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Patient and public involvement in the design of clinical trials: An overview of systematic reviews
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Background: Funders encourage lay‐volunteer inclusion in research. There are controversy and resistance, given concerns of role confusion, exploratory methods, and limited evidence about what value lay‐volunteers bring to research. This overview explores these areas. Methods: Eleven databases were searched without date or language restrictions for systematic reviews of public and patient involvement (PPI) in clinical trials design. This systematic overview of PPI included 27 reviews from which areas of good and bad practice were identified. Strengths, weaknesses, opportunities, and threats of PPI were explored through use of meta‐narrative analysis. Results: Inclusion criteria were met by 27 reviews ranging in quality from high ( n = 7), medium ( n = 14) to low ( n = 6) reviews. Reviews were assessed using CERQUAL NICE, CASP for qualitative research and CASP for systematic reviews. Four reviews report risk of bias. Public involvement roles were primarily in agenda setting, steering committees, ethical review, protocol development, and piloting. Research summaries, follow‐up, and dissemination contained PPI, with lesser involvement in data collection, analysis, or manuscript authoring. Trialists report difficulty in finding, retaining, and reimbursing volunteers. Respectful inclusion, role recognition, mutual flexibility, advance planning, and sound methods were reported as facilitating public involvement in research. Public involvement was reported to have increased the quantity and quality of patient relevant priorities and outcomes, enrollment, funding, design, implementation, and dissemination. Challenges identified include lack of clarity within common language, roles, and research boundaries, while logistical needs include extra time, training, and funding. Researchers report struggling to report involvement and avoid tokenism. Conclusions: Involving patients and the public in clinical trials design can be beneficial but requires resources, preparation, training, flexibility, and time. Issues to address include reporting deficits for risk of bias, study quality, and conflicts of interests. We need to address these tensions and improve dissemination strategies to increase PPI and health literacy.
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“Input from the patient and public contributors and partners186 can help researchers to identify and prioritise research topics and questions, identify relevant outcome measures, boost recruitment and retention, improve trial design and tools, and improve the ethical acceptability of trial protocols to potential participants.186 187 188”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [187]
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Metadata
- Authors
- Price, A., Albarqouni, L., Kirkpatrick, J., Clarke, M., Liew, S. M., Roberts, N., & Burls, A.
- Affiliations
- University of Oxford (GB)
- Bond University (AU)
- Empower‐2‐Go UK and USA
- Queen's University Belfast (GB)
- University of Malaya (MY)
- City, University of London (GB)
- Corresponding author
- Price, Amy
- Venue
- Journal of Evaluation in Clinical Practice
- Publisher
- Wiley
- Published
- 2017-10-27
- Volume
- 24
- Issue
- 1
- Pages
- 240-253
- ISSN
- 1356-1294 (ISSN-L)
- 1365-2753
- OpenAlex
- W2766144316
- Cited by
- 234
- References
- 70
- Citations by year
- 2026: 23 · 2025: 29 · 2024: 32 · 2023: 34 · 2022: 29 · 2021: 39 · 2020: 23 · 2019: 14 · 2018: 10
- FWCI
- 2.26
- Type
- journal article
- Language
- en
- Open access
- green
- research.bond.edu.au
- Licence
- Locations
- Journal of Evaluation in Clinical Practice (publishedVersion)
- PubMed (publishedVersion)
- City Research Online (City University London) (acceptedVersion)
- Bond University Research Portal (Bond University) (submittedVersion, other-oa)
- Research Portal (Queen's University Belfast) (submittedVersion)
- Funders
- Public Health Agency (STL/5334/17)
- Topics
- Health Sciences › Health Professions › General Health Professions › Mental Health and Patient Involvement
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Keywords
- patient and public involvement, clinical trial design, lay volunteers, research ethics committees, trial steering committee, barriers to research participation, tokenism, health literacy, research dissemination, patient-relevant outcomes
- MeSH terms
- Clinical Trials as Topic, Humans, Patient Participation, Public Opinion, Research Design
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