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Development and validation of a symptom-based activity index for adults with eosinophilic esophagitis.

Abstract：

BACKGROUND & AIMS:Standardized instruments are needed to assess the activity of eosinophilic esophagitis (EoE) and to provide end points for clinical trials and observational studies. We aimed to develop and validate a patient-reported outcome (PRO) instrument and score, based on items that could account for variations in patient assessments of disease severity. We also evaluated relationships between patient assessment of disease severity and EoE-associated endoscopic, histologic, and laboratory findings. METHODS:We collected information from 186 patients with EoE in Switzerland and the United States (69.4% male; median age, 43 y) via surveys (n = 135), focus groups (n = 27), and semistructured interviews (n = 24). Items were generated for the instruments to assess biologic activity based on physician input. Linear regression was used to quantify the extent to which variations in patient-reported disease characteristics could account for variations in patient assessment of EoE severity. The PRO instrument was used prospectively in 153 adult patients with EoE (72.5% male; median age, 38 y), and validated in an independent group of 120 patients with EoE (60.8% male; median age, 40.5 y). RESULTS:Seven PRO factors that are used to assess characteristics of dysphagia, behavioral adaptations to living with dysphagia, and pain while swallowing accounted for 67% of the variation in patient assessment of disease severity. Based on statistical consideration and patient input, a 7-day recall period was selected. Highly active EoE, based on endoscopic and histologic findings, was associated with an increase in patient-assessed disease severity. In the validation study, the mean difference between patient assessment of EoE severity (range, 0-10) and PRO score (range, 0-8.52) was 0.15. CONCLUSIONS:We developed and validated an EoE scoring system based on 7 PRO items that assess symptoms over a 7-day recall period. Clinicaltrials.gov number: NCT00939263.

journal_name

Gastroenterology

journal_title

Gastroenterology

authors

Schoepfer AM,Straumann A,Panczak R,Coslovsky M,Kuehni CE,Maurer E,Haas NA,Romero Y,Hirano I,Alexander JA,Gonsalves N,Furuta GT,Dellon ES,Leung J,Collins MH,Bussmann C,Netzer P,Gupta SK,Aceves SS,Chehade M,Moawad F

doi

10.1053/j.gastro.2014.08.028

subject

Has Abstract

pub_date

2014-12-01 00:00:00

pages

1255-66.e21

issue

eissn

0016-5085

issn

1528-0012

pii

S0016-5085(14)01039-7

journal_volume

147

pub_type

杂志文章

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Development and validation of a symptom-based activity index for adults with eosinophilic esophagitis.