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The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence
Open accessAbstract
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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“The feasibility of participant recruitment and retention in RCTs can differ from that in one-group pretest-posttest design studies due to additional psychological burdens in participants that arise from the RCT process, such as a lack of control and anxiety that result from random allocation and disappointment when allocated to a less favorable control group condition”
From The feasibility and preliminary effects of a pilot randomized controlled trial: Videoconferencing acceptance and commitment therapy in distressed family caregivers of people with dementia. (2023) · cites this paper as Naidoo et al., 2020
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Metadata
- Authors
- Naidoo, N., Nguyen, V. T., Ravaud, P., Young, B., Amiel, P., Schanté, D., Clarke, M., & Boutron, I.
- Affiliations
- Inserm (FR)
- University of Liverpool (GB)
- Institut National du Cancer (FR)
- Queen's University Belfast (GB)
- Corresponding author
- Boutron, Isabelle
- ORCID
- Venue
- BMC Medicine
- Published
- 2020-01-20
- Volume
- 18
- Issue
- 1
- Pages
- 6-6
- ISSN
- 1741-7015 (ISSN-L)
- PMC
- PMC6970283
- OpenAlex
- W2999900278
- Cited by
- 144
- References
- 53
- Citations by year
- 2026: 27 · 2025: 22 · 2024: 19 · 2023: 18 · 2022: 22 · 2021: 30 · 2020: 6
- FWCI
- 3.18
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- BMC Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- HAL (submittedVersion, cc-by)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Columbia Academic Commons (Columbia University)
- Funders
- Institut National Du Cancer
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Health Sciences › Health Professions › General Health Professions › Mental Health and Patient Involvement
- Keywords
- research burden, randomized controlled trials, patient experience, psychological burden, physical burden, financial burden, trial follow-up, trial closure, randomization, trial recruitment, trial retention
- MeSH terms
- Humans, Volunteers, Randomized Controlled Trials as Topic, Cost of Illness, Qualitative Research
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