Large sample inference for a win ratio analysis of a composite outcome based on prioritized components

Biostatistics - Tập 17 Số 1 - Trang 178-187 - 2016
Ionut Bebu1, John M. Lachin1
1The Biostatistics Center, The George Washington University, 6110 Executive Blvd., Rockville, MD 20852, USA.

Tóm tắt

Từ khóa


Tài liệu tham khảo

Alosh, 2013, Advanced multiplicity adjustment methods in clinical trials, Statistics in Medicine, 33, 693, 10.1002/sim.5974

Bakal, 2012, Impact of weighted composite compared to traditional composite outcomes for the design of randomized controlled trials, Statistical Methods in Medical Research

Bakal, 2015, Applying novel methods to assess clinical outcomes: insights from the TRILOGY ACS trial, European Heart Journal, 36, 385, 10.1093/eurheartj/ehu262

Buyse, 2010, Generalized pairwise comparisons of prioritized outcomes in the two-sample problem, Statistics in Medicine, 29, 3245, 10.1002/sim.3923

Ciolino, 2015, Reanalysis or redefinition of the hypothesis?, European Heart Journal, 36, 340, 10.1093/eurheartj/ehu311

Claggett, 2013, Moving beyond our comfort zone, European Heart Journal, 34, 869, 10.1093/eurheartj/ehs485

Demidenko, 2008, General multistage gatekeeping procedures, Biometrical Journal, 50, 667, 10.1002/bimj.200710464

Fine, 2001, On semi-competing risks data, Biometrika, 88, 907, 10.1093/biomet/88.4.907

Finkelstein, 1999, Combining mortality and longitudinal measures in clinical trials, Statistics in Medicine, 18, 1341, 10.1002/(SICI)1097-0258(19990615)18:11<1341::AID-SIM129>3.0.CO;2-7

Freemantle, 2003, Composite outcomes in randomized trials: greater precision but with greater uncertainty?, The Journal of the American Medical Association, 289, 2554, 10.1001/jama.289.19.2554

Huque, 2011, Addressing multiplicity issues of a composite outcome and its components in clinical trials, Journal of Biopharmaceutical Statistics, 21, 610, 10.1080/10543406.2011.551327

Khawaja, 2014, The percutaneous coronary interventiona prior to transcatherer aortic valve implantation (ACTIVATION) trial: study protocol for a randomized controlled trial, Trial, 15, 300, 10.1186/1745-6215-15-300

Kirtane, 2012, The placement of aortic transcatheter valve (PARTNER) trial: clinical trialist perspective, Circulation, 125, 3229, 10.1161/CIRCULATIONAHA.112.093070

Lachin, 2011, Biostatistical Methods: The Assessment of Relative Risks, 2nd edition

Lachin, 2015, Application of the Wei–Lachin multivariate one-sided test to multiple event-time outcomes, Clinical Trials, 10.1177/1740774515601027

Lehmann, 1963, Robust estimation in analysis of variance, The Annals of Mathematical Statistics, 34, 957, 10.1214/aoms/1177704018

Luo, 2015, An alternative approach to confidence interval estimation for the win ratio statistics, Biometrics, 71, 139, 10.1111/biom.12225

Neaton, 2005, Key issues in end point selection for heart failure trials: composite end points, Journal of Cardiac Failure, 11, 567, 10.1016/j.cardfail.2005.08.350

Pocock, 1997, Clinical trials with multiple outcomes: a statistical perspective on their design, analysis, and interpretation, Controlled Clinical Trials, 18, 530, 10.1016/S0197-2456(97)00008-1

Pocock, 2012, The win ratio: a new approach to the analysis of composite outcomes in clinical trials based on clinical priorities, European Heart Journal, 33, 176, 10.1093/eurheartj/ehr352

Rauch, 2014, Opportunities and challenges of combined effect measures based on prioritized outcomes, Statistics in Medicine, 33, 1104, 10.1002/sim.6010

The PEACE Trial Investigators, 2004, Angiotensin-converting-enzyme inhibition in stable coronary artery disease, The New England Journal of Medicine, 351, 2058, 10.1056/NEJMoa042739

Wiens, 2005, The fallback procedure for evaluating a single family of hypothesis, Journal of Biopharmaceutical Statistics, 15, 929, 10.1080/10543400500265660