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The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence.

Abstract：

BACKGROUND:Participation in randomized controlled trials (RCTs) may be quite demanding and could represent an important burden for patients. We aimed to explore this research burden (i.e., the psychological, physical, and financial burdens) experienced by patients through their participation in a RCT. METHODS:We conducted a systematic review of qualitative studies exploring adult patients' experiences with RCT participation. We searched MEDLINE (PubMed), CINAHL, PSYCHINFO, and Embase (search date March 2018) for eligible reports. Qualitative data coding and indexing were assisted by NVivo. The quality of reports was assessed by using the Critical Appraisal Skills Program (CASP) tool. RESULTS:We included 45 qualitative studies that involved 1732 RCT participants. Important psychological burdens were identified at every stage of the trial process. Participants reported feeling anxiety and being afraid of "being a 'guinea pig'" and described undergoing randomization and allocation to a placebo as particularly difficult resulting in disappointment, anger, and depression. Patients' follow-up and trial closure were also responsible for a wide range of psychological, physical, and financial burdens. Furthermore, factors related to burdensome impacts and consequences were discerned. These factors involved trial information, poorly organized and too-demanding follow-up, and lack of appropriate management when the patient's participation ended. Trial participation was also associated with beneficial effects such as the satisfaction of feeling "useful," gaining "a sense of control," and receiving special attention. CONCLUSIONS:Our finding provides a detailed description of research burden across the whole RCT process. Many of the burdens described could be anticipated, and some avoided in a movement toward minimally disruptive clinical research. Such an approach could improve trial recruitment and retention. REVIEW REGISTRATION:PROSPERO CRD42018098994.

journal_name

BMC Med

journal_title

BMC medicine

authors

Naidoo N,Nguyen VT,Ravaud P,Young B,Amiel P,Schanté D,Clarke M,Boutron I

doi

10.1186/s12916-019-1476-5

subject

Has Abstract

pub_date

2020-01-20 00:00:00

pages

issue

issn

1741-7015

pii

10.1186/s12916-019-1476-5

journal_volume

pub_type

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The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence.