Mark A Samaan1, Bo Shen2, Mahmoud H Mosli3, Guangyong Zou4, William J Sandborn5, Lisa M Shackelton6, Sigrid Nelson6, Larry Stitt6, Stuart Bloom7, Darrell S Pardi8, Paolo Gionchetti9, James Lindsay10, Simon Travis11, Ailsa Hart12, Mark S Silverberg13, Brian G Feagan14, Geert R D'Haens15, Vipul Jairath14. 1. Department of Gastroenterology, Guy's & St. Thomas' Hospital, London, United Kingdom; Robarts Clinical Trials Inc, London, Ontario, Canada. 2. Center for Inflammatory Bowel Diseases, Digestive Disease Institute, The Cleveland Clinic Foundation, Cleveland, Ohio, USA. 3. Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia. 4. Robarts Clinical Trials Inc, London, Ontario, Canada; Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada. 5. Robarts Clinical Trials Inc, London, Ontario, Canada; Division of Gastroenterology, University of California San Diego, La Jolla, California, USA. 6. Robarts Clinical Trials Inc, London, Ontario, Canada. 7. Department of Gastroenterology, University College London Hospital, NHS Trust, London, United Kingdom. 8. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA. 9. Department of Medical and Surgical Sciences (DIMEC), University of Bologna-Italy, Bologna, Italy. 10. Bart's Health NHS Trust, The Royal London Hospital, London, United Kingdom. 11. Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, United Kingdom. 12. St. Mark's Hospital Inflammatory Bowel Disease Unit, Imperial College, London, United Kingdom. 13. Division of Gastroenterology, Mount Sinai Hospital Inflammatory Bowel Disease Centre, Toronto, Ontario, Canada. 14. Robarts Clinical Trials Inc, London, Ontario, Canada; Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada; Department of Medicine, University of Western Ontario, London, Ontario, Canada. 15. Department of Gastroenterology, Academic Medical Center, Amsterdam, Netherlands.
Abstract
BACKGROUND AND AIMS: Pouchitis is a common adverse event after proctocolectomy with ileal pouch anal anastomosis for ulcerative colitis. Evaluation of pouchitis disease activity and response to treatment requires use of validated indices. We assessed the reliability of items evaluating endoscopic pouchitis disease activity. METHODS: Twelve panelists used a modified RAND appropriateness methodology to rate the appropriateness of items evaluating endoscopic pouchitis disease activity derived from a systematic review and also identified additional potential endoscopic items based on expert opinion. Four central readers then evaluated 50 pouchoscopy videos in triplicate, in random order. Intra- and inter-rater reliability for each item was assessed by calculating and comparing intraclass correlation coefficients (ICCs). A Delphi process identified common sources of disagreement among the readers. RESULTS: Ten existing endoscopic items were identified from the systematic review and an additional 7 exploratory items from the panelists. ICCs for inter-rater reliability were highest for the existing item of pouch ulceration (.72; 95% confidence interval [CI], .60-.82) and for the exploratory item of ulcerated surface in the pouch body (.67; 95% CI, .53-.75). Inter-rater reliability for all other existing and exploratory items was "moderate" (ICC < .60). The item "ulcerated surface in the pouch body" demonstrated the best correlation with a global evaluation of lesion severity (r = .80; 95% CI, .73-.85). CONCLUSION: Substantial reliability was observed only for the endoscopic items of ulceration and ulcerated surface in the pouch body. Future studies should assess responsiveness to treatment in the next stage toward development of an endoscopic pouchitis disease activity index.
BACKGROUND AND AIMS: Pouchitis is a common adverse event after proctocolectomy with ileal pouch anal anastomosis for ulcerative colitis. Evaluation of pouchitis disease activity and response to treatment requires use of validated indices. We assessed the reliability of items evaluating endoscopic pouchitis disease activity. METHODS: Twelve panelists used a modified RAND appropriateness methodology to rate the appropriateness of items evaluating endoscopic pouchitis disease activity derived from a systematic review and also identified additional potential endoscopic items based on expert opinion. Four central readers then evaluated 50 pouchoscopy videos in triplicate, in random order. Intra- and inter-rater reliability for each item was assessed by calculating and comparing intraclass correlation coefficients (ICCs). A Delphi process identified common sources of disagreement among the readers. RESULTS: Ten existing endoscopic items were identified from the systematic review and an additional 7 exploratory items from the panelists. ICCs for inter-rater reliability were highest for the existing item of pouch ulceration (.72; 95% confidence interval [CI], .60-.82) and for the exploratory item of ulcerated surface in the pouch body (.67; 95% CI, .53-.75). Inter-rater reliability for all other existing and exploratory items was "moderate" (ICC < .60). The item "ulcerated surface in the pouch body" demonstrated the best correlation with a global evaluation of lesion severity (r = .80; 95% CI, .73-.85). CONCLUSION: Substantial reliability was observed only for the endoscopic items of ulceration and ulcerated surface in the pouch body. Future studies should assess responsiveness to treatment in the next stage toward development of an endoscopic pouchitis disease activity index.
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