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BMC Gastroenterology

, 11:126

First Online: 18 November 2011Received: 07 April 2011Accepted: 18 November 2011

Abstract

BackgroundPrevious attempts to measure symptoms in pediatric Eosinophilic Esophagitis EoE have not fully included patients and parents in the item development process. We sought to identify and validate key patient self-reported and parent proxy-reported outcomes PROs specific to EoE.

MethodsWe developed methodology for focus and cognitive interviews based on the Food and Drug Administration FDA guidelines for PROs, the validated generic PedsQL™ guidelines, and the consolidated criteria for reporting qualitative research COREQ. Both child ages 8-12 and 13-18 and parent-proxy ages 2-4, 5-7, 8-12, and 13-18 interviews were conducted.

ResultsWe conducted 75 interviews to construct the new instrument. Items were identified and developed from individual focus interviews, followed by cognitive interviews for face and content validation. Initial domains of symptom frequency and severity were developed, and open-ended questions were used to generate specific items during the focus interviews. Once developed, the instrument construct, instructions, timeframe, scoring, and specific items were systematically reviewed with a separate group of patients and their parents during the cognitive interviews.

ConclusionsTo capture the full impact of pediatric EoE, both histologic findings and PROs need to be included as equally important outcome measures. We have developed the face and content validated Pediatric Eosinophilic Esophagitis Symptom Score PEESS™ v2.0. The PEESS™ v2.0 metric is now undergoing multisite national field testing as the next iterative instrument development phase.

Electronic supplementary materialThe online version of this article doi:10.1186-1471-230X-11-126 contains supplementary material, which is available to authorized users.

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Autor: James P Franciosi - Kevin A Hommel - Charles W DeBrosse - Allison B Greenberg - Alexandria J Greenler - J Pablo Abonia

Fuente: https://link.springer.com/



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