Abstract Background The Symptoms and Impacts Questionnaire for Crohn’s Disease (SIQ-CD) and Ulcerative Colitis (SIQ-UC) are patient-reported outcome measures developed to support endpoint assessment in Crohn’s disease (CD) and ulcerative colitis (UC) clinical trials.1 Based upon regulatory feedback, the SIQ-CD/UC were revised and are currently used in clinical studies such as the actiVE ulcerative colitis, a RanDomIsed Controlled Trial (VERDICT).2 Here we report results of a cross-sectional psychometric validation study of the new version of the SIQ-CD/UC. Methods Adult participants (≥18 years of age) with an established diagnosis of CD or UC were eligible. All participants had an initial clinical assessment, as well as a centrally-read endoscopy for those without an ostomy or perianal disease. Participants were divided into pre-specified subgroups based on disease extent and endoscopic severity in UC, and clinical scores in CD, to capture the full spectrum of disease activity. The study consisted of two parts. Part 1 aimed to finalise the content validity of the new version of the SIQ measures. Part 2, conducted in the USA, the UK, and Canada, performed psychometric evaluation of the SIQ scores, such that the SIQ-CD (35item, 11 domains) or SIQ-UC (33-item, 10 domains) was assessed for 7 consecutive days after inclusion. In Part 1, the completion of SIQ scoring was followed by an interview to evaluate the content validity of the score. In Part 2, approximately the first 40 participants included in each disease category completed the SIQ score for 14 days. Results The cognitive debriefing interviews (Part 1) involved 18 participants with CD and 19 with UC (Table). The revised SIQ measures were well understood and conceptually relevant. The validation study (Part 2) involved 120 participants with CD (mean age 41 years; 56% male) and 120 participants with UC (mean age 43 years; 50% male) (Table). Test-retest reliability was assessed with 66/120 participants (SIQ-CD) and 77/120 (SIQ-UC), finding an interclass correlation coefficient 0.7 for all domains in both scores except for “Nausea and Vomiting” in SIQCD. Both scores also had a good relationship to disease severity (although not to disease extent in UC). Overall domain consistency was good in both scores (Cronbach’s alpha 0.70), except for the “Nausea and Vomiting” domain (Cronbach’s alpha =0.63). Inter-item correlations were generally 0.9, except for items related to fatigue in both scores, quality of life in UC, and abdominal pain in CD. Conclusion Overall, these results show good psychometric properties of the revised SIQ-CD/UC and confirm the scale structure. Future studies are needed to evaluate responsiveness and meaningful change thresholds. References: 1. Dulai PS, Jairath V, Khanna R, et al. Development of the symptoms and impacts questionnaire for Crohn’s disease and ulcerative colitis. Aliment Pharmacol Ther. 2020;51:1047-1066. Doi:10.1111/apt.15726 2. Jairath V, Zou G, Wang Z, et al. Determining the optimal treatment target in patients with ulcerative colitis: rationale, design, protocol, and interim analysis for the randomised controlled VERDICT trial. BMJ Open Gastroenterol. 2024;11:e001218. Doi:10.1136/bmjgast-2023-001218 Conflict of interest: Hupé, Marianne: Marianne Hupé has received consulting fees from AbbVie, Celltrion Healthcare, Johnson & Johnson, Pfizer, Amgen, Takeda, and Lilly. Narula, Neeraj: Neeraj Narula holds a McMaster University AFP Clinician Researcher Award and has received honoraria from Janssen, AbbVie, Takeda, Pfizer, Sandoz, Novartis, Iterative Health, Innomar Strategies, Fresinius Kabi, Amgen, Organon, Eli Lilly, and Ferring. Grant: Takeda, Pfizer, Abbvie Personal Fees: Abbvie, Janssen, Takeda, Pfizer, Merck, Amgen, Sandoz, Iterative Health, Innomar Strategies, Fresinius Kabi, Viatris, Celltrion, Organon, Eli Lilly, Ferring Non-financial Support: Abbvie, Janssen, Takeda, Pfizer, Ferring Silverberg, Mark: Mark Silverberg has received consulting fees, speaker fees and/or research support from AbbVie, Abbivax, Alimentiv Inc., Amgen, BMS, Celltrion, Eli Lilly, Ferring, Galapagos, Fresenius Kabi, Gilead, Janssen, Merck, Organon, Pfizer, Sanofi, and Takeda. Bressler, Brian: Personal Fees: Janssen, AbbVie, Takeda, Pfizer, Alimentiv Inc., Pendopharm, Genentech, Merck, CSL Other: Stock Options: Qu Biologics, Dova Health Intelligence Ma, Christopher: Dr. Ma has received consulting fees from AbbVie, Alimentiv Inc., Amgen, Anaptys Bio, AVIR Pharma Inc, Bristol Myers Squibb, Celltrion, Domain Therapeutics, Eupraxia, Eli Lilly, Ferring, Forte Biosciences, Fresenius Kabi, Gilead, Janssen, McKesson, Mirador Therapeutics, Pendopharm, Pfizer, Prometheus Biosciences Inc., Roche, Sanofi, Takeda, Tillotts Pharma speaker’s fees from AbbVie, Amgen, AVIR Pharma Inc, Alimentiv Inc., Bristol Myers Squibb, Eli Lilly, Ferring, Fresenius Kabi, Janssen, Merck, Organon, Pendopharm, Pfizer, Sanofi, Takeda, and Tillotts Pharma royalties from Springer Publishing and research support from AbbVie, Eli Lilly, Ferring, and Pfizer. 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. Radford, Shellie: Shellie Radford has received research funding from Pfizer meeting/travel support from Pfizer and honorarium from MA Healthcare, Eli Lilly, and Johnson & Johnson. Battat, Robert: Speaker/consulting/moderator: Bristol Myers Squibb, Johnson and Johnson Innovative Medicine, AbbVie, Takeda, Ferring, Celltrion, Pfizer, Merck, Eli Lilly Advisory boards: Celltrion, AbbVie, Pfizer, Janssen, Bristol Myers Squibb, Takeda, Merck, Eli Lilly Educational grants and educational sponsorships: Abbvie, Johnson and Johnson Innovative Medicine, Pfizer, Eli Lilly, Amgen, Pendopharm, Kye Pharma, Merck, Celltrion, Organon, Takeda Travel support: Pfizer, Celltrion, Johnson and Johnson Innovative Medicine, Abbvie. Green, Daniel: No conflict of interest Afif, Waqqas: Grant: Abbvie, Takeda, Pfizer, Janssen Personal Fees: Advisory Boards: Abbvie, Amgen, BMS, Eupraxia, Eli-Lilly, GSK, Janssen, Innomar, Merck, Pfizer, Sandoz, Sanofi, Takeda Remillard, Julie: Julie Rémillard is an employee of Alimentiv Inc. Kitchen, Helen: Helen Kitchen is an employee and stockholder of Clarivate, which received funding from Alimentiv Inc. to conduct patient interviews and analysis. Al-Zubeidi, Tamara: Tamara Al-Zubeidi is an employee and stockholder of Clarivate, which received funding from Alimentiv Inc. to conduct patient interviews and analysis. Collins, Elizabeth: Elizabeth Collins is an employee and stockholder of Clarivate, which received funding from Alimentiv Inc. to conduct patient interviews and analysis. Burns, Danielle: Danielle Burns is an employee and stockholder of Clarivate, which received funding from Alimentiv to conduct patient interviews and analysis. Katsampouris, Evangelos: Evangelos Katsampouris is an employee and stockholder of Clarivate, which received funding from Alimentiv to conduct patient interviews and analysis. Ho, Kai Fai: Kai Fai Ho has received funding from Alimentiv Inc. to conduct analysis and consulting fees from Janssen, Epineuron, and SterileCare in the past 12 months. Feagan, Brian Gordon: Brian Feagan is a scientific advisory board member for AbbVie, Allergan, Amgen, AstraZeneca, Avaxia Biologics Inc., Boehringer-Ingelheim, Bristol-Myers Squibb, Celgene, Elan, Biogen, Ferring, Genentech–Roche, Janssen–Johnson & Johnson, Merck, Millennium, Nestlé, Novo Nordisk, Novartis, Pfizer, Prometheus, Protagonist, Receptos, Salix, Sigmoid Pharma, Takeda, Teva, TiGenix, Tillotts Pharma, and UCB Pharma has received consulting fees from AbbVie, Actogenix, Akros, Albireo Pharma, Allergan, Amgen, AstraZeneca, Avaxia Biologics, Avir Pharma, Axcan, Baxter Healthcare, Biogen Idec, Boehringer Ingelheim, Bristol-Myers Squibb, Calypso Biotech, Celgene, Elan–Biogen, EnGene, F
Hupé et al. (Thu,) studied this question.
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