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Clin Gastroenterol Hepatol. 2018 Nov 23. pii: S1542-3565(18)31275-8. doi: 10.1016/j.cgh.2018.11.032. [Epub ahead of print]

Variation in Endoscopic Activity Assessment and Endoscopy Score Validation in Adults with Eosinophilic Esophagitis.

Author information

1
Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois / CHUV, Lausanne, Switzerland. Electronic address: alain.schoepfer@chuv.ch.
2
Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
3
Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
4
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
5
Center for Esophageal Diseases and Swallowing, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
6
Center for Food Related Diseases, Division of Pediatric Allergy and Immunology, Division of Gastroenterology, Tufts Medical Center and Floating Hospital for Children, Boston, MA, USA.
7
Viollier AG, Institute for Pathology, Basel, Switzerland.
8
Division of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
9
Department of Pathology, Rady Children's Hospital, University of California, San Diego, San Diego, CA, USA.
10
Department of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine, Rochester, MN, USA.
11
Department of Pathology and Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
12
Department of Pathology, Northwestern University Feinberg School of Medicine, Chicago, USA.
13
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA; Department of Otolaryngology, Mayo Clinic, Rochester, MN, USA; GI Outcomes Unit, Mayo Clinic, Rochester, MN, USA.
14
Gastrointestinal Eosinophilic Diseases Program, Department of Pediatrics, University of Colorado School of Medicine; Digestive Health Institute, Children's Hospital Colorado, Aurora, CO, USA.
15
Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN, USA.
16
Division of Allergy and Immunology, Rady Children's Hospital, University of California, San Diego, San Diego, CA, USA.
17
Departments of Pediatrics and Medicine, Mount Sinai Center for Eosinophilic Disorders, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
18
Divisions of Allergy and Immunology, Department of Pediatrics, The Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Philadelphia, PA, USA.
19
Division of Gastroenterology, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
20
Adare Pharmaceuticals, Inc.
21
Kimberton Drug Development Consulting, LLC.
22
Swiss EoE Clinic, Division of Gastroenterology, University Hospital Zuerich, Zuerich, Switzerland.

Abstract

BACKGROUND & AIMS:

Eosinophilic esophagitis (EoE) is assessed endoscopically (endoscopic activity), based on grades of edema, rings, exudates, furrows, and strictures (EREFS). We examined variations in endoscopic assessments of severity, developed and validated 3 EREFS-based scoring systems, and assessed responsiveness of these systems using data from a randomized placebo-controlled trial of patients with EoE.

METHODS:

For the development set, 5 gastroenterologists reviewed EREFS findings from 266 adults with EoE and provided endoscopist global assessment scores (EndoGA, scale of 0 to 10); variation (ΔEndoGA) was assessed using linear regression. We evaluated simple scores (features given arbitrary values from 0 to 3) and developed 2 scoring systems (adjusted score range, 0-100). We then fitted our linear regression model with mean EndoGA to data from 146 adults recruited in centers in Switzerland and the United States between April 2011 and December 2012. For the validation set, we collected data from 120 separate adults (recruited in centers in Switzerland and the United States between May 2013 and July 2014), assessing regression coefficient-based scores using Bland-Altman method. We assessed the responsiveness of our scoring systems using data from a randomized trial of patients with EoE given fluticasone (n=16) or placebo (n=8).

RESULTS:

The distribution of EndoGA values differed among endoscopists (mean ΔEndoGA, 2.6±1.8; range 0-6.6). We developed 2 regression-based scoring systems to assess overall and proximal and distal esophageal findings; variation in endoscopic features accounted for more than 90% of the mean EndoGA variation. In the validation group, differences between mean EndoGA and regression-based scores were small (ranging from -4.70 to 2.03), indicating good agreement. In analyses of data from the randomized trial, the baseline to end of study change in patients given fluticasone was a reduction of 24.3 in simple score (reduction of 4.6 in patients given placebo, P=.052); a reduction of 23.5 in regression-based overall score (reduction of 6.56 in patients given placebo, P=.12), and a reduction of 23.8 (reduction of 8.44 in patients given placebo, P=.11).

CONCLUSION:

Assessments of endoscopic activity in patients with EoE vary among endoscopists. In an analysis of data from a randomized controlled trial, we found that newly developed scoring systems are no better than simple scoring system in detecting changes in endoscopic activity. These results support the use of a simple scoring system in evaluation of endoscopic activity in patients with EoE. clinicaltrials.gov no: NCT00939263 and NCT 01386112.

KEYWORDS:

esophagus; index; instrument; variability in endoscopic assessment

PMID:
30476587
DOI:
10.1016/j.cgh.2018.11.032

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