1. A systematic review of measurement of endoscopic disease activity and mucosal healing in Crohn's disease: recommendations for clinical trial design
- Author
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K. Adam Baker, Geert DʼHaens, Barrett G. Levesque, Brian G. Feagan, Reena Khanna, William J. Sandborn, Guillaume Bouguen, Elena Dubcenco, Amicus Therapeutics, Foie, métabolismes et cancer, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Université de Rennes (UNIV-RENNES), Robarts Clinical Trials, Robarts Research Institute [Canada], University of Western Ontario (UWO)-University of Western Ontario (UWO), Gastroenterology, University of California [San Diego] (UC San Diego), University of California-University of California, Division of Gastroenterology, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Université de Rennes (UR), and University of California (UC)-University of California (UC)
- Subjects
medicine.medical_specialty ,Biomedical Research ,[SDV]Life Sciences [q-bio] ,MEDLINE ,Guidelines as Topic ,Cochrane Library ,Severity of Illness Index ,Gastroenterology ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Crohn Disease ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Humans ,Immunology and Allergy ,Clinical Trials as Topic ,Wound Healing ,Crohn's disease ,Mucous Membrane ,business.industry ,Clinical study design ,Endoscopy ,medicine.disease ,3. Good health ,Clinical trial ,Systematic review ,Research Design ,030220 oncology & carcinogenesis ,Inclusion and exclusion criteria ,030211 gastroenterology & hepatology ,business - Abstract
Background Crohn's disease (CD) is a chronic idiopathic inflammatory disorder of the gastrointestinal tract. Recently, mucosal healing has been proposed as a goal of therapy because clinical symptoms are subjective. Evaluative indices that measure endoscopic disease activity are required to define mucosal healing for clinical trials. The primary objective of this systematic review was to assess the existing evaluative indices that measure disease activity in CD and evaluate their role as outcome measures in clinical trials. Methods A systematic literature review was performed using MEDLINE (Ovid), EMBASE (Ovid), PubMed, the Cochrane Library (CENTRAL), and DDW abstracts to identify randomized controlled trials and controlled clinical trials that used a relevant evaluative index from inception to February 2013. The data obtained from these trials were reviewed and summarized. Results The initial literature searches identified 2300 citations. After duplicates were removed, 1454 studies remained. After application of the apriori inclusion and exclusion criteria, 109 articles were included and 3 were identified with handsearches. In total, 9 evaluative indices for CD were identified and reviewed. The Crohn's Disease Endoscopic Index of Severity (CDEIS) and the Simple Endoscopic Score in Crohn's Disease (SES-CD) are indices with the most extensively described operating properties. Conclusions Both the endoscopic evaluative instrument selected and the definition chosen for mucosal healing affect the validity of assessing endoscopic disease activity during a clinical trial for CD. Currently, the CDEIS and SES-CD have the most data regarding operating properties; however, further validation is required.
- Published
- 2014