Further Validation of the Crohn's and Ulcerative Colitis Questionnaire-32 (CUCQ-32) to Measure the Quality of Life in Patients Treated with Biologics Therapy.

Background: Crohn's and Ulcerative Colitis Questionnaire-32 (CUCQ-32) is a validated questionnaire to measure the quality of life (QoL) in Inflammatory Bowel Disease (IBD). However, it does not have stoma-specific questions and can be lengthy. This study aimed to validate a subset of the CUCQ-32 that would be suitable for patients with a stoma. Methods: Baseline data were collected from a cohort of patients with acute ulcerative colitis who were participating in the CONSTRUCT multicentre clinical trial. A subset of the CUCQ-32 questions was selected by stepwise regression. Further validation was examined using data from the UK IBD biological therapies audit. Construct validity was carried out using the EuroQol 5 dimensions (EQ5D) questionnaire, Simple Clinical Colitis Activity Index (SCCAI), and the Harvey−Bradshaw Index (HBI). Results: Using the data from 124 patients, a short-version questionnaire (CUCQ-12) was developed. Data from 484 patients with IBD (382 patients with Crohn's disease, 76 patients with ulcerative colitis, and 26 patients with IBD-Unclassified) and 61 patients with stoma provided further validation of the CUCQ-12. A literature review and an expert focus group identified supplementary stoma-specific questions for the CUCQ-12+. The CUCQ-12+ demonstrated excellent internal consistency (Cronbach's α = 0.86); established effective reproducibility (intra-class correlation coefficient = 0.74); correlated well with the EQ5D (r= −0.48), HBI (r = 0.45), and SCCAI (r = 0.43); and represented good responsiveness statistics (>0.5). Conclusions: CUCQ-12+ is a valid and reliable QoL measure used for all patients with IBD in clinical practice, including patients with a stoma.

Systematic Review of the Clinical Disease Severity Indices for Inflammatory Bowel Disease.

BACKGROUND: Clinical disease severity indices are increasingly being used in choosing treatment and monitoring the response of patients with inflammatory bowel disease (IBD). The aim of this study was to systematically review the clinical disease severity indices in IBD and to appraise their measurement properties and methodological quality. METHODS: We searched the MEDLINE, Embase, and PsycINFO databases for original articles describing the development and/or evaluation of one or more of the measurement properties of clinical disease severity indices used in IBD. We assessed these properties (e.g., internal consistency, reliability, validity, responsiveness) using a standardized checklist. RESULTS: We examined the full text of 142 articles that we deemed potentially eligible and identified 22 clinical disease severity indices in IBD. No clinical disease index has met all the required measurement properties. All of the validation studies were not descriptive enough to allow assessment of their methodology. CONCLUSIONS: Although commonly used in multiple clinical trials, none of the clinical disease severity indices in IBD had all the required measurement properties. Further validation studies are required.

Systematic review of health-related quality of life measures for inflammatory bowel disease.

BACKGROUND AND AIM: Several measures have been developed to assess the health-related quality of life [HRQoL] of patients with inflammatory bowel disease [IBD]. Our aim is to systematically review the HRQoL measures specific for patients with IBD and to appraise their measurement properties and methodological quality. METHODS: We searched the PubMed, Embase, and PsycINFO databases for original articles describing the development and/or evaluation of one or more of the measurement properties [e.g. internal consistency, reliability, validity, responsiveness] of HRQoL measures specific for IBD. We assessed the measurement properties and examined the methodological quality of the measurement properties of each instrument using a standardized checklist. RESULTS: We examined the full text of 75 articles that we deemed potentially eligible and identified 10 disease-specific HRQoL measures in IBD that covered different aspects of patients' lives. Internal consistency, construct validity, and content validity were the commonly evaluated measurement properties. Seven HRQoL measures scored positive for at least four of eight measurement properties. The majority of studies were rated as 'fair' to 'poor' when assessing their methodology quality. The most established HRQoL measure in the literature was the Inflammatory Bowel Disease Questionnaire [IBDQ]. CONCLUSIONS: Most of the included HRQoL measures did not include all the required measurement properties or had a problem with their methodological quality. The most widely used and validated measure was the IBDQ. Further validation studies are required to support the use of other HRQoL measures.

Development and validation of a new disease severity index: the Inflammatory Bowel Disease Index (IBDEX).

OBJECTIVE: To develop, validate and apply a generic clinical severity index applicable to all adult patients with inflammatory bowel disease (IBD). DESIGN: A review of the literature and an expert focus group consultation were carried out in order to draw out relevant items from existing literature. The new index was called the IBD Index (IBDEX). Standard psychometric analysis was carried out. The construct validity was assessed against biochemical markers, clinical and endoscopic indices. The new index was completed again within 6 weeks to check responsiveness and reproducibility. RESULTS: IBDEX was used to assess 255 adult patients with IBD (125 with Crohn's disease and 130 with ulcerative colitis), and 64 patients were re-evaluated within 6 weeks. It had good internal consistency (Cronbach's α=0.79) and correlated very well with the Harvey Bradshaw Index (r=0.94), the Simple Clinical Colitis Activity Index (r=0.92), the Mayo Clinic Index (r=0.87) and the Simple Endoscopic Score (r=0.76), all with p values <0.05. IBDEX had a moderate but positive correlation with C reactive protein (r=0.51) and erythrocyte sedimentation rate (r=0.36) p values both <0.05. The test-retest reliability was good (intraclass correlation coefficient 0.97) and responsiveness ratio was 2.27. CONCLUSIONS: IBDEX is the first properly validated Clinical Disease Severity Index in IBD. Our results showed that it is valid, reliable and reproducible and has the potential to be used in clinical practice.

Development of a short questionnaire to assess the quality of life in Crohn's disease and ulcerative colitis.

BACKGROUND AND AIMS: Most of the disease-specific quality of life (QoL) measures for inflammatory bowel disease (IBD) are lengthy and time consuming. None have been established for routine use in clinical practice. We designed this study to develop a short QoL measure in IBD. METHODS: A 32-item questionnaire, the Crohn's and ulcerative colitis questionnaire (CUCQ)-32 was developed by reviewing the literature of the previously validated questionnaires and by consultation with patients and experts. Construct validity was carried out using the Short Form 12 and the EuroQol 5 dimensions questionnaires and two disease severity measures (the Simple Clinical Colitis Activity Index and the Harvey-Bradshaw Index). Test-retest analysis was done by asking patients to complete the CUCQ questionnaire twice within a period of two weeks. RESULTS: Data were obtained from 205 patients with IBD who completed the CUCQ-32. Psychometric analysis showed that Cronbach's α was 0.88, item-total correlations were good, and there were no ceiling or flooring effects. Stepwise regression identified eight items that accounted for >95% of the variance in the CUCQ-32. The resulting CUCQ-8 demonstrated good internal consistency (Cronbach's α = 0.84), had good reproducibility (intraclass correlation coefficient = 0.94), was well correlated with the EuroQol 5 dimensions questionnaire (r = 0.58) and the Short Form-12 (r = 0.65 for physical component and r = 0.63 for mental component), and was responsive to change (responsiveness ratio was 0.64, p-value < 0.05). CONCLUSIONS: CUCQ-8 is a short questionnaire that has the potential to be an efficient tool for assessing the QoL of all patients with IBD in clinical practice.