The DOI matches its Crossref record; 70 of the 71 references it cites were found in a registry or an index, and 1 are not checked yet.
Patient and public involvement in the design of clinical trials: An overview of systematic reviews
Open accessAbstract
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.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In the citing paper
“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]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
Cochrane Handbook for Systematic Reviews of Interventions: Cochrane Book Series
(2008) · doi:10.1002/9780470712184 · Cited by 25,048
Liberati, A., Altman, D. G., Tetzlaff, J., Mulrow, C., Gotzsche, P. C., Ioannidis, J. P. A., Clarke, M., Devereaux, P. J., Kleijnen, J., & Moher, D. (2009) · BMJ · doi:10.1136/bmj.b2700 · Cited by 17,648
Self-citationGRADE guidelines: 1. Introduction—GRADE evidence profiles and summary of findings tables
Guyatt, G., Oxman, A. D., Akl, E. A., Kunz, R., Vist, G., Brozek, J., Norris, S., Falck-Ytter, Y., Glasziou, P., & deBeer, H. (2011) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2010.04.026 · Cited by 10,681
Cochrane Handbook for Systematic Reviews of Interventions
Tarsilla, M. (2010) · Journal of MultiDisciplinary Evaluation · doi:10.56645/jmde.v6i14.284 · Cited by 5,232
Patient engagement in research: a systematic review
Domecq, J. P., Prutsky, G., Elraiyah, T., Wang, Z., Nabhan, M., Shippee, N., Brito, J. P., Boehmer, K., Hasan, R., Firwana, B., et al. (2014) · BMC Health Services Research · doi:10.1186/1472-6963-14-89 · Cited by 1,773
Brett, J., Staniszewska, S., Mockford, C., Herron‐Marx, S., Hughes, J., Tysall, C., & Suleman, R. (2014) · Health Expectations · doi:10.1111/j.1369-7625.2012.00795.x · Cited by 1,598
Increasing value and reducing waste in research design, conduct, and analysis
Ioannidis, J. P. A., Greenland, S., Hlatky, M. A., Khoury, M. J., Macleod, M. R., Moher, D., Schulz, K. F., & Tibshirani, R. (2014) · The Lancet · doi:10.1016/s0140-6736(13)62227-8 · Cited by 1,597
JAGOSH, J., MACAULAY, A. C., PLUYE, P., SALSBERG, J., BUSH, P. L., HENDERSON, J., SIRETT, E., WONG, G., CARGO, M., HERBERT, C. P., et al. (2012) · The Milbank Quarterly · doi:10.1111/j.1468-0009.2012.00665.x · Cited by 1,268
Joseph‐Williams, N., Elwyn, G. J., & Edwards, A. (2013) · Patient Education and Counseling · doi:10.1016/j.pec.2013.10.031 · Cited by 1,244
Methodology in conducting a systematic review of systematic reviews of healthcare interventions
Smith, V., Devane, D., Begley, C. M., & Clarke, M. (2011) · BMC Medical Research Methodology · doi:10.1186/1471-2288-11-15 · Cited by 1,227
Self-citation
Research works printed but not linked: 13
- The Mendeley Support Team, 2011, Getting Started with Mendeley. Mendeley Desktop, 1
- CASP, 2013, Critical Appriasal Skills Programme (CASP) Systematic Review Checklist, 1
- National Institute for Health and Care Excellence, 2012, Methods for the development of NICE public health guidence
- 10.1111/hex.12007 · DOI
- BrettJ StaniszewskaS MockfordC SeersK Herron‐marxS BaylissH.The PIRICOM Study: A systematic review of the conceptualisation measurement impact and outcomes of patients and public involvement in health and social care research. University of Warwick.2010.
- Stokes G, 2015, Review 3: Community engagement for health via coalitions, collaborations and partnerships ( on‐line social media and social networks) A systematic review and meta‐analysis
- Tarpey M, 2014, Public involvement in research applications to the National Research Ethics Service: Comparative analysis of 2010 and 2012 data
- Price A, 2016, The evidence informed patient, BMJ, 4
- Price A, 2017, Developing tools for practice that support patient choice, The BMJ, 6
- Price A, 2017, Cochrane Canada Symposium
- Price A, 2017, Building Public Participation in Research. In: FORCE11 Scholarly Communication Institute (FSCI)
- 10.1111/j.1369-7625.2010.00648.x · DOI
- BlazebyJM GargonE AltmanDG ClarkeM WilliamsonPR.The COMET (Core Outcome Measures in Effectiveness Trials) Initiative. Trials Conference: Clinical Trials Methodology Conference.2011;20111004(20111005).
Cited by
Sorted by citations
Crocker, J. C., Ricci‐Cabello, I., Parker, A., Hirst, J. A., Chant, A., Petit-Zeman, S., Evans, D., & Rees, S. (2018) · BMJ · doi:10.1136/bmj.k4738 · Cited by 650
CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials
Hopewell, S., Chan, A.-W., Collins, G. S., Hróbjartsson, A., Moher, D., Schulz, K. F., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · BMJ · doi:10.1136/bmj-2024-081124 · Cited by 205
Vat, L. E., Finlay, T., Jan Schuitmaker‐Warnaar, T., Fahy, N., Robinson, P., Boudes, M., Diaz, A., Ferrer, E., Hivert, V., Purman, G., et al. (2020) · Health Expectations · doi:10.1111/hex.12951 · Cited by 173
Price, A. I., Schroter, S., Snow, R., Hicks, M. D., Harmston, R., Staniszewska, S. H., Parker, S., & Richards, T. (2018) · BMJ Open · doi:10.1136/bmjopen-2017-020452 · Cited by 155
Self-citationSPIRIT 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
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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
