P156 Translation into Spanish, adaptation and validation of the “IBD- control”, a short validated English PRO (patients reported outcomes) questionnaire: the EII-Control

Abstract

Abstract Background The measure of patient reported outcomes (PROM) in inflammatory bowel disease (IBD) clinical practice, is hardly to use as it lacks a simple and valid tool. There is a short, generic and validated English questionnaire for this purpose: the IBD Control. Its validation and application in other IBD populations is necessary and would support its practical use. Our purpose is to translate into Spanish, adapt and validate the “IBD- control” in our ambit and culture, in order to have a useful measure for clinical practice. Methods The IBD-control was translated into Spanish, demonstrating its understandability, content, validity and acceptability for patients, generating the EII-Control instrument. Subsequently, the EII-Control was prospectively validated, using current psychometric standards. At the baseline visit, consecutive patients completed the EII-Control, the short form of IBD quality of life (QOL) questionnaire (CVEII-9), the generic QOL instrument (EQ-5D), the hospital anxiety and depression scale (HDA and HDS), the fatigue questionnaire (FSS), as well as a clinical assessment, blind to the questionnaires (global clinical rating, Harvey-Bradshaw indice or simple index of clinical activity of colitis (SSCAI) and treatment outcome). A subgroup of patients repeated the assessment on a second visit within the study period. The usefulness of summary scales of the IBD-Control, was also analyzed (EII-Control-8 and EII-control-VAS). Results 249 patients completed the baseline surveys (Crohn’s disease, n = 177; ulcerative colitis, n = 71 and indeterminate colitis, n = 1) and 101 repeated the same assessment on a second routine visit. Internal consistency: Cronbach’s for EII-control 0.83 with strong correlation between EII-Control-8 and EII-Control-VAS subscales (r = 0.5). Reproducibility: intraclass correlation = 0.70 for EII-Control and 0.61 for EII-Control-VAS. Construct validity: moderate to strong correlations between EII-Control versus activity, anxiety, depression, fatigue or quality of life indices Discriminant validity: (mean scores of the instruments for remission, mild, moderate or severe): p <0.001. Sensitivity to change: same response in effect size and mean differences as CCVEII-9. Sensitivity and specificity at cut-off 14 of 0.696 and 0.903 respectively to determine the quiescent state. Conclusion The EII-Control is a rapid, reliable, valid and sensitive instrument to measure the overall control of the disease from the perspective of the patient in spanish culture. Its simplicity, ease of use, and generic applicability make it a candidate for supporting routine care, including telemedicine, and also to use in clinical research.