Abstract Background Benign pelvic and perineal colorectal surgery for Inflammatory Bowel Disease (IBD) and related conditions can have profound effects on sex and intimacy. Previous patient-led research1 has shown that these issues are rarely discussed in clinical or research settings. This study aims to develop a Sexual Function Patient-Reported Outcome Measure (Sex-PROM) to facilitate conversations about sexual function and quantify it in this population. Phase 1 qualitative interviews informed a conceptual framework encompassing libido, physical, emotional, relational and body image domains. We report the results of Phase 2 cognitive interviews that evaluated the clarity, comprehensibility, relevance and comprehensiveness of the draft PROM. Methods A cognitive debriefing study was conducted using COSMIN methodology. Recruitment via social media, IBD charities and outpatient clinics ensured diversity in age, gender, ethnicity, sexual orientation and activity, religion and relationship status. Participants completed ‘think-aloud’ interviews to provide real-time feedback on each item. After every 3-5 interviews, the multidisciplinary team (patient researcher, colorectal surgeon, gastroenterologist, and qualitative researcher) reviewed feedback and implemented revisions. This iterative process continued until Version 7 of the sex-PROM. A cross-disciplinary expert survey confirmed content validity. Results Cognitive interviews were conducted (n = 32, 12 cis-males, 18 cis-females, 2 trans-gender female; median age 41 range 25-67) across Crohn’s disease, Ulcerative Colitis, and other benign perianal conditions. Participants had undergone multiple procedures including fistula surgery, stoma formation, proctectomy and ileo-anal pouch formation. Refinements of the PROM improved clarity, inclusivity for all genders and sexual orientations and sensitivity to individual lived experiences. Participants described the questionnaire as clear, relevant and comprehensive. This resulted in a sex-PROM comprising draft items across eight domains: libido, sexual activity and behaviour, physical function, sensation/orgasm, body image, psychological impact, relationships, and sexual self, with an optional section on communication with clinical teams. Conclusion These interviews have produced the first patient-designed, patient-centred sex-PROM reflecting the lived experiences of patients undergoing benign pelvic and perineal colorectal surgery. This tool is designed to facilitate open communication about sex and intimacy and enable timely recognition of post-surgical concerns. Phase 3 psychometric validation will evaluate reliability and responsiveness, and reduce the survey to the key decisional questions, prior to implementation. Reference: 1) Dames NB, Squire SE, Devlin AB, Fish R, Bisset CN, Tozer P; Respondents to the Sex After Colorectal Surgery Survey. ‘Let’s talk about sex’: a patient-led survey on sexual function after colorectal and pelvic floor surgery. Colorectal Dis. 2021 Jun;23(6):1524-1551. doi: 10.1111/codi.15598. Epub 2021 Mar 22. PMID: 33615666; PMCID: PMC9291989. Conflict of interest: Ms. Joshi, Shivani: No conflict of interest Pelly, Theo: Speaker Fees from Lilly Al Rubaiy, Laith K Qassim: No conflict of interest Dames, Nicola: No conflict of interest Dibley, Lesley: Grant: I have received grants from Janssen and Takeda to support research costs Personal Fees: I have received speaker fees from Janssen, AbbVie and WebMD Fourie, Simona: No conflict of interest Rajeswaran, Kahverry: No conflict of interest White, Isabella: No conflict of interest Hart, Ailsa: Grant: Takeda Personal Fees: Abbvie, Amgen, Arena, AZ, Falk, Celltrion, Eli Lilly, Ferring, Genentech/Roche, GSK, Pfizer, Takeda, Napp, Pharmacosmos, Janssen (J & J), Bristol-Myers Squibb, Gilead, Galapagos, Alfasigma Tozer, Philip: Personal Fees: Takeda - speakers fees, member of Inspire, and advisory boards Ferring - speakers fees Falk - speakers fees Tillott’s - speakers fees J & J - speakers fees Abbvie - speakers fees
Joshi et al. (Thu,) studied this question.