N of 1 trials in diabetes: Making individual therapeutic decisions

Diabetologia

Volumn 51, Issue 6, 2008, Pages 921-925

  Tsapas, A ^a,b,c   Matthews, D R ^b  

^a ARISTOTLE UNIVERSITY OF THESSALONIKI   (Greece)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c CHURCHILL HOSPITAL   (United Kingdom)

Author keywords

Diabetes; N of 1; Therapeutic decisions; Trials

Indexed keywords

AMITRIPTYLINE; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; EXENDIN 4; GLITAZONE DERIVATIVE; ISOPHANE INSULIN; METFORMIN; PIOGLITAZONE; SULFONYLUREA;

CLINICAL PRACTICE; CLINICAL TRIAL; CROSSOVER PROCEDURE; DECISION MAKING; DIABETES MELLITUS; DIABETIC NEUROPATHY; ETHICS; EVIDENCE BASED MEDICINE; HUMAN; HYPERGLYCEMIA; HYPERTENSION; LIFESTYLE MODIFICATION; PRIORITY JOURNAL; REVIEW;

BLOOD GLUCOSE; CLINICAL TRIALS AS TOPIC; DECISION MAKING; DIABETES MELLITUS; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; EVIDENCE-BASED MEDICINE; HUMANS; HYPERGLYCEMIA; HYPOGLYCEMIC AGENTS; JUDGMENT; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 43049146530     PISSN: 0012186X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00125-008-0983-2     Document Type: Review

References (26)

1. 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 Engl J Med 329:977-986
2. The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group (2003) Intensive diabetes therapy and carotid intima-media thickness in type 1 diabetes mellitus. N Engl J Med 348:2294-2303
3. Stratton IM, Adler AI, Neil HA et al (2000) Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 321:405-412
4. American Diabetes Association (2008) Standards of medical care in diabetes-2008. Diabetes Care 31:S12-S54
5. Nathan DM, Buse JB, Davidson MB et al (2006) Management of hyperglycaemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia 49:1711-1721
6. The Diabetes Control and Complications Trial Research Group (1997) Hypoglycemia in the diabetes control and complications trial. Diabetes 46:271-286
7. National Institutes of Health (2008) For safety, NHLBI changes intensive blood sugar treatment strategy in clinical trial of diabetes and cardiovascular disease. Available from http://public.nhlbi.nih.gov/newsroom/home/ GetPressRelease.aspx?id=2551,accessed14/02/2008
8. Anderson RM, Robins LS (1998) How do we know? Reflections on qualitative research in diabetes. Diabetes Care 21:1387-1388
9. Daar AS, Singer PA, Persad DL et al (2007) Grand challenges in chronic non-communicable diseases. Nature 450:494-496
10. Goldberg RB, Holman R, Drucker DJ (2008) Clinical decisions. Management of type 2 diabetes. N Engl J Med 358:293-297
11. Halperin F, Ingelfinger JR, McMahon GT (2008) Clinical decisions. Management of type 2 diabetes-polling results. N Engl J Med 358:e8
12. Gaede P, Lund-Andersen H, Parving H-H, Pedersen O (2008) Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med 358:580-591
13. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS (1996) Evidence based medicine: what it is and what it isn't. BMJ 312:71-72
14. Guyatt GH, Haynes RB, Jaeschke RZ et al (2000) Users' guides to the medical literature: XXV. Evidence-based medicine: principles for applying the users' guides to patient care. JAMA 284:1290-1296
15. Nikles CJ, Clavarino AM, Del Mar CB (2005) Using n-of-1 trials as a clinical tool to improve prescribing. Br J Gen Pract 55:175-180
16. Guyatt G, Sackett D, Adachi J et al (1988) A clinician's guide for conducting randomized trials in individual patients. CMAJ 139:497-503
17. Sackett DL, Havnes RB, Guyatt SH, Tugwell P (1991) Clinical epidemiology: a basic science for clinical medicine. Little, Brown & Co., Boston
18. Brookes ST, Biddle L, Paterson C, Woolhead G, Dieppe P (2007) "Me's me and you's you" Exploring patients' perspectives of single patient (n-of-1) trials in the UK. Trials 8:10
19. Irwig L, Glasziou P, March L (1995) Ethics of n-of-1 trials. Lancet 345:469
20. Mahon JL, Feagan BG, Laupacis A (1995) Ethics of n-of-1 trials. Lancet 345:989
21. Avins AL, Bent S, Neuhaus JM (2005) Use of an embedded N-of-1 trial to improve adherence and increase information from a clinical study. Contemp Clin Trials 26:397-401
22. Golin CE, DiMatteo MR, Gelberg L (1996) The role of patient participation in the doctor visit. Implications for adherence to diabetes care. Diabetes Care 19:1153-1164
23. Brody DS, Miller SM, Lerman CE, Smith DG, Caputo GC (1989) Patient perception of involvement in medical care: relationship to illness attitudes and outcomes. J Gen Intern Med 4:506-511
24. Ong LM, de Haes JC, Hoos AM, Lammes FB (1995) Doctor-patient communication: a review of the literature. Soc Sci Med 40:903-918
25. Stewart MA (1995) Effective physician-patient communication and health outcomes: a review. CMAJ 152:1423-1433
26. Hoogwerf BJ (1985) Amitriptyline treatment of painful diabetic neuropathy: an inadvertent single-patient clinical trial. Diabetes Care 8:526-527