Protocol for a prospective multicentre cohort study to develop and validate two new outcome measures for patients with inflammatory bowel disease

INTRODUCTION: Most of the health-related quality of life (HRQoL) measures for patients with inflammatory bowel disease (IBD) were designed to be used in outpatient settings and are therefore not suitable for use in acute inpatient settings. None of the currently used clinical severity indices for patients with IBD have been properly validated. The aim of this study was to describe the development of a new HRQoL questionnaire and a clinical severity index for patients with ulcerative colitis or Crohn's disease that were short, valid and suitable at any stage of their disease. The new HRQoL and disease severity index will be easily used at the point of care, and invaluable monitoring tools for clinical care, audit and research. METHODS AND ANALYSIS: This is a prospective multisite validation study of two new outcome measures, the Crohn's and Colitis quality of life (CCQ) questionnaire and the Clinical IBD severity score (CISS). We plan to recruit patients with ulcerative colitis or Crohn's disease. The questionnaire items will be selected through extensive literature review and a focus group involving patients, methodologists, statisticians and IBD specialists. The CCQ questionnaire will be completed by patients attending IBD clinics, having endoscopy procedures or when admitted to hospital. CISS will be completed by clinicians while assessing patients with IBD. Psychometric analysis will be carried out to test the validity and reliability of the questionnaires and to determine the potential to produce shorter versions of CISS and CCQ. The construct validity of CCQ will be tested against short form-12 and the European Quality of Life Five Dimensions. The construct validity of CISS will be tested against biochemical markers, clinical and endoscopic indices to assess severity. ETHICS: This study was approved by the South East Wales Research Ethics Committee (Ref 11/WA/0239).