures. RESULTS:
Participants described 93% of the symptoms from the a priori
list, supporting the validity of current depression
measures. Interpersonal difficulties were underscored as was
anger. In general, results from the focus groups did not
require the generation of new items for depression and
supported the content validity of the PROMIS hierarchical
framework and item pool created originally. CONCLUSIONS:
This work supports the validity of current depression
assessment, but suggests further investigation of
interpersonal functioning and anger may add to the depth and
breadth of depression assessment.},
Language = {ENG},
Doi = {10.1348/014466510X493926},
Key = {fds276686}
}
@article{fds276682,
Author = {Cella, D and Riley, W and Stone, A and Rothrock, N and Reeve, B and Yount,
S and Amtmann, D and Bode, R and Buysse, D and Choi, S and Cook, K and Devellis, R and DeWalt, D and Fries, JF and Gershon, R and Hahn, EA and Lai, J-S and Pilkonis, P and Revicki, D and Rose, M and Weinfurt, K and Hays, R and PROMIS Cooperative Group},
Title = {The Patient-Reported Outcomes Measurement Information System
(PROMIS) developed and tested its first wave of adult
self-reported health outcome item banks:
2005-2008.},
Journal = {J Clin Epidemiol},
Volume = {63},
Number = {11},
Pages = {1179-1194},
Year = {2010},
Month = {November},
ISSN = {1878-5921},
url = {http://www.ncbi.nlm.nih.gov/pubmed/20685078},
Keywords = {Adult • Female • Health Status • Health
Surveys • Humans • Information Systems • Male
• Outcome Assessment (Health Care) • Patient
Satisfaction • Quality of Life • Questionnaires
• Self Disclosure • United States •
standards* • statistics & numerical
data*},
Abstract = {OBJECTIVES: Patient-reported outcomes (PROs) are essential
when evaluating many new treatments in health care; yet,
current measures have been limited by a lack of precision,
standardization, and comparability of scores across studies
and diseases. The Patient-Reported Outcomes Measurement
Information System (PROMIS) provides item banks that offer
the potential for efficient (minimizes item number without
compromising reliability), flexible (enables optional use of
interchangeable items), and precise (has minimal error in
estimate) measurement of commonly studied PROs. We report
results from the first large-scale testing of PROMIS items.
STUDY DESIGN AND SETTING: Fourteen item pools were tested in
the U.S. general population and clinical groups using an
online panel and clinic recruitment. A scale-setting
subsample was created reflecting demographics proportional
to the 2000 U.S. census. RESULTS: Using item-response theory
(graded response model), 11 item banks were calibrated on a
sample of 21,133, measuring components of self-reported
physical, mental, and social health, along with a 10-item
Global Health Scale. Short forms from each bank were
developed and compared with the overall bank and with other
well-validated and widely accepted ("legacy") measures. All
item banks demonstrated good reliability across most of the
score distributions. Construct validity was supported by
moderate to strong correlations with legacy measures.
CONCLUSION: PROMIS item banks and their short forms provide
evidence that they are reliable and precise measures of
generic symptoms and functional reports comparable to legacy
instruments. Further testing will continue to validate and
test PROMIS items and banks in diverse clinical
populations.},
Language = {eng},
Doi = {10.1016/j.jclinepi.2010.04.011},
Key = {fds276682}
}
@article{fds276679,
Author = {Beskow, LM and Friedman, JY and Hardy, NC and Lin, L and Weinfurt,
KP},
Title = {Developing a simplified consent form for
biobanking.},
Journal = {PLoS One},
Volume = {5},
Number = {10},
Pages = {e13302},
Year = {2010},
Month = {October},
ISSN = {1932-6203},
url = {http://www.ncbi.nlm.nih.gov/pubmed/20949049},
Keywords = {Confidentiality • Cost-Benefit Analysis • Diabetes
Mellitus • Humans • Informed Consent* •
Tissue Banks* • physiopathology},
Abstract = {BACKGROUND: Consent forms have lengthened over time and
become harder for participants to understand. We sought to
demonstrate the feasibility of creating a simplified consent
form for biobanking that comprises the minimum information
necessary to meet ethical and regulatory requirements. We
then gathered preliminary data concerning its content from
hypothetical biobank participants. METHODOLOGY/PRINCIPAL
FINDINGS: We followed basic principles of plain-language
writing and incorporated into a 2-page form (not including
the signature page) those elements of information required
by federal regulations and recommended by best practice
guidelines for biobanking. We then recruited diabetes
patients from community-based practices and randomized half
(n = 56) to read the 2-page form, first on paper and
then a second time on a tablet computer. Participants were
encouraged to use "More information" buttons on the
electronic version whenever they had questions or desired
further information. These buttons led to a series of
"Frequently Asked Questions" (FAQs) that contained
additional detailed information. Participants were asked to
identify specific sentences in the FAQs they thought would
be important if they were considering taking part in a
biorepository. On average, participants identified 7 FAQ
sentences as important (mean 6.6, SD 14.7, range: 0-71). No
one sentence was highlighted by a majority of participants;
further, 34 (60.7%) participants did not highlight any FAQ
sentences. CONCLUSIONS: Our preliminary findings suggest
that our 2-page form contains the information that most
prospective participants identify as important. Combining
simplified forms with supplemental material for those
participants who desire more information could help minimize
consent form length and complexity, allowing the most
substantively material information to be better highlighted
and enabling potential participants to read the form and ask
questions more effectively.},
Language = {eng},
Doi = {10.1371/journal.pone.0013302},
Key = {fds276679}
}
@article{fds276680,
Author = {Hall, MA and Friedman, JY and King, NMP and Weinfurt, KP and Schulman,
KA and Sugarman, J},
Title = {Commentary: Per capita payments in clinical trials:
reasonable costs versus bounty hunting.},
Journal = {Acad Med},
Volume = {85},
Number = {10},
Pages = {1554-1556},
Year = {2010},
Month = {October},
ISSN = {1938-808X},
url = {http://www.ncbi.nlm.nih.gov/pubmed/20881671},
Abstract = {Paying more for clinical research than the cost of doing the
work may create a conflict of interest that could lead to
overzealous recruitment, putting participants and scientific
integrity at risk. Thus, although various policies prohibit
"finder's fees" simply for recruiting patients, paying the
actual costs for research is permissible. Whereas
industry-sponsored research routinely pays for the costs of
each patient enrolled, the line between reasonable and
excessive costs merits more attention. In academic medical
centers (AMCs), institutional review boards and conflict of
interest committees usually are not involved in reviewing
research budgets to determine whether per capita payments
are excessive. Also, the costs for clinical services in
research are not standardized. Instead, budgets are
negotiated both internally, among departments within
research institutions, and externally, between researchers
and sponsors. Sometimes, rates paid by sponsors exceed what
researchers usually receive or are actually paid for
particular services, generating a surplus. Nevertheless, the
authors see only limited cause for concern because, at the
AMCs with which the authors are familiar, any monetary
surplus generally remains within the research enterprise to
cover unanticipated budget shortfalls or to support research
staff in the future during lean times. In addition, the
surplus from research budgets is not shared directly with
individual investigators. However, further investigation is
needed to determine whether practices outside AMCs pose
greater concerns.},
Language = {eng},
Doi = {10.1097/ACM.0b013e3181ef9cc6},
Key = {fds276680}
}
@article{fds276689,
Author = {Flynn, KE and Shelby, RA and Mitchell, SA and Fawzy, MR and Hardy, NC and Husain, AM and Keefe, FJ and Krystal, AD and Porter, LS and Reeve, BB and Weinfurt, KP},
Title = {Sleep-wake functioning along the cancer continuum: focus
group results from the Patient-Reported Outcomes Measurement
Information System (PROMIS(®)).},
Journal = {Psychooncology},
Volume = {19},
Number = {10},
Pages = {1086-1093},
Year = {2010},
Month = {October},
ISSN = {1099-1611},
url = {http://www.ncbi.nlm.nih.gov/pubmed/20013938},
Keywords = {Adult • Aged • Aged, 80 and over • Female
• Focus Groups • Humans • Information Systems
• Male • Middle Aged • Neoplasms •
Outcome Assessment (Health Care)* • Qualitative
Research • Quality of Life • Questionnaires •
Self Disclosure* • Sleep Disorders, Circadian Rhythm
• complications* • physiopathology •
psychology},
Abstract = {OBJECTIVE: Cancer and its treatments disturb sleep-wake
functioning; however, there is little information available
on the characteristics and consequences of sleep problems
associated with cancer. As part of an effort to improve
measurement of sleep-wake functioning, we explored the scope
of difficulties with sleep in a diverse group of patients
diagnosed with cancer. METHODS: We conducted 10 focus groups
with patients recruited from the Duke University tumor
registry and oncology/hematology clinics. Separate groups
were held with patients scheduled to begin or currently
undergoing treatment for breast, prostate, lung, colorectal,
hematological, and other cancer types and with patients who
were in posttreatment follow-up. The content of the focus
group discussions was transcribed and analyzed for major
themes by independent coders. RESULTS: Participants not only
reported causes of sleep disturbance common in other
populations, such as pain and restless legs, but they also
reported causes that may be unique to cancer populations,
including abnormal dreams, anxiety about cancer diagnosis
and recurrence, night sweats, and problems with sleep
positioning. Many participants felt that sleep problems
reduced their productivity, concentration, social
interactions, and overall quality of life. Many also shared
beliefs about the increased importance of sleep when
fighting cancer. CONCLUSIONS: The findings underscore the
need for interventions that minimize the negative impact of
cancer and its treatments on sleep. This study will inform
efforts now underway to develop a patient-reported measure
of sleep-wake functioning that reflects the breadth of
concepts considered important by patients with
cancer.},
Language = {eng},
Doi = {10.1002/pon.1664},
Key = {fds276689}
}
@article{fds276681,
Author = {Beskow, LM and Friedman, JY and Hardy, NC and Lin, L and Weinfurt,
KP},
Title = {Simplifying informed consent for biorepositories:
stakeholder perspectives.},
Journal = {Genet Med},
Volume = {12},
Number = {9},
Pages = {567-572},
Year = {2010},
Month = {September},
ISSN = {1530-0366},
url = {http://www.ncbi.nlm.nih.gov/pubmed/20697289},
Keywords = {Adult • Biological Specimen Banks* • Clinical
Trials as Topic • Consent Forms • Ethics
Committees, Research • Humans • Informed Consent
• Male • Medical Records • Middle Aged •
Privacy • standards*},
Abstract = {PURPOSE: Complex and sometimes controversial information
must be conveyed during the consent process for
participation in biorepositories, and studies suggest that
consent documents in general are growing in length and
complexity. As a first step toward creating a simplified
biorepository consent form, we gathered data from multiple
stakeholders about what information was most important for
prospective participants to know when making a decision
about taking part in a biorepository. METHODS: We recruited
52 research participants, 12 researchers, and 20
institutional review board representatives from Durham and
Kannapolis, NC. These subjects were asked to read a model
biorepository consent form and highlight sentences they
deemed most important. RESULTS: On average, institutional
review board representatives identified 72.3% of the
sentences as important; researchers selected 53.0%, and
participants 40.4% (P = 0.0004). Participants most often
selected sentences about the kinds of individual research
results that might be offered, privacy risks, and
large-scale data sharing. Researchers highlighted sentences
about the biorepository's purpose, privacy protections,
costs, and participant access to individual results.
Institutional review board representatives highlighted
sentences about collection of basic personal information,
medical record access, and duration of storage. CONCLUSION:
The differing mandates of these three groups can translate
into widely divergent opinions about what information is
important and appropriate to include a consent form. These
differences could frustrate efforts to move simplified
forms--for biobanking as well as for other kinds of
research--into actual use, despite continued calls for such
forms.},
Language = {eng},
Doi = {10.1097/GIM.0b013e3181ead64d},
Key = {fds276681}
}
@article{fds276684,
Author = {Sulmasy, DP and Astrow, AB and He, MK and Seils, DM and Meropol, NJ and Micco, E and Weinfurt, KP},
Title = {The culture of faith and hope: patients' justifications for
their high estimations of expected therapeutic benefit when
enrolling in early phase oncology trials.},
Journal = {Cancer},
Volume = {116},
Number = {15},
Pages = {3702-3711},
Year = {2010},
Month = {August},
ISSN = {0008-543X},
url = {http://www.ncbi.nlm.nih.gov/pubmed/20564120},
Keywords = {Attitude to Health* • Clinical Trials as Topic* •
Comprehension • Female • Humans • Informed
Consent • Interviews as Topic • Male • Middle
Aged • Neoplasms • Patient Selection •
Religion and Medicine • Therapeutic Misconception
• ethics • ethics* • psychology* •
therapy*},
Abstract = {BACKGROUND: Patients' estimates of their chances of
therapeutic benefit from participation in early phase trials
greatly exceed historical data. Ethicists worry that this
therapeutic misestimation undermines the validity of
informed consent. METHODS: The authors interviewed 45
patients enrolled in phase 1 or 2 oncology trials about
their expectations of therapeutic benefit and their reasons
for those expectations. They used a phenomenological,
qualitative approach with 1 primary coder to identify
emergent themes, verified by 2 independent coders. RESULTS:
Median expectations of therapeutic benefit varied from 50%
to 80%, depending on how the question was asked.
Justifications universally invoked hope and optimism, and 27
of 45 participants used 1 of these words. Three major themes
emerged: 1) optimism as performative, that is, the notion
that positive thoughts and expressions improve chances of
benefit; 2) fighting cancer as a battle; and 3) faith in
God, science, or both. Many participants described a culture
in which optimism was encouraged and expected, such that
trial enrollment became a way of reflecting this
expectation. Many reported they had been told few patients
would benefit and appeared to understand the uncertainties
of clinical research, yet expressed high expected personal
therapeutic benefit. More distressed participants were less
likely to invoke performative justifications for their
expectations (50% vs 84%; P=.04). CONCLUSIONS: Expressions
of high expected therapeutic benefit had little to do with
reporting knowledge and more to do with expressing optimism.
These results have implications for understanding how to
obtain valid consent from participants in early phase
clinical trials.},
Language = {eng},
Doi = {10.1002/cncr.25201},
Key = {fds276684}
}
@article{fds276688,
Author = {Weinfurt, KP and Hall, MA and Hardy, NC and Friedman, JY and Schulman,
KA and Sugarman, J},
Title = {Oversight of financial conflicts of interest in commercially
sponsored research in academic and nonacademic
settings.},
Journal = {J Gen Intern Med},
Volume = {25},
Number = {5},
Pages = {460-464},
Year = {2010},
Month = {May},
ISSN = {1525-1497},
url = {http://www.ncbi.nlm.nih.gov/pubmed/20186498},
Keywords = {Academic Medical Centers • Biomedical Research •
Clinical Trials as Topic • Clinical Trials, Phase III
as Topic • Conflict of Interest • Ethics
Committees, Research • Humans • economics •
economics* • ethics},
Abstract = {BACKGROUND: Studies of conflicts of interest in clinical
research have focused on academic centers, but most clinical
research takes place in nonacademic settings. OBJECTIVE: To
compare oversight and management of investigators' financial
relationships in academic and nonacademic research settings.
DESIGN, SETTING, AND PARTICIPANTS: Survey of officials at
199 sites that contributed participants to commercially
sponsored phase 3 clinical trials published in JAMA or the
New England Journal of Medicine in 2006 and 2007.
MEASUREMENTS AND MAIN RESULTS: Response rates were 66% for
academic medical centers, 37% for nonacademic medical
centers (inpatient), and 27% for outpatient nonacademic
sites. Almost all academic medical centers (97%) and most
nonacademic medical centers (87%) followed written
conflict-of-interest policies, whereas 44% of outpatient
nonacademic sites had written policies (P < 0.001). Academic
and nonacademic medical centers relied mainly on internal
institutional review boards (69% and 71%, respectively);
outpatient nonacademic sites relied primarily on independent
institutional review boards (59%; P < 0.001). CONCLUSIONS:
Nonacademic sites have substantially different approaches to
the oversight and management of financial relationships in
commercially sponsored clinical research than academic
medical centers. These differences warrant more attention to
how financial relationships are monitored in community
research settings.},
Language = {eng},
Doi = {10.1007/s11606-010-1264-6},
Key = {fds276688}
}
@article{fds276687,
Author = {Fortune-Greeley, AK and Hardy, NC and Lin, L and Friedman, JY and Lawlor, JS and Muhlbaier, LH and Hall, MA and Schulman, KA and Sugarman,
J and Weinfurt, KP},
Title = {Patient reactions to confidentiality, liability, and
financial aspects of informed consent in cardiology
research.},
Journal = {Circ Cardiovasc Qual Outcomes},
Volume = {3},
Number = {2},
Pages = {151-158},
Year = {2010},
Month = {March},
ISSN = {1941-7705},
url = {http://www.ncbi.nlm.nih.gov/pubmed/20233979},
Keywords = {Academic Medical Centers • Aged • Ambulatory Care
Facilities • Cardiology* • Chi-Square Distribution
• Clinical Trials as Topic* • Comprehension •
Confidentiality* • Conflict of Interest • Decision
Making • Female • Health Knowledge, Attitudes,
Practice • Humans • Informed Consent* •
Interviews as Topic • Language • Liability, Legal*
• Linear Models • Logistic Models • Male
• Middle Aged • Patient Selection* • Research
Design* • Research Subjects • economics •
ethics • legislation & jurisprudence •
psychology*},
Abstract = {BACKGROUND: Although the informed consent process is
supposed to help potential research participants make
informed and voluntary decisions about participating in
research, little is known about how participants react to
language in the informed consent document and whether their
reactions are related to their willingness to enroll in
clinical trials. We examined the relationship between
patients' reactions to standard informed consent language
and their willingness to participate in a hypothetical
clinical trial. METHODS AND RESULTS: We simulated the
consent process for a hypothetical cardiology clinical trial
with 470 patients in an outpatient cardiovascular medicine
clinic at a large academic medical center. We analyzed the
spontaneous comments and questions that participants made
during the interviews about each section of the informed
consent document. Few participants made positive comments.
Participants made the most negative comments about the
sections on risks, study purpose or protocol, and payment
for injury. Having a negative reaction to any section was
associated with a lower likelihood of participating in the
clinical trial. Using a multivariable model, we found that
negative reactions in the patient rights, financial
disclosure, and confidentiality sections predicted
willingness to participate (P<0.001). CONCLUSIONS:
Recognizing elements of informed consent that elicit
questions and concerns from potential research participants
may help investigators design clinical research trials and
model language in a way that reduces concerns or increases
participant understanding, thereby enhancing informed
consent for research.},
Language = {eng},
Doi = {10.1161/CIRCOUTCOMES.109.849273},
Key = {fds276687}
}
@article{fds348596,
Author = {Flynn, KE and Pina, IL and Whellan, DJ and Lin, L and Blumenthal, JA and Ellis, SJ and Fine, LJ and Howlett, JG and Keteyian, SJ and Kitzman, DW and Kraus, WE and Miller, NH and Schulman, KA and Spertus, JA and O'Connor,
CM and Weinfurt, KP},
Title = {Effects of Exercise Training on Health Status in Patients
With Chronic Heart Failure: HF-ACTION Randomized Controlled
Trial (vol 301, pg 1451, 2009)},
Journal = {JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION},
Volume = {302},
Number = {21},
Pages = {2322-2322},
Publisher = {AMER MEDICAL ASSOC},
Year = {2009},
Month = {December},
Key = {fds348596}
}
@article{fds276691,
Author = {Flynn, KE and Lin, L and Ellis, SJ and Russell, SD and Spertus, JA and Whellan, DJ and Piña, IL and Fine, LJ and Schulman, KA and Weinfurt,
KP and HF-ACTION Investigators},
Title = {Outcomes, health policy, and managed care: relationships
between patient-reported outcome measures and clinical
measures in outpatients with heart failure.},
Journal = {Am Heart J},
Volume = {158},
Number = {4 Suppl},
Pages = {S64-S71},
Year = {2009},
Month = {October},
ISSN = {1097-6744},
url = {http://www.ncbi.nlm.nih.gov/pubmed/19782791},
Keywords = {Ambulatory Care* • Attitude to Health • Exercise
Test • Exercise Tolerance • Female • Health
Policy* • Health Status* • Heart Failure •
Humans • Male • Managed Care Programs* •
Middle Aged • Outcome Assessment (Health Care) •
Oxygen Consumption • Prognosis • Quality of Life
• Questionnaires • Ventricular Dysfunction, Left
• diagnosis • diagnosis* • physiology •
physiopathology • standards • statistics &
numerical data • therapy • therapy*},
Abstract = {BACKGROUND: Patient-reported outcomes are increasingly used
to assess the efficacy of new treatments. Understanding
relationships between these and clinical measures can
facilitate their interpretation. We examined associations
between patient-reported measures of health-related quality
of life and clinical indicators of disease severity in a
large, heterogeneous sample of patients with heart failure.
METHODS: Patient-reported measures, including the Kansas
City Cardiomyopathy Questionnaire (KCCQ) and the EuroQol
Visual Analog Scale (VAS), and clinical measures, including
peak VO(2), 6-minute walk distance, and New York Heart
Association (NYHA) class, were assessed at baseline in 2331
patients with heart failure. We used general linear models
to regress patient-reported measures on each clinical
measure. Final models included for significant
sociodemographic variables and 2-way interactions. RESULTS:
The KCCQ was correlated with peak VO(2) (r = .21) and
6-minute walk distance (r = .27). The VAS was correlated
with peak VO(2) (r = .09) and 6-minute walk distance (r =
.11). Using the KCCQ as the response variable, a 1-SD
difference in peak Vo(2) (4.7 mL/kg/min) was associated with
a 2.86-point difference in the VAS (95% CI, 1.98-3.74) and a
4.75-point difference in the KCCQ (95% CI, 3.78-5.72). A
1-SD difference in 6-minute walk distance (105 m) was
associated with a 2.78-point difference in the VAS (95% CI,
1.92-3.64) and a 5.92-point difference in the KCCQ (95% CI,
4.98-6.87); NYHA class III was associated with an 8.26-point
lower VAS (95% CI, 6.59-9.93) and a 12.73-point lower KCCQ
(95% CI, 10.92-14.53) than NYHA class II. CONCLUSIONS: These
data may inform deliberations about how to best measure
benefits of heart failure interventions, and they generally
support the practice of considering a 5-point difference on
the KCCQ and a 3-point difference on the VAS to be
clinically meaningful.},
Language = {eng},
Doi = {10.1016/j.ahj.2009.07.010},
Key = {fds276691}
}
@article{fds276692,
Author = {Fortune-Greeley, AK and Flynn, KE and Jeffery, DD and Williams, MS and Keefe, FJ and Reeve, BB and Willis, GB and Weinfurt, KP and PROMIS
Sexual Function Domain Committee},
Title = {Using cognitive interviews to evaluate items for measuring
sexual functioning across cancer populations: improvements
and remaining challenges.},
Journal = {Qual Life Res},
Volume = {18},
Number = {8},
Pages = {1085-1093},
Year = {2009},
Month = {October},
ISSN = {1573-2649},
url = {http://www.ncbi.nlm.nih.gov/pubmed/19672697},
Keywords = {Adaptation, Psychological • Adult • Aged •
Cognition* • Female • Focus Groups • Humans
• Male • Middle Aged • Models, Theoretical
• Neoplasms • Patient Satisfaction •
Psychometrics • Qualitative Research • Quality
Indicators, Health Care • Quality of Life* •
Questionnaires • Sexual Behavior* • Sexual
Dysfunctions, Psychological • Stress, Psychological*
• Treatment Outcome • United States •
complications* • epidemiology • etiology* •
statistics & numerical data*},
Abstract = {PURPOSE: One goal of the Patient-Reported Outcomes
Measurement Information System (PROMIS) is to develop a
measure of sexual functioning that broadens the definition
of sexual activity and incorporates items that reflect
constructs identified as important by patients with cancer.
We describe how cognitive interviews improved the quality of
the items and discuss remaining challenges to assessing
sexual functioning in research with cancer populations.
METHODS: We conducted 39 cognitive interviews of patients
with cancer and survivors on the topic of sexual experience.
Each of the 83 candidate items was seen by 5-24
participants. Participants included both men and women and
varied by cancer type, treatment trajectory, race, and
literacy level. Significantly revised items were retested in
subsequent interviews. RESULTS: Cognitive interviews
provided useful feedback about the relevance, sensitivity,
appropriateness, and clarity of the items. Participants
identified broad terms (e.g., "sex life") to assess sexual
experience and exposed the challenges of measuring sexual
functioning consistently, considering both adjusted and
unadjusted sexual experiences. CONCLUSIONS: Cognitive
interviews were critical for item refinement in the
development of the PROMIS measure of sexual function.
Efforts are underway to validate the measure in larger
cancer populations.},
Language = {eng},
Doi = {10.1007/s11136-009-9523-x},
Key = {fds276692}
}
@article{fds276690,
Author = {Weinfurt, KP and Hall, MA and King, NMP and Friedman, JY and Schulman,
KA and Sugarman, J},
Title = {Disclosure of financial relationships to participants in
clinical research.},
Journal = {N Engl J Med},
Volume = {361},
Number = {9},
Pages = {916-921},
Year = {2009},
Month = {August},
ISSN = {1533-4406},
url = {http://www.ncbi.nlm.nih.gov/pubmed/19710491},
Keywords = {Biomedical Research • Conflict of Interest* •
Disclosure* • Ethics Committees, Research •
Ethics, Research* • Humans • Liability, Legal
• Patient Rights • Research Subjects • United
States • economics • ethics • ethics* •
legislation & jurisprudence},
Language = {eng},
Doi = {10.1056/NEJMsb0902598},
Key = {fds276690}
}
@article{fds276695,
Author = {Flynn, KE and Piña, IL and Whellan, DJ and Lin, L and Blumenthal, JA and Ellis, SJ and Fine, LJ and Howlett, JG and Keteyian, SJ and Kitzman, DW and Kraus, WE and Miller, NH and Schulman, KA and Spertus, JA and O'Connor,
CM and Weinfurt, KP and HF-ACTION Investigators},
Title = {Effects of exercise training on health status in patients
with chronic heart failure: HF-ACTION randomized controlled
trial.},
Journal = {JAMA},
Volume = {301},
Number = {14},
Pages = {1451-1459},
Year = {2009},
Month = {April},
ISSN = {1538-3598},
url = {http://www.ncbi.nlm.nih.gov/pubmed/19351942},
Keywords = {Aged • Ambulatory Care • Chronic Disease •
Exercise • Exercise Test • Exercise Therapy*
• Female • Health Status* • Heart Failure
• Humans • Male • Middle Aged • Quality
of Life* • Self Care • Sickness Impact Profile
• Treatment Outcome • rehabilitation*},
Abstract = {CONTEXT: Findings from previous studies of the effects of
exercise training on patient-reported health status have
been inconsistent. OBJECTIVE: To test the effects of
exercise training on health status among patients with heart
failure. DESIGN, SETTING, AND PATIENTS: Multicenter,
randomized controlled trial among 2331 medically stable
outpatients with heart failure with left ventricular
ejection fraction of 35% or less. Patients were randomized
from April 2003 through February 2007. INTERVENTIONS: Usual
care plus aerobic exercise training (n = 1172), consisting
of 36 supervised sessions followed by home-based training,
vs usual care alone (n = 1159). Randomization was stratified
by heart failure etiology, which was a covariate in all
models. MAIN OUTCOME MEASURES: Kansas City Cardiomyopathy
Questionnaire (KCCQ) overall summary scale and key subscales
at baseline, every 3 months for 12 months, and annually
thereafter for up to 4 years. The KCCQ is scored from 0 to
100 with higher scores corresponding to better health
status. Treatment group effects were estimated using linear
mixed models according to the intention-to-treat principle.
RESULTS: Median follow-up was 2.5 years. At 3 months, usual
care plus exercise training led to greater improvement in
the KCCQ overall summary score (mean, 5.21; 95% confidence
interval, 4.42 to 6.00) compared with usual care alone
(3.28; 95% confidence interval, 2.48 to 4.09). The
additional 1.93-point increase (95% confidence interval,
0.84 to 3.01) in the exercise training group was
statistically significant (P < .001). After 3 months, there
were no further significant changes in KCCQ score for either
group (P = .85 for the difference between slopes), resulting
in a sustained, greater improvement overall for the exercise
group (P < .001). Results were similar on the KCCQ
subscales, and no subgroup interactions were detected.
CONCLUSIONS: Exercise training conferred modest but
statistically significant improvements in self-reported
health status compared with usual care without training.
Improvements occurred early and persisted over time. TRIAL
REGISTRATION: clinicaltrials.gov Identifier:
NCT00047437.},
Language = {eng},
Doi = {10.1001/jama.2009.457},
Key = {fds276695}
}
@article{fds276696,
Author = {Jeffery, DD and Tzeng, JP and Keefe, FJ and Porter, LS and Hahn, EA and Flynn, KE and Reeve, BB and Weinfurt, KP},
Title = {Initial report of the cancer Patient-Reported Outcomes
Measurement Information System (PROMIS) sexual function
committee: review of sexual function measures and domains
used in oncology.},
Journal = {Cancer},
Volume = {115},
Number = {6},
Pages = {1142-1153},
Year = {2009},
Month = {March},
ISSN = {0008-543X},
url = {http://www.ncbi.nlm.nih.gov/pubmed/19195044},
Keywords = {Female • Health Surveys* • Humans • Male
• National Institutes of Health (U.S.) • Neoplasms
• Outcome Assessment (Health Care)* •
Psychometrics* • Quality of Life* • Questionnaires
• Research Design • Sexual Behavior* • Sexual
Dysfunction, Physiological • Survivors* • United
States • epidemiology* • therapy*},
Abstract = {For this report, the authors described the initial
activities of the Cancer Patient-Reported Outcomes
Measurement Information System (PROMIS)-Sexual Function
domain group, which is part of the National Institutes of
Health Roadmap Initiative to develop brief questionnaires or
individually tailored assessments of quality-of-life
domains. Presented are a literature review of sexual
function measures used in cancer populations and
descriptions of the domains found in those measures. By
using a consensus-driven approach, an electronic
bibliographic search was conducted for articles that were
published from 1991 to 2007, and 486 articles were
identified for in-depth review. In total, 257 articles
reported the administration of a psychometrically evaluated
sexual function measure to individuals who were diagnosed
with cancer. Apart from the University of California-Los
Angeles Prostate Cancer Index, the International Index of
Erectile Function, and the Female Sexual Function Index, the
31 identified measures have not been tested widely in cancer
populations. Most measures were multidimensional and
included domains related to the sexual response cycle and to
general sexual satisfaction. The current review supports the
need for a flexible, psychometrically robust measure of
sexual function for use in oncology settings and strongly
justifies the development of the PROMIS-Sexual Function
instrument. When the PROMIS-Sexual Function instrument is
available publicly, cancer clinicians and researchers will
have another measure with which to assess patient-reported
sexual function outcomes in addition to the few legacy
measures that were identified through this
review.},
Language = {eng},
Doi = {10.1002/cncr.24134},
Key = {fds276696}
}
@article{fds276702,
Author = {Zafar, SY and Alexander, SC and Weinfurt, KP and Schulman, KA and Abernethy, AP},
Title = {Decision making and quality of life in the treatment of
cancer: a review.},
Journal = {Support Care Cancer},
Volume = {17},
Number = {2},
Pages = {117-127},
Year = {2009},
Month = {February},
ISSN = {0941-4355},
url = {http://www.ncbi.nlm.nih.gov/pubmed/18802727},
Abstract = {INTRODUCTION: Complexity in decision making for cancer
treatment arises from many factors. When considering how to
treat patients, physicians prioritize factors such as stage
of disease, patient age, and comorbid illnesses. However,
physicians must balance these priorities with the patient's
preferences, quality of life, social responsibilities, and
fear of uncertainty. Although these factors are important,
physicians are often unable to effectively judge their
patients' preferences. Patients are often unable to fully
understand their prognoses and the treatment intent.
DISCUSSION: These differences influence how patients and
physicians make treatment-related decisions. Partially due
to these differences, patients are initially more likely
than their physicians to accept greater risk for lesser
benefit from treatment. As time progresses and as they
experience treatment, a patient's preference changes, yet
little is known about this process since few studies have
examined it in a prospective longitudinal manner. We present
an overview of the literature related to patient and
physician decision making and quality of life in patients
with advanced cancer, and we propose approaches to future
decision-making models in cancer treatment.},
Doi = {10.1007/s00520-008-0505-2},
Key = {fds276702}
}
@article{fds276694,
Author = {Hall, MA and Weinfurt, KP and Lawlor, JS and Friedman, JY and Schulman,
KA and Sugarman, J},
Title = {Community hospital oversight of clinical investigators'
financial relationships.},
Journal = {IRB},
Volume = {31},
Number = {1},
Pages = {7-13},
Year = {2009},
Month = {January},
ISSN = {0193-7758},
url = {http://www.ncbi.nlm.nih.gov/pubmed/19241734},
Keywords = {Conflict of Interest* • Ethics Committees, Research*
• Ethics, Research • Hospitals, Community •
Humans • Research Personnel • United States •
economics* • ethics*},
Key = {fds276694}
}
@article{fds276700,
Author = {Meropol, NJ and Egleston, BL and Buzaglo, JS and Benson, AB and Cegala,
DJ and Diefenbach, MA and Fleisher, L and Miller, SM and Sulmasy, DP and Weinfurt, KP and CONNECT Study Research Group},
Title = {Cancer patient preferences for quality and length of
life.},
Journal = {Cancer},
Volume = {113},
Number = {12},
Pages = {3459-3466},
Year = {2008},
Month = {December},
ISSN = {0008-543X},
url = {http://www.ncbi.nlm.nih.gov/pubmed/18988231},
Keywords = {Adult • Aged • Aged, 80 and over •
Communication • Decision Making • Female •
Humans • Longevity* • Male • Middle Aged
• Neoplasms • Patient Satisfaction* •
Physician-Patient Relations • Quality of Life* •
psychology*},
Abstract = {BACKGROUND: Optimal patient decision making requires
integration of patient values, goals, and preferences with
information received from the physician. In the case of a
life-threatening illness such as cancer, the weights placed
on quality of life (QOL) and length of life (LOL) represent
critical values. The objective of the current study was to
describe cancer patient values regarding QOL and LOL and
explore associations with communication preferences.
METHODS: Patients with advanced cancer completed a
computer-based survey before the initial consultation with a
medical oncologist. Assessments included sociodemographics,
physical and mental health state, values regarding quality
and length of life, communication preferences, and
cancer-related distress. RESULTS: Among 459 patients with
advanced cancer, 55% placed equal valued on QOL and LOL, 27%
preferred QOL, and 18% preferred LOL. Patients with a QOL
preference had lower levels of cancer-related distress (P <
.001). A QOL preference was also associated with older age
(P = .001), male sex (P = .003), and higher educational
level (P = .062). Patients who preferred LOL over QOL
desired a more supportive and less pessimistic communication
style from their oncologists. CONCLUSIONS: These data
indicate that a values preference for LOL versus QOL may be
simply measured, and is associated with wishes regarding the
nature of oncologist communication. Awareness of these
values during the clinical encounter could improve decision
making by influencing the style and content of the
communication between oncologists and their
patients.},
Language = {eng},
Doi = {10.1002/cncr.23968},
Key = {fds276700}
}
@article{fds276701,
Author = {Abernethy, AP and Herndon, JE and Wheeler, JL and Patwardhan, M and Shaw, H and Lyerly, HK and Weinfurt, K},
Title = {Improving health care efficiency and quality using tablet
personal computers to collect research-quality,
patient-reported data.},
Journal = {Health Serv Res},
Volume = {43},
Number = {6},
Pages = {1975-1991},
Year = {2008},
Month = {December},
ISSN = {1475-6773},
url = {http://www.ncbi.nlm.nih.gov/pubmed/18761678},
Keywords = {Adult • Aged • Aged, 80 and over • Breast
Neoplasms • Efficiency, Organizational* • Female
• Humans • Medical Oncology • Microcomputers*
• Middle Aged • Patient Satisfaction* • Pilot
Projects • Point-of-Care Systems • Quality of
Health Care* • Questionnaires},
Abstract = {OBJECTIVE: To determine whether e/Tablets (wireless tablet
computers used in community oncology clinics to collect
review of systems information at point of care) are
feasible, acceptable, and valid for collecting
research-quality data in academic oncology. DATA/SETTING:
Primary/Duke Breast Cancer Clinic. DESIGN: Pilot study
enrolling sample of 66 breast cancer patients. METHODS: Data
were collected using paper- and e/Tablet-based surveys:
Functional Assessment of Cancer Therapy General, Functional
Assessment of Cancer Therapy-Breast, MD Anderson Symptom
Inventory, Functional Assessment of Chronic Illness Therapy
(FACIT), Self-Efficacy; and two questionnaires: feasibility,
satisfaction. PRINCIPAL FINDINGS: Patients supported
e/Tablets as: easy to read (94 percent), easy to respond to
(98 percent), comfortable weight (87 percent). Generally,
electronic responses validly reflected responses provided by
standard paper data collection on nearly all subscales
tested. CONCLUSIONS: e/Tablets offer a valid, feasible,
acceptable method for collecting research-quality,
patient-reported outcomes data in outpatient academic
oncology.},
Language = {eng},
Doi = {10.1111/j.1475-6773.2008.00887.x},
Key = {fds276701}
}
@article{fds276703,
Author = {Epstein, SA and Hooper, LM and Weinfurt, KP and DePuy, V and Cooper, LA and Harless, WG and Tracy, CM},
Title = {Primary care physicians' evaluation and treatment of
depression: Results of an experimental study using video
vignettes.},
Journal = {Med Care Res Rev},
Volume = {65},
Number = {6},
Pages = {674-695},
Year = {2008},
Month = {December},
ISSN = {1077-5587},
url = {http://www.ncbi.nlm.nih.gov/pubmed/18832109},
Abstract = {Little is known about how patient and primary care physician
characteristics are associated with quality of depression
care. The authors conducted structured interviews of 404
randomly selected primary care physicians after their
interaction with CD-ROM vignettes of actors portraying
depressed patients. Vignettes varied along the dimensions of
medical comorbidity, attributions regarding the cause of
depression, style, race/ethnicity, and gender. Results show
that physicians showed wide variation in treatment
decisions; for example, most did not inquire about suicidal
ideation, and most did not state that they would inform the
patient that there can be a delay before an antidepressant
is therapeutic. Several physician characteristics were
significantly associated with management decisions. Notably,
physician age was inversely correlated with a number of
quality-of-care measures. In conclusion, quality of care
varies among primary care physicians and appears to be
associated with physician characteristics to a greater
extent than patient characteristics.},
Doi = {10.1177/1077558708320987},
Key = {fds276703}
}
@article{fds276685,
Author = {Hooper, LM and Weinfurt, KP and Cooper, LA and Mensh, J and Harless, W and Kuhajda, MC and Epstein, SA},
Title = {Virtual standardized patients: an interactive method to
examine variation in depression care among primary care
physicians.},
Journal = {Prim Health Care Res Dev},
Volume = {9},
Number = {4},
Pages = {257-268},
Year = {2008},
Month = {October},
ISSN = {1477-1128},
url = {http://www.ncbi.nlm.nih.gov/pubmed/20463864},
Abstract = {BACKGROUND: Some primary care physicians provide less than
optimal care for depression (Kessler et al., Journal of the
American Medical Association 291, 2581-90, 2004). However,
the literature is not unanimous on the best method to use in
order to investigate this variation in care. To capture
variations in physician behaviour and decision making in
primary care settings, 32 interactive CD-ROM vignettes were
constructed and tested. AIM AND METHOD: The primary aim of
this methods-focused paper was to review the extent to which
our study method - an interactive CD-ROM patient vignette
methodology - was effective in capturing variation in
physician behaviour. Specifically, we examined the following
questions: (a) Did the interactive CD-ROM technology work?
(b) Did we create believable virtual patients? (c) Did the
research protocol enable interviews (data collection) to be
completed as planned? (d) To what extent was the targeted
study sample size achieved? and (e) Did the study interview
protocol generate valid and reliable quantitative data and
rich, credible qualitative data? FINDINGS: Among a sample of
404 randomly selected primary care physicians, our
voice-activated interactive methodology appeared to be
effective. Specifically, our methodology - combining
interactive virtual patient vignette technology,
experimental design, and expansive open-ended interview
protocol - generated valid explanations for variations in
primary care physician practice patterns related to
depression care.},
Language = {ENG},
Doi = {10.1017/S1463423608000820},
Key = {fds276685}
}
@article{fds276697,
Author = {Weinfurt, KP and Hall, MA and Friedman, JY and Hardy, C and Fortune-Greeley, AK and Lawlor, JS and Allsbrook, JS and Lin, L and Schulman, KA and Sugarman, J},
Title = {Effects of disclosing financial interests on participation
in medical research: a randomized vignette
trial.},
Journal = {Am Heart J},
Volume = {156},
Number = {4},
Pages = {689-697},
Year = {2008},
Month = {October},
ISSN = {1097-6744},
url = {http://www.ncbi.nlm.nih.gov/pubmed/18946893},
Keywords = {Adult • Disclosure* • Ethics, Research •
Female • Humans • Informed Consent • Male
• Patient Selection* • Research Personnel •
Research Support as Topic • Trust • economics
• economics* • ethics},
Abstract = {BACKGROUND: Little is known about the effects of
investigators' financial disclosures on potential research
participants. METHODS: We conducted a vignette trial in
which 470 participants in a telephone survey were randomly
assigned to receive a simulated informed consent document
that contained 1 of 2 financial disclosures (per capita
payments to the research institution or equity ownership by
the investigator) or no disclosure. The main outcome
measures were trust in medical research and willingness to
participate in a hypothetical clinical trial. RESULTS:
Participants in the equity group reported less willingness
to participate than participants in the per capita payments
group (P = .01) and the no disclosure group (P = .03). Trust
in the investigator was highest in the per capita payments
group and lowest in the equity group (P < .001). Trust among
participants who received no disclosure was also greater
than trust among participants in the equity group (P = .04)
but did not differ significantly from trust among
participants in the per capita payments group (P = .15).
Participants in the equity group made 3 times as many
negative comments as participants in the per capita payments
group; and 10 participants in the equity group spontaneously
said they would not participate in the hypothetical trial
because of the financial interest, compared with only 1 such
participant from the other groups. CONCLUSIONS: Although
investigators' financial disclosures in research do not
substantially affect willingness to participate, potential
research participants are more troubled by equity interests
than by per capita payments.},
Language = {eng},
Doi = {10.1016/j.ahj.2008.06.001},
Key = {fds276697}
}
@article{fds152126,
Author = {SY Zafar and SC Alexander and KP Weinfurt and KA Schulman and AP
Abernethy},
Title = {Decision making and quality of life in the treatment of
cancer: a review.},
Journal = {Supportive care in cancer : official journal of the
Multinational Association of Supportive Care in
Cancer},
Year = {2008},
Month = {September},
ISSN = {0941-4355},
Abstract = {INTRODUCTION: Complexity in decision making for cancer
treatment arises from many factors. When considering how to
treat patients, physicians prioritize factors such as stage
of disease, patient age, and comorbid illnesses. However,
physicians must balance these priorities with the patient's
preferences, quality of life, social responsibilities, and
fear of uncertainty. Although these factors are important,
physicians are often unable to effectively judge their
patients' preferences. Patients are often unable to fully
understand their prognoses and the treatment intent.
DISCUSSION: These differences influence how patients and
physicians make treatment-related decisions. Partially due
to these differences, patients are initially more likely
than their physicians to accept greater risk for lesser
benefit from treatment. As time progresses and as they
experience treatment, a patient's preference changes, yet
little is known about this process since few studies have
examined it in a prospective longitudinal manner. We present
an overview of the literature related to patient and
physician decision making and quality of life in patients
with advanced cancer, and we propose approaches to future
decision-making models in cancer treatment.},
Key = {fds152126}
}
@article{fds276693,
Author = {Flynn, KE and Weinfurt, KP and Seils, DM and Lin, L and Burnett, CB and Schulman, KA and Meropol, NJ},
Title = {Decisional conflict among patients who accept or decline
participation in phase I oncology studies.},
Journal = {J Empir Res Hum Res Ethics},
Volume = {3},
Number = {3},
Pages = {69-77},
Year = {2008},
Month = {September},
ISSN = {1556-2646},
url = {http://www.ncbi.nlm.nih.gov/pubmed/19122780},
Abstract = {WE COMPARED DECISIONAL CONFLICT among adults with advanced
cancer who had accepted or declined participation in phase I
cancer clinical trials. Respondents completed a 121-item
questionnaire that included the Decisional Conflict Scale
(DCS), which was designed to measure uncertainty in making
health decisions. We used standardized effect sizes to
compare the DCS scores of accepters (n = 250) and decliners
(n = 65). Accepters had lower decisional conflict than
decliners overall (d = 0.42; 95% confidence interval,
0.17--0.68) and on all subscales. Whether greater decisional
conflict among decliners represents suboptimal
decision-making and is reason for bioethical concern depends
on how the results are interpreted. We offer three scenarios
to explain the differences and describe opportunities for
future empirical work.},
Language = {eng},
Doi = {10.1525/jer.2008.3.3.69},
Key = {fds276693}
}
@article{fds276704,
Author = {Weinfurt, KP and Hall, MA and Dinan, MA and DePuy, V and Friedman, JY and Allsbrook, JS and Sugarman, J},
Title = {Effects of disclosing financial interests on attitudes
toward clinical research.},
Journal = {J Gen Intern Med},
Volume = {23},
Number = {6},
Pages = {860-866},
Year = {2008},
Month = {June},
ISSN = {1525-1497},
url = {http://www.ncbi.nlm.nih.gov/pubmed/18386101},
Keywords = {Adult • Aged • Asthma • Biomedical Research
• Clinical Trials as Topic • Conflict of Interest
• Data Collection • Decision Making* •
Diabetes Mellitus • Disclosure* • Female •
Humans • Male • Middle Aged • Patient
Participation* • Research Subjects • Trust •
drug therapy • ethics* • psychology*},
Abstract = {BACKGROUND: The effects of disclosing financial interests to
potential research participants are not well understood.
OBJECTIVE: To examine the effects of financial interest
disclosures on potential research participants' attitudes
toward clinical research. DESIGN AND PARTICIPANTS:
Computerized experiment conducted with 3,623 adults in the
United States with either diabetes mellitus or asthma,
grouped by lesser and greater severity. Respondents read a
description of a hypothetical clinical trial relevant to
their diagnosis that included a financial disclosure
statement. Respondents received 1 of 5 disclosure
statements. MEASUREMENTS: Willingness to participate in the
hypothetical clinical trial, relative importance of
information about the financial interest, change in trust
after reading the disclosure statement, surprise regarding
the financial interest, and perceived effect of the
financial interest on the quality of the clinical trial.
RESULTS: Willingness to participate in the hypothetical
clinical trial did not differ substantially among the types
of financial disclosures. Respondents viewed the disclosed
information as less important than other factors in deciding
to participate. Disclosures were associated with some
respondents trusting the researchers less, although trust
among some respondents increased. Most respondents were not
surprised to learn of financial interests. Researchers
owning equity were viewed as more troubling than researchers
who were compensated for the costs of research through per
capita payments. CONCLUSIONS: Aside from a researcher
holding an equity interest, the disclosure to potential
research participants of financial interests in research, as
recommended in recent policies, is unlikely to affect
willingness to participate in research.},
Language = {eng},
Doi = {10.1007/s11606-008-0590-4},
Key = {fds276704}
}
@article{fds276706,
Author = {Fleisher, L and Buzaglo, J and Collins, M and Millard, J and Miller, SM and Egleston, BL and Solarino, N and Trinastic, J and Cegala, DJ and Benson,
AB and Schulman, KA and Weinfurt, KP and Sulmasy, D and Diefenbach, MA and Meropol, NJ},
Title = {Using health communication best practices to develop a
web-based provider-patient communication aid: the CONNECT
study.},
Journal = {Patient Educ Couns},
Volume = {71},
Number = {3},
Pages = {378-387},
Year = {2008},
Month = {June},
ISSN = {0738-3991},
url = {http://www.ncbi.nlm.nih.gov/pubmed/18417312},
Abstract = {OBJECTIVE: Although there is broad consensus that careful
content vetting and user testing is important in the
development of technology-based educational interventions,
often these steps are overlooked. This paper highlights the
development of a theory-guided, web-based communication aid
(CONNECT), designed to facilitate treatment decision-making
among patients with advanced cancer. METHODS: The
communication aid included an on-line survey, patient skills
training module and an automated physician report.
Development steps included: (1) evidence-based content
development; (2) usability testing; (3) pilot testing; and
(4) patient utilization and satisfaction. RESULTS: Usability
testing identified some confusing directions and navigation
for the on-line survey and validated the relevance of the
"patient testimonials" in the skills module. Preliminary
satisfaction from the implementation of the communication
aid showed that 66% found the survey length reasonable and
70% found it helpful in talking with the physician. Seventy
percent reported the skills module helpful and about half
found it affected the consultation. CONCLUSION: Designing
patient education interventions for translation into
practice requires the integration of health communication
best practice including user feedback along the
developmental process. PRACTICE IMPLICATIONS: This
developmental process can be translated to a broad array of
community-based patient and provider educational
interventions.},
Doi = {10.1016/j.pec.2008.02.017},
Key = {fds276706}
}
@article{fds276707,
Author = {Glickman, SW and Anstrom, KJ and Lin, L and Chandra, A and Laskowitz,
DT and Woods, CW and Freeman, DH and Kraft, M and Beskow, LM and Weinfurt,
KP and Schulman, KA and Cairns, CB},
Title = {Challenges in enrollment of minority, pediatric, and
geriatric patients in emergency and acute care clinical
research.},
Journal = {Ann Emerg Med},
Volume = {51},
Number = {6},
Pages = {775-780.e3},
Year = {2008},
Month = {June},
url = {http://www.ncbi.nlm.nih.gov/pubmed/18191297},
Abstract = {STUDY OBJECTIVE: Emergency department (ED) -based clinical
research has the potential to include patient populations
that are typically underrepresented in clinical research.
The objective of this study is to assess how emergency
clinical care and research processes, informed consent, and
patient demographic factors (age, sex, and ethnicity/race)
affect enrollment and consent in clinical research in the
ED. METHODS: This was an analysis of prospectively collected
data of all patients (aged 2 to 101 years) eligible for one
of 7 clinical research studies from February 2005 to April
2007 in an academic ED. We measured rates of enrollment and
consent in the clinical studies. RESULTS: One thousand two
hundred two of the 4418 patients screened for participation
in 7 clinical studies were clinically eligible for
enrollment. Of the 868 patients who were able to provide a
voluntary decision regarding consent, 639 (73.6%) agreed to
participate; an overall enrollment rate of 53.2%. The mean
age of patients enrolled was 51.8 years (range 3 to 98
years). Black patients (49.2% enrollment) and Latino
patients (18.4% enrollment) were less likely to be enrolled
in comparison with white patients (58.3% enrollment)
(adjusted odds ratio [OR] of enrollment for blacks=0.64; 95%
confidence interval [CI] 0.50 to 0.82; adjusted OR of
enrollment for Latinos=0.16; 95% CI 0.08 to 0.33).
Enrollment rates were lower among pediatric (40.0%) and
geriatric patients (49.1%) in comparison with adult patients
ages 18 to 64 years (55.5%) (adjusted OR of enrollment for
pediatric patients=0.70, 95% CI 0.34 to 1.43; adjusted OR of
enrollment for geriatric patients=0.69, 95% CI 0.53 to
0.90). Unique issues contributing to underenrollment
included challenges in consent among pediatric and elderly
patients, language issues in Latino patients, reduced
voluntary consent rates among black patients, and perhaps
underuse of minimal risk waivers. CONCLUSION: In a large
academic ED, minority, pediatric, and geriatric patients
were less likely to be enrolled in acute care clinical
research studies than middle-aged whites. Enrollment and
consent strategies designed to enhance research
participation in these important patient populations may be
necessary to address disparities in the development and
application of evidence-based emergency and acute
care.},
Doi = {10.1016/j.annemergmed.2007.11.002},
Key = {fds276707}
}
@article{fds276631,
Author = {Cella, D and Lai, J and Garcia, SF and Reeve, BB and Weinfurt, KP and George, J and Stone, A},
Title = {The patient reported outcomes measurement information
system—Cancer (PROMIS-Ca): Cancer-specific application of
a generic fatigue measure},
Journal = {Journal of Clinical Oncology},
Volume = {26},
Number = {15_suppl},
Pages = {6537-6537},
Publisher = {American Society of Clinical Oncology (ASCO)},
Year = {2008},
Month = {May},
ISSN = {0732-183X},
url = {http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000208457402513&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=47d3190e77e5a3a53558812f597b0b92},
Abstract = {6537 Background: PROMIS-Ca is a cancer-specific extension of
an NIH Roadmap effort to standardize measures of
self-reported symptoms (pain; fatigue; anxiety; depression),
physical function, and social function (
http://www.nihpromis.org ). PROMIS provides item banks that
support brief-yet-precise computerized adaptive testing and
multiple short form options. PROMIS-Ca extends PROMIS to
oncology by ensuring the cancer-relevance and performance of
its generic item banks. To illustrate, we customized the
PROMIS Fatigue item bank to cancer and developed a link
("cross-walk") between the generic PROMIS-Fatigue and the
cancer-specific PROMIS-Ca Fatigue banks. METHODS: We first
calibrated a 95-item PROMIS Fatigue bank on a sample of 803
people representative of the US general population, with
norms set on a T distribution (M=50; SD=10). The 72-item
PROMIS-Ca Fatigue bank contains 56 calibrated items from the
generic PROMIS Fatigue bank. Its psychometric properties
were evaluated on a second sample of 513 cancer patients
(72% female, 81% White, mean age=56, mean time since
diagnosis=4.1 years). Analyses included item scalability,
dimensionality, and IRT model fit. Using general population
calibration data, we examined differential item functioning
(DIF) between PROMIS-Ca Fatigue and PROMIS Fatigue banks. A
cross- walk between these banks was established by equating
item parameters using non-DIF items via the Stocking-Lord
method. RESULTS: All pre-set analysis criteria were met by
54 items; however, 6 showed DIF between PROMIS and
PROMIS-Ca. Stocking-Lord results (using 48 non-DIF items)
showed that the cancer sample was slightly more homogeneous
and reported more severe fatigue (T-score=53.3) compared to
norms. Thus, a fatigue continuum was built by equating item
parameters from PROMIS and PROMIS-Ca Fatigue banks.
CONCLUSIONS: Comparable item parameters between PROMIS and
PROMIS-Ca Fatigue banks provide cross-walk information that
enables one to measure fatigue with questions relevant to
oncology, and compare their fatigue results to the general
US population. Further research in this area will enable
comparisons across multiple diseases. No significant
financial relationships to disclose.},
Doi = {10.1200/jco.2008.26.15_suppl.6537},
Key = {fds276631}
}
@article{fds276705,
Author = {Weinfurt, KP and Seils, DM and Tzeng, JP and Lin, L and Schulman, KA and Califf, RM},
Title = {Consistency of financial interest disclosures in the
biomedical literature: the case of coronary
stents.},
Journal = {PLoS One},
Volume = {3},
Number = {5},
Pages = {e2128},
Year = {2008},
Month = {May},
ISSN = {1932-6203},
url = {http://www.ncbi.nlm.nih.gov/pubmed/18461146},
Keywords = {Conflict of Interest • Coronary Disease •
Disclosure* • Editorial Policies • Financial
Support* • Humans • Peer Review, Research •
Publications • Research Support as Topic • Stents
• Truth Disclosure* • economics* • standards
• standards* • surgery},
Abstract = {BACKGROUND: Disclosure of authors' financial interests has
been proposed as a strategy for protecting the integrity of
the biomedical literature. We examined whether authors'
financial interests were disclosed consistently in articles
on coronary stents published in 2006. METHODOLOGY/PRINCIPAL
FINDINGS: We searched PubMed for English-language articles
published in 2006 that provided evidence or guidance
regarding the use of coronary artery stents. We recorded
article characteristics, including information about
authors' financial disclosures. The main outcome measures
were the prevalence, nature, and consistency of financial
disclosures. There were 746 articles, 2985 authors, and 135
journals in the database. Eighty-three percent of the
articles did not contain disclosure statements for any
author (including declarations of no interests). Only 6% of
authors had an article with a disclosure statement. In
comparisons between articles by the same author, the types
of disagreement were as follows: no disclosure statements vs
declarations of no interests (64%); specific disclosures vs
no disclosure statements (34%); and specific disclosures vs
declarations of no interests (2%). Among the 75 authors who
disclosed at least 1 relationship with an organization,
there were 2 cases (3%) in which the organization was
disclosed in every article the author wrote.
CONCLUSIONS/SIGNIFICANCE: In the rare instances when
financial interests were disclosed, they were not disclosed
consistently, suggesting that there are problems with
transparency in an area of the literature that has important
implications for patient care. Our findings suggest that the
inconsistencies we observed are due to both the policies of
journals and the behavior of some authors.},
Language = {eng},
Doi = {10.1371/journal.pone.0002128},
Key = {fds276705}
}
@article{fds276635,
Author = {Lewis, EF and Li, Y and Pfeffer, MA and Solomon, SD and Weinfurt, KP and Velazquez, EJ and Califf, R and White, HD and Rouleau, JL and Schulman,
KA and Reed, SD},
Title = {PCV65 CHANGE IN HEALTH-RELATED QUALITY OF LIFE FOLLOWING
NON-FATAL CARDIOVASCULAR EVENTS IN POST-MYOCARDIAL
INFARCTION PATIENTS},
Journal = {Value in Health},
Volume = {11},
Number = {3},
Pages = {A205-A206},
Publisher = {Elsevier BV},
Year = {2008},
Month = {May},
ISSN = {1098-3015},
url = {http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000255945400651&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=47d3190e77e5a3a53558812f597b0b92},
Doi = {10.1016/s1098-3015(10)70652-5},
Key = {fds276635}
}
@article{fds145740,
Author = {L Fleisher and J Buzaglo and M Collins and J Millard and SM Miller and BL
Egleston, N Solarino and J Trinastic and DJ Cegala and AB Benson and KA
Schulman, KP Weinfurt and D Sulmasy and MA Diefenbach and NJ
Meropol},
Title = {Using health communication best practices to develop a
web-based provider-patient communication aid: The
CONNECTtrade mark study.},
Journal = {Patient education and counseling},
Year = {2008},
Month = {April},
ISSN = {0738-3991},
Abstract = {OBJECTIVE: Although there is broad consensus that careful
content vetting and user testing is important in the
development of technology-based educational interventions,
often these steps are overlooked. This paper highlights the
development of a theory-guided, web-based communication aid
(CONNECTtrade mark), designed to facilitate treatment
decision-making among patients with advanced cancer.
METHODS: The communication aid included an on-line survey,
patient skills training module and an automated physician
report. Development steps included: (1) evidence-based
content development; (2) usability testing; (3) pilot
testing; and (4) patient utilization and satisfaction.
RESULTS: Usability testing identified some confusing
directions and navigation for the on-line survey and
validated the relevance of the "patient testimonials" in the
skills module. Preliminary satisfaction from the
implementation of the communication aid showed that 66%
found the survey length reasonable and 70% found it helpful
in talking with the physician. Seventy percent reported the
skills module helpful and about half found it affected the
consultation. CONCLUSION: Designing patient education
interventions for translation into practice requires the
integration of health communication best practice including
user feedback along the developmental process. PRACTICE
IMPLICATIONS: This developmental process can be translated
to a broad array of community-based patient and provider
educational interventions.},
Key = {fds145740}
}
@article{fds144917,
Author = {SW Glickman and KJ Anstrom and L Lin and A Chandra and DT Laskowitz and CW
Woods, DH Freeman and M Kraft and LM Beskow and KP Weinfurt and KA
Schulman, CB Cairns},
Title = {Challenges in Enrollment of Minority, Pediatric, and
Geriatric Patients in Emergency and Acute Care Clinical
Research.},
Journal = {Ann Emerg Med},
Year = {2008},
Month = {January},
ISSN = {1097-6760},
Abstract = {STUDY OBJECTIVE: Emergency department (ED) -based clinical
research has the potential to include patient populations
that are typically underrepresented in clinical research.
The objective of this study is to assess how emergency
clinical care and research processes, informed consent, and
patient demographic factors (age, sex, and ethnicity/race)
affect enrollment and consent in clinical research in the
ED. METHODS: This was an analysis of prospectively collected
data of all patients (aged 2 to 101 years) eligible for one
of 7 clinical research studies from February 2005 to April
2007 in an academic ED. We measured rates of enrollment and
consent in the clinical studies. RESULTS: One thousand two
hundred two of the 4418 patients screened for participation
in 7 clinical studies were clinically eligible for
enrollment. Of the 868 patients who were able to provide a
voluntary decision regarding consent, 639 (73.6%) agreed to
participate; an overall enrollment rate of 53.2%. The mean
age of patients enrolled was 51.8 years (range 3 to 98
years). Black patients (49.2% enrollment) and Latino
patients (18.4% enrollment) were less likely to be enrolled
in comparison with white patients (58.3% enrollment)
(adjusted odds ratio [OR] of enrollment for blacks=0.64; 95%
confidence interval [CI] 0.50 to 0.82; adjusted OR of
enrollment for Latinos=0.16; 95% CI 0.08 to 0.33).
Enrollment rates were lower among pediatric (40.0%) and
geriatric patients (49.1%) in comparison with adult patients
ages 18 to 64 years (55.5%) (adjusted OR of enrollment for
pediatric patients=0.70, 95% CI 0.34 to 1.43; adjusted OR of
enrollment for geriatric patients=0.69, 95% CI 0.53 to
0.90). Unique issues contributing to underenrollment
included challenges in consent among pediatric and elderly
patients, language issues in Latino patients, reduced
voluntary consent rates among black patients, and perhaps
underuse of minimal risk waivers. CONCLUSION: In a large
academic ED, minority, pediatric, and geriatric patients
were less likely to be enrolled in acute care clinical
research studies than middle-aged whites. Enrollment and
consent strategies designed to enhance research
participation in these important patient populations may be
necessary to address disparities in the development and
application of evidence-based emergency and acute
care.},
Key = {fds144917}
}
@article{fds276698,
Author = {Flynn, KE and Dombeck, CB and DeWitt, EM and Schulman, KA and Weinfurt,
KP},
Title = {Using item banks to construct measures of patient reported
outcomes in clinical trials: investigator
perceptions.},
Journal = {Clin Trials},
Volume = {5},
Number = {6},
Pages = {575-586},
Year = {2008},
ISSN = {1740-7745},
url = {http://www.ncbi.nlm.nih.gov/pubmed/19029206},
Keywords = {Attitude of Health Personnel* • Clinical Trials as
Topic* • Databases as Topic* • Diffusion of
Innovation • Feasibility Studies • Female •
Humans • Male • Outcome Assessment (Health Care)
• Reproducibility of Results • Research Design
• Research Personnel • Self-Assessment •
Sensitivity and Specificity • methods* •
psychology*},
Abstract = {BACKGROUND: Item response theory (IRT) promises more
sensitive and efficient measurement of patient-reported
outcomes (PROs) than traditional approaches; however, the
selection and use of PRO measures from IRT-based item banks
differ from current methods of using PRO measures. PURPOSE:
To anticipate barriers to the adoption of IRT item banks
into clinical trials. METHODS: We conducted semistructured
telephone or in-person interviews with 42 clinical
researchers who published results from clinical trials in
the Journal of the American Medical Association, the New
England Journal of Medicine, or other leading clinical
journals from July 2005 through May 2006. Interviews
included a brief tutorial on IRT item banks. RESULTS: After
the tutorial, 39 of 42 participants understood the novel
products available from an IRT item bank, namely customized
short forms and computerized adaptive testing. Most
participants (38/42) thought that item banks could be useful
in their clinical trials, but they mentioned several
potential barriers to adoption, including economic and
logistical constraints, concerns about whether item banks
are better than current PRO measures, concerns about how to
convince study personnel or statisticians to use item banks,
concerns about FDA or sponsor acceptance, and the lack of
availability of item banks validated in specific disease
populations. LIMITATIONS: Selection bias might have led to
more positive responses to the concept of item banks in
clinical trials. CONCLUSIONS: Clinical investigators are
open to a new method of PRO measurement offered in IRT item
banks, but bank developers must address investigator and
stakeholder concerns before widespread adoption can be
expected.},
Language = {eng},
Doi = {10.1177/1740774508098414},
Key = {fds276698}
}
@article{fds276699,
Author = {Weinfurt, KP},
Title = {Varieties of uncertainty and the validity of informed
consent.},
Journal = {Clin Trials},
Volume = {5},
Number = {6},
Pages = {624-625},
Year = {2008},
ISSN = {1740-7745},
url = {http://www.ncbi.nlm.nih.gov/pubmed/19029211},
Keywords = {Clinical Trials, Phase I as Topic • Disclosure •
Humans • Informed Consent • Neoplasms •
Patient Education as Topic • Risk Assessment •
Uncertainty* • drug therapy* • ethics •
ethics* • psychology • psychology*},
Language = {eng},
Doi = {10.1177/1740774508098690},
Key = {fds276699}
}
@article{fds276708,
Author = {Weinfurt, KP and Seils, DM and Tzeng, JP and Compton, KL and Sulmasy,
DP and Astrow, AB and Solarino, NA and Schulman, KA and Meropol,
NJ},
Title = {Expectations of benefit in early-phase clinical trials:
implications for assessing the adequacy of informed
consent.},
Journal = {Med Decis Making},
Volume = {28},
Number = {4},
Pages = {575-581},
Year = {2008},
ISSN = {0272-989X},
url = {http://www.ncbi.nlm.nih.gov/pubmed/18378940},
Keywords = {Clinical Trials as Topic • Comprehension* • Female
• Humans • Informed Consent • Male •
Middle Aged • Neoplasms • psychology* •
therapy},
Abstract = {BACKGROUND: Participants in early-phase clinical trials have
reported high expectations of benefit from their
participation. There is concern that participants
misunderstand the trials to which they have consented, which
is based on assumptions about what patients mean when
responding to questions about likelihood of benefit.
METHODS: Participants were 27 women and 18 men in
early-phase oncology trials at 2 academic medical centers in
the United States. To determine whether expectations of
benefit differ depending on how patients are queried, the
authors randomly assigned participants to 1 of 3 interviews
corresponding to 3 questions about likelihood of benefit:
frequency type, belief type, and vague. In semistructured
interviews, participants were queried about how they
understood and answered the question. Participants then
answered and discussed 1 of the other questions. RESULTS:
Expectations of benefit in response to the belief-type
question were significantly greater than expectations in
response to the frequency-type and vague questions (P=0:02).
The most common justifications involved positive attitude
(n=27 [60%]) and references to physical health (n=23 [51%]).
References to positive attitude were most common among
participants with higher (> 70%) expectations (n = 11 [85%])
and least common among those with lower ( < 50%)
expectations (n = 3 [27%]). CONCLUSIONS: The wording of
questions about likelihood of benefit shapes the
expectations that patients express. Patients who express
high expectations may not do so to communicate understanding
but rather to register optimism. Ongoing research will
clarify the meaning of high expectations and examine methods
for assessing understanding.},
Language = {eng},
Doi = {10.1177/0272989X08315242},
Key = {fds276708}
}
@article{fds276714,
Author = {Garcia, SF and Cella, D and Clauser, SB and Flynn, KE and Lad, T and Lai,
J-S and Reeve, BB and Smith, AW and Stone, AA and Weinfurt,
K},
Title = {Standardizing patient-reported outcomes assessment in cancer
clinical trials: a patient-reported outcomes measurement
information system initiative.},
Journal = {J Clin Oncol},
Volume = {25},
Number = {32},
Pages = {5106-5112},
Year = {2007},
Month = {November},
ISSN = {1527-7755},
url = {http://www.ncbi.nlm.nih.gov/pubmed/17991929},
Keywords = {Clinical Trials as Topic* • Continuity of Patient Care
• Humans • Neoplasms • Patient Satisfaction*
• Psychometrics • Quality Indicators, Health Care
• Quality of Life* • Reproducibility of Results
• Sickness Impact Profile* • Treatment Outcome*
• instrumentation* • standards • standards*
• therapy*},
Abstract = {Patient-reported outcomes (PROs), such as symptom scales or
more broad-based health-related quality-of-life measures,
play an important role in oncology clinical trials. They
frequently are used to help evaluate cancer treatments, as
well as for supportive and palliative oncology care. To be
most beneficial, these PROs must be relevant to patients and
clinicians, valid, and easily understood and interpreted.
The Patient-Reported Outcomes Measurement Information System
(PROMIS) Network, part of the National Institutes of Health
Roadmap Initiative, aims to improve appreciably how PROs are
selected and assessed in clinical research, including
clinical trials. PROMIS is establishing a publicly available
resource of standardized, accurate, and efficient PRO
measures of major self-reported health domains (eg, pain,
fatigue, emotional distress, physical function, social
function) that are relevant across chronic illnesses
including cancer. PROMIS is also developing measures of
self-reported health domains specifically targeted to
cancer, such as sleep/wake function, sexual function,
cognitive function, and the psychosocial impacts of the
illness experience (ie, stress response and coping; shifts
in self-concept, social interactions, and spirituality). We
outline the qualitative and quantitative methods by which
PROMIS measures are being developed and adapted for use in
clinical oncology research. At the core of this activity is
the formation and application of item banks using item
response theory modeling. We also present our work in the
fatigue domain, including a short-form measure, as a sample
of PROMIS methodology and work to date. Plans for future
validation and application of PROMIS measures are
discussed.},
Language = {eng},
Doi = {10.1200/JCO.2007.12.2341},
Key = {fds276714}
}
@article{fds348603,
Author = {Jeffery, DD and Reeve, BB and Tzeng, J and Weinfurt, KP and Flynn, KE and Keefe, FJ and Porter, LS and Hahn, EA and Cella, D},
Title = {The sexual function domain of the NIHPROMIS: Preliminary
report},
Journal = {PSYCHO-ONCOLOGY},
Volume = {16},
Number = {9},
Pages = {S233-S233},
Publisher = {JOHN WILEY & SONS LTD},
Year = {2007},
Month = {September},
Key = {fds348603}
}
@article{fds276721,
Author = {DePuy, V and Anstrom, KJ and Castel, LD and Schulman, KA and Weinfurt,
KP and Saad, F},
Title = {Effects of skeletal morbidities on longitudinal
patient-reported outcomes and survival in patients with
metastatic prostate cancer.},
Journal = {Support Care Cancer},
Volume = {15},
Number = {7},
Pages = {869-876},
Year = {2007},
Month = {July},
ISSN = {0941-4355},
url = {http://www.ncbi.nlm.nih.gov/pubmed/17262196},
Keywords = {Aged • Bone Neoplasms • Diphosphonates •
Humans • Imidazoles • Male • Musculoskeletal
System • Neoplasm Metastasis • Prognosis •
Prostatic Neoplasms • Quality of Life* • Risk
Factors • Survival • Treatment Outcome* •
drug therapy • mortality • pathology* •
psychology • secondary* • therapeutic
use},
Abstract = {GOALS OF WORK: Patients with prostate cancer metastasized to
bone frequently experience skeletal morbidities as a result
of their disease. We sought to quantify the longitudinal
effects on patient-reported outcomes of skeletal-related
events (SREs) and to ascertain the declines in
health-related quality of life (HRQOL) and pain experienced
by patients who experienced SREs. MATERIALS AND METHODS:
Data are from a clinical trial for the treatment of SREs
associated with advanced prostate cancer metastatic to bone.
Outcome measures included the Functional Assessment of
Cancer Therapy-General (FACT-G) and the Brief Pain
Inventory. Among patients who survived 6 months after
randomization, patients with no SREs in the initial 6 months
after randomization were matched via propensity scores with
those experiencing one or more SREs. Similarly, patients
with one SRE were matched with a subset of patients with two
or more SREs. MAIN RESULTS: Patients with SREs in the
initial period had significantly worse survival and HRQOL
than those with no SREs. Significant differences were found
between the pain differences, FACT-G total scores, and
FACT-G physical, emotional, and functional subscales.
Comparisons of patients with single vs multiple SREs showed
similar patterns. CONCLUSIONS: The presence of SREs is
significantly associated with worse survival and poorer
HRQOL in this patient population. Increasing SRE intensity
shows a pattern of increasingly decreased survival and
poorer HRQOL.},
Doi = {10.1007/s00520-006-0203-x},
Key = {fds276721}
}
@article{fds276710,
Author = {Revicki, DA and Gnanasakthy, A and Weinfurt, K},
Title = {Documenting the rationale and psychometric characteristics
of patient reported outcomes for labeling and promotional
claims: the PRO Evidence Dossier.},
Journal = {Qual Life Res},
Volume = {16},
Number = {4},
Pages = {717-723},
Year = {2007},
Month = {May},
ISSN = {0962-9343},
url = {http://www.ncbi.nlm.nih.gov/pubmed/17268927},
Keywords = {Advertising as Topic • Clinical Trials as Topic •
Decision Making • Documentation • Drug Approval
• Drug Industry* • Drug Labeling • Humans
• Outcome Assessment (Health Care) • Psychometrics
• Quality of Life* • United States • United
States Food and Drug Administration • methods •
methods* • standards*},
Abstract = {The Food and Drug Administration (FDA) and European
Medicines Agency (EMEA) are willing to consider including
information on patient reported outcomes (PROs) in product
labeling and advertising. Pharmaceutical industry
researchers must provide sufficient evidence supporting PRO
benefit before an approval may be granted. This report
describes the purpose and content of a PRO Evidence Dossier,
which consists of important information supporting PRO
claims. The dossier should be completed by pharmaceutical
industry or other researchers to document the planning of
the PRO assessment strategy, psychometric evidence, desired
target labeling statements, and the clinical trial evidence
of PRO benefits. The systematic reporting and documentation
of information on the rationale for including PROs,
rationale for the selection of specific PRO instruments,
evidence on the psychometric qualities of the PRO measures,
and guidelines for interpreting PRO findings will facilitate
achieving a PRO labeling or promotional claim. Combining all
the relevant information into a single document will
facilitate the review and evaluation process for clinical
and regulatory reviewers. The PRO Evidence Dossier may also
be helpful to industry and academic researchers in
identifying further information that will need to be
developed to support the clinical development program and
the PRO endpoints.},
Language = {eng},
Doi = {10.1007/s11136-006-9153-5},
Key = {fds276710}
}
@article{fds276724,
Author = {Weinfurt, KP},
Title = {Value of high-cost cancer care: a behavioral science
perspective.},
Journal = {J Clin Oncol},
Volume = {25},
Number = {2},
Pages = {223-227},
Year = {2007},
Month = {January},
ISSN = {1527-7755},
url = {http://www.ncbi.nlm.nih.gov/pubmed/17210944},
Keywords = {Behavioral Sciences • Health Expenditures* •
Humans • Neoplasms • Patient Acceptance of Health
Care • Quality of Life • Treatment Outcome •
economics* • psychology* • therapy},
Abstract = {Concerns about the high costs of cancer care have led to a
renewed interest in understanding how patients value the
outcomes of care. Psychologists, economists, and others have
highlighted some of the ways in which patients and
caregivers perceive and make treatment decisions. Prospect
theory is the predominant framework for understanding
decisions made in situations where the outcomes of each
choice are uncertain. Prospect theory assumes that a patient
values the outcomes of care not in absolute terms, such as
years of life saved, but as deviations from the patient's
point of reference. This article discusses some of the
implications of this notion, along with discussing
differences among people in their reference points. These
and other considerations from the psychology of decision
making help to clarify why some patients might be inclined
to seek expensive or risky treatments in the hopes of
achieving benefits that others might consider not
worthwhile. An appreciation of these psychological issues
might improve the quality of debates concerning the rising
costs of cancer care.},
Language = {eng},
Doi = {10.1200/JCO.2006.08.9029},
Key = {fds276724}
}
@article{fds276720,
Author = {Friedman, JY and Sugarman, J and Dhillon, JK and Depuy, V and Pierre,
CK and Dinan, MA and Allsbrook, JS and Schulman, KA and Weinfurt,
KP},
Title = {Perspectives of clinical research coordinators on disclosing
financial conflicts of interest to potential research
participants.},
Journal = {Clin Trials},
Volume = {4},
Number = {3},
Pages = {272-278},
Year = {2007},
ISSN = {1740-7745},
url = {http://www.ncbi.nlm.nih.gov/pubmed/17715256},
Keywords = {Awareness • Clinical Trials as Topic • Conflict of
Interest* • Demography • Disclosure* • Female
• Humans • Informed Consent • Male •
ethics*},
Abstract = {BACKGROUND: Disclosing financial interests to potential
research participants during the informed consent process is
one strategy for managing conflicts of interest. Given that
clinical research coordinators are typically charged with
administering the informed consent process, it is critical
to understand their experiences, attitudes and beliefs
regarding the disclosure of financial interests in research.
PURPOSE: To understand the role of clinical research
coordinators in disclosing financial interests in research,
and potential barriers to such disclosures. METHODS: We
developed a survey designed to measure clinical research
coordinators' awareness of financial interests in clinical
research, previous experience with disclosing financial
interests, comfort with answering questions about financial
interests and barriers to disclosing financial interests to
potential research participants. Next we conducted cognitive
interviews with 10 clinical research coordinators to assess
understandability and content validity and to further refine
the survey. We then administered the survey to clinical
research coordinators attending the 2006 Global Conference
of the Association of Clinical Research Professionals.
RESULTS: Among 300 clinical research coordinators who
completed the survey, there was a general awareness of
financial interests in research. Forty-one percent reported
disclosing such financial interests to potential research
participants, and 28% reported being asked about them.
Greater comfort in responding to questions about financial
interests was associated with previous experience with
disclosure, previous experience answering questions about
financial interests, and greater length of time obtaining
informed consent. Respondents indicated that there were
barriers to disclosure, including lack of information (76%)
and that participants would not understand disclosures
(26%). LIMITATIONS: Possible sample bias due to using a
convenience sample. CONCLUSIONS: Making information about
financial interests in research readily available to
clinical research coordinators, as well as providing
education and training, should facilitate the disclosure of
financial interests in research to potential research
participants during the informed consent
process.},
Language = {eng},
Doi = {10.1177/1740774507079239},
Key = {fds276720}
}
@article{fds276722,
Author = {Shea, AM and DePuy, V and Allen, JM and Weinfurt,
KP},
Title = {Use and perceptions of clinical practice guidelines by
internal medicine physicians.},
Journal = {Am J Med Qual},
Volume = {22},
Number = {3},
Pages = {170-176},
Year = {2007},
ISSN = {1062-8606},
url = {http://www.ncbi.nlm.nih.gov/pubmed/17485558},
Keywords = {Adult • Attitude to Health • Benchmarking •
Cardiology • Conflict of Interest • Data
Collection • Evidence-Based Medicine • Female
• Guideline Adherence • Humans • Internal
Medicine • Internet • Male • Physicians
• Practice Guidelines as Topic • psychology*
• standards • standards*},
Abstract = {The authors sought to explore the use and perceptions of
clinical practice guidelines among internal medicine
physicians. Through a Web-based survey, 201 board-certified
internal medicine physicians rated their opinions on several
statements using 7-point Likert scales. Most respondents
(74.7%) felt that guidelines were suitable for at least half
of their patients, although a failure to take comorbid
conditions into account was a frequently cited barrier. For
patients with cardiovascular disease, there was no
difference between individual internists' perceptions of
their own compliance with guidelines and their estimates of
cardiologists' compliance (P = .14). A large majority of
respondents (70.7%) believed that guideline committee member
participation in industry-funded research introduces bias
into guideline content (median [interquartile range], 5
[4-6]). Although most respondents felt that measuring
physicians against guideline-based performance measures
encourages evidence-based medicine (76.5%), opinions were
split as to whether this practice distracts from patient
care or compromises physician autonomy.},
Language = {eng},
Doi = {10.1177/1062860607300291},
Key = {fds276722}
}
@article{fds276765,
Author = {Weinfurt, KP and Allsbrook, JS and Friedman, JY and Dinan, MA and Hall,
MA and Schulman, KA and Sugarman, J},
Title = {Developing model language for disclosing financial interests
to potential clinical research participants.},
Journal = {IRB},
Volume = {29},
Number = {1},
Pages = {1-5},
Year = {2007},
ISSN = {0193-7758},
url = {http://www.ncbi.nlm.nih.gov/pubmed/17364012},
Keywords = {Biomedical Research • Disclosure • Ethics
Committees, Research • Humans • Research Subjects
• economics* • organization & administration*
• standards*},
Language = {eng},
Key = {fds276765}
}
@article{fds276711,
Author = {Hall, MA and Camacho, F and Lawlor, JS and Depuy, V and Sugarman, J and Weinfurt, K},
Title = {Measuring trust in medical researchers.},
Journal = {Med Care},
Volume = {44},
Number = {11},
Pages = {1048-1053},
Year = {2006},
Month = {November},
ISSN = {0025-7079},
url = {http://www.ncbi.nlm.nih.gov/pubmed/17063137},
Keywords = {Adult • African Americans • Attitude •
Biomedical Research* • Consumer Participation •
Data Collection • Education • Ethics, Research*
• Ethnic Groups • Health Status • Humans
• Income • Physicians • Pilot Projects •
Public Policy • Questionnaires • Safety •
Trust* • psychology},
Abstract = {BACKGROUND: Concern is widespread that the public's and
participants' trust in medical research is threatened, but
few empirical measures of research trust exist. This project
aims to enable more rigorous study of researcher trust by
developing and testing appropriate survey measures. METHODS:
Survey items were developed based on a conceptual model of
the primary domains of researcher trust (safety, fidelity,
honesty, global trust). Pilot testing was conducted on a
regional convenience sample of adults (n = 124). Exploratory
factor analyses of the data were performed, and an item
selection procedure reduced the number of survey questions.
A final set of 12 items was validated, and a 4-item short
version of the researcher trust scale was selected and
tested in a national web-based survey of asthma and diabetes
patients (n = 3623). Further factor analysis and validation
were performed on this larger sample. RESULTS: Both the full
and short scales have a single-factor structure with
acceptable internal reliability (alphas of 0.87 [12 items]
and 0.72 [4 items]). Trust in physician researchers and
trust in medical researchers generally were found not to be
separate constructs. In the national sample, the short scale
was positively associated with better health status, prior
participation in medical research, and willingness to
participate in a hypothetical medical research study, and
negatively associated with African-American race and higher
education. CONCLUSIONS: Trust in medical researchers is a
measurable single-factor construct including trust in
safety, researcher fidelity, and honesty. This new scale
provides an empirical tool for informing the ethics and
public policy of medical research.},
Language = {eng},
Doi = {10.1097/01.mlr.0000228023.37087.cb},
Key = {fds276711}
}
@article{fds276741,
Author = {Weinfurt, KP and Friedman, JY and Allsbrook, JS and Dinan, MA and Hall,
MA and Sugarman, J},
Title = {Views of potential research participants on financial
conflicts of interest: barriers and opportunities for
effective disclosure.},
Journal = {J Gen Intern Med},
Volume = {21},
Number = {9},
Pages = {901-906},
Year = {2006},
Month = {September},
ISSN = {1525-1497},
url = {http://www.ncbi.nlm.nih.gov/pubmed/16918732},
Keywords = {Adolescent • Adult • Disclosure • Focus
Groups* • Humans • Middle Aged • Qualitative
Research • Research Subjects • Research Support as
Topic • ethics* • psychology* •
standards},
Abstract = {BACKGROUND: There is little guidance regarding how to
disclose researchers' financial interests to potential
research participants. OBJECTIVE: To determine what
potential research participants want to know about financial
interests, their capacity to understand disclosed
information and its implications, and the reactions of
potential research participants to a proposed disclosure
statement. DESIGN AND PARTICIPANTS: Sixteen focus groups in
3 cities, including 6 groups of healthy adults, 6 groups of
adults with mild chronic illness, 1 group of parents of
healthy children, 1 group of parents of children with
leukemia or brain tumor, 1 group of adults with heart
failure, and 1 group of adults with cancer. APPROACH: Focus
group discussions covered a range of topics including
financial relationships in clinical research, whether people
should be told about them, and how they should be told.
Audio-recordings of focus groups were transcribed, verified,
and coded for analysis. RESULTS: Participants wanted to know
about financial interests, whether or not those interests
would affect their participation. However, they varied in
their desire and ability to understand the nature and
implications of financial interests. Whether disclosure was
deemed important depended upon the risk of the research.
Trust in clinicians was also related to views regarding
disclosure. If given the opportunity to ask questions during
the consent process, some participants would not have known
what to ask; however, after the focus group sessions,
participants could identify information they would want to
know. CONCLUSIONS: Financial interests are important to
potential research participants, but obstacles to effective
disclosure exist.},
Language = {eng},
Doi = {10.1111/j.1525-1497.2006.00502.x},
Key = {fds276741}
}
@article{fds276747,
Author = {Weinfurt, KP and Anstrom, KJ and Castel, LD and Schulman, KA and Saad,
F},
Title = {Effect of zoledronic acid on pain associated with bone
metastasis in patients with prostate cancer.},
Journal = {Ann Oncol},
Volume = {17},
Number = {6},
Pages = {986-989},
Year = {2006},
Month = {June},
ISSN = {0923-7534},
url = {http://www.ncbi.nlm.nih.gov/pubmed/16533874},
Keywords = {Aged • Aged, 80 and over • Bone Density
Conservation Agents • Bone Neoplasms •
Diphosphonates • Humans • Imidazoles •
Infusions, Intravenous • Male • Pain • Pain
Measurement • Placebos • Prostatic Neoplasms
• administration & dosage • pathology •
physiopathology* • prevention & control* •
secondary* • therapeutic use*},
Abstract = {BACKGROUND: Zoledronic acid reduces skeletal-related events
associated with prostate cancer and has long-term efficacy
in pain outcomes. Findings of treatment group differences in
pain early in treatment are less reliable. We used a
recently recommended analytic approach to examine the effect
of zoledronic acid on pain. MATERIALS AND METHODS: In a
trial of zoledronic acid (n = 214) versus placebo (n = 208),
we used the Brief Pain Inventory to assess pain at baseline,
3 weeks, 6 weeks and every 6 weeks thereafter for a total of
60 weeks. We used a modified longitudinal rank test to
determine whether clinically meaningful changes in pain were
related to treatment group. RESULTS: Seventy-six of 214
patients (35.5%) receiving zoledronic acid and 62 of 208
patients (29.8%) receiving placebo completed the 60-week
visit (P = 0.22). In all 11 pain assessments, patients
receiving zoledronic acid reported more favorable,
clinically meaningful changes in pain scores. Overall,
patients receiving zoledronic acid had a 33% chance of a
favorable response, compared with 25% for patients receiving
placebo (P = 0.04; 95% CI 0.5% to 15.6%). CONCLUSIONS:
Zoledronic acid was more likely than placebo to be
associated with clinically meaningful reductions in pain.
Thus, zoledronic acid may help to avert the pain experienced
by patients with progressing metastatic disease secondary to
prostate cancer.},
Language = {eng},
Doi = {10.1093/annonc/mdl041},
Key = {fds276747}
}
@article{fds276629,
Author = {Weinfurt, KP and Hall, MA and Dinan, MA and Depuy, V and Friedman, JY and Allsbrook, JS and Sugarman, J},
Title = {What is necessary to support informed decision making
regarding financial conflicts of interests in
research?},
Journal = {JOURNAL OF GENERAL INTERNAL MEDICINE},
Volume = {21},
Pages = {164-164},
Publisher = {SPRINGER},
Year = {2006},
Month = {April},
ISSN = {0884-8734},
url = {http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000202962000584&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=47d3190e77e5a3a53558812f597b0b92},
Key = {fds276629}
}
@article{fds276630,
Author = {Weinfurt, KP and Friedman, JY and Allsbrook, JS and Dinan, MA and Hall,
MA and Sugarman, J},
Title = {Views of potential research participants on financial
conflicts of interest: Barriers and opportunities for
effective disclosure},
Journal = {JOURNAL OF GENERAL INTERNAL MEDICINE},
Volume = {21},
Pages = {160-160},
Publisher = {SPRINGER},
Year = {2006},
Month = {April},
ISSN = {0884-8734},
url = {http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000202962000571&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=47d3190e77e5a3a53558812f597b0b92},
Key = {fds276630}
}
@article{fds276632,
Author = {Weinfurt, KP and Hall, MA and Dinan, MA and Depuy, V and Friedman, JY and Allsbrook, JS and Sugarman, J},
Title = {The effects of disclosing financial conflicts of interest in
clinical research: Evidence from a large national
survey},
Journal = {JOURNAL OF GENERAL INTERNAL MEDICINE},
Volume = {21},
Pages = {142-142},
Publisher = {SPRINGER},
Year = {2006},
Month = {April},
ISSN = {0884-8734},
url = {http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000202962000506&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=47d3190e77e5a3a53558812f597b0b92},
Key = {fds276632}
}
@article{fds276743,
Author = {Weinfurt, KP and Dinan, MA and Allsbrook, JS and Friedman, JY and Hall,
MA and Schulman, KA and Sugarman, J},
Title = {Policies of academic medical centers for disclosing
financial conflicts of interest to potential research
participants.},
Journal = {Acad Med},
Volume = {81},
Number = {2},
Pages = {113-118},
Year = {2006},
Month = {February},
ISSN = {1040-2446},
url = {http://www.ncbi.nlm.nih.gov/pubmed/16436571},
Keywords = {Academic Medical Centers • Biomedical Research •
Conflict of Interest • Data Collection •
Disclosure • Ethics Committees, Research • Humans
• Organizational Policy* • Research Personnel
• Research Support as Topic • United States •
economics • economics* • ethics • ethics*
• organization & administration*},
Abstract = {PURPOSE: To document the current state of institutional
review board (IRB) and conflict of interest committee
policies regarding disclosures of financial conflicts of
interest to potential research participants, and to use this
information to identify and share models for effectively
achieving disclosure. METHOD: The authors identified the 123
U.S. academic medical centers that have IRBs and sought
their IRB and institutional policies regarding financial
conflicts of interest. In February and March 2004, using
manual and key word searches, each institution's Web site
was searched to identify documents containing information
regarding the disclosure of financial conflicts of interest.
Letters were sent to 24 institutions that had either no
information or incomplete information posted on their Web
sites. To assess institutions' guidelines for disclosure,
the authors extracted and content coded each institution's
information on disclosure. RESULTS: Relevant information was
obtained from 120 (98%) academic medical centers (AMCs), of
which 57 (48%) mentioned disclosing financial conflicts to
potential research participants. Of these 57, 33 (58%)
included verbatim language that could be used in informed
consent documents. AMCs' recommendations and requirements
for disclosure included details of the financial
arrangement, administrative management of conflicts of
interest, and encouragement of dialogue between the
investigator and the potential research participant.
CONCLUSIONS: Considerable variability exists concerning the
specific information that should be disclosed. Most of the
AMCs' policies were consistent with the goal of protection
from legal liability. Significant questions remain, however,
concerning the goals of disclosure and the most effective
methods for achieving those goals.},
Language = {eng},
Doi = {10.1097/00001888-200602000-00003},
Key = {fds276743}
}
@article{fds276736,
Author = {Voils, CI and Oddone, EZ and Weinfurt, KP and Friedman, JY and Bright,
CM and Schulman, KA and Bosworth, HB},
Title = {Racial differences in health concern.},
Journal = {J Natl Med Assoc},
Volume = {98},
Number = {1},
Pages = {36-42},
Year = {2006},
Month = {January},
ISSN = {1943-4693},
url = {http://www.ncbi.nlm.nih.gov/pubmed/16532976},
Keywords = {Adolescent • Adult • African Americans • Aged
• Aged, 80 and over • Analysis of Variance •
Attitude to Health • Diet • European Continental
Ancestry Group • Exercise • Female • Hispanic
Americans • Humans • Male • Middle Aged
• North Carolina • Physician-Patient Relations
• ethnology* • psychology*},
Abstract = {An understanding of racial differences in risk-related
affect may help explain racial differences in health
behaviors and outcomes and provide additional opportunities
for intervention. In phone interviews with a random
community sample of 197 whites, 155 blacks and 163 Latinos,
we assessed concern that respondents' health would be hurt
by their diet, an inability to exercise, an inability to
follow a doctor's recommendations and disease. A
multivariate analysis of variance with follow-up profile
analysis revealed that whites were less concerned than
blacks and Latinos about an inability to follow their
doctors' recommendations (ps < 0.01). There were no racial
differences in the other health concern variables.
Interventions to inform blacks and Latinos about their
health risks must strike a balance between creating enough
health concern to encourage health behavior but not so much
that it interferes with health-promoting
behaviors.},
Key = {fds276736}
}
@article{fds276719,
Author = {Dinan, MA and Weinfurt, KP and Friedman, JY and Allsbrook, JS and Gottlieb, J and Schulman, KA and Hall, MA and Dhillon, JK and Sugarman,
J},
Title = {Comparison of conflict of interest policies and reported
practices in academic medical centers in the United
States.},
Journal = {Account Res},
Volume = {13},
Number = {4},
Pages = {325-342},
Year = {2006},
ISSN = {0898-9621},
url = {http://www.ncbi.nlm.nih.gov/pubmed/17849643},
Keywords = {Academic Medical Centers • Conflict of Interest* •
Disclosure* • Ethics Committees, Research • Health
Policy* • Humans • Interviews • United States
• standards*},
Abstract = {The authors reviewed the conflict of interest policies of 9
academic medical centers in the United States and
interviewed members of the Institutional Review Boards
(IRBs) and Conflict of Interest Committees (COICs) at those
institutions. They found that many institutions used
processes for reporting and managing conflicts of interest
that were more decentralized than the processes described in
their policies. Also, most institutions had no clear and
comprehensive policy to guide investigators regarding
disclosure of conflicts of interest to potential research
participants. Considerable differences in understanding of
conflict of interest policies were observed between IRB and
COIC officials.},
Doi = {10.1080/08989620601003414},
Key = {fds276719}
}
@article{fds276723,
Author = {Weinfurt, KP and Friedman, JY and Dinan, MA and Allsbrook, JS and Hall,
MA and Dhillon, JK and Sugarman, J},
Title = {Disclosing conflicts of interest in clinical research: views
of institutional review boards, conflict of interest
committees, and investigators.},
Journal = {J Law Med Ethics},
Volume = {34},
Number = {3},
Pages = {581-481},
Year = {2006},
ISSN = {1073-1105},
url = {http://www.ncbi.nlm.nih.gov/pubmed/17144182},
Keywords = {Attitude of Health Personnel* • Biomedical Research
• Communication Barriers • Conflict of Interest
• Decision Making • Disclosure • Ethics
Committees, Research • Human Experimentation •
Humans • Informed Consent • Interviews as Topic
• Liability, Legal • Organizational Policy •
Research Subjects • Research Support as Topic* •
Trust • United States • economics* • ethics
• ethics* • psychology},
Abstract = {Strategies for disclosing investigators' financial interests
to potential research participants have been adopted by many
research institutions. However, little is known about how
decisions are made regarding disclosures of financial
interests to potential research participants, including what
is disclosed and the rationale for making these
determinations. We sought to understand the attitudes,
beliefs, and practices of institutional review board chairs,
conflict of interest committee chairs, and investigators
regarding disclosure of financial interests to potential
research participants. Several themes emerged, including
general attitudes toward conflicts of interest,
circumstances in which financial interests should be
disclosed, rationales and benefits of disclosure, what
should be disclosed, negative effects of and barriers to
disclosure, and timing and presentation of disclosure.
Respondents cited several rationales for disclosure,
including enabling informed decision making, promoting trust
in researchers and research institutions, and reducing legal
liability. There was general agreement that disclosure
should happen early in the consent process. Respondents
disagreed about whether to disclose the amounts of
particular financial interests. Clarifying the goals of
disclosure and understanding how potential research
participants use the information will be critical in efforts
to ensure the integrity of clinical research and to protect
the rights and interests of participants.},
Language = {eng},
Doi = {10.1111/j.1748-720x.2006.00072.x},
Key = {fds276723}
}
@article{fds276709,
Author = {Dutton, MA and Kaltman, S and Goodman, LA and Weinfurt, K and Vankos,
N},
Title = {Patterns of intimate partner violence: correlates and
outcomes.},
Journal = {Violence Vict},
Volume = {20},
Number = {5},
Pages = {483-497},
Year = {2005},
Month = {October},
ISSN = {0886-6708},
url = {http://www.ncbi.nlm.nih.gov/pubmed/16248486},
Keywords = {Adult • Battered Women • Cluster Analysis •
Domestic Violence • Female • Humans •
Mid-Atlantic Region • Prevalence • Questionnaires
• Sexual Partners* • Spouse Abuse • Stress
Disorders, Post-Traumatic • Women's Health* •
classification* • epidemiology* • etiology •
prevention & control • psychology • statistics &
numerical data*},
Abstract = {Battered women experience different constellations of
violence and abusive behavior characterized by various
combinations of physical violence, sexual violence,
psychological abuse, and stalking. The goals of the current
study were to determine whether it was possible to identify
empirically derived and meaningful patterns of intimate
partner violence (IPV) and to examine correlates and
outcomes of the IPV patterns. Three IPV patterns were
identified using cluster analysis. Pattern 1 was
characterized by moderate levels of physical violence,
psychological abuse, and stalking but little sexual
violence. Pattern 2 was characterized by high levels of
physical violence, psychological abuse, and stalking but low
levels of sexual violence. Pattern 3 was characterized by
high levels of all violence types. IPV Pattern 3 was
associated with the highest prevalence of posttraumatic
stress disorder and depression, and IPV Pattern 2 had the
highest levels of revictimization during the year following
recruitment. The clinical and policy implications of the
findings are discussed.},
Doi = {10.1891/0886-6708.2005.20.5.483},
Key = {fds276709}
}
@article{fds276727,
Author = {Rathore, SS and Weinfurt, KP and Foody, JM and Krumholz,
HM},
Title = {Performance of the Thrombolysis in Myocardial Infarction
(TIMI) ST-elevation myocardial infarction risk score in a
national cohort of elderly patients.},
Journal = {Am Heart J},
Volume = {150},
Number = {3},
Pages = {402-410},
Year = {2005},
Month = {September},
ISSN = {1097-6744},
url = {http://www.ncbi.nlm.nih.gov/pubmed/16169316},
Keywords = {Aged • Aged, 80 and over • Cohort Studies •
Electrocardiography • Female • Humans • Male
• Middle Aged • Myocardial Infarction •
Reproducibility of Results • Risk Assessment •
Thrombolytic Therapy* • drug therapy* • methods*
• mortality • physiopathology},
Abstract = {BACKGROUND: The TIMI ST-elevation myocardial infarction
(STEMI) score was developed and validated in a randomized
controlled trial population. We sought to assess its
accuracy in a community-based cohort of elderly patients
hospitalized with STEMI. METHODS: We evaluated the TIMI
STEMI score in 47,882 patients aged > or = 65 years
hospitalized with STEMI in US hospitals from 1994 to 1996.
We assessed TIMI STEMI score discrimination and calibration
for 30-day mortality and compared observed and published
TIMI mortality rates. RESULTS: The cohort's median TIMI
score was 6 (25th-75th percentile 4, 8). Thirty-day
mortality rates were higher among patients with higher TIMI
scores (TIMI score 2: 4.4% vs TIMI score > 8: 35.6%, P <
.0001 for trend). However, the TIMI score provided only
modest discrimination (c = 0.67) and calibration
(goodness-of-fit P < .0001). Mortality rates for TIMI scores
differed between patients who did and did not receive
reperfusion therapy (P < .0001 for TIMI score x reperfusion
therapy interaction). Thirty-day mortality rates in the
cohort were higher than published TIMI estimates (P = .001;
eg, TIMI score 2: 4.4% cohort vs 2.2% published rate).
CONCLUSIONS: The TIMI score provided modest prognostic
discrimination and calibration among elderly patients with
STEMI. Our findings highlight the difficulties in applying
risk scores developed in randomized controlled trial cohorts
to elderly patients.},
Doi = {10.1016/j.ahj.2005.03.069},
Key = {fds276727}
}
@article{fds344721,
Author = {Matchar, DB and Patwardhan, MB and Samsa, GP},
Title = {Improving adherence with clinical guidelines},
Pages = {475-489},
Year = {2005},
Month = {August},
url = {http://dx.doi.org/10.4324/9781410615626},
Doi = {10.4324/9781410615626},
Key = {fds344721}
}
@article{fds276754,
Author = {Reed, SD and Radeva, JI and Weinfurt, KP and McMurray, JJV and Pfeffer,
MA and Velazquez, EJ and Allsbrook, JS and Masselink, LE and Sellers,
MA and Califf, RM and Schulman, KA and VALIANT Investigators},
Title = {Resource use, costs, and quality of life among patients in
the multinational Valsartan in Acute Myocardial Infarction
Trial (VALIANT).},
Journal = {Am Heart J},
Volume = {150},
Number = {2},
Pages = {323-329},
Year = {2005},
Month = {August},
ISSN = {1097-6744},
url = {http://www.ncbi.nlm.nih.gov/pubmed/16086938},
Keywords = {Ambulatory Care • Angiotensin II Type 1 Receptor
Blockers • Angiotensin-Converting Enzyme Inhibitors
• Captopril • Drug Costs • Health Care Costs
• Health Resources • Heart Failure, Congestive
• Hospital Costs • Hospitalization • Humans
• Myocardial Infarction • Prospective Studies
• Quality of Life • Tetrazoles • Valine
• Ventricular Dysfunction, Left • World Health
• analogs & derivatives* • complications •
drug therapy • drug therapy* • economics •
etiology • psychology • statistics & numerical
data • therapeutic use • therapeutic use* •
utilization • utilization*},
Abstract = {BACKGROUND: In a multinational clinical trial, valsartan was
statistically not inferior to captopril in reducing
mortality and cardiovascular morbidity after myocardial
infarction (MI) in patients with signs of heart failure
and/or left ventricular dysfunction. We conducted a
prospective economic evaluation to compare within-trial
resource use, costs, and quality of life in patients
receiving valsartan, captopril, or both after MI. METHODS:
We assigned country-specific unit costs to resource use data
for 14703 patients and measured health-related quality of
life in a subset of 4524 patients. We used the nonparametric
bootstrap method to compare rates of resource use and costs,
and a piecewise linear mixed-effects regression analysis to
compare longitudinal measures of quality of life. RESULTS:
There were no significant differences in rates of resource
use between the valsartan and captopril groups. During an
average follow-up of 2 years, total costs for patients
receiving valsartan were significantly higher than for
patients receiving captopril (USD 14103 vs USD 13038; 95% CI
USD 369-USD 1875). The cost differential was caused
primarily by the cost of the study medications (USD 1056 for
valsartan vs USD 165 for captopril; 95% CI USD 867 to USD
912). Quality of life did not differ significantly between
groups. CONCLUSIONS: For most patients at high risk after
MI, the availability of generic captopril confers a cost
advantage over valsartan because of lower medication costs.
The difference will be smaller or nonexistent in settings
where brand-name ACE inhibitors are prescribed.},
Doi = {10.1016/j.ahj.2004.08.037},
Key = {fds276754}
}
@article{fds276763,
Author = {Van Houtven and CH and Voils, CI and Oddone, EZ and Weinfurt, KP and Friedman, JY and Schulman, KA and Bosworth, HB},
Title = {Perceived discrimination and reported delay of pharmacy
prescriptions and medical tests.},
Journal = {J Gen Intern Med},
Volume = {20},
Number = {7},
Pages = {578-583},
Year = {2005},
Month = {July},
ISSN = {1525-1497},
url = {http://www.ncbi.nlm.nih.gov/pubmed/16050850},
Keywords = {Empirical Approach • Health Care and Public
Health},
Abstract = {BACKGROUND: Access to health care varies according to a
person's race and ethnicity. Delaying treatment is one
measure of access with important health consequences.
OBJECTIVE: Determine whether perceptions of unfair treatment
because of race or ethnicity are associated with reported
treatment delays, controlling for economic constraints,
self-reported health, depression, and demographics. DESIGN:
Cross-sectional, observational study. PARTICIPANTS: A
randomly selected community sample of 181 blacks, 148
Latinos, and 193 whites in Durham County, NC. MEASUREMENTS:
A phone survey conducted in 2002 to assess discrimination,
trust in medical care, quality of care, and access to care.
Treatment delays were measured by whether or not a person
reported delaying or forgoing filling a prescription and
delaying or forgoing having a medical test/treatment in the
past 12 months. Perceived discrimination was measured as
unfair treatment in health care and as racism in local
health care institutions. RESULTS: The odds of delaying
filling prescriptions were significantly higher (odds ratio
(OR)=2.02) for persons who perceived unfair treatment,
whereas the odds of delaying tests or treatments were
significantly higher (OR=2.42) for persons who thought
racism was a problem in health care locally. People with
self-reported depression and people who reported not working
had greater odds of delaying both types of care.
CONCLUSIONS: A prospective cohort study with both personal
and macro measures of discrimination, as well as more
refined measures of treatment delays, would help us better
understand the relationship between perceived discrimination
and treatment delays.},
Doi = {10.1111/j.1525-1497.2005.0123.x},
Key = {fds276763}
}
@article{fds276737,
Author = {Weinfurt, KP and Li, Y and Castel, LD and Saad, F and Timbie, JW and Glendenning, GA and Schulman, KA},
Title = {The significance of skeletal-related events for the
health-related quality of life of patients with metastatic
prostate cancer.},
Journal = {Ann Oncol},
Volume = {16},
Number = {4},
Pages = {579-584},
Year = {2005},
Month = {April},
ISSN = {0923-7534},
url = {http://www.ncbi.nlm.nih.gov/pubmed/15734776},
Keywords = {Aged • Bone Neoplasms • Humans • Male •
Prostatic Neoplasms • Quality of Life* •
Randomized Controlled Trials as Topic • methods •
pathology* • secondary*},
Abstract = {BACKGROUND: We examined the clinical relevance of
skeletal-related events (SREs) for health state preferences,
pain and health-related quality of life in patients with
advanced prostate cancer and a history of bone metastases.
PATIENTS AND METHODS: Data were from a clinical trial of
zoledronic acid versus placebo in the treatment of SREs
associated with advanced prostate cancer metastatic to bone.
Patients (n=248) were included if they experienced an SRE
during the study. Outcome measures were assessed at fixed
intervals. We used mixed-effects models to estimate changes
in outcomes after each patient's first SRE. RESULTS: There
were clinically meaningful and statistically significant
declines in physical well-being after: radiation and
pathologic fractures; functional well-being after radiation;
and emotional well-being after radiation and pathologic
fractures. There also were meaningful and significant
declines in preference and utility scores after radiation
and fracture. Pain intensity declined after radiation, but
not after other SREs; no other pain measure changed
substantively. CONCLUSIONS: SREs have important and
significant effects on measures of health-related quality of
life in men with prostate cancer. Treatments that prevent
SREs may not demonstrate corresponding effects on outcomes
if the effects of SREs occur between scheduled outcome
assessments. Implications for trial design are
discussed.},
Language = {eng},
Doi = {10.1093/annonc/mdi122},
Key = {fds276737}
}
@article{fds276713,
Author = {Goodman, L and Dutton, MA and Vankos, N and Weinfurt,
K},
Title = {Women's resources and use of strategies as risk and
protective factors for reabuse over time.},
Journal = {Violence Against Women},
Volume = {11},
Number = {3},
Pages = {311-336},
Year = {2005},
Month = {March},
ISSN = {1077-8012},
url = {http://www.ncbi.nlm.nih.gov/pubmed/16043552},
Keywords = {Adult • African Americans • Attitude to Health
• Battered Women • Female • Humans •
Mid-Atlantic Region • Middle Aged • Multivariate
Analysis • Needs Assessment • Patient Acceptance
of Health Care • Primary Prevention • Recurrence
• Risk Factors • Social Support* •
Socioeconomic Factors • Spouse Abuse • Women's
Health* • epidemiology • methods • prevention
& control • psychology • statistics & numerical
data • statistics & numerical data*},
Abstract = {Using a longitudinal and ecological approach, we
investigated the relationships between women's material and
emotional resources and strategies and their ability to stay
safe over time in a sample of 406 help-seeking African
American women. The multivariate analysis demonstrated that
social support served as a protective factor and resistance
strategies as risk factors for reabuse during a 1-year
period. It also showed an interaction between social support
and history of violence such that for participants who had
experienced the most severe violence, social support did not
serve as a protective factor; however, for the other
participants, those with the least amount of social support
had a 65% predicted probability of reabuse during the next
year, compared to a 20% predicted probability for women
reporting the highest level of social support. Policy and
programmatic implications of these findings are
discussed.},
Language = {eng},
Doi = {10.1177/1077801204273297},
Key = {fds276713}
}
@article{fds276744,
Author = {Weinfurt, KP and Depuy, V and Castel, LD and Sulmasy, DP and Schulman,
KA and Meropol, NJ},
Title = {Understanding of an aggregate probability statement by
patients who are offered participation in Phase I clinical
trials.},
Journal = {Cancer},
Volume = {103},
Number = {1},
Pages = {140-147},
Year = {2005},
Month = {January},
ISSN = {0008-543X},
url = {http://www.ncbi.nlm.nih.gov/pubmed/15534885},
Keywords = {Adult • Aged • Clinical Trials, Phase I as Topic
• Cognition Disorders* • Communication •
Decision Making* • Female • Health Care Surveys
• Humans • Informed Consent* • Male •
Middle Aged • Neoplasms • Patient Participation*
• Physician-Patient Relations • Risk Factors
• Sampling Studies • Truth Disclosure •
ethics* • therapy},
Abstract = {BACKGROUND: There is concern that patients with poor
numeracy may have difficulty understanding the information
necessary to make informed treatment decisions. The authors
sought to characterize a special form of numeracy among
patients with advanced cancer who were offered participation
in Phase I oncology clinical trials. METHODS: Surveys were
administered to 328 cancer patients who were considering
Phase I trials. Their frequency-type numeracy was assessed
using a multiple-choice question involving a hypothetical
scenario in which a physician stated that an experimental
treatment would control cancer in "40% of cases like yours."
In univariate and multivariable analyses, patient
characteristics that were associated with better numeracy
were identified. RESULTS: The correct frequency-type
interpretation was selected by 72% of respondents. Fourteen
percent of respondents incorrectly selected a belief-type
answer, "The doctor is 40% confident that the treatment will
control my cancer." In a multivariable model, patients who
answered incorrectly tended to have less formal education
and less experience with experimental therapies.
CONCLUSIONS: Because the misunderstandings some patients
demonstrated may influence their treatment decision making
adversely, it is critical to identify such patients and to
give them special consideration when communicating
information about potential risks and benefits of
treatment.},
Language = {eng},
Doi = {10.1002/cncr.20730},
Key = {fds276744}
}
@article{fds331318,
Author = {Weinfurt, KP},
Title = {Experience, Grammar, and the Stuff of Psychology},
Journal = {Theory & Psychology},
Volume = {15},
Number = {3},
Pages = {407-409},
Publisher = {SAGE Publications},
Year = {2005},
Month = {January},
url = {http://dx.doi.org/10.1177/095935430501500307},
Doi = {10.1177/095935430501500307},
Key = {fds331318}
}
@article{fds134947,
Title = {Weinfurt KP. Experience, grammar, and the stuff of
psychology. Theory Psychol. 2005;15:407-409.},
Year = {2005},
Key = {fds134947}
}
@article{fds276732,
Author = {Voils, CI and Oddone, EZ and Weinfurt, KP and Friedman, JY and Schulman,
KA and Bosworth, HB},
Title = {For the patient. Who trusts healthcare institutions? Results
from a community-based sample.},
Journal = {Ethn Dis},
Volume = {15},
Number = {1},
Pages = {150},
Year = {2005},
ISSN = {1049-510X},
url = {http://www.ncbi.nlm.nih.gov/pubmed/15720061},
Keywords = {Continental Population Groups • Delivery of Health Care
• Humans • Trust* • standards* •
statistics & numerical data*},
Key = {fds276732}
}
@article{fds276761,
Author = {Friedman, JY and Anstrom, KJ and Weinfurt, KP and McIntosh, M and Bosworth, HB and Oddone, EZ and Bright, CM and Schulman,
KA},
Title = {Perceived racial/ethnic bias in healthcare in Durham County,
North Carolina: a comparison of community and national
samples.},
Journal = {N C Med J},
Volume = {66},
Number = {4},
Pages = {267-275},
Year = {2005},
ISSN = {0029-2559},
url = {http://www.ncbi.nlm.nih.gov/pubmed/16206530},
Keywords = {Adult • African Americans • Attitude to Health
• Female • Health Care Surveys • Health
Services Accessibility* • Hispanic Americans •
Humans • Male • Middle Aged • North Carolina
• Prejudice* • Residence Characteristics •
Social Perception* • ethnology* •
psychology*},
Abstract = {BACKGROUND: We sought to compare findings of a national
survey of perceptions of racial/ethnic discrimination in
healthcare to those of a community survey, with emphasis on
the perceptions of Latinos. METHODS: Responses from a
national survey were compared to a telephone survey of
residents of Durham County, North Carolina. RESULTS: Black
respondents in the Durham sample were more likely than those
in the national sample to feel that a healthcare provider
had treated them with disrespect because of health insurance
status (28% vs 14%; P < 0.001). Approximately one third of
Durham Latinos and 14% of Latinos in the national sample
felt they had been treated with disrespect because of their
English-language ability (P < 0.01). Compared to a national
sample of white participants, white respondents in Durham
were more likely to believe that black persons are worse off
in terms of receiving routine medical care (40% vs 27%; P <
0.01) and having health insurance (58% vs 43%; P < 0.01). As
compared to their national counterparts, there was a similar
trend for how white respondents in Durham perceived how
Latinos fared (P < 0.001 for all comparisons). CONCLUSIONS:
Overall the perception of bias in healthcare was greater
among Durham residents, especially among newly immigrated
Latinos, than among their national counterparts.},
Key = {fds276761}
}
@article{fds276762,
Author = {Rasiel, EB and Weinfurt, KP and Schulman, KA},
Title = {Can prospect theory explain risk-seeking behavior by
terminally ill patients?},
Journal = {Med Decis Making},
Volume = {25},
Number = {6},
Pages = {609-613},
Year = {2005},
ISSN = {0272-989X},
url = {http://www.ncbi.nlm.nih.gov/pubmed/16282211},
Keywords = {Decision Making • Humans • Models, Theoretical*
• Risk-Taking* • Terminally Ill •
psychology*},
Abstract = {Patients with life-threatening conditions sometimes appear
to make risky treatment decisions as their condition
declines, contradicting the risk-averse behavior predicted
by expected utility theory. Prospect theory accommodates
such decisions by describing how individuals evaluate
outcomes relative to a reference point and how they exhibit
risk-seeking behavior over losses relative to that point.
The authors show that a patient's reference point for his or
her health is a key factor in determining which treatment
option the patient selects, and they examine under what
circumstances the more risky option is selected. The authors
argue that patients' reference points may take time to
adjust following a change in diagnosis, with implications
for predicting under what circumstances a patient may select
experimental or conventional therapies or select no
treatment.},
Doi = {10.1177/0272989X05282642},
Key = {fds276762}
}
@article{fds276766,
Author = {Voils, CI and Oddone, EZ and Weinfurt, KP and Friedman, JY and Schulman,
KA and Bosworth, HB},
Title = {Who trusts healthcare institutions? Results from a
community-based sample.},
Journal = {Ethn Dis},
Volume = {15},
Number = {1},
Pages = {97-103},
Year = {2005},
ISSN = {1049-510X},
url = {http://www.ncbi.nlm.nih.gov/pubmed/15720055},
Keywords = {Adult • Chi-Square Distribution • Continental
Population Groups • Delivery of Health Care •
Female • Humans • Likelihood Functions •
Logistic Models • Male • North Carolina •
Questionnaires • Trust* • psychology* •
standards*},
Abstract = {OBJECTIVE: The goal of this research was to examine racial
differences in trust in various healthcare institutions.
METHOD: In telephone interviews, 195 Whites, 183 Blacks, and
171 Latinos from Durham, NC indicated how often they trust
various institutions (community doctors, local hospitals,
county health department, insurance companies, and state and
federal government) to do what is best for patients.
RESULTS: In bivariate analyses, trust in various healthcare
institutions was associated with race; Whites and Latinos
trusted physicians more often than Blacks, and Latinos
trusted the health department, insurance companies, and both
government entities more often than Whites and Blacks (Ps <
.01). In adjusted analyses controlling for marital status,
financial status, and education, race was still associated
with trust. Whites trusted physicians more often than
Blacks, and Latinos trusted insurance companies, the state
government, and the federal government more often than
Whites and Blacks (Ps < .01). CONCLUSIONS: Racial
differences in trust of healthcare institutions vary by
institution type. Future studies of trust and interventions
designed to improve trust must account for race and target
institution differences.},
Key = {fds276766}
}
@article{fds276670,
Author = {Hong, TB and Oddone, EZ and Weinfurt, KP and Friedman, JY and Schulman,
KA and Bosworth, HB},
Title = {The relationship between perceived barriers to healthcare
and self-rated health},
Journal = {Psychology, Health and Medicine},
Volume = {9},
Number = {4},
Pages = {476-482},
Publisher = {Informa UK Limited},
Year = {2004},
Month = {November},
url = {http://dx.doi.org/10.1080/13548500412331298966},
Abstract = {The main purpose of the current investigation is to examine
the extent to which health care barriers are uniquely
associated with individual differences in self-rated health.
Self-rated health can be easily assessed and is predictive
of mortality, health care use and other health outcomes. In
this sample of 586 community residents, the six healthcare
barriers examined uniquely accounted for 12% of the variance
in self-rated health and demographic variables uniquely
accounted for an additional 11% of the variance in
self-rated health. In conclusion, healthcare barriers were
just as important as age, race, gender, and education when
accounting for explained variance in self-rated health.
Future studies should consider intervening on health care
barriers to improve self appraisals of health and
subsequently improve health outcomes.},
Doi = {10.1080/13548500412331298966},
Key = {fds276670}
}
@article{fds276746,
Author = {Friedman, JY and Reed, SD and Weinfurt, KP and Kahler, KH and Walter,
EB and Schulman, KA},
Title = {Parents' reported preference scores for childhood atopic
dermatitis disease states.},
Journal = {BMC Pediatr},
Volume = {4},
Number = {1},
Pages = {21},
Year = {2004},
Month = {October},
ISSN = {1471-2431},
url = {http://www.ncbi.nlm.nih.gov/pubmed/15491500},
Keywords = {Adolescent • Adult • Child • Child, Preschool
• Dermatitis, Atopic • Female • Health
Status* • Humans • Infant • Male •
Parents* • Population Surveillance • Quality of
Life* • Severity of Illness Index •
classification*},
Abstract = {BACKGROUND: We sought to elicit preference weights from
parents for health states corresponding to children with
various levels of severity of atopic dermatitis. We also
evaluated the hypothesis that parents with children who had
been diagnosed with atopic dermatitis would assign different
preferences to the health state scenarios compared with
parents who did not have a child with atopic dermatitis.
METHODS: Subjects were parents of children aged 3 months to
18 years. The sample was derived from the General Panel,
Mommies Sub-Panel, and Chronic Illness Sub-Panel of Harris
Interactive. Participants rated health scenarios for atopic
dermatitis, asthma, and eyeglasses on a visual analog scale,
imagining a child was experiencing the described state.
RESULTS: A total of 3539 parents completed the survey.
Twenty-nine percent had a child with a history of atopic
dermatitis. Mean preference scores for atopic dermatitis
were as follows: mild, 91 (95% confidence interval [CI],
90.7 to 91.5); mild/moderate, 84 (95%CI, 83.5 to 84.4);
moderate, 73 (95%CI, 72.5 to 73.6); moderate/severe, 61
(95%CI, 60.6 to 61.8); severe, 49 (95% CI, 48.7 to 50.1);
asthma, 58 (95%CI, 57.4 to 58.8); and eyeglasses, 87(95%CI,
86.3 to 87.4). CONCLUSIONS: Parents perceive that atopic
dermatitis has a negative effect on quality of life that
increases with disease severity. Estimates of parents'
preferences can provide physicians with insight into the
value that parents place on their children's treatment and
can be used to evaluate new medical therapies for atopic
dermatitis.},
Doi = {10.1186/1471-2431-4-21},
Key = {fds276746}
}
@article{fds369243,
Author = {Weinfurt, KP and Anstrom, KJ and Castel, LD and Brandman, J and Schulman, KA},
Title = {Effect of zoledronic acid on clinically meaningful changes
in pain associated with metastatic prostate
cancer.},
Journal = {J Clin Oncol},
Volume = {22},
Number = {14_suppl},
Pages = {4680},
Year = {2004},
Month = {July},
Abstract = {4680 Background: Zoledronic acid (ZA) has been shown to
significantly decrease skeletal-related events (SREs) in
patients with prostate cancer by 11% relative to placebo.
Trends were seen in pain improvement with ZA vs placebo, but
there were no reliable treatment group differences. The
objective of this study was to reexamine the pain outcomes
using an alternative analytic framework that focuses on the
frequency of clinically meaningful changes in pain scores.
METHODS: Patients were randomized to ZA 4mg (n=214) or
placebo (n=208). The Brief Pain Inventory Composite Score
(BPI) was used to assess pain at baseline, 3 weeks, 6 weeks,
and every 6 weeks for a total of 60 weeks. We determined
whether clinically meaningful pain changes from baseline
(+/- 2 BPI points) were related to treatment assignment
using a modified non-parametric rank test. RESULTS: The
rapid progression of the prostate cancer led to high rates
of dropout as only 76 of 214 (35.5%) patients randomized to
ZA and 62 of 208 (29.8%) patients randomized to PL completed
their 60 week visit (p=0.21). At 10 of 11 assessment times,
ZA patients reported more favorable clinically meaningful
changes in pain scores (see table). Overall, a typical ZA
patient had a 27% chance of having a favorable response
(ZA>PL) compared with a typical PL patient who had an 19%
chance of a favorable response (PL>ZA)-a difference that was
statistically significant (95% CI: 1.1% - 15.5%).
CONCLUSIONS: Patients receiving ZA were 8% more likely to
have clinically beneficial changes in pain scores compared
to patients receiving placebo. This is roughly consistent
with the 11% difference between groups in the incidence of
SREs as reported in the primary clinical analysis. Thus, ZA
4 mg significantly reduces the occurrence of
skeletal-related events and the associated changes in pain
they produce. [Figure: see text] [Table: see
text].},
Key = {fds369243}
}
@article{fds276734,
Author = {Weinfurt, KP and Castel, LD and Li, Y and Timbie, JW and Glendenning,
GA and Schulman, KA},
Title = {Health-related quality of life among patients with breast
cancer receiving zoledronic acid or pamidronate disodium for
metastatic bone lesions.},
Journal = {Med Care},
Volume = {42},
Number = {2},
Pages = {164-175},
Year = {2004},
Month = {February},
ISSN = {0025-7079},
url = {http://www.ncbi.nlm.nih.gov/pubmed/14734954},
Keywords = {Bone Neoplasms • Breast Neoplasms • Canada •
Diphosphonates • Double-Blind Method • Female
• Humans • Imidazoles • Middle Aged •
Outcome and Process Assessment (Health Care) •
Prospective Studies • Quality of Life* • United
States • drug therapy* • pathology* •
secondary* • therapeutic use*},
Abstract = {BACKGROUND: Research on individual differences in
health-related quality of life (HRQOL) can identify
intervention targets and important covariates in analyses of
treatment outcomes. OBJECTIVES: The objectives of this study
were to describe HRQOL trajectories for women with
metastatic breast cancer in a randomized trial of
bisphosphonates and to identify characteristics associated
with variations in HRQOL. RESEARCH DESIGN: We conducted a
prospective quality-of-life study within a randomized,
controlled trial. SUBJECTS: We studied women with metastatic
breast cancer receiving zoledronic acid or pamidronate
disodium to reduce the incidence of skeletal-related events
(SREs). MAIN OUTCOME MEASURES: HRQOL was measured at fixed
time points during the trial. Individual growth-curve
modeling was used to describe longitudinal trajectories and
to identify predictors of trajectories. RESULTS: For most
domains of HRQOL, the mean trajectory reflected a mild
increase, which leveled off later in the trial. Older age
and full-time employment were associated with higher
baseline HRQOL. Longer time from cancer diagnosis to
randomization, lower Eastern Cooperative Oncology Group
(ECOG) status (score of 2 ["inactive"]), and a history of
SREs were associated with lower baseline HRQOL. Significant
differences across geographic regions were observed for all
domains. Active ECOG status (score of 0-1) at baseline was
predictive of greater increases in all domains of HRQOL
except Social/Family Well-Being. Age, geographic region, and
time from first bone metastases to randomization were
associated with longitudinal changes in some domains.
CONCLUSIONS: Women with metastatic breast cancer receiving
bisphosphonates for prevention of SREs experienced an
overall increase in HRQOL. Variations among women's
experiences are explained partly by such characteristics as
a history of SREs.},
Language = {eng},
Doi = {10.1097/01.mlr.0000108746.69256.45},
Key = {fds276734}
}
@article{fds369245,
Author = {Meropol, NJ and Castel, LD and Schulman, KA and Weinfurt,
KP},
Title = {In Reply:},
Journal = {Journal of Clinical Oncology},
Volume = {22},
Number = {3},
Pages = {572-573},
Publisher = {American Society of Clinical Oncology (ASCO)},
Year = {2004},
Month = {February},
url = {http://dx.doi.org/10.1200/jco.2004.99.273},
Doi = {10.1200/jco.2004.99.273},
Key = {fds369245}
}
@article{fds276664,
Author = {Weinfurt, KP},
Title = {Discursive Versus Information-Processing Perspectives on a
Bioethical Problem: The Case of ‘Unrealistic’ Patient
Expectations},
Journal = {Theory & Psychology},
Volume = {14},
Number = {2},
Pages = {191-203},
Publisher = {SAGE Publications},
Year = {2004},
Month = {January},
ISSN = {0959-3543},
url = {http://dx.doi.org/10.1177/0959354304042016},
Abstract = {This article discusses an example of how the adoption of
different theoretical views of the person can have practical
implications for the field of bioethics. Patients who agree
to receive new medical treatments with little chance of
benefit routinely report strong confidence that they will
experience benefit. These ‘unrealistic’ expectations are
interpreted as false beliefs about treatment, and thus as
evidence that the informed consent process has failed. This
interpretation of patient reports is consistent with an
information-processing framework in which the patient is
viewed as transmitting information that enjoys an
independent existence in the mental machinery of the person.
The perspective of discursive psychology, on the other hand,
views the patients’ reports as activities undertaken to
achieve specific aims within particular discursive contexts.
It is argued that if bioethicists adopt the discursive
perspective, some cases of ‘false belief’ might not pose
a bioethical problem. © 2004, SAGE Publications. All rights
reserved.},
Doi = {10.1177/0959354304042016},
Key = {fds276664}
}
@article{fds134946,
Title = {Weinfurt KP. Discursive versus information-processing
perspectives on a bioethical problem: the case of
"unrealistic" patient expectations. Theory Psychol.
2004;14:191-203.},
Year = {2004},
Key = {fds134946}
}
@article{fds276729,
Author = {Gaskin, DJ and Weinfurt, KP and Castel, LD and DePuy, V and Li, Y and Balshem, A and Benson, A and Burnett, CB and Corbett, S and Marshall, J and Slater, E and Sulmasy, DP and Van Echo and D and Meropol, NJ and Schulman,
KA},
Title = {An exploration of relative health stock in advanced cancer
patients.},
Journal = {Med Decis Making},
Volume = {24},
Number = {6},
Pages = {614-624},
Year = {2004},
ISSN = {0272-989X},
url = {http://www.ncbi.nlm.nih.gov/pubmed/15534342},
Keywords = {Clinical Trials, Phase I • Costs and Cost Analysis
• Decision Making* • Decision Support Techniques
• Female • Health Knowledge, Attitudes, Practice
• Health Status* • Humans • Male •
Middle Aged • Neoplasm Staging • Neoplasms •
Patient Participation • Quality of Life • Risk
Assessment • pathology • psychology •
psychology* • therapy},
Abstract = {OBJECTIVE: The authors sought to empirically test whether
relative health stock, a measure of patients' sense of loss
in their health due to illness, influences the treatment
decisions of patients facing life-threatening conditions.
Specifically, they estimated the effect of relative health
stock on advanced cancer patients' decisions to participate
in phase I clinical trials. METHOD: A multicenter study was
conducted to survey 328 advanced cancer patients who were
offered the opportunity to participate in phase I trials.
The authors asked patients to estimate the probabilities of
therapeutic benefits and toxicity, their relative health
stock, risk preference, and the importance of quality of
life. RESULTS: Controlling for health-related quality of
life, an increase in relative health stock by 10 percentage
points reduced the odds of choosing to participate in a
phase I trial by 16% (odds ratio = 0.84, 95% confidence
interval = 0.72, 0.97). CONCLUSION: Relative health stock
affects advanced cancer patients' treatment
decisions.},
Doi = {10.1177/0272989X04271041},
Key = {fds276729}
}
@article{fds369246,
Author = {Meropol, NJ and Weinfurt, KP and Schulman, KA},
Title = {In Reply:},
Journal = {Journal of Clinical Oncology},
Volume = {21},
Number = {24},
Pages = {4659-4660},
Publisher = {American Society of Clinical Oncology (ASCO)},
Year = {2003},
Month = {December},
url = {http://dx.doi.org/10.1200/jco.2003.99.198},
Doi = {10.1200/jco.2003.99.198},
Key = {fds369246}
}
@article{fds369247,
Author = {Rathore, SS and Weinfurt, KP and Gross, CP and Krumholtz,
H},
Title = {Validity of a simple ST-elevation acute myocardial
infarction risk index: Are randomized trial prognostic
estimates generalizable to elderly patients?
Response},
Journal = {CIRCULATION},
Volume = {108},
Number = {1},
Pages = {E9-E10},
Publisher = {LIPPINCOTT WILLIAMS & WILKINS},
Year = {2003},
Month = {July},
Key = {fds369247}
}
@article{fds276738,
Author = {Weinfurt, KP and Castel, LD and Li, Y and Sulmasy, DP and Balshem, AM and Benson, AB and Burnett, CB and Gaskin, DJ and Marshall, JL and Slater,
EF and Schulman, KA and Meropol, NJ},
Title = {The correlation between patient characteristics and
expectations of benefit from Phase I clinical
trials.},
Journal = {Cancer},
Volume = {98},
Number = {1},
Pages = {166-175},
Year = {2003},
Month = {July},
ISSN = {0008-543X},
url = {http://www.ncbi.nlm.nih.gov/pubmed/12833469},
Keywords = {Adult • Aged • Clinical Trials, Phase I as Topic*
• Decision Making • Female • Humans •
Informed Consent • Male • Middle Aged •
Neoplasms • Patient Participation • Patient
Selection • Patients • Perception • Quality
of Life • Truth Disclosure • psychology* •
therapy},
Abstract = {BACKGROUND: Patients in Phase I clinical trials sometimes
report high expectations regarding the benefit of treatment.
The authors examined a range of patient characteristics to
determine which factors were associated with greater
expectations of benefit from Phase I trials. METHODS:
Participants were adult patients with cancer who had been
offered participation in Phase I studies and had decided to
participate. Patients completed interviewer-administered
surveys before initiation of treatment. Physicians assessed
Eastern Cooperative Oncology Group performance status for
each patient. Statistical analyses (Pearson product moment
correlation and t tests) used multiple imputation to account
for missing data. RESULTS: Overall, 593 patients who were
offered participation in Phase I trials were contacted, and
328 patients agreed to participate in a study of decision
making by cancer patients. Of these, 260 patients (79%)
enrolled in a Phase I trial. Patients' expectations
regarding the chance that their disease would be controlled
with experimental therapy were unrelated to age, gender,
living situation, education level, or functional status.
Expectations were correlated positively with beliefs about
the benefit of standard therapy and the maximum benefit
patients may experience from experimental therapy. Greater
expectations of benefit were associated with better
health-related quality of life, stronger religious faith,
optimism, relative health stock, monetary risk seeking, and
poorer numeracy. CONCLUSIONS: Expectations expressed as
beliefs in personal outcomes may be related more to quality
of life and personality variables than to patients'
knowledge or functional status. Whether such expectations
are accurate reflections of knowledge has important
implications for evaluating the informed consent
process.},
Language = {eng},
Doi = {10.1002/cncr.11483},
Key = {fds276738}
}
@article{fds276768,
Author = {Meropol, NJ and Weinfurt, KP and Burnett, CB and Balshem, A and Benson,
AB and Castel, L and Corbett, S and Diefenbach, M and Gaskin, D and Li, Y and Manne, S and Marshall, J and Rowland, JH and Slater, E and Sulmasy, DP and Van Echo and D and Washington, S and Schulman, KA},
Title = {Perceptions of patients and physicians regarding phase I
cancer clinical trials: implications for physician-patient
communication.},
Journal = {J Clin Oncol},
Volume = {21},
Number = {13},
Pages = {2589-2596},
Year = {2003},
Month = {July},
ISSN = {0732-183X},
url = {http://www.ncbi.nlm.nih.gov/pubmed/12829680},
Keywords = {Adult • Aged • Attitude • Clinical Trials,
Phase I* • Communication* • Data Collection •
Decision Making • Female • Humans • Male
• Middle Aged • Neoplasms • Patient
Participation* • Perception • Physician-Patient
Relations* • Prognosis • Quality of Life •
Truth Disclosure • therapy},
Abstract = {PURPOSE: To describe and compare the perceptions of cancer
patients and their physicians regarding phase I clinical
trials. METHODS: Eligible patients had been offered phase I
trial participation and had decided to participate but had
not yet begun treatment. Each patient's physician also
served as a study subject. Patients and physicians completed
questionnaires with domains including perceptions of
potential benefit and harm from treatment (experimental and
standard), relative value of quality and length of life, and
perceived content of patient-physician consultations.
RESULTS: Three hundred twenty-eight patients and 48
physicians completed surveys. Patients had high expectations
regarding treatment outcomes (eg, median 60% benefit from
experimental therapy), with those choosing to participate in
a phase I trial being more optimistic than those declining
phase I participation. Patients predicted a higher
likelihood of both benefit and adverse reactions from
treatment (experimental and standard) than their physicians
(P <.0001 for all comparisons). Although 95% of patients
reported that quality of life was at least as important as
length of life, only 28% reported that changes in quality of
life with treatment were discussed with their physicians. In
contrast, 73% of physicians reported that this topic was
discussed (P <.0001). CONCLUSION: Cancer patients offered
phase I trial participation have expectations for treatment
benefit that exceed those of their physicians. The
discordant perceptions of patients and physicians may
possibly be explained by patient optimism and confidence;
however, the discrepancies in reports of consultation
content, particularly given patients' stated values
regarding quality of life, raise the possibility that
communication in this context is suboptimal.},
Doi = {10.1200/JCO.2003.10.072},
Key = {fds276768}
}
@article{fds369248,
Author = {Weinfurt, KP and Li, Y and Castel, LD and Glendenning, A and Schulman,
KA},
Title = {PMD6: ESTIMATING THE TRAJECTORY-ADJUSTED IMPACT OF ACUTE
EVENTS ON PATIENT-REPORTED OUTCOMES},
Journal = {Value in Health},
Volume = {6},
Number = {3},
Pages = {293-293},
Publisher = {Elsevier BV},
Year = {2003},
Month = {May},
url = {http://dx.doi.org/10.1016/s1098-3015(10)64084-3},
Doi = {10.1016/s1098-3015(10)64084-3},
Key = {fds369248}
}
@article{fds276740,
Author = {Rathore, SS and Weinfurt, KP and Gross, CP and Krumholz,
HM},
Title = {Validity of a simple ST-elevation acute myocardial
infarction risk index: are randomized trial prognostic
estimates generalizable to elderly patients?},
Journal = {Circulation},
Volume = {107},
Number = {6},
Pages = {811-816},
Year = {2003},
Month = {February},
ISSN = {1524-4539},
url = {http://www.ncbi.nlm.nih.gov/pubmed/12591749},
Keywords = {Aged • Aged, 80 and over • Calibration •
Cohort Studies • Electrocardiography* • Female
• Humans • Inpatients • Male •
Myocardial Infarction • Myocardial Reperfusion •
Predictive Value of Tests • Prognosis • Randomized
Controlled Trials • Reproducibility of Results •
Retrospective Studies • Risk • Risk Assessment
• Survival Analysis • diagnosis* • mortality*
• physiopathology • statistics & numerical
data},
Abstract = {BACKGROUND: Risk-stratification scores derived from
randomized clinical trial (RCT) data should be evaluated in
community-based populations. A simple risk-stratification
index for patients with ST-segment elevation myocardial
infarction derived from an RCT population was recently
proposed, but it has not been validated in a community-based
cohort. METHODS AND RESULTS: We evaluated the simple risk
index using data from 49 711 patients > or =65 years of age
hospitalized with ST-elevation myocardial infarction. We
evaluated the distribution of patients in the 5 simple risk
index groups, compared observed and published 30-day
mortality rates, and assessed the score's discrimination and
calibration. The simple risk index provided poor
discrimination (c=0.62) and calibration (goodness of fit
P<0.001) for survival at 30 days. Risk score distribution
was skewed, because two thirds (66.1%) of all patients were
classified in the highest-risk group, whereas fewer than
11.0% were classified in the 3 lowest-risk groups.
Thirty-day mortality estimates were lower than those
observed in the cohort (risk group 2 to 5: 1.9% to 17.4%
versus 5.3% to 27.9%). Risk index discrimination,
calibration, score distribution, and mortality estimates
were worse among patients who did not receive acute
reperfusion therapy than among those who did. CONCLUSIONS:
The limited performance of the simple risk index highlights
the limitations of applying prognostic models derived in RCT
populations to the general population of patients 65 years
and older. Prognostic scores must be validated in
community-based cohorts before integration into clinical
practice.},
Doi = {10.1161/01.cir.0000049743.45748.02},
Key = {fds276740}
}
@article{fds276663,
Author = {Goodman, L and Dutton, MA and Weinfurt, K and Cook,
S},
Title = {The intimate partner violence strategies index. Development
and application},
Journal = {Violence Against Women},
Volume = {9},
Number = {2},
Pages = {163-186},
Publisher = {SAGE Publications},
Year = {2003},
Month = {February},
ISSN = {1077-8012},
url = {http://dx.doi.org/10.1177/1077801202239004},
Abstract = {Although research has documented the myriad ways that
victims of IPV struggle to keep themselves safe, little
research has gone the next step to investigate patterns in
women's use of strategies, the factors that influence choice
of strategies, or which strategies are most effective. One
obstacle to conducting such research is the absence of an
instrument to measure the nature and extent of battered
women's strategic responses to violence across specific
domains of strategies. This article describes the
development of such an instrument, the Intimate Partner
Violence Strategies Index, in the context of a longitudinal
study of battered women's experience over time. © 2003 Sage
Publications.},
Doi = {10.1177/1077801202239004},
Key = {fds276663}
}
@article{fds276735,
Author = {Weinfurt, KP},
Title = {Outcomes research related to patient decision making in
oncology.},
Journal = {Clin Ther},
Volume = {25},
Number = {2},
Pages = {671-683},
Year = {2003},
Month = {February},
ISSN = {0149-2918},
url = {http://www.ncbi.nlm.nih.gov/pubmed/12749521},
Keywords = {Decision Making* • Humans • Neoplasms •
Outcome Assessment (Health Care)* • Patient Education
• Patient Participation* • Patient Satisfaction
• Quality of Life • psychology* •
therapy*},
Abstract = {For outcomes research, what are the implications of seeing
the patient as a decision maker? In the current medical
environment, greater emphasis is placed on the role played
by the patient in clinical decision making. In the past 2
decades, considerable work has been done to identify and
measure decision-related outcomes, including knowledge about
the treatment options (risks and benefits), satisfaction,
anxiety, decisional conflict, and involvement in the
decision process. Attempts to improve these decision-related
outcomes involve patient decision aids, which convey
patient-specific information and sometimes help patients
proceed through an explicit decision-making process. These
interventions have produced positive results, especially
with respect to improving patient knowledge. Future research
is needed to understand which aspects of the interventions
work and for what types of patients. Research is also needed
to better understand the decision making process of patients
who do not use decision aids.},
Doi = {10.1016/s0149-2918(03)80104-2},
Key = {fds276735}
}
@article{fds276748,
Author = {Weinfurt, KP and Sulmasy, DP and Schulman, KA and Meropol,
NJ},
Title = {Patient expectations of benefit from phase I clinical
trials: linguistic considerations in diagnosing a
therapeutic misconception.},
Journal = {Theor Med Bioeth},
Volume = {24},
Number = {4},
Pages = {329-344},
Year = {2003},
ISSN = {1386-7415},
url = {http://www.ncbi.nlm.nih.gov/pubmed/14620488},
Keywords = {Analytical Approach • Biomedical and Behavioral
Research},
Abstract = {The ethical treatment of cancer patients participating in
clinical trials requires that patients are well-informed
about the potential benefits and risks associated with
participation. When patients enrolled in phase I clinical
trials report that their chance of benefit is very high,
this is often taken as evidence of a failure of the informed
consent process. We argue, however, that some simple themes
from the philosophy of language may make such a conclusion
less certain. First, the patient may receive conflicting
statements from multiple speakers about the expected outcome
of the trial. Patients may be reporting the message they
like best. Second, there is a potential problem of
multivocality. Expressions of uncertainty of the frequency
type (e.g., "On average, 5 out of every 100 patients will
benefit") can be confused with expressions of uncertainty of
the belief type (e.g., "The chance that I will benefit is
about 80%"). Patients may be informed using frequency-type
statements and respond using belief-type statements. Third,
each speech episode involving the investigator and the
patient regarding outcomes may subserve multiple speech
acts, some of which may be indirect. For example, a patient
reporting a high expected benefit may be reporting a belief
about the future, reassuring family members, and/or
attempting to improve his or her outcome by a public
assertion of optimism. These sources of linguistic confusion
should be considered in judging whether the patient's
reported expectation is grounds for a bioethical concern
that there has been a failure in the informed consent
process.},
Language = {eng},
Doi = {10.1023/a:1026072409595},
Key = {fds276748}
}
@article{fds276749,
Author = {Onken, JE and Friedman, JY and Subramanian, S and Weinfurt, KP and Reed,
SD and Malenbaum, JH and Schmidt, T and Schulman,
KA},
Title = {Treatment patterns and costs associated with sessile
colorectal polyps.},
Journal = {Am J Gastroenterol},
Volume = {97},
Number = {11},
Pages = {2896-2901},
Year = {2002},
Month = {November},
ISSN = {0002-9270},
url = {http://www.ncbi.nlm.nih.gov/pubmed/12425565},
Keywords = {Adenoma • Aged • Carcinoma • Cohort Studies
• Colonic Polyps • Digestive System Surgical
Procedures • Female • Health Care Costs •
Humans • Male • Middle Aged • Odds Ratio
• Physician's Practice Patterns • Referral and
Consultation • Retrospective Studies • United
States • economics • economics* • pathology
• statistics & numerical data* • surgery •
surgery* • utilization*},
Abstract = {OBJECTIVES: Because of the paucity of existing literature on
treatment and costs associated with sessile lesions, the
objectives of this study were to perform a retrospective
analysis on patients with sessile polyps to identify patient
and polyp characteristics, to determine treatment patterns,
and to estimate the cost of treating these patients.
METHODS: We conducted a retrospective, observational cohort
study of 280 patients who presented to a large teaching
hospital between 1997 and 2000 with at least one sessile or
broad-based pedunculated colorectal polyp of any size or
histology, not including adenocarcinoma greater than stage
T1. RESULTS: Mean polyp size was 1.3 cm, and two thirds of
polyps were removed in a single procedure. The number of
repeat procedures increased with polyp size (Kendall T-b =
0.47; 95% CI = 0.39-0.55). Patients with polyps > or = 2 cm
were 5.88 times more likely than patients with smaller
polyps to undergo a surgical procedure. Surgical procedures
required 88.01 min longer than nonsurgical procedures (95%
CI = 74.43-102.42). Mean total cost of treatment was $2,038
(range $153 to $14,838). Open resection ($6,165) was the
most costly surgical procedure, and piecemeal polypectomy
($892) was the most costly nonsurgical therapeutic
procedure. CONCLUSIONS: One third of polyps required more
than one procedure. Surgical procedures accounted for the
majority of resource use in this sample. Finally, patients
with polyps > or = 2 cm incurred almost half the total costs
while accounting for only 22% of the sample. The greatest
economic gains could be made by improving efficiency of
polyp removal for these patients.},
Doi = {10.1111/j.1572-0241.2002.07058.x},
Key = {fds276749}
}
@article{fds276725,
Author = {Schulman, KA and Seils, DM and Timbie, JW and Sugarman, J and Dame, LA and Weinfurt, KP and Mark, DB and Califf, RM},
Title = {A national survey of provisions in clinical-trial agreements
between medical schools and industry sponsors.},
Journal = {N Engl J Med},
Volume = {347},
Number = {17},
Pages = {1335-1341},
Year = {2002},
Month = {October},
ISSN = {1533-4406},
url = {http://www.ncbi.nlm.nih.gov/pubmed/12397192},
Keywords = {Biomedical and Behavioral Research • Empirical
Approach},
Abstract = {BACKGROUND: Concerned about threats to the integrity of
clinical trials in a research environment increasingly
controlled by private interests, the International Committee
of Medical Journal Editors (ICMJE) has issued revised
guidelines for investigators' participation in the study
design, access to data, and control over publication. It is
unclear whether research conducted at academic institutions
adheres to these new standards. METHODS: From November 2001
through January 2002, we interviewed officials at U.S.
medical schools about provisions in their institutions'
agreements with industry sponsors of multicenter clinical
trials. A subgroup of the respondents were also asked about
coordinating-center agreements for such trials. RESULTS: Of
the 122 medical schools that are members of the Association
of American Medical Colleges, 108 participated in the
survey. The median number of site-level agreements executed
per institution in the previous year was 103 (interquartile
range, 50 to 210). Scores for compliance with a wide range
of provisions--from ensuring that authors of reports on
multicenter trials have access to all trial data (1 percent
[interquartile range, 0 to 21]) to addressing the plan for
data collection and monitoring (10 percent [interquartile
range, 1 to 50])--demonstrated limited adherence to the
standards embodied in the new ICMJE guidelines. Scores for
coordinating-center agreements were somewhat higher for most
survey items. CONCLUSIONS: Academic institutions routinely
engage in industry-sponsored research that fails to adhere
to ICMJE guidelines regarding trial design, access to data,
and publication rights. Our findings suggest that a
reevaluation of the process of contracting for clinical
research is urgently needed.},
Doi = {10.1056/NEJMsa020349},
Key = {fds276725}
}
@article{fds276756,
Author = {LaPointe, NMA and Kramer, JM and Weinfurt, KP and Califf,
RM},
Title = {Practitioner acceptance of the dofetilide risk-management
program.},
Journal = {Pharmacotherapy},
Volume = {22},
Number = {8},
Pages = {1041-1046},
Year = {2002},
Month = {August},
ISSN = {0277-0008},
url = {http://www.ncbi.nlm.nih.gov/pubmed/12173789},
Keywords = {Drug Information Services* • Drug Utilization •
Humans • Nurses • Pharmacists •
Phenethylamines • Physicians • Practice Guidelines
• Program Evaluation • Questionnaires* • Risk
Management* • Sulfonamides • adverse effects
• methods* • therapeutic use*},
Abstract = {STUDY OBJECTIVE: To assess the opinions and knowledge
retention of practitioners after participation in the
dofetilide risk-management program. DESIGN: A 21-item
questionnaire. SETTING: A large academic medical center.
PARTICIPANTS: One hundred forty-six practitioners were given
the questionnaire; 91 (62%) completed it. MEASUREMENTS AND
RESULTS: The questionnaire assessed practitioners' opinions
of the program and guidelines, preparation time for
implementing dofetilide treatment, and retention of facts
from the program. Responses were graded on a 5-point Likert
scale. Practitioners took a mean of 0.86 +/- 0.44 hours to
complete the program; physicians took the least time,
pharmacists the most. Practitioners agreed the program was
necessary but were undecided about whether the guidelines
were easily understood or implemented. Nurses answered one
of the two knowledge-retention questions incorrectly
significantly more often than physicians or pharmacists.
Identification of seven drugs that should not be taken with
dofetilide differed significantly (p < 0.0001) across groups
(mean accuracy score was 41% for nurses, 80% for
pharmacists, and 86% for physicians). CONCLUSION: This
risk-management program has been well received by
practitioners at our institution. We are gathering data to
determine whether the program is effective in reducing
inappropriate administration of dofetilide.},
Doi = {10.1592/phco.22.12.1041.33611},
Key = {fds276756}
}
@article{fds276730,
Author = {Weinfurt, KP and Trucco, SM and Willke, RJ and Schulman,
KA},
Title = {Measuring agreement between patient and proxy responses to
multidimensional health-related quality-of-life measures in
clinical trials. An application of psychometric profile
analysis.},
Journal = {J Clin Epidemiol},
Volume = {55},
Number = {6},
Pages = {608-618},
Year = {2002},
Month = {June},
ISSN = {0895-4356},
url = {http://www.ncbi.nlm.nih.gov/pubmed/12063103},
Keywords = {Activities of Daily Living • Craniocerebral Trauma*
• Decision Making • Health Status* • Humans
• Outcome Assessment (Health Care) • Proxy* •
Psychometrics • Quality of Life* • Randomized
Controlled Trials as Topic • Research Design •
methods*},
Abstract = {When patients cannot provide responses to health-related
quality-of-life (HRQOL) measures in clinical trials, family
or friends may be asked to respond. We present a simple,
comprehensive method for assessing agreement between
patients with head injury and their proxy responders. In
contrast to more traditional approaches, this method defines
agreement separately for each patient-proxy pair, and
compares HRQOL profiles along three dimensions-level, or the
average of the ratings; scatter, or the variability in the
ratings; and shape, or the ranks of the ratings. We
demonstrate this method in the context of a clinical trial
of a treatment for traumatic head injury and compare the
results to those obtained using traditional analyses.
Options for incorporating proxy responses into clinical
trial analyses are discussed.},
Language = {eng},
Doi = {10.1016/s0895-4356(02)00392-x},
Key = {fds276730}
}
@article{fds276757,
Author = {Seils, DM and Castel, LD and Curtis, LH and Weinfurt,
KP},
Title = {Welfare reform and Latinas' use of perinatal health
care.},
Journal = {Am J Public Health},
Volume = {92},
Number = {5},
Pages = {699-700},
Year = {2002},
Month = {May},
ISSN = {0090-0036},
url = {http://www.ncbi.nlm.nih.gov/pubmed/11988423},
Keywords = {Eligibility Determination • Employment • Female
• Health Services Research • Hispanic Americans
• Humans • Maternal Welfare • Medicaid •
Pregnancy • Pregnancy Outcome • Prenatal Care
• United States • economics • ethnology*
• legislation & jurisprudence • legislation &
jurisprudence* • standards • statistics &
numerical data* • utilization*},
Doi = {10.2105/ajph.92.5.699-a},
Key = {fds276757}
}
@article{fds276769,
Author = {Weaver, CH and Buckner, CD and Curtis, LH and Bajwa, K and Weinfurt, KP and Wilson-Relyea, BJ and Schulman, KA},
Title = {Economic evaluation of filgrastim, sargramostim, and
sequential sargramostim and filgrastim after
myelosuppressive chemotherapy.},
Journal = {Bone Marrow Transplant},
Volume = {29},
Number = {2},
Pages = {159-164},
Year = {2002},
Month = {January},
ISSN = {0268-3369},
url = {http://www.ncbi.nlm.nih.gov/pubmed/11850711},
Keywords = {Adult • Antineoplastic Agents • Breast Neoplasms
• Costs and Cost Analysis • Drug Costs* •
Drug Therapy, Combination • Female • Filgrastim
• Granulocyte Macrophage Colony-Stimulating Factors,
Recombinant • Health Care Costs • Humans •
Immunosuppressive Agents • Lymphoma • Male •
Middle Aged • Randomized Controlled Trials •
economics • economics* • statistics & numerical
data • therapeutic use • therapy},
Abstract = {Filgrastim alone and sequential sargramostim and filgrastim
have been shown to be more effective than sargramostim alone
in the mobilization of CD34(+) cells after myelosuppressive
chemotherapy (MC). We sought to compare costs and resource
use associated with these regimens. Data were collected
prospectively alongside a multicenter, randomized trial of
filgrastim, sargramostim, and sequential sargramostim and
filgrastim. Direct medical costs were calculated for
inpatient and outpatient visits and procedures, including
administration of growth factors and MC. We followed 156
patients for 30 days or until initiation of high-dose
chemotherapy. The main outcome measures were resource use
and costs of inpatient and outpatient visits, platelet and
red blood cell transfusions, antibiotic use, and apheresis
procedures. Hospital admissions, red blood cell
transfusions, and use of i.v. antibiotics were significantly
more common in the sargramostim group than in the other
treatment arms. In univariate and multivariable analyses,
total costs were higher for patients receiving sargramostim
alone than for patients in the other groups. Mean costs in
multivariable analysis for the filgrastim and sequential
sargramostim and filgrastim arms were not significantly
different. Filgrastim alone and sequential sargramostim and
filgrastim are less costly than sargramostim alone after MC,
as well as therapeutically more beneficial.},
Doi = {10.1038/sj.bmt.1703341},
Key = {fds276769}
}
@article{fds276728,
Author = {Rathore, SS and Gersh, BJ and Weinfurt, KP and Oetgen, WJ and Schulman,
KA and Solomon, AJ},
Title = {The role of reperfusion therapy in paced patients with acute
myocardial infarction.},
Journal = {Am Heart J},
Volume = {142},
Number = {3},
Pages = {516-519},
Year = {2001},
Month = {September},
ISSN = {0002-8703},
url = {http://www.ncbi.nlm.nih.gov/pubmed/11526367},
Keywords = {Age Factors • Aged • Aged, 80 and over •
Angioplasty, Transluminal, Percutaneous Coronary* •
Electrocardiography • Female • Humans • Male
• Medicare • Myocardial Infarction •
Myocardial Reperfusion* • Retrospective Studies •
Survival Analysis • Treatment Outcome • United
States • pathology • therapy*},
Abstract = {BACKGROUND/OBJECTIVE: Our purpose was to evaluate the
effectiveness of reperfusion therapy among elderly paced
patients with acute myocardial infarction (MI). Current
guidelines make no recommendation for the use of reperfusion
therapy among patients who have a paced rhythm during MI.
METHODS: We evaluated 1954 Medicare beneficiaries 65 years
and older treated for acute MI between 1994 and 1996 who had
a paced rhythm for use of reperfusion therapy. Use of
reperfusion therapy was evaluated for associations with
outcomes by logistic regression and Cox proportional hazards
models incorporating propensity score analysis. RESULTS:
Reperfusion therapy was used in 171 (8.8%) patients; 70 were
treated with primary PTCA and 101 with thrombolytic therapy.
Patients who received reperfusion therapy had 30-day
mortality rates similar to those who did not receive
reperfusion (26.3% vs 25.7%, P =.87). Multivariate
adjustment for mortality risk factors and treatment
propensity indicated no survival benefit associated with
reperfusion therapy at 30 days (relative risk [RR] 1.07, 95%
confidence interval [CI] 0.77-1.43) or long-term follow-up
(hazard ratio [HR] 0.86, 95% CI 0.68-1.10). Mortality risks
varied by type of reperfusion therapy. Patients treated with
primary percutaneous transluminal coronary angioplasty were
at comparable risk of mortality at 30 days (RR 0.73, 95% CI
0.40-1.23) but at lower risk at long-term follow-up (HR
0.60, 95% CI 0.40-0.88). Mortality risks were unchanged
among patients treated with thrombolytics at 30 days (RR
1.32, 95% CI 0.92-1.79) and long-term follow-up (HR 1.08,
95% CI 0.82-1.43). CONCLUSION: We find suggestive evidence
that primary percutaneous transluminal coronary angioplasty
provides a long-term survival benefit in the treatment of
elderly patients with acute MI who have a paced
rhythm.},
Doi = {10.1067/mhj.2001.117602},
Key = {fds276728}
}
@article{fds276751,
Author = {Polsky, D and Weinfurt, KP and Kaplan, B and Kim, J and Fastenau, J and Schulman, KA},
Title = {An economic and quality-of-life assessment of basiliximab vs
antithymocyte globulin immunoprophylaxis in renal
transplantation.},
Journal = {Nephrol Dial Transplant},
Volume = {16},
Number = {5},
Pages = {1028-1033},
Year = {2001},
Month = {May},
ISSN = {0931-0509},
url = {http://www.ncbi.nlm.nih.gov/pubmed/11328911},
Keywords = {Antibodies, Monoclonal • Antilymphocyte Serum •
Drug Costs* • Economics • Female • Humans
• Immunosuppressive Agents • Kidney
Transplantation* • Male • Middle Aged •
Quality of Life* • Recombinant Fusion Proteins* •
Risk Factors • Survival Analysis • economics*
• therapeutic use*},
Abstract = {BACKGROUND: Immunosuppressive therapy with cyclosporin A has
substantially improved clinical outcomes for renal
transplantation. Whether basiliximab (a chimeric monoclonal
antibody) demonstrates economic and quality-of-life
advantages over other induction therapies has not yet been
shown. METHODS: A multi-centre open-label clinical trial was
conducted among renal transplant recipients in the US, in
which patients were randomized into two induction therapy
regimens: basiliximab and antithymocyte globulin (ATG) as
part of a quadruple immunosuppressive regimen. Medical
resources used and a EuroQol visual analogue scale (VAS)
rating of quality of life were collected prospectively for
the 135 dosed subjects for a period of 1 year
post-treatment. We analysed the differences between
treatment groups in 1-year costs and 1-year quality-adjusted
survival. We also conducted a post hoc analysis of outcomes
among the subgroup of patients identified as high risk.
RESULTS: A significant difference was observed in first-year
post-treatment costs (basiliximab, $45857; ATG, $54729;
difference, $8872 (95% CI, $1169 to $16573). The savings
from basiliximab can be attributed to the less expensive
induction therapy (basiliximab, $2378; ATG, $8670;
difference, $6292 (95% CI, $5165 to $7419)) and other
savings during the initial hospitalization totalling $2609.
One-year quality-adjusted survival was the same in both
groups (basiliximab, 81.5; ATG, 81.1; difference, 0.45 (95%
CI, -5.9 to 6.8)). The results of the post hoc analysis of
the 48 high-risk patients were comparable to the analysis of
all patients. CONCLUSIONS: These results demonstrate lower
first-year post-treatment costs in renal-transplant
recipients receiving basiliximab compared to ATG with no
differences in quality-adjusted survival. The results also
suggest similar differences among high-risk
subjects.},
Doi = {10.1093/ndt/16.5.1028},
Key = {fds276751}
}
@article{fds276753,
Author = {Rathore, SS and Weinfurt, KP and Gersh, BJ and Oetgen, WJ and Schulman,
KA and Solomon, AJ},
Title = {Treatment of patients with myocardial infarction who present
with a paced rhythm.},
Journal = {Ann Intern Med},
Volume = {134},
Number = {8},
Pages = {644-651},
Year = {2001},
Month = {April},
ISSN = {0003-4819},
url = {http://www.ncbi.nlm.nih.gov/pubmed/11304104},
Keywords = {Adrenergic beta-Antagonists • Aged • Aged, 80 and
over • Angioplasty, Transluminal, Percutaneous Coronary
• Aspirin • Cardiac Pacing, Artificial* •
Female • Fibrinolytic Agents • Follow-Up Studies
• Hospital Mortality • Humans • Male •
Myocardial Infarction • Proportional Hazards Models
• Regression Analysis • Retrospective Studies
• Thrombolytic Therapy • Treatment Outcome •
diagnosis* • mortality • physiopathology •
therapeutic use • therapy*},
Abstract = {BACKGROUND: A paced rhythm can mask the electrocardiographic
features of an acute myocardial infarction, complicating
timely recognition and treatment. OBJECTIVE: To evaluate
characteristics, treatment, and outcomes among patients
presenting with paced rhythms during myocardial infarction.
DESIGN: Retrospective cohort study. SETTING: U.S. acute care
hospitals. PATIENTS: 102 249 Medicare beneficiaries at least
65 years of age who were treated for acute myocardial
infarction between 1994 and 1996. MEASUREMENTS: Provision of
three treatments for acute myocardial infarction (emergent
reperfusion, aspirin, and beta-blockers), death at 30 days,
and long-term follow-up. RESULTS: 1954 patients (1.9%)
presented with paced rhythms during myocardial infarction.
These patients were older; were predominantly male; and had
higher rates of congestive heart failure, diabetes, and
previous infarction. They were significantly less likely to
receive emergent reperfusion (relative risk [RR], 0.27 [95%
CI, 0.22 to 0.33]), aspirin (RR at admission, 0.91 [CI, 0.88
to 0.94]; RR at discharge, 0.87 [CI, 0.83 to 0.92]), and
beta-blockers at admission (RR, 0.89 [CI, 0.82 to 0.96]). In
addition, there was a trend toward decreased use of
beta-blockers at discharge (RR, 0.91 [CI, 0.76 to 1.06]).
Crude mortality rates were higher among patients with paced
rhythms than among those without at 30 days (25.8% vs.
21.3%; P = 0.001) and at 1 year (47.1% vs. 36.1%; P =
0.001). Among patients with paced rhythms, risk for death at
30 days decreased after adjustment for illness severity and
decreased use of therapy (RR, 1.03 [CI, 0.93 to 1.14]).
Patients with paced rhythms remained at additional risk for
long-term mortality (hazard ratio, 1.12 [CI, 1.06 to 1.18]).
CONCLUSIONS: Patients with paced rhythms were less likely
than those without to receive treatment for acute myocardial
infarction and had poorer short- and long-term outcomes.
However, this mortality risk diminished after adjustment for
treatment. This suggests that improved recognition and
treatment of myocardial infarction may improve outcomes,
particularly in the short term.},
Doi = {10.7326/0003-4819-134-8-200104170-00009},
Key = {fds276753}
}
@article{fds276759,
Author = {Weinfurt, KP and Maghaddam, FM},
Title = {Culture and social distance: a case study of methodological
cautions.},
Journal = {J Soc Psychol},
Volume = {141},
Number = {1},
Pages = {101-110},
Year = {2001},
Month = {February},
ISSN = {0022-4545},
url = {http://www.ncbi.nlm.nih.gov/pubmed/11294145},
Keywords = {Adult • Cultural Diversity* • Emigration and
Immigration* • Ethnic Groups • Female •
Humans • Male • Personality Assessment •
Quebec • Social Distance* • psychology*},
Abstract = {The authors presented, as a case study of methodological
challenges in cross-cultural research, E. S. Bogardus's
(1925) Social Distance Scale, which requires respondents to
indicate the social distance between themselves and others.
The meaningfulness of the scale depends on the assumption
that respondents believe that the magnitude of social
distance increases as one moves through the social
categories of family member, friend, neighbor, coworker, and
citizen. The authors tested this assumption for English
Canadian, French Canadian, Jewish, Indian, Algerian, and
Greek participants, all 1st-generation immigrants in
Montreal. The participants rated their willingness to
associate with members of each of the other ethnic groups in
5 social categories. The percentage of respondents in each
sample whose data conformed to the prediction ranged from
63.7% to 98.0%, with English Canadian, French Canadian, and
Jewish respondents providing responses most consistent with
the predicted pattern. The Indian and Algerian respondents'
data were the least consistent with the predicted pattern,
especially when rating members of their own ethnic
groups.},
Language = {eng},
Doi = {10.1080/00224540109600526},
Key = {fds276759}
}
@article{fds276742,
Author = {Rathore, SS and Gersh, BJ and Berger, PB and Weinfurt, KP and Oetgen,
WJ and Schulman, KA and Solomon, AJ},
Title = {Acute myocardial infarction complicated by heart block in
the elderly: prevalence and outcomes.},
Journal = {Am Heart J},
Volume = {141},
Number = {1},
Pages = {47-54},
Year = {2001},
Month = {January},
ISSN = {0002-8703},
url = {http://www.ncbi.nlm.nih.gov/pubmed/11136486},
Keywords = {Age Factors • Aged • Female • Heart Block
• Humans • Male • Myocardial Infarction
• Prevalence • Prognosis • complications*
• epidemiology* • etiology*},
Abstract = {BACKGROUND: Although second- and third-degree heart block
(HB) are common conduction disorders associated with acute
myocardial infarction (MI), patient characteristics and HBs
association with outcomes, particularly among the elderly,
remain poorly defined. METHODS: We evaluated 106,780
Medicare beneficiaries aged 65 years and older treated for
acute MI between January 1994 and February 1996 for
development of HB. HB and non-HB patients were compared by
univariate analysis, and the influence of HB on outcomes was
evaluated by unadjusted and multiple logistic regression.
RESULTS: HB was documented in 5048 (4.7%) patients; 1646
presented with HB and 3402 developed HB during
hospitalization. HB was more common among patients with
inferior infarctions than anterior infarctions (7.3% vs
3.0%, P =.001), particularly the cohort of patients with
inferior MI treated with reperfusion therapy (8.3%). HB
patients had higher rates of in-hospital mortality (29.6%
vs. 17.5% vs. non-HB patients, P =.001). After adjustment
for demographic and clinical factors, HB remained an
independent predictor of in-hospital mortality (relative
risk [RR] 1.41, 95% confidence interval [CI] 1. 34-1.48),
but HB had no prognostic significance at 1 year among
hospital survivors (RR 0.94, 95% CI 0.88-1.01). Mortality
risks varied on the basis of MI location. Both anterior MI
(RR 1.46, 95% CI 1.30-1.63) and inferior MI (RR 1.52, 95% CI
1.39-1.66) patients with HB had increased risks of
in-hospital mortality. There was a trend toward increased
mortality among patients with anterior MI (RR 1.15, 95% CI
0.99-1.32) at 1 year, whereas those with inferior MI were at
lower risk (RR 0.83, 95% CI 0.75-0.98). CONCLUSIONS: HB is a
common complication of acute MI in elderly patients,
particularly among patients with inferior MIs who received
reperfusion therapy. HB is independently associated with
short-term but not long-term mortality.},
Doi = {10.1067/mhj.2001.111259},
Key = {fds276742}
}
@article{fds276716,
Author = {Epstein, SA and Gonzales, JJ and Weinfurt, K and Boekeloo, B and Yuan,
N and Chase, G},
Title = {Are psychiatrists' characteristics related to how they care
for depression in the medically ill? Results from a national
case-vignette survey.},
Journal = {Psychosomatics},
Volume = {42},
Number = {6},
Pages = {482-489},
Year = {2001},
ISSN = {0033-3182},
url = {http://www.ncbi.nlm.nih.gov/pubmed/11815683},
Keywords = {Adult • Antidepressive Agents • Certification
• Chronic Disease • Depressive Disorder •
Drug Utilization • Female • Humans • Male
• Middle Aged • Physician's Practice Patterns
• Psychiatry • Quality of Health Care •
Questionnaires • Specialty Boards • United States
• diagnosis* • drug therapy* • etiology
• psychology • standards • standards* •
statistics & numerical data • statistics & numerical
data* • therapeutic use},
Abstract = {The authors' goal was to examine the relationship between
psychiatrists' characteristics and their decisions regarding
depression care. A national sampling of 278 psychiatrists
answered diagnosis and treatment questions for one of four
case vignettes with depression and various degrees of
medical comorbidity. They also responded to a questionnaire
assessing practice and demographic characteristics. Tendency
to diagnose major depression was significantly associated
with being board certified, being in practice for less time,
having a greater percentage of patients with managed care,
and having a greater percentage of patients on psychotropic
medications. Tendency to recommend an antidepressant was
significantly associated with the psychiatrist being male,
being less satisfied with practice, and having a greater
percentage of patients on psychotropic medications. These
findings remained significant even after controlling for
case characteristics. Diagnostic and prescribing tendencies
of psychiatrists appear to be associated with specific
physician characteristics and not simply case
characteristics. These findings have implications for
further studies of predictors of quality of
care.},
Doi = {10.1176/appi.psy.42.6.482},
Key = {fds276716}
}
@article{fds276764,
Author = {Sheifer, SE and Rathore, SS and Gersh, BJ and Weinfurt, KP and Oetgen,
WJ and Breall, JA and Schulman, KA},
Title = {Time to presentation with acute myocardial infarction in the
elderly: associations with race, sex, and socioeconomic
characteristics.},
Journal = {Circulation},
Volume = {102},
Number = {14},
Pages = {1651-1656},
Year = {2000},
Month = {October},
ISSN = {1524-4539},
url = {http://www.ncbi.nlm.nih.gov/pubmed/11015343},
Keywords = {Acute Disease • Aged • Continental Population
Groups • Emergency Medical Services • Female
• Humans • Logistic Models • Male •
Myocardial Infarction • Risk Factors • Sex Factors
• Social Class • Time Factors • epidemiology
• genetics • physiopathology*},
Abstract = {BACKGROUND: Although prompt treatment is a cornerstone of
the management of acute myocardial infarction (AMI), prior
studies have shown that one fourth of AMI patients arrive at
the hospital >6 hours after symptom onset. It would be
valuable to identify individuals at highest risk for late
arrival, but predisposing factors have yet to be fully
characterized. METHODS AND RESULTS: Data from the
Cooperative Cardiovascular Project, involving Medicare
beneficiaries aged >65 years hospitalized between January
1994 and February 1996 with confirmed AMI, were used to
identify patients who presented "late" (>/=6 hours after
symptom onset). Patient characteristics were tested for
associations with late presentation by use of backward
stepwise logistic regression. Among 102 339 subjects, 29.4%
arrived late. Significant predictors of late arrival (odds
ratio, 95% CI) included diabetes (1.11, 1.07 to 1.14) and a
history of angina (1.32, 1.28 to 1.35), whereas prior MI
(0.82, 0.79 to 0.85), prior angioplasty (0.80, 0.75 to
0.85), prior bypass surgery (0.93, 0.89 to 0.98), and
cardiac arrest (0.52, 0.46 to 0. 58) predicted early
presentation. Additionally, initial evaluation at an
outpatient clinic (2.63, 2.51 to 2.75) and daytime
presentation (1.67, 1.59 to 1.72) predicted late arrival.
Finally, female sex, black race, and poverty, which were
evaluated with an 8-level race-sex-socioeconomic status
interaction term, were also risk factors for delay.
CONCLUSIONS: Delayed hospital presentation is a common
problem among Medicare beneficiaries with AMI. Factors
associated with delay include not only clinical and
logistical issues but also race, sex, and socioeconomic
characteristics. Education efforts designed to hasten AMI
treatment should be directed at individuals with risk
factors for late arrival.},
Doi = {10.1161/01.cir.102.14.1651},
Key = {fds276764}
}
@article{fds276767,
Author = {Rathore, SS and Berger, AK and Weinfurt, KP and Feinleib, M and Oetgen,
WJ and Gersh, BJ and Schulman, KA},
Title = {Race, sex, poverty, and the medical treatment of acute
myocardial infarction in the elderly.},
Journal = {Circulation},
Volume = {102},
Number = {6},
Pages = {642-648},
Year = {2000},
Month = {August},
ISSN = {1524-4539},
url = {http://www.ncbi.nlm.nih.gov/pubmed/10931804},
Keywords = {African Americans* • Aged • Aged, 80 and over
• European Continental Ancestry Group* • Female
• Health Services Misuse* • Humans • Male
• Myocardial Infarction • Poverty* • Sex
Factors* • ethnology • therapy*},
Abstract = {BACKGROUND: Race, sex, and poverty are associated with the
use of diagnostic cardiac catheterization and coronary
revascularization during treatment of acute myocardial
infarction (AMI). However, the association of
sociodemographic characteristics with the use of less
costly, more readily available medical therapies remains
poorly characterized. METHODS AND RESULTS: We evaluated 169
079 Medicare beneficiaries >/=65 years of age treated for
AMI between January 1994 and February 1996 to determine the
association of patient race, sex, and poverty with the use
of medical therapy. Multivariable regression models were
constructed to evaluate the unadjusted and adjusted
influence of sociodemographic characteristics on the use of
2 admission (aspirin, reperfusion) and 2 discharge therapies
(aspirin, beta-blockers) indicated during the treatment of
AMI. Therapy use varied by patient race, sex, and poverty
status. Black patients were less likely to undergo
reperfusion (RR 0.84, 95% CI 0. 78, 0.91) or receive aspirin
on admission (RR 0.97, 95% CI 0.96, 0. 99) and beta-blockers
(RR 0.94, 95% CI 0.88, 1.00) at discharge. Female patients
were less likely to receive aspirin on admission (RR 0.98,
95% CI 0.97, 0.99) and discharge (RR 0.98, 95% CI 0.96,
0.99). Poor patients were less likely to receive aspirin (RR
0.97, 95% CI 0. 96, 0.98) or reperfusion (RR 0.97, 95% CI
0.93, 1.00) on admission and aspirin (RR 0.98, 95% CI 0.96,
1.00), or beta-blockers (RR 0.95, 95% CI 0.91, 0.99) on
discharge. CONCLUSIONS: Medical therapies are currently
underused in the treatment of black, female, and poor
patients with AMI.},
Doi = {10.1161/01.cir.102.6.642},
Key = {fds276767}
}
@article{fds276758,
Author = {Rathore, SS and Lenert, LA and Weinfurt, KP and Tinoco, A and Taleghani,
CK and Harless, W and Schulman, KA},
Title = {The effects of patient sex and race on medical students'
ratings of quality of life.},
Journal = {Am J Med},
Volume = {108},
Number = {7},
Pages = {561-566},
Year = {2000},
Month = {May},
ISSN = {0002-9343},
url = {http://www.ncbi.nlm.nih.gov/pubmed/10806285},
Keywords = {Adult • African Continental Ancestry Group* •
Analysis of Variance • European Continental Ancestry
Group* • Female • Health Status* • Humans
• Male • Quality of Life* • Questionnaires
• Sex Factors* • Students, Medical • United
States • statistics & numerical data*},
Abstract = {PURPOSE: Although previous studies have examined race and
sex differences in health care, few studies have
investigated the possible role of physician bias. We
evaluated the influence of race and sex on medical students'
perceptions of patients' symptoms to determine if there are
differences in these perceptions early in medical training.
SUBJECTS AND METHODS: One-hundred sixty-four medical
students were randomly assigned to view a video of a black
female or white male actor portraying patients with
identical symptoms of angina. We evaluated students'
perceptions of the actors' health state (based on their
assessment of quality of life) using a visual analog scale
and a standard rating technique, as well as the type of
chest pain diagnosis. RESULTS: Students assigned a lower
value (indicating a less desirable health state) to the
black woman than to the white man with identical symptoms
[visual scale (mean +/- SD): 72 +/- 13 vs 67 +/- 12, P
<0.02; standard gamble: 87 +/- 10 vs 80 +/- 15, P < 0.001).
Nonminority students reported higher mean values for the
white male patient (standard gamble: 89 +/- 8 vs 81 +/- 14
for the black female patient), whereas minority students'
assessments did not differ by patient. Male students
assigned a slightly lower value to the black female patient
(standard gamble: 76 +/- 16 vs 87 +/- 10 for the white male
patient). Students were less likely to characterize the
black female patient's symptoms as angina (46% vs 74% for
the white male patient, P = 0.001). CONCLUSIONS: The way
that medical students perceive patient symptoms appears to
be affected by nonmedical factors.},
Doi = {10.1016/s0002-9343(00)00352-1},
Key = {fds276758}
}
@article{fds276750,
Author = {Sheifer, SE and Canos, MR and Weinfurt, KP and Arora, UK and Mendelsohn,
FO and Gersh, BJ and Weissman, NJ},
Title = {Sex differences in coronary artery size assessed by
intravascular ultrasound.},
Journal = {Am Heart J},
Volume = {139},
Number = {4},
Pages = {649-653},
Year = {2000},
Month = {April},
ISSN = {0002-8703},
url = {http://www.ncbi.nlm.nih.gov/pubmed/10740147},
Keywords = {Adult • Aged • Coronary Arteriosclerosis •
Coronary Vessels • Female • Humans •
Hypertension • Male • Middle Aged • Prognosis
• Reference Values • Regression Analysis •
Sex Characteristics* • Ultrasonography, Interventional*
• ultrasonography • ultrasonography*},
Abstract = {BACKGROUND: Women have worse outcomes after myocardial
infarction and coronary revascularization. The explanations
are likely multifactorial but may include smaller coronary
artery size. Smaller luminal diameter has been confirmed
angiographically; however, because of possible confounding
effects of coronary remodeling, angiographically silent
atherosclerosis, and body size, it is unclear if there is a
true sex influence on arterial size. METHODS: We performed
intravascular ultrasound on left main (LM) and proximal left
anterior descending (LAD) coronary artery segments that were
free of significant atherosclerosis in 50 men and 25 women.
Arterial and luminal areas were measured by planimetry and
corrected for body surface area. We evaluated associations
between sex and coronary dimensions with univariate and then
multiple linear regression analyses. RESULTS: Mean
uncorrected LM and LAD arterial areas were smaller in women
than in men (21.53 vs 26.95 mm(2), P <.001, and 14. 68 vs
19.94 mm(2), P =.002, respectively), as were mean LM and LAD
luminal areas (15.94 vs 18.79 mm(2), P =.020, and 10.13 vs
12.71 mm(2), P =.036, respectively). In multivariate models
accounting for body surface area and controlling for other
factors, sex independently predicted corrected LM and LAD
arterial area. In analyses that additionally controlled for
plaque area, sex independently predicted corrected LAD
luminal area. CONCLUSIONS: LM and LAD arteries are smaller
in women, independent of body size. This suggests an
intrinsic sex effect on coronary dimensions. Future studies
should investigate underlying mechanisms because they may
lead to novel therapeutic strategies and improved outcomes
for women with coronary artery disease.},
Doi = {10.1016/s0002-8703(00)90043-7},
Key = {fds276750}
}
@article{fds276755,
Author = {Weinfurt, KP and Willke, RJ and Glick, HA and Freimuth, WW and Schulman,
KA},
Title = {Relationship between CD4 count, viral burden, and quality of
life over time in HIV-1-infected patients.},
Journal = {Med Care},
Volume = {38},
Number = {4},
Pages = {404-410},
Year = {2000},
Month = {April},
ISSN = {0025-7079},
url = {http://www.ncbi.nlm.nih.gov/pubmed/10752972},
Keywords = {Adult • Aged • Anti-HIV Agents • CD4
Lymphocyte Count* • Delavirdine • Didanosine
• Double-Blind Method • Drug Therapy, Combination
• Female • HIV Infections • HIV-1* •
Health Status Indicators • Humans • Male •
Middle Aged • Quality of Life* • RNA, Viral •
Viral Load* • blood • diagnosis* • drug
therapy • psychology • therapeutic
use},
Abstract = {BACKGROUND: Although surrogate markers such as CD4 counts
and viral burden (HIV-1 RNA) are predictive of AIDS-related
disease progression, little is known about the relationship
between changes in surrogate markers and health-related
quality of life (HRQOL) outcomes. This study investigated
how changes in CD4/mm3 and viral burden (RNA copies/mL) are
related to changes in HRQOL as indexed by the Medical
Outcomes Study HIV Health Survey (MOS-HIV-30). METHODS:
Subjects were HIV-1-infected patients with CD4 counts
<300/mm3 enrolled in a double-blind, randomized clinical
trial of delavirdine. As part of the clinical protocol,
patients completed the MOS-HIV-30, from which the Physical
Health (PHS) and Mental Health (MHS) summary scores were
used for analyses. HRQOL and surrogate marker data assessed
up to 2 years after randomization were analyzed for a total
of 1,112 patients. RESULTS: Individual patients' initial
status (intercepts) and rates of change (slopes) over time
for log CD4, log RNA, PHS, and MHS were estimated with the
use of empirical Bayes. Early response to treatment
correlated with HRQOL better for RNA than for CD4. However,
the relationship between weekly change and HRQOL was
stronger for CD4 than for RNA. CONCLUSIONS: Surrogate
markers are significantly associated with HRQOL outcomes.
Improvements in HRQOL over time are associated with lower
initial viral load and with increases in CD4 counts.
Limitations concerning the restricted variability of the
change scores are addressed.},
Language = {eng},
Doi = {10.1097/00005650-200004000-00007},
Key = {fds276755}
}
@article{fds276745,
Author = {Rathore, SS and Berger, AK and Weinfurt, KP and Schulman, KA and Oetgen,
WJ and Gersh, BJ and Solomon, AJ},
Title = {Acute myocardial infarction complicated by atrial
fibrillation in the elderly: prevalence and
outcomes.},
Journal = {Circulation},
Volume = {101},
Number = {9},
Pages = {969-974},
Year = {2000},
Month = {March},
ISSN = {1524-4539},
url = {http://www.ncbi.nlm.nih.gov/pubmed/10704162},
Keywords = {Aged • Aged, 80 and over • Atrial Fibrillation
• Cohort Studies • Female • Hospital
Mortality • Hospitalization • Humans • Male
• Myocardial Infarction • Myocardial
Revascularization • Prevalence • Prognosis •
Regression Analysis • Survival Analysis •
complications* • epidemiology • etiology* •
mortality • surgery},
Abstract = {BACKGROUND: Although atrial fibrillation (AF) is a common
complication of acute myocardial infarction (MI), patient
characteristics and association with outcomes remain poorly
defined in the elderly. METHODS AND RESULTS: We evaluated
106 780 Medicare beneficiaries > or =65 years of age from
the Cooperative Cardiovascular Project treated for acute MI
between January 1994 and February 1996 to determine the
prevalence and prognostic significance of AF complicating
acute MI in elderly patients. Patients were categorized on
the basis of the presence of AF, and those with AF were
further subdivided by time of AF (present on arrival versus
developing during hospitalization). AF and non-AF patients
were compared by univariate analysis, and logistic
regression modeling was used to identify clinical predictors
of AF. The influence of AF on outcomes was evaluated by
unadjusted Kaplan-Meier survival curves and logistic
regression models. AF was documented in 23 565 patients (22.
1%): 11 510 presented with AF and 12,055 developed AF during
hospitalization. AF patients were older, had more advanced
heart failure, and were more likely to have had a prior MI
and undergone coronary revascularization. AF patients had
poorer outcomes, including higher in-hospital (25.3% versus
16.0%), 30-day (29.3% versus 19.1%), and 1-year (48.3%
versus 32.7%) mortality. AF remained an independent
predictor of in-hospital (odds ratio [OR], 1. 21), 30-day
(OR, 1.20), and 1-year (OR, 1.34) mortality after
multivariate adjustment. Patients developing AF during
hospitalization had a worse prognosis than patients who
presented with AF. CONCLUSIONS: AF is a common complication
of acute MI in elderly patients and independently influences
mortality, particularly when it develops during
hospitalization.},
Doi = {10.1161/01.cir.101.9.969},
Key = {fds276745}
}
@article{fds276733,
Author = {Freeman, VG and Rathore, SS and Weinfurt, KP and Schulman, KA and Sulmasy, DP},
Title = {Lying for patients: physician deception of third-party
payers.},
Journal = {Arch Intern Med},
Volume = {159},
Number = {19},
Pages = {2263-2270},
Year = {1999},
Month = {October},
ISSN = {0003-9926},
url = {http://www.ncbi.nlm.nih.gov/pubmed/10547165},
Keywords = {Empirical Approach • Health Care and Public
Health},
Abstract = {BACKGROUND: Some physicians may resort to deception to
secure third-party payer approval for patient procedures.
Related physician attitudes, including willingness to use
deception, are not well understood. OBJECTIVE: To determine
physician willingness to deceive a third-party payer and
physician attitudes toward deception of third-party payers.
METHODS: A cross-sectional mailed survey was used to
evaluate physician willingness to use deception in 6
vignettes of varying clinical severity: coronary bypass
surgery, arterial revascularization, intravenous pain
medication and nutrition, screening mammography, emergent
psychiatric referral, and cosmetic rhinoplasty. We evaluated
169 board-certified internists randomly selected from 4
high- and 4 low-managed care penetration metropolitan
markets nationwide for willingness to use deception in each
vignette. RESULTS: Physicians were willing to use deception
in the coronary bypass surgery (57.7%), arterial
revascularization (56.2%), intravenous pain medication and
nutrition (47.5%), screening mammography (34.8%), and
emergent psychiatric referral (32.1%) vignettes. There was
little willingness to use deception for cosmetic rhinoplasty
(2.5%). Rates were highest for physicians practicing in
predominantly managed care markets, for clinically severe
vignettes, and for physicians spending less time in clinical
practice. Physician ratings of the justifiability of
deception varied by perspective and vignette. CONCLUSIONS:
Many physicians sanction the use of deception to secure
third-party payers' approval of medically indicated care.
Such deception may reflect a tension between the traditional
ethic of patient advocacy and the new ethic of cost control
that restricts patient and physician choice in the use of
limited resources.},
Doi = {10.1001/archinte.159.19.2263},
Key = {fds276733}
}
@article{fds276717,
Author = {Goodman, LA and Thompson, KM and Weinfurt, K and Corl, S and Acker, P and Mueser, KT and Rosenberg, SD},
Title = {Reliability of reports of violent victimization and
posttraumatic stress disorder among men and women with
serious mental illness.},
Journal = {J Trauma Stress},
Volume = {12},
Number = {4},
Pages = {587-599},
Year = {1999},
Month = {October},
ISSN = {0894-9867},
url = {http://www.ncbi.nlm.nih.gov/pubmed/10646178},
Keywords = {Adolescent • Adult • Child Abuse, Sexual •
Chronic Disease • Crime Victims • Female •
Humans • Life Change Events • Male • Mental
Disorders • Pilot Projects • Prevalence •
Questionnaires • Reproducibility of Results • Self
Assessment (Psychology) • Severity of Illness Index
• Stress Disorders, Post-Traumatic • Violence
• diagnosis • diagnosis* • epidemiology
• etiology* • psychology • psychology* •
statistics & numerical data},
Abstract = {Although violent victimization is highly prevalent among men
and women with serious mental illness (SMI; e.g.,
schizophrenia, bipolar disorder), future research in this
area may be impeded by controversy concerning the ability of
individuals with SMI to report traumatic events reliably.
This article presents the results of a study exploring the
temporal consistency of reports of childhood sexual abuse,
adult sexual abuse, and adult physical abuse, as well as
current symptoms of posttraumatic stress disorder (PTSD)
among 50 people with SMI. Results show that trauma history
and PTSD assessments can, for the most part, yield reliable
information essential to further research in this area. The
study also demonstrates the importance of using a variety of
statistical methods to assess the reliability of
self-reports of trauma history.},
Doi = {10.1023/A:1024708916143},
Key = {fds276717}
}
@article{fds276752,
Author = {Weinfurt, KP and Rathore, SS and Schulman, KA},
Title = {ACI-TIPI clinical trial. Acute cardiac ischemia
time-insensitive predictive instrument.},
Journal = {Ann Intern Med},
Volume = {131},
Number = {6},
Pages = {476-477},
Year = {1999},
Month = {September},
ISSN = {0003-4819},
url = {http://www.ncbi.nlm.nih.gov/pubmed/10498573},
Keywords = {Chest Pain • Diagnosis, Computer-Assisted* •
Electrocardiography* • Humans • Myocardial
Ischemia • Safety • adverse effects •
diagnosis* • etiology},
Language = {eng},
Doi = {10.7326/0003-4819-131-6-199909210-00023},
Key = {fds276752}
}
@article{fds331319,
Author = {Cai, L and Weinfurt, KP},
Title = {Computer Program Exchange: An SAS/IML Module for the
Johnson-Neyman Procedure},
Journal = {Applied Psychological Measurement},
Volume = {23},
Number = {4},
Pages = {308},
Publisher = {SAGE Publications},
Year = {1999},
Month = {January},
url = {http://dx.doi.org/10.1177/01466216990234008},
Doi = {10.1177/01466216990234008},
Key = {fds331319}
}
@article{fds276726,
Author = {Weinfurt, KP and Willke, R and Glick, HA and Schulman,
KA},
Title = {Towards a composite scoring solution for the Neurobehavioral
Functioning Inventory.},
Journal = {Qual Life Res},
Volume = {8},
Number = {1-2},
Pages = {17-24},
Year = {1999},
ISSN = {0962-9343},
url = {http://www.ncbi.nlm.nih.gov/pubmed/10457735},
Keywords = {Activities of Daily Living • Adult • Aggression
• Analysis of Variance • Craniocerebral Trauma
• Factor Analysis, Statistical • Female •
Health Status* • Humans • Male • Mental
Health • Neuropsychological Tests • Quality of
Life* • Questionnaires • Reproducibility of
Results • Severity of Illness Index •
physiopathology • psychology • psychology* •
standards*},
Abstract = {Little research has been conducted towards the development
and evaluation of a measure of quality of life specific to
head/brain injury populations. Accordingly, we examined
responses to the Neurobehavioral Functioning Inventory in
the context of a clinical trial for head injury patients (n
= 655) conducted in 14 countries. To reduce the 66 item
scale into a smaller number of composite scales, principal
components analysis was conducted. Scales were constructed
assessing four categories of symptoms: cognitive deficits,
depression, aggression and somatization. The internal
reliabilities (alpha coefficient) of the four scales were
generally acceptable (range = 0.79-0.92). Scores on all four
scales correlated significantly with patient-rated overall
quality of life and all but the aggression scale correlated
significantly with overall clinical severity. The need for
more formal evaluation of this and other disease-specific
measures is discussed.},
Language = {eng},
Doi = {10.1023/a:1026411129270},
Key = {fds276726}
}
@article{fds276661,
Author = {Ostrander, R and Weinfurt, KP and Nay, WR},
Title = {The role of age, family support, and negative cognitions in
the prediction of depressive symptoms},
Journal = {School Psychology Review},
Volume = {27},
Number = {1},
Pages = {121-137},
Year = {1998},
Month = {December},
Abstract = {Cognitive diathesis-stress models of depression suggest that
children with a cognitive vulnerability are more likely to
be depressed when confronted with developmentally salient
sources of stress. The current study examined developmental
changes in the relationship between negative cognitions
(cognitive errors) and stressful family characteristics
(unsupportive family) in the prediction of depression in
young people. Participants (N = 102) were between 7 and 18
years of age and included both outpatient clinic and
school-based samples. Hierarchical regression analysis
demonstrated a significant 3-way interaction between age,
negative cognitions, and family unsupportiveness. With
younger children, either higher levels of negative
cognitions or a highly unsupportive family were sufficient
to predict increases in depression. During the transition
between late childhood and early adolescence, negative
cognitions and an unsupportive family contributed in an
additive fashion to increases in depression. The
diathesis-stress model was manifested only in late
adolescence with greater family unsupportiveness predicting
higher levels of depression most for those adolescents high
in negative cognitions. Results are discussed as they relate
to developmental changes in self-concept, cognitions, and
the salience of the family.},
Key = {fds276661}
}
@article{fds276739,
Author = {Ostrander, R and Weinfurt, KP and Yarnold, PR and August,
GJ},
Title = {Diagnosing attention deficit disorders with the Behavioral
Assessment System for Children and the Child Behavior
Checklist: test and construct validity analyses using
optimal discriminant classification trees.},
Journal = {J Consult Clin Psychol},
Volume = {66},
Number = {4},
Pages = {660-672},
Year = {1998},
Month = {August},
ISSN = {0022-006X},
url = {http://www.ncbi.nlm.nih.gov/pubmed/9735584},
Keywords = {Attention Deficit Disorder with Hyperactivity •
Behavioral Symptoms • Case-Control Studies • Child
• Discriminant Analysis • Female • Humans
• Male • Models, Psychological • Psychiatric
Status Rating Scales • Psychometrics •
Reproducibility of Results • Sampling Studies •
Sensitivity and Specificity • classification* •
diagnosis* • standards*},
Abstract = {The usefulness of the Behavioral Assessment System for
Children (BASC) and Child Behavior Checklist (CBCL) Parent
scales was examined with respect to (a) differentiating
students with attention deficit-hyperactivity disorder
(ADHD) from non-ADHD students and (b) discriminating between
the predominantly inattentive-type and combined-type
ADHD-afflicted students. For both the BASC and the CBCL, a
different optimal discriminant classification tree analysis
(CTA) model was developed for each of the 2 diagnostic
predictions. For distinguishing ADHD students from non-ADHD
students, the BASC model was more parsimonious and accurate
than the CBCL model. Toward the goal of differentiating
between primarily inattentive and combined types, the CBCL's
model was superior for predicting primarily inattentive
students. The results demonstrate the diagnostic utility of
the BASC and CBCL and describe salient behavioral dimensions
associated with subtypes of ADHD.},
Doi = {10.1037/0022-006X.66.4.660},
Key = {fds276739}
}
@article{fds276712,
Author = {Crystal, DS and Watanabe, H and Weinfurt, K and Wu,
C},
Title = {Concepts of human differences: a comparison of American,
Japanese, and Chinese children and adolescents.},
Journal = {Dev Psychol},
Volume = {34},
Number = {4},
Pages = {714-722},
Year = {1998},
Month = {July},
ISSN = {0012-1649},
url = {http://www.ncbi.nlm.nih.gov/pubmed/9681263},
Keywords = {Adolescent • Child • China • Cultural
Characteristics* • Female • Human Body* •
Humans • Japan • Male • Perception •
Self Concept* • United States},
Abstract = {Concepts of human differences were studied among 5th and
11th graders in the United States (n = 175), Japan (n =
256), and the People's Republic of China (n = 160). Relative
to their peers in the other 2 cultures, more American
students noted differences in appearance and attractiveness
and material resources; more Japanese students noted various
physical features, and more Chinese students noted specific
behaviors. On the whole, Japanese responses resembled those
of the American students more closely than those of the
Chinese students. With increasing age, American students
reported a larger number, whereas Asian students tended to
report a smaller number of distinct categories of human
differences. Results are discussed in terms of cultural
construals of self and theories of cognitive
development.},
Doi = {10.1037//0012-1649.34.4.714},
Key = {fds276712}
}
@article{fds276662,
Author = {Cai, L and Weinfurt, KP},
Title = {Computer program exchange SAS/IML modules for producing
bootstrapped significance levels},
Journal = {Applied Psychological Measurement},
Volume = {22},
Number = {4},
Pages = {394},
Publisher = {SAGE Publications},
Year = {1998},
Month = {January},
url = {http://dx.doi.org/10.1177/014662169802200412},
Doi = {10.1177/014662169802200412},
Key = {fds276662}
}
@article{fds276715,
Author = {Swain, SM and Rowland, J and Weinfurt, K and Berg, C and Lippman, ME and Walton, L and Egan, E and King, D and Spertus, I and Honig,
SF},
Title = {Intensive outpatient adjuvant therapy for breast cancer:
results of dose escalation and quality of
life.},
Journal = {J Clin Oncol},
Volume = {14},
Number = {5},
Pages = {1565-1572},
Year = {1996},
Month = {May},
ISSN = {0732-183X},
url = {http://www.ncbi.nlm.nih.gov/pubmed/8622073},
Keywords = {Adult • Ambulatory Care • Antineoplastic Agents
• Breast Neoplasms • Chemotherapy, Adjuvant •
Cyclophosphamide • Dose-Response Relationship, Drug
• Doxorubicin • Feasibility Studies • Female
• Granulocyte Colony-Stimulating Factor • Humans
• Middle Aged • Pilot Projects • Quality of
Life* • administration & dosage • adverse effects
• adverse effects* • drug therapy* •
psychology • therapeutic use*},
Abstract = {PURPOSE: A dose-escalation study was conducted to determine
the maximum-tolerated dose (MTD) and dose-limiting
toxicities (DLTs) of cyclophosphamide (CY) in combination
with granulocyte colony-stimulating factor (G-CSF0 and
doxorubicin (DOX) given every 2 weeks for eight cycles as
outpatient adjuvant therapy for node-positive breast cancer.
A pilot study to assess quality of life (QOL) was performed.
PATIENTS AND METHODS: From March 1991 to April 1993, 19
patients were entered. Patients received escalating doses of
CY intravenously (i.v.) (1,000 mg/m2, 1,500 mg/m2, 2,000
mg/m2, or 2,500 mg/m2) with DOX 40 mg/m2, G-CSF 10
micrograms/kg/d on days 2 to 12, and mesna, every 2 weeks
for eight cycles. QOL was measured by the Profile of Mood
States (POMS), the Psychosocial Adjustment to Illness
Scale-Self Report (PAIS-SR), and a 27-item QOL scale.
RESULTS: The CY dose of 2,500 mg/m2 every 2 weeks elicited
toxicities that required dose reductions secondary to a
combination of thrombocytopenia, hematuria, and anemia that
required transfusion. The dose of 2,000 mg/m2 resulted in an
acceptable toxicity profile. Ninety-two percent of cycles at
the 2,000-mg/m2 dose were delivered on schedule and 77%
without hospitalization. QOL assessments indicated high
levels of distress measured by POMS in 47%, poor overall
quality of life in 40%, and significant problems with
physical symptoms in less than 27% of all patients for any
given cycle. CONCLUSION: A dose of CY at 2,000 mg/m2 can be
administered every 2 weeks with DOX and G-CSF for eight
cycles in the outpatient setting with manageable toxicity.
The majority of women described levels of physical symptoms
and emotional distress as tolerable during
treatment.},
Doi = {10.1200/JCO.1996.14.5.1565},
Key = {fds276715}
}
@article{fds276760,
Author = {Weinfurt, KP and Bush, PJ},
Title = {Contradictory subject response in longitudinal
research.},
Journal = {J Stud Alcohol},
Volume = {57},
Number = {3},
Pages = {273-282},
Year = {1996},
Month = {May},
ISSN = {0096-882X},
url = {http://www.ncbi.nlm.nih.gov/pubmed/8709586},
Keywords = {Cannabis* • Child • Humans • Longitudinal
Studies • Research • Substance-Related
Disorders*},
Abstract = {OBJECTIVE: This study investigated the prevalence of logical
and estimation errors in a 4-year longitudinal survey of
substance abuse for elementary and junior high school
students. Logical errors occur when a subject reports having
used a substance on one measurement occasion, but reports
never having used the substance on a second measurement
occasion. Estimation errors occur when a subject reports a
lifetime frequency of use on a later survey that is less
than the lifetime frequency of use reported for an earlier
survey. METHOD: Substance abuse surveys were completed every
year for four years by predominantly black District of
Columbia students, beginning when the students were in
4th/5th grade, and ending when they were in 7th/8th grade.
(Ns ranged from 5,671 to 6,421). Errors for alcohol,
cigarette and marijuana use were calculated for every pair
of years. Background characteristics such as demographic and
academic performance variables were also assessed for each
of the four years. RESULTS: Logical errors decreased for all
substances as student got older, whereas estimation errors
remained stable. Marijuana had the highest frequency of
logical errors in every pair of years except one, and had
the lowest frequency of estimation errors. Students who made
errors in Years 1-2 were 1.64 times more likely to make
errors again in Years 3-4. For some of the years, students
who made any kind of error had lower school grades, were
judged untrustworthy by their peers and were more likely to
be males. CONCLUSIONS: The alarming prevalence of errors
should be considered when conducting longitudinal substance
abuse research. Several methods of dealing with these errors
are reviewed. In most cases, the best a researcher can do is
assess the error rates and report them.},
Language = {eng},
Doi = {10.15288/jsa.1996.57.273},
Key = {fds276760}
}
@article{fds331320,
Author = {Weinfurt, KP},
Title = {A SAS Macro for Producing SAS t Test Output When Raw Data
are Not Available},
Journal = {Applied Psychological Measurement},
Volume = {20},
Number = {1},
Pages = {99},
Publisher = {SAGE Publications},
Year = {1996},
Month = {January},
url = {http://dx.doi.org/10.1177/014662169602000109},
Doi = {10.1177/014662169602000109},
Key = {fds331320}
}
@article{fds331321,
Author = {Weinfurt, KP},
Title = {A SAS Macro for Calculating Positive Predictive Values
Across a Range of Base Rates},
Journal = {Applied Psychological Measurement},
Volume = {20},
Number = {1},
Pages = {100},
Publisher = {SAGE Publications},
Year = {1996},
Month = {January},
url = {http://dx.doi.org/10.1177/014662169602000110},
Doi = {10.1177/014662169602000110},
Key = {fds331321}
}
@article{fds276718,
Author = {Epstein, SA and Gonzales, JJ and Onge, JS and Carter-Campbell, J and Weinfurt, K and Leibole, M and Goldberg, RL},
Title = {Practice patterns in the diagnosis and treatment of anxiety
and depression in the medically ill. A survey of
psychiatrists.},
Journal = {Psychosomatics},
Volume = {37},
Number = {4},
Pages = {356-367},
Year = {1996},
ISSN = {0033-3182},
url = {http://www.ncbi.nlm.nih.gov/pubmed/8701014},
Keywords = {Adult • Anxiety Disorders • Cohort Studies •
Community Psychiatry • Data Collection •
Depressive Disorder • Female • Humans • Male
• Middle Aged • Physician's Practice Patterns*
• Referral and Consultation* • diagnosis* •
manpower • therapy*},
Abstract = {By use of a survey that assessed practice patterns and
responses to case vignettes of anxiety and depression in the
medically ill, 38 psychiatrists were compared with 10
national leaders in consultation-liaison psychiatry. On the
case vignettes, percentage agreement with the experts varied
significantly by case and by question. Fifty-eight percent
of the time the psychiatrists agreed with the experts on
whether to order laboratory tests as compared with an 81%
agreement level on whether to use psychotherapy. Multiple
regression analysis revealed that the best model to predict
lower agreement with the experts was years in practice plus
percentage of time spent in solo (vs. group) practice (r2 =
0.40). This study extended previous data-based
pharmacoepidemiology by assessing multiple aspects of
psychiatrists' practice patterns. Psychiatrists who are more
distant from training years and more isolated from the
current stimulation of colleagues may be particularly
appropriate targets for continuing education.},
Doi = {10.1016/S0033-3182(96)71549-9},
Key = {fds276718}
}
@article{fds276731,
Author = {Iannotti, RJ and Bush, PJ and Weinfurt, KP},
Title = {Perception of friends' use of alcohol, cigarettes, and
marijuana among urban schoolchildren: a longitudinal
analysis.},
Journal = {Addict Behav},
Volume = {21},
Number = {5},
Pages = {615-632},
Year = {1996},
ISSN = {0306-4603},
url = {http://www.ncbi.nlm.nih.gov/pubmed/8876761},
Keywords = {African Americans • Age Factors • Alcohol Drinking
• Chi-Square Distribution • Child •
Cross-Sectional Studies • Family Health • Female
• Humans • Likelihood Functions •
Longitudinal Studies • Male • Marijuana Smoking
• Models, Psychological • Multivariate Analysis
• Odds Ratio • Peer Group* • Regression
Analysis • Sampling Studies • Smoking •
Social Control, Informal* • Social Perception* •
Substance-Related Disorders • Urban Health •
epidemiology • epidemiology* • etiology •
psychology • statistics & numerical
data*},
Abstract = {Relations between adolescents' substance use and perceptions
of their friends' substance use were examined
cross-sectionally and longitudinally in a predominantly
African-American school district. Fourth- and fifth-grade
students were surveyed and tracked for 4 consecutive years.
Cross-sectional samples included 3,073, 5,955, 7,701, and
6,616 students in years 1 to 4, respectively; the
longitudinal sample included 1,802 students surveyed in
every year. Self-reported substance use of friends and
classmates also was assessed. Perceived friends' substance
use had a stronger association with prior substance use than
friends' self-reported substance use in every year.
Perceived family use and classmates' self-reported use also
made independent contributions to regression models.
Longitudinal structural equation analyses indicated that
perceived friends' use is more likely to be a product of an
adolescent's previous substance use than a precursor of
subsequent substance use. The findings contradict prevailing
theories on the influence of peers on substance
use.},
Doi = {10.1016/0306-4603(95)00086-0},
Key = {fds276731}
}
@article{fds323349,
Author = {Weinfurt, KP and Bush, PJ},
Title = {Peer Assessment of Early Adolescents Solicited to
Participate in Drug Trafficking: A Longitudinal
Analysis},
Journal = {Journal of Applied Social Psychology},
Volume = {25},
Number = {24},
Pages = {2141-2157},
Publisher = {WILEY},
Year = {1995},
Month = {January},
url = {http://dx.doi.org/10.1111/j.1559-1816.1995.tb01830.x},
Abstract = {This study examined differences in peer‐ascribed
sociometric ratings of preadolescent and adolescent students
who were, versus who were not, solicited to help someone
sell crack cocaine 1 year later. The sample consisted of 3,
838 predominantly Black, urban public‐school students in
6th/7th grade. In the first year, students rated their
classmates on 16 psychosocial descriptors; in the next year,
students self‐reported their involvement in cocaine
trafficking. Discriminant analyses performed separately for
males and females indicated that solicited and unsolicited
students differed significantly on the 16 sociometric items.
Solicited students were more likely to be rated as not
friendly, not shy, restless, untrustworthy, disliked by
teachers, and not liking school. In addition, solicited male
students were judged to be good at sports, liked by
classmates, and were not picked on by others. The salience
of particular items differed between genders. A longitudinal
prediction model correctly predicted 61.88% and 64.30% of
male and female students, respectively. However, sensitivity
for solicited students was less for females (55.28%) than
males (61.20%). Copyright © 1995, Wiley Blackwell. All
rights reserved},
Doi = {10.1111/j.1559-1816.1995.tb01830.x},
Key = {fds323349}
}
@article{fds331324,
Author = {Weinfurt, KP and Bryant, FB and Yarnold, PR},
Title = {The Factor Structure of the Affect Intensity Measure: In
Search of a Measurement Model},
Journal = {Journal of Research in Personality},
Volume = {28},
Number = {3},
Pages = {314-331},
Publisher = {Elsevier BV},
Year = {1994},
Month = {September},
url = {http://dx.doi.org/10.1006/jrpe.1994.1023},
Abstract = {Larsen (1984) developed the Affect Intensity Measure (AIM)
as a putative measure of a unidimensional construct referred
to as affect intensity, or the characteristic strength with
which people experience emotions. Using a sample of 673
college undergraduates (409 females, 264 males), the
one-factor model was found to be untenable as an explanation
for subjects′ responses to the AIM. Based on exploratory
principal components analysis, confirmatory analysis
unveiled an oblique four-factor model (Positive Affectivity,
Negative Intensity, Serenity, Negative Reactivity) that
achieved only mediocre goodness of fit. Further attempts to
find a better fitting model were futile. The common practice
of scoring the AIM using the one-factor model emphasizes
known external validity over conceptual clarity; future use
of the four-factor model, for which external validity is
unknown, would emphasize conceptual precision. Future
research should aim toward developing a better conceptual
framework for understanding the nature of affective
experience. © 1994 Academic Press. All rights
reserved.},
Doi = {10.1006/jrpe.1994.1023},
Key = {fds331324}
}
@article{fds276659,
Author = {Weinfurt, KP},
Title = {Some uncertainty regarding uncertainty reduction},
Journal = {Journal of Theoretical and Philosophical
Psychology},
Volume = {14},
Number = {2},
Pages = {193-199},
Publisher = {American Psychological Association (APA)},
Year = {1994},
Month = {January},
ISSN = {1068-8471},
url = {http://dx.doi.org/10.1037/h0091362},
Abstract = {Tryon (1991a) has proposed the definition of a scientific
explanation as an explanation that reduces uncertainty, and
relates this to the reduction of statistical variance.
Lamiell (1991) criticizes Tryon on several grounds, arguing
that the reduction of criterion variance does not yield
knowledge of the sort Tryon desires. This paper comments on
Tryon's proposal, including his reply (1991b) to Lamiell's
criticisms. It is concluded that explanation as uncertainty
reduction is a simple recapitulation of the Hempelian model
of explanation at the theoretical level, and an erroneous
conception of statistical epistemology at the methodological
level.},
Doi = {10.1037/h0091362},
Key = {fds276659}
}
@article{fds276660,
Author = {Bush, PJ and Weinfurt, KP and Iannotti, RJ},
Title = {Families versus peers: Developmental influences on drug use
from grade 4-5 to grade 7-8},
Journal = {Journal of Applied Developmental Psychology},
Volume = {15},
Number = {3},
Pages = {437-456},
Publisher = {Elsevier BV},
Year = {1994},
Month = {January},
ISSN = {0193-3973},
url = {http://dx.doi.org/10.1016/0193-3973(94)90041-8},
Abstract = {This study examined the relative influence of family and
peers on abusable substance use, and whether relative
influences on problem behaviors are behavior specific as
children move from pre- to early adolescence. In 1988-1989,
urban public school students in Grades 4-5 completed a
substance abuse survey. The survey was repeated in each of
the following 3 years into Grades 7-8; 1,802 students, of
whom 91% were black, participated on all four occasions.
Data were analyzed using structural equation modeling with
cross-validation. Perceived family use was a stronger
influence on abusable substance use relative to perceived
peer use when the students were younger, whereas perceived
peer use had more influence when they were older. Prior use
predicted perceived family as well as perceived peer use.
Varying direct and indirect pathways predicted licit drug
use, illicit drug use, and other problem behaviors in Grades
7 and 8, although perceived peer use predicted all three.
The results suggest that the relative shift from the
influence of families to peers observed among adolescents is
consistent among younger urban children. Drug use
predisposes children toward greater perceptions of drug use
among families and peers, and relative influences on problem
behaviors may vary with the specific behavior. Interventions
should begin in elementary school as the influence on
students is shifting from family toward peers. ©
1994.},
Doi = {10.1016/0193-3973(94)90041-8},
Key = {fds276660}
}
@article{fds331322,
Author = {Weinfurt, KP},
Title = {INTERGRAPH: A SAS Macro for Interpreting and Graphing
Regression Interactions},
Journal = {Applied Psychological Measurement},
Volume = {18},
Number = {3},
Pages = {276},
Publisher = {SAGE Publications},
Year = {1994},
Month = {January},
url = {http://dx.doi.org/10.1177/014662169401800307},
Doi = {10.1177/014662169401800307},
Key = {fds331322}
}
@article{fds331323,
Author = {Weinfurt, KP},
Title = {MacSidak: A SAS Macro That Generates Critical p Values for a
Sidak Type I Error Control Procedure},
Journal = {Applied Psychological Measurement},
Volume = {18},
Number = {3},
Pages = {298},
Publisher = {SAGE Publications},
Year = {1994},
Month = {January},
url = {http://dx.doi.org/10.1177/014662169401800311},
Doi = {10.1177/014662169401800311},
Key = {fds331323}
}
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