Are randomized controlled trials sufficient evidence to guide clinical practice in Type II (non-insulin-dependent) diabetes mellitus?

Diabetologia

Volumn 43, Issue 1, 2000, Pages 125-130

  Vijan, S ^a,b   Kent, D M ^c   Hayward, R A ^a  

^a VETERANS AFFAIRS MEDICAL CENTER   (United States)

^b VA HSR/D   (United States)

^c NONE

Author keywords

[No Author keywords available]

Indexed keywords

BETA ADRENERGIC RECEPTOR BLOCKING AGENT; FIBRINOLYTIC AGENT; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C; TISSUE PLASMINOGEN ACTIVATOR;

CLINICAL PRACTICE; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DISEASE ASSOCIATION; EPIDEMIOLOGY; EVIDENCE BASED MEDICINE; HEALTH CARE COST; HUMAN; NON INSULIN DEPENDENT DIABETES MELLITUS; PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; VASCULAR DISEASE;

EID: 0034107607     PISSN: 0012186X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s001250050017     Document Type: Review

References (48)

1. 1. Doll R (1994) Summation of conference. Doing more good than harm: the evaluation of health care interventions. Ann NY Acad Sci 703:313
2. 2. Javitt JC, Aiello L (1997) Cost-effectiveness of detecting and treating diabetic retinopathy. Ann Intern Med 124: 164-169
3. 3. Hayward RA, Manning WG, Kaplan SH, Wagner EH, Greenfield S (1997) Starting insulin therapy in patients with Type II diabetes: effectiveness, complications, and resource utilization. JAMA 278: 1663-1669
4. 4. The Diabetes Control and Complications Trial Research Group (1993) The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus. N Eng J Med 329: 977-986
5. 5. UK Prospective Diabetes Study Group (1998) Cost effectiveness analysis of improved blood pressure control in hypertensive patients with type 2 diabetes: UKPDS 40. BMJ 317: 720-726
6. 6. Vijan S, Hofer TP, Hayward RA (1997) Estimated Benefits of Glycaemic Control in Microvascular Complications in Type II Diabetes. Ann Intern Med 127: 788-795
7. 7. Eastman RC, Javitt JC, Herman WH et al. (1997) Model of complications of NIDDM. II. Analysis of the health benefits and cost-effectiveness of treating NIDDM with the goal of normoglycemia [see comments]. Diabetes Care 20: 735-744
8. 8. Eastman RC, Javitt JC, Herman WH et al. (1997) Model of complications of NIDDM. I. Model construction and assumptions [see comments]. Diabetes Care 20: 725-734
9. 9. Black N (1996) Why we need observational studies to evaluate the effectiveness of health care. Lancet 312: 1215-1218
10. 10. Mant D (1999) Evidence and primary care: Can randomised trials inform clinical decisions about individual patients? Lancet 353: 743-746
11. 11. Glasziou P, Irwig L (1995) An evidence based approach to individualising treatment. BMJ 311: 1356-1359
12. 12. Fahey T (1998) Applying the results of clinical trials to patients to general practice: perceived problems, strengths, assumptions, and challenges for the future. Br J Gen Pract 48: 1173-1178
13. 13. American Diabetes Association (1998) Economic conse-quences of diabetes mellitus in the US in 1997. Diabetes Care 21: 296-309
14. 14. UK Prospective Diabetes Study (UKPDS) Group (1998) Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with Type II diabetes (UKPDS 33). Lancet 352: 837-853
15. 15. UK Prospective Diabetes Study Group (1998) Effect of intensive blood-glucose control with metformin on complications in overweight patients with Type II diabetes (UKPDS 34). Lancet 352: 854-865
16. 16. UK Prospective Diabetes Study Group (1998) Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in Type II diabetes: UKPDS 39. BMJ 317: 713-720
17. 17. UK Prospective Diabetes Study Group (1998) Tight blood pressure control and risk of macrovascular and microvascular complications in Type II diabetes: UKPDS 38. BMJ 317: 703-713
18. 18. American Diabetes Association (1999) Implications of the United Kingdom Prospective Diabetes Study. Diabetes Care 22: [Suppl] S27-S31
19. 19. Hulley S, Cummings S (eds) (1988) Designing Clinical Research. 1st edn. Williams & Wilkins Baltimore
20. 20. Pirart J (1978) Diabetes Mellitus and Its Degenerative Complications: A Prospective Study of 4400 Patients Observed Between 1947 and 1973. Diabetes Care 1: 168-188, 252-261
21. 21. Klein R, Klein BEK, Moss SE et al. (1988) Glycosylated hemoglobin predicts the incidence and progression of diabetic retinopathy. JAMA 260: 2864-2871
22. 22. Omenn GS (1998) Chemoprevention of lung cancer: the rise and demise of beta-carotene. Annu Rev Public Health 19: 73-99
23. 23. Summary of the Second Report of the National Cholesterol Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). (1990) JAMA 264: 723-726
24. 24. Ward LC, Fielding JWL, Dunn JA, Kelly KA (1992) The selection of cases for randomized trials: a registry of concurrent trial and non-trial participants. Br J Cancerl 66: 943-962
25. 25. Stiller CA (1994) Decentralised treatment, entry to trials, and survival. Br J Cancer 70: 352-362
26. 26. Cross design synthesis: a new strategy for studying medical outcomes? (1992) [editorial] Lancet 340: 944-946
27. 27. Stampfer M (1997) Observational epidemiology is the preferred means of evaluating effects of behavioral and lifestyle modification. Controll Clin Trials 18: 494-499
28. 28. Dans AL, Dans LF, Guyatt GH, Richardson S (1998) Users' guides to the medical literature: XIV. How to decide on the applicability of clinical trial results to your patient. Evidence-Based Medicine Working Group. JAMA 279: 545-549
29. 29. Guyatt GH, Sackett DL, Cook DJ (1994) Users' guides to the medical literature. II. How to use an article about therapy or prevention. B. What were the results and will they help me in caring for my patients? Evidence-Based Medicine Working Group. JAMA 271: 59-63
30. 30. Ioannidis J, Lau J (1997) The impact of high-risk patients on the results of clinical trials. J Clin Epidemiol 50: 1089-1098
31. 31. Horwitz RI (1996) The dark side of evidence-based medicine. Cleve Clin J Med 63: 320-323
32. 32. Buyse ME (1989) Analysis of clinical trial outcomes: some comments on subgroup analyses. Control Clin Trials 10: 187S-194S
33. 33. Detsky AS, Naglie IG (1995) Subgroup analyses: primary and secondary [editorial]. ACP J Club 122:A12-A14
34. 34. Yusuf S, Wittes J, Probstfield J, Tyroler HA (1991) Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA 266: 93-98
35. 35. Oxman AD, Guyatt GH (1992) A consumer's guide to subgroup analyses. Ann Int Med 116: 78-84
36. 36. Naylor C (1995) Grey zones of clinical practice: Some limits to evidence-based medicine. Lancet 345: 840-842
37. 37. Nathan D (1998) Some answers, more controversy, from UKPDS. Lancet 352 (commentary): 832-834
38. 38. Ohkubo Y, Kishikawa H, Araki E et al. (1995) Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract 28: 103-117
39. 39. Abraira C, Colwell JA, Nuttall FQ et al. (1995) Veterans Affair Cooperative Study on Glycemic Control and Complications in Type II Diabetes (VA CSDM): Results of the feasibility trial. Diabetes Care 18: 1113-1123
40. 40. Rothwell P (1995) Can overall results of clinical trials be applied to all patients? Lancet 345: 1616-1619
41. 41. The Diabetes Control and Complications Trial Research Group (1995) The Relationship of Glycemic Exposure (HBA 1c) to the Risk of Development and Progression of Retinopathy in the Diabetes Control and Complications Trial. Diabetes 44: 968-983
42. 42. Sonnenberg FA, Beck JR (1993) Markov models in medical decision making: a practical guide. Med Decis Making 13: 322-338
43. 43. Hlatky MA, Califf RM, Harrell FE, Lee KL, Mark DB, Pryor D (1988) Comparison of predictions based on observational data with the results of randomised controlled trials of coronary artery bypass surgery. J Am Coll Cardiol 11: 237-245
44. 44. Yusuf S, Peto R, Lewis J, Collins R, Sleight P (1985) Beta blockade during and after myocardial infarction. Prog Cardiovasc Dis 27: 335-371
45. 45. Califf R, Harrel F, Lee K et a. (1989) The evolution of medical and surgical therapy for coronary artery disease. A 15 year perspective. JAMA 261: 2077-2086
46. 46. Califf R, Woodlief L, Harrell F et al. Selection of thrombolytic therapy for individual patients: Development of a clinical model. Am Heart J 133: 630-639
47. 47. Fuchs V (1972) Healthcare and the United States economic system: An essay in abnormal physiology. Millbank Q 50: 211-237
48. 48. Ioannidis J, Lau J (1998) Heterogeneity of the baseline risk within patient populations of clinical trials: A proposed evaluation algorithm. Am J Epidemiol 148: 117-1126