Development and validation of a rapid, generic measure of disease control from the patient's perspective: the IBD-control questionnaire

Keith Bodger, Clare Ormerod, Daniela Shackcloth, Melanie Harrison, IBD Control Collaborative, Suhail Ahmed, Katherine Bowering, Elizabeth Brown, Anne Hurst, Tamsin Gledhill, Keith Bodger, Clare Ormerod, Daniela Shackcloth, Melanie Harrison, IBD Control Collaborative, Suhail Ahmed, Katherine Bowering, Elizabeth Brown, Anne Hurst, Tamsin Gledhill

Abstract

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.

Keywords: Ibd Clinical; Inflammatory Bowel Disease; Quality Of Life.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Figures

Figure 1
Figure 1
Flow chart summarising development and validation of IBD-Control. IBD, inflammatory bowel disease.
Figure 2
Figure 2
Validity of IBD-Control summary scores in relation to UK-IBD-QoL Questionnaire. IBD, inflammatory bowel disease; QoL, quality of life.
Figure 3
Figure 3
Validity of IBD-Control summary scores in relation to physician global assessment.
Figure 4
Figure 4
Validity of IBD-Control-8 subscore in relation to EuroQol (EQ-5D) utility index. IBD, inflammatory bowel disease; QoL, quality of life.
Figure 5
Figure 5
Performance of IBD-Control as a screening test to identify ‘quiescent’ patients: Receiver operating characteristic (ROC) curves for IBD-Control-8 subscore (solid line; area under curve: 0.90; p<0.001) and IBD-Control-VAS (broken line; area under curve: 0.86; p<0.001). For IBD-Control-8, a cut-off of ≥13 points identified patients with quiescent IBD with 67.5% sensitivity and 90.6% specificity, whereas for IBD-Control-VAS a cut-off of ≥85 points achieved 64.3% sensitivity and 90% specificity. The quiescent state was defined using strict composite criteria (see text). IBD, inflammatory bowel disease.

References

    1. Dawson J, Doll H, Fitzpatrick R, et al. The routine use of patient reported outcome measures in healthcare settings. Br Med J 2010;340:c186.
    1. Department of Health. The NHS Outcomes Framework 2012/13. London, 2011
    1. Truelove SC, Witts LJ. Cortisone in ulcerative colitis; final report on a therapeutic trial. Br Med J 1955;2:1041–8
    1. Best WR, Becktel JM, Singleton JW, et al. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology 1976;70:439–44
    1. Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet 1980;1:514.
    1. Walmsley RS, Ayres RC, Pounder RE, et al. A simple clinical colitis activity index. Gut 1998;43:29–32
    1. Cooney RM, Warren BF, Altman DG, et al. Outcome measurement in clinical trials for Ulcerative Colitis: towards standardisation. Trials 2007;8:17.
    1. de Dombal FT, Softley A. IOIBD report no 1: Observer variation in calculating indices of severity and activity in Crohn's disease. International Organisation for the Study of Inflammatory Bowel Disease. Gut 1987;28:474–81
    1. Irvine EJ. Development and subsequent refinement of the inflammatory bowel disease questionnaire: a quality-of-life instrument for adult patients with inflammatory bowel disease. J Pediatr Gastroenterol Nutr 1999;28:S23–27
    1. Guyatt G, Mitchell A, Irvine EJ, et al. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology 1989;96:804–10
    1. Drossman DA, Li Z, Leserman J, et al. Ulcerative colitis and Crohn's disease health status scales for research and clinical practice. J Clin Gastroenterol 1992;15:104–12
    1. Farmer RG, Easley KA, Farmer JM. Quality of life assessment by patients with inflammatory bowel disease. Cleve Clin J Med 1992;59:35–42
    1. Irvine EJ, Feagan B, Rochon J, et al. Quality of life: a valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Canadian Crohn's Relapse Prevention Trial Study Group. Gastroenterology 1994;106:287–96
    1. Hjortswang H, Strom M, Almeida RT, et al. Evaluation of the RFIPC, a disease-specific health-related quality of life questionnaire, in Swedish patients with ulcerative colitis. Scand J Gastroenterol 1997;32:1235–40
    1. Achleitner U, Coenen M, Colombel JF, et al. Identification of areas of functioning and disability addressed in inflammatory bowel disease-specific patient reported outcome measures. J Crohn's Colitis 2012;6:507–17
    1. Williams JG, Cheung WY, Russell IT, et al. Open access follow up for inflammatory bowel disease: pragmatic randomised trial and cost effectiveness study. Br Med J 2000;320:544–8
    1. Cheung WY, Garratt AM, Russell IT, et al. The UK IBDQ—A British version of the inflammatory bowel disease questionnaire: development and validation. J Clin Epidemiol 2000;53:297–306
    1. Irvine EJ, Zhou Q, Thompson AK. The Short Inflammatory Bowel Disease Questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT Investigators. Canadian Crohn's Relapse Prevention Trial. Am J Gastroenterol 1996;91:1571–8
    1. Casellas F, Alcala MJ, Prieto L, et al. Assessment of the influence of disease activity on the quality of life of patients with inflammatory bowel disease using a short questionnaire. Am J Gastroenterol 2004;99:457–61
    1. Fitzpatrick RD, Davy C, Buxton MJ, et al. Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess 1998;2:3–47
    1. United States Department for Health. FDA Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes 2006;4:79.
    1. Frost MH, Reeve BB, Liepa AM, et al. What is sufficient evidence for the reliability and validity of patient-reported outcome measures? Value Health 2007;10(Suppl 2):S94–S105
    1. Bassi A, Dodd S, Williamson P, et al. Cost of illness of inflammatory bowel disease in the UK: a single centre retrospective study. Gut 2004;53:1471–8
    1. The EuroQol Group. A new facility for the measurement of health-related quality of life. Health Policy 1990;16:199–208
    1. Snaith RP, Zigmond AS. The hospital anxiety and depression scale. Br Med J 1986;292:344.
    1. Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika 1951;16:297–334
    1. Higgins PD, Schwartz M, Mapili J, et al. Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis. Gut 2005;54:782–8
    1. Irvine EJ. Quality of life issues in patients with inflammatory bowel disease. Am J Gastroenterol 1997;92:18S–24S
    1. Cohen RD. The quality of life in patients with Crohn's disease. Aliment Pharmacol Ther 2002;16:1603–9
    1. Drossman DA. Measuring quality of life in inflammatory bowel disease. PharmacoEconomics 1994;6:578–80
    1. Royal College of Physicians. The United Kingdom Inflammatory Bowel Disease Audit. (accessed 1 Jul 2013).
    1. Siegel CA, Allen JI, Melmed GY. Translating improved quality of care into an improved quality of life for patients with inflammatory bowel disease. Clin Gastroenterol Hepatol 2013;11:908–12

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅