Moving beyond our comfort zone

European Heart Journal

Volumn 34, Issue 12, 2013, Pages 869-871

  Claggett, Brian ^a   Wei, Lee Jen ^a   Pfeffer, Marc A ^b  

^a HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONGESTIVE HEART FAILURE; CONSULTATION; EXPERIMENTAL THERAPY; FIBRINOLYSIS; HAZARD RATIO; HOSPITALIZATION; HUMAN; MORBIDITY; MORTALITY; NULL HYPOTHESIS; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS; SHOCK; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION;

HUMANS; MYOCARDIAL INFARCTION; PERCUTANEOUS CORONARY INTERVENTION; THROMBOLYTIC THERAPY;

EID: 84875626630     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehs485     Document Type: Review

References (14)

1. Anker SD, McMurray JV.Time to move on from 'time-to-first': should all events be included in the analysis of clinical trials? Eur Heart J 2012;33:2764-2765.
2. Kaul S, Diamond GA. Trial and error: how to avoid commonly encountered limitations of published clinical trials. J Am Coll Cardiol 2010;55:415-427.
3. DeMets DL, Califf RM. Lessons learned from recent cardiovascular clinical trials (part I). Circulation 2002;106:746-751.
4. Ferreira-González I, Busse JW, Heels-Ansdell D, Montori VM, Akl EA, Bryant DM, Alonso-Coello P, Alonso J, Worster A, Upadhye S, Jaeschke R, Schunemann HJ, Permanyer-Miralda G, Pacheco-Huergo V, Domingo-Salvany A, Wu P, Mills EJ, Guyatt GH. Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials. BMJ 2007;334:786.
5. Bakal JA, Westerhout CM, Cantor WJ, Fernández-Avilés F, Welsh RC, Fitchett D, Goodman SG, Armstrong PW. Evaluation of early percutaneous coronary intervention vs. standard therapy after fibrinolysis for ST-segment elevation myocardial infarction: contribution of weighting the composite endpoint. Eur Heart J 2013;34:903-908.
6. Sampson UK, Metcalfe C, Pfeffer MA, Solomon SD, Zou KH. Composite outcomes: weighting component events according to severity assisted interpretation but reduced statistical power. J Clin Epidemiol 2010;63:1156-1158.
7. Claggett B, Tian L, Castagno D, Wei LJ. Treatment selections using risk-benefit profiles based on data from comparative randomized clinical trials with multiple endpoints. (November 2012). Harvard University Biostatistics Working Paper Series. Working Paper 153. http://biostats.bepress.com/ harvardbiostat/paper153
8. Ariti CA, Cleland JG, Pocock SJ, Pfeffer MA, Swedberg K, Granger CB, McMurray JJ, Michelson EL, Ostergren J, Yusuf S. Days alive and out of hospital and the patient journey in patients with heart failure: insights from the candesartan in heart failure: assessment of reduction in mortality and morbidity (CHARM) program. Am Heart J 2011;162:900-906.
9. Bakal JA, Westerhout CM, Armstrong PW. Impact of weighted composite compared to traditional composite endpoints for the design of randomized controlled trials. Stat Methods Med Res 2012;in press.
10. Wei LJ, Lin DY, Weissfeld L. Regression analysis of multivariate incomplete failure time data by modeling marginal distributions. J Am Stat Assoc 1989;84:1064-1072.
11. Andersen PK., Gill RD. Cox's regression model for counting processes: a large sample study, Ann Stat 1982;10:1100-1120.
12. Wei LJ, Glidden DV. An overview of statistical methods for multiple failure time data in clinical trials. Stat Med 1997;16:833-839.
13. Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J 2012;33:176-182.
14. Altman DG, Andersen PK. Calculating the number needed to treat for trials where the outcome is time to an event. BMJ 1999;319:1492.