title: Development and validation of the Nancy histological index for UC.
abstract: We developed a validated index for assessing histological disease activity in UC and established its responsiveness.
  
  
  
  Two hundred biopsies were scored. The outcome was the Global Visual Evaluation (GVE). Eight histological features were tested. The Nancy index was developed by multiple linear regression and bootstrap process to create an index that best matched the GVE. Goodness of fit was assessed by the adjusted R squared (adjusted R2). The second step was the validation of the index: 100 biopsies were scored for the Nancy index by three pathologists from different centres. Inter-reader reliability was evaluated for each reader. The relationship between the change of the Nancy index and the Geboes index was assessed to assess the responsiveness.
  
  
  
  After backward selection with bootstrap validation, 3/8 items were selected: ulceration (adjusted R2=0.55), acute inflammatory infiltrate (adjusted R2=0.88) and chronic inflammatory infiltrate (adjusted R2=0.79). The Nancy index is defined by a 5-level classification ranging from grade 0 (absence of significant histological disease activity) to grade 4 (severely active disease). The intraclass correlation coefficient (ICC) for the intrareader reliability was 0.88 (95% CI 0.82 to 0.92) and the index had good inter-reader reliability (ICC=0.86 (0.81 to 0.99)). The correlation between the Nancy index and the Geboes score or the GVE was very good. The index had a good responsiveness with a high correlation between changes in the Geboes score and changes in the Nancy index (0.910 (0.813 to 0.955)).
  
  
  
  A three descriptor histological index has been validated for use in clinical practice and clinical trials.
authors.affiliation: Department of Pathology, University of Reims et Champagne-Ardenne, Reims, France.|Inserm U954, Genetic Nutrition and Exposure to Environmental Risks (NGERE), University of Lorraine, Vandoeuvre- lès-Nancy, France.
authors.forename: Aude
authors.initials: A
authors.lastname: Marchal-Bressenot
authors.affiliation: Department of Biostatistics, Institute de Cancérologie de Lorraine, Vandoeuvre-lès-Nancy, France.
authors.forename: Julia
authors.initials: J
authors.lastname: Salleron
authors.affiliation: Department of Pathology, University of Reims et Champagne-Ardenne, Reims, France.
authors.forename: Camille
authors.initials: C
authors.lastname: Boulagnon-Rombi
authors.affiliation: Department of Pathology, University Hospital of Lorraine, Vandoeuvre-lès-Nancy, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Bastien
authors.affiliation: Department of Pathology, Centre Hospitalier Sud Francilien, Corbeil Essonnes, France.
authors.forename: Virginie
authors.initials: V
authors.lastname: Cahn
authors.affiliation: Department of Hepato-Gastroenterology, University Hospital of Reims et Champagne-Ardenne, Reims, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Cadiot
authors.affiliation: Department of Pathology, University of Reims et Champagne-Ardenne, Reims, France.
authors.forename: Marie-Danièle
authors.initials: MD
authors.lastname: Diebold
authors.affiliation: Humanitas Clinical and Research Center and Humanitas University, Rozzano, Milan,Italy.
authors.forename: Silvio
authors.initials: S
authors.lastname: Danese
authors.affiliation: Department of Gastroenterology, IBD Center, Humanitas Research Hospital, Rozzano, Milan, Italy.
authors.forename: Walter
authors.initials: W
authors.lastname: Reinisch
authors.affiliation: Department Medicine I, University-Hospital Schleswig-Holstein, Kiel, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Schreiber
authors.affiliation: Translational Gastroenterology Unit, Oxford University Hospitals, Oxford, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Travis
authors.affiliation: Inserm U954, Genetic Nutrition and Exposure to Environmental Risks (NGERE), University of Lorraine, Vandoeuvre- lès-Nancy, France.|Department of Hepato-Gastroenterology, University Hospital of Lorraine, Vandoeuvre-lès-Nancy, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Peyrin-Biroulet
mesh_terms: D000465:Algorithms; D001706:Biopsy; D003093:Colitis, Ulcerative / Q000473:pathology*; D003106:Colon / Q000473:pathology*; D006801:Humans; D016014:Linear Models; D015588:Observer Variation; D015203:Reproducibility of Results; D012720:Severity of Illness Index
keywords: MUCOSAL PATHOLOGY; ULCERATIVE COLITIS