Der IBD-Control-Fragebogen: Deutsche Übertragung und Validierung des standardisierten Fragebogens zur Messung des Outcomes aus Patientensicht bei chronisch entzündlichen Darmerkrankungen

Zusammenfassung

Hintergrund Auf dem Weg zu einer wertebasierten und patientenzentrierten medizinischen Versorgung rückt das subjektiv vom Patienten empfundene Ergebnis einer Behandlung zunehmend in den Fokus. Als Messinstrument dienen dabei Patient-reported Outcome Measures (PROMs). Bei chronisch entzündlichen Darmerkrankungen hat sich der englischsprachig validierte Fragebogen IBD-Control zur Messung des Behandlungserfolgs aus Patientensicht etabliert. Da dieser bisher nicht auf Deutsch vorliegt, machte sein Einsatz in der deutschsprachigen Schweiz im Vorfeld eine Übersetzung sowie Validierung notwendig.

Methoden Die englischsprachige Originalversion des IBD-Control-Fragebogens wurde mittels „forward-backward translation“ ins Deutsche übertragen und anschließend an 154 Patienten mit Morbus Crohn oder Colitis ulcerosa validiert.

Resultat Die Übersetzung des IBD-Control erfolgte durch eine multidisziplinäre Expertengruppe sowie Fachübersetzer. Der IBD-Control-D zeigte eine große Akzeptanz. Eine starke Korrelation zwischen dem IBD-Control-8-Subscore mit der visuellen Analogskala des IBD-Control-D (r=0,632) zeigt die Validität des Instruments. Die Konstruktvalidität zeigt sich in der starken Korrelation zwischen der Krankheitsaktivität der letzten 6 Monate und dem IBD-Control-8-Subscore (r=0,640) sowie dem IBD-Control-VAS-Score (r=0,622) sowie zwischen dem IBD-Control-8-Subscore und dem Harvey Bradshaw Index (r=–0,620) und dem partiellen Mayo Score (r=–0,679) wie auch zwischen dem IBD-Control-VAS-Score und dem Harvey Bradshaw Index (r=–0,484) sowie dem Mayo Score (r=–0,435). Die interne Konsistenz ist gegeben (Cronbachs α = 0,840).

Schlussfolgerung Mit der hier vorgestellten deutschen Version des IBD-Control, dem IBD-Control-D, liegt nun auch im deutschsprachigen Raum ein valides, benutzerfreundliches und geeignetes Instrument vor, um das subjektive Krankheitsempfinden und das Behandlungsoutcome im Kontext chronisch entzündlicher Darmerkrankungen zu erfassen.

Abstract

Background Subjectively perceived results of treatment will be in the center of defining treatment success on the way to value-based and patient-centered health care. Patient-reported outcome measures (PROMs) serve as an instrument to measure treatment success. In inflammatory bowel disease (IBD), measuring treatment success from a patient’s point of view is performed with the validated IBD-Control questionnaire. Because the IBD-Control questionnaire has not been published in German yet, the translation and validation of the IBD-Control in the German-speaking part of Switzerland was necessary before use.

Methods We have translated the English original version of the IBD-Control questionnaire into German in a state-of-the-art procedure of „forward-backward translation” and validated the translated IBD-Control questionnaire with 154 patients with Crohn’s disease or with ulcerative colitis.

Results Professional health care and translation experts have contributed to the translation of the IBD-Control into German. The IBD-Control-D is an accepted questionnaire. Spearmans Rho showed high consistency between the IBD-Control-8-Subscore and the IBD-Control-VAS-Score (r=0.632). The disease activity in the past 6 months highly correlated with the IBD-8 subscore (r=0.640) as well as with the IBD-Control-VAS-Score (r=0.622). The IBD-Control-8-Subscore highly correlated with the Harvey Bradshaw Index (r=–0.620) and the partial Mayo Score (r=–0.679), as well as the IBD-Control-VAS-Score with the Harvey Bradshaw Index (r=–0.484) and the Mayo Score (r=–0.435), showing sufficient construct validity. The result is the German version of the IBD-Control, the IBD-Control-D, published here.

Conclusion The original English version is a valid instrument, and its use has proven to be a suitable instrument in German-speaking areas to make the subjective feeling of illness and treatment outcome measurable.

Schlüsselwörter

chronisch entzündliche Darmerkrankungen - PROMs - ICHOM - Behandlungsqualität

Keywords

Inflammatory Bowel Disease - patient-reported outcomes - IBD-Control - quality improvement

• Literatur

• 1 Niess JH, Monnikes H, Dignass AU. et al. Review on the influence of stress on immune mediators, neuropeptides and hormones with relevance for inflammatory bowel disease. Digestion 2002; 65: 131-140
• 2 Abraham C, Cho JH. Inflammatory bowel disease. N Engl J Med 2009; 361: 2066-2078
• 3 Collaborators GBDIBD. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol 2020; 5: 17-30
• 4 Bahler C, Vavricka SR, Schoepfer AM. et al. Trends in prevalence, mortality, health care utilization and health care costs of Swiss IBD patients: a claims data based study of the years 2010, 2012 and 2014. BMC Gastroenterol 2017; 17: 138
• 5 Schoepfer A, Vavricka SR, Brungger B. et al. Systematic analysis of annual health resource utilization and costs in hospitalized patients with inflammatory bowel disease in Switzerland. Eur J Gastroenterol Hepatol 2018; 30: 868-875
• 6 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: 439-444
• 7 Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet 1980; 1: 514
• 8 Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med 1987; 317: 1625-1629
• 9 Porter ME, Teisberg EO. How physicians can change the future of health care. JAMA 2007; 297: 1103-1111
• 10 Ye BD, Travis S. Improving the quality of care for inflammatory bowel disease. Intest Res 2019; 17: 45-53
• 11 Turner GM, Litchfield I, Finnikin S. et al. General practitioners' views on use of patient reported outcome measures in primary care: a cross-sectional survey and qualitative study. BMC Fam Pract 2020; 21: 14
• 12 Noonan VK, Lyddiatt A, Ware P. et al. Montreal Accord on Patient-Reported Outcomes (PROs) use series - Paper 3: patient-reported outcomes can facilitate shared decision-making and guide self-management. J Clin Epidemiol 2017; 89: 125-135
• 13 Kim AH, Roberts C, Feagan BG. et al. Developing a Standard Set of Patient-Centred Outcomes for Inflammatory Bowel Disease-an International, Cross-disciplinary Consensus. J Crohns Colitis 2018; 12: 408-418
• 14 Bodger K, Ormerod C, Shackcloth D. et al. Development and validation of a rapid, generic measure of disease control from the patient's perspective: the IBD-control questionnaire. Gut 2014; 63: 1092-1102
• 15 Wild D, Grove A, Martin M. et al. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health 2005; 8: 94-104
• 16 Epstein J, Santo RM, Guillemin F. A review of guidelines for cross-cultural adaptation of questionnaires could not bring out a consensus. J Clin Epidemiol 2015; 68: 435-441
• 17 de Jong ME, Taal E, Thomas PWA. et al. Cross-cultural translation and validation of the IBD-control questionnaire in The Netherlands: a patient-reported outcome measure in inflammatory bowel disease. Scand J Gastroenterol 2021; 56: 155-161
• 18 Hauser W, Dietz N, Grandt D. et al. Validation of the inflammatory bowel disease questionnaire IBDQ-D, German version, for patients with ileal pouch anal anastomosis for ulcerative colitis. Z Gastroenterol 2004; 42: 131-139
• 19 Rose M, Fliege H, Hildebrandt M. et al. Validation of the new German translation version of the "Short Inflammatory Bowel Disease Questionnaire" (SIBDQ). Z Gastroenterol 2000; 38: 277-286
• 20 Caviezel D, Maissen S, Niess JH. et al. High Prevalence of Vitamin D Deficiency among Patients with Inflammatory Bowel Disease. Inflamm Intest Dis 2018; 2: 200-210
• 21 Kaymak T, Moriconi F, Niess JH. et al. Low Discontinuation Rate of Infliximab Treatment in Steroid-Dependent/Refractory Crohn's Disease Patients. Inflamm Intest Dis 2018; 2: 171-179
• 22 Safroneeva E, Vavricka SR, Fournier N. et al. Prevalence and Risk Factors for Therapy Escalation in Ulcerative Colitis in the Swiss IBD Cohort Study. Inflamm Bowel Dis 2015; 21: 1348-1358