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.
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University of Alabama at Birmingham. Project ASSIST for Chronic Illness Caregiver (5 RO1 NR008285). Year 2 ROGRESS REPORT SUMMARY: Submitted May, 2004 to National Institute of Nursing Research. Principal Investigator: Linda Lindsey Davis.
Biography
Linda Lindsey Davis is at the School of Nursing, Duke University, Durham, NC.
Biography
Michael Weaver is a Professor, School of Nursing and Department of Biostatistics, at the University of Alabama at Birmingham, Birmingham, AL.
Biography
Barbara Habermann is an Assistant Professor, School of Nursing, and a Scientist, Center for Aging, at the University of Alabama at Birmingham, Birmingham, AL.
Biography
Kathleen Buckwalter is a Professor, College of Nursing, and Associate Provost for Health Sciences at the University of Iowa, Iowa City, IA.
Article info
Footnotes
This article was written with support from National Institute of Nursing Research grant 5 RO1 NR008285.
Identification
Copyright
© 2005 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
