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

Abstract

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.

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-025-09218-6.

Background

The hypertensive disorders of pregnancy affect approximately 10% of pregnancies, and are responsible for substantial maternal and fetal/newborn mortality and morbidity [1]. The majority of women with a hypertensive disorder of pregnancy have either chronic or gestational hypertension; chronic hypertension is elevated blood pressure (BP) that develops before or during the first half of pregnancy, and gestational hypertension is elevated BP that first develops during the second half of pregnancy without evidence of pre-eclampsia-related end-organ dysfunction [1].

The WILL Trial (When to Induce Labour to Limit risk in pregnancy hypertension) was undertaken to evaluate the best timing of birth for women with chronic or gestational hypertension, who reach term gestational age and remain well [2]. Four hundred and three women were randomised to one of two timing of birth arms: intervention (planned early term birth at 38⁺⁰–38⁺³ weeks’ gestation) or control (expectant care until 40⁺⁰ weeks, later revised to ‘usual care at term’), between 03 June 2019 to 19 December 2022, when the funder decided to close the trial early due to lower than anticipated recruitment. Feedback from site research delivery teams highlighted that some eligible women were declining to take part because they wanted to wait for birth to start naturally. This was despite evidence that among WILL participants, only ≈ 25% of women in the control group experienced spontaneous onset of labour, and most required planned birth, by either labour induction or Caesarean in response to a clinical maternal or fetal need for birth [3].

The WILL site teams expressed the view that there was an under-appreciation of the risks associated with chronic or gestational hypertension, and that many clinicians and women believed that maternal and perinatal risks are not elevated when BP is controlled and women are asymptomatic. In August 2020, the Trial Management team developed a relevant training page for the monthly newsletter [4]; the site teams reported the page to be useful, but insufficient, to inform patients and families of the potential risks. We were unable to identify a relevant, existing, resource, including in the relevant NICE guidance on the hypertensive disorders of pregnancy (NG133) [5] and resources on the Action on Pre-Eclampsia Charity (APEC) website [6].

The WILL trial had a Sands Charity Patient and Public Involvement and Engagement (PPIE) co-applicant and APEC provided us with expert PPIE input throughout the planning and ongoing phases of the trial. However, the WILL trial was funded by the National Institute for Health and Care Research (NIHR) prior to the requirement to have a funded (PPIE) co-lead with responsibility for delivering the public involvement strategy for a project, including engaging with, supporting and mentoring public contributors and running, reporting on and evaluating public involvement events. It was determined that a team comprised of women and members of the public should be involved in development of a patient-facing infographic about the risks of chronic or gestational hypertension at term gestational age. Here we report our experience of undertaking this, including operational issues, PPIE resources accessed, our learnings, and a ‘how to’ guide/checklist for researchers.

Methods

Resources for PPIE

The Senior Trial Manager (KK) and two Lead Research Midwives (ST, JW) from the WILL Trial Management team attended the NIHR PPIE training course [8], met with fellow researchers and local trust leads experienced in running PPIE groups and reviewed NIHR and Health Research Authority (HRA) resources [9–15]. These comprised several guidance documents, including a comprehensive resources page [9], handbook on PPIE [10] and UK Standards for Public Involvement in Research [11], diversity and inclusion in public involvement [12, 13], reimbursement for PPIE [14] and co-production of research [15]. These resources complement the UK HRA best-practice guidance on using PPIE to plan and improve research [16]. However, challenges may still arise when implementing the available guidance [17].

Involving and engaging with PPIE group members

To involve and engage a PPIE group which represented women likely to be eligible for the WILL trial, we undertook a number of strategies. First, we asked WILL recruiting sites to contact former WILL trial participants who they thought may be interested in joining the group. Second, an advertisement was published on the APEC website. Third, we placed an advertisement on the NIHR ‘People in Research’ website [18], which advertises opportunities for public involvement in NHS, public health, and social care research; the advert invited expressions of interest from anyone who had either experienced hypertension in pregnancy (personally or through their partner or family member) or had an interest in pregnancy hypertension care. In line with contemporary NIHR guidance for payment of PPIE members, we offered reimbursement of £20 per participant per hour, the standard rate at the time (2021–2022), since updated to £25 per hour [14]. We advertised that we were particularly interested in hearing from people from minority ethnic groups, who might provide a different perspective on timed birth (by labour induction or Caesarean), the intervention in WILL.

To screen potential group members, we emailed everyone who had expressed interest, to clarify our aims and the expectations for participating in a series of small-group videoconference meetings over the next 4–6 months. Potential members were encouraged via email to explain why they were interested in being part of the group, and specify if they had experience of hypertension in pregnancy.

Meeting preparation

Following NIHR recommendations, we developed a charter ‘Terms of Reference’, outlining the rules and expectations of the group to which all members must agree (Additional file 2). A Lead PPIE Officer (ST) was nominated who was already a Senior Research Midwife within the WILL Trial Management Team. In addition to her primary trial management responsibilities, she took on accountability for the PPIE group and responsibility for facilitating group activities.

We assembled a list of questions/discussion points to guide conversation and improve understanding of the key information we aimed to feature in the infographic. Discussion points included how to explain the complications of chronic and gestational hypertension; use of clear, appropriate wording; and use of inclusive images and their aesthetics. At the first meeting, the Senior Trial Manager provided a short presentation summarising the WILL Trial’s aims and the current evidence for the risks of chronic and gestational hypertension at term gestational age, to ensure that all members had a shared understanding of the research context.

During the COVID-19 pandemic, virtual meetings had become commonplace, so this was the chosen format for all meetings, in line with guidance by the National Coordinating Centre for Public Engagement [19]. A meeting scheduling poll was emailed to members to organise the timing of the first meeting; we suggested a range of days and times, including those outside normal office hours, with at least 2 weeks’ notice. We selected a date and time that accommodated the majority of members and emailed calendar invitations, the Terms of Reference, a brief outline of our aims, questions/discussion points and the WILL PIS and Introductory Pamphlet for context [7]. We produced ‘Welcome Packs’ containing all of these documents, and posted them to each member. In awareness of potential barriers to participation, such as digital divide or visual impairments, we offered members a range of media to access these materials.

Meetings

The initial meeting began with introductions, and a request for permission to record the session. It was explained that minutes would be taken and shared after the meeting. Members were asked to leave their cameras on, if possible, to replicate the feeling of a face-to-face meeting. We presented a brief slideshow to explain what PPIE is, introduce the WILL Trial and set out our aims to develop an infographic that would educate women with chronic or gestational hypertension about their condition in pregnancy, empower them to initiate discussions with their care-providers and highlight the need for more research into timing of birth. We discussed the PPIE Terms of Reference, invited feedback and sought verbal agreement on the terms.

To accommodate as many members as possible, sessions were held at various times of the day, including evenings. After each session, all members were provided with the minutes to review by email or post, along with an expense form for reimbursement for their time spent in, or preparing for meetings or providing feedback. At subsequent sessions, feedback was explored further with the group and incorporated into the draft infographic. Open discussion was encouraged and comments invited verbally or via the chat function within Microsoft Teams. This exchange continued for four sessions, until saturation of ideas and consensus had been reached. The infographic was designed in Microsoft Publisher by the Senior Trial Manager (KK), and a QR code was incorporated into the design to signpost potential participants to the WILL Trial Introductory Pamphlet. The final version was submitted for ethical approval.

Results

The seven PPIE members engaged with the trial team independently of the WILL trial sites. Six responded to our advertisement on the NIHR People in Research website [18] and one via APEC. Most had no prior PPIE experience, but all had either lived experience of pregnancy hypertension or personal/family interest in the condition, and so were broadly representative of the intended participant population and their families. All 42 sites open to WILL at the time were contacted to provide details of WILL participants willing to take part in a PPIE group; one person came forward to express interest, but then did not reply to further communication.

All PPIE members confirmed that they had relevant experience or interest in pregnancy hypertension and shared background information about themselves. The group included five members from minority ethnic groups, one healthcare translator and five with experience related to pregnancy hypertension, including one partner (not mutually exclusive).

Meetings were scheduled close together to maintain momentum for the project. PPIE activity over the course of 9 months amounted to a significant proportion of the team’s working hours. Four meetings were held between 22 February and 28 June 2022. Each meeting had a median of five members in attendance, with no meeting attended by all PPIE members. Feedback was provided by those not in attendance on two occasions, by a total of four people, by email or telephone. One member preferred to provide feedback in writing for the PPIE Officer to relay to the group.

Meeting materials were provided in alternative formats, upon request. The meetings were not recorded, as some members did not provide permission. Minutes were taken by the Senior Trial Manager and shared with members, as planned. Technical issues common to online meetings were sometimes experienced, including poor Wi-Fi signal, poor sound quality and problems with webcams, which resulted in some members not being seen.

Group members raised interesting viewpoints from their own cultural perspectives. They felt that it was important to use inclusive images for greatest appeal, such as those of people with a disability, and a variety of skin colours, cultures and genders.

The infographic went through 15 iterations over 9 months. This extended timeline reflected the need for multiple rounds of detailed feedback, consensus-building across diverse perspectives and iterative redesign to incorporate suggestions. Delays also arose from scheduling across members who had not worked together previously, technical issues during online meetings, and the need to obtain REC approval after revisions. In hindsight, earlier agreement on core design principles and a more streamlined process for collating feedback may have shortened this process.

During discussions of language, the group did not reach unanimous agreement on gender-neutral terminology. This generated discussion about the process of consensus-building and how to consider the opinions of all members of the group. Despite use of gendered language in the WILL Trial materials to date (approved 3 years earlier and without negative feedback), the majority supported non-gendered wording as more inclusive, and the compromise reached was to use phrases such as ‘pregnancies affected by hypertension’ rather than ‘women with pregnancy hypertension’. While this may not reflect the preferences of all members, the group agreed it was an acceptable balance. We accepted a majority consensus for the key elements of the poster (i.e. content, wording, images/aesthetics, font style and size).

The final version of the infographic was submitted 8 months after the first meeting, in October 2022, to the Fulham Research Ethics Committee (REC) as a substantial protocol amendment for the WILL trial. The REC responded that, ‘…the information as presented is too stark and needs to be much more nuanced especially as it uses the blanket term “pregnancy hypertension” which includes mild to severe hypertension’. despite our reassurances that this wording was carefully considered and agreed following engagement with our PPIE group, with the aim of providing people with facts about the risks. Considering the urgent need to improve recruitment, we amended the message to obtain REC approval. In particular, we replaced a reference to a ‘1 in 1000 risk of stillbirth’ with, ‘Sadly, there is also a small increased risk of stillbirth after 36 weeks’. Given the urgency noted, the Trial Management team considered it imperative that the infographic could be utilised by recruiting sites as quickly as possible, and therefore, this final edit was made without consultation with the wider PPIE group. Some PPIE members expressed disappointment that the group’s agreed phrasing was not retained. However, they accepted the trial team’s decision to comply with REC requirements, to ensure that the infographic could be used in practice. REC approval for the infographic was granted on 18 November 2022 (Fig. 1).

Fig. 1.

WILL Hypertension in Pregnancy Infographic V1.0 08Nov2022. Legend: Infographic showing the risks of chronic or gestational hypertension in pregnancy

Our learnings are listed in a PPIE ‘checklist’ (Table 1), that summarises: recommended reading, composition and purpose of a PPIE group, reimbursement or payment, advertising for members, pre-meeting planning, and process during, following, and between meetings.

Table 1.

Checklist for PPIE

Essential steps	Details
Recommended reading	• NIHR (https://www.nihr.ac.uk/documents/ppi-patient-and-public-involvement-resources-for-applicants-to-nihr-research-programmes/23437) • Health Research Authority (https://www.hra.nhs.uk/planning-and-improving-research/best-practice/public-involvement/) • Research Support Service (https://www.nihr.ac.uk/support-and-services/research-support-service) • National Coordinating Centre for Public Engagement (https://www.publicengagement.ac.uk/resources/guide/online-engagement-guide-creating-and-running-virtual-events) • Local Biomedical Research Centre (for information on PPIE training (https://local.nihr.ac.uk/lcrn/) • Local Clinical Research Network (https://local.nihr.ac.uk/lcrn/) • Contact the PPIE Lead in your organisation, if available • Public Involvement in Research Impact Toolkit (PIRIT Tool) Public Involvement in Research Impact Toolkit (PIRIT)—Marie Curie Research Centre—Cardiff University [25] (https://www.cardiff.ac.uk/marie-curie-research-centre/patient-and-public-involvement/public-involvement-in-research-impact-toolkit-pirit)
Composition and purpose of PPIE group	• Consider the person specification of PPIE members (e.g. age, ethnicity, geographic area, lived experience [direct or indirect] of a specific condition) that reflects the group or population of research interest • Consider selection criteria and a process for shortlisting • Define the purpose of the group
Reimbursement or payment	• Consult NIHR Guidance on PPIE payments (https://www.nihr.ac.uk/documents/payment-guidance-for-researchers-and-professionals/27392) • Understand your PPIE budget. Consult your Finance Officer if necessary
Advertising for members	Consider how to advertise for members so that your target population can apply. Suggestions could include: • Websites (trial, condition-specific charity, NIHR People in Research [https://www.peopleinresearch.org/]); • Social media (e.g. Facebook, X); • Posters/flyers (e.g. in shops, GP surgeries, hospital clinics, charity shops, churches, existing PPIE groups) Include the following information in the advert: • Person specification; • Number of anticipated meetings (i.e. 3 times a year, monthly) and types of opportunities available; • Anticipated objectives; • Meeting platform (e.g. face-to-face, virtual, hybrid); • Reimbursement opportunities (accommodation, travel, subsistence, time); • Closing date of advert; • Main point of contact; • Use plain language Consider other forms of communication to include those with different needs (e.g. translation into other languages, braille, or audible adverts)
Pre-meeting planning	• Discuss meeting requirements with a PPIE co-lead, if possible • Assess members’ prior experience, identifying any barriers to participation and plan to provide appropriate support where required • Decide on a meeting format (online, face to face or mixed) that encourages involvement from a variety of contributors and types of contribution • Define roles within the group (e.g. Chair, minute-taker, PPIE Lead) • Agree timelines for outputs • Develop an Agenda & Meeting Pack to send at least 1 week before meetings (e.g. cover letter with contact details, expenses form, essential information about your study, and objectives of the group • Create a dedicated folder within the Trial Master File to document PPIE activity
Process during meetings	• Outline housekeeping rules, follow the agenda, and keep to time • Co-produce and seek agreement on clear Terms of Reference • Negotiate and agree objectives for the PPIE contributors • Provide minutes from previous meeting and review any post-meeting feedback that has been received • Consider differences of opinions within the group and how to resolve these • Close meetings by summarising what has been discussed and setting out plans for and timing of next meeting • Remind members to complete expenses forms
Process following meetings	• Circulate meeting minutes/summary and encourage feedback • Process expense forms promptly • Prepare for next meeting(s)
Process between meetings	• Consider how to keep the group engaged between meetings (e.g. WhatsApp group)

NIHR (National Institute for Health and Care Research), PPIE (Patient and Public Involvement and Engagement)

Discussion

Summary of findings

Our experience of setting up a PPIE group without a funded PPIE co-lead revealed that the process was more complex and required more time than anticipated. We found that despite the number of resources available in this area, there was a need for further guidance about practicalities of PPIE group development processes [9–16, 20]. Technical difficulties were sometimes experienced which are familiar to users of online meetings. Given diverse opinions within the group, we were not always able to reach consensus; however, all views were carefully considered and the rationale for decision-making was communicated to the group, which was always the majority view. Finally, the infographic generated was not initially accepted by the REC, who insisted on revising the PPIE-approved wording about the risk of stillbirth.

Comparison with the literature

The experience of developing an infographic related to timing of birth highlighted the importance of understanding different cultural perspectives related to birth. PPIE members, particularly those from ethnic minority backgrounds, expressed concerns regarding medical interventions, such as induction of labour or caesarean section (the intervention in WILL), independent of previous birth experience [21]. While it is possible that broader PPIE input before trial funding might have highlighted some cultural concerns around the acceptability of induction of labour, such a process requires funding that had not yet been secured for participant payment.

A stumbling block in engaging with patients and the public is a lack of professionals’ knowledge, skills and expertise in this area, particularly in adapting resources to their specific situation [22]. This was certainly the case for our team. When the WILL application was submitted, we had a PPIE co-applicant and PPIE time for members in our budget, but not funding for a PPIE co-Lead, which is now standard practice to bring skills in public engagement, using personal and professional networks and established contacts [23, 24]. PPIE co-leads are valuable liaisons between the research team and PPIE members, helping to create a sense of cohesiveness, and guide between-meeting activities. However, given the wealth of research ongoing in the UK and the limited number of experienced PPIE co-leads available to organisations and specific researchers, we felt that practical guidance could help support trial management teams who are less-experienced in PPIE. Due to considerable interest from the research community, a toolkit has been made freely accessible for wider use under licence by researchers at the Marie Curie Research Centre. The Public Involvement in Research Impact Tool (PIRIT) [25] was developed in 2023 with the aim ‘to support researchers working with public contributors to integrate effective public involvement at all stages of a research study’. While there is overlap with regards to involvement of the appropriate population to meet your project’s PPIE needs, and how to organise the PPIE activities, most of the PIRIT checklist covers how PPIE makes a difference, how to document that difference for your project and ideas that arise for improvement to PPIE for the future. The WILL Checklist for PPIE complements PIRIT, by providing practical guidance for conducting PPIE meetings, especially those focussing on a particular output, with items presented chronologically and covers additional areas of recommended reading, details of meeting planning, and engagement between meetings.

For our online meetings, we deliberated about the use of cameras. Advantages include improved relationships, communication, engagement and trust building, as documented in a survey of 4200 work-from-home employees [28]. However, potential concerns include privacy, judgement on appearance or living space, fears about being on camera and technical difficulties. PPIE terms of reference should address these considerations before meetings start, and provide clear and co-produced guidance regarding meeting etiquette.

In an analysis of REC applications for NHS-based research in England (2014), researchers were found rarely to describe PPIE involvement in enough detail to help REC members evaluate whether the research was acceptable to those who would take part [26]. However, our experience suggests that some work is required at the regulatory level, to understand how to respond to clearly-labelled PPIE-directed material. The stance taken by the responsible REC was contrary to the concept of offering primacy to PPIE group members’ expressed views, and the stance taken by Sands (the relevant charity), over the opinions of (often) non-expert REC members.

Strengths and limitations

Reflecting on the strengths of this project, we note that our PPIE group was highly-diverse in age, experience, culture, ethnicity and gender, and that members were deeply engaged in the subject matter. The group’s contributions were directly translated into tangible changes in patient-facing materials, ensuring that inclusivity and cultural sensitivity were embedded. The documentation of our process, including practical challenges and consensus-building, provides an important contribution to PPIE practice by offering trial teams an applied example and a pragmatic checklist to guide future activities.

A limitation of our work was that PPIE members were primarily recruited via NIHR People in Research and APEC, rather than through community groups or local networks [10, 20, 27]. While we considered these routes, they were logistically difficult to implement across > 40 trial sites within available resources. Future projects should plan dedicated time and funding for community-based recruitment to broaden representation further.

The infographic development process took longer than anticipated and reflects the absence of early consensus on design and feedback processes. Establishing clear principles and streamlined workflows at the outset may help other teams avoid similar delays. Unfortunately, by the time the infographic was approved for use at sites, the funder had cited slower-than-anticipated recruitment and closed the trial. As such, we were unable to fully implement the infographic at sites, or evaluate its impact on recruitment.

The NIHR People in Research website was a promising resource to find potential members who are likely to be research-aware and digitally-able; however, pre-meeting discussions with individual PPIE members, to craft clear and co-produced terms of reference, are important to ensure that the expectations of PPIE members and researchers are aligned, and additional resources can be identified to balance different levels of experience within the group. Nevertheless, People in Research is a valuable resource for researchers looking to recruit PPIE members to new groups or established ones, to refresh a grass-roots perspective.

We acknowledge that while online meetings enabled participation from geographically dispersed members and allowed some members to maintain privacy (by not turning on their camera), a face-to-face or hybrid model might have strengthened relationship-building and reduced technical challenges. Future PPIE activities should consider a blended approach to balance accessibility with richer group dynamics.

Finally, we did not collect formal, structured feedback from PPIE members on their experience of working with the research team. Such feedback could help refine future approaches. We suggest that future projects build systematic evaluation of PPIE members’ experiences into their design, in line with emerging frameworks, such as PIRIT.

Conclusions

We have produced a checklist as an additional resource for researchers, informed by our experience of working with PPIE members whilst developing an infographic for the WILL trial. The checklist aims to provide practical support for researchers seeking to establish PPIE groups, especially if they lack the input of a PPIE co-lead. Further work could investigate how best to support RECs to review PPIE co-produced resources.

Abbreviations

APEC

Action on Pre-eclampsia Charity

HTA

Health Technology Assessment

NIHR

National Institute for Health and Care Research

PIRIT

Public Involvement in Research Impact Toolkit

PPIE

Patient and Public Involvement and Engagement

REC

Research Ethics Committee

WILL

When to Induce Labour to Limit risk in pregnancy hypertension Trial

Authors’ contributions

The trial was conceived by LAM, PvD and JH and JS, listed in Additional File 1. All authors contributed to the design and delivery of the trial. The authors KK and ST assume responsibility for the accuracy and completeness of data reporting. KK and ST drafted the manuscript, which was revised and approved by all authors.

Funding

The trial was funded by the National Institute of Health Research (NIHR) Health Technology Assessment Programme (project number 16/167/123) that was not involved in data collection or analysis.

Data availability

Not applicable.

Declarations

Ethics approval and consent to participate

Ethics approval has been obtained (NHS Health Research Authority London Fulham Research Ethics Committee, 18/LO/2033).

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.