Abstract
Objectives
The objective was to investigate the patient-reported diabetes symptoms predictors of generic health-related quality of life (HRQOL) in adolescents and young adults (AYA) with type 1 or type 2 diabetes.
Methods
The 15-item PedsQL™ 3.2 Diabetes Module Diabetes Symptoms Summary Score and PedsQL™ 4.0 Generic Core Scales were completed in a 10-site national field test study by 513 AYA ages 13–25 years with type 1 (n = 424) or type 2 (n = 89) diabetes. Diabetes symptoms were tested for bivariate and multivariate linear associations with generic HRQOL.
Results
Diabetes symptoms were associated with decreased HRQOL in bivariate analyses. In predictive analytics models utilizing hierarchical multiple regression analyses controlling for relevant demographic and clinical covariates, diabetes symptoms accounted for 38 and 39% of the variance in patient-reported generic HRQOL for type 1 and type 2 diabetes, respectively, reflecting large effect sizes. The diabetes symptoms facets hyperglycemia symptoms, hypoglycemia symptoms, and nonspecific diabetes symptoms individually accounted for a significant percentage of the variance in separate exploratory predictive analytics models after controlling for demographic and clinical covariates, with small-to-large effect sizes.
Conclusions
Diabetes symptoms are potentially modifiable predictors of generic HRQOL in AYA with diabetes. Identifying specific diabetes symptoms or symptoms facets that are the most important predictors from the patient perspective facilitates a patient-centered approach in clinical research, clinical trials, and practice designed to enhance overall generic HRQOL in AYA with diabetes.
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Abbreviations
- FDA:
-
Food and Drug Administration
- HbA1c:
-
Hemoglobin A1c (glycated hemoglobin)
- HRQOL:
-
Health-Related Quality of Life
- PedsQL™:
-
Pediatric Quality of Life Inventory™
- PRO:
-
Patient-reported outcome
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Acknowledgements
The investigators thank the following individuals for their involvement in participant recruitment, data collection, and/or data verification: Marta Pardo, Morgan Drake, Luke Hamilton, Natalie Beauregard, Cisco Pascual, Nora Chokr, Marie Nader, Jacqueline Shea, Kylie Benson, Lisa Keys, Vanessa Guzman, Jeanette Velez, and Elizabeth Dabrowski.
Pediatric Quality of Life Inventory™ (PedsQL™) 3.2 Diabetes Module Testing Study Consortium: The PedsQL™ 3.2 Diabetes Module Testing Study Consortium sites include a Network and Statistical Center at the Center for Health Systems & Design, Colleges of Architecture and Medicine, Texas A&M University, College Station, TX (PI: James W. Varni, PhD), and 10 primary research data collection sites: Department of Pediatrics, Mailman Center for Child Development, University of Miami Miller School of Medicine, Miami, FL; (PI: Alan M. Delamater, PhD); Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford, CA (PI: Korey K. Hood, PhD); Department of Pediatrics, Division of Endocrinology, University of Texas Southwestern Medical Center, Dallas, TX (PIs: Ellen K. Grishman, MD, Melissa A. Faith, PhD, ABPP); Center for Endocrinology, Diabetes, & Metabolism, Children’s Hospital Los Angeles, Los Angeles, CA (PIs: Jennifer K. Raymond, MD, MCR, Nancy T. Chang, PhD, MSN, FNP); Department of Pediatrics, Barbara Davis Center for Diabetes, University of Colorado Denver, Denver, CO (PI: Kimberly A. Driscoll, PhD); The Madison Clinic for Pediatric Diabetes and Department of Pediatrics, Division of Endocrinology, University of California San Francisco, San Francisco, CA (PI: Jenise C. Wong, MD, PhD); Seattle Children's Research Institute, Seattle, WA (PI: Joyce P. Yi-Frazier, PhD); Department of Pediatrics, Division of Endocrinology and Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children’s Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH (PIs: Sarah D. Corathers, MD, Jessica C. Kichler, PhD, CDE); Department of Pediatrics, Division of Pediatric Endocrinology, Ann and Robert H. Lurie Children’s Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL (PI: Jennifer L. Miller, MD); Cook Children's Medical Center, Fort Worth, TX (PI: Don P. Wilson, MD).
Funding
No funding was specifically designated for the PedsQL™ 3.2 Diabetes Module field test study data collection effort or manuscript preparation.
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Conflict of interest
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 Company, Indianapolis. Dr. Varni 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™. Dr. Varni did not receive funding from Eli Lilly and Company for the current quantitative methods field test study. The other authors report no competing interests related to this study.
Ethical approval
The research protocol for the field test study was approved by the Institutional Review Board at each participating institution. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committees.
Informed consent
Informed consent was obtained from all individual participants included in the study.
Additional information
A list of the Pediatric Quality of Life Inventory™ 3.2 Diabetes Module Testing Study Consortium sites is contained in Acknowledgements.
Appendix
Appendix
See Table 5.
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Varni, J.W., Delamater, A.M., Hood, K.K. et al. Diabetes symptoms predictors of health-related quality of life in adolescents and young adults with type 1 or type 2 diabetes. Qual Life Res 27, 2295–2303 (2018). https://doi.org/10.1007/s11136-018-1884-6
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DOI: https://doi.org/10.1007/s11136-018-1884-6