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

International EEsAI Study Group

Research output: Contribution to journalArticle

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

Original languageEnglish (US)
Pages (from-to)1477-1488.e10
JournalClinical Gastroenterology and Hepatology
Volume17
Issue number8
DOIs
StatePublished - Jul 1 2019

Fingerprint

Eosinophilic Esophagitis
Endoscopy
Placebos
Exudates and Transudates
Linear Models
Edema
Pathologic Constriction
Switzerland
Information Systems
Randomized Controlled Trials

Keywords

  • Esophagus
  • Index
  • Instrument
  • Variability in Endoscopic Assessment

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Variation in Endoscopic Activity Assessment and Endoscopy Score Validation in Adults With Eosinophilic Esophagitis. / International EEsAI Study Group.

In: Clinical Gastroenterology and Hepatology, Vol. 17, No. 8, 01.07.2019, p. 1477-1488.e10.

Research output: Contribution to journalArticle

@article{f0d86bfeb1f34c2eb71819828fdf1dad,
title = "Variation in Endoscopic Activity Assessment and Endoscopy Score Validation in Adults With Eosinophilic Esophagitis",
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",
author = "{International EEsAI Study Group} and Schoepfer, {Alain M.} and Ikuo Hirano and Michael Coslovsky and Roumet, {Marie C.} and Marcel Zwahlen and Kuehni, {Claudia E.} and David Hafner and Alexander, {Jeffrey A.} and Dellon, {Evan S.} and Nirmala Gonsalves and John Leung and Christian Bussmann and Collins, {Margaret H.} and Newbury, {Robert O.} and Smyrk, {Thomas C.} and Woosley, {John T.} and Yang, {Guang Yu} and Yvonne Romero and Katzka, {David A.} and Furuta, {Glenn T.} and Sandeep Gupta and Aceves, {Seema S.} and Mirna Chehade and Spergel, {Jonathan M.} and Falk, {Gary W.} and Meltzer, {Brian A.} and Comer, {Gail M.} and Alex Straumann and Ekaterina Safroneeva and Achem, {Sami R.} and Arora, {Amindra S.} and Oral Alpan and David Armstrong and Attwood, {Stephen E.} and Butterfield, {Joseph H.} and Crowell, {Michael D.} and DeVault, {Kenneth R.} and Eric Drouin and Benjamin Enav and Enders, {Felicity T.} and Fleischer, {David E.} and Amy Foxx-Orenstein and Francis, {Dawn L.} and Guyatt, {Gordon H.} and Harris, {Lucinda A.} and Kagalwalla, {Amir F.} and Hirohito Kita and Murli Krishna and Lee, {James J.} and John Wo",
year = "2019",
month = "7",
day = "1",
doi = "10.1016/j.cgh.2018.11.032",
language = "English (US)",
volume = "17",
pages = "1477--1488.e10",
journal = "Clinical Gastroenterology and Hepatology",
issn = "1542-3565",
publisher = "W.B. Saunders Ltd",
number = "8",

}

TY - JOUR

T1 - Variation in Endoscopic Activity Assessment and Endoscopy Score Validation in Adults With Eosinophilic Esophagitis

AU - International EEsAI Study Group

AU - Schoepfer, Alain M.

AU - Hirano, Ikuo

AU - Coslovsky, Michael

AU - Roumet, Marie C.

AU - Zwahlen, Marcel

AU - Kuehni, Claudia E.

AU - Hafner, David

AU - Alexander, Jeffrey A.

AU - Dellon, Evan S.

AU - Gonsalves, Nirmala

AU - Leung, John

AU - Bussmann, Christian

AU - Collins, Margaret H.

AU - Newbury, Robert O.

AU - Smyrk, Thomas C.

AU - Woosley, John T.

AU - Yang, Guang Yu

AU - Romero, Yvonne

AU - Katzka, David A.

AU - Furuta, Glenn T.

AU - Gupta, Sandeep

AU - Aceves, Seema S.

AU - Chehade, Mirna

AU - Spergel, Jonathan M.

AU - Falk, Gary W.

AU - Meltzer, Brian A.

AU - Comer, Gail M.

AU - Straumann, Alex

AU - Safroneeva, Ekaterina

AU - Achem, Sami R.

AU - Arora, Amindra S.

AU - Alpan, Oral

AU - Armstrong, David

AU - Attwood, Stephen E.

AU - Butterfield, Joseph H.

AU - Crowell, Michael D.

AU - DeVault, Kenneth R.

AU - Drouin, Eric

AU - Enav, Benjamin

AU - Enders, Felicity T.

AU - Fleischer, David E.

AU - Foxx-Orenstein, Amy

AU - Francis, Dawn L.

AU - Guyatt, Gordon H.

AU - Harris, Lucinda A.

AU - Kagalwalla, Amir F.

AU - Kita, Hirohito

AU - Krishna, Murli

AU - Lee, James J.

AU - Wo, John

PY - 2019/7/1

Y1 - 2019/7/1

N2 - 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

AB - 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

KW - Esophagus

KW - Index

KW - Instrument

KW - Variability in Endoscopic Assessment

UR - http://www.scopus.com/inward/record.url?scp=85066067214&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85066067214&partnerID=8YFLogxK

U2 - 10.1016/j.cgh.2018.11.032

DO - 10.1016/j.cgh.2018.11.032

M3 - Article

C2 - 30476587

AN - SCOPUS:85066067214

VL - 17

SP - 1477-1488.e10

JO - Clinical Gastroenterology and Hepatology

JF - Clinical Gastroenterology and Hepatology

SN - 1542-3565

IS - 8

ER -