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PedsQL Eosinophilic Esophagitis Module: Feasibility, Reliability, and Validity

Franciosi, James P.*; Hommel, Kevin A.; Bendo, Cristiane B.#; King, Eileen C.||; Collins, Margaret H.; Eby, Michael D.§; Marsolo, Keith; Abonia, J. Pablo§; von Tiehl, Karl F.§; Putnam, Philip E.*; Greenler, Alexandria J.*; Greenberg, Allison B.§; Bryson, Ronald A.; Davis, Carla M.**; Olive, Anthony P.††; Gupta, Sandeep K.‡‡; Erwin, Elizabeth A.§§; Klinnert, Mary D.¶¶; Spergel, Jonathan M.##; Denham, Jolanda M.||||; Furuta, Glenn T.***; Rothenberg, Marc E.§; Varni, James W.†††

Journal of Pediatric Gastroenterology & Nutrition: July 2013 - Volume 57 - Issue 1 - p 57–66
doi: 10.1097/MPG.0b013e31828f1fd2
Original Articles: Gastroenterology

Objective: Eosinophilic esophagitis (EoE) is a chronic esophageal inflammatory condition with a paucity of information on health-related quality of life (HRQOL). The objective of the study was to report on the measurement properties of the PedsQL EoE Module.

Methods: The PedsQL EoE Module was completed in a multisite study by 196 pediatric patients with EoE and 262 parents of patients with EoE.

Results: The PedsQL EoE Module scales evidenced excellent feasibility (0.6%–3.1% missing), excellent group comparison reliability across total scale scores (patient α 0.93; parent proxy α 0.94), good reliability for the 7 individual scales (patient α 0.75–0.87; parent proxy α 0.81–0.92), excellent test–retest reliability (patient intraclass correlation coefficient 0.88; parent intraclass correlation coefficient 0.82), demonstrated no floor effects and low ceiling effects, and demonstrated a high percentage of scaling success for most scales. Intercorrelations with the PedsQL Generic Core Scales were in the medium (0.30) to large (0.50) range. PedsQL EoE Module scores were worse among patients with active histologic disease (≥5 eos/hpf) compared with those in remission (patient self-report: 63.3 vs 69.9 [P < 0.05]; parent proxy report: 65.1 vs 72.3 [P < 0.01]), and those treated with dietary restrictions compared with those with no restrictions (patient self-report: 61.6 vs 74.3 [P < 0.01]; parent proxy report: 65.5 vs 74.7 [P < 0.01]).

Conclusions: The results demonstrate excellent measurement properties of the PedsQL EoE Module. Patients with active histologic disease and those treated with dietary restrictions demonstrated worse PedsQL scores. The PedsQL EoE Module may be used in the evaluation of pediatric EoE disease-specific HRQOL in clinical research and practice.

*Division of Gastroenterology, Hepatology, and Nutrition

Division of Behavioral Medicine and Clinical Psychology

Division of Pathology and Laboratory Medicine

§Division of Allergy and Immunology

||Division of Biostatistics and Epidemiology

Division of Informatics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH

#Department of Pediatric Dentistry and Orthodontics, Federal University of Minas Gerais, Belo Horizonte, MG, Brazil

**Department of Pediatrics, Allergy, and Immunology

††Department of Pediatrics, Division of Gastroenterology, Hepatology, and Nutrition, Baylor College of Medicine, Houston, TX

‡‡Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Riley Hospital for Children, Indiana University, Indianapolis, IN

§§Division of Allergy, Asthma, and Immunology

||||Division of Gastroenterology, Hepatology, and Nutrition, Ohio State University, Nationwide Children's Hospital, Columbus, OH

¶¶Division of Pediatric Behavioral Health, National Jewish Health, Denver, CO

##Allergy Section, Center for Pediatric Eosinophilic Disorders, The Children's Hospital of Philadelphia, Perelman School of Medicine at University of Pennsylvania, Philadelphia, PA

***Section of Gastroenterology, Hepatology, and Nutrition, Gastrointestinal Eosinophilic Diseases Program, University of Colorado Denver School of Medicine, Digestive Health Institute, Children's Hospital Colorado, Aurora, CO

†††Department of Pediatrics, College of Medicine, Texas A&M University, College Station, TX, and the ‡‡‡Department of Landscape Architecture and Urban Planning, College of Architecture, Texas A&M University, College Station, TX.

Address correspondence and reprint requests to James P. Franciosi, MD, MS, Nemours Children's Hospital, 13535 Nemours Parkway, Orlando, FL 32728 (e-mail: jpfranciosi@yahoo.com).

Received 31 July, 2012

Accepted 25 February, 2013

Drs Franciosi and Hommel participated equally in this study.

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This work was financially supported by Children's Digestive Health and Nutrition Foundation, TAP, an AstraZeneca Eosinophilic Esophagitis Young Investigators Award, Food Allergy Initiative, the Buckeye Foundation, the Campaign Urging Research for Eosinophilic Disorders Foundation, the Angels for Eosinophilic Research Foundation, Public Health Service Grant P30 DK078392, and in part by the NIH/NCRR Colorado CTSI Grant Number UL1 RR025780. C.B.B. was supported by a scholarship from the Coordination for the Improvement of Higher Level Education Personnel (CAPES), Brazil.

J.W.V. holds the copyright and the trademark for the PedsQL and receives financial compensation from the Mapi Research Trust, which is a nonprofit research institute that charges distribution fees to for-profit companies that use the Pediatric Quality of Life Inventory. M.E.R. has an equity interest in Teva Pharmaceuticals reslizumab, is Chief Scientific Officer of Immune Pharmaceuticals, and is inventor of several EoE-related patents owned by Cincinnati Children's Hospital Medical Center. The other authors report no conflicts of interest.

© 2013 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,