Comparing disease activity indices in ulcerative colitis |
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| Affiliation: | 1. Currently at Department of Gastroenterology, St Vincent''s Hospital, Sydney, Australia;2. Medical Sciences Division, University of Oxford, Oxford, UK;3. Currently at Department of Surgery, Universitas Hospital, University of the Free State, Bloemfontein, South Africa;4. Currently at Department of Gastroenterology, Princess Alexandra Hospital, Brisbane, Australia;5. Currently at Department of Biomedical Sciences, University of Sheffield, Sheffield, UK;6. Centre for Statistics in Medicine, University of Oxford, Oxford, UK;7. Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, UK;1. School of Nursing and Midwifery, University of South Australia, Adelaide, Australia;2. Department of Health Sciences, University of York, York, United Kingdom;3. Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, Australia;4. School of Medicine, University of Adelaide, Adelaide, Australia;1. Mount Sinai Hospital Centre for Inflammatory Bowel Disease, University of Toronto, Toronto, Ontario, Canada;2. Institute for Health Policy Management and Evaluation, University of Toronto, Canada;3. Division of Gastroenterology and Hepatology, Johns Hopkins School of Medicine, USA;4. Department of Medicine, Lakeridge Health, Oshawa, Ontario, Canada;1. Center for Medical Research, Department of Internal Medicine, Section for Transplantation Immunology and Immunohematology, University of Tübingen, Germany;2. Clinical Research Group KFO 273, University of Tübingen, Germany;3. Department of Urology, University of Tübingen, Germany;4. Department of Immunology, Oslo University Hospital, Oslo, Norway;5. Institute of Basic Medical Sciences, University of Oslo, Norway;6. Siegfried Weller Institute for Trauma Research, Eberhard Karls University Tübingen, Germany;7. Department of Trauma and Reconstructive Surgery, Eberhard Karls University Tübingen, Germany;8. Department of Urology, University of Lübeck Schleswig-Holstein, Ratzeburger Allee 160, 23538 Lübeck, Germany |
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| Abstract: | BackgroundComparisons between disease activity indices for ulcerative colitis (UC) are few. This study evaluates three indices, to determine the potential impact of inter-observer variation on clinical trial recruitment or outcome as well as their clinical relevance.MethodsOne hundred patients with UC were prospectively evaluated, each by four specialists, followed by videosigmoidoscopy, which was later scored by each specialist. The Simple Clinical Colitis Activity (SCCAI), Mayo Clinic and Seo indices were compared by assigning a disease activity category from published thresholds for remission, mild, moderate and severe activity. Inter-observer variation was evaluated using Kappa statistics and its effect for each patient on recruitment and outcome measures for representative clinical trials calculated. Clinical relevance was assessed by comparing an independently assigned clinical category, taking all information into account as if in clinic, with the disease activity assigned by the indices.ResultsInter-observer agreement for SCCAI (κ = 0.75, 95% CI 0.70–0.81), Mayo Clinic (κ = 0.72, 95% CI 0.67–0.78) and Seo (κ = 0.89, 95% CI 0.83–0.95) indices was good or very good as was the agreement for rectal bleeding (κ = 0.77) and stool frequency (κ = 0.90). Endoscopy in the Mayo Clinic index had the greatest variation (κ = 0.38). Inter-observer variation alone would have excluded up to 1 in 5 patients from recruitment or remission criteria in representative trials. Categorisation by the SCCAI, Mayo Clinic and Seo indices agreed with the independently assigned clinical category in 61%, 67% and 47% of cases respectively.ConclusionsTrial recruitment and outcome measures are affected by inter-observer variation in UC activity indices, and endoscopic scoring was the component most susceptible to variation. |
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