Explore the vast range of titles available.

Background Patient and Public Involvement and Engagement (PPIE) is an essential element of any clinical trial, to ensure that the research design and resources are acceptable and the trial produces findings that are relevant to research participants and service-users. The WILL (When to Induce Labour to Limit risk in pregnancy hypertension) Trial Management Team involved a group of patient and public members to develop an infographic, for service-users and -providers, to communicate the risks of chronic and gestational hypertension at term gestational age. Methods Based on national resources in the UK for PPIE, including those from the National Institute for Health and Care Research (NIHR) and Health Research Authority, active trial sites (all in the UK) were approached to invite women with pregnancy hypertension to the PPIE group, and advertisements were placed on the Action on Pre-Eclampsia Charity (APEC) and NIHR People in Research websites. PPIE resources were established by the Trial Management Team and virtual meetings with the PPIE members held to co-design and develop the infographic from existing trial materials, using Microsoft Publisher. Results Seven diverse PPIE members were involved, six from NIHR People in Research and one from APEC. No members were engaged from active sites. From initial set-up to REC approval of the infographic took 9 months, and a considerable time commitment from the Trial Manager and Senior Research Midwives, to navigate practicalities (e.g. team consensus-building). Four meetings were held and 15 iterations of the infographic were developed with the group. The infographic incorporated requests from PPIE members for a design that was inclusive of all races, cultures, abilities and genders. Discussions with PPIE group members improved our understanding of the acceptability of the trial intervention to some cultures. The Research Ethics Committee (REC) requested revisions to PPIE-approved wording about the risk of stillbirth, from ‘1 in 1000’ to ‘small increased risk’ prior to issuing approval for use. Conclusions More practical support would be useful for researchers seeking to establish PPIE groups, and RECs reviewing resources that are co-produced. Our case study provides a practical, step-by-step account of establishing a PPIE group without a funded co-lead, highlighting strengths such as the diversity of members, the incorporation of cultural perspectives, and the development of inclusive patient-facing materials. These findings add to PPIE practice by offering operational guidance, lessons learned and a summary checklist as an additional resource that can complement existing high-level frameworks. Trial registration ISRCTN77258279, registered on 05 December 2018.

Patient and Public Involvement and Engagement (PPIE) is an essential element of any clinical trial, to ensure that the research design and resources are acceptable and the trial produces findings that are relevant to research participants and service-users. The WILL (When to Induce Labour to Limit risk in pregnancy hypertension) Trial Management Team involved a group of patient and public members to develop an infographic, for service-users and -providers, to communicate the risks of chronic and gestational hypertension at term gestational age. Based on national resources in the UK for PPIE, including those from the National Institute for Health and Care Research (NIHR) and Health Research Authority, active trial sites (all in the UK) were approached to invite women with pregnancy hypertension to the PPIE group, and advertisements were placed on the Action on Pre-Eclampsia Charity (APEC) and NIHR People in Research websites. PPIE resources were established by the Trial Management Team and virtual meetings with the PPIE members held to co-design and develop the infographic from existing trial materials, using Microsoft Publisher. Seven diverse PPIE members were involved, six from NIHR People in Research and one from APEC. No members were engaged from active sites. From initial set-up to REC approval of the infographic took 9 months, and a considerable time commitment from the Trial Manager and Senior Research Midwives, to navigate practicalities (e.g. team consensus-building). Four meetings were held and 15 iterations of the infographic were developed with the group. The infographic incorporated requests from PPIE members for a design that was inclusive of all races, cultures, abilities and genders. Discussions with PPIE group members improved our understanding of the acceptability of the trial intervention to some cultures. The Research Ethics Committee (REC) requested revisions to PPIE-approved wording about the risk of stillbirth, from '1 in 1000' to 'small increased risk' prior to issuing approval for use. More practical support would be useful for researchers seeking to establish PPIE groups, and RECs reviewing resources that are co-produced. Our case study provides a practical, step-by-step account of establishing a PPIE group without a funded co-lead, highlighting strengths such as the diversity of members, the incorporation of cultural perspectives, and the development of inclusive patient-facing materials. These findings add to PPIE practice by offering operational guidance, lessons learned and a summary checklist as an additional resource that can complement existing high-level frameworks.