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The role of centralized reading of endoscopy in a randomized controlled trial of mesalamine for ulcerative colitis

Abstract:

Background & Aims Interobserver differences in endoscopic assessments contribute to variations in rates of response to placebo in ulcerative colitis (UC) trials. We investigated whether centralized review of images could reduce these variations. Methods We performed a 10-week, randomized, double-blind, placebo-controlled study of 281 patients with mildly to moderately active UC, defined by an Ulcerative Colitis Disease Activity Index (UCDAI) sigmoidoscopy score ≥2, that evaluated the e...

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Publication status:
Published
Peer review status:
Peer reviewed
Version:
Author's Original

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Publisher copy:
10.1053/j.gastro.2013.03.025

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Institution:
University of Oxford
Department:
Oxford, MSD
Feagan, BG More by this author
Sandborn, WJ More by this author
D'Haens, G More by this author
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Publisher:
Elsevier Inc. Publisher's website
Journal:
Gastroenterology Journal website
Volume:
145
Issue:
1
Pages:
149-159
Publication date:
2013-03-22
Acceptance date:
2013-03-16
DOI:
ISSN:
0016-5085
URN:
uuid:dac16f17-1268-440b-9a48-2ab73d4093c1
Source identifiers:
629474
Local pid:
pubs:629474
Keywords:

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