Standardisation of intestinal ultrasound scoring in clinical trials for luminal Crohn’s disease
Thomas M. Goodsall, Vipul Jairath, Brian G. Feagan, Claire E. Parker, Tran M. Nguyen, Leonardo Guizzetti, Anil K. Asthana, Jakob Begun, Britt Christensen, Antony B. Friedman, Torsten Kucharzik, Andrew Lee, Peter J. Lewindon, Christian Maaser, Kerri L. Novak, Jordi Rimola, Kirstin M. Taylor, Stuart A. Taylor, Lauren S. White, Rune Wilkens, Stephanie R. Wilson, Emily K. Wright, Robert V. Bryant, Christopher Ma- Pharmacology (medical)
- Gastroenterology
- Hepatology
Summary
Background
Intestinal ultrasound (IUS) is a valuable tool for assessment of Crohn’s disease (CD). However, there is no widely accepted luminal disease activity index.
Aims
To identify appropriate IUS protocols, indices, items, and scoring methods for measurement of luminal CD activity and integration of IUS in CD clinical trials.
Methods
An expert international panel of adult and paediatric gastroenterologists (n = 15) and radiologists (n = 3) rated the appropriateness of 120 statements derived from literature review and expert opinion (scale of 1‐9) using modified RAND/UCLA methodology. Median panel scores of 1 to ≤3.5, >3.5 to <6.5 and ≥6.5 to 9 were considered inappropriate, uncertain and appropriate ratings respectively. The statement list and survey results were discussed prior to voting.
Results
A total of 91 statements were rated appropriate with agreement after two rounds of voting. Items considered appropriate measures of disease activity were bowel wall thickness (BWT), vascularity, stratification and mesenteric inflammatory fat. There was uncertainty if any of the existing IUS disease activity indices were appropriate for use in CD clinical trials. Appropriate trial applications for IUS included patient recruitment qualification when diseased segments cannot be adequately assessed by ileocolonoscopy and screening for exclusionary complications. At outcome assessment, remission endpoints including BWT and vascularity, with or without mesenteric inflammatory fat, were considered appropriate. Components of an ideal IUS disease activity index were identified based upon panel discussions.
Conclusions
The panel identified appropriate component items and applications of IUS for CD clinical trials. Empiric evidence, and development and validation of an IUS disease activity index are needed.