-
1
-
-
33749236625
-
30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: A randomised non-inferiority result
-
The SPACE Collaborative Group
-
The SPACE Collaborative Group. 30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised non-inferiority result. Lancet 2006; 368: 1239-1247.
-
(2006)
Lancet
, vol.368
, pp. 1239-1247
-
-
-
2
-
-
0037165259
-
Voriconazole compared with liposomal amphotericin B for empirical antifungal therapy in patients with neutropenia and persistent fever
-
for the National Institute of Allergy and Infectious Diseases Mycoses Study Group
-
Walsh TJ, Pappas P, Winston DJ, et al for the National Institute of Allergy and Infectious Diseases Mycoses Study Group. Voriconazole compared with liposomal amphotericin B for empirical antifungal therapy in patients with neutropenia and persistent fever. N Engl J Med 2002; 346: 225-234.
-
(2002)
N Engl J Med
, vol.346
, pp. 225-234
-
-
Walsh, T.J.1
Pappas, P.2
Winston, D.J.3
-
3
-
-
0242490542
-
Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both
-
for the Valsartan in Acute Myocardial Infarction Trial Investigators
-
Pfeffer MA, McMurray JJV, Velazquez EJ, et al for the Valsartan in Acute Myocardial Infarction Trial Investigators. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. N Engl J Med 2003; 349: 1893-1906.
-
(2003)
N Engl J Med
, vol.349
, pp. 1893-1906
-
-
Pfeffer, M.A.1
McMurray, J.J.V.2
Velazquez, E.J.3
-
4
-
-
42049095662
-
Diagnosis of pulmonary embolism by multidetector CT alone or combined with venous ultrasonography of the leg: A randomised non-inferiority trial
-
Righini M, Le Gal G, Aujesky D, et al. Diagnosis of pulmonary embolism by multidetector CT alone or combined with venous ultrasonography of the leg: a randomised non-inferiority trial. Lancet 2008; 371: 1343-1352.
-
(2008)
Lancet
, vol.371
, pp. 1343-1352
-
-
Righini, M.1
Le Gal, G.2
Aujesky, D.3
-
5
-
-
0037038987
-
-
Kinley H, Czoski-Murray C, George S, et al on behalf of the OpCheck Study Group. Effectiveness of appropriately trained nurses in preoperative assessment: randomised controlled equivalence/ non-inferiority trial. BMJ 2002; 325: 1323-1327.
-
Kinley H, Czoski-Murray C, George S, et al on behalf of the OpCheck Study Group. Effectiveness of appropriately trained nurses in preoperative assessment: randomised controlled equivalence/ non-inferiority trial. BMJ 2002; 325: 1323-1327.
-
-
-
-
6
-
-
27544490169
-
Equivalence and noninferiority trials - are they viable alternatives for registration of new drugs? (III)
-
Pater C. Equivalence and noninferiority trials - are they viable alternatives for registration of new drugs? (III). Curr Control Trials Cardiovasc Med 2004; 5: 8.
-
(2004)
Curr Control Trials Cardiovasc Med
, vol.5
, pp. 8
-
-
Pater, C.1
-
7
-
-
9444255722
-
Improving the quality of reporting of randomized controlled trials: The CONSORT statement
-
Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996; 276: 637-639.
-
(1996)
JAMA
, vol.276
, pp. 637-639
-
-
Begg, C.1
Cho, M.2
Eastwood, S.3
-
8
-
-
33644792767
-
CONSORT Group. Reporting of noninferiority and equivalence randomized trials: An extension of the CONSORT statement
-
Piaggio G, Elbourne DR, Altman DG, et al; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006; 295: 1152-1160.
-
(2006)
JAMA
, vol.295
, pp. 1152-1160
-
-
Piaggio, G.1
Elbourne, D.R.2
Altman, D.G.3
-
10
-
-
0345414673
-
Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): Randomised controlled trial
-
Executive Steering Committee on behalf of the SPORTIF III Investigators
-
Executive Steering Committee on behalf of the SPORTIF III Investigators. Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): randomised controlled trial. Lancet 2003; 362: 1691-1698.
-
(2003)
Lancet
, vol.362
, pp. 1691-1698
-
-
-
11
-
-
23944434055
-
SPORTIF Executive Steering Committee for the SPORTIF V Investigators. Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: A randomized trial
-
Albers GW, Diener HC, Frison L, et al; SPORTIF Executive Steering Committee for the SPORTIF V Investigators. Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial. JAMA 2005; 293: 690-698.
-
(2005)
JAMA
, vol.293
, pp. 690-698
-
-
Albers, G.W.1
Diener, H.C.2
Frison, L.3
-
12
-
-
0041694480
-
Executive Steering Committee, SPORTIF III and V Study Investigators. Ximelagatran compared with warfarin for prevention of thromboembolism in patients with nonvalvular atrial fibrillation: Rationale, objectives, and design of a pair of clinical studies and baseline patient characteristics (SPORTIF III and V)
-
Halperin JL; Executive Steering Committee, SPORTIF III and V Study Investigators. Ximelagatran compared with warfarin for prevention of thromboembolism in patients with nonvalvular atrial fibrillation: rationale, objectives, and design of a pair of clinical studies and baseline patient characteristics (SPORTIF III and V). Am Heart J 2003; 146: 431-438.
-
(2003)
Am Heart J
, vol.146
, pp. 431-438
-
-
Halperin, J.L.1
-
13
-
-
0028244264
-
-
Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Analysis of pooled data from five randomised controlled trials. Arch Intern Med 1994; 154: 1449-1457.
-
Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Analysis of pooled data from five randomised controlled trials. Arch Intern Med 1994; 154: 1449-1457.
-
-
-
-
14
-
-
28244432534
-
Trials and tribulations of non-inferiority: The ximelagatran experience
-
Kaul S, Diamond GA, Weintraub WS. Trials and tribulations of non-inferiority: the ximelagatran experience. J Am Coll Cardiol 2005; 46: 1986-1995.
-
(2005)
J Am Coll Cardiol
, vol.46
, pp. 1986-1995
-
-
Kaul, S.1
Diamond, G.A.2
Weintraub, W.S.3
-
15
-
-
63249130931
-
Guideline on the choice of the non-inferiority margin
-
Committee for Medicinal Products for Human Use, accessed Aug 2008
-
Committee for Medicinal Products for Human Use. Guideline on the choice of the non-inferiority margin. London: European Medicines Agency, 2005. http://www.emea.europa.eu/pdfs/human/ewp/215899en.pdf (accessed Aug 2008).
-
(2005)
London: European Medicines Agency
-
-
-
16
-
-
15244355307
-
Choice of delta: Requirements and reality - results of a systematic review
-
Lange S, Freitag G. Choice of delta: requirements and reality - results of a systematic review. Biom J 2005; 47: 12-27.
-
(2005)
Biom J
, vol.47
, pp. 12-27
-
-
Lange, S.1
Freitag, G.2
-
17
-
-
3142652493
-
Clinically important differences in health status for patients with heart disease: An expert consensus panel report
-
Wyrwich KW, Spertus JA, Kroenke K, et al. Clinically important differences in health status for patients with heart disease: an expert consensus panel report. Am Heart J 2004; 147: 615-622.
-
(2004)
Am Heart J
, vol.147
, pp. 615-622
-
-
Wyrwich, K.W.1
Spertus, J.A.2
Kroenke, K.3
-
18
-
-
33745931889
-
Good enough: A primer on the analysis and interpretation of noninferiority trials
-
Kaul S, Diamond GA. Good enough: a primer on the analysis and interpretation of noninferiority trials. Ann Intern Med 2006; 145: 62-69.
-
(2006)
Ann Intern Med
, vol.145
, pp. 62-69
-
-
Kaul, S.1
Diamond, G.A.2
-
19
-
-
40949113623
-
Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: Meta-epidemiological study
-
Wood L, Egger M, Gluud LL, et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ 2008; 336: 601-608.
-
(2008)
BMJ
, vol.336
, pp. 601-608
-
-
Wood, L.1
Egger, M.2
Gluud, L.L.3
-
20
-
-
0034595229
-
Claims of equivalence in medical research: Are they supported by the evidence?
-
Greene WL, Concato J, Feinstein AR. Claims of equivalence in medical research: are they supported by the evidence? Ann Intern Med 2000; 132: 715-722.
-
(2000)
Ann Intern Med
, vol.132
, pp. 715-722
-
-
Greene, W.L.1
Concato, J.2
Feinstein, A.R.3
-
21
-
-
33644789375
-
Quality of reporting of noninferiority and equivalence randomized trials
-
Le Henanff A, Giraudeau B, Baron G, Ravaud P. Quality of reporting of noninferiority and equivalence randomized trials. JAMA 2006; 295: 1147-1151.
-
(2006)
JAMA
, vol.295
, pp. 1147-1151
-
-
Le Henanff, A.1
Giraudeau, B.2
Baron, G.3
Ravaud, P.4
-
22
-
-
36549021534
-
Non-inferiority trials are unethical because they disregard patients' interests
-
Garattini S, Bertele V. Non-inferiority trials are unethical because they disregard patients' interests. Lancet 2007; 370: 1875-1877.
-
(2007)
Lancet
, vol.370
, pp. 1875-1877
-
-
Garattini, S.1
Bertele, V.2
-
23
-
-
0032569383
-
When placebo controlled trials are essential and equivalence trials are inadequate
-
Tramèr MR, Reynolds DJ, Moore RA, McQuay HJ. When placebo controlled trials are essential and equivalence trials are inadequate. BMJ 1998; 317: 875-880.
-
(1998)
BMJ
, vol.317
, pp. 875-880
-
-
Tramèr, M.R.1
Reynolds, D.J.2
Moore, R.A.3
McQuay, H.J.4
-
24
-
-
33644815619
-
Lessons from and cautions about noninferiority and equivalence randomised trials
-
Gotzsche PC. Lessons from and cautions about noninferiority and equivalence randomised trials. JAMA 2006; 295: 1172-1174.
-
(2006)
JAMA
, vol.295
, pp. 1172-1174
-
-
Gotzsche, P.C.1
-
25
-
-
0037445366
-
Therapeutic equivalence: Fallacies and falsification
-
Garrett AD. Therapeutic equivalence: fallacies and falsification. Stat Med 2003; 22: 741-762.
-
(2003)
Stat Med
, vol.22
, pp. 741-762
-
-
Garrett, A.D.1
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