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Development and Testing of the Insulin Treatment Experience Questionnaire (ITEQ)

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Abstract

Objectives: To develop and psychometrically evaluate a domain-specific questionnaire to assess subtle but clinically relevant differences in treatment experiences and satisfaction over a wide range of currently available insulin therapy regimens. The study focussed on patients with type 2 diabetes mellitus and placed particular attention on the impact of different forms of insulin therapy on diabetes self-management.

Methods: The development of the Insulin Treatment Experience Questionnaire (ITEQ) was conducted in three steps: (i) a qualitative phase to generate relevant items and identify relevant domains; (ii) a pilot study to reduce the number of generated items; and (iii) a validation study to assess major psychometric properties of the final ITEQ version.

Results: The final version of the questionnaire comprised 28 items with the subscales ‘leisure activities’ (four items), ‘psychological barriers’ (two items), ‘handling’ (five items), ‘diabetes control’ (six items), ‘dependence’ (five items), ‘weight control’ (three items), ‘sleep’ (two items), and one further item assessing general treatment satisfaction. The subscales’ internal consistencies (Cronbach’s alpha) ranged from 0.52 to 0.83. Motivated by the homogenous structure of inter-scale-correlations (range 0.10–0.46), a summary composite score was calculated (alpha = 0.86). Construct validity showed statistically significant correlations with other scales (ITEQ vs the Problem Areas in Diabetes [PAID] questionnaire total score −0.60, ITEQ vs the Diabetes Treatment Satisfaction Questionnaire [DTSQ] total score 0.52).

Conclusion: The newly developed ITEQ displayed satisfactory to good psychometric properties, thereby allowing the assessment of everyday life experience and treatment satisfaction in patients with insulin-treated type 2 diabetes. Additional research is needed to assess test-retest reliability and sensitivity to change.

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References

  1. Wild S, Roglic G, Green A, et al. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004; 27(5): 1047–53

    Article  PubMed  Google Scholar 

  2. Massi-Benedetti M. The cost of diabetes type II in Europe: the CODE-2 study. Diabetologica 2002; 45: S1–4

    Article  CAS  Google Scholar 

  3. Turner RC, Millns H, Neil HAW, et al. Risk factors for coronary artery disease in non-insulin dependent diabetes mellitus: United Kingdom Prospective Diabetes Study (UKPDS: 23). BMJ 1998; 316(7134): 823–8

    Article  PubMed  CAS  Google Scholar 

  4. Hogan P, Dall T, Nikolov P. Economic costs of diabetes in the US in 2002. Diabetes Care 2003; 26: 917–32

    Article  PubMed  Google Scholar 

  5. American Diabetes Association. Economic costs of diabetes in the US in 2007. Diabetes Care 2008; 31(3): 596–615

    Article  Google Scholar 

  6. Rubin RR, Peyrot M. Quality of life and diabetes. Diabetes Metab Res 1999; 15:205–18

    Article  CAS  Google Scholar 

  7. Watkins K, Connell CM. Measurement of health-related QOL in diabetes mellitus. Pharmacoeconomics 2004; 22(17): 1109–26

    Article  PubMed  Google Scholar 

  8. Rose M, Burkert U, Scholler G, et al. Determinants of quality of life of patients with diabetes under intensified insulin therapy. Diabetes Care 1998; 21: 1876–83

    Article  PubMed  CAS  Google Scholar 

  9. Bradley C. The Diabetes Treatment Satisfaction Questionnaire: DTSQ. In: Bradley C, editor. Handbook of psychology and diabetes: a guide to psychological measurement in diabetes research and practice. Amsterdam: Harwood Academic Publishers, 1994: 111–32

    Google Scholar 

  10. Anderson RT, Skovlund SE, Marrero D, et al. Development and validation of the insulin treatment satisfaction questionnaire. Clin Ther 2004; 26(4): 565–78

    Article  PubMed  Google Scholar 

  11. Hermanns N, Kulzer B, Krichbaum M, et al. How to screen for depression and emotional problems in patients with diabetes: comparison of screening characteristics of depression questionnaires, measurement of diabetes-specific emotional problems and standard clinical assessment. Diabetologia 2006; 49: 469–77

    Article  PubMed  CAS  Google Scholar 

  12. FDA. Draft guidance for industry on patient-reported outcome measures: use in medicinal product development to support labelling claims. Fed Register 2006; 71: 5862–63

    Google Scholar 

  13. Committee for Medicinal Products for Human Use. Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. 2005 Jul 25 [online]. Available from URL: http://www.emea.europa.eu/pdfs/human/ewp/-13939104en.pdf [Accessed 2009 Feb 11]

  14. Quinn Patton M. Qualitative research and evaluation methods. 3rd ed. Thousand Oaks (CA): Sage Publications, 2002

    Google Scholar 

  15. Neumann WL. Basics of social research: qualitative and quantitative approaches. Boston (MA): Pearson, 2007

    Google Scholar 

  16. Kitzinger J. Introducing focus groups. BMJ 1995; 311: 299–302

    Article  PubMed  CAS  Google Scholar 

  17. Silverman D. Doing qualitative research: a practical handbook. Newbury Park (CA): Sage, 2000

    Google Scholar 

  18. Harb B, Kubiak T, Roth R. Der Diabetes Treatment Satisfaction Questionnaire. In: Bengel JC, Wirtz M, Zwingmann C, editors. Diagnostische Verfahren in der Rehabilitation: Verfahren zum krankheitsübergreifenden Einsatz und für ausgewählte Indikationsgebiete. Göttingen: Hogrefe, 2008: 266–9

    Google Scholar 

  19. Polonsky WH, Anderson BJ, Lohrer PA, et al. Assessment of diabetes-related distress. Diabetes Care 1995; 18(6): 754–60

    Article  PubMed  CAS  Google Scholar 

  20. Kubiak T, Hermanns N, Kulzer B. Der Problem Areas in Diabetes (PAID) Fragebogen. In: Bengel J, Wirtz M, Zwingmann C, editors. Diagnostische Verfahren in der Rehabilitation-Verfahren zum krankheitsübergreifenden Einsatz und für ausgewählte Indikationsgebiete. Göttingen: Hogrefe, 2008: 276–9

    Google Scholar 

  21. Streiner DL, Norman GR. Health measurement scales: a practical guide to their development and use. 3rd ed. Oxford: Oxford University Press, 2003

    Google Scholar 

  22. Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika 1951; 16: 297–334

    Article  Google Scholar 

  23. Nunnally JC, Bernstein IH. Psychometric theory. 3rd ed. New York: McGraw-Hill Inc, 1994

    Google Scholar 

  24. Hays RD, Hayashi T. Beyond internal consistency reliability: rationale and user’s guide for Multitrait analysis program on the microcomputer. Behav Res Methods Instrum Comput 1990; 22: 167–75

    Article  Google Scholar 

  25. Fayers PM, Machin D. Quality of life: the assessment analysis and interpretation of patient reported outcomes. 2nd ed. Chichester: John Wiley & Sons, 2007

    Google Scholar 

  26. Campbell DT, Fiske DW. Convergent and discriminate validation by multitrait-multimethod matrix. Psychol Bull 1959; 56(2): 81–105

    Article  PubMed  CAS  Google Scholar 

  27. Howard KI, Forehand GC. A method for correcting item-total correlations for the effect of relevant item inclusion. Educat Psychol Measures 1962; 22: 731

    Article  Google Scholar 

  28. Juniper EF, Gordon HG, Roman J. How to develop and validate a new health-related quality of life instrument. In: Spilker B, editor. Quality of life and pharmacoeconomics in clinical trials. 2nd ed. Philadelphia (PA): Lippincott-Raven Publishers, 1996: 49–56

    Google Scholar 

  29. Cappelleri JC, Gerber RA, Kourides IA, et al. Development and factor analysis of a questionnaire to measure patient satisfaction with injected and inhaled insulin for type 1 diabetes. Diabetes Care 2000; 23(12): 1799–803

    Article  PubMed  CAS  Google Scholar 

  30. Brod M, Christensen T, Bushnell D. Maximizing the value of validation findings to better understand treatment satisfaction issues for diabetes. Qual Life Res 2007; 16: 1053–63

    Article  PubMed  Google Scholar 

  31. Brod M, Cobden D, Lammert M, et al. Examining correlates of treatment satisfaction for injectable insulin in type 2 diabetes: lessons learned from a clinical trial comparing biphasic and basal analogues. Health Qual Life Outcomes 2007; 5: 8

    Article  PubMed  Google Scholar 

  32. Brod M, Skovlund SE, Wittrup-Jensen KU. Measuring the impact of diabetes through patient report of treatment satisfaction, productivity and symptom experience. Qual Life Res 2006; 15(3): 481–91

    Article  PubMed  Google Scholar 

  33. Atkinson MJ, Sinha A, Hass SL, et al. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes 2004; 2: 12

    Article  PubMed  Google Scholar 

  34. Revicki DA, Osoba D, Fairclough D, et al. Recommendations on health-related quality of life research to support labeling and promotional claims in the United States. Qual Life Res 2000; 9: 887–900

    Article  PubMed  CAS  Google Scholar 

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Acknowledgments

The authors would like to thank the expert panel for helpful recommendations and sanofi-aventis for their financial support of this project. The authors gratefully acknowledge the constructive comments and suggestions received from the anonymous referees.

This study was sponsored by sanofi-aventis Deutschland GmbH, Germany, which manufactures drugs for patients with diabetes. Franz Hessel is a current employee of sanofi-aventis. Jörn Moock and Thomas Kohlmann have received honoraria from sanofi-aventis for presentations.

All authors participated in the study design and conceptualization. Diana Ziegeler administered the qualitative section. Jörn Moock and Diana Ziegeler collected the data in both samples. Jörn Moock, Thomas Kubiak, Franz Hessel, and Thomas Kohlmann participated in data analyses planning and execution. All authors read and approved the manuscript.

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Authors and Affiliations

  1. Institute for Community Medicine, University of Greifswald, Walther-Rathenau-Strasse 48, 17475, Greifswald, Germany

    Jörn Moock, Diana Ziegeler & Thomas Kohlmann

  2. Sanofi-aventis Deutschland GmbH, Berlin, Germany

    Franz Hessel

  3. Institute of Psychology, University of Greifswald, Greifswald, Germany

    Thomas Kubiak

Authors
  1. Jörn Moock
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  2. Franz Hessel
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  3. Diana Ziegeler
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  4. Thomas Kubiak
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  5. Thomas Kohlmann
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Correspondence to Jörn Moock.

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Moock, J., Hessel, F., Ziegeler, D. et al. Development and Testing of the Insulin Treatment Experience Questionnaire (ITEQ). Patient-Patient-Centered-Outcome-Res 3, 45–58 (2010). https://doi.org/10.2165/11319510-000000000-00000

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