作者
Rocio Sedano, Christopher Ma, Rish K Pai, Geert D'Haens, Leonardo Guizzetti, Lisa M Shackelton, Julie Remillard, Paolo Gionchetti, Ilyssa O Gordon, Stefan Holubar, Maia Kayal, Gregory Y Lauwers, Reetesh K Pai, Darrell S Pardi, Mark A Samaan, David F Schaeffer, Bo Shen, Mark S Silverberg, Brian G Feagan, William J Sandborn, Vipul Jairath
发表日期
2021/5
期刊
Alimentary Pharmacology & Therapeutics
卷号
53
期号
10
页码范围
1108-1117
简介
Background
Pouchitis is a condition with large unmet medical needs and no approved therapies. Lack of validated instruments to measure disease activity and treatment response is a major barrier to drug development.
Aim
To conduct a modified RAND/University of California Los Angeles appropriateness process to produce a standardised assessment of pouchitis disease activity in clinical trials.
Methods
A list of 164 items generated upon a systematic review and expert opinion were rated based on a 9‐point scale (appropriate, uncertain and inappropriate), by a panel including 16 gastroenterologists, surgeons and histopathologists.
Results
Items rated as appropriate to evaluate in pouchitis clinical trials were: (a) clinical: stool frequency and faecal urgency; (b) endoscopic: primary assessment in the pouch body according to the percentage of affected area (<50%, 50%‐75% and >75%), evaluation of the …
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R Sedano, C Ma, RK Pai, G D'Haens, L Guizzetti… - Alimentary Pharmacology & Therapeutics, 2021