The original version of the IBD-Control.

<div><p>Background</p><p>A demand exists for user-friendly patient-reported outcome measures for patients with inflammatory bowel disease (IBD). The IBD-Control Questionnaire has been recently developed to assess overall disease control from the patient’s view but has not been available in China.</p><p>Methods</p><p>Translation and cultural adaption of the IBD-Control into Chinese was conducted through four steps (forward translation, backward translation, expert panel, and pilot testing). Afterwards, a prospective validation study was conducted from February 2022 to February 2023. The translated IBD-Control, Short Health Scale, EQ-5D-5L, and disease activity measurements using either the Physician Global Assessment and Simple Clinical Colitis Activity Index or the Crohn’s Disease Activity Index were used. Acceptability, test-retest reliability, internal consistency, content validity, convergent validity, structural validity, discriminant ability, and receiver operating characteristic curves were analyzed.</p><p>Results</p><p>Questionnaires were completed by 150 participants with IBD (31 with Crohn’s disease [CD] and 119 with ulcerative colitis [UC]). The Cronbach’s alpha coefficient was 0.823 for the IBD-Control-8 scale. The correlations between individual item and total score varied from 0.485 to 0.892 among CD patients and from 0.588 to 0.712 among UC patients. The S-CVI/Ave was 0.98. Convergent validity analyses exhibited moderate to strong correlations between other measurements and IBD-Control-8-subscore (0.555–0.675) or IBD-Control VAS (0.503–0.671). Test-retest analysis showed that the mean scores were 75.23±17.33 versus 72.10±14.99 (<i>r</i> = 0.894, <i>p<</i>0.01) for VAS scores and 12.75±3.49versus 12.80±3.29 for IBD-Control-8 subscore (<i>r</i> = 0.963, <i>p<</i>0.01), respectively. The IBD-Control-8-subscore and IBD-Control-VAS exhibited significant discriminative capability among the PGA categories (ANOVA, <i>p</i> < .001). The ROC analysis revealed an optimal cut-off point for the IBD-Control-8 subscore of 14 points (sensitivity: 70.9%, specificity 83.5%), versus a cut-off of 70 on the IBD-Control VAS score (sensitivity: 84.4%, specificity 69.3%).</p><p>Conclusion</p><p>The Chinese IBD-Control proves to be a disease-specific, reliable, and valid tool for revealing overall disease control from the patient’s viewpoint. Both healthcare professionals and patients may find it to be a useful patient-reported outcome measurement for triaging IBD patients in China or complementing routine care.</p></div>