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

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 | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article 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 Katie Louise Kirkham, Sue Tohill, Julie Wade, Clive Stubbs, Peter von Dadelszen, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5326038/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 21 Jan, 2026 Read the published version in Trials → Version 1 posted You are reading this latest preprint version 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 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. public patient involvement engagement trial management Figures Figure 1 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 ]. 403 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 NIHR guidance for payment of PPIE members, we offered reimbursement of £20 per participant per hour [14]. We advertised that we were particularly interested in hearing from those 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 expressed an interest, to clarify our aims and expectations of involvement in a series of regular meetings over the next 4-6 months, via videoconference in a small group format. 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 was nominated (ST) who was accountable to the PPIE group and responsible 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. A brief presentation was produced, outlining our aims and the role of PPIE members in helping us to achieve them. 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 two 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. 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 expenses form for reimbursement of 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. 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. APEC connected us with one woman with lived experience of pregnancy hypertension. Six people engaged with us directly from an advertisement on the NIHR People in Research website, having invited seven who initially expressed interest [ 18 ]. 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 nine 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. Fifteen drafts of the infographic were designed. The group discussed use of inclusive, non-gender-based language. At the final meeting, the group suggested removing gender-based words, such as “women” or “mothers”, but while this sentiment was supported by the majority of members, it was not unanimous. This generated discussion about the process of consensus-building and how to consider the opinions of all members of the group. We reached a compromise in the agreed wording, maintaining gender-neutral principles by referring to “pregnancies affected by hypertension”, rather than “women with pregnancy hypertension”, referring to readers as “you” rather than “women” or “mothers”, and changing sentences to eliminate the need for female terminology. 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 eight 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. REC approval for the infographic was granted on 18 November 2022 (Fig. 1 WILL Hypertension in Pregnancy Infographic V1.0 08Nov2022 ). 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 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]. 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 A strength of the WILL PPIE group was that they were diverse in age, experience, culture, ethnicity, and gender. Members were very engaged in the subject matter and expanded our understanding and perceptions of pregnancy hypertension. Limitations included our recruitment from primarily one source; we considered placing advertisements on social media, or posting flyers in areas where one would expect to find one’s population of interest (e.g. GP surgeries or hospital clinics) [10, 20, 27], but this was a more complicated route in a trial with such a large number of sites. The infographic development process took longer than anticipated and 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 it’s 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. 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 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. Availability of data and materials Not applicable. Competing interests The authors declare that they have no competing interests. The views expressed are those of the author(s) and not necessarily those of NIHR, the NHS, or the Department of Health and Social Care, UK. 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. 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. Acknowledgments We wish to thank the women who participated in the trial, and the large number of site contributors, listed in Additional File 1 who made possible this study. We extend our sincere thanks to our independent Trial Steering (Tim Draycott [Chair], Graeme MacLennan, Lucy MacKillop, Paul Mannix, Ruth Unstead-Joss) and Data Monitoring (Diana Elbourne (Chair), Henk Groen (Vice-Chair), Deborah Harrington, Edile Murdoch, Sarah Stock, and David Odd) Committees for generously contributing their time and guidance. We would also like to thank Daphna Fenchel for reviewing the manuscript and resources. Patient and public involvement (PPIE) The trial had two PPIE members in the Co-Investigator Group (see Additional File 1 ), a PPIE representative on the TSC (Ruth Unstead-Joss), and a bespoke PPIE group (including Emma Jukes, Fatima Rami, Al Richards, Khilna Rupen, and Debs Smith) that reviewed patient and public-facing material for trial promotion and recruitment. References Magee LA, Brown MA, Hall DR, Gupte S, Hennessy A, Karumanchi SA, et al. 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Res Involv Engagem 3, 30 (2017). https://doi.org/10.1186/s40900-017-0080-0 Local Clinical Research Network: https://local.nihr.ac.uk/lcrn/ Accessed 25 Sep 2024 Barrero, Jose Maria, Nicholas Bloom, and Steven J. Davis, 2021.“Why working from home will stick,” National Bureau of Economic Research Working Paper 28731. www.wfhresearch.com Accessed 25 Sep 2024 Supplementary Files Additonalfile1WILLTrialStudyGroup.docx Additional file 1: WILL Trial Study Group (.docx) Additionalfile2TermsofreferencePPIE.docx Additional file 2: Terms of Reference PPIE (.docx) Cite Share Download PDF Status: Published Journal Publication published 21 Jan, 2026 Read the published version in Trials → Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Kirkham","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA70lEQVRIiWNgGAWjYBACCQbmBsYGAwYDAwYGxseMDTDxA/i0MMK1MBuToIUBrIVNmigtkkANjDMK7hmbs59Oqy7cYRfNwH74ATPPGdxapEG2bDAoNrPsyd12e+aZ5NwGnjQDZp4buLXIgbQ8MEiwMTgA1MLbxpzbwJDDwMzzgRgt599uK+Ztq89t4H+DXwvUYQlmBjdytzHzth3ObZAA2YLHYZLNjA0HZxgkGBvceLtZembb8dw2iWcGB+fg8b7E8eaDD3v+JBhuOJ+78XNhW3VuP3/ywwdvjuHWwsCMHgdsDHhjZRSMglEwCkYBMQAAI2lSga6eeSQAAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0001-5727-6049","institution":"University of Birmingham Clinical Trials Unit","correspondingAuthor":true,"prefix":"","firstName":"Katie","middleName":"Louise","lastName":"Kirkham","suffix":""},{"id":468789509,"identity":"60d9b521-9bf6-4188-993a-28b0f10a33a4","order_by":1,"name":"Sue Tohill","email":"","orcid":"","institution":"University of Birmingham Clinical Trials Unit","correspondingAuthor":false,"prefix":"","firstName":"Sue","middleName":"","lastName":"Tohill","suffix":""},{"id":468789510,"identity":"f9f43c09-3e0e-48b3-babc-dca9069c841f","order_by":2,"name":"Julie Wade","email":"","orcid":"","institution":"Guy's and St Thomas' Hospitals NHS Trust: Guy's and St Thomas' NHS Foundation Trust","correspondingAuthor":false,"prefix":"","firstName":"Julie","middleName":"","lastName":"Wade","suffix":""},{"id":468789511,"identity":"881d6b46-6e56-4a49-a423-0580b38d2629","order_by":3,"name":"Clive Stubbs","email":"","orcid":"","institution":"University of Birmingham Clinical Trials Unit","correspondingAuthor":false,"prefix":"","firstName":"Clive","middleName":"","lastName":"Stubbs","suffix":""},{"id":468789512,"identity":"eba349b1-dcb8-4f6c-b60c-4d98bdff355b","order_by":4,"name":"Peter von Dadelszen","email":"","orcid":"","institution":"King's College Hospital NHS Trust: King's College Hospital NHS Foundation Trust","correspondingAuthor":false,"prefix":"","firstName":"Peter","middleName":"","lastName":"von Dadelszen","suffix":""},{"id":468789513,"identity":"84900681-95af-4c3c-8cc0-39ad1b408195","order_by":5,"name":"Al Richards","email":"","orcid":"","institution":"Public Citizen","correspondingAuthor":false,"prefix":"","firstName":"Al","middleName":"","lastName":"Richards","suffix":""},{"id":468789514,"identity":"3363b4b7-08c6-48af-a6ce-8fd0a9d865fb","order_by":6,"name":"Emma Margaret Jukes","email":"","orcid":"","institution":"Public Citizen","correspondingAuthor":false,"prefix":"","firstName":"Emma","middleName":"Margaret","lastName":"Jukes","suffix":""},{"id":468789515,"identity":"4a8acdab-e811-46aa-8641-c7210cf561bf","order_by":7,"name":"Laura A Magee","email":"","orcid":"","institution":"King's College Hospital NHS Trust: King's College Hospital NHS Foundation Trust","correspondingAuthor":false,"prefix":"","firstName":"Laura","middleName":"A","lastName":"Magee","suffix":""}],"badges":[],"createdAt":"2024-10-24 13:00:14","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5326038/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5326038/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13063-025-09218-6","type":"published","date":"2026-01-21T15:57:50+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":85068779,"identity":"b96c8833-1b02-4b82-b6d7-9b0e15f93a26","added_by":"auto","created_at":"2025-06-20 15:25:11","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":602063,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eWILL Hypertension in Pregnancy Infographic V1.0 08Nov2022\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eLegend\u003cstrong\u003e: \u003c/strong\u003eInfographic showing the risks of chronic or gestational hypertension in pregnancy\u003c/p\u003e","description":"","filename":"Figure1WILLHypertensioninPregnancyInfographic.png","url":"https://assets-eu.researchsquare.com/files/rs-5326038/v1/f65b049f46786e7f6532f5dd.png"},{"id":101151731,"identity":"6af238fa-0bf4-49f9-9c57-0118f22b4109","added_by":"auto","created_at":"2026-01-26 16:03:36","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1241794,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5326038/v1/0c8b8b65-bff6-4749-a6d9-df5c8595c8b5.pdf"},{"id":85069923,"identity":"9fa3806e-c701-42e5-ab4e-1b8cd1b3ead3","added_by":"auto","created_at":"2025-06-20 15:33:12","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":18687,"visible":true,"origin":"","legend":"\u003cp\u003eAdditional file 1: WILL Trial Study Group (.docx)\u003c/p\u003e","description":"","filename":"Additonalfile1WILLTrialStudyGroup.docx","url":"https://assets-eu.researchsquare.com/files/rs-5326038/v1/60313883fa73c9f74ae3f1fb.docx"},{"id":85069924,"identity":"e47bd08c-84b8-4e92-9d43-c4f2b3b70654","added_by":"auto","created_at":"2025-06-20 15:33:12","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":147739,"visible":true,"origin":"","legend":"\u003cp\u003eAdditional file 2: Terms of Reference PPIE (.docx)\u003c/p\u003e","description":"","filename":"Additionalfile2TermsofreferencePPIE.docx","url":"https://assets-eu.researchsquare.com/files/rs-5326038/v1/e010a1fc1db86b6c79ec9bdc.docx"}],"financialInterests":"","formattedTitle":"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","fulltext":[{"header":"BACKGROUND","content":"\u003cp\u003eThe hypertensive disorders of pregnancy affect approximately 10% of pregnancies, and are responsible for substantial maternal and fetal/newborn mortality and morbidity [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. 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 [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe 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 [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. 403 women were randomised to one of two timing of birth arms: intervention (planned early term birth at 38\u003csup\u003e+\u0026thinsp;0\u003c/sup\u003e\u0026ndash;38\u003csup\u003e+\u0026thinsp;3\u003c/sup\u003e weeks\u0026rsquo; gestation) or control (expectant care until 40\u003csup\u003e+\u0026thinsp;0\u003c/sup\u003e weeks, later revised to \u0026lsquo;usual care at term\u0026rsquo;), 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\u0026thinsp;\u0026asymp;\u0026thinsp;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 [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe 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 [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]; 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) [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e] and resources on the Action on Pre-Eclampsia Charity (APEC) website [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe 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 \u0026lsquo;how to\u0026rsquo; guide/checklist for researchers.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cp\u003e\u003cem\u003eResources for PPIE\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe 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].\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eInvolving and Engaging with PPIE group members\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eTo 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 \u0026lsquo;People in Research\u0026rsquo; 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 NIHR guidance for payment of PPIE members, we offered reimbursement of \u0026pound;20 per participant per hour [14]. We advertised that we were particularly interested in hearing from those from minority ethnic groups, who might provide a different perspective on timed birth (by labour induction or Caesarean), the intervention in WILL.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTo screen potential group members, we emailed everyone who expressed an interest, to clarify our aims and expectations of involvement in a series of regular meetings over the next 4-6 months, via videoconference in a small group format. 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.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eMeeting preparation\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eFollowing NIHR recommendations, we developed a charter \u0026lsquo;Terms of Reference\u0026rsquo;, outlining the rules and expectations of the group to which all members must agree (\u003cstrong\u003eAdditional file 2\u003c/strong\u003e). A Lead PPIE Officer was nominated (ST) who was accountable to the PPIE group and responsible for facilitating group activities.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe 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. A brief presentation was produced, outlining our aims and the role of PPIE members in helping us to achieve them.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDuring 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 two weeks\u0026rsquo; 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. We produced \u0026lsquo;Welcome Packs\u0026rsquo; 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.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eMeetings\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe 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. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTo 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 expenses form for reimbursement of 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.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eThis 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.\u0026nbsp;\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003eThe seven PPIE members engaged with the trial team independently of the WILL trial sites. 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. APEC connected us with one woman with lived experience of pregnancy hypertension. Six people engaged with us directly from an advertisement on the NIHR People in Research website, having invited seven who initially expressed interest [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAll 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).\u003c/p\u003e \u003cp\u003eMeetings were scheduled close together to maintain momentum for the project. PPIE activity over the course of nine months amounted to a significant proportion of the team\u0026rsquo;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.\u003c/p\u003e \u003cp\u003eMeeting 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.\u003c/p\u003e \u003cp\u003eGroup 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. Fifteen drafts of the infographic were designed. The group discussed use of inclusive, non-gender-based language. At the final meeting, the group suggested removing gender-based words, such as \u0026ldquo;women\u0026rdquo; or \u0026ldquo;mothers\u0026rdquo;, but while this sentiment was supported by the majority of members, it was not unanimous. This generated discussion about the process of consensus-building and how to consider the opinions of all members of the group. We reached a compromise in the agreed wording, maintaining gender-neutral principles by referring to \u0026ldquo;pregnancies affected by hypertension\u0026rdquo;, rather than \u0026ldquo;women with pregnancy hypertension\u0026rdquo;, referring to readers as \u0026ldquo;you\u0026rdquo; rather than \u0026ldquo;women\u0026rdquo; or \u0026ldquo;mothers\u0026rdquo;, and changing sentences to eliminate the need for female terminology. We accepted a majority consensus for the key elements of the poster (i.e., content, wording, images/aesthetics, font style, and size).\u003c/p\u003e \u003cp\u003eThe final version of the infographic was submitted eight 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, \u003cem\u003e\u0026ldquo;\u0026hellip;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.\u0026rdquo;\u003c/em\u003e 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 \u003cem\u003e\u0026ldquo;1 in 1000 risk of stillbirth\u0026rdquo;\u003c/em\u003e with, \u003cem\u003e\u0026ldquo;Sadly, there is also a small increased risk of stillbirth after 36 weeks.\u0026rdquo;\u003c/em\u003e 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. REC approval for the infographic was granted on 18 November 2022 (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e \u003cb\u003eWILL Hypertension in Pregnancy Infographic V1.0 08Nov2022\u003c/b\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eOur learnings are listed in a PPIE \u0026lsquo;checklist\u0026rsquo; (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e), 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.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eChecklist for PPIE\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEssential steps\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDetails\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eRecommended reading\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; NIHR (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.nihr.ac.uk/documents/ppi-patient-and-public-involvement-resources-for-applicants-to-nihr-research-programmes/23437\u003c/span\u003e\u003cspan address=\"https://www.nihr.ac.uk/documents/ppi-patient-and-public-involvement-resources-for-applicants-to-nihr-research-programmes/23437\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e)\u003c/span\u003e\u003c/p\u003e \u003cp\u003e\u0026bull; Health Research Authority (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.hra.nhs.uk/planning-and-improving-research/best-practice/public-involvement/\u003c/span\u003e\u003cspan address=\"https://www.hra.nhs.uk/planning-and-improving-research/best-practice/public-involvement/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e)\u003c/span\u003e\u003c/p\u003e \u003cp\u003e\u0026bull; Research Support Service (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.nihr.ac.uk/support-and-services/research-support-service\u003c/span\u003e\u003cspan address=\"https://www.nihr.ac.uk/support-and-services/research-support-service\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e)\u003c/span\u003e\u003c/p\u003e \u003cp\u003e\u0026bull; National Coordinating Centre for Public Engagement (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.publicengagement.ac.uk/resources/guide/online-engagement-guide-creating-and-running-virtual-events\u003c/span\u003e\u003cspan address=\"https://www.publicengagement.ac.uk/resources/guide/online-engagement-guide-creating-and-running-virtual-events\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e)\u003c/span\u003e\u003c/p\u003e \u003cp\u003e\u0026bull; Local Biomedical Research Centre (for information on PPIE training (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://local.nihr.ac.uk/lcrn/\u003c/span\u003e\u003cspan address=\"https://local.nihr.ac.uk/lcrn/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e)\u003c/span\u003e\u003c/p\u003e \u003cp\u003e\u0026bull; Local Clinical Research Network (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://local.nihr.ac.uk/lcrn/\u003c/span\u003e\u003cspan address=\"https://local.nihr.ac.uk/lcrn/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e)\u003c/span\u003e\u003c/p\u003e \u003cp\u003e\u0026bull; Contact the PPIE Lead in your organisation, if available.\u003c/p\u003e\u003cp\u003e\u0026bull; Public Involvement in Research Impact Toolkit (PIRIT Tool) \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003ePublic Involvement in Research Impact Toolkit (PIRIT) - Marie Curie Research Centre - Cardiff University\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eComposition and purpose of PPIE group\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; 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.\u003c/p\u003e \u003cp\u003e\u0026bull; Consider selection criteria and a process for shortlisting.\u003c/p\u003e \u003cp\u003e\u0026bull; Define the purpose of the group.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eReimbursement or payment\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Consult NIHR Guidance on PPIE payments (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.nihr.ac.uk/documents/payment-guidance-for-researchers-and-professionals/27392\u003c/span\u003e\u003cspan address=\"https://www.nihr.ac.uk/documents/payment-guidance-for-researchers-and-professionals/27392\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e)\u003c/span\u003e\u003c/p\u003e \u003cp\u003e\u0026bull; Understand your PPIE budget. Consult your Finance Officer if necessary.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAdvertising for members\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eConsider how to advertise for members so that your target population can apply Suggestions could include:\u003c/p\u003e \u003cp\u003e\u0026bull; Websites (trial, condition-specific charity, NIHR People in Research [\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.peopleinresearch.org/\u003c/span\u003e\u003cspan address=\"https://www.peopleinresearch.org/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e]);\u003c/span\u003e\u003c/p\u003e \u003cp\u003e\u0026bull; Social media (e.g. Facebook, X);\u003c/p\u003e \u003cp\u003e\u0026bull; Posters/flyers (e.g., in shops, GP surgeries, hospital clinics, charity shops, churches, existing PPIE groups)\u003c/p\u003e \u003cp\u003eInclude the following information in the advert:\u003c/p\u003e \u003cp\u003e\u0026bull; Person specification;\u003c/p\u003e \u003cp\u003e\u0026bull; Number of anticipated meetings (i.e. 3 times a year, monthly) and types of opportunities available;\u003c/p\u003e \u003cp\u003e\u0026bull; Anticipated objectives;\u003c/p\u003e \u003cp\u003e\u0026bull; Meeting platform (e.g., face-to-face, virtual, hybrid);\u003c/p\u003e \u003cp\u003e\u0026bull; Reimbursement opportunities (accommodation, travel, subsistence, time);\u003c/p\u003e \u003cp\u003e\u0026bull; Closing date of advert;\u003c/p\u003e \u003cp\u003e\u0026bull; Main point of contact;\u003c/p\u003e \u003cp\u003e\u0026bull; Use plain language.\u003c/p\u003e \u003cp\u003eConsider other forms of communication to include those with different needs (e.g. translation into other languages, braille, or audible adverts).\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePre-meeting planning\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Discuss meeting requirements with a PPIE co-lead, if possible.\u003c/p\u003e \u003cp\u003e\u0026bull; Assess members\u0026rsquo; prior experience, identifying any barriers to participation and plan to provide appropriate support where required.\u003c/p\u003e \u003cp\u003e\u0026bull; Decide on a meeting format (online, face to face or mixed) that encourages involvement from a variety of contributors and types of contribution.\u003c/p\u003e \u003cp\u003e\u0026bull; Define roles within the group (e.g., Chair, minute-taker, PPIE Lead).\u003c/p\u003e \u003cp\u003e\u0026bull; Agree timelines for outputs.\u003c/p\u003e \u003cp\u003e\u0026bull; Develop an Agenda \u0026amp; 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.\u003c/p\u003e \u003cp\u003e\u0026bull; Create a dedicated folder within the Trial Master File to document PPIE activity.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eProcess during meetings\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Outline housekeeping rules, follow the agenda, and keep to time.\u003c/p\u003e \u003cp\u003e\u0026bull; Co-produce and seek agreement on clear Terms of Reference.\u003c/p\u003e \u003cp\u003e\u0026bull; Negotiate and agree objectives for the PPIE contributors.\u003c/p\u003e \u003cp\u003e\u0026bull; Provide minutes from previous meeting and review any post-meeting feedback that has been received.\u003c/p\u003e \u003cp\u003e\u0026bull; Consider differences of opinions within the group and how to resolve these.\u003c/p\u003e \u003cp\u003e\u0026bull; Close meetings by summarising what has been discussed and setting out plans for and timing of next meeting.\u003c/p\u003e \u003cp\u003e\u0026bull; Remind members to complete expenses forms\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eProcess following meetings\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Circulate meeting minutes/summary and encourage feedback.\u003c/p\u003e \u003cp\u003e\u0026bull; Process expense forms promptly.\u003c/p\u003e \u003cp\u003e\u0026bull; Prepare for next meeting(s).\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eProcess between meetings\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Consider how to keep the group engaged between meetings (e.g., WhatsApp group).\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"2\"\u003e\u003cem\u003eNIHR (National Institute for Health and Care Research), PPIE (Patient and Public Involvement and Engagement)\u003c/em\u003e\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003e\u003cem\u003eSummary of findings\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eOur 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 \u003cem\u003epracticalities\u003c/em\u003e 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.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eComparison with the literature\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe 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].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA stumbling block in engaging with patients and the public is a lack of professionals\u0026rsquo; 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 \u0026ldquo;to support researchers working with public contributors to integrate effective public involvement at all stages of a research study\u0026rdquo;. While there is overlap with regards to involvement of the appropriate population to meet your project\u0026rsquo;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.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFor 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.\u003c/p\u003e\n\u003cp\u003eIn 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\u0026rsquo; expressed views, and the stance taken by Sands (the relevant charity), over the opinions of (often) non-expert REC members.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStrengths and limitations\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eA strength of the WILL PPIE group was that they were diverse in age, experience, culture, ethnicity, and gender. Members were very engaged in the subject matter and expanded our understanding and perceptions of pregnancy hypertension.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eLimitations included our recruitment from primarily one source; we considered placing advertisements on social media, or posting flyers in areas where one would expect to find one\u0026rsquo;s population of interest (e.g. GP surgeries or hospital clinics) [10, 20, 27], but this was a more complicated route in a trial with such a large number of sites. The infographic development process took longer than anticipated and 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 it\u0026rsquo;s impact on recruitment .\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe 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.\u003c/p\u003e\n\u003cp\u003eNevertheless, 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.\u0026nbsp;\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eWe 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.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eAPEC \u0026ndash; Action on Pre-eclampsia Charity\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eHTA \u0026ndash; Health Technology Assessment\u003c/p\u003e\n\u003cp\u003eNIHR \u0026ndash; National Institute for Health and Care Research\u003c/p\u003e\n\u003cp\u003ePIRIT \u0026ndash; Public Involvement in Research Impact Toolkit\u003c/p\u003e\n\u003cp\u003ePPIE \u0026ndash; Patient and Public Involvement and Engagement\u003c/p\u003e\n\u003cp\u003eREC \u0026ndash; Research Ethics Committee\u003c/p\u003e\n\u003cp\u003eWILL \u0026ndash; When to Induce Labour to Limit risk in pregnancy hypertension Trial\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cem\u003eEthics approval and consent to participate\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eEthics approval has been obtained (NHS Health Research Authority London Fulham Research Ethics Committee, 18 /LO /2033).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eConsent for publication\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAvailability of data and materials\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eCompeting interests\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u0026nbsp;The views expressed are those of the author(s) and not necessarily those of NIHR, the NHS, or the Department of Health and Social Care, UK.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eFunding\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe trial was funded by the\u0026nbsp;National Institute of Health Research (NIHR) Health Technology Assessment Programme\u0026nbsp;(project number 16/167/123) that was not involved in data collection or analysis.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAuthors\u0026rsquo; contributions\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe trial was conceived by LAM, PvD \u0026nbsp;and JH and JS, listed in \u003cstrong\u003eAdditional File 1\u003c/strong\u003e, . All authors contributed to the design and delivery of the trial.\u0026nbsp;The authors KK and ST assume responsibility for the accuracy and completeness of data reporting.\u0026nbsp;\u0026nbsp;KK and ST drafted the manuscript, which was revised and approved by all authors.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAcknowledgments\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eWe wish to thank the women who participated in the trial, and the large number of site contributors, listed in \u003cstrong\u003eAdditional File 1\u0026nbsp;\u003c/strong\u003ewho made possible this study. We extend our sincere thanks to our independent Trial Steering (Tim Draycott [Chair], Graeme MacLennan, Lucy MacKillop, Paul Mannix, Ruth Unstead-Joss) and Data Monitoring (Diana Elbourne (Chair), Henk Groen (Vice-Chair), Deborah Harrington, Edile Murdoch, Sarah Stock, and David Odd) Committees for generously contributing their time and guidance. We would also like to thank Daphna Fenchel for reviewing the manuscript and resources.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePatient and public involvement (PPIE)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe trial had two PPIE members in the Co-Investigator Group (see \u003cstrong\u003eAdditional\u003c/strong\u003e \u003cstrong\u003eFile 1\u003c/strong\u003e), a PPIE representative on the TSC (Ruth Unstead-Joss), and a bespoke PPIE group (including Emma Jukes, Fatima Rami, Al Richards, Khilna Rupen, and Debs Smith) that reviewed patient and public-facing material for trial promotion and recruitment.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eMagee LA, Brown MA, Hall DR, Gupte S, Hennessy A, Karumanchi SA, et al. The 2021 International Society for the Study of Hypertension in Pregnancy classification, diagnosis \u0026amp; management recommendations for international practice. Pregnancy Hypertens. 2022;27:148-69.\u003c/li\u003e\n\u003cli\u003eKirkham K, Tohill S, Hutcheon JA, Dorling J, Gkini E, Moakes CA, et al. WILL (When to induce labour to limit risk in pregnancy hypertension): Protocol for a multicentre randomised trial. Pregnancy Hypertens. 2023;32:35-42.\u003c/li\u003e\n\u003cli\u003eMagee LA, Kirkham K, Tohill S, Gkini E, Moakes C, Dorling J et al. Determining optimal timing of birth for women with chronic or gestational hypertension at term: The WILL (When to Induce Labour to Limit risk in pregnancy hypertension) randomised trial. PLOS Medicine, in press October 2024.\u003c/li\u003e\n\u003cli\u003eWILL Trial Training Page for Site Staff: Complications of Chronic and Gestational Hypertension. https://www.birmingham.ac.uk/documents/college-mds/trials/bctu/will/training-pages/from-newsletter/training-nl-2020.08-hypertension.pdf Accessed 25 Sep 2024.\u003c/li\u003e\n\u003cli\u003eHypertension in pregnancy: diagnosis and management. NICE guideline [NG133] Published: 25 June 2019 Last updated: 17 April 2023. https://www.nice.org.uk/guidance/NG133 Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003eAction on Pre-eclampsia. https://action-on-pre-eclampsia.org.uk/ Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003eWILL Trial Patient Information Sheet. https://www.birmingham.ac.uk/documents/college-mds/trials/bctu/will/trial-documentation/will-pis-version-6.0-25-may-2022.pdf Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003eNIHR. Online Public Reviewing Course. A course for reviewers of health and social care research (learningforinvolvement.org.uk) Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003eNIHR. PPI (Patient and Public Involvement) resources for applicants to NIHR research programmes. https://www.nihr.ac.uk/documents/ppi-patient-and-public-involvement-resources-for-applicants-to-nihr-research-programmes/23437 Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003eNIHR. Patient and public involvement in health and social care research: a handbook for researchers 2014. RDS-PPI-Handbook-2014-v8-FINAL-2.pdf (nihr.ac.uk) Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003eNIHR. UK Standards for public involvement in research 2019. UK Standards for Public Involvement - The UK Standards (google.com) Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003eNIHR. Equality, Diversity and Inclusion Strategy 2022-2027. https://www.nihr.ac.uk/equality-diversity-and-inclusion-strategy-2022-2027 Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003eNIHR. The Race Equality Framework\u0026mdash;a practitioner\u0026rsquo;s guide for public involvement in research. 2022. https://www.nihr.ac.uk/nihr-race-equality-framework Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003eNIHR. Payment guidance for researchers and professionals 2022. https://www.nihr.ac.uk/documents/payment-guidance-for-researchers-and-professionals/27392?pr Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003eNIHR. Guidance on co-producing a research project 2018. https://www.invo.org.uk/wp-content/uploads/2019/04/Copro_Guidance_Feb19.pdf Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003eHRA. Public Involvement. https://www.hra.nhs.uk/planning-and-improving-research/best-practice/public-involvement/ Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003eAiyegbusi, O.L., McMullan, C., Hughes, S.E. et al. Considerations for patient and public involvement and engagement in health research. Nat Med 29, 1922\u0026ndash;1929 (2023). https://doi.org/10.1038/s41591-023-02445-x\u003c/li\u003e\n\u003cli\u003eNIHR. People in Research. https://www.peopleinresearch.org/ Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003eNational Coordinating Centre for Public Engagement. Online Engagement: A guide to creating and running virtual events. https://www.publicengagement.ac.uk/resources/guide/online-engagement-guide-creating-and-running-virtual-events Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003eBiomedical Research Centre (local): https://www.nihr.ac.uk/about-us/what-we-do/infrastructure/biomedical-research-centres#four Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003eKang HK. Influence of culture and community perceptions on birth and perinatal care of immigrant women: doulas\u0026apos; perspective. J Perinat Educ. 2014 Winter;23(1):25-32. https://doi.org/10.1891/1058-1243.23.1.25\u003c/li\u003e\n\u003cli\u003eWicks P, Richards T, Denegri S, Godlee F. Patients\u0026apos; roles and rights in research. BMJ. 2018 Jul 25;362:k3193. https://doi.org/10.1136/bmj.k3193\u003c/li\u003e\n\u003cli\u003eNIHR Definition and role of the designated PPI (Patient and Public Involvement) lead in a research team https://www.nihr.ac.uk/documents/definition-and-role-of-the-designated-ppi-patient-and-public-involvement-lead-in-a-research-team/23441 Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003eNIHR Research Support Service https://www.nihr.ac.uk/explore-nihr/support/research-support-service/ Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003ePublic Involvement in Research Impact Toolkit (PIRIT) Public Involvement in Research Impact Toolkit (PIRIT) - Marie Curie Research Centre - Cardiff University Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003eStaley, K., Elliott, J. Public involvement could usefully inform ethical review, but rarely does: what are the implications? Res Involv Engagem 3, 30 (2017). https://doi.org/10.1186/s40900-017-0080-0\u003c/li\u003e\n\u003cli\u003eLocal Clinical Research Network: https://local.nihr.ac.uk/lcrn/ Accessed 25 Sep 2024\u003c/li\u003e\n\u003cli\u003eBarrero, Jose Maria, Nicholas Bloom, and Steven J. Davis, 2021.\u0026ldquo;Why working from home will stick,\u0026rdquo; National Bureau of Economic Research Working Paper 28731. www.wfhresearch.com Accessed 25 Sep 2024\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"public, patient, involvement, engagement, trial management","lastPublishedDoi":"10.21203/rs.3.rs-5326038/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5326038/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: 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.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: 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 \u0026nbsp;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.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: 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.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e: 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.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration\u003c/strong\u003e: ISRCTN77258279, registered on 05 December 2018.\u003c/p\u003e","manuscriptTitle":"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","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-06-20 15:25:07","doi":"10.21203/rs.3.rs-5326038/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"cba86482-2695-4d81-8b05-7211b4a3bd6e","owner":[],"postedDate":"June 20th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-01-26T16:00:44+00:00","versionOfRecord":{"articleIdentity":"rs-5326038","link":"https://doi.org/10.1186/s13063-025-09218-6","journal":{"identity":"trials","isVorOnly":false,"title":"Trials"},"publishedOn":"2026-01-21 15:57:50","publishedOnDateReadable":"January 21st, 2026"},"versionCreatedAt":"2025-06-20 15:25:07","video":"","vorDoi":"10.1186/s13063-025-09218-6","vorDoiUrl":"https://doi.org/10.1186/s13063-025-09218-6","workflowStages":[]},"version":"v1","identity":"rs-5326038","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5326038","identity":"rs-5326038","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}