Clinical event adjudication in cardiovascular device trials: An Food and Drug Administration perspective

被引:12
作者
Farb, Andrew [1 ]
Zuckerman, Bram D. [1 ]
机构
[1] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA
关键词
CLAIMS DATA; DEFINITIONS;
D O I
10.1016/j.ahj.2017.05.010
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
引用
收藏
页码:62 / 64
页数:3
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共 5 条
[1]   Linking the National Cardiovascular Data Registry CathPCI Registry With Medicare Claims Data Validation of a Longitudinal Cohort of Elderly Patients Undergoing Cardiac Catheterization [J].
Brennan, J. Matthew ;
Peterson, Eric D. ;
Messenger, John C. ;
Rumsfeld, John S. ;
Weintraub, William S. ;
Anstrom, Kevin J. ;
Eisenstein, Eric L. ;
Milford-Beland, Sarah ;
Grau-Sepulveda, Maria V. ;
Booth, Michael E. ;
Dokholyan, Rachel S. ;
Douglas, Pamela S. .
CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES, 2012, 5 (01) :134-140
[2]   Clinical end points in coronary stent trials - A case for standardized definitions [J].
Cutlip, Donald E. ;
Windecker, Stephan ;
Mehran, Roxana ;
Boam, Ashley ;
Cohen, David J. ;
van Es, Gerrit-Anne ;
Steg, P. Gabriel ;
Morel, Marie-angele ;
Mauri, Laura ;
Vranckx, Pascal ;
McFadden, Eugene ;
Lansky, Alexandra ;
Hamon, Martial ;
Krucoff, Mitchell W. ;
Serruys, Patrick W. .
CIRCULATION, 2007, 115 (17) :2344-2351
[3]   Updated standardized endpoint definitions for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 consensus document [J].
Kappetein, A. Pieter ;
Head, Stuart J. ;
Genereux, Philippe ;
Piazza, Nicolo ;
van Mieghem, Nicolas M. ;
Blackstone, Eugene H. ;
Brott, Thomas G. ;
Cohen, David J. ;
Cutlip, Donald E. ;
van Es, Gerrit-Anne ;
Hahn, Rebecca T. ;
Kirtane, Ajay J. ;
Krucoff, Mitchell W. ;
Kodali, Susheel ;
Mack, Michael J. ;
Mehran, Roxana ;
Rodes-Cabau, Josep ;
Vranckx, Pascal ;
Webb, John G. ;
Windecker, Stephan ;
Serruys, Patrick W. ;
Leon, Martin B. .
JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, 2013, 145 (01) :6-23
[4]   Study of Cardiovascular Health Outcomes in the Era of Claims Data The Cardiovascular Health Study [J].
Psaty, Bruce M. ;
Delaney, Joseph A. ;
Arnold, Alice M. ;
Curtis, Lesley H. ;
Fitzpatrick, Annette L. ;
Heckbert, Susan R. ;
McKnight, Barbara ;
Ives, Diane ;
Gottdiener, John S. ;
Kuller, Lewis H. ;
Longstreth, W. T., Jr. .
CIRCULATION, 2016, 133 (02) :156-164
[5]   Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium [J].
Seltzer, Jonathan H. ;
Heise, Ted ;
Carson, Peter ;
Canos, Daniel ;
Hiatt, Jo Carol ;
Vranckx, Pascal ;
Christen, Thomas ;
Cutlip, Donald E. .
AMERICAN HEART JOURNAL, 2017, 190 :76-85