title: Development of a validated patient-reported symptom metric for pediatric eosinophilic esophagitis: qualitative methods.
abstract: BACKGROUND
  Previous 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.
  
  
  METHODS
  We 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.
  
  
  RESULTS
  We 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.
  
  
  CONCLUSIONS
  To 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.
authors.affiliation: Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA. james.franciosi@cchmc.org
authors.forename: James P
authors.initials: JP
authors.lastname: Franciosi
authors.forename: Kevin A
authors.initials: KA
authors.lastname: Hommel
authors.forename: Charles W
authors.initials: CW
authors.lastname: DeBrosse
authors.forename: Allison B
authors.initials: AB
authors.lastname: Greenberg
authors.forename: Alexandria J
authors.initials: AJ
authors.lastname: Greenler
authors.forename: J Pablo
authors.initials: JP
authors.lastname: Abonia
authors.forename: Marc E
authors.initials: ME
authors.lastname: Rothenberg
authors.forename: James W
authors.initials: JW
authors.lastname: Varni
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D057765:Eosinophilic Esophagitis / Q000150:complications*; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D010290:Parents; D036301:Qualitative Research; D057566:Self Report; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
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