Experiences of conducting effective Patient and Public Involvement and Engagement (PPIE) by the WILL Trial (When to Induce Labour to Limit risk in pregnancy hypertension) management team

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 for PPIE, including those from the National Institute for Health and Care Research (NIHR) and Health Research Authority, active trial sites 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 nine 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. Based on our experiences, we offer a summary checklist as an additional resource for PPIE.

Trial registration: ISRCTN77258279, registered on 05 December 2018.