An Orwellian discourse on the meaning and measurement of noninferiority

被引：7

作者：

Diamond, George A. ^{[1
]}

Kaul, Sanjay

机构：

[1] Univ Calif Los Angeles, Cedars Sinai Med Ctr, Div Cardiol, Los Angeles, CA 90024 USA

[2] Univ Calif Los Angeles, David Geffen Sch Med, Los Angeles, CA 90024 USA

来源：

AMERICAN JOURNAL OF CARDIOLOGY | 2007年 / 99卷 / 02期

关键词：

D O I：

10.1016/j.amjcard.2006.07.090

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

The customary interpretation of active-controlled noninferiority trials is founded on a number of unverifiable assumptions. These assumptions can be circumvented, and the semantic and statistic interpretation of the trials placed on a more rational foundation, if treatment comparisons are analyzed from a Bayesian perspective. In conclusion, the resultant probabilistic measures thereby render the meaning of noninferiority more transparent and clinically relevant. (c) 2007 Elsevier Inc. All rights reserved.

引用

页码：284 / 287

页数：4

共 21 条

[11] Quality of reporting of noninferiority and equivalence randomized trials [J].

Le Henanff, A ;

Giraudeau, B ;

Baron, G ;

Ravaud, P .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2006, 295 (10) :1147-1151

[12] Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention - REPLACE-2 Randomized Trial [J].

Lincoff, AM ;

Bittl, JA ;

Harrington, RA ;

Feit, F ;

Kleiman, NS ;

Jackman, JD ;

Sarembock, IJ ;

Cohen, DJ ;

Spriggs, D ;

Ebrahimi, R ;

Keren, G ;

Carr, J ;

Cohen, EA ;

Betriu, A ;

Desmet, W ;

Kereiakes, DJ ;

Rutsch, W ;

Wilcox, RG ;

de Feyter, PJ ;

Vahanian, A ;

Topol, EJ .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2003, 289 (07) :853-863

[13] A critique of clinical equipoise - Therapeutic misconception in the ethics of clinical trials [J].

Miller, FG ;

Brody, H .

HASTINGS CENTER REPORT, 2003, 33 (03) :19-28

[14] Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both [J].

Pfeffer, MA ;

McMurray, JJV ;

Velazquez, EJ ;

Rouleau, JL ;

Kober, L ;

Maggioni, AP ;

Solomon, SD ;

Swedberg, K ;

Van de Werf, F ;

White, H ;

Leimberger, JD ;

Henis, M ;

Edwards, S ;

Zelenkofske, S ;

Sellers, MA ;

Califf, RM ;

Aylward, P ;

Armstrong, P ;

Barvik, S ;

Belenkov, Y ;

Dalby, A ;

Diaz, R ;

Drexler, H ;

Ertl, G ;

Francis, G ;

Hampton, J ;

Harsanyi, A ;

Kvasnicka, J ;

Mareev, V ;

Marin-Neto, J ;

Murin, J ;

Myers, M ;

Nordlander, R ;

Opolski, G ;

Soler-Soler, J ;

Spac, J ;

Stefenelli, T ;

Sugrue, D ;

Van Gilst, W ;

Varshavsky, S ;

Weaver, D ;

Zannad, F ;

Aguilar, D ;

Alvarez, A ;

Al-Taweel, M ;

Anavekar, N ;

Finn, P ;

Lopez-Jimenez, F ;

Mercier, R ;

Lewis, E .

NEW ENGLAND JOURNAL OF MEDICINE, 2003, 349 (20) :1893-1906

[15] Reporting of noninferiority and equivalence randomized trials - An extension of the CONSORT Statement [J].

Piaggio, G ;

Elbourne, DR ;

Altman, DG ;

Pocock, SJ ;

Evans, SJW .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2006, 295 (10) :1152-1160

[16]

Snapinn Steven M, 2004, J Biopharm Stat, V14, P263, DOI 10.1081/BIP-120037178

[17] Placebo-controlled trials and active-control trials in the evaluation of new treatments - Part 1: Ethical and scientific issues [J].

Temple, R ;

Ellenberg, SS .

ANNALS OF INTERNAL MEDICINE, 2000, 133 (06) :455-463

[18]

Topol E, 1997, NEW ENGL J MED, V337, P1118

[19] Comparison of two platelet glycoprotein IIb/IIIa inhibitors, tirofiban and abciximab, for the prevention of ischemic events with percutaneous coronary revascularization. [J].

Topol, EJ ;

Moliterno, DJ ;

Herrmann, HC ;

Powers, ER ;

Grines, CL ;

Cohen, DJ ;

Cohen, EA ;

Bertrand, M ;

Neumann, FJ ;

Stone, GW ;

DiBattiste, PM ;

Demopoulos, L .

NEW ENGLAND JOURNAL OF MEDICINE, 2001, 344 (25) :1888-1894

[20]

VandeWerf F, 1997, NEW ENGL J MED, V337, P1124

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