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Development and Psychometric Evaluation of 2 Age-stratified Versions of the Pediatric GERD Symptom and Quality of Life Questionnaire

Kleinman, Leah*; Nelson, Suzanne; Kothari-Talwar, Smita; Roberts, Laurie*; Orenstein, Susan R§; Mody, Reema R; Hassall, Eric||; Gold, Ben; Revicki, Dennis A*; Dabbous, Omar

Journal of Pediatric Gastroenterology & Nutrition: May 2011 - Volume 52 - Issue 5 - p 514–522
doi: 10.1097/MPG.0b013e318205970e
Original Articles: Gastroenterology

Objectives: The Pediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ) represents 2 related age-stratified tools developed to assess pediatric gastroesophageal reflux disease (GERD). These include the PGSQ-Cp (for children ages 2 to 8 years, parent/caregiver report) and the PGSQ-A (for adolescents ages 9–17 years). The objective of the present study was to develop and evaluate PGSQ measurement properties.

Materials and Methods: The PGSQ items were generated based on information from focus groups, expert clinician review, and cognitive debriefing interviews. The symptoms of pediatric GERD and the effect of these symptoms were addressed. The tools were evaluated in a 3-week psychometric evaluation with participants from 11 clinical sites in the United States. The study included other measures such as the Pediatric Quality of Life questionnaire (PedsQL) and clinician-rated GERD severity. After item reduction, internal consistency, reproducibility, construct validity, known-group validity, and responsiveness were assessed.

Results: The 231 participants included 75 parents of children ages 2 to 8 years and 75 children ages 9 to 17 years with GERD and 41 parents of children and 40 children ages 9 to 17 years without GERD. Exploratory factor analysis demonstrated 4 symptom subscales for the PGSQ-Cp and 3 symptom subscales for the PGSQ-A. Both had subscales for total impact and school impact. High to moderate internal consistency was observed, ranging from 0.76 to 0.96 for the PGSQ-Cp and from 0.67 to 0.94 for the PGSQ-A. The PGSQ significantly differentiated between patients with GERD and controls (P < 0.0001, PGSQ-Cp; P < 0.0022–0.0001, PGSQ-A) and demonstrated responsiveness.

Conclusions: These results support the reliability, validity, and responsiveness of both versions of the PGSQ. The instruments should be useful for clinical studies.

*United BioSource Corporation, Bethesda, MD, USA

Feinberg School of Medicine, Northwestern University, Chicago, IL, USA

Takeda Pharmaceuticals North America, Inc, Lake Forest, IL, USA

§University of Pittsburgh School of Medicine, Pittsburgh, PA, USA

||Pediatric Gastroenterology, Pediatrics, BC Children's Hospital, University of British Columbia, Vancouver, Canada

Pediatric Gastroenterology, Hepatology, and Nutrition, Emory University School of Medicine, Atlanta, GA, USA.

Received 21 April, 2010

Accepted 7 November, 2010

Address correspondence and reprint requests to Leah Kleinman, DrPH, United BioSource Corporation, 7101 Wisconsin Ave, Suite 600, Bethesda, MD 20814 (e-mail: leah.kleinman@unitedbiosource.com).

The work reported here was performed under contract for Takeda by United BioSource Corporation. Authors Leah Kleinman, Laurie Roberts, and Dennis Revicki work for United BioSource Corporation, which performed this work under contract. Authors Susan R. Orenstein, University of Pittsburgh School of Medicine, Pittsburgh, PA; Suzanne Nelson, Feinberg School of Medicine, Northwestern University, Chicago, IL; Ben Gold, Pediatric Gastroenterology, Hepatology, and Nutrition, Emory University School of Medicine, Atlanta, GA; and Eric Hassall, Pediatrics, BC Children's Hospital, University of British Columbia, Vancouver, Canada, served as advisory board members and are contracted consultants to Takeda. Reema R. Mody and Omar Dabbous are employees of Takeda. Smita Kothari-Talwar was an employee of TAP Pharmaceuticals at the time this article was written.

The studies described in this article were presented at the American College of Gastroenterology annual meeting, Orlando, FL, October 3–8, 2008; the International Society for Quality of Life Research annual meeting, Toronto, ON, Canada, October 10–13, 2007; and the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition annual meeting, Salt Lake City, UT, October 25–27, 2007 and May 3–7, 2008.

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