Patient and public involvement is suboptimal in randomized controlled trials addressing a chronic condition
Open accessAbstract
Objectives To describe patient and public involvement (PPI) in randomized controlled trials (RCTs) addressing a chronic condition and to analyze whether PPI is associated with trial characteristics.Study design and setting We used PubMed search to identify RCTs addressing a chronic condition and published in journals with a mandatory PPI statement.Results Across 101 RCTs; 40 (40%) reported PPI at any stage of the research process. PPI contribution occurred mostly at the design stage of RCTs (n = 36), especially for assessing the burden of the intervention (n = 24), and at the conduct stage (n = 21), with the elaboration of communication materials (n = 14). Less than one-third (13/40) of RCTs included PPI in the development or choice of outcome measures. As compared with non-PPI RCTs, PPI RCTs more frequently were published in The BMJ, had a corresponding author from the United Kingdom, reported a public funding source, had a higher inclusion rate, used usual care as a control and evaluated a digital intervention. PPI RCTs were associated with less frequent use of placebo as a control group.Conclusion Our results underline that PPI is not uncommon in RCTs of chronic conditions but infrequently occurred at a key stage. Yet, the engagement of patients as a real partner in RCTs of chronic conditions should be enhanced.
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In articles published in The BMJ family journals, which require a patient and public involvement section, about 40% of these statements reported that such activities were conducted.
“In articles published in The BMJ family journals, which require a patient and public involvement section, about 40% of these statements reported that such activities were conducted.185”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [185]
Most of these trials included patient and public contributors at the trial design stage.
“Most of these trials included patient and public contributors at the trial design stage.185”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [185]
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SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials
Hróbjartsson, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · BMJ · doi:10.1136/bmj-2024-081660 · Cited by 171 · see citing works
- Authors
- Husson, M., Dechartres, A., Ramdjee, B., Diverres, M., Zejli, T., L'Hénaff, M., Jehanno, E., Tubach, F., & Caille, A.
- Affiliations
- Sorbonne Université (FR)
- Inserm (FR)
- Université de Tours (FR)
- Corresponding author
- Caille, Agnès
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2023-08
- Volume
- 160
- Pages
- 71-82
- ISSN
- 0895-4356 (ISSN-L)
- OpenAlex
- W4381853514
- Cited by
- 20
- References
- 26
- Citations by year
- 2026: 6 · 2025: 12 · 2024: 1 · 2023: 1
- FWCI
- 7.04
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.elsevier.com/tdm/userlicense/1.0/ (tdm)
- www.elsevier.com/legal/tdmrep-license (tdm)
- www.elsevier.com/open-access/userlicense/1.0/ (am, 352 d)
- doi.org/10.15223/policy-017 (stm-asf)
- doi.org/10.15223/policy-037 (stm-asf)
- doi.org/10.15223/policy-012 (stm-asf)
- doi.org/10.15223/policy-029 (stm-asf)
- doi.org/10.15223/policy-004 (stm-asf)
- Locations
- Journal of Clinical Epidemiology (acceptedVersion)
- SSRN Electronic Journal (acceptedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion, other-oa)
- Funders
- Sydney Partnership for Health, Education, Research and Enterprise (U1246)
- Institut National de la Santé et de la Recherche Médicale
- Topics
- Health Sciences › Health Professions › General Health Professions › Mental Health and Patient Involvement
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Keywords
- patient and public involvement, randomized controlled trials, chronic disease, trial design, trial conduct, outcome measure development, patient engagement, digital interventions, placebo comparison
- MeSH terms
- Chronic Disease, United Kingdom, Humans, Patient Participation, Randomized Controlled Trials as Topic, Outcome Assessment, Health Care
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