​​Patient and public involvement

Item 11: Details of, or plans for, patient or public involvement in the design, conduct, and reporting of the trial.

Example

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“The study involved consumer representatives (n=2) in all aspects of the study design providing input to the processes and assessments of this research project. The Consumer and Community Health Research Network, through The Consumer and Community Involvement Coordinator (Mr BH) based at Edith Cowan University, assisted our Involvement Strategy by supporting us to find the most appropriate consumers for this work. The consumers were women over the age of 65 years who have attended five meetings, including four visits to the Medical Research Foundation and one visit to the Bone Density Department, over the last 12 months, prior to the start of the study. The women contributed to the design of the study, the informational material (results letter, handouts and videos) which supported the intervention and gave feedback about the burden of the intervention from the patient’s perspective (including clinical assessments and online questionnaires). The two women from the community involved in this research provided feedback on their own clinical results and contributed to the dissemination plan of the study by suggesting which information should be provided and how it should be presented (graphic representation of scan results, providing feedback on the wording of all documents and questionnaires provided). The consumers were provided with a AU$30 gift card for each hour involved in the study" [179].

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Explanation

Patient and public involvement in health research entails collaborating or partnering with patients and members of the public to design, conduct, interpret or disseminate research: the research is done “by” or “with” patients and the public rather than “for”, “at” or “about” them [180-182]. Importantly, patient and public involvement is distinct from including patients or members of the public in a trial as participants.

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The terminology used differs internationally: for example, such activity is most commonly called “patient and public involvement” in the United Kingdom, whereas “patient engagement” is more common in mainland Europe and North America, “community and public engagement” in Africa, and “consumer involvement” in Australia [181-183]. 

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Funding bodies are increasingly encouraging or requiring researchers to include patient and public contributors in grant applications [180, 184, 185]. In articles published in BMJ family journals, which require a patient and public involvement section, approximately 40% of these statements reported that such activities were conducted [186]. Most of these trials included patient and public contributors at the trial design stage [186].

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Input from the patient and public contributors and partners [187, 188] 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 [187, 189, 190]. Public involvement in other types of health research has been shown to help researchers to engage under-served populations and recruit diverse participant groups [187]. 

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Transparent reporting of patient and public contributors in a trial protocol is essential to allow interested parties, including potential participants and trial personnel, research ethics committees/institutional review boards, and funders, to appraise the importance and ethical foundation of the trial.

We recommend that protocol authors report whether, and if so, how patient and public involvement influenced the development of the protocol (e.g., the number of patient representatives, their background, and their role); and describe any plans for similar involvement during the conduct and reporting of the trial. The GRIPP2 (Guidance for Reporting Involvement of Patients and the Public) checklist provides more in-depth guidance [191]. 

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Summary of key elements to address

• Planned methods of patient and public involvement at the different study stages (e.g., design, conduct, reporting)

• Who will be involved (e.g., patients, carers, members of the public)

• If no patient or public involvement planned, this should be stated