PedsQL™ Gastroparesis Symptoms Module Domain and Item Development: Qualitative Methods

Authors

James W Varni
Robert J Shulman
Mariella M Self
Liz Febo-Rodriguez
Heather Charron
Kent Williams
Sam Nurko
Rachel L Rosen
Bruno P Chumpitazi

Publication Date

8-1-2021

Journal

Journal of Pediatric Gastroenterology and Nutrition

DOI

10.1097/MPG.0000000000003146

PMID

33853112

PMCID

PMC8373654

PubMedCentral® Posted Date

8-1-2022

PubMedCentral® Full Text Version

Author MSS

Published Open-Access

yes

Keywords

Child, Gastroparesis, Humans, Parents, Psychometrics, Qualitative Research, Quality of Life, Reproducibility of Results, Surveys and Questionnaires, PedsQL, gastroparesis, gastrointestinal, symptoms, pediatrics, patient-reported outcomes, qualitative methods, health-related quality of life

Abstract

Objectives: Like adults, children suffer from gastroparesis; however, there are currently no validated instruments to determine the impact of gastroparesis in pediatric patients. The objective of this study was to develop the items and domains to support the content validity of the new Pediatric Quality of Life Inventory (PedsQL™) Gastroparesis Symptoms Module.

Methods: Patients were recruited from the National Institute of Diabetes and Digestive and Kidney Diseases Pediatric Gastroparesis Registry. The qualitative methods involved an iterative process comprising a literature review of existing questionnaires and gastroparesis clinical research, an expert review panel of pediatric gastroenterologists who provided feedback on the conceptual framework in developing the semi-structured interview, and in-depth focus interviews with six pediatric patients with gastroparesis and five of their parents (one did not participate) in developing relevant domains and item content. In the subsequent cognitive interviews phase, five additional patients with gastroparesis and their parents provided detailed feedback on item content, relevance, importance, and understandability of the domains and items.

Results: Ten domains/scales were derived from the qualitative methods, with item content saturation achieved at 67 items, with no further themes or content identified during the final cognitive interviews. The Module is comprised of 10 individual scales measuring nausea, stomach fullness when eating, vomiting, dry heaves, heartburn and reflux, stomach pain and hurt, food and drink limits, bloating, appetite, and worry.

Conclusions: Our study supports the content validity of the new PedsQL Gastroparesis Symptoms Module. The Module field test study will be conducted in a multisite national study.