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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Vydáno v:	BMC medicine Ročník 18; číslo 1; s. 6 - 11
Hlavní autoři:	Naidoo, Nivantha, Nguyen, Van Thu, Ravaud, Philippe, Young, Bridget, Amiel, Philippe, Schanté, Daniel, Clarke, Mike, Boutron, Isabelle
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	London BioMed Central 20.01.2020 BioMed Central Ltd Springer Nature B.V BMC
Témata:	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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Popis
Shrnutí:	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
Bibliografie:	ObjectType-Article-2 SourceType-Scholarly Journals-1 content type line 14 ObjectType-Feature-3 ObjectType-Evidence Based Healthcare-1 ObjectType-Article-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 PMCID: PMC6970283
ISSN:	1741-7015 1741-7015
DOI:	10.1186/s12916-019-1476-5