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Quality of Life Research

, Volume 22, Issue 8, pp 2169–2181 | Cite as

Content validity of the PedsQL™ 3.2 Diabetes Module in newly diagnosed patients with Type 1 diabetes mellitus ages 8–45

  • James W. Varni
  • Bradley H. Curtis
  • Linda N. Abetz
  • Kathryn E. Lasch
  • Elisabeth C. Piault
  • Andrea A. Zeytoonjian
Article

Abstract

Objectives

The content validity of the 28-item PedsQL™ 3.0 Diabetes Module has not been established in research on pediatric and adult patients with newly diagnosed Type 1 diabetes across a broad age range. This study aimed to document the content validity of three age-specific versions (8–12 years, 13–18 years, and 18–45 years) of the PedsQL™ Diabetes Module in a population of newly diagnosed patients with Type 1 diabetes.

Methods

The study included in-depth interviews with 31 newly diagnosed patients with Type 1 diabetes between the ages of 8 and 45 years, as well as 14 parents and/or caregivers of child and teenage patients between the ages of 8 and 18 years of age; grounded theory data collection and analysis methods; and review by clinical and measurement experts.

Results

Following the initial round of interviews, revisions reflecting patient feedback were made to the Child and Teen versions of the Diabetes Module, and an Adult version of the Diabetes Module was drafted. Cognitive interviews of the modified versions of the Diabetes Module were conducted with an additional sample of 11 patients. The results of these interviews support the content validity of the modified 33-item PedsQL™ 3.2 Diabetes Module for pediatric and adult patients, including interpretability, comprehensiveness, and relevance suitable for all patients with Type 1 Diabetes.

Conclusions

Qualitative methods support the content validity of the modified PedsQL™ 3.2 Diabetes Module in pediatric and adult patients. It is recommended that the PedsQL™ 3.2 Diabetes Module replaces version 3.0 and is suitable for measuring patient-reported outcomes in all patients with newly diagnosed, stable, or long-standing diabetes in clinical research and practice.

Keywords

Diabetes Type 1 PedsQL Patient-reported outcomes Quality of Life Pediatrics Adults 

Abbreviations

PedsQL™

Pediatric Quality of Life Inventory™

FDA

Food and Drug Administration

HRQOL

Health-related Quality of Life

PROs

Patient-reported outcomes

Notes

Acknowledgments

This study was funded by Eli Lilly and Company, Indianapolis.

Conflict of interest

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. Curtis is a full-time employee and shareholder of Eli Lilly and Company.

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Copyright information

© Springer Science+Business Media Dordrecht 2012

Authors and Affiliations

  • James W. Varni
    • 1
  • Bradley H. Curtis
    • 2
  • Linda N. Abetz
    • 3
  • Kathryn E. Lasch
    • 3
  • Elisabeth C. Piault
    • 3
  • Andrea A. Zeytoonjian
    • 3
  1. 1.Department of Pediatrics, College of Medicine, Department of Landscape Architecture and Urban Planning, College of ArchitectureTexas A&M UniversityCollege StationUSA
  2. 2.Global Health Outcomes, Eli Lilly and Company, Lilly Corporate CenterIndianapolisUSA
  3. 3.Mapi ValuesBostonUSA

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