Fear of hypoglycaemia: Defining a minimum clinically important difference in patients with type 2 diabetes

Health and Quality of Life Outcomes

Volumn 7, Issue , 2009, Pages

  Stargardt, Tom ^a,b   Gonder Frederick, Linda ^c   Krobot, Karl J ^d   Alexander, Charles M ^e  

^a UNIVERSITY OF MUNICH   (Germany)

^b INSTITUTE OF EPIDEMIOLOGY   (Germany)

^c UNIVERSITY OF VIRGINIA   (United States)

^d Outcomes Research   (Germany)

^e MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLITAZONE DERIVATIVE; METFORMIN; ORAL ANTIDIABETIC AGENT; SULFONYLUREA DERIVATIVE; ANTIDIABETIC AGENT;

ADULT; ARTICLE; CLINICAL ASSESSMENT TOOL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; FEAR; FEMALE; GERMANY; HEALTH CARE NEED; HUMAN; HYPOGLYCEMIA; HYPOGLYCEMIA FEAR SURVEY II; MAJOR CLINICAL STUDY; MALE; MINIMUM CLINICALLY IMPORTANT DIFFERENCE; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; OBSERVATIONAL STUDY; SCORING SYSTEM; TREATMENT SATISFACTION QUESTIONNAIRE FOR MEDICATION; BLOOD; COMPARATIVE STUDY; MIDDLE AGED; PATIENT SATISFACTION; PSYCHOLOGICAL ASPECT; QUALITATIVE RESEARCH; QUESTIONNAIRE; STATISTICS;

DIABETES MELLITUS, TYPE 2; FEAR; FEMALE; GERMANY; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; PATIENT SATISFACTION; QUALITATIVE RESEARCH; QUESTIONNAIRES;

EID: 71149086018     PISSN: None     EISSN: 14777525     Source Type: Journal    
DOI: 10.1186/1477-7525-7-91     Document Type: Article

References (40)

1. Cook MN, Girman CJ, Stein PP, Alexander CM, Holman RR. Glycemic control continues to deteriorate after sulfonylureas are added to metformin among patients with type 2 diabetes. Diabetes Care 2005, 28:995-1000. 10.2337/diacare.28.5.995, 15855556.
2. Nathan DM, Buse JB, Mayer BD, Heine RJ, Holman RR, Sherwin R. Management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. Diabetes Care 2006, 29:1963-1972. 10.2337/dc06-9912, 16873813.
3. Cook MN, Girman CJ, Stein PP, Alexander CM. Initial monotherapy with either metformin or sulphonylureas often fails to achieve or maintain current glycaemic goals in patients with type 2 diabetes in UK primary care. Diabet Med 2007, 24:350-358. 10.1111/j.1464-5491.2007.02078.x, 17335466.
4. Home PD, Jones NP, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M. Rosiglitazone RECORD study: glucose control outcomes at 18 months. Diabet Med 2007, 24:626-634. 10.1111/j.1464-5491.2007.02160.x, 1974811, 17517066.
5. Charbonnel B, Schernthaner G, Brunetti P, Matthews DR, Tan MH, Hanefeld M. Long-term efficacy and tolerability of add-on pioglitazone therapy to failing monotherapy compared with addition of gliclazide or metformin in patients with type 2 diabetes. Diabetologia 2005, 48:1093-1104. 10.1007/s00125-005-1751-1, 15889234.
6. Chelliah A, Burke MR. Hypoglycemia in elderly patients with diabetes mellitus. Drugs & Aging 2004, 21:511-530.
7. Davis S, Alonso MD. Hypoglycemia as a barrier to glycemic control. J Diabetes Complications 2004, 18:60-68.
8. Amiel SA, Dixon T, Mann R, Jameson K. Hypoglycaemia in type 2 diabetes. Diabet Med 2008, 25:245-254. 2327221, 18215172.
9. Banarer S, Cryer PE. Gypoglycemia in type 2 diabetes. The Medical Clinics of North America 2004, 88:1107-1116.
10. Boyle PJ, Zrebiec J. Physiological and behavioral aspects of glycemic control and hypoglycemia in diabetes. South Med J 2007, 100:175-182.
11. Murata GH, Duckworth WC, Shah JH, Wendel CS, Mohler MJ, Hoffmann RM. Hypoglycemia in stable, insulin-treated verterans with type 2 diabetes, a retrospective study of 1662 episodes. J Diabetes Complications 2005, 19:10-17.
12. Zammitt NN, Frier BM. Hypoglycemia in type 2 diabetes. Diabetes Care 2005, 28:2948-2961.
13. Frier BM. Hypoglycemia and cognitive function in diabetes. Int J Clin Pract 2001, S123:30-37.
14. Rosenthal JM, Amiel SA, Yágüez L, Bullmore E, Hopkins D, Evans M. The effect of acute hypoglycemia on brain function and activation. Diabetes 2001, 50:1618-1626.
15. Whitmer RA, Karter AJ, Yaffe K, Quesenberry CP, Selby JV. Hypoglycemic episodes and risk of dementia in older patients with type 2 diabetes mellitus. JAMA 2009, 301:1565-1572.
16. American Diabetes Association Workgroup on Hypoglycemia Defining and reporting hypoglycemia in diabetes. Diabetes Care 2005, 28:1245-1249.
17. Boyle PJ, Zrebiec J. Management of diabetes-related hypoglycemia. South Med J 2007, 100:183-194.
18. Nattrass M, Lauritzen T. Review of prandial glucose regulation with reaglinide: a solution to the problem of hyoglycemia in the treatment of type 2 diabetes. Int J Obes 2000, 24:21-31.
19. Gonder-Frederick L, Cox DJ, Clarke W, Julian D. Blood glucose awareness training. Psychology in diabetes Care 2000, 169-206. New York: Wiley, Snoek FJ, Skinner TC.
20. Cox DJ, Gonder-Frederick L, Polonsky W, Schlundt D, Kovatchev B, Clarke W. Blood glucose awareness training (BGAT-2): Long-term benefits. Diabetes Care 2001, 24:638-42.
21. Johnson JA, Kotovych M, Ryan EA, Shapiro AM. Reduced fear of hypoglycemia in successful islet transplantation. Diabetes Care 2004, 27:624-25.
22. Jaeschke R, Singer J, Guyatt DH. Measurement of health status: ascertaining the minimal clinically important difference. Control Clin Trials 1989, 10:407-415.
23. Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR, . the clinical significance consensus meeting group Methods to explain the clinical significance of health status measures. Mayo Clin Proc 2002, 77:371-383.
24. Atkinson MJ, Sinha A, Hass SL, Colman SS, Kumar RN, Brod M. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionaire for Medication (TSQM), using a national panel study of chronic disease. Health and Quality of Life Outcomes 2004, 2:1-13. 333432, 14713317.
25. Cox DJ, Irvine A, Gonder-Frederick L, Nowacek G, Butterfield J. Fear of hypoglycemia: quantification, validation and utilization. Diabetes Care 1987, 10:617-621.
26. Irvine A, Cox DJ, Gonder-Frederick L. The Fear of hypoglycemia scale. Handbook of psychology and diabetes: a guide to psychological measurement and diabetes research and practice 1994, 133-158. Langhorne: Hardwood Academia Publishing, Bradley C.
27. Revicki DA, Hays RD, Cella D, Sloan JA. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol 2008, 61:102-9.
28. U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health Guidance for industry: patient-reported outcome measures: use in medical product development to support labelling claims. Health and Quality of Life Outcomes 2006, 4:1-20. 1360061, 16393335.
29. Yost KJ, Cella D, Chawla A, Holmgren E, Eton DT, Ayanian JZ. Minimally important differences were estimated for the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) instrument using a combination of distribution- and anchor-based approaches. J Clin Epidemiol 2005, 58:1241-1251.
30. Beaton D, Bombardier C, Katz JN, Wright JG, Wells GA, Boers M. Looking for important change/differences in studies of responsiveness. The Journal of Rheumatology 2001, 28:400-405.
31. Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6d. Qual Life Res 2005, 14:1523-1532.
32. Wells GA, Tugwell P, Kraag GR, Baker PRA, Groh J, Redelmeier DA. Minimum important difference between patients with rheumatoid arthitis: the patient's perspective. The Journal of Rheumatology 1993, 20:557-560.
33. Leese GP, Wang J, Broomhall J, Kelly P, Marsden A, Morrison W. Frequency of severe hypoglycemia requiring emergency treatment in type 1 and type 2 diabetes. Diabetes Care 2003, 26:1176-1180.
34. Lydick E, Epstein R. Interpretation of quality of life changes. Qual Life Res 1993, 2:221-6.
35. Marquis P, Chassany O, Abetz L. A comprehensive strategy for the interpretation of quality-of-life data based existing methods. Value in Health 2004, 7:93-104.
36. Wells GA, Beaton D, Shea B, Boers M, Simon L, Strand V. Minimal clinically important differences: review of methods. The Journal of Rheumatology 2001, 28:406-412.
37. Norquist J, Girman C, Santanello N. Some considerations for the interpretation of health-related quality of life data. Value in Health 2005, 8:80-81.
38. Riedel A, Heien H, Wogen J, Plauschinat C. Loss of glycemic control in patients with type 2 diabetes mellitus who were receiving initial metformin, sulfonylurea, or thiazolidinedione monotherapy. Pharmacotherapy 2007, 27:1102-1110.
39. McKee M, Brotton A, Black N, McPherson K, Sanderson C, Bain C. Methods in health services research: Interpreting the evidence: choosing between randomised and non-randomised studies. BMJ 1999, 319:312-315. 1126943, 10426754.
40. Murata GH, Hoffmann RM, Shah JH, Wendel CS, Duckworth WC. A probabilistic model for predicting hypoglycemia in type 2 diabetes mellitus. Arch Intern Med 2004, 164:1445-1450.