nach oben

Erschienen in:

01.10.2013

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

verfasst von: James W. Varni, Bradley H. Curtis, Linda N. Abetz, Kathryn E. Lasch, Elisabeth C. Piault, Andrea A. Zeytoonjian

Erschienen in: Quality of Life Research | Ausgabe 8/2013

Einloggen, um Zugang zu erhalten

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.

Nur mit Berechtigung zugänglich

A.D.A. (2009). Type 1 Diabetes. American Diabetes Association (ADA) Website.

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

12.

Aday, L. A. (1996). Designing and conducting health surveys: A comprehensive guide (2nd ed.). San Francisco: Jossey-Bass.

13.

Fowler, F. J. (1995). Improving survey questions: Design and evaluation. Thousand Oaks, CA: Sage.

14.

Schwarz, N., & Sudman, N. (Eds.). (1996). Answering questions: Methodology for determining cognitive and communicative processes in survey research. San Francisco: Jossey-Bass.

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.PubMedCrossRef

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.

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMed

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

25.

Ericsson, K. A., & Simon, H. A. (1993). Protocol Analysis: Verbal reports as data. Cambridge, MA: MIT Press.

26.

Willis, G. B. (2005). Cognitive interviewing: A tool for improving questionnaire design. Thousand Oaks, CA: Sage Publications.

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.CrossRef

28.

Glaser, B., & Strauss, A. L. (1967). Discovery of Grounded Theory: Strategies for Qualitative Research. New York: Aldine de Gruyter.

29.

Strauss, A., & Corbin, J. (1998). Basics of qualitative research: Techniques and procedures for developing grounded theory. London: Sage.

30.

Friese, S. (2011). ATLAS.ti 6 user manual. Berlin: ATLAS.ti Scientific Software Development.

31.

Weitzman, E. A., & Miles, M. B. (1995). Computer programs for qualitative data analysis. London: Sage Publications.

32.

Morse, J. M. (1995). The significance of saturation. Qualitative Health Research, 5, 147–149.CrossRef

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.CrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.CrossRef

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.PubMedCrossRef

48.

Piaget, J. (1960). The child’s conception of physical causality. Totowa: Littlefield, Adams and Company.

49.

Scarr, S., Weinberg, R. A., & Levine, A. (1986). Understanding development. Orlando: Harcourt Brace Jovanovich.

Titel: Content validity of the PedsQL™ 3.2 Diabetes Module in newly diagnosed patients with Type 1 diabetes mellitus ages 8–45
verfasst von: James W. Varni
Bradley H. Curtis
Linda N. Abetz
Kathryn E. Lasch
Elisabeth C. Piault
Andrea A. Zeytoonjian
Publikationsdatum: 01.10.2013
Verlag: Springer Netherlands
Erschienen in: Quality of Life Research / Ausgabe 8/2013
Print ISSN: 0962-9343
Elektronische ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-012-0339-8

Springer Medizin

Abstract

Objectives

Methods

Results

Conclusions

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

Weitere Artikel der Ausgabe 8/2013

Health-related quality of life improvement via telemedicine for epilepsy: printed versus SMS-based education intervention

SF-36v2 norms and its’ discriminative properties among healthy households of tuberculosis patients in Malaysia

Confirmatory factor analysis of the PedsQL among youth in a residential treatment setting

Contribution of taking part in sport to the association between physical activity and quality of life

Commentary on “A new indicator for the measurement of change with ordinal scores”

A new indicator for the measurement of change with ordinal scores