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PedsQL Gastrointestinal Symptoms Module: Feasibility, Reliability, and Validity

Varni, James W.*; Bendo, Cristiane B.; Denham, Jolanda; Shulman, Robert J.§; Self, Mariella M.||; Neigut, Deborah A.; Nurko, Samuel#; Patel, Ashish S.**; Franciosi, James P.††; Saps, Miguel‡‡; Verga, Barbara§§; Smith, Alicia; Yeckes, Alyson; Heinz, Nicole#; Langseder, Annette§§; Saeed, Shehzad††; Zacur, George M.††; Pohl, John F.||||

Journal of Pediatric Gastroenterology & Nutrition: September 2014 - Volume 59 - Issue 3 - p 347–355
doi: 10.1097/MPG.0000000000000414
Original Articles: Gastroenterology

Objective: The objective of this study was to report on the measurement properties of the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module for patients with functional gastrointestinal (GI) disorders (FGIDs) and organic GI diseases, hereafter referred to as “GI disorders,” for patient self-report ages between 5 and 18 and parent proxy-report for ages between 2 and 18 years.

Methods: The 74-item PedsQL GI Module and 23-item PedsQL Generic Core Scales were completed in a 9-site study by 584 patients and 682 parents. Patients had physician-diagnosed GI disorders (such as chronic constipation, functional abdominal pain, irritable bowel syndrome, functional dyspepsia, Crohn disease, ulcerative colitis, gastroesophageal reflux disease).

Results: Fourteen unidimensional scales were derived measuring stomach pain, stomach discomfort when eating, food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood, diarrhea, worry, medicines, and communication. The PedsQL GI Module Scales evidenced excellent feasibility, excellent reliability for the Total Scale Scores (patient self-report α = 0.97, parent proxy-report α = 0.97), and good-to-excellent reliability for the 14 individual scales (patient self-report α = 0.67–0.94, parent proxy-report α = 0.77–0.95). Intercorrelations with the Generic Core Scales supported construct validity. Individual Symptoms Scales known-groups validity across 7 GI disorders was generally supported. Factor analysis supported the unidimensionality of the individual scales.

Conclusions: The PedsQL GI Module Scales demonstrated acceptable-to-excellent measurement properties and may be used as common metrics to compare GI-specific symptoms in clinical research and practice both within and across patient groups for FGIDs and organic GI diseases.

*Department of Pediatrics, College of Medicine, Department of Landscape Architecture and Urban Planning, College of Architecture, Texas A&M University, College Station

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

Division of Pediatric Gastroenterology, Nationwide Children's Hospital, Ohio State University School of Medicine, Columbus

§Department of Pediatrics, Baylor College of Medicine, Children's Nutrition Research Center

||Departments of Psychiatry and Pediatrics, Baylor College of Medicine, Texas Children's Hospital, Houston

Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital Colorado, Aurora

#Center for Motility and Functional Gastrointestinal Disorders, Boston Children's Hospital, Harvard Medical School, Boston, MA

**Division of Pediatric Gastroenterology, Children's Medical Center of Dallas, University of Texas Southwestern Medical School, Dallas

††Division of Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, OH

‡‡Division of Gastroenterology, Hepatology, and Nutrition, Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL

§§Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Goryeb Children's Hospital, Morristown Medical Center, Morristown, NJ

||||Department of Pediatric Gastroenterology, Primary Children's Hospital, University of Utah, Salt Lake City.

Address correspondence and reprint requests to James W. Varni, PhD, College of Architecture, Texas A&M University, 3137 TAMU, College Station, TX 77843-3137 (e-mail: jvarni@arch.tamu.edu).

Received 22 January, 2014

Accepted 25 April, 2014

Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal's Web site (www.jpgn.org).

Item development for the PedsQL Gastrointestinal Symptoms Module was supported by Takeda Pharmaceuticals North America (Deerfield, IL).

J.P.F. and J.D. are now at the Division of Gastroenterology, Hepatology, and Nutrition, Nemours Children's Hospital, Orlando, FL. G.M.Z. is now at the Division of Pediatric Gastroenterology, C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, MI.

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. J.W.V. also received investigator-initiated funding from Takeda Pharmaceuticals North America for the previous item generation qualitative methods study. J.F.P. received investigator-initiated funding from Takeda Pharmaceuticals North America for the previous item generation qualitative methods study. J.W.V. and J.F.P. did not receive funding from Takeda Pharmaceuticals North America for the present quantitative methods field test study. J.F.P. has received the following funding: INSPPIRE to Study Acute Recurrent and Chronic Pancreatitis in Children (grant no. 10987759), National Institutes of Health (NIH), and National Institute of Diabetes and Digestive and Kidney Diseases. S.N. is supported by NIH (grant no. K24DK082792A). These grants are not related to the present study. The other authors report no conflicts of interest.

© 2014 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,