Background The reported outcome level of patients with inflammatory bowel disease (IBD) has received attention. There are few mature outcome scales with Chinese cultural characteristics for patients with IBD, and the developed scales need strict evaluation.
Objective To analyze and evaluate the measurement properties of the Inflammatory Bowel Disease Patient-Reported Outcome Measurement Scale〔PROISCD-IBD (V1.0) 〕, to provide basis for scientific evaluation of reported outcomes in patients with IBD.
Methods From October 2020 to January 2022, PROISCD-IBD (V1.0) was used to detect 274 IBD patients who were treated in the Outpatient and Inpatient Departments of Gastroenterology in the First Affiliated Hospital of Kunming Medical University and the Affiliated Hospital of Guangdong Medical University. PROISCD IBD (V1.0) consisted of 1 commonality module and 1 IBD specific module (TIBD) . The commonality module had 30 items, which were divided into 4 domains of physical health (PHD) , mental health (MHD) , social health (SHD) , and spiritual/belief health (SBD) . TIBD covered four aspects of digestive system symptoms (DSS) , extraintestinal symptom (EXS) , special psychological symptoms (SPP) , and treatment side effects (TSE) . Cronbach's α coefficient and split-half coefficient were used to test the reliability. Correlation coefficient method, exploratory factor analysis and structural equation model were used to analyze the structural validity. Clinical validity of each domain was analyzed using t test.
Results The Cronbach's α coefficients of PHD, MHD, SHD, SBD and TIBD of PROISCD-IBD (V1.0) were 0.732, 0.838, 0.781, 0.673 and 0.884, respectively. Cronbach's α coefficient of total scale was 0.932. The half-score coefficients of PHD, MHD, SHD, SBD and TIBD were 0.669, 0.859, 0.610, 0.494 and 0.795, respectively, and the half-score reliability of the total scale was 0.879. Correlation analysis showed that the phase coefficients of PHD, MHD, SHD and SBD scores and commonality module score were all >0.6 (P<0.05) . Three principal components were extracted from exploratory factor analysis, and the cumulative variance contribution rate was 58.05%. Structural equation model showed that χ2/df=2.568, root-mean-square error of approximation (RMSEA) =0.076, normed fit index (NFI) =0.677, non-normed fit index (NNFI) =0.774, comparative fit index (CFI) =0.772, incremental fit index (IFI) =0.774, SRMR=0.103 1. IBD patients were divided into active stage (n=90) and remission stage (n=184) according to clinical stages. The total scores of various domains, common modules, TIBD and scale in remission stage were higher than those in active stage (P<0.05) .
Conclusion PROISCD-IBD (V1.0) has good reliability and validity for reporting outcome measures in patients with IBD.
