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

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

International Standard Serial Number (ISSN)

  • 0029-6554

Digital Object Identifier (DOI)

  • 10.1016/j.outlook.2004.05.005

Language

  • eng

Conference Location

  • United States