Mark A Samaan1, Mahmoud H Mosli, William J Sandborn, Brian G Feagan, Geert R DʼHaens, Elena Dubcenco, Kenneth A Baker, Barrett G Levesque. 1. *Robarts Clinical Trials, Inc, London, ON, Canada; †Department of Gastroenterology, Academic Medical Center, Amsterdam, the Netherlands; ‡Department of Medicine, Division of Gastroenterology, King Abdulaziz University, Jeddah, Saudi Arabia; §Department of Epidemiology, McGill University, Montreal, QC, Canada; ‖Division of Gastroenterology, University of California, San Diego, La Jolla, California; and Departments of ¶Medicine, and **Epidemiology and Biostatistics, Western University, London, ON, Canada.
Abstract
BACKGROUND: Assessment of endoscopic disease activity, as measured by various endoscopic evaluative instruments, is an essential part of quantifying disease activity in clinical trials in patients with ulcerative colitis (UC). Evaluative instruments have specific definitions and operating properties that influence the interpretation of clinical trial results. Our objective was to systematically review all endoscopic evaluative instruments that measure endoscopic disease activity in UC and to describe their definitions and operating characteristics (reliability, responsiveness, and predictive validity). METHODS: We performed a systematic review of evaluative instruments assessing endoscopic disease activity in UC. MEDLINE (Ovid), EMBASE (Ovid), PubMed, the Cochrane Library (CENTRAL), and Digestive Disease Week abstracts of clinical trials were searched from inception to January 2013. RESULTS: In total, 5885 studies were identified and screened for inclusion criteria. Four hundred twenty-two studies involving 31 evaluative instruments were identified. Two types of indices were found, numerical scoring systems and stepwise grading scales. CONCLUSIONS: Both the endoscopic evaluative instrument selected and the definition chosen for mucosal healing affect the validity of assessing endoscopic disease activity during a clinical trial for UC. Currently, the sigmoidoscopic component of the Mayo Score and the ulcerative colitis endoscopic index of severity show the most promise as reliable evaluative instruments of endoscopic disease activity. However, further validation is required.
BACKGROUND: Assessment of endoscopic disease activity, as measured by various endoscopic evaluative instruments, is an essential part of quantifying disease activity in clinical trials in patients with ulcerative colitis (UC). Evaluative instruments have specific definitions and operating properties that influence the interpretation of clinical trial results. Our objective was to systematically review all endoscopic evaluative instruments that measure endoscopic disease activity in UC and to describe their definitions and operating characteristics (reliability, responsiveness, and predictive validity). METHODS: We performed a systematic review of evaluative instruments assessing endoscopic disease activity in UC. MEDLINE (Ovid), EMBASE (Ovid), PubMed, the Cochrane Library (CENTRAL), and Digestive Disease Week abstracts of clinical trials were searched from inception to January 2013. RESULTS: In total, 5885 studies were identified and screened for inclusion criteria. Four hundred twenty-two studies involving 31 evaluative instruments were identified. Two types of indices were found, numerical scoring systems and stepwise grading scales. CONCLUSIONS: Both the endoscopic evaluative instrument selected and the definition chosen for mucosal healing affect the validity of assessing endoscopic disease activity during a clinical trial for UC. Currently, the sigmoidoscopic component of the Mayo Score and the ulcerative colitis endoscopic index of severity show the most promise as reliable evaluative instruments of endoscopic disease activity. However, further validation is required.
Authors: Christopher Andrew Lamb; Nicholas A Kennedy; Tim Raine; Philip Anthony Hendy; Philip J Smith; Jimmy K Limdi; Bu'Hussain Hayee; Miranda C E Lomer; Gareth C Parkes; Christian Selinger; Kevin J Barrett; R Justin Davies; Cathy Bennett; Stuart Gittens; Malcolm G Dunlop; Omar Faiz; Aileen Fraser; Vikki Garrick; Paul D Johnston; Miles Parkes; Jeremy Sanderson; Helen Terry; Daniel R Gaya; Tariq H Iqbal; Stuart A Taylor; Melissa Smith; Matthew Brookes; Richard Hansen; A Barney Hawthorne Journal: Gut Date: 2019-09-27 Impact factor: 23.059
Authors: Robert Battat; Parambir S Dulai; Christopher Ma; Vipul Jairath; Brian G Feagan; William J Sandborn; Reena Khanna Journal: Curr Treat Options Gastroenterol Date: 2020-01-04
Authors: Maryam Alkhatry; Ahmad Al-Rifai; Vito Annese; Filippos Georgopoulos; Ahmad N Jazzar; Ahmed M Khassouan; Zaher Koutoubi; Rahul Nathwani; Mazen S Taha; Jimmy K Limdi Journal: World J Gastroenterol Date: 2020-11-21 Impact factor: 5.742
Authors: Mark A Samaan; Polychronis Pavlidis; Jonathan Digby-Bell; Emma L Johnston; Angad Dhillon; Ramesh Paramsothy; Abisoye O Akintimehin; Lucy Medcalf; Guy Chung-Faye; Patrick DuBois; Ioannis Koumoutsos; Nick Powell; Simon H C Anderson; Jeremy Sanderson; Bu' Hussain Hayee; Peter M Irving Journal: Frontline Gastroenterol Date: 2017-10-11