Content validity of the PedsQL™ 3.2 Diabetes Module in newly diagnosed patients with Type 1 diabetes mellitus ages 8–45
- 719 Downloads
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.
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.
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.
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.
KeywordsDiabetes Type 1 PedsQL Patient-reported outcomes Quality of Life Pediatrics Adults
Pediatric Quality of Life Inventory™
Food and Drug Administration
Health-related Quality of Life
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.
- 1.A.D.A. (2009). Type 1 Diabetes. American Diabetes Association (ADA) Website.Google Scholar
- 6.Tierney, S., Webb, K., Jones, A., Dodd, M., McKenna, D., Rowe, R., et al. (2008). Living with cystic fibrosis-related diabetes or type 1 diabetes mellitus: a comparative study exploring health-related quality of life and patients’ reported experiences of hypoglycaemia. Chronic Illness, 4, 278–288.PubMedCrossRefGoogle Scholar
- 7.FDA. (2009). Guidance for Industry: Patient-reported outcome measures: Use in medical product development to support labeling claims: Food and Drug Administration. Rockville, MD: U.S. Department of Health and Human Services.Google Scholar
- 11.Varni, J. W., Burwinkle, T. M., Jacobs, J. R., Gottschalk, M., Kaufman, F., & Jones, K. L. (2003). The PedsQL™ in Type 1 and Type 2 diabetes: Reliability and validity of the Pediatric Quality of Life Inventory™ Generic Core Scales and Type 1 Diabetes Module. Diabetes Care, 26, 631–637.PubMedCrossRefGoogle Scholar
- 12.Aday, L. A. (1996). Designing and conducting health surveys: A comprehensive guide (2nd ed.). San Francisco: Jossey-Bass.Google Scholar
- 13.Fowler, F. J. (1995). Improving survey questions: Design and evaluation. Thousand Oaks, CA: Sage.Google Scholar
- 14.Schwarz, N., & Sudman, N. (Eds.). (1996). Answering questions: Methodology for determining cognitive and communicative processes in survey research. San Francisco: Jossey-Bass.Google Scholar
- 16.Weissberg-Benchell, J., Nansel, T., Holmbeck, G., Chen, R., Anderson, B., Wysocki, T., & Laffel, L. (2009). Generic and diabetes-specific parent–child behaviors and quality of life among youth with Type 1 Diabetes. Journal of Pediatric Psychology, 34, 977–988.Google Scholar
- 19.Nansel, T. R., Weisberg-Benchell, J., Wysocki, T., Laffel, L., & Anderson, B. (2008). Quality of life in children with Type 1 diabetes: A comparison of general and disease-specific measures and support for a unitary diabetes quality of life construct. Diabetic Medicine, 25, 1316–1323.PubMedGoogle Scholar
- 20.Rothman, M., Burke, L., Erickson, P., Leidy, N. K., Patrick, D. L., & Petrie, C. D. (2009). Use of existing patient-reported outcome (PRO) instruments and their modification: The ISPOR Good Research Practices for evaluating and documenting content validity for the use of existing instruments and their modification PRO Task Force Report. Value in Health, 12, 1075–1083.PubMedCrossRefGoogle Scholar
- 23.Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., et al. (2011). Content validity—Establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 1—Eliciting concepts for a new PRO Instrument. Value in Health, 14, 967–977.PubMedCrossRefGoogle Scholar
- 24.Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., et al. (2011). Content validity—Establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 2—Assessing respondent understanding. Value in Health, 14, 978–988.PubMedCrossRefGoogle Scholar
- 25.Ericsson, K. A., & Simon, H. A. (1993). Protocol Analysis: Verbal reports as data. Cambridge, MA: MIT Press.Google Scholar
- 26.Willis, G. B. (2005). Cognitive interviewing: A tool for improving questionnaire design. Thousand Oaks, CA: Sage Publications.Google Scholar
- 28.Glaser, B., & Strauss, A. L. (1967). Discovery of Grounded Theory: Strategies for Qualitative Research. New York: Aldine de Gruyter.Google Scholar
- 29.Strauss, A., & Corbin, J. (1998). Basics of qualitative research: Techniques and procedures for developing grounded theory. London: Sage.Google Scholar
- 30.Friese, S. (2011). ATLAS.ti 6 user manual. Berlin: ATLAS.ti Scientific Software Development.Google Scholar
- 31.Weitzman, E. A., & Miles, M. B. (1995). Computer programs for qualitative data analysis. London: Sage Publications.Google Scholar
- 37.Mortensen, H. B., Swift, P. G., Holl, R. W., Hougaard, P., Hansen, L., Bjoerndalen, H., et al. (2010). Multinational study in children and adolescents with newly diagnosed type 1 diabetes: Association of age, ketoacidosis, HLA status, and autoantibodies on residual beta-cell function and glycemic control 12 months after diagnosis. Pediatric Diabetes, 11, 218–226.PubMedCrossRefGoogle Scholar
- 44.Hassan, K., Rodriguez, L. M., Johnson, S. E., Tadlock, S., & Heptulla, R. A. (2008). A randomized, controlled trial comparing twice-a-day insulin glargine mixed with rapid-acting insulin analogs versus standard neutral protamine hagedorn (NPH) therapy in newly diagnosed Type 1 diabetes. Pediatrics, 121, e466–e472.PubMedCrossRefGoogle Scholar
- 48.Piaget, J. (1960). The child’s conception of physical causality. Totowa: Littlefield, Adams and Company.Google Scholar
- 49.Scarr, S., Weinberg, R. A., & Levine, A. (1986). Understanding development. Orlando: Harcourt Brace Jovanovich.Google Scholar