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

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 RC...

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Published in:BMC medicine Vol. 18; no. 1; pp. 6 - 11
Main Authors: Naidoo, Nivantha, Nguyen, Van Thu, Ravaud, Philippe, Young, Bridget, Amiel, Philippe, Schanté, Daniel, Clarke, Mike, Boutron, Isabelle
Format: Journal Article
Language:English
Published: London BioMed Central 20.01.2020
BioMed Central Ltd
Springer Nature B.V
BMC
Subjects:
Anxiety
Biomedicine
Clinical trials
Codes
Consent
Cost of Illness
Data collection
Depression (Mood disorder)
Economic aspects
Finance
Guinea pigs
Humans
Life Sciences
Medical research
Medicine
Medicine & Public Health
Methods
Participation
Patients
Physiological aspects
Psychological aspects
Psychological research
Public opinion
Qualitative analysis
Qualitative Research
Quality assessment
Randomization
Randomized controlled trials
Randomized Controlled Trials as Topic
Research Article
Research burden
Santé publique et épidémiologie
Trial participation
Volunteers - psychology
France
Trial participation
Research burden
Randomized controlled trials
ISSN:1741-7015, 1741-7015
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Description
Summary: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
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PMCID: PMC6970283
ISSN:1741-7015
1741-7015
DOI:10.1186/s12916-019-1476-5