What to write
Details of patient or public involvement in the design, conduct, and reporting of the trial
Examples
“A study patient advisory group advised on study design before funding, in study set-up, and during recruitment. They chose the term best current treatment and informed the design of clinic procedures (including how best to reduce the burden of intervention), questionnaire design, and participant information. This group informed protocol modifications in response to low recruitment, and guided interpretation of the findings. Two public contributors were members of the independent trial steering committee.”1
“The UK Musculoskeletal Trauma Patient and Public Involvement (PPI) Group co-designed this study. In particular, the group advised on the choice of outcome measures and the follow-up arrangements, which were designed to limit the number of face-to-face hospital visits needed. Subsequently, a patient member from this group became a member of the DRAFFT2 Trial Management Group, overseeing all elements of the set-up and delivery of the trial and the dissemination of the lay summary at completion. Another patient member of the group was also a member of the independent Trial Steering Committee.”2
“Office workers, workplace champions, and managers within the target organisation were involved in the study design during the grant application process and the study delivery phase. During the grant application phase, the purpose and design of the study as well as the suggested intervention strategies were presented to two large groups of council employees. As a result of these meetings, the study design included using finger prick blood testing rather than taking venous blood samples, participants receiving feedback on health measures, and incentives for attending follow-up. During the study set-up and delivery, a council employee advisory group met several times and provided advice on delivery of the interventions (feedback showed that workplace champions would not be comfortable delivering the initial education session because of the training and planning time required, so this session was delivered online instead), recruitment processes (feedback was provided on participant documents and recruitment messages and strategies within the council), installation of the height adjustable desk, and troubleshooting. Two council employees were also part of the trial steering committee, which met twice a year during the study”.3
“In the context of the pandemic and the need to design the study in a short period, no patients were involved in setting the research questions or the outcome measures, nor were they involved in developing plans for recruitment, design, or implementation of the study. No patients were asked to advise on interpretation or writing up of results.”4
Explanation
Patient and public involvement (PPI) has been shown to be particularly beneficial in clinical trials.5 It 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 acceptability of trials.5,6 PPI can also improve the communication and dissemination of the trial results to participants. Public involvement in other types of health research has been shown to help researchers to engage under-served populations and recruit diverse participant groups.5 Thus, transparent reporting of PPI is essential to allow readers to appraise the relevance and usefulness of findings to end users and to fully evaluate and understand a trial’s methodology and conduct. If patients and the public were not involved, authors should report this with the reasons why.
PPI in health research entails collaborating or partnering with patients and members of the public to design, conduct, report, interpret, or disseminate research: the research is done by or with patients and the public—rather than done for, at, or about them.7,89 Importantly, this is distinct from including patients or members of the public in a trial as participants. PPI contributors can be people with current or past experience of a health condition; their families, carers, and advocates; members of communities who are target users of an intervention or service; or members of the wider public with a broader perspective. The terminology used differs internationally: for example, such activity is most commonly known as “patient and public involvement” in the UK, whereas “patient engagement” is more common in mainland Europe and North America,8,9, “community and public engagement” is commonly used in part of Africa, and “consumer involvement” is frequently used in Australia.10
The GRIPP (Guidance for Reporting Involvement of Patients and Public) checklist was developed in 2011 with the aim of improving the reporting of PPI activities in health research11; followed in 2017 by GRIPP2.12 The GRIPP2 checklist includes GRIPP2-SF, which is a short form of the GRIPP2 checklist where PPI is the secondary focus of the research.12 Examples of reporting of PPI involvement could include whether and how patients were involved in the trial objectives, whether patients advised on optimising patient recruitment and retention, and whether and how patients were included in selection of the trial outcomes.
Funding bodies are increasingly encouraging or requiring researchers to include PPI in grant applications,7,13,14 but mandating of PPI reporting by journals has remained uncommon. In 2014, The BMJ introduced a requirement for submitted manuscripts to include a PPI statement,15 and this was extended to other BMJ journals from 2018.16,17 A 2023 study of trials addressing chronic conditions found that approximately 80% of trial reports published in these journals included a PPI subsection, and around 40% of these reported that PPI activities had been conducted.18 Few other journals have followed suit in mandating reporting of PPI activities.19–21 In the absence of an explicit requirement, reporting of PPI activities remains infrequent, appearing in an estimated 0-5% of published trial reports.22–24 There is limited evidence to indicate the extent to which this reflects a lack of PPI activity versus PPI activity being conducted but not reported. In a small survey of authors of trials published in high impact factor journals, only one of 29 respondents reported PPI activities having been included but not mentioned in the published article24; while in a survey of authors of pragmatic trials, 47% reported including PPI activities during a trial but less than a quarter of these reported the activity in the corresponding publication.25
Training
The UK EQUATOR Centre runs training on how to write using reporting guidelines.
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