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. 2025 Dec 4;11(1):144.
doi: 10.1186/s40900-025-00807-y.

Patient and public involvement and engagement in methodology research: process, experiences, and recommendations from the SPIRIT- and CONSORT-Surrogate project

Anthony Muchai Manyara  1   2 , Derek Stewart  3 , Sarah Markham  4 , Andrew Worrall  5 , Ray Harris  6 , Philippa Davies  7 , Christopher J Weir  8 , Amber E Young  7 , Jane Blazeby  7   9   10 , Nancy J Butcher  11   12 , Sylwia Bujkiewicz  13 , An-Wen Chan  14   15 , Dalia Dawoud  16 , Martin Offringa  11   17 , Mario Ouwens  18 , Gary S Collins  19   20 , Joseph S Ross  21   22 , Rod S Taylor  23   24 , Oriana Ciani  25
Affiliations

Patient and public involvement and engagement in methodology research: process, experiences, and recommendations from the SPIRIT- and CONSORT-Surrogate project

Anthony Muchai Manyara et al. Res Involv Engagem. .
No abstract available

Keywords: Methodology research; PPIE; Patient and public involvement; Reporting guidelines.

Plain language summary

This study looked at how patients and the public can be helpfully included in creating guidelines for reporting medical research. In the past, these research guidelines have been created only by scientists; however, involving patients and the general public is increasingly viewed as helpful for everyone in helping to ground guidelines in reality.The researchers created a detailed plan explaining exactly how people would be involved, particularly in the two main activities: a survey to gather opinions and a meeting to discuss the final decisions on the guidelines.To prepare patients and members of the public, researchers held a workshop attended by 19 people, most of whom then participated in the survey. Four of those who participated in the survey joined a meeting to finalise the guidelines, actively contributing patient viewpoints. These partners became co-authors of the final guidelines and helped create an educational video explaining the guidelines’ importance.The involvement of patients and members of the public was successful because of supportive measures like preparatory workshops. Both researchers and patient partners agreed that the involvement was helpful and improved the final guidelines.Based on their experience, the researchers suggest six practices: involve patients from the beginning; create a clear involvement plan; ensure participation is valuable; provide enough support and create a welcoming environment; regularly gather feedback on the process; and budget well to pay for participants’ time fairly.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The SPIRIT- and CONSORT-Surrogate project received ethical approval on 24th May 2022 from the University of Glasgow College of Medical, Veterinary, and Life Sciences Ethics Committee (Project No: 200210151). All PPIE partners consented to participate in project activities. Consent for publication: Not applicable. Competing interests: Sylwia Bujkiewicz is a member of the NICE Decision Support Unit (DSU) and NICE Guidelines Technical Support Unit (TSU), has served as a paid consultant, providing methodological advice, to NICE, Roche, IQVIA and RTI Health Solutions, received payments for educational events from Roche and has received research funding from European Federation of Pharmaceutical Industries & Associations (EEPIA) and Johnson & Johnson. Mario Ouwens works for and has shares in AstraZeneca. Joseph Ross is a Deputy Editor at JAMA, was formerly an Associate Editor at BMJ, and is co-founder (unpaid) of medRxiv; he has received research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164, R01HL144644), and from Arnold Ventures and was an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. that was settled in September 2022. Nancy Butcher has received consulting fees from Nobias Therapeutics, Inc. Oriana Ciani is an Associate Editor for Value in Health and has received consulting fees from MSD and Janssen. Ray Harris has shares in Johnson and Johnson.

Figures

Fig. 1
Fig. 1
Phases in the development of SPIRIT-and CONSORT-Surrogate guidelines with PPIE integration
See this image and copyright information in PMC

References

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