P1045The impact of patient and public involvement and engagement (PPIE) on the design and operationalisation of a multi-centre inception cohort study: Insights from Open-IBD

Abstract Background Patient and Public Involvement and Engagement (PPIE) is now an expected component of clinical research. Meaningful PPIE has the potential to transform study design, enhance participant experience, and improve recruitment and retention. We describe the process and impact of PPIE on the design and operationalisation of Open-IBD, a multi-omic observational inception cohort study recruiting across seven UK hospitals. Methods Open-IBD is a prospective longitudinal cohort study aiming to provide a deep multi-omic characterisation of early-stage IBD. The study will recruit 2,000 treatment-naive people with suspected IBD. Uniquely, participant consent is obtained before a formal diagnosis, at the point of referral from primary care, and biosamples (blood, stool, intestinal biopsies), patient-reported outcomes, and clinical metadata are collected at baseline, with continued sampling and follow-up for up to four years in 1,000 people confirmed to have IBD. Approaching patients prior to diagnosis represents a challenge, and a Lived Experience Advisory Panel (LEAP) of people living with Crohn’s disease and ulcerative colitis was convened through Crohn’s & Colitis UK to provide guidance regarding study design and delivery, with virtual workshops occurring prior to and during recruitment launch. The panel will continue to provide guidance for the duration of the study. Results In total, twelve LEAP meetings informed multiple aspects of the study, including: methods and timing of potential participant approach with study information, acceptability and burden of questionnaires, inclusion of symptoms to capture, outcomes and covariates prioritised by patients, strategies to improve engagement and retention, ensuring appropriate ethnic representation and co-developing eventual dissemination plans. The LEAP co-authored participant information sheets and formally presented their recommendations to research teams on participant communication and recruitment strategies. Key protocol and material changes arising from LEAP input are summarised in Table 1. Across the consortium, current recruitment has exceeded projections, with 214 participants enrolled by October 2025, compared to 125 forecasted. Site staff and participant feedback has attributed study acceptability and recruitment success in part to LEAP-driven recommendations. Conclusion PPIE has fundamentally shaped recruitment strategy, study materials, and participant pathways in Open-IBD. Our findings demonstrate that embedding PPIE throughout study development is not only essential for acceptability but can act as a driver of recruitment and sustained engagement. PPIE should therefore be recognised as a strategy to optimise operational effectiveness across research studies. Conflict of interest: Mrs. Jacques, Katherine: No conflict of interest Mulligan, Robert: Robert J. Mulligan acknowledges research support from Open Targets, Wellcome Trust, European Bioinformatics Institute (EMBL-EBI), Genentech, GlaxoSmithKline, Merck Sharp and Dohme, Pfizer, and Sanofi and support for educational meeting attendance from Ferring. Allerton, Dean: No conflict of interest Anderson, Carl: Personal Fees: Carl Anderson (CAA) has received consultancy or speaker fees from Genomics plc, BridgeBio Ltd and Glaxo Smith Kline. Andrew, Simon: No conflict of interest Bates, Georgina: No conflict of interest Best, Katie: No conflict of interest Bibby, Irena: No conflict of interest Blackwell, Jonathan: No conflict of interest Cotobal Martin, Cristina: No conflict of interest Dong, Chaonan: No conflict of interest Ganendran, Melissa: No conflict of interest Gardner, Richard: No conflict of interest Irving, Peter Miles: Grant: MSD, Pfizer, Takeda, Celltrion, Galapagos Personal Fees: AbbVie, Arena, BMS, Boomerang Medical, Celgene, Celltrion, Falk Pharma, Ferring, Galapagos, Genentech, Gilead, Hospira, Janssen, Lilly, MSD, Pfizer, Pharmacosmos, Prometheus, Roche, Sandoz, Samsung Bioepis, Sapphire Medical, Sandoz, Shire, Takeda, Tillotts, Topivert, VH2, Vifor Pharma, Warner Chilcott Kennedy, Nicholas Alexander: Grant: Dr Kennedy’s department has received research funding from AbbVie, Biogen, Celgene, Celtrion, Galapagos, MSD, Napp, Pfizer, Pharmacosmos, Roche and Takeda Personal Fees: Dr Kennedy has served as a speaker and/or advisory board member for AbbVie, Amgen, BMS, Falk, Ferring, Galapagos, Janssen, Mylan, Pharmacosmos, Sandoz, Takeda and Tillotts Non-financial Support: Dr Kennedy has had support to attend meetings from AbbVie, Falk, Janssen and Tillotts McCormick, Samantha: No conflict of interest McGregor, Naomi: No conflict of interest Megginson, Andrew: No conflict of interest Parkes, Gareth: Dr Gareth Parkes reports personal payments, honoraria, speaker fees, travel grants and/or fellowships from AbbVie, Allergan, Bristol Myers Squibb, Celltrion, Ferring, Galapagos, Janssen, Napp, Takeda, and Tillotts, and directorship and shareholding with Ampersand Health. Dr. Parkes reports personal grants from AbbVie personal consulting fees from AbbVie, Arena, Aslan, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Ferring, Galapagos, Gilead, GlaxoSmithKline, Heptares, LabGenius, Janssen, Monte Rosa, MSD, Mylan, Novartis, Numab, Pfizer, Roche, Sandoz, Takeda, UCB, and XAP membership of the ECCO Scientific Committee, and membership in the UEG Scientific Committee director of Endoread. Patel, Kamal Vijaykant: No conflict of interest Prichard, Jonathan: No conflict of interest Saunders, Kelly: No conflict of interest Speight, Ally: Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: AbbVie, Lilly, Dr Falk Pharma Janssen Support for attending meetings and/or travel: AbbVie, Dr Falk Pharma Janssen, Tillott’s pharmaceuticals Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: BSG IBD Section Committee (unpaid) Subramanian, Sreedhar: SS has received speaker fees from Janssen, Takeda, AbbVie, Lilly and Dr Falk Pharmaceuticals educational grants from AbbVie and has served on advisory boards for AbbVie, Dr Falk Pharmaceuticals, and Vifor Pharmaceuticals. Stewart, Christopher: No conflict of interest Young, Greg: No conflict of interest Watson, Hannah: No conflict of interest Lamb, Christopher Andrew: Grant: In the last 5 years I have undertaken research supported by grants from the following: Genentech, Janssen, Takeda, AbbVie, Eli Lilly, Pfizer, Roche, UCB Biopharma, Sanofi Aventis, Biogen IDEC, Orion OYJ and AstraZeneca. Personal Fees: In the last 5 years I have received honoraria for speaking at educational events from Takeda, Janssen, Dr Falk, Ferring and Nordic pharma. Other: The following companies were corporate sponsors of an educational event, IBD Newcastle 2023, I convened at Newcastle University on 29th November 2023 Amgen, Celltrion Healthcare, Janssen, Tillotts Pharma, Pharmacosmos, Dr Falk Pharma, Galapagos, Ferring, AbbVie, Takeda, Eli Lilly and Bristol Myers Squibb.