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

While there are increasing calls for Public and Patient Involvement and Engagement (PPIE) in methodology research, including the development of reporting guidelines, practices continue to emerge. This paper reports on the process, experiences, reflections, and recommendations of both the PPIE partners and other researchers participating in the development of (Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT)-Surrogate reporting guidelines. Development of the SPIRIT- and CONSORT-Surrogate guidelines involved four phases: (1) literature reviews; (2) an e-Delphi survey; (3) a consensus meeting, and (4) knowledge translation. PPIE was integrated in Phases 2, 3 and 4. An encompassing budgeted PPIE strategy detailing involvement in all project phases was prepared and implemented by researchers and PPIE partners. Implementation included a learning workshop (attended by 19 PPIE partners) to build PPIE partners’ capacity and confidence to participate in the e-Delphi survey (Phase 2) and the invitation of four PPIE partners to the consensus meeting (Phase 3). Experiences and reflections of PPIE in the project, based on feedback surveys from PPIE partners participating in the project and reflective notes from meetings, were used to formulate recommendations. In total, 19 PPIE partners took part in the e-Delphi survey (Phase 2), four joined the consensus meeting (Phase 3), and consequently co-authored the guidelines and contributed to the development of an educational animation video (Phase 4). Partners felt that facilitators for involvement in Phase 2 included a learning workshop, financial compensation, support during e-Delphi survey participation (such as a glossary and help texts) and for Phase 3, the main facilitator was allowing partners to contribute first during the consensus meeting. The PPIE partners who joined the consensus meeting (Phase 3) presented the patient perspective; reminded researchers of why the project was important; helped with clarification of issues; corrected grammar; suggested strategies to disseminate and implement the extensions; and created humour. Reflecting on the involvement, both the PPIE partners and researchers felt it was valuable to the project. Based on the experiences, we make six recommendations for integrating PPIE in projects to develop reporting guidelines: involve early; involve with a plan and layered approach; involve meaningfully in a genuine way; involve with support and in safe spaces; involve with reflection and feedback; and involve with a budget to compensate for time and effort. 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.