Validation of the inflammatory bowel disease disability index in a population-based cohort

Article; Crohn disease; Crohn Disease Activity Index; Frenchman; Adult; Colitis, Ulcerative; Disability Evaluation; Female; Humans; Male; Prospective Studies; Reproducibility of Results; Severity of Illness Index; Sex Factors; Surveys and Questionnaires; Time Factors; Young Adult

Abstract :

[en] Background: IBDs are chronic destructive disorders that negatively affect the functional status of patients. Recently, the Inflammatory Bowel Disease Disability Index (IBD-DI) was developed according to standard WHO processes. The aims of the current study were to validate the IBD-DI in an independent patient cohort, to develop an index-specific scoring system and to describe the disability status of a well-defined population-based cohort of French patients with IBD. Methods: From February 2012 to March 2014, the IBD-DI questionnaire was administered to a random sample of adult patients with an established diagnosis of IBD issued from a French population-based registry. The IBD-DI consists of 28 items that evaluate the four domains of body functions, activity participation, body structures and environmental factors. Validation included item reduction and data structure, construct validity, internal consistency, interobserver and intraobserver reliability evaluations. Results: 150 patients with Crohn's disease (CD) and 50 patients with UC completed the IBD-DI validation phase. The intraclass correlation coefficient for interobserver reliability was 0.91 and 0.54 for intraobserver reliability. Cronbach's α of internal consistency was 0.86. IBD-DI scores varied from 0 to 100 with a mean of 35.3 (Q1=19.6; Q3=51.8). IBD-DI scores were highly correlated with Inflammatory Bowel Disease Questionnaire (-0.82; p<0.001) and SF-36 (-0.61; p<0.05) scores. Female gender (p<0.001), clinical disease activity (p<0.0001) and disease duration (p=0.02) were associated with higher IBD-DI scores. Conclusions: The IBD-DI has been validated for use in clinical trials and epidemiological studies. The IBD-DI showed high internal consistency, interobserver reliability and construct validity, and a moderate intraobserver reliability. It comprises 14 questions and ranges from 0 to 100. The mean IBD-DI score was 35.3 and was associated with gender, clinical disease activity and disease duration. Further research is needed to confirm the structural validity and to assess the responsiveness of IBD-DI. Trial registration number: 2011-A00877-34. © 2017, BMJ Publishing Group. All rights reserved.

Disciplines :

Gastroenterology & hepatology

Author, co-author :

Gower-Rousseau, C.; Public Health, Epidemiology and Economic Health, Registre Epimad, Maison Régionale de La Recherche Clinique, Centre Hospitalier Universitaire Régional, Lille Cedex, France, Lille Inflammation Research International Center LIRIC - UMR 995 Inserm/Université Lille 2/CHRU de Lille, Equipe IBD and Environmental Factors: Epidemiology and Functional Analyses, Lille University, France

Sarter, H.; Public Health, Epidemiology and Economic Health, Registre Epimad, Maison Régionale de La Recherche Clinique, Centre Hospitalier Universitaire Régional, Lille Cedex, France, Lille Inflammation Research International Center LIRIC - UMR 995 Inserm/Université Lille 2/CHRU de Lille, Equipe IBD and Environmental Factors: Epidemiology and Functional Analyses, Lille University, France

Savoye, G.; Gastroenterology Unit, Epimad Registry, Hôpital Charles Nicolle, Rouen University Hospital, Rouen, France

Tavernier, N.; Gastroenterology Unit, Hôpital Huriez, Lille University Hospital, France

Fumery, M.; Gastroenterology Unit, Epimad Registry, CHU Amiens Sud, Amiens University Hospital, Avenue Laennec-Salouel, France

Sandborn, W. J.; Division of Gastroenterology, University of California San Diego, San Diego, CA, United States

Feagan, B. G.; University of Western Ontario, London, ON, Canada

Duhamel, A.; Univ. Lille, CHU Lille, EA 2694 - Santé Publique : Épidémiologie et Qualité des Soins, Lille, France

Guillon-Dellac, N.; Public Health, Epidemiology and Economic Health, Registre Epimad, Maison Régionale de La Recherche Clinique, Centre Hospitalier Universitaire Régional, Lille Cedex, France, Lille Inflammation Research International Center LIRIC - UMR 995 Inserm/Université Lille 2/CHRU de Lille, Equipe IBD and Environmental Factors: Epidemiology and Functional Analyses, Lille University, France

Colombel, J.-F.; Icahn School of Medicine at Mount Sinai, New York, NY, United States

More authors (31 more)

Language :

English

Title :

Validation of the inflammatory bowel disease disability index in a population-based cohort

Publication date :

2017

Journal title :

Gut

ISSN :

0017-5749

eISSN :

1468-3288

Publisher :

BMJ Publishing Group

Volume :

Issue :

Pages :

588-596

Peer reviewed :

Peer Reviewed verified by ORBi

Additional URL :

https://doi.org/10.1136/GUTJNL-2015-310151

Name of the research project :

Programme Hospitalier de Recherche Clinique Inter Regional» 2011

Funders :

INSERM - Institut National de la Santé et de la Recherche Médicale
AFA - Association François Aupetit
Ministère de la Santé et de la Prévention
AbbVie

Available on ORBi :

since 23 March 2018

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Bibliography

Casellas F, López-Vivancos J, Vergara M, et al. Impact of inflammatory bowel disease on health-related quality of life. Dig Dis 1999;17:208-18.
Peyrin-Biroulet L. What is the patient's perspective: How important are patient-reported outcomes, quality of life and disability? Dig Dis 2010;28:463-71.
Peyrin-Biroulet L, Cieza A, Sandborn WJ, et al. Disability in inflammatory bowel diseases: developing ICF Core Sets for patients with inflammatory bowel diseases based on the International Classification of Functioning, Disability, and Health. Inflamm Bowel Dis 2010;16:15-22.
Williet N, Sandborn WJ, Peyrin-Biroulet L. Patient-reported outcomes as primary end points in clinical trials of inflammatory bowel disease. Clin Gastroenterol Hepatol 2014;12:1246-56.
Levesque BG, Sandborn WJ, Ruel J, et al. Converging goals of treatment of inflammatory bowel disease from clinical trials and practice. Gastroenterology 2015;148:37-51.
Services DoHaH. US Food and Drug Administration (FDA). Guidance for Industry: patients-reported outcomes measures use in medical product development to support labeling claims. In: Department of Health and Human Services (US) FaDa, Center for Drug Evaluation and Research (CDER), eds. Rockville, http://www.fda.gov/downloads/Drugs/Guidance Compliance Regulatory Information/Guidances/UCM193282.pdf
Thompson PW, Pegley FS. A comparison of disability measured by the Stanford Health Assessment Questionnaire disability scales (HAQ) in male and female rheumatoid outpatients. Br J Rheumatol 1991;30:298-300.
Noseworthy JH, Vandervoort MK, Wong CJ, et al. Interrater variability with the Expanded Disability Status Scale (EDSS) and Functional Systems (FS) in a multiple sclerosis clinical trial. The Canadian Cooperation MS Study Group. Neurology 1990;40:971-5.
Butzkueven H, Kappos L, Pellegrini F, et al. Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results. J Neurol Neurosurg Psychiatry 2014;85:1190-7.
Dasgupta B, Combe B, Louw I, et al. Patient and physician expectations of add-on treatment with golimumab for rheumatoid arthritis: relationships between expectations and clinical and quality of life outcomes. Arthritis Care Res (Hoboken) 2014;66:1799-807.
Peyrin-Biroulet L, Cieza A, Sandborn WJ, et al. Development of the first disability index for inflammatory bowel disease based on the international classification of functioning, disability and health. Gut 2012;61:241-7.
Sellin J. Disability in IBD : the devil is in the details. Inflamm Bowel Dis 2010;16:23-6.
Leong RWL, Huang T, Ko Y, et al. Prospective validation study of the international classification of functionning disability and health score in Crohn's disease and ulcerative colitis. J Crohns Colitis 2014;8:1237-45.
Beaton DE, Bombardier C, Guillemin F, et al. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976) 2000;25:3186-91.
Gower-Rousseau C, Vasseur F, Fumery M, et al. Epidemiology of inflammatory bowel diseases: new insights from a French population-based registry (EPIMAD). Dig Liver Dis 2013;45:89-94.
Gower-Rousseau C, Salomez JL, Dupas JL, et al. Incidence of inflammatory bowel disease in northern France (1988-1990). Gut 1994;35:1433-8.
Molinié F, Gower-Rousseau C, Yzet T, et al. Opposite evolution in incidence of Crohn's disease and ulcerative colitis in Northern France (1988-1999). Gut 2004;53:843-8.
Chouraki V, Savoye G, Dauchet L, et al. The changing pattern of Crohn's disease incidence in northern France: a continuing increase in the 10- to 19-year-old age bracket (1988-2007). Aliment Pharmacol Ther 2011;33:1133-42.
Satsangi J, Silverberg MS, Vermeire S, et al. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut 2006;55:749-53.
Best WR. Predicting the Crohn's disease activity index from the Harvey-Bradshaw Index. Inflamm Bowel Dis 2006;12:304-10.
Lewis JD, Chuai S, Nessel L, et al. Use of the noninvasive components of the Mayo score to assess clinical response in ulcerative colitis. Inflamm Bowel Dis 2008;14:1660-6.
Nunnally JC, Bernstein IH, Eds. Psychometric theory. 3rd ed. New York: McGraw-Hill, 1978.
Giraudeau B, Mary JY. Planning a reproducibility study: how many subjects and how many replicates per subject for an expected width of the 95 per cent confidence interval of the intraclass correlation coefficient. Stat Med 2001;20:3205-14.
de Boer AG, Wijker W, Bartelsman JF, et al. Inflammatory Bowel Disease Questionnaire: cross-cultural adaptation and further validation. Eur J Gastroenterol Hepatol 1995;7:1043-50.
Hawthorne G, Osborne RH, Taylor A, et al. The SF36 Version 2: critical analyses of population weights, scoring algorithms and population norms. Qual Life Res 2007;16:661-73.
De Vet HCW, Terwee CB, Mokkikk LB, et al. Measurement in medicine: a practical guide. New York, NY: Cambridge University Press, 2011.
Horn JL. A rationale and test for the number of factors in factor analysis. Psychometrika 1965;30:179-85.
Mokkink LB, Terwee CB, Patrick DL, et al. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol 2010;63:737-45.
Hernaez R. Reliability and agreement studies: a guide for clinical investigators. Gut 2015;64:1018-27.
Kohler F, Xu J, Silva-Withmory C, et al. Feasibility of using a checklist based on the International Classification of Functioning, Disability and Health as an outcome measure in individuals following lower limb amputation. Prosthet Orthot Int 2011;35:294-301.
Saketkoo LA, Escorpizo R, Keen KJ, et al. EUSTAR. International Classification of Functioning, Disability and Health Core Set construction in systemic sclerosis and other rheumatic diseases: a EUSTAR initiative. Rheumatology (Oxford) 2012;51:2170-6.
Vergara M, Montserrat A, Casellas F, et al. Development and validation of the Crohn's disease perceived work disability questionnaire. Inflamm Bowel Dis 2011;17:2350-7.
Allen PB, Kamm MA, Peyrin-Biroulet L, et al. Development and validation of a patient-reported disability measurement tool for patients with inflammatory bowel disease. Aliment Pharmacol Ther 2013;37:438-44.
Disability and Health (World Health Organization. Document A29/INFDOCI/1; 1976 [Geneva, Switzerland].
Camacho EM, Verstappen SM, Lunt M, et al. Influence of age and sex on functional outcome over time in a cohort of patients with recent-onset inflammatory polyarthritis: results from the Norfolk Arthritis Register. Arthritis Care Res (Hoboken) 2011;63:1745-52.
Fernández O, Baumstarck-Barrau K, Simeoni MC, et al. MusiQoL study group. Patient characteristics and determinants of quality of life in an international population with multiple sclerosis: assessment using the MusiQoL and SF-36 questionnaires. Mult Scler 2011;17:1238-49.