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.
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.
Authors: Johan F K F Ilvemark; Tawnya Hansen; Thomas M Goodsall; Jakob B Seidelin; Heba Al-Farhan; Mariangela Allocca; Jakob Begun; Robert V Bryant; Dan Carter; Britt Christensen; Marla C Dubinsky; Krisztina B Gecse; Torsten Kucharzik; Cathy Lu; Christian Maaser; Giovanni Maconi; Kim Nylund; Carolina Palmela; Stephanie R Wilson; Kerri Novak; Rune Wilkens Journal: J Crohns Colitis Date: 2022-05-10 Impact factor: 10.020
Authors: Jan Marsal; Manuel Barreiro-de Acosta; Irina Blumenstein; Maria Cappello; Thomas Bazin; Shaji Sebastian Journal: Front Med (Lausanne) Date: 2022-06-15
Authors: Rose Vaughan; Douglas Tjandra; Ashwin Patwardhan; Nicholas Mingos; Robert Gibson; Alex Boussioutas; Zaid Ardalan; Aysha Al-Ani; Peter R Gibson; Britt Christensen Journal: Aliment Pharmacol Ther Date: 2022-03-28 Impact factor: 9.524
Authors: Pierluigi Puca; Livio Enrico Del Vecchio; Maria Elena Ainora; Antonio Gasbarrini; Franco Scaldaferri; Maria Assunta Zocco Journal: Diagnostics (Basel) Date: 2022-08-17