Patient and public involvement and engagement in genomic preterm birth research: shaping study delivery and materials in the PRESTIGE-PTB study

Patient and public involvement and engagement in genomic preterm birth research: shaping study delivery and materials in the PRESTIGE-PTB study | 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 Patient and public involvement and engagement in genomic preterm birth research: shaping study delivery and materials in the PRESTIGE-PTB study Megumi Nimura, Olivia Walker, Tina Prendeville, Dally Kaur, Amena Khanom, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9161270/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Preterm birth (PTB) disproportionately affects women from ethnic minority backgrounds, yet these communities remain underrepresented in genomic research. The PRESTIGE-PTB study uses whole genome sequencing to investigate genetic determinants of spontaneous PTB and embeds patient and public involvement and engagement (PPIE) to promote inclusivity, acceptability, and responsiveness to lived experience. Methods Monthly online PPIE meetings were conducted with three contributors from ethnically diverse backgrounds between December 2024 and September 2025. Activities included co-development of participant materials, discussion of recruitment challenges, and refinement of communication strategies. Meeting minutes and evaluation forms from contributors and researchers were analysed descriptively. Reporting was guided by the GRIPP2 short-form checklist. Results Nine PPIE meetings were held. Contributor feedback led to revisions of posters and social media materials, improved cultural sensitivity in recruitment communication, and targeted outreach through charities and community groups, contributing to increased self-referrals. Contributors reported increased knowledge, confidence, and sense of value, while researchers described enhanced awareness of inclusivity and patient experience. Limitations included late introduction of PPIE and restricted influence on foundational study documents. Conclusions Regular, well-supported PPIE enhanced study materials, communication, and inclusivity in genomic PTB research. Early involvement, broader diversity, and sustained funding are essential to maximise the impact of PPIE in future maternal and genomic research. Trial registration Not applicable. PPIE Patient and Public Involvement and Engagement Preterm Birth Maternity Research Genomics Research Pregnancy Inclusivity Figures Figure 1 Plain English summary Preterm birth affects many families and is more common among women from ethnic minority backgrounds. The PRESTIGE-PTB study aims to understand whether genetics play a role in spontaneous preterm birth by using whole genome sequencing. To make sure the research reflects the needs and experiences of the communities most affected, the study included regular meetings with women from diverse ethnic backgrounds who had experienced pregnancy complications or preterm birth. Three contributors met monthly with the research team to share their views on study language, participant materials, recruitment, and communication. Their feedback led to clearer and more culturally sensitive posters and social media messages, improved ways of explaining the study, and new outreach through charities and community groups. These changes helped more people hear about the study and feel comfortable taking part. Contributors reported that the meetings increased their understanding of research and made them feel valued and listened to. Researchers expressed the contributors’ insights improved the study and influenced how they think about involving patients in future work. This project shows how working closely with the public can make research more inclusive, respectful, and effective. Background Preterm birth (PTB) defined as any birth before 37 weeks of gestation 1 , affects around 8% of pregnancies in the UK 2 . Preterm infants often face immediate and lifelong health challenges, placing economic and emotional strain on families and healthcare systems 3 . Black and South Asian women have higher rates of PTB compared to White women in the UK 4,5 , and this trend is also observed globally 6 . Preterm birth can be subdivided into three separate categories; 1) spontaneous PTB (sPTB) where there is antecedent cervical dilatation, 2) sPTB associated with preterm, prelabour rupture of amniotic membranes (PPROM), and 3) PTB as a consequence of the actions of healthcare staff, also described at iatrogenic PTB. In high income countries, the relative proportion of PTB that is related to each category is estimated as 30%–78% sPTB, 10%–30% PPROM and 22%–55% iatrogenic 7 . While the underlying causes of sPTB and PPROM remain complex and not fully understood, growing evidence points to a genetic component 8 – 10 . However, the majority of genetic data collected globally is from individuals of European ancestry, limiting insights into other ethnic groups 11 . The lack of diverse data in genomic research may be contributing to health disparities in women from underrepresented ancestral backgrounds. Addressing this lack of diverse data requires strategies to increase access to genomic research across different communities. 12 The PRESTIGE-PTB study (Whole Genome Sequencing to Identify the Genetic Determinants of Spontaneous Preterm Birth: A Nationwide Multicentre Cohort Study) is a national research project in England that aims to use whole genome sequencing (WGS) to identify genetic factors linked to sPTB. Supported by Imperial College London, Tommy's National Centre for Preterm Birth Research, and Genomics England, the PRESTIGE-PTB study was designed to address these disparities by actively recruiting participants from ethnically diverse and historically underrepresented communities. This inclusive approach is crucial for both robust scientific evidence and to address inequalities in research participation and generation of data of relevance to the health of people of all ethnicities. Central to the PRESTIGE project is a strong commitment to Patient and Public Involvement and Engagement (PPIE). PPIE refers to the active collaboration between researchers and individuals with or without lived experience of the condition under study 13 . PPIE ensures their voices shape the research from start to finish, through study design, delivery, and dissemination. Within PRESTIGE, PPIE took two main forms. First, regular meetings with a dedicated PPIE group enabled joint refinement of research questions, strengthened recruitment strategies, co-development of participant materials, and ensured communications were culturally sensitive and accessible. This article focuses on those activities. Second, the study included a series of educational workshops co-produced with the Mosaic Community Trust (MCT), a local organisation with ethnically diverse communities; these workshops are discussed in a separate article. The ultimate goal of our PPIE activities was to create a sustainable research environment where diverse voices are genuinely heard and embedded in decision-making. The aim of this paper is to describe and reflect on the development, structure, and impact of the PPIE meetings within the PRESTIGE project. We also highlight both the challenges and the value of embedding inclusive, equity-driven engagement in genomic research. Methods Study design and reporting framework This article provides a descriptive analysis of PPIE meetings within the PRESTIGE-PTB study. Reporting was guided by the Guidance for Reporting Involvement of Patients and the Public version2 (GRIPP2) short-form checklist 14 . Patient and public involvement and engagement PPIE activities were developed and supported by the Patient Experience Research Centre (PERC) at Imperial College London, in collaboration with the National Institute for Health and Care Research (NIHR) Imperial Biomedical Research Centre (BRC) 15 . Oversight and coordination were led by a multidisciplinary PPIE team consisting of a PPIE administrator, a research nurse, a research midwife, a scientist, and a clinician. Two trained team members (PPIE administrator and research nurse) facilitated the meetings using PERC resources. PPIE members were recruited by a PPIE administrator at Genomics England, primarily through Bliss, a UK-based charity that supports families with preterm and sick babies. The group comprised three women from ethnically diverse backgrounds who had personal experiences with pregnancy complications and/or preterm birth. Members were compensated for their time and contributions in line with Genomics England’s remuneration policy and NIHR guidance on payment for involvement 16 . An initial PPIE meeting was held by Genomics England PPIE administrator during the project's setup phase in December 2023, primarily to share the study concept. As this meeting was not organised by the study authors, further details are not included in this article. Setting and duration PPIE meetings were held monthly via online video calls. Each session lasted approximately one hour and included three PPIE members. Meetings began in December 2024 and continued through the end of the study in September 2025. Meeting activities Each meeting served several purposes: To share study updates (e.g., recruitment numbers, participant demographics, site setup). To consult on study challenges such as recruitment difficulties and participant engagement. To review and revise study materials, including posters and social media content. To assess the accessibility, cultural relevance, and inclusivity of communications. To discuss strategies for outreach and community engagement. Meetings were recorded, and detailed minutes were produced and shared with the wider study team. Data collection and analysis This article draws on the documented minutes of each meeting. Meeting content was categorised and analysed descriptively to identify key themes and outcomes. Additionally, both researchers and PPIE members completed evaluation forms designed to gather quantitative and qualitative feedback on the meetings. These forms are included in Supplementary material 1 and 2. PPIE members also reviewed and contributed to writing of this article. Ethical approval PPIE activities were approved as part of the PRESTIGE study by the South West-Frenchay Research Ethics Committee (REC reference: 24/SW/0060). The study was conducted in accordance with the principles of the Declaration of Helsinki. Results The completed GRIPP2 short-form checklist is provided in Supplementary material 3. PPIE monthly meetings Nine PPIE meetings were held between December 2024 and September 2025, during the PRESTIGE study’s data collection phase. Before the meetings began, PPIE members reviewed key study documents including protocol, patient information sheet (PIS) and informed consent form via email in February 2024. Each meeting included a PowerPoint presentation summarising study progress, such as recruitment numbers, decline rates and reasons, participant ethnicity breakdown, and site setup status. Key activities, including conference and poster presentations, meetings with Genomics England and Tommy’s, online and social media outreach, and educational workshops with the local community, were also highlighted. Following the updates, each meeting focused on specific topics for discussion. Table 1 summarises the topics covered, member’s feedback, and resulting impact by category: Participant engagement, Recruitment strategy, Equity in participation, Inclusivity and diversity, Consent process, Study promotion, Study materials, Understanding data management, Dissemination of study results. Structured feedback from PPIE members informed multiple aspects of study design, communication, recruitment, and dissemination. Core engagement themes included respectful communication, such as correctly using participants’ names and avoiding jargon or medical abbreviations, and emphasising the broader impact of the study beyond individual pregnancies. Members also valued local community-based workshops for public education and recommended a layered approach to recontact (initial letter/email followed by optional text or call) to minimise perceived intrusiveness. In relation to recruitment, members raised concerns about approaching participants during high-stress clinical events, and researchers responded by ensuring that recruitment occured only with clinical team approval. Members advocated for participant autonomy when partners attempted to decline on their behalf. They also suggested diversifying recruitment settings beyond hospitals; however, resource and ethical constraints limited this. Proposals to introduce simplified study materials, including a one-page information sheet, were considered but not implemented due to time constraints, although the team agreeed to adopt this approach in future studies. In discussions about equity in participation, members highlighted the need for fair reimbursement, particularly for those facing logistical barriers, however, budget limitations restricted changes to reimbursement. They emphasised the importance of comprehensive ethnicity recording, and researchers confirmed that ethnicity records will be updated prior to data analysis. Although the study already demonstrated strong ethnic diversity, members encouraged more targeted outreach based on age, location, and platform preferences to engage underrepresented communities. This feedback led to expanded social media advertising and updated study posters. Consent processes were also discussed. Members suggested reorganising consent forms to place mandatory statements at the beginning to improve clarity, however, the short study timeline precluded these changes. To enhance study promotion, one member recommended partnering with Bliss, a UK charity supporting families with preterm and sick babies, while another volunteered to liaise with the Mid and South Essex Maternity and Neonatal Voices Partnership (MNVP). Targeted advertisements were subsequently launched through these organisations’s social media channels, contributing to a noticeable increase in self-referral form submissions. In total, over 250 self-referrals were received through web and social media promotions coordinated by multiple support groups and organisations. Study materials underwent multiple revisions to improve clarity, tone, and cultural sensitivity. Social media advertisements were co-designed with members, resulting in five finalised versions (see Supplementary material 4). Posters targeting both the public and clinicians were updated with clearer language and more inclusive visuals. Figure 1 shows key differences between the original and revised posters. Finally, members committed to supporting dissemination of study findings by co-authoring the current article and contributing to the development and review of a lay summary of the final study report. They also expressed willingness to participate in future PPIE activities, reinforcing the collaborative and inclusive nature of the research process. PPIE evaluation from researchers and PPIE members We distributed evaluation forms to seven researchers (five from Imperial College London and two from Genomics England) and three PPIE members. We received six responses from researchers (four complete, two incomplete) and three complete responses from PPIE members. The two Genomics England researchers submitted a joint response. The two incomplete researcher responses from Imperial College London were due to limited direct involvement in PPIE meetings. Summary of PPIE member evaluation Evaluation forms from three PPIE members demonstrated a substantial positive impact of the PPIE meetings on their understanding of research, confidence in engaging with research activities, and perception of their role within the study. Members reported increased knowledge of the research process, particularly regarding research ethics, the value of diverse perspectives in study design, and the importance of incorporating lived experience into health research. All contributors felt that their input was meaningfully received and, in some cases, directly influenced the research team’s approach, including suggestions on culturally sensitive communication, revisions to participant-facing language, and outreach strategies to improve community engagement. One contributor stressed the psychological impact of language used in maternity settings, particularly for ethnic minority communities. Online delivery and the frequenct of meetings were generally well received and viewed as convenient and inclusive, especially for those with caregiving responsibilities. Suggestions for improvement included receiving agendas or presentation materials in advance to enhance preparation. Quantitative findings (Table 2) supported these qualitative impressions. Members reported an increase in confidence to support research within a PPIE role, with average ratings rising from 3.00 (range: 1–5) before the meetings to 4.33 after. All contributors agreed or strongly agreed that their knowledge and skills improved (mean = 4.67), indicating the educational value of the process. All members also felt that their participation met or exceeded expectations (mean = 4.33), and expressed a strong likelihood of engaging in future PPIE activities (mean = 5.00). Perceptions of their impact on the research varied slightly (mean = 4.00), but all believed their contribution was meaningful. Overall, these findings support the value of well-structured, inclusive, and accessible PPIE models in building contributor confidence, facilitating knowledge exchange, and encouraging long-term engagement. High scores across most questions suggest that contributors felt respected, heard, and genuinely involved in shaping research directions. Table2: Summary of quantitative responses from PPIE members Evaluation question Member1 Member2 Member3 Mean Range Confidence before meetings (1–5) a 3 4 2 3.00 2–4 Confidence after meetings (1–5) a 4 5 4 4.33 4–5 Knowledge/perspective/skills improved (1–5) b 4 5 5 4.67 4–5 Involvement met expectations (1–5) b 5 4 4 4.33 4–5 Impactfulness of PPIE group involvement (1–5) c 5 4 3 4.00 3–5 Likelihood of participating in future PPIE groups (1–5) d 5 5 5 5.00 5–5 a) 1: Not confident – 5: Extremely confident b) 1: Strongly disagree – 5: Strongly agree c) 1: Not at all impactful – 5: Extremely impactful d) 1: Not at all likely – 5: Extremely likely Quotes from PPIE contributor s “Participating in the PPIE meetings has given me a completely different perspective and a clearer appreciation of how individual studies shape future healthcare practices.” “I have learned a lot about preterm birth and how genomics can detect genetic characteristics associated with PTB across different ethnic backgrounds.” “This experience has increased my confidence to talk about research outside the meetings and I feel more motivated to raise awareness of its vital.” “Several times I have suggested different ways or wordings to reach out to participants, and these were directly adopted or updated as a result.” “One key point I raised was about language used in maternity wards; I hope I have encouraged researchers to consider how more compassionate, culturally sensitive communication can improve experiences.” “I have gained further knowledge of how research is conducted and samples collected ethically, and how much consideration goes into studies before any work begins!” “In every meeting I gained knowledge, heard differnt ideas and views, and helped ensure that patients’ needs were considered inclusively.” “I feel I have supported and listened to the team, and helped them find positive ways to achieve better findings and respect diverse cultures.” Summary of research member evaluation Six researchers completed the evaluation forms, with varying levels of engagement: two attended meetings regularly, while four engaged indirectly through colleague feedback. Despite different levels of direct involvement, all respondents acknowledged the influence of PPIE input on the study and found the process valuable for improving communication strategies, study design, and inclusivity. Researchers highlighted specific contributions from the PPIE group, including feedback on tone and accessibility of study materials, improvements to recruitment posters, advice on culturally sensitive communication, and insights into the lived experiences of patients in high-stress settings. A notable example was the recommendation to collaborate with Bliss and the Mid and South Essex MNVP, which led to a marked increase in self-referrals. There was strong consensus that PPIE shaped communication and outreach methods by helping tailor materials to diverse audiences and prompting reflection on patient needs, emotional readiness, and barriers to participation. For several researchers, working with members of the public shifted their perspective on research practice, especially regarding diversity, engagement, and inclusive communication. Some reported strengthened confidence in PPIE approaches and greater commitment to embedding public perspectives in future work. Challenges were also identified. Researchers stressed that PPIE activities began too late to influence core documents such as the protocol, patient information sheet (PIS), and consent form. Although PIS and consent form were reviwed by PPIE menbers priore to finalisation, earlier involvement would have enabled more substantive input and avoided last-minute amendments. Additional challenges indludes scheduling difficulties, limited group diversity, and absence of funding to support PPIE throughout the full research cycle, including final write-up. Quantitative responses (Table 3) further illustrated the perceived impact. Prior experience with PPIE was modest (mean = 2.83; range: 1–5), but most researchers reported significant gains in experience (mean = 4.2). Knowledge and perspective expanded markedly (mean = 4.33), expectations were met or exceeded (mean = 4.6), and the overall perceived impact of the meetings was high (mean = 4.17). Importantly, all respondents indicated they were very likely to involve a PPIE group in future projects (mean = 5.0). Regarding research design and delivery, PPIE involvement had particularly strong effects on study materials (mean = 4.8) and patient communication (mean = 4.8) and supported greater inclusivity and equity in participation (mean = 4.2). Impacts on recruitment (mean = 3.5) and study methods (mean = 3.4) were more variable, reflecting the late introduction of PPIE input and the limited scope for changes due to the study design. Quotes from researchers “We received extensive insight from members of the public, including how patients may be feeling and when they are most receptive to discussing research participation.” “We received very genuine feedback, emphasising the importance of inclusivity and diversity so that no one is left out of the study.” “Feedback on the communications strategy (posters etc.) was very helpful and led to improvement; the question about what participants might expect at the end of the study was particularly insightful.” “The PPIE meetings improved the quality of the study, particularly in terms of communication with patients, understanding participants’ needs, and refining study materials.” “The group identified Bliss, and after we reached out, we received a large number of self-referrals as a result.” “It has helped us understand how to best engage and recruit this particular population and what their expectations are of us.” “Working with this group has strengthened my belief that PPIE should be embedded in every study.” “It has helped me appreciate that everyone’s experience is different and that it is important to listen to everyone to be as inclusive as possible.” “The meeting made me reflect on how I can more effectively communicate the aims of our research to the public.” Discussion This study examined the structure and impact of PPIE meetings within the PRESTIGE-PTB study, demonstrating sustained collaboration with contributors can influence study design, participant materials, and operational decisions. Evaluations from both contributors and researchers highlighted that co-creation and collaborative delivery were experienced as rewarding and beneficial. Persistent inequalities in maternal care and the limited representation of women’s voices in the UK remain well documented. Despite overall improvements, Black women continue to experience maternal mortality rates twice as high as those of White women 17 . The Women’s Health Strategy for England highlights the urgent need to embed the perspectives of diverse women across all areas of policy and service development 18 . Yet, ethnic minority groups remain underrepresented in research studies, contributing to unequal health outcomes 19 , underscoring the importance of involving diverse communities and ensuring equitable access to research and healthcare. PPIE in maternity research is still relatively limited and often poorly reported. The time-limited nature of pregnancy and the competing demands of caregiving, health, and employment make sustained engagement challenging 20 , while critiques of women’s health research point to tokenistic approaches that fail to centre lived experience 21 . Within this context, the PRESTIGE study’s regular monthly PPIE meetings provided a consistent structure for contributors to shape recruitment messaging, study materials, and outreach strategies. This reflects best practices for engagement, continuity, co-learning, and respect for lived experience, and directly led to real-time improvements, including revised posters, culturally sensitive communication, and co-created social media content. Contributors reported increased understanding of research ethics, genomics, preterm birth, and participant rights, reinforcing the role of PPIE in building public capacity and trust. They valued being heard and seeing their feedback reflected, and they emphasised respectful language and psychological sensitivity in maternity settings as areas where standard research practice can improve. Suggestions to partner with community organisations such as Bliss and the Mid and South Essex MNVP broadened the study’s reach. Researchers confirmed the value of PPIE, particularly in enhancing communication and outreach and deepening understanding of participatmn’s lived experiences. Their reflections suggest that engagement with PPIE members can shift research perspectives and strengthen cultural sensitivity, echoing wider evience that co-production improves the relevance and accessibility of research. A key limitation was that regular PPIE meetings were introduced only after recruitment had begun, limiting thier influence on foundational documents like the protocol and PIS. Earlier involvement, ideally during the concept phase (more than12 months before study launch), would have enabled more substantive contributions and reduced protocol amendments, as highlighted in existing literature 22,23 . Additional challenges included scheduling difficulties, limited group diversity, and insufficient funding to support PPIE across the full research cycle. These barriers mirror structural issues seen in other PPIE initiatives but are important to address if PPIE is to become standard practice rather than an add-on. Future studies could strengthen impact assessment by introducing tools like pre-meeting questionnaires to track changes in contributors’ knowledge, expectations, and confidence over time. Appointing a dedicated PPIE lead at project outset would enable earlier and more coordinated involvement. Broader diversity among PPIE contributors—across age, geography, language, and lived experience—should be prioritoised, especially in genomic and preterm birth research where inequalities are pronounced. Adopting multilingual materials, flexible engagement formats, and robust partnerships with community organisations will be critical; the collaboration between PRESTIGE and the Mosaic Community Trust provided a foundation on which to build. In genomics and maternal health research, where trust and understanding are crucial, sustained and inclusive PPIE is essential. As NHS England implements its ten-year plan to expand access to genomic healthcare 24 , engagement will need to shift toward genuine co-creation—where contributors move beyond providing feedback to actively shaping the study’s direction. Conclusion The PRESTIGE-PTB study shows that even small, well-supported PPIE initiatives can significantly improve research delivery. Contributors helped shape study materials, enhance outreach, and improve inclusivity, while gaining knowledge, confidence, and ownership in the process. Future research should prioritise earlier and more comprehensive public involvement, ensuring diversity, accessibility, and sustained collaboration. PRESTIGE-PTB offers a practical example of inclusive research in action and a blueprint for future studies aiming for equity and impact. Abbreviations BRC: Biomedical Research Centre GRIPP2: Guidance for Reporting Involvement of Patients and the Public version2 NIHR: National Institute for Health and Care Research MCT: Mosaic Community Trust MNVP: Maternity and Neonatal Voices Partnership PERC: Patient Experience Research Centre PIS: Patient Information Sheet PPIE: Patient and Public Involvement and Engagement PPROM: Preterm Prelabour Rupture of Amniotic Membranes PRESTIGE-PTB study: Whole Genome Sequencing to Identify the Genetic Determinants of Spontaneous Preterm Birth: A Nationwide Multicentre Cohort Study PTB: Preterm Birth REC: Research Ethics Committee sPTB: Spontaneous Preterm Birth WGS: Whole Genome Sequencing Declarations Ethics approval and consent to participate Ethical approval for the PRESTIGE-PTB study, including PPIE activities, was obtained from the South West – Frenchay Research Ethics Committee (REC reference: 24/SW/0060). The study was conducted in accordance with the principles of the Declaration of Helsinki. Consent for publication Not applicable Availability of data and materials Available on request Competing interests The authors declare that they have no competing interests. Funding The project was funded by Genomics England and Tommy's National Centre for Preterm Birth Research. Authors' contributions MN drafted the manuscript as first author. All authors read and approved the final manuscript. Acknowledgements We thank Genomics England, Tommy’s National Centre for Preterm Birth Research, North Thames Genomic Medicine Service Alliance, the Mosaic Community Trust (MCT), the NIHR BRC Imperial Patient Experience Research Centre ( PERC ), Women’s Health Reserch Centre (WHRC), Imperial College London, and Imperial College Healthcare NHS Trust for their support. 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Crocker JC, Ricci-Cabello I, Parker A, et al. Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis. BMJ . 2018;363:k4738. doi:10.1136/bmj.k4738 Year Health Plan for England: fit for the future. https://www.gov.uk/government/publications/10-year-health-plan-for-england-fit-for-the-future. Accessed 07 March 2026. Table 1 and 3 Table 1 and 3 are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Supplementarymaterial1.docx Supplementary material 1: PPIE evaluation form for researchers Supplementarymaterial2.docx Supplementary material 2: PPIE evaluation form for PPIE members Supplementarymaterial3.docx Supplementary material 3: The completed GRIPP2 short-form checklist Supplementarymaterial4.pdf Supplementary material 4: Social media advertisement Table13.docx Cite Share Download PDF Status: Posted 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. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-9161270","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":610766194,"identity":"23ea60b4-107a-46fc-974e-5e9d6070414d","order_by":0,"name":"Megumi Nimura","email":"","orcid":"","institution":"Inperial College London","correspondingAuthor":false,"prefix":"","firstName":"Megumi","middleName":"","lastName":"Nimura","suffix":""},{"id":610766195,"identity":"d6edea4b-c1de-4f29-a7f3-b3b128e66f43","order_by":1,"name":"Olivia Walker","email":"","orcid":"","institution":"Inperial College London","correspondingAuthor":false,"prefix":"","firstName":"Olivia","middleName":"","lastName":"Walker","suffix":""},{"id":610766196,"identity":"53f9b983-869a-4517-9d7c-88e0460161dc","order_by":2,"name":"Tina Prendeville","email":"","orcid":"","institution":"Inperial College London","correspondingAuthor":false,"prefix":"","firstName":"Tina","middleName":"","lastName":"Prendeville","suffix":""},{"id":610766197,"identity":"9a10292f-3279-4381-97b2-b22f67b7de1b","order_by":3,"name":"Dally Kaur","email":"","orcid":"","institution":"PPIE Contributor","correspondingAuthor":false,"prefix":"","firstName":"Dally","middleName":"","lastName":"Kaur","suffix":""},{"id":610766198,"identity":"9d02e54d-cb82-40de-b637-8a2ae8c4bb05","order_by":4,"name":"Amena Khanom","email":"","orcid":"","institution":"PPIE Contributor","correspondingAuthor":false,"prefix":"","firstName":"Amena","middleName":"","lastName":"Khanom","suffix":""},{"id":610766199,"identity":"ae287932-f403-4aef-aab8-a8045fa23cb6","order_by":5,"name":"Misa Ichinose","email":"","orcid":"","institution":"PPIE Contributor","correspondingAuthor":false,"prefix":"","firstName":"Misa","middleName":"","lastName":"Ichinose","suffix":""},{"id":610766200,"identity":"ee61f768-b30b-4b8c-8ebd-1332f75a9fb7","order_by":6,"name":"Catherine Williamson","email":"data:image/png;base64,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","orcid":"","institution":"Inperial College London","correspondingAuthor":true,"prefix":"","firstName":"Catherine","middleName":"","lastName":"Williamson","suffix":""}],"badges":[],"createdAt":"2026-03-18 15:53:19","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-9161270/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-9161270/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":105321143,"identity":"94cbb2b9-edf7-4dbb-a509-ff6330976e0d","added_by":"auto","created_at":"2026-03-24 17:20:56","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":4824573,"visible":true,"origin":"","legend":"\u003cp\u003eStudy posters: revised and original\u003c/p\u003e","description":"","filename":"Figure1.png","url":"https://assets-eu.researchsquare.com/files/rs-9161270/v1/89e88c4bec849d3a5e9f8140.png"},{"id":108877211,"identity":"32588096-8cae-4cfa-81c7-cce6d029e9ae","added_by":"auto","created_at":"2026-05-09 15:11:51","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":5207610,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9161270/v1/af8155af-123f-4339-99b1-ebfe042cda5c.pdf"},{"id":105321145,"identity":"e6f82b24-beb1-47d5-a388-9567ad9cce6c","added_by":"auto","created_at":"2026-03-24 17:20:56","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":22324,"visible":true,"origin":"","legend":"\u003cp\u003eSupplementary material 1: PPIE evaluation form for researchers\u0026nbsp;\u003c/p\u003e","description":"","filename":"Supplementarymaterial1.docx","url":"https://assets-eu.researchsquare.com/files/rs-9161270/v1/0fb6f7d6080e5b8ab4db2ba5.docx"},{"id":105321147,"identity":"c8bb9c7a-1773-407d-b86d-a50f78deb528","added_by":"auto","created_at":"2026-03-24 17:20:56","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":20635,"visible":true,"origin":"","legend":"\u003cp\u003eSupplementary material 2: PPIE evaluation form for PPIE members\u0026nbsp;\u003c/p\u003e","description":"","filename":"Supplementarymaterial2.docx","url":"https://assets-eu.researchsquare.com/files/rs-9161270/v1/c897f501603de39473820130.docx"},{"id":105321146,"identity":"8cc52fc2-f676-4d7b-8f8b-ac36e427d428","added_by":"auto","created_at":"2026-03-24 17:20:56","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":16560,"visible":true,"origin":"","legend":"\u003cp\u003eSupplementary material 3: The completed GRIPP2 short-form checklist\u0026nbsp;\u003c/p\u003e","description":"","filename":"Supplementarymaterial3.docx","url":"https://assets-eu.researchsquare.com/files/rs-9161270/v1/2918e1be32eb713a994c7b07.docx"},{"id":105321144,"identity":"04f7e1d4-aef4-45d9-a878-c61ae98e64ea","added_by":"auto","created_at":"2026-03-24 17:20:56","extension":"pdf","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":750907,"visible":true,"origin":"","legend":"\u003cp\u003eSupplementary material 4: Social media advertisement\u003c/p\u003e","description":"","filename":"Supplementarymaterial4.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9161270/v1/d54bfb9ad772eb0f250415d6.pdf"},{"id":105321148,"identity":"4428b806-baa7-406d-a933-a872c14d473f","added_by":"auto","created_at":"2026-03-24 17:20:56","extension":"docx","order_by":5,"title":"","display":"","copyAsset":false,"role":"supplement","size":23063,"visible":true,"origin":"","legend":"","description":"","filename":"Table13.docx","url":"https://assets-eu.researchsquare.com/files/rs-9161270/v1/c3a00c1567feacdb40e5a05c.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Patient and public involvement and engagement in genomic preterm birth research: shaping study delivery and materials in the PRESTIGE-PTB study","fulltext":[{"header":"Plain English summary","content":"\u003cp\u003ePreterm birth affects many families and is more common among women from ethnic minority backgrounds. The PRESTIGE-PTB study aims to understand whether genetics play a role in spontaneous preterm birth by using whole genome sequencing. To make sure the research reflects the needs and experiences of the communities most affected, the study included regular meetings with women from diverse ethnic backgrounds who had experienced pregnancy complications or preterm birth.\u003c/p\u003e\n\u003cp\u003eThree contributors met monthly with the research team to share their views on study language, participant materials, recruitment, and communication. Their feedback led to clearer and more culturally sensitive posters and social media messages, improved ways of explaining the study, and new outreach through charities and community groups. These changes helped more people hear about the study and feel comfortable taking part.\u003c/p\u003e\n\u003cp\u003eContributors reported that the meetings increased their understanding of research and made them feel valued and listened to. Researchers expressed the contributors\u0026rsquo; insights improved the study and influenced how they think about involving patients in future work. This project shows how working closely with the public can make research more inclusive, respectful, and effective.\u003c/p\u003e"},{"header":"Background","content":"\u003cp\u003ePreterm birth (PTB) defined as any birth before 37 weeks of gestation\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u003c/sup\u003e, affects around 8% of pregnancies in the UK\u003csup\u003e2\u003c/sup\u003e. Preterm infants often face immediate and lifelong health challenges, placing economic and emotional strain on families and healthcare systems\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e. Black and South Asian women have higher rates of PTB compared to White women in the UK\u003csup\u003e4,5\u003c/sup\u003e, and this trend is also observed globally\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e. Preterm birth can be subdivided into three separate categories; 1) spontaneous PTB (sPTB) where there is antecedent cervical dilatation, 2) sPTB associated with preterm, prelabour rupture of amniotic membranes (PPROM), and 3) PTB as a consequence of the actions of healthcare staff, also described at iatrogenic PTB. In high income countries, the relative proportion of PTB that is related to each category is estimated as 30%\u0026ndash;78% sPTB, 10%\u0026ndash;30% PPROM and 22%\u0026ndash;55% iatrogenic\u003csup\u003e7\u003c/sup\u003e. While the underlying causes of sPTB and PPROM remain complex and not fully understood, growing evidence points to a genetic component\u003csup\u003e\u003cspan additionalcitationids=\"CR9\" citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e. However, the majority of genetic data collected globally is from individuals of European ancestry, limiting insights into other ethnic groups\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e. The lack of diverse data in genomic research may be contributing to health disparities in women from underrepresented ancestral backgrounds. Addressing this lack of diverse data requires strategies to increase access to genomic research across different communities.\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe PRESTIGE-PTB study (Whole Genome Sequencing to Identify the Genetic Determinants of Spontaneous Preterm Birth: A Nationwide Multicentre Cohort Study) is a national research project in England that aims to use whole genome sequencing (WGS) to identify genetic factors linked to sPTB. Supported by Imperial College London, Tommy's National Centre for Preterm Birth Research, and Genomics England, the PRESTIGE-PTB study was designed to address these disparities by actively recruiting participants from ethnically diverse and historically underrepresented communities. This inclusive approach is crucial for both robust scientific evidence and to address inequalities in research participation and generation of data of relevance to the health of people of all ethnicities.\u003c/p\u003e \u003cp\u003eCentral to the PRESTIGE project is a strong commitment to Patient and Public Involvement and Engagement (PPIE). PPIE refers to the active collaboration between researchers and individuals with or without lived experience of the condition under study\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. PPIE ensures their voices shape the research from start to finish, through study design, delivery, and dissemination.\u003c/p\u003e \u003cp\u003eWithin PRESTIGE, PPIE took two main forms. First, regular meetings with a dedicated PPIE group enabled joint refinement of research questions, strengthened recruitment strategies, co-development of participant materials, and ensured communications were culturally sensitive and accessible. This article focuses on those activities. Second, the study included a series of educational workshops co-produced with the Mosaic Community Trust (MCT), a local organisation with ethnically diverse communities; these workshops are discussed in a separate article. The ultimate goal of our PPIE activities was to create a sustainable research environment where diverse voices are genuinely heard and embedded in decision-making.\u003c/p\u003e \u003cp\u003eThe aim of this paper is to describe and reflect on the development, structure, and impact of the PPIE meetings within the PRESTIGE project. We also highlight both the challenges and the value of embedding inclusive, equity-driven engagement in genomic research.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design and reporting framework\u003c/h2\u003e \u003cp\u003eThis article provides a descriptive analysis of PPIE meetings within the PRESTIGE-PTB study. Reporting was guided by the Guidance for Reporting Involvement of Patients and the Public version2 (GRIPP2) short-form checklist\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003ePatient and public involvement and engagement\u003c/h3\u003e\n\u003cp\u003ePPIE activities were developed and supported by the Patient Experience Research Centre (PERC) at Imperial College London, in collaboration with the National Institute for Health and Care Research (NIHR) Imperial Biomedical Research Centre (BRC)\u003csup\u003e\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u003c/sup\u003e. Oversight and coordination were led by a multidisciplinary PPIE team consisting of a PPIE administrator, a research nurse, a research midwife, a scientist, and a clinician. Two trained team members (PPIE administrator and research nurse) facilitated the meetings using PERC resources.\u003c/p\u003e \u003cp\u003ePPIE members were recruited by a PPIE administrator at Genomics England, primarily through Bliss, a UK-based charity that supports families with preterm and sick babies. The group comprised three women from ethnically diverse backgrounds who had personal experiences with pregnancy complications and/or preterm birth.\u003c/p\u003e \u003cp\u003eMembers were compensated for their time and contributions in line with Genomics England\u0026rsquo;s remuneration policy and NIHR guidance on payment for involvement\u003csup\u003e\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eAn initial PPIE meeting was held by Genomics England PPIE administrator during the project's setup phase in December 2023, primarily to share the study concept. As this meeting was not organised by the study authors, further details are not included in this article.\u003c/p\u003e\n\u003ch3\u003eSetting and duration\u003c/h3\u003e\n\u003cp\u003ePPIE meetings were held monthly via online video calls. Each session lasted approximately one hour and included three PPIE members. Meetings began in December 2024 and continued through the end of the study in September 2025.\u003c/p\u003e\n\u003ch3\u003eMeeting activities\u003c/h3\u003e\n\u003cp\u003eEach meeting served several purposes:\u003c/p\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eTo share study updates (e.g., recruitment numbers, participant demographics, site setup).\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eTo consult on study challenges such as recruitment difficulties and participant engagement.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eTo review and revise study materials, including posters and social media content.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eTo assess the accessibility, cultural relevance, and inclusivity of communications.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eTo discuss strategies for outreach and community engagement.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003cp\u003eMeetings were recorded, and detailed minutes were produced and shared with the wider study team.\u003c/p\u003e\n\u003ch3\u003eData collection and analysis\u003c/h3\u003e\n\u003cp\u003eThis article draws on the documented minutes of each meeting. Meeting content was categorised and analysed descriptively to identify key themes and outcomes. Additionally, both researchers and PPIE members completed evaluation forms designed to gather quantitative and qualitative feedback on the meetings. These forms are included in Supplementary material 1 and 2. PPIE members also reviewed and contributed to writing of this article.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eEthical approval\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePPIE activities were approved as part of the PRESTIGE study by the South West-Frenchay Research Ethics Committee (REC reference: 24/SW/0060). The study was conducted in accordance with the principles of the Declaration of Helsinki.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eThe completed\u0026nbsp;GRIPP2 short-form checklist is provided in Supplementary material 3.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePPIE monthly meetings\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNine PPIE meetings were held between December 2024 and September 2025, during the PRESTIGE study\u0026rsquo;s data collection phase. Before the meetings began, PPIE members reviewed key study documents including protocol, patient information sheet (PIS) and informed consent form via email in February 2024.\u003c/p\u003e\n\u003cp\u003eEach meeting included a PowerPoint presentation summarising study progress, such as recruitment numbers, decline rates and reasons, participant ethnicity breakdown, and site setup status. Key activities, including conference and poster presentations, meetings with Genomics England and Tommy\u0026rsquo;s, online and social media outreach, and educational workshops with the local community, were also highlighted.\u003c/p\u003e\n\u003cp\u003eFollowing the updates, each meeting focused on specific topics for discussion. Table 1 summarises the topics covered, member\u0026rsquo;s feedback, and resulting impact by category: Participant engagement, Recruitment strategy, Equity in participation, Inclusivity and diversity, Consent process, Study promotion, Study materials, Understanding data management, Dissemination of study results.\u003c/p\u003e\n\u003cp\u003eStructured feedback from PPIE members informed multiple aspects of study design, communication, recruitment, and dissemination. Core engagement themes included respectful communication, such as correctly using participants\u0026rsquo; names and avoiding jargon or medical abbreviations, and emphasising the broader impact of the study beyond individual pregnancies. Members also valued local community-based workshops for public education and recommended a layered approach to recontact (initial letter/email followed by optional text or call) to minimise perceived intrusiveness.\u003c/p\u003e\n\u003cp\u003eIn relation to recruitment, members raised concerns about approaching participants during high-stress clinical events, and researchers responded by ensuring that recruitment occured only with clinical team approval. Members advocated for participant autonomy when partners attempted to decline on their behalf. They also suggested diversifying recruitment settings beyond hospitals; however, resource and ethical constraints limited this. Proposals to introduce simplified study materials, including a one-page information sheet, were considered but not implemented due to time constraints, although the team agreeed to adopt this approach in future studies.\u003c/p\u003e\n\u003cp\u003eIn discussions about equity in participation, members highlighted the need for fair reimbursement, particularly for those facing logistical barriers, however, budget limitations restricted changes to reimbursement. They emphasised the importance of comprehensive ethnicity recording, and researchers confirmed that ethnicity records will be updated prior to data analysis. Although\u0026nbsp;the\u0026nbsp;study already demonstrated strong ethnic diversity, members encouraged more targeted outreach based on age, location, and platform preferences to engage underrepresented communities. This feedback led to expanded social media advertising and updated study posters.\u003c/p\u003e\n\u003cp\u003eConsent processes were also discussed. Members suggested reorganising consent forms to place mandatory statements at\u0026nbsp;the beginning to improve clarity, however, the short study timeline precluded these changes.\u003c/p\u003e\n\u003cp\u003eTo enhance study promotion, one member\u0026nbsp;recommended partnering with Bliss, a UK charity supporting families with preterm and sick babies, while another volunteered to liaise with the Mid and South Essex Maternity and Neonatal Voices Partnership (MNVP). Targeted advertisements were subsequently launched through these organisations\u0026rsquo;s social media channels, contributing to a noticeable increase in self-referral form submissions. In total, over 250 self-referrals were received through web and social media promotions coordinated by multiple support groups and organisations.\u003c/p\u003e\n\u003cp\u003eStudy materials underwent multiple revisions to improve clarity, tone, and cultural sensitivity. Social media advertisements were co-designed with members, resulting in five finalised versions (see Supplementary material 4). Posters targeting both the public and clinicians were updated with clearer language and more inclusive visuals. Figure 1 shows key differences between the original and revised posters.\u003c/p\u003e\n\u003cp\u003eFinally, members committed to supporting dissemination of study findings by co-authoring the current article and contributing to the development and review of a lay summary of the final study report. They also expressed willingness to participate in future PPIE activities, reinforcing the collaborative and inclusive nature of the research process.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePPIE evaluation from researchers and PPIE members\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe distributed evaluation forms to seven researchers (five from Imperial College London and two from Genomics England) and three PPIE members. We received six responses from researchers (four complete, two incomplete) and three complete responses from PPIE members. The two Genomics England researchers submitted a joint response. The two incomplete researcher responses from Imperial College London were due to limited direct involvement in PPIE meetings.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSummary of PPIE member evaluation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEvaluation forms from three PPIE members demonstrated a substantial positive impact of the PPIE meetings on their understanding of research, confidence in engaging with research activities, and perception of their role within the study. Members reported increased knowledge of the research process, particularly regarding research ethics, the value of diverse perspectives in study design, and the importance of incorporating lived experience into health research.\u003c/p\u003e\n\u003cp\u003eAll contributors felt that their input was meaningfully received and, in some cases, directly influenced the research team\u0026rsquo;s approach, including suggestions on culturally sensitive communication, revisions to participant-facing language, and outreach strategies to improve community engagement. One contributor stressed the psychological impact of language used in maternity settings, particularly for ethnic minority communities.\u003c/p\u003e\n\u003cp\u003eOnline delivery and the frequenct of meetings were generally well received and viewed as convenient and inclusive, especially for those with caregiving responsibilities. Suggestions for improvement included receiving agendas or presentation materials in advance to enhance preparation.\u003c/p\u003e\n\u003cp\u003eQuantitative findings (Table 2) supported these qualitative impressions. Members reported an increase in confidence to support research within a PPIE role, with average ratings rising from 3.00 (range: 1\u0026ndash;5) before the meetings to 4.33 after. All contributors agreed or strongly agreed that their knowledge and skills improved\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e(mean = 4.67), indicating the educational value of the process. All members also felt that their participation met or exceeded expectations (mean = 4.33), and expressed a strong likelihood of engaging in future PPIE activities (mean = 5.00). Perceptions of their impact on the research varied slightly (mean = 4.00), but all believed their contribution was meaningful.\u003c/p\u003e\n\u003cp\u003eOverall, these findings support the value of well-structured, inclusive, and accessible PPIE models in building contributor confidence, facilitating knowledge exchange, and encouraging long-term engagement. High scores across most questions suggest that contributors felt respected, heard, and genuinely involved in shaping research directions.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable2: Summary of quantitative responses from PPIE members\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"3\" cellpadding=\"0\"\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eEvaluation question\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eMember1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eMember2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eMember3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eMean\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eRange\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eConfidence before meetings (1\u0026ndash;5)\u003csup\u003ea\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e3.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e2\u0026ndash;4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eConfidence after meetings (1\u0026ndash;5)\u003csup\u003ea\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e4.33\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e4\u0026ndash;5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eKnowledge/perspective/skills improved (1\u0026ndash;5)\u003csup\u003eb\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e4.67\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e4\u0026ndash;5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eInvolvement met expectations \u0026nbsp; \u0026nbsp;(1\u0026ndash;5)\u003csup\u003eb\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e4.33\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e4\u0026ndash;5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eImpactfulness of PPIE group involvement (1\u0026ndash;5)\u003csup\u003ec\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e4.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e3\u0026ndash;5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eLikelihood of participating in future PPIE groups (1\u0026ndash;5)\u003csup\u003ed\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e5.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e5\u0026ndash;5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;a) \u0026nbsp;1: Not confident \u0026ndash; 5: Extremely confident\u003c/p\u003e\n\u003cp\u003eb) \u0026nbsp;1: Strongly disagree \u0026ndash; 5: Strongly agree\u003c/p\u003e\n\u003cp\u003ec)\u0026nbsp;\u0026nbsp;1: Not at all impactful \u0026ndash; 5: Extremely impactful\u003c/p\u003e\n\u003cp\u003ed) \u0026nbsp;1: Not at all likely \u0026ndash; 5: Extremely likely\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eQuotes from PPIE contributor\u003c/strong\u003e\u003cstrong\u003es\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;Participating in the PPIE meetings has given me a completely different perspective and a clearer appreciation of how individual studies shape future healthcare practices.\u0026rdquo;\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;I have learned a lot about preterm birth and how genomics can detect genetic characteristics associated with PTB across different ethnic backgrounds.\u0026rdquo;\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;This experience has increased my confidence to talk about research outside the meetings and I feel more motivated to raise awareness of its vital.\u0026rdquo;\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;Several times I have suggested different ways or wordings to reach out to participants, and these were directly adopted or updated as a result.\u0026rdquo;\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;One key point I raised was about language used in maternity wards; I hope I have encouraged researchers to consider how more compassionate, culturally sensitive communication can improve experiences.\u0026rdquo;\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;I have gained further knowledge of how research is conducted and samples collected ethically, and how much consideration goes into studies before any work begins!\u0026rdquo;\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;In every meeting I gained knowledge, heard differnt ideas and views, and helped ensure that patients\u0026rsquo; needs were considered inclusively.\u0026rdquo;\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;I feel I have supported and listened to the team, and helped them find positive ways to achieve better findings and respect diverse cultures.\u0026rdquo;\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSummary of research member evaluation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSix researchers completed the evaluation forms, with varying levels of engagement: two attended meetings regularly, while four engaged indirectly through colleague feedback. Despite different levels of direct involvement, all respondents acknowledged the influence of PPIE input on the study and found the process valuable for improving communication strategies, study design, and inclusivity.\u003c/p\u003e\n\u003cp\u003eResearchers highlighted specific contributions from the PPIE group, including feedback on tone and accessibility of study materials, improvements to recruitment posters, advice on culturally sensitive communication, and insights into the lived experiences of patients in high-stress settings. A notable example was the recommendation to collaborate with Bliss and the Mid and South Essex MNVP, which led to a marked increase in self-referrals.\u003c/p\u003e\n\u003cp\u003eThere was strong consensus that PPIE shaped communication and outreach methods by helping tailor materials to diverse audiences and prompting reflection on patient needs, emotional readiness, and barriers to participation. For several researchers, working with members of the public shifted their perspective on research practice, especially regarding diversity, engagement, and inclusive communication. Some reported strengthened confidence in PPIE approaches and greater commitment to embedding public perspectives in future work.\u003c/p\u003e\n\u003cp\u003eChallenges were also identified. Researchers stressed that PPIE activities began too late to influence core documents such as the protocol, patient information sheet (PIS), and consent form. Although PIS and consent form were reviwed by PPIE menbers priore to finalisation, earlier involvement would have enabled more substantive input and avoided last-minute amendments. Additional challenges indludes scheduling difficulties, limited group diversity, and absence of funding to support PPIE throughout the full research cycle, including final write-up.\u003c/p\u003e\n\u003cp\u003eQuantitative responses (Table 3) further illustrated the perceived impact. Prior experience with PPIE was modest (mean = 2.83; range: 1\u0026ndash;5), but most researchers reported significant gains in experience (mean = 4.2). Knowledge and perspective expanded markedly (mean = 4.33), expectations were met or exceeded (mean = 4.6), and the overall perceived impact of the meetings was high (mean = 4.17). Importantly, all respondents indicated they were very likely to involve a PPIE group in future projects (mean = 5.0).\u003c/p\u003e\n\u003cp\u003eRegarding research design and delivery, PPIE involvement had particularly strong effects on study materials (mean = 4.8) and patient communication (mean = 4.8) and supported greater inclusivity and equity in participation (mean = 4.2). Impacts on recruitment (mean = 3.5) and study methods (mean = 3.4) were more variable, reflecting the late introduction of PPIE input and the limited scope for changes due to the study design.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQuotes from researchers\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;We received extensive insight from members of the public, including how patients may be feeling and when they are most receptive to discussing research participation.\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;We received very genuine feedback, emphasising the importance of inclusivity and diversity so that no one is left out of the study.\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;Feedback on the communications strategy (posters etc.) was very helpful and led to \u0026nbsp;improvement; the question about what participants might expect at the end of the study was particularly insightful.\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;The PPIE meetings improved the quality of the study, particularly in terms of communication with patients, understanding participants\u0026rsquo; needs, and refining study materials.\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;The group identified Bliss, and after we reached out, we received a large number of self-referrals as a result.\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;It has helped us understand how to best engage and recruit this particular population and what their expectations are of us.\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;Working with this group has strengthened my belief that PPIE should be embedded in every study.\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;It has helped me appreciate that everyone\u0026rsquo;s experience is different and that it is important to listen to everyone to be as inclusive as possible.\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;The meeting made me reflect on how I can more effectively communicate the aims of our research to the public.\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n"},{"header":"Discussion","content":"\u003cp\u003eThis study examined the structure and impact of PPIE meetings within the PRESTIGE-PTB study, demonstrating sustained collaboration with contributors can influence study design, participant materials, and operational decisions. Evaluations from both contributors and researchers highlighted that co-creation and collaborative delivery were experienced as rewarding and beneficial.\u003c/p\u003e\n\u003cp\u003ePersistent inequalities in maternal care and the limited representation of women\u0026rsquo;s voices in the UK remain well documented. Despite overall improvements, Black women continue to experience maternal mortality rates twice as high as those of White women\u003csup\u003e17\u003c/sup\u003e. The \u003cem\u003eWomen\u0026rsquo;s Health Strategy for England\u003c/em\u003e highlights the urgent need to embed the perspectives of diverse women across all areas of policy and service development\u003csup\u003e18\u003c/sup\u003e. Yet, ethnic minority groups remain underrepresented in research studies, contributing to unequal health outcomes\u003csup\u003e19\u003c/sup\u003e, underscoring the importance of involving diverse communities and ensuring equitable access to research and healthcare.\u003c/p\u003e\n\u003cp\u003ePPIE in maternity research is still relatively limited and often poorly reported. The time-limited nature of pregnancy and the competing demands of caregiving, health, and employment make sustained engagement challenging\u003csup\u003e20\u003c/sup\u003e, while critiques of women\u0026rsquo;s health research point to tokenistic approaches that fail to centre lived experience\u003csup\u003e21\u003c/sup\u003e. Within this context, the PRESTIGE study\u0026rsquo;s regular monthly PPIE meetings provided a consistent structure for contributors to shape recruitment messaging, study materials, and outreach strategies. This reflects best practices for engagement, continuity, co-learning, and respect for lived experience, and directly led to real-time improvements, including revised posters, culturally sensitive communication, and co-created social media content.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eContributors reported increased understanding of research ethics, genomics, preterm birth, and participant rights, reinforcing the role of PPIE in building public capacity and trust. They valued being heard and seeing their feedback reflected, and they emphasised respectful language and psychological sensitivity in maternity settings as areas where standard research practice can improve. Suggestions to partner with community organisations such as Bliss and the Mid and South Essex MNVP broadened the study\u0026rsquo;s reach.\u003c/p\u003e\n\u003cp\u003eResearchers confirmed the value of PPIE, particularly in enhancing communication and outreach and deepening understanding of participatmn\u0026rsquo;s lived experiences. Their reflections suggest that engagement with PPIE members can shift research perspectives and strengthen cultural sensitivity, echoing wider evience that co-production improves the relevance and accessibility of research.\u003c/p\u003e\n\u003cp\u003eA key limitation was that regular PPIE meetings were introduced only after recruitment had begun, limiting thier influence on foundational documents like the protocol and PIS. Earlier involvement, ideally during the concept phase (more than12 months before study launch), would have enabled more substantive contributions and reduced protocol amendments, as highlighted in existing literature\u003csup\u003e22,23\u003c/sup\u003e. Additional challenges included scheduling difficulties, limited group diversity, and insufficient funding to support PPIE across the full research cycle. These barriers mirror structural issues seen in other PPIE initiatives but are important to address if PPIE is to become standard practice rather than an add-on.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFuture studies could strengthen impact assessment by introducing tools like pre-meeting questionnaires to track changes in contributors\u0026rsquo; knowledge, expectations, and confidence over time. Appointing a dedicated PPIE lead at project outset would enable earlier and more coordinated involvement. Broader diversity among PPIE contributors\u0026mdash;across age, geography, language, and lived experience\u0026mdash;should be prioritoised, especially in genomic and preterm birth research where inequalities are pronounced.\u0026nbsp;Adopting multilingual materials, flexible engagement formats, and robust partnerships with community organisations will be critical; the collaboration between PRESTIGE and the Mosaic Community Trust provided a foundation on which to build.\u003c/p\u003e\n\u003cp\u003eIn genomics and maternal health research, where trust and understanding are crucial, sustained and inclusive PPIE is essential. As NHS England implements its ten-year plan to expand access to genomic healthcare\u003csup\u003e24\u003c/sup\u003e, engagement will need to shift toward genuine \u0026nbsp;co-creation\u0026mdash;where contributors move beyond providing feedback to actively shaping the study\u0026rsquo;s direction.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe PRESTIGE-PTB study shows that even small, well-supported PPIE initiatives can significantly improve research delivery. Contributors helped shape study materials, enhance outreach, and improve inclusivity, while gaining knowledge, confidence, and ownership in the process.\u003c/p\u003e\n\u003cp\u003eFuture research should prioritise earlier and more comprehensive public involvement, ensuring diversity, accessibility, and sustained collaboration. PRESTIGE-PTB offers a practical example of inclusive research in action and a blueprint for future studies aiming for equity and impact.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eBRC: Biomedical Research Centre\u003c/p\u003e\n\u003cp\u003eGRIPP2: Guidance for Reporting Involvement of Patients and the Public version2\u003c/p\u003e\n\u003cp\u003eNIHR: National Institute for Health and Care Research\u003c/p\u003e\n\u003cp\u003eMCT: Mosaic Community Trust\u003c/p\u003e\n\u003cp\u003eMNVP: Maternity and Neonatal Voices Partnership\u003c/p\u003e\n\u003cp\u003ePERC:\u0026nbsp;Patient Experience Research Centre\u003c/p\u003e\n\u003cp\u003ePIS: Patient Information Sheet\u003c/p\u003e\n\u003cp\u003ePPIE: Patient and Public Involvement and Engagement\u003c/p\u003e\n\u003cp\u003ePPROM: Preterm Prelabour Rupture of Amniotic Membranes\u003c/p\u003e\n\u003cp\u003ePRESTIGE-PTB study: Whole Genome Sequencing to Identify the Genetic Determinants of Spontaneous Preterm Birth: A Nationwide Multicentre Cohort Study\u003c/p\u003e\n\u003cp\u003ePTB: Preterm Birth\u003c/p\u003e\n\u003cp\u003eREC: Research Ethics Committee\u003c/p\u003e\n\u003cp\u003esPTB: Spontaneous\u0026nbsp;Preterm Birth\u003c/p\u003e\n\u003cp\u003eWGS: Whole Genome Sequencing\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthical approval for the PRESTIGE-PTB study, including PPIE activities, was obtained from the South West \u0026ndash; Frenchay Research Ethics Committee (REC reference: 24/SW/0060). The study was conducted in accordance with the principles of the Declaration of Helsinki.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAvailable on request\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe project was funded by Genomics England and\u0026nbsp;\u003cem\u003eTommy\u0026apos;s National Centre for Preterm Birth Research.\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMN drafted the manuscript as first author. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe thank Genomics England, Tommy\u0026rsquo;s National Centre for Preterm Birth Research, North Thames Genomic Medicine Service Alliance, the Mosaic Community Trust (MCT), the NIHR BRC \u003cem\u003eImperial\u003c/em\u003e Patient Experience Research Centre (\u003cem\u003ePERC\u003c/em\u003e), Women\u0026rsquo;s Health Reserch Centre (WHRC), Imperial College London, and Imperial College Healthcare NHS Trust for their support.\u003c/p\u003e\n"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eWorld Health Organization (WHO), Preterm birth. https://www.who.int/news-room/fact-sheets/detail/preterm-birth\u003c/li\u003e\n\u003cli\u003eOffice for National Statistics. Birth characteristics in England and Wales: 2022. https://www.ons.gov.uk/peoplepopula\ntionandcommunity/birthsdeathsandma\nrriages/livebirths/\nbulletins/birthcharacteristicsinengland\nandwales/2022. Accessed 07 March 2026.\u003c/li\u003e\n\u003cli\u003ePlatt MJ. Outcomes in preterm infants. \u003cem\u003ePublic Health\u003c/em\u003e. 2014/05/01/ 2014;128(5):399-403. doi:https://doi.org/10.1016/j.puhe.2014.03.010\u003c/li\u003e\n\u003cli\u003eKayode G, Howell A, Burden C, et al. Socioeconomic and ethnic disparities in preterm births in an English maternity setting: a population-based study of 1.3 million births. \u003cem\u003eBMC Medicine\u003c/em\u003e. 2024/09/20 2024;22(1):371. doi:10.1186/s12916-024-03493-x\u003c/li\u003e\n\u003cli\u003eHindes I, Ibrahim B, Jardine J, Zenner D, Iliodromiti S. Inequalities in Preterm Birth in England: A Retrospective National Cohort Study Focusing on Deprivation and Ethnicity, Using Routinely Collected Maternity Hospital Data. \u003cem\u003eBjog\u003c/em\u003e. Nov 2025;132(12):1866-1874. doi:10.1111/1471-0528.18331\u003c/li\u003e\n\u003cli\u003ePopulation-based rates, risk factors and consequences of preterm births in South-Asia and sub-Saharan Africa: A multi-country prospective cohort study. \u003cem\u003eJ Glob Health\u003c/em\u003e. 2022;12:04011. doi:10.7189/jogh.12.04011\u003c/li\u003e\n\u003cli\u003eAughey H, Jardine J, Knight H, et al. Iatrogenic and spontaneous preterm birth in England: A population-based cohort study. \u003cem\u003eBjog\u003c/em\u003e. Jan 2023;130(1):33-41. doi:10.1111/1471-0528.17291\u003c/li\u003e\n\u003cli\u003eVoltolini C, Torricelli M, Conti N, Vellucci FL, Severi FM, Petraglia F. Understanding Spontaneous Preterm Birth: From Underlying Mechanisms to Predictive and Preventive Interventions. \u003cem\u003eReproductive Sciences\u003c/em\u003e. 2013/11/01 2013;20(11):1274-1292. doi:10.1177/1933719113477496\u003c/li\u003e\n\u003cli\u003eBhattacharjee E, Maitra A. Spontaneous preterm birth: the underpinnings in the maternal and fetal genomes. \u003cem\u003enpj Genomic Medicine\u003c/em\u003e. 2021/06/08 2021;6(1):43. doi:10.1038/s41525-021-00209-5\u003c/li\u003e\n\u003cli\u003eGoldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. \u003cem\u003eThe Lancet\u003c/em\u003e. 2008;371(9606):75-84. doi:10.1016/s0140-6736(08)60074-4\u003c/li\u003e\n\u003cli\u003eCorpas M, Pius M, Poburennaya M, et al. Bridging genomics\u0026apos; greatest challenge: The diversity gap. \u003cem\u003eCell Genom\u003c/em\u003e. Jan 8 2025;5(1):100724. doi:10.1016/j.xgen.2024.100724\u003c/li\u003e\n\u003cli\u003eThe NHS Race and Health Observatory, Ethnic inequities in genomics and precision medicine review report. https://nhsrho.org/research/ethnic-inequities-in-genomics-and-precision-medicine-review-report/. Accessed 07 March 2026.\u003c/li\u003e\n\u003cli\u003ePublic involvement, Health Researc Authority. https://www.hra.nhs.uk/planning-and-improving-research/best-practice/public-involvement/\u003cu\u003e. \u003c/u\u003eAccessed 07 March 2026.\u003c/li\u003e\n\u003cli\u003eStaniszewska S, Brett J, Simera I, et al. GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research. \u003cem\u003eBMJ\u003c/em\u003e. 2017;358:j3453. doi:10.1136/bmj.j3453\u003c/li\u003e\n\u003cli\u003eNational Institute for Health and Care Research (NIHR), Patient and public involvement in health and social care research: A handbook for researchers. https://oxfordbrc.nihr.ac.uk/wp-content/uploads/2017/03/RDS-PPI-Handbook-2014-v8-FINAL-2.pdf. Accessed 07 March 2026.\u003c/li\u003e\n\u003cli\u003eNIHR public contributor payment policy. https://www.nihr.ac.uk/nihr-public-contributor-payment-policy#:~:text=For%20example%2C%20a%20teleconference%20with,approximately%20half%20a%20day\u0026apos;s%20activity. Accessed 07 March 2026.\u003c/li\u003e\n\u003cli\u003eMBRRACE-UK. Saving Lives, Improving Mothers\u0026apos; Care 2025 - Lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2021-23. https://www.npeu.ox.ac.uk/mbrrace-uk/reports/maternal-reports/maternal-report-2021-2023. Accessed 07 March 2026.\u003c/li\u003e\n\u003cli\u003eDepartment of Health and Social Care. Women\u0026apos;s Health Strategy for England, Women\u0026rsquo;s voices. https://www.gov.uk/government/publications/womens-health-strategy-for-england/womens-health-strategy-for-england#womens-voices. Accessed 07 March 2026.\u003c/li\u003e\n\u003cli\u003eSmart A, Harrison E. The under-representation of minority ethnic groups in UK medical research. \u003cem\u003eEthnicity \u0026amp; Health\u003c/em\u003e. 2017/01/02 2017;22(1):65-82. doi:10.1080/13557858.2016.1182126\u003c/li\u003e\n\u003cli\u003eRack J, Hundley V, van Teijlingen E, Luce A. The pregnant pause: Engaging and involving public contributors in maternal health research. \u003cem\u003eMidwifery\u003c/em\u003e. 2025/03/01/ 2025;142:104279. doi:https://doi.org/10.1016/j.midw.2024.104279\u003c/li\u003e\n\u003cli\u003ePerry AG, Mullins E. \u0026pound;25 and a biscuit: Women\u0026rsquo;s Health Research and Public Engagement in the UK. \u003cem\u003eResearch Involvement and Engagement\u003c/em\u003e. 2023/12/15 2023;9(1):120. doi:10.1186/s40900-023-00519-1\u003c/li\u003e\n\u003cli\u003eNclusiv, When Should PPIE Be Started? Early Integration Guide. https://nclusiv.co.uk/blog/f/when-should-ppie-be-started-early-integration-guide. Accessed 07 March 2026.\u003c/li\u003e\n\u003cli\u003eCrocker JC, Ricci-Cabello I, Parker A, et al. Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis. \u003cem\u003eBMJ\u003c/em\u003e. 2018;363:k4738. doi:10.1136/bmj.k4738\u003c/li\u003e\n\u003cli\u003eYear Health Plan for England: fit for the future. https://www.gov.uk/government/publications/10-year-health-plan-for-england-fit-for-the-future. Accessed 07 March 2026.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Table 1 and 3","content":"\u003cp\u003eTable 1 and 3 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"PPIE, Patient and Public Involvement and Engagement, Preterm Birth, Maternity Research, Genomics Research, Pregnancy, Inclusivity","lastPublishedDoi":"10.21203/rs.3.rs-9161270/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9161270/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003ePreterm birth (PTB) disproportionately affects women from ethnic minority backgrounds, yet these communities remain underrepresented in genomic research. The PRESTIGE-PTB study uses whole genome sequencing to investigate genetic determinants of spontaneous PTB and embeds patient and public involvement and engagement (PPIE) to promote inclusivity, acceptability, and responsiveness to lived experience.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eMonthly online PPIE meetings were conducted with three contributors from ethnically diverse backgrounds between December 2024 and September 2025. Activities included co-development of participant materials, discussion of recruitment challenges, and refinement of communication strategies. Meeting minutes and evaluation forms from contributors and researchers were analysed descriptively. Reporting was guided by the GRIPP2 short-form checklist.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eNine PPIE meetings were held. Contributor feedback led to revisions of posters and social media materials, improved cultural sensitivity in recruitment communication, and targeted outreach through charities and community groups, contributing to increased self-referrals. Contributors reported increased knowledge, confidence, and sense of value, while researchers described enhanced awareness of inclusivity and patient experience. Limitations included late introduction of PPIE and restricted influence on foundational study documents.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eRegular, well-supported PPIE enhanced study materials, communication, and inclusivity in genomic PTB research. Early involvement, broader diversity, and sustained funding are essential to maximise the impact of PPIE in future maternal and genomic research.\u003c/p\u003e\u003ch2\u003eTrial registration\u003c/h2\u003e \u003cp\u003eNot applicable.\u003c/p\u003e","manuscriptTitle":"Patient and public involvement and engagement in genomic preterm birth research: shaping study delivery and materials in the PRESTIGE-PTB study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-03-24 17:20:51","doi":"10.21203/rs.3.rs-9161270/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"68928a87-e106-4de7-95bc-1784a096be73","owner":[],"postedDate":"March 24th, 2026","published":true,"recentEditorialEvents":[{"type":"decision","content":"Rejected","date":"2026-05-09T14:55:59+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-05-07T15:20:59+00:00","index":108,"fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-05-06T16:39:45+00:00","index":107,"fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-04-30T14:31:57+00:00","index":106,"fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-05-09T15:10:18+00:00","versionOfRecord":[],"versionCreatedAt":"2026-03-24 17:20:51","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-9161270","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-9161270","identity":"rs-9161270","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}