Article Text

Original article
Development and validation of a rapid, generic measure of disease control from the patient's perspective: the IBD-Control questionnaire
  1. Keith Bodger1,2,
  2. Clare Ormerod1,2,
  3. Daniela Shackcloth2,
  4. Melanie Harrison2,
  5. on behalf of the IBD Control Collaborative
  1. 1Department of Gastroenterology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK
  2. 2Digestive Diseases Centre, Aintree University Hospital NHS Trust, Liverpool, UK
  1. Correspondence to Dr Keith Bodger, Room 3.14, Clinical Sciences Centre, Aintree University Hospital NHS Trust, Lower Lane, Liverpool L9 7AL, UK; kbodger{at}


Introduction The use of patient reported outcome measures to support routine inflammatory bowel disease (IBD) care is not widespread and suggests that existing questionnaires lack relevance to day-to-day decisions or are too cumbersome to administer. We developed a simple, generic tool for capturing disease control from the patient's perspective to address these barriers.

Methods Development based on literature review, patient focus groups/interviews and a steering group, defining a limited set of generic questions. The ‘IBD-Control’ questionnaire comprises 13 items plus a visual analogue scale (VAS) (0–100). Prospective validation involved baseline completion of IBD-Control, quality of life (QoL) questionnaire (UK-IBD-Q), EuroQol (EQ-5D), Hospital Anxiety and Depression Score; and clinician assessment (blinded to questionnaire; recording Harvey-Bradshaw Index or Simple Clinical Colitis Activity Index; Global Clinician Rating; treatment outcome).

Results 299 patients returned baseline surveys (Crohn's disease, n=160; ulcerative colitis, n=139) and 138 attended for repeat visits. Completion time (mean; SD): 1 min 15 s; 25 s; Internal consistency: Cronbach's α for all 13 items (0.85); for subgroup of eight questions (‘IBD-Control-8’; 0.86). Strong correlation between IBD-Control-8 and IBD-Control-VAS (r=0.81). Test-retest reliability (2 week repeat): intra-class correlation=0.97 for IBD-Control-8 and 0.96 for IBD-Control-VAS. Construct validity: Moderate-to-strong correlations between IBD-Control-8 and IBD-Control-VAS versus activity indices, UK-IBD-Q and EQ-5D (utility) with r values 0.52–0.86. Discriminant validity (mean instrument scores for remission, mild, moderate or severe): p<0.001 (analysis of variance (ANOVA)). Sensitivity to change: Effect sizes: 0.76–1.44.

Conclusions The IBD-Control is a rapid, reliable, valid and sensitive instrument for measuring overall disease control from the patient's perspective. Unlike existing patient reported outcome measures, its simplicity, ease-of-use and generic applicability make it a candidate for supporting routine care.

  • Inflammatory Bowel Disease
  • Ibd Clinical
  • Quality Of Life

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