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


OBJECTIVE
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.
Davis
Linda Lindsey
LL
School of Nursing, Duke University, Durham, NC 27210, USA. davis317@mc.duke.edu
Weaver
Michael
M
Habermann
Barbara
B
Buckwalter
Kathleen
K
D000223:Adaptation, Psychological; D000704:Analysis of Variance; D001294:Attitude to Health; D017028:Caregivers / Q000193:education / Q000523:psychology / Q000706:statistics & numerical data; D003153:Community Health Services / Q000592:standards; D015986:Confounding Factors, Epidemiologic; D005163:Factor Analysis, Statistical; D006801:Humans; D007258:Informed Consent; D016014:Linear Models; D009013:Morale; D011369:Professional-Patient Relations; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards*; D012108:Research Personnel / Q000193:education / Q000523:psychology; D016896:Treatment Outcome