Abstract
Even a small improvement in satisfaction with treatment for a chronic disease can be valuable. However, sensitive measurements instruments are needed to assess the effects of treatment changes in patients already well satisfied with baseline treatment. Such instruments were thought to be necessary to deal with ceiling effects in scores of satisfaction with functional insulin treatment (FIT) accommodating full flexibility of food intake and lifestyle in diabetes by manipulation of insulin (FIT; Howorka etal. 2000). The Status(S) version of the Diabetes Treatment Satisfaction Questionnaire (DTSQ, Bradley 1994) was extended with items measuring specific components of FIT and its psychometric properties investigated in a validation study with 171 FIT patients with diabetes. A new Change(C) version of DTSQ extended for FIT was used together with the DTSQ(S) by 52 participants in a subsequent randomised cross-over study involving new fast-acting lispro vs. regular insulin, where treatment satisfaction was the primary outcome variable. Insulin lispro use improved satisfaction (p ≤ 0.001) both, on classical and extended versions of DTSQ(S) and (C), despite high baseline levels of satisfaction. However, the DTSQ(C) augmented the effects of lispro (p = 0.0001) apparent on DTSQ(S) scores and revealed significant treatment effects (p ≤ 0.01) not significant with DTSQ(S). In parallel, glycaemic control improved with lispro (e.g., HbA1c, p = 0.023). Improved satisfaction with treatment was more apparent with DTSQ(C) than DTSQ(S) in patients who at baseline were at or near ceiling for treatment satisfaction.
Similar content being viewed by others
References
Howorka K. Functional insulin treatment. 2nd English edn. Berlin: Springer, 1996 (4th German edn. Berlin: Springer, 1996; 1st Polish edn. Bielsko-Biala: Alfa Medica-press, 1997; 1st Hungarian edn. Budapest: Springer Hungarica, 1997).
Howorka K. Insulinabhängig...? Functional use of insulin. Patient manual for FIT. 7th German edn. Mainz: Kirch-heim publ., 1999 (1st Czech edn. Mainz: Kirchheim publ., 1996, English edn. in press, FIT USA Foundation Minne-apolis, USA 2000).
Howorka K, Pumprla J, Wagner-Nosiska D, Grillmayr H, Schlusche CH, Schabmann A. Empowering diabetes out-patients with structured education: Short-term and long-term efects of functional insulin treatment on perceived control over diabetes. J Psychosom Res 2000; 48: 37–44.
Waldhä usl W, Howorka K, Derfier K, et al. Failure and eficacy of insulin therapy in insulin dependent (Type I) diabetic patients. Acta Diabetol Lat 1985; 22: 279–294.
Mühlhauser I, Bruckner J, Howorka K. Near-normo-glycaemia and microvascular complications (Letter). Dia-betologia 1987; 30: 47–48.
Bradley C, Todd C, Gorton T, Symonds E, Martin A, Plowright R. The development of an individualized ques-tionnaire measure of perceived impact of diabetes on quality of life: The ADDQoL. Quality of Life Research 1999; 8(1-2): 79–91.
Howey DC, Bowsher RR, Brunelle RL, Woodworth JR. [Lys(B28), Pro(B29)]-human insulin: A rapidly absorbed analogue of human insulin. Diabetes 1994; 43: 396–402.
Gale E. Insulin Lispro: The first insulin analogue to reach the market. Pract Diabet Internat 1996; 13.
Anderson JH, Brunelle RL, Koivisto VA, et al. and the Multicenter Insulin Lispro Study Group. Reduction of postprandial hyperglycemia and frequency of hypoglycemia in IDDM patients during insulin analog treatment. Dia-betes 1997; 46: 265–270.
Anderson JH, Brunelle RL, Keohane P, et al. Mealtime treatment with insulin analog improves postprandial hy-perglycemia and hypoglycemia in patients with non insulin dependent diabetes mellitus. Arch Int Med 1997; 157: 1249–1255.
Kotsanos JG, Vignati L, Huster W, et al. Health-related quality-of-life results from multinational clinical trials of insulin lispro. Diabetes Care 1997; 20: 948–958.
Bradley C (ed) Handbook of psychology and diabetes: A guide to psychological measurement in diabetes research and practice. Chur, Switzerland: Harwood Academic Publishers, 1994.
Bradley C. Psychological issues in clinical trial design. Irish J Psychol C 1997; 18: 67–87.
Bindman AB, Keane D, Lurie N. Measuring health changes among severely ill patients: The ¯oor phenomenon. Medical Care 1990; 28(12): 1142–1152.
Baker DW, Hays RD, Brook RH. Understanding changes in health status: Is the floor phenomenon merely the last step of the staircase? Medical Care 1997; 35(1): 1–15.
Aseltine RH, Carlson KJ, Fowler FJ, Barry MJ. Compar-ing prospective and retrospective measures of treatment outcomes. Medical Care 1995; 33(Suppl 4): 67–76.
Bradley C, Lewis KS. Measures of psychological well-being and treatment satisfaction developed from the responses of people with tablet-treated diabetes. Diabetic Med 1990; 7: 445–451.
Plowright R, Witthaus E, Bradley C. Psychometric evalu-ation of Diabetes Treatment Satisfaction Questionnaire in 8 languages. Proceedings of the British Psychological Society 2000; 8(2): 43.
Wredling R, Stalhammar J, Adamson U, Berne C, Larsson Y, OÈstman J. Well-being and treatment satisfaction in adults with diabetes: A Swedish population-based study. Quality of Life Res 1995; 4: 515–522.
Howorka K, Pumprla J, Schlusche Ch. Algorithm ad-aptation under functional insulin treatment during transfer from regular to insulin lispro. Diabetes Nutrition and Metabolism/Clinical and Experimental 1998; 11: 266–272.
Helsinki Recommendations guiding medical physicians in biomedical research involving human subjects (revised version). JAMA 1997; 277: 925-926.
Howorka K, Kletschka G, Pumprla J, Thoma H. ISO 9001 ±conformity in research, graduate education and rehabili-tation. Biomed Technik 1998; 43: 19–24.
Kohlmann CW, Küstner E, Schuler M. IPC-Diabetes Fragebogen: Version 3.1 für Typ 1-Diabetiker (IPC-Dia-betes Questionnaire: Version 3.1. for Type 1 diabetes pa-tients). Mainz: Johannes Gutenberg Universität, Psychologisches Institut, 1991.
Kohlmann CW, Schuler M, Petrak F, Küstner E, Krohne W, Beyer J. Associations between type of treatment and illness-specific locus of control in Type I diabetes patients. Psychol Health 1993.
Senn S. Cross-over trials in clinical research. Chichester, United Kingdom: John Wiley, 1993.
Kline P. A Handbook of Test Construction (p. 143). Lon-don, United Kingdom: Methuen, 1986.
Ware JE, Hays RD. Methods for measuring patient satis-faction with specific medical encounters. Medical Care 1988; 26: 393–402.
Pouwer F, Snoek FJ, Heine RJ. Ceiling efect reduces the validity of the Diabetes Treatment Satisfaction Questionnaire. Diabetes Care 1998; 21: 2039.
Bradley C. The Diabetes Treatment Satisfaction Ques-tionnaire (DTSQ): Change version for use alongside status version provides appropriate solution where ceiling efects occur (letter, comments on Pouwer et al.) Diabetes Care 1999; 22: 530–253.
Gale EAM. A randomised, controlled trial comparing in-sulin lispro with human soluble insulin in patients with Type 1 diabetes on intensified insulin therapy (for the UK Trial Group). Diabetic Medicine 2000; 17: 209–214, 231.
Skyler JS, Skyler DL, Seigler DE, O'Sullivan MJ. Algo-rithms for adjustment of insulin dosage by patients who monitor blood glucose. Diabetes Care 1981; 4: 311–318.
Torlone E, Pampanelli S, Lalli C, et al. Efects of the short-acting insulin analog [Lys(B28), Pro(B29)] on postprandial blood glucose control in IDDM. Diabetes Care 1996; 19: 945–952.
Zinman B, Tildesley H, Chiasson JL, Tsui E, Strack T. Insulin lispro in CSII. Results of a double-blind cross-over study. Diabetes 1997; 46: 440–443.
Howorka K, Heger G, Schabmann A, Anderer P, Tribl G, Zeitlhofer J. Severe hypoglycemia unawareness is associat-ed with an early decrease in vigilance during hypoglycemia. Psychoneuroendocrinology 1996; 21(3): 295–312.
Howorka K, Heger G, Schabmann A, Skrabal F, Pumprla J. Weak relationships between symptom perception and objective hypoglycaemia induced changes of autonomic function in hypoglycaemia unawareness in diabetes. Acta Diabetologica 1998; 35: 1-8.
Howorka K, Pumprla J, Saletu B, Anderer P, Krieger M, Schabmann A. Decrease of vigilance assessed by EEG-mapping in type 1 diabetic patients with history of recurrent severe hypoglycaemia. Psychoneuroendocrinology 2000; 25: 85–105.
Bradley C, Plowright R, Stewart J, Witthaus E. Diabetes Treatment Satisfaction Questionnaire (change) in English and German evaluated in insulin glargine trials. Diabetologia 2000; 43(Suppl 1): A196.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Howorka, K., Pumprla, J., Schlusche, C. et al. Dealing with ceiling baseline treatment satisfaction level in patients with diabetes under flexible, functional insulin treatment: Assessment of improvements in treatment satisfaction with a new insulin analogue. Qual Life Res 9, 915–930 (2000). https://doi.org/10.1023/A:1008921419108
Issue Date:
DOI: https://doi.org/10.1023/A:1008921419108