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Development and validation of the Nancy histological index for UC
  1. Aude Marchal-Bressenot1,2,
  2. Julia Salleron3,
  3. Camille Boulagnon-Rombi1,
  4. Claire Bastien4,
  5. Virginie Cahn5,
  6. Guillaume Cadiot6,
  7. Marie-Danièle Diebold1,
  8. Silvio Danese7,
  9. Walter Reinisch8,
  10. Stefan Schreiber9,
  11. Simon Travis10,
  12. Laurent Peyrin-Biroulet2,11
  1. 1Department of Pathology, University of Reims et Champagne-Ardenne, Reims, France
  2. 2Inserm U954, Genetic Nutrition and Exposure to Environmental Risks (NGERE), University of Lorraine, Vandoeuvre- lès-Nancy, France
  3. 3Department of Biostatistics, Institute de Cancérologie de Lorraine, Vandoeuvre-lès-Nancy, France
  4. 4Department of Pathology, University Hospital of Lorraine, Vandoeuvre-lès-Nancy, France
  5. 5Department of Pathology, Centre Hospitalier Sud Francilien, Corbeil Essonnes, France
  6. 6Department of Hepato-Gastroenterology, University Hospital of Reims et Champagne-Ardenne, Reims, France
  7. 7Humanitas Clinical and Research Center and Humanitas University, Rozzano, Milan,Italy
  8. 8Department of Gastroenterology, IBD Center, Humanitas Research Hospital, Rozzano, Milan, Italy
  9. 9Department Medicine I, University-Hospital Schleswig-Holstein, Kiel, Germany
  10. 10Translational Gastroenterology Unit, Oxford University Hospitals, Oxford, UK
  11. 11Department of Hepato-Gastroenterology, University Hospital of Lorraine, Vandoeuvre-lès-Nancy, France
  1. Correspondence to Professor Laurent Peyrin-Biroulet, Inserm U954 and Department of Gastroenterology, Université de Lorraine, Allée du Morvan, Vandoeuvre-lès-Nancy 54511, France; peyrinbiroulet{at}gmail.com

Abstract

Objective We developed a validated index for assessing histological disease activity in UC and established its responsiveness.

Methods 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.

Results 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)).

Conclusions A three descriptor histological index has been validated for use in clinical practice and clinical trials.

  • ULCERATIVE COLITIS
  • MUCOSAL PATHOLOGY

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