PedsQL 3.2 Diabetes Module for Children, Adolescents, and Young Adults: Reliability and Validity in Type 1 Diabetes

Varni, James W.
Delamater, Alan M.
Hood, Korey K.
Raymond, Jennifer K.
Chang, Nancy T.
Driscoll, Kimberly A.
Wong, Jenise C.
Yi-Frazier, Joyce P.
Grishman, Ellen K.
Faith, Melissa A.
Corathers, Sarah D.
Kichler, Jessica C.
Miller, Jennifer L.
Doskey, Elena M.
Heffer, Robert W.
Wilson, Don P.

¹Department of Pediatrics, College of Medicine, and Department of Landscape Architecture and Urban Planning, College of Architecture, Texas A&M University, College Station, TX
²Mailman Center for Child Development, Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL
³Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA
⁴Division of Endocrinology, Diabetes and Metabolism, Children's Hospital Los Angeles, Los Angeles, CA
⁵Department of Pediatrics, Barbara Davis Center for Diabetes, University of Colorado Denver, Denver, CO
⁶The Madison Clinic for Pediatric Diabetes and Division of Endocrinology, Department of Pediatrics, University of California, San Francisco, San Francisco, CA
⁷Seattle Children’s Research Institute, Seattle, WA
⁸Division of Pediatric Endocrinology, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX
⁹Division of Endocrinology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH
¹⁰Division of Behavioral Medicine and Clinical Psychology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH
¹¹Division of Pediatric Endocrinology, Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL
¹²Department of Educational Psychology, Texas A&M University, College Station, TX
¹³Department of Psychological & Brain Sciences, Texas A&M University, College Station, TX
¹⁴Cook Children’s Medical Center, Fort Worth, TX

Corresponding author: James W. Varni, e-mail; [email protected].

Received December 28, 2017/Accepted July 6, 2018; previously published online July 30, 2018

This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc17-2707/-/DC1.

M.A.F. is now at the Institute for Brain Protection Sciences, Johns Hopkins All Children’s Hospital, St. Petersburg, FL. E.M.D. is now at the University of Oklahoma Health Sciences Center, Oklahoma City, OK.

^*A list of the Pediatric Quality of Life Inventory 3.2 Diabetes Module Testing Study Consortium sites and principal investigators is in the Supplementary Data online.

Diabetes Care 41(10):p 2064-2071, October 2018. | DOI: 10.2337/dc17-2707

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 α = 0.88-0.90; parent proxy report α = 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). HbA_1c was significantly correlated with the Diabetes Symptoms and Diabetes Management Summary Scores (r = −0.21 to −0.29, 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.