Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments
Open Access
- 22 July 2020
- Vol. 70 (2), 418-426
- https://doi.org/10.1136/gutjnl-2020-320690
Abstract
Central reading, that is, independent, off-site, blinded review or reading of imaging endpoints, has been identified as a crucial component in the conduct and analysis of inflammatory bowel disease clinical trials. Central reading is the final step in a workflow that has many parts, all of which can be improved. Furthermore, the best reading algorithm and the most intensive central reader training cannot make up for deficiencies in the acquisition stage (clinical trial endoscopy) or improve on the limitations of the underlying score (outcome instrument). In this review, academic and industry experts review scoring systems, and propose a theoretical framework for central reading that predicts when improvements in statistical power, affecting trial size and chances of success, can be expected: Multireader models can be conceptualised as statistical or non-statistical (social). Important organisational and operational factors, such as training and retraining of readers, optimal bowel preparation for colonoscopy, video quality, optimal or at least acceptable read duration times and other quality control matters, are addressed as well. The theory and practice of central reading and the conduct of endoscopy in clinical trials are interdisciplinary topics that should be of interest to many, regulators, clinical trial experts, gastroenterology societies and those in the academic community who endeavour to develop new scoring systems using traditional and machine learning approaches.Keywords
This publication has 60 references indexed in Scilit:
- Reliability and Initial Validation of the Ulcerative Colitis Endoscopic Index of SeverityGastroenterology, 2013
- Validation of Endoscopic Activity Scores in Patients With Crohn's Disease Based on a Post Hoc Analysis of Data From SONICGastroenterology, 2013
- Impact of mucosal healing on long‐term outcomes in ulcerative colitis treated with infliximab: a multicenter experienceAlimentary Pharmacology & Therapeutics, 2013
- Developing an instrument to assess the endoscopic severity of ulcerative colitis: the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)Gut, 2011
- Bowel cleansing for colonoscopy: prospective randomized assessment of efficacy and of induced mucosal abnormality with three preparation agentsEndoscopy, 2011
- Is sigmoidoscopy sufficient for evaluating inflammatory status of ulcerative colitis patients?Journal of Gastroenterology and Hepatology, 2011
- Quality indicators for colonoscopyGastrointestinal Endoscopy, 2006
- Development and validation of a new, simplified endoscopic activity score for Crohn's disease: the SES-CDGastrointestinal Endoscopy, 2004
- Coated Oral 5-Aminosalicylic Acid Therapy for Mildly to Moderately Active Ulcerative ColitisNew England Journal of Medicine, 1987
- Variation Between Observers in Describing Mucosal Appearances in ProctocolitisBMJ, 1964