title: A systematic review of measurement of endoscopic disease activity and mucosal healing in Crohn's disease: recommendations for clinical trial design.
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.
authors.affiliation: *Robarts Clinical Trials, Western University, London, ON, Canada; †Department of Medicine, University of Western Ontario, London, ON, Canada; ‡Inflammatory Bowel Disease Centre, Academic Medical Centre, Amsterdam, Netherlands; §Service des Maladie de l'Appareil Digestif et INSERM U991, Centre Hospitalier Universitaire Pontchaillou et université de Rennes 1, Rennes, France; and ‖Division of Gastroenterology, University of California San Diego, La Jolla, California.
authors.forename: Reena
authors.initials: R
authors.lastname: Khanna
authors.forename: Guillaume
authors.initials: G
authors.lastname: Bouguen
authors.forename: Brian G
authors.initials: BG
authors.lastname: Feagan
authors.forename: Geert
authors.initials: G
authors.lastname: DʼHaens
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Elena
authors.initials: E
authors.lastname: Dubcenco
authors.forename: K Adam
authors.initials: KA
authors.lastname: Baker
authors.forename: Barrett G
authors.initials: BG
authors.lastname: Levesque
mesh_terms: D035843:Biomedical Research; D002986:Clinical Trials as Topic; D003424:Crohn Disease / Q000473:pathology* / Q000628:therapy*; D004724:Endoscopy / Q000379:methods*; D017408:Guidelines as Topic; D006801:Humans; D009092:Mucous Membrane / Q000503:physiopathology*; D012107:Research Design; D012720:Severity of Illness Index; D014945:Wound Healing