Z Gastroenterol 2018; 56(10): 1267-1275
DOI: 10.1055/a-0605-4080
Originalarbeit
© Georg Thieme Verlag KG Stuttgart · New York

Validation of the “German Inflammatory Bowel Disease Activity Index (GIBDI)”: An Instrument for Patient-Based Disease Activity Assessment in Crohn’s Disease and Ulcerative Colitis

Validierung des „German Inflammatory Bowel Disease Activity Index (GIBDI)“: Ein Instrument zur patientenseitigen Beurteilung der Krankheitsaktivität bei Morbus Crohn und Colitis ulcerosa
Angelika Hüppe
1   Institut für Sozialmedizin und Epidemiologie, Universität zu Lübeck, Germany
,
Jana Langbrandtner
1   Institut für Sozialmedizin und Epidemiologie, Universität zu Lübeck, Germany
,
Winfried Häuser
2   Klinik Innere Medizin I, Klinikum Saarbrücken gGmbH, Saarbrücken, Germany
,
Heiner Raspe
3   Zentrum für Bevölkerungsmedizin und Versorgungsforschung, Universität Lübeck, Germany
,
Bernd Bokemeyer
4   Gastroenterologische Gemeinschaftspraxis Minden, Germany
› Author Affiliations
Further Information

Publication History

31 January 2018

06 April 2018

Publication Date:
09 May 2018 (online)

Abstract

Introduction Assessment of disease activity in Crohn’s disease (CD) and ulcerative colitis (UC) is usually based on the physician’s evaluation of clinical symptoms, endoscopic findings, and biomarker analysis. The German Inflammatory Bowel Disease Activity Index for CD (GIBDICD) and UC (GIBDIUC) uses data from patient-reported questionnaires. It is unclear to what extent the GIBDI agrees with the physicians’ documented activity indices.

Methods Data from 2 studies were reanalyzed. In both, gastroenterologists had documented disease activity in UC with the partial Mayo Score (pMS) and in CD with the Harvey Bradshaw Index (HBI). Patient-completed GIBDI questionnaires had also been assessed. The analysis sample consisted of 151 UC and 150 CD patients. Kappa coefficients were determined as agreement measurements.

Results Rank correlations were 0.56 (pMS, GIBDIUC) and 0.57 (HBI, GIBDICD), with p < 0.001. The absolute agreement for 2 categories of disease activity (remission yes/no) was 74.2 % (UC) and 76.6 % (CD), and for 4 categories (none/mild/moderate/severe) 60.3 % (UC) and 61.9 % (CD). The kappa values ranged between 0.47 for UC (2 categories) and 0.58 for CD (4 categories).

Discussion There is satisfactory agreement of GIBDI with the physician-documented disease activity indices. GIBDI can be used in health care research without access to assessments of medical practitioners. In clinical practice, the index offers a supplementary source of information.

Zusammenfassung

Einleitung Die Bestimmung der Krankheitsaktivität bei Morbus Crohn (MC) und Colitis ulcerosa (CU) stützt sich meist auf Arzturteile, endoskopische Befunde oder Biomarker-Analysen. Der German Inflammatory Bowel Disease Activity Index für MC (GIBDIMC) und CU (GIBDICU) nutzt patientenberichtete Fragebogendaten. Unklar ist, inwieweit der GIBDI mit ärztlicherseits dokumentierten Aktivitätsindizes übereinstimmt.

Methodik Daten aus 2 Studien wurden reanalysiert. In beiden dokumentierten Gastroenterologen die Krankheitsaktivität bei CU mit dem partial Mayo Score (pMS), bei MC mit dem Harvey Bradshaw Index (HBI). Patienten bearbeiteten den GIBDI. Die Analysestichprobe bildeten 151 CU- und 150 MC-Patienten. Als Übereinstimmungsmaße wurden Kappa-Koeffizienten bestimmt.

Ergebnisse Es zeigen sich Rangkorrelationen von 0.56 (pMS, GIBDICU) und 0.57 (HBI, GIBDIMC), jeweils p < 0.001. Die absolute Übereinstimmung bei zwei Kategorien der Krankheitsaktivität (Remission ja/nein) ist 74,2 % (CU) bzw. 76,6 % (MC), bei vier Kategorien (keine/leichte/mittlere/schwere) 60,3 % (CU) bzw. 61,9 % (MC). Die Kappa-Werte liegen zwischen 0,47 bei CU (zwei Kategorien) und 0,58 bei MC (vier Kategorien).

Diskussion Der GIBDI zeigt eine zufriedenstellende Übereinstimmung mit den ärztlich dokumentierten Aktivitätsindizes. Sein Einsatz bietet sich in Versorgungsforschungsstudien ohne Zugang zu Urteilen ärztlicher Behandler an. In der klinischen Praxis lässt sich der Index als ergänzende Informationsquelle nutzen.

 
  • References

  • 1 Henriksen M, Jahnsen J, Lygren I. et al. Clinical course in Crohn’s disease: results of a five-year population-based follow-up study (the IBSEN study). Scand J Gastroenterol 2007; 42: 602-610
  • 2 Henriksen M, Jahnsen J, Lygren I. et al. Ulcerative colitis and clinical course: results of a 5-year population-based follow-up study (the IBSEN study). Inflamm Bowel Dis 2006; 12: 543-550
  • 3 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
  • 4 Harvey RF, Bradshaw JM. A simple index of Crohn’s-disease activity. Lancet 1980; 1: 514-514
  • 5 Rachmilewitz D. Coated mesalazine (5-aminosalicyclic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomized trial. BMJ 1989; 298: 82-86
  • 6 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: 1660-1666
  • 7 Peyrin-Biroulet L, Panés J, Sandborn WJ. Defining disease severity in inflammatory bowel diseases: current and future directions. Clin Gastroenterol Hepatol 2016; 14: 348-354
  • 8 D’Incà R, Caccaro R. Measuring disease activity in Crohn’s disease: what is currently available to the clinician. Clin Exp Gastroenterol 2014; 7: 151-161
  • 9 Walsh AJ, Bryant RV, Travis SP. Current best practice for disease activity assessment in IBD. Nat Rev Gastroenterol Hepatol 2016; 13: 567-579
  • 10 af Björkesten CG, Nieminen U, Turunen U. et al. Surrogate markers and clinical indices, alone or combined, as indicators for endoscopic remission in anti-TNF-treated luminal Crohn’s disease. Scand J Gastroenterol 2012; 47: 528-537
  • 11 Falvey JD, Hoskin T, Meijer B. et al. Disease activity assessment in IBD: clinical indices and biomarkers fail to predict endoscopic remission. Inflamm Bowel Dis 2015; 21: 824-831
  • 12 Schoepfer AM, Beglinger C, Straumann A. et al. Fecal calprotectin correlates more closely with the Simple Endoscopic Score for Crohn’s disease (SES-CD) than CRP, blood leukocytes, and the CDAI. Am J Gastroenterol 2010; 105: 162-169
  • 13 Peyrin-Biroulet L, Sandborn W, Sands BE. et al. Selecting therapeutic targets in inflammatory bowel disease (STRIDE): determining therapeutic goals for treat-to-target. Am J Gastroenterol 2015; 110: 1324-1338
  • 14 Janke KH, Raible A, Bauer M. et al. Questions on life satisfaction (FLZM) inflammatory bowel disease. Int J Colorectal Dis 2004; 19: 343-353
  • 15 Hardt J, Muche-Borowski C, Conrad S. et al. Chronisch entzündliche Darmerkrankungen als multifokale Erkrankungen: körperliche und psychosoziale Probleme von Patienten mit CED. Ergebnisse eines Fragebogen-Surveys. Z Gastroenterol 2010; 48: 381-391
  • 16 Hüppe A, Langbrandtner J, Raspe H. Komplexe psychosoziale Problemlagen bei Morbus Crohn und Colitis ulcerosa – Fragebogengestütztes Assessment als erster Schritt zur Aktivierung von Patientinnen und Patienten. Z Gastroenterol 2013; 51: 257-270
  • 17 Hüppe A, Langbrandtner J, Raspe H. Inviting patients with inflammatory bowel disease to active involvement in their own care: a randomized controlled trial. Inflamm Bowel Dis 2014; 20: 1057-1069
  • 18 Reusch A, Weiland R, Gerlich C. et al. Self-management education for rehabilitation inpatients suffering from inflammatory bowel disease: a cluster-randomized controlled trial. Health Educ Res 2016; 31: 782-791
  • 19 Berding A, Witte C, Gottschald M. et al. Beneficial effects of education on emotional distress, self-management, and coping in patients with inflammatory bowel disease: a prospective randomized controlled study. Inflamm Intest Dis 2016; 1: 182-190
  • 20 Janke KH, Klump B, Gregor M. et al. Determinants of life satisfaction in inflammatory bowel disease. Inflamm Bowel Dis 2005; 11: 272-282
  • 21 Langbrandtner J, Hüppe A, Jessen P. et al. Quality of care in inflammatory bowel disease: results of a prospective controlled cohort study in Germany (NETIBD). Clin Exp Gastroenterol 2017; 10: 215-227
  • 22 Hüppe A, Steimann G, Janotta M. et al. Auf dem Prüfstand: stationäre medizinische Rehabilitation bei chronisch entzündlichen Darmerkrankungen. Die Rehabilitation 2016; 55: 248-255
  • 23 Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd. ed Hillsdale: NJ: Erlbaum; 1988
  • 24 Fleiss JL, Cohen J. The equivalence of weighted kappa and the intraclass correlation coefficient as measures of reliability. Educ Psychol Meas 1973; 33: 613-619
  • 25 Grouven U, Bender R, Ziegler A. et al. Der Kappa-Koeffizient. Dtsch Med Wochenschr 2007; 132: e65-e68
  • 26 Altman DG. Practical Statistics for Medical Research. Boca Raton: FL: Chapman & Hall; 1991
  • 27 Lowry R. VassarStats: Statistical Computation Website. Available at http://vassarstats.net/kappa.html Accessed on January 30, 2018
  • 28 Timmer A, Kemptner D, Takses A. et al. A survey-based index was validated for measuring disease activity inflammatory bowel disease. An evaluation study. J Clin Epidemiol 2009; 62: 771-778
  • 29 Clara I, Lix LM, Walker JR. et al. The Manitoba IBD Index: Evidence for a new and simple indicator of IBD activity. Am J Gastroenterol 2009; 104: 1754-1763
  • 30 Bennebroek Evertsz’ F, Nieuwkerk PT, Stokkers PC. et al. The patient simple clinical colitis activity index (P-SCCAI) can detect ulcerative colitis (UC) disease activity in remission: a comparison of the P-SCCAI with clinician-based SCCAI and biological markers. J Crohns Colitis 2013; 7: 890-900
  • 31 Bennebroek Evertsz’ F, Hoeks CC, Nieuwkerk PT. et al. Development of the patient Harvey Bradshaw index and a comparison with a clinician-based Harvey Bradshaw index assessment of Crohn’s disease activity. J Clin Gastroenterol 2013; 47: 850-856