Development and validation of the inflammatory bowel disease objective disability index (IBDODI)

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Abstract Introduction Many scores aiming to measure Inflammatory bowel disease (IBD)-related disability have been validated. However, they rely mostly on patients’ subjective perceptions, and may, therefore, be biased by them. To obtain a more objective measure of disability, the present study aimed to develop and validate an IBD-related disability index based on objective and measurable variables. Methods Answering an online survey, IBD patients reported their officially recognised degree of general and work disability plus a number of objective parameters for its assessment. Responses were randomly allocated to one of two datasets: a) training or b) validation. Multiple logistic regression tests were performed in the training set. Variables that were statistically or clinically significant were used to model two scores: The Unweighted IBD Objective Disability Index (U-IBDODI), where all variables had the same weight, and the Weighted IBD Objective Disability Index (W-IBDODI), in which variables were weighted according to the regression results. Both scores were subsequently validated. Results The analysis included 930 valid questionnaires. Patients’ mean age was 41±11, 642 (65.4%) were women, and 582 (59.3%) had Crohn’s Disease. The training dataset included 665 surveys. In the validation set (n=265), U-IBDODI mean values were 3.7 +/-1.3 for patients with work disability and 2.3+/-1.4 for patients without (p<0.001). U-IBDODI AUROCs for predicting work and general disability were 0.839 and 0.675 respectively. The corresponding W-IBDODI values were 10.9 +/-3.7 and 6.9+/-3.7 (p<0.001), 0.837 and 0.606. Discussion Both U-IBDODI and W-IBDODI scores are easy-to-use, objective and valid tools for measuring work disability in IBD patients. DISCLOSURE STATEMENT LM has served as a speaker and consultant for MSD, Abbvie, Janssen, Takeda, Tillotts, Kern, Chiesi. AV has served as a speaker and consultant for MSD and Abbvie. EB has served as a speaker and consultant for Jansen, Kern and Chiesi. XC has received grants for research from Janssen, Kern, Abbott, MSD, Pfizer, Galapagos and Vifor, and fees for advisory board services from Janssen, Abbvie, MSD, Takeda and Vifor. He has also given lectures for Janssen, Abbvie, MSD, Takeda, Shire and Allergan. AUTHORS’ CONTRIBUTIONS LM and XC designed the study, analyzed the data and wrote the manuscript. OV analyzed data. LM, XC, EB, AV, MV, AP, LL, OV critically reviewed the text and provided important intellectual content. All authors definitively approved the submitted version. FUNDING The project won the VII "Antonio Obrador" grant from GETECCU (grupo español de trabajo en enfermedad de Crohn y Colitis ulcerosa - Spanish working group on Crohn’s disease and Ulcerative Colitis

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