Participant-centered adaptations in caregiver trials: strategies for managing confounds

Document Type


Peer Reviewed


Publication Date


NLM Title Abbreviation

Nurs Outlook

Journal/Book/Conference Title

Nursing outlook

PubMed ID


DOI of Published Version



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/education/psychology/statistics & numerical data, Community Health Services/standards, Confounding Factors (Epidemiology), Factor Analysis, Statistical, Humans, Informed Consent, Linear Models, Morale, Professional-Patient Relations, Randomized Controlled Trials as Topic/standards, Research Design/standards, Research Personnel/education/psychology, Treatment Outcome

Published Article/Book Citation

Nursing outlook, 53:2 (2005) pp.73-78. DOI:10.1016/j.outlook.2004.05.005.

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