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Refereed Publications

  1. Davis, L. L. and Weaver, M. and Habermann, B. and Buckwalter, K., Participant-centered adaptations in caregiver trials: strategies for managing confounds., Nursing outlook, vol. 53 no. 2 (June, 2005), pp. 73-8, ISSN 0029-6554 [doi]
    (last updated on 2010/10/20)

    BACKGROUND: Randomized trials have been criticized for being more protocol than participant-centered, with concerns raised about higher subject attrition and limited generalizability under controlled conditions. Informal caregivers are similar to other participants in community-based trials: many are unlikely to remain in a trial without procedural adaptations to meet some of their needs. PURPOSE: This article discusses design and statistical strategies for tracking potential confounds associated with 3 participant-centered adaptations that may be made in community-based caregiver trials: tailoring multi-component interventions, using interpersonal contacts for participant maintenance, and non-blinding of trial participants. The intent of the article is to initiate dialogue on the seldom-discussed issue of participant-centered adaptations in community-based trials. CONCLUSIONS: Participant-centered adaptations may reduce subject attrition and enhance generalizability, but protocol adaptation can compromise trial integrity. The challenge for investigators is to develop scientifically sound methods for tracking / controlling potential confounds associated with each adaptation.

    Adaptation, Psychological* • Analysis of Variance • Attitude to Health • Caregivers • Community Health Services • Confounding Factors (Epidemiology) • Factor Analysis, Statistical • Humans • Informed Consent • Linear Models • Morale • Professional-Patient Relations • Randomized Controlled Trials as Topic • Research Design • Research Personnel • Treatment Outcome • education • psychology • standards • standards* • statistics & numerical data