Objectives: The objective of the present qualitative study was to develop the items and support the content validity for the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module for pediatric patients with functional gastrointestinal (GI) disorders and organic GI diseases, hereafter referred to as GI disorders.
Methods: The iterative process included multiphase qualitative methods. A literature review of GI disorders was conducted to generate domains for the focus interviews. Six pediatric gastroenterologists with extensive clinical experience in GI disorders provided expert opinion regarding the conceptual framework. A total of 98 participants, 46 pediatric patients ages 5 to 18, and 52 parents of patients ages 2 to 18 with physician-diagnosed GI disorders (chronic constipation, functional abdominal pain, irritable bowel syndrome, inflammatory bowel disease [Crohn disease, ulcerative colitis], gastroesophageal reflux disease), participated in the focus interviews and cognitive interviewing phases, including think-aloud and cognitive debriefing protocols.
Results: Eleven domains were derived from the qualitative methods involving patient and parent interviews and expert opinion, with content saturation achieved, resulting in 76 items. The 11 domains consisted of items measuring stomach pain, stomach upset, food and drink limits, trouble swallowing, heartburn and reflux, gas and bloating, constipation, diarrhea, worry, medicines, and communication.
Conclusions: Qualitative methods involving pediatric patients and their parents in the item generation process support the content validity for the new PedsQL Gastrointestinal Symptoms Module. The PedsQL Gastrointestinal Symptoms Module is undergoing national multisite field testing as the next iterative phase.
*Department of Pediatrics, College of Medicine, Department of Landscape Architecture and Urban Planning, College of Architecture, Texas A&M University, College Station, TX
†Clinical Pharmacology Program, University of Utah, Salt Lake City, UT
‡Department of Psychology and Neuroscience, Baylor University, Waco, TX
§Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, OH
||Department of Pediatric Gastroenterology, Primary Children's Medical Center, University of Utah, Salt Lake City, UT.
Address correspondence and reprint requests to James W. Varni, PhD, Professor of Architecture and Medicine, College of Architecture, Texas A&M University, 3137 TAMU, College Station, TX 77843-3137 (e-mail: firstname.lastname@example.org; the PedsQL is available at http://www.pedsql.org).
Received 3 June, 2011
Accepted 21 July, 2011
This work has been supported by Takeda Pharmaceuticals North America.
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).
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. He has received investigator-initiated funding from Takeda Pharmaceuticals North America. (Deerfield, IL). J.F.P. has received investigator-initiated funding from Takeda Pharmaceuticals North America and Eurnad Pharmaceuticals (Yardley, PA). The other authors report no conflicts of interests.