Abstract
OBJECTIVE: The objective of the study was to report on the measurement properties of the revised and updated Pediatric Quality of Life Inventory (PedsQL) 3.2 Diabetes Module for children, adolescents, and young adults with type 1 diabetes. RESEARCH DESIGN AND METHODS: The 33-item PedsQL 3.2 Diabetes Module and PedsQL Generic Core Scales were completed in a 10-site national field test study by 656 families of patients ages 2-25 years with type 1 diabetes. RESULTS: The 15-item Diabetes Symptoms Summary Score and 18-item Diabetes Management Summary Score were derived from the factor analysis of the items. The Diabetes Symptoms and Diabetes Management Summary Scores evidenced excellent reliability (patient self-report a = 0.88-0.90; parent proxy report a = 0.89-0.90). The Diabetes Symptoms and Diabetes Management Summary Scores demonstrated construct validity through medium to large effect size correlations with the Generic Core Scales Total Scale Score (r = 0.43-0.67, P < 0.001). HbA1c was significantly correlated with the Diabetes Symptoms and Diabetes Management Summary Scores (r = 20.21 to 20.29, P < 0.001). Minimal clinically important difference scores ranged from 5.05 to 5.55. CONCLUSIONS: The PedsQL 3.2 Diabetes Module Diabetes Symptoms and Diabetes Management Summary Scores demonstrated excellent measurement properties and may be useful as standardized patient-reported outcomes of diabetes symptoms and diabetes management in clinical research, clinical trials, and practice in children, adolescents, and young adults with type 1 diabetes.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 2064-2071 |
| Number of pages | 8 |
| Journal | Diabetes care |
| Volume | 41 |
| Issue number | 10 |
| DOIs | |
| State | Published - Oct 1 2018 |
Funding
Acknowledgments. The investigators thank the following individuals for their involvement in participant recruitment, data collection, and/ or data verification: Vincent Aguirre, Marta Pardo, and Morgan Drake (Texas A&M University); Natalie Beauregard and Cisco Pascual (Seattle Children’s Research Institute); Nora Chokr and Marie Nader (University of California, San Francisco); Jacqueline Shea and Kylie Benson (University of Colorado Denver); Lisa Keys and Elizabeth Dabrowski (Northwestern University Feinberg School of Medicine); Esti Iturralde and Bianca Agustin (Stanford University School of Medicine). Funding and Duality of Interest. No funding was specifically designated for this field test study data collection effort or manuscript preparation. New item development and item modification of the existing PedsQL 3.0 Diabetes Module for the published item generation qualitative methods study for the PedsQL 3.2 Diabetes Module was previously funded by Eli Lilly and Co., Indianapolis, IN. 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 PedsQL. He did not receive funding from Eli Lilly and Co. for the current quantitative methods field test study. No other potential conflicts of interest relevant to this article were reported. Author Contributions. J.W.V. was involved in the conception and design of the study, the writing of the first draft of the manuscript, the statistical analysis of the data, and the interpretation of the data. A.M.D., K.K.H., J.K.R., N.T.C., K.A.D., J.C.W., J.P.Y.-F., E.K.G., M.A.F., S.D.C., J.C.K., J.L.M., and D.P.W. were involved in the conception and design of the study, the acquisition of the data, the interpretation of the data, and the critical revision of the manuscript for important intellectual content. E.M.D. and R.W.H. were involved in the conception and design of the study, the interpretation of the data, and the critical revision of the manuscript for important intellectual content. All authors approved the final version of the manuscript. J.W.V. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
ASJC Scopus subject areas
- Advanced and Specialized Nursing
- Internal Medicine
- Endocrinology, Diabetes and Metabolism
