Verstockt, B

Abstract Background Global data demonstrate an inverse relationship between hospital ileoanal pouch volume and adverse outcomes, highlighting the need for quality metrics for this technically demanding procedure.1-4 Currently, there are no standardised quality indicators to define high-quality pouch surgery. This study aimed to establish international consensus on key performance indicators (KPIs) in pouch surgery. Methods A modified Delphi process was conducted among an international, multidisciplinary panel of experts. Participants were identified through professional networks, literature review, and direct email invitation; additional participants recruited via a snowball sampling approach over one month. Candidate KPIs were generated from literature review and expert input across 5 domains. Each item was rated on a 9-point Likert scale (1 = not important, 9 = critically important); consensus was predefined as ≥ 80% of respondents rating an item 7–9. Items not reaching consensus were re-rated in a second round following anonymized group feedback. Results Round 1 included 312 participants from 37 countries. Demographics (Table 1): 53% were age 45 years, 35.2% were female, and included surgeons (68.6%) and gastroenterologists (31.1%). Most (76.6%) practice at academic or university hospitals, with a median of 11 (5–17) years in practise; 78.9% perform >1 pouchoscopy per month, and 39.5% of surgeons perform 5 pouches/year. Respondents’ regions included North America (51%), Europe (26%), Oceania (9%), Asia (6%), Latin America (4%), and the Middle East/Africa (4%). Seven (18%) countries (Denmark, Lithuania, Malaysia, Norway, United Arab Emirates, Sweden, and Switzerland) reported pouch surgery is already centralised, while 70.6% agreed pouch centralisation should be implemented. Cost/logistics and professional autonomy were the most important barriers to centralisation, whereas capacity and training exposure were least important. Overall, 37/59 (62.7%) candidate KPIs reached consensus after Round 1. The Round 2 response rate was 61%, and 2 additional KPIs reached consensus (preop ileitis and long-term risk of pouchitis). Additionally, 14 of 25 (56%) informed consent items reached consensus, and 64% of respondents felt informed consent for pouch surgery requires 2 or more office visits. Consensus items were used to populate a KPIPS Checklist (Figure 1). Conclusion Through an international Delphi process, the KPIPS study identified a consensus-derived set of key performance indicators to measure quality in pouch surgery. These quality metrics provide a foundation for benchmarking outcomes and represent a critical step towards centralization and the development of designated pouch centres of excellence to improve global standards of care for pouch patients. References: 1. Worley GHT, Fearnhead NS, Brown SR, et al. Review of current practice and outcomes following ileoanal pouch surgery: Lessons learned from the ileoanal pouch registry and the 2017 ileoanal pouch report. Colorectal Dis 2018;20:913–22. 2. Giddings HL, Yang PF, Steffens D, Solomon MJ, Ng KS. Influence of hospital-level and surgeon factors on the outcomes after ileo-anal pouch surgery for inflammatory bowel disease: Systematic review. Br J Surg 2024;111. 3. Hoang CM, Maykel JA, Davids JS, et al. Distribution of elective ileal pouch-anal anastomosis cases for ulcerative colitis: A study utilizing the university health system consortium database. J Gastrointest Surg 2020;24:2613–9. 4. Moojen TB, Visser E, Reijntjes MA, et al. One-year stoma-free survival of ileoanal pouches for uc in european centers: The miracle project. Ann Surg Open 2025;6:e596. Conflict of interest: Prof. Holubar, Stefan: No conflict of interest Soop, Mattias: No conflict of interest Poskus, Tomas: No conflict of interest Neary, Peter: No conflict of interest Uchino, Tairin: No conflict of interest Yang, Song-soo: No conflict of interest Adamina, Michel: No conflict of interest Avellaneda, Nicolas Luis: No conflict of interest Barnes, Edward: No conflict of interest Brouquet, Antoine: No conflict of interest Brown, Steven Ross: No conflict of interest De Buck Van Overstraeten, Anthony: No conflict of interest Buskens, Christianne J.: No conflict of interest Chiorean, Michael: No conflict of interest Clark, David: No conflict of interest Cohen, Benjamin: No conflict of interest El Ouali, Sara: No conflict of interest Faiz, Omar Darius: No conflict of interest Fichera, Alessandro: No conflict of interest Hahnloser, Dieter: No conflict of interest Hancock, Laura: No conflict of interest Herfarth, Hans: No conflict of interest Johnston, Michael: No conflict of interest Kayal, Maia: No conflict of interest Laharie, David: No conflict of interest Liberman, Sender: No conflict of interest Loftus, Jr, Edward: No conflict of interest Moeslein, Gabriela: No conflict of interest Myrelid, Pär: No conflict of interest Poylin, Vitaliy: No conflict of interest Qazi, Taha: No conflict of interest Raffals, Laura: No conflict of interest Rubin, David T.: No conflict of interest Spinelli, Antonino: No conflict of interest Steinhagen, Emily: No conflict of interest Tozer, Philip: No conflict of interest Verstockt, Bram: No conflict of interest Warusavitarne, Janindra: No conflict of interest Wexner, Steven: No conflict of interest Winter, Desmond: No conflict of interest

Abstract Background The STRIDE-II recommendations highlighted the importance of targeting objective measures of disease control, including endoscopic healing, in patients (pts) with ulcerative colitis (UC).1 Risankizumab (RZB), an interleukin-23 specific inhibitor, showed improvement in the outcomes of clinical remission and endoscopic improvement compared to placebo in pts with moderately-to-severely active UC.2 Visualizing the changes of endoscopic scores from induction and maintenance may provide insight into pt disease course during treatment. Thus, this analysis sought to provide an overview of change in endoscopic scores of pts enrolled in UC clinical studies. Methods Using individual pt data from the Phase 2b/3 studies of RZB in UC, changes in Mayo endoscopic scores in induction and maintenance were assessed. For induction, pts received either intravenous (IV) placebo (PBO) or RZB for 12 weeks (wks). Pts from the Phase 2b and Phase 3 INSPIRE studies who had a clinical response to induction treatment were rerandomized into the maintenance study [COMMAND] and received subcutaneous PBO (withdrawal), RZB 180 mg, or RZB 360 mg every 8 wks for 52 wks. To be eligible for INSPIRE, pts had to have a baseline (BL) Mayo endoscopic score of 3 or 2 confirmed by central review. For this analysis, endoscopic scores are reported for induction BL and wk 12 and maintenance BL and wk 52 for each treatment. "Endoscopic improvement" was defined as a score of 1 or 0 at the time of follow-up. Results Among pts with a Mayo endoscopic score of 3 at induction BL, 28% achieved endoscopic improvement after 12-wk treatment with RZB 1200 mg; 57% of pts with a BL score of 2 showed endoscopic improvement (Fig. 1). In contrast, among PBO-treated pts with a score of 3 or 2 at BL, 11% and 18%, respectively, achieved endoscopic improvement after induction. Most PBO-treated pts (63%) had no score change at wk 12. During the maintenance study, 29%–35% of pts in the RZB treatment groups had an endoscopic score of 2 or 3 at maintenance BL. (Fig. 2). For those with a BL score of 3, most pts receiving RZB 360 mg achieved endoscopic improvement (62%); similarly, 65% of those with a BL score of 2 showed endoscopic improvement at wk 52. Trends were similar for RZB 180 mg with ≥80% of pts with a BL score of 1 or 0 maintained a 1 or 0 through wk 52. Among PBO-treated pts, ≥60% maintained a score of 3 or 2 from maintenance BL to wk 52; approximately one third of pts’ scores improved to 1 or 0. Conclusion This analysis showed that RZB treatment improved endoscopic outcomes from wk 0 to wk 12 of induction and wk 0 to wk 52 of maintenance. These findings may help inform treatment expectations and shared decision-making for pts with UC initiating RZB treatment. References 1.Turner D, et al. Gastroenterology. 2021;160(5):1570-1583. 2.Louis E, et al. JAMA. 2024;332(11):881-897.