Participant-centered adaptations in caregiver trials: strategies for managing confounds.
Published
Journal Article (Review)
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.
Full Text
Duke Authors
Cited Authors
- Davis, LL; Weaver, M; Habermann, B; Buckwalter, K
Published Date
- March 2005
Published In
Volume / Issue
- 53 / 2
Start / End Page
- 73 - 78
PubMed ID
- 15858525
Pubmed Central ID
- 15858525
Electronic International Standard Serial Number (EISSN)
- 1528-3968
International Standard Serial Number (ISSN)
- 0029-6554
Digital Object Identifier (DOI)
- 10.1016/j.outlook.2004.05.005
Language
- eng