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

Adolescent Adult Aged Anti-Inflammatory Agents / administration & dosage Dose-Response Relationship, Drug Eosinophilic Esophagitis / diagnosis Esophagoscopy / methods Esophagus / pathology Female Fluticasone / administration & dosage Humans Male Middle Aged Prognosis Severity of Illness Index Young Adult

Esophagus Index Instrument Variability in Endoscopic Assessment

Journal

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

ISSN: 1542-7714

Titre abrégé: Clin Gastroenterol Hepatol

Pays: United States

ID NLM: 101160775

Informations de publication

Date de publication:
07 2019

Historique:

received: 02 08 2018

revised: 04 10 2018

accepted: 13 11 2018

pubmed: 27 11 2018

medline: 22 10 2020

entrez: 27 11 2018

Statut: ppublish

Résumé

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. 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). 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). 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 NCT01386112.

Sections du résumé

BACKGROUND & AIMS

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 NCT01386112.

Identifiants

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

pubmed: 30476587

pii: S1542-3565(18)31275-8

doi: 10.1016/j.cgh.2018.11.032

pii:

doi:

Substances chimiques

Anti-Inflammatory Agents 0

Fluticasone CUT2W21N7U

Banques de données

ClinicalTrials.gov

['NCT00939263', 'NCT01386112']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

1477-1488.e10

Investigateurs

Sami R Achem (SR)

Amindra S Arora (AS)

Oral Alpan (O)

David Armstrong (D)

Stephen E Attwood (SE)

Joseph H Butterfield (JH)

Michael D Crowell (MD)

Kenneth R DeVault (KR)

Eric Drouin (E)

Benjamin Enav (B)

Felicity T Enders (FT)

David E Fleischer (DE)

Amy Foxx-Orenstein (A)

Dawn L Francis (DL)

Gordon H Guyatt (GH)

Lucinda A Harris (LA)

Amir F Kagalwalla (AF)

Hirohito Kita (H)

Murli Krishna (M)

James J Lee (JJ)

John C Lewis (JC)

Kaiser Lim (K)

G Richard Locke (GR)

Joseph A Murray (JA)

Cuong C Nguyen (CC)

Diana M Orbelo (DM)

Shabana F Pasha (SF)

Francisco C Ramirez (FC)

Javed Sheikh (J)

Sarah B Umar (SB)

Catherine R Weiler (CR)

John M Wo (JM)

Tsung-Teh Wu (TT)

Kathleen J Yost (KJ)