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



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.


Diabetes 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


Patient-reported outcomes



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. 1.
    A.D.A. (2009). Type 1 Diabetes. American Diabetes Association (ADA) Website.Google Scholar
  2. 2.
    Kyvik, K. O., Nystrom, L., Gorus, F., Songini, M., Oestman, J., Castell, C., et al. (2004). The epidemiology of Type 1 diabetes mellitus is not the same in young adults as in children. Diabetologia, 47, 377–384.PubMedCrossRefGoogle Scholar
  3. 3.
    Soltesz, G., Patterson, C. C., & Dahlquist, G. (2007). Worldwide childhood type 1 diabetes incidence: What can we learn from epidemiology? Pediatric Diabetes, 8(Suppl), 6–14.PubMedCrossRefGoogle Scholar
  4. 4.
    Van Belle, T. L., Coppieters, K. T., & von Herrath, M. G. (2011). Type 1 diabetes: Etiology, immunology, and therapeutic strategies. Physiological Reviews, 91, 79–118.PubMedCrossRefGoogle Scholar
  5. 5.
    Bott, U., Muhlhauser, I., Overmann, H., & Berger, M. (1998). Validation of a diabetes-specific quality-of-life scale for patients with type 1 diabetes. Diabetes Care, 21, 757–769.PubMedCrossRefGoogle Scholar
  6. 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. 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
  8. 8.
    Varni, J. W., Seid, M., & Rode, C. A. (1999). The PedsQL™: Measurement model for the pediatric quality of life inventory. Medical Care, 37, 126–139.PubMedCrossRefGoogle Scholar
  9. 9.
    Varni, J. W., Seid, M., & Kurtin, P. S. (2001). PedsQL™ 4.0: Reliability and validity of the Pediatric Quality of Life Inventory™ Version 4.0 Generic Core Scales in healthy and patient populations. Medical Care, 39, 800–812.PubMedCrossRefGoogle Scholar
  10. 10.
    Varni, J. W., & Limbers, C. A. (2009). The pediatric quality of life inventory™: Measuring pediatric health-related quality of life from the perspective of children and their parents. Pediatric Clinics of North America, 56, 843–863.PubMedCrossRefGoogle Scholar
  11. 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. 12.
    Aday, L. A. (1996). Designing and conducting health surveys: A comprehensive guide (2nd ed.). San Francisco: Jossey-Bass.Google Scholar
  13. 13.
    Fowler, F. J. (1995). Improving survey questions: Design and evaluation. Thousand Oaks, CA: Sage.Google Scholar
  14. 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
  15. 15.
    Lawrence, J. M., Yi-Frazier, J. P., Black, M. H., Anderson, A., Hood, K., Imperatore, G., et al. (2012). Demographic and clinical correlates of diabetes-related quality of life among youth with type 1 diabetes. Journal of Pediatrics, 161, 201–207.PubMedCrossRefGoogle Scholar
  16. 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
  17. 17.
    Ingerski, L. M., Laffel, L., Drotar, D., Repaske, D., & Hood, K. K. (2010). Correlates of glycemic control and quality of life outcomes in adolescents with type 1 diabetes. Pediatric Diabetes, 11, 563–571.PubMedCrossRefGoogle Scholar
  18. 18.
    Kalyva, E., Malakonaki, E., Eiser, C., & Mamoulakis, D. (2011). Health-related quality of life (HRQoL) of children with type 1 diabetes mellitus (T1DM): Self and parental perceptions. Pediatric Diabetes, 12, 34–40.PubMedCrossRefGoogle Scholar
  19. 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. 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
  21. 21.
    Lasch, K. E., Marquis, P., Vigneux, M., Abetz, L., Arnould, B., Bayliss, M., et al. (2010). PRO development: Rigorous qualitative research as the crucial foundation. Quality of Life Research, 19, 1087–1096.PubMedCrossRefGoogle Scholar
  22. 22.
    Brod, M., Tesler, L. E., & Christensen, T. L. (2009). Qualitative research and content validity: Developing best practices based on science and experience. Quality of Life Research, 18, 1263–1278.PubMedCrossRefGoogle Scholar
  23. 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. 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. 25.
    Ericsson, K. A., & Simon, H. A. (1993). Protocol Analysis: Verbal reports as data. Cambridge, MA: MIT Press.Google Scholar
  26. 26.
    Willis, G. B. (2005). Cognitive interviewing: A tool for improving questionnaire design. Thousand Oaks, CA: Sage Publications.Google Scholar
  27. 27.
    Charmaz, K. (1995). Grounded theory. In J. A. Smith, R. Harre, & L. Van Langenhove (Eds.), Rethinking methods in psychology (pp. 27–49). London: Sage.CrossRefGoogle Scholar
  28. 28.
    Glaser, B., & Strauss, A. L. (1967). Discovery of Grounded Theory: Strategies for Qualitative Research. New York: Aldine de Gruyter.Google Scholar
  29. 29.
    Strauss, A., & Corbin, J. (1998). Basics of qualitative research: Techniques and procedures for developing grounded theory. London: Sage.Google Scholar
  30. 30.
    Friese, S. (2011). ATLAS.ti 6 user manual. Berlin: ATLAS.ti Scientific Software Development.Google Scholar
  31. 31.
    Weitzman, E. A., & Miles, M. B. (1995). Computer programs for qualitative data analysis. London: Sage Publications.Google Scholar
  32. 32.
    Morse, J. M. (1995). The significance of saturation. Qualitative Health Research, 5, 147–149.CrossRefGoogle Scholar
  33. 33.
    Guest, G., Bunce, A., & Johnson, L. (2006). How many interviews are enough? An experiment with data saturation and variability. Field Methods, 18, 59–82.CrossRefGoogle Scholar
  34. 34.
    Kaas, A., Pfleger, C., Kharagjitsingh, A. V., Schloot, N. C., Hansen, L., Buschard, K., et al. (2012). Association between age, IL-10, IFNc, stimulated C-peptide and disease progression in children with newly diagnosed Type 1 diabetes. Diabetic Medicine, 29, 734–741.PubMedCrossRefGoogle Scholar
  35. 35.
    Schwartz, D. D., Axelrad, M. E., Cline, V. D., & Anderson, B. J. (2011). Feasibility, acceptability, and predictive validity of a psychosocial screening program for children and youth newly diagnosed with type 1 diabetes. Diabetes Care, 34, 326–331.PubMedCrossRefGoogle Scholar
  36. 36.
    Szypowska, A., & Skorka, A. (2011). The risk factors of ketoacidosis in children with newly diagnosed type 1 diabetes mellitus. Pediatric Diabetes, 12, 302–306.PubMedCrossRefGoogle Scholar
  37. 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
  38. 38.
    Smith-Palmer, J., Curtis, B. H., Boye, K. S., Goodall, G., & Pillemer, S. R. (2010). Anti-CD3 monoclonal antibody treatment in newly diagnosed Type 1 diabetes patients: A hypothetical modelling analysis. Diabetic Medicine, 27, 189–196.PubMedCrossRefGoogle Scholar
  39. 39.
    Martin, S., Herder, C., Schloot, N. C., Koenig, W., Heise, T., Heinemann, L., et al. (2011). Residual beta cell function in newly diagnosed Type 1 diabetes after treatment with Atorvastatin: The randomized DIATOR trial. PLoS ONE, 6(3), e17554.PubMedCrossRefGoogle Scholar
  40. 40.
    Sumpter, K. M., Adhikari, S., Grishman, E. K., & White, P. C. (2011). Preliminary studies related to anti-interleukin-1β therapy in children with newly diagnosed type 1 diabetes. Pediatric Diabetes, 12, 656–667.PubMedCrossRefGoogle Scholar
  41. 41.
    Lachin, J. M., McGee, P. L., Greenbaum, C. J., Palmer, J., Pescovitz, M. D., Gottlieb, P., et al. (2011). Sample size requirements for studies of treatment effects on beta-cell function in newly diagnosed Type 1 diabetes. PLoS ONE, 6(11), e26471.PubMedCrossRefGoogle Scholar
  42. 42.
    Tiberg, I., Katarina, S. C., Carlsson, A., & Hallström, I. (2012). Children diagnosed with type 1 diabetes: A randomized controlled trial comparing hospital versus home-based care. Acta Paediatrica, 101, 1069–1073.PubMedCrossRefGoogle Scholar
  43. 43.
    Mastrandrea, L., Albini, C., Yu, J., Fourtner, S., Behrens, T., Quattrin, T., et al. (2009). Etanercept treatment in children with new-onset Type 1 diabetes: Pilot randomized, placebo-controlled, double-blind study. Diabetes Care, 32, 1244–1249.PubMedCrossRefGoogle Scholar
  44. 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
  45. 45.
    Ludvigsson, J., Faresjö, M., Hjorth, M., Axelsson, S., Chéramy, M., Pihl, M., et al. (2008). GAD treatment and insulin secretion in recent-onset Type 1 diabetes. New England Journal of Medicine, 359, 1909–1920.PubMedCrossRefGoogle Scholar
  46. 46.
    Tahirovi, H., Toromanovi, A., Tahirovi, E., Begi, H., & Varni, J. W. (2012). Health-related quality of life and metabolic control in children with Type 1 Diabetes Mellitus in Bosnia and Herzegovina. Collegium Antropologicum, 36, 117–121.CrossRefGoogle Scholar
  47. 47.
    Sand, P., Kljajić, M., Schaller, J., & Forsander, G. (2012). The reliability of the health related quality of life questionnaire PedsQL 3.0 Diabetes Module for Swedish children with Type 1 diabetes. Acta Paediatrica, 101, e344–e349.PubMedCrossRefGoogle Scholar
  48. 48.
    Piaget, J. (1960). The child’s conception of physical causality. Totowa: Littlefield, Adams and Company.Google Scholar
  49. 49.
    Scarr, S., Weinberg, R. A., & Levine, A. (1986). Understanding development. Orlando: Harcourt Brace Jovanovich.Google Scholar

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

Personalised recommendations