A Global Ranking Approach to End Points in Trials of Mechanical Circulatory Support Devices

Journal of Cardiac Failure

Volumn 14, Issue 5, 2008, Pages 368-372

  Felker, G Michael ^a,b   Anstrom, Kevin J ^a   Rogers, Joseph G ^a,b  

^a DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Clinical trials; end points; heart failure; ventricular assist device

Indexed keywords

ARTICLE; ASSISTED CIRCULATION; BIOMEDICAL TECHNOLOGY ASSESSMENT; CLINICAL RESEARCH; HEART ASSIST DEVICE; HEART FAILURE; HUMAN; MORTALITY; OUTCOME ASSESSMENT; OUTCOMES RESEARCH; PRIORITY JOURNAL;

CLINICAL TRIALS AS TOPIC; ENDPOINT DETERMINATION; HEALTH STATUS INDICATORS; HEART FAILURE; HEART-ASSIST DEVICES; HUMANS;

EID: 44349154267     PISSN: 10719164     EISSN: 15328414     Source Type: Journal    
DOI: 10.1016/j.cardfail.2008.01.009     Document Type: Article

References (17)

1. Baughman K.L., and Jarcho J.A. Bridge to life-cardiac mechanical support. N Engl J Med 357 (2007) 846-849
2. Rose E.A., Gelijns A.C., Moskowitz A.J., Heitjan D.F., Stevenson L.W., Dembitsky W.P., et al. Long term use of left-ventricular assist device for end-stage heart failure. N Engl J Med 345 (2001) 1435-1443
3. Rogers J.G., Butler J., Lansman S.L., Gass A., Portner P.M., Pasque M.K., et al. Chronic mechanical circulatory support for inotrope-dependent heart failure patients who are not transplant candidates: results of the INTrEPID Trial. J Am Coll Cardiol 50 (2007) 741-747
4. Miller L.W., Pagani F.D., Russell S.D., John R., Boyle A.J., Aaronson K.D., et al. Use of a continuous-flow device in patients awaiting heart transplantation. N Engl J Med 357 (2007) 885-896
5. Stevenson L.W., and Couper G. On the fledgling field of mechanical circulatory support. J Am Coll Cardiol 50 (2007) 748-751
6. Neaton J.D., Normand S.L., Gelijns A., Starling R.C., Mann D.L., and Konstam M.A. Designs for mechanical circulatory support device studies. J Card Fail 13 (2007) 63-74
7. Neaton J.D., Gray G., Zuckerman B.D., and Konstam M.A. Key issues in end point selection for heart failure trials: composite end points. J Card Fail 11 (2005) 567-575
8. Yusuf S., and Negassa A. Choice of clinical outcomes in randomized trials of heart failure therapies: disease-specific or overall outcomes?. Am Heart J 143 (2002) 22-28
9. O'Brien P.C. Procedures for comparing samples with multiple endpoints. Biometrics 40 (1984) 1079-1087
10. Califf R.M., Harrelson-Woodlief L., and Topol E.J. Left ventricular ejection fraction may not be useful as an end point of thrombolytic therapy comparative trials. Circulation 82 (1990) 1847-1853
11. Temkin N.R., Anderson G.D., Winn H.R., Ellenbogen R.G., Britz G.W., Schuster J., et al. Magnesium sulfate for neuroprotection after traumatic brain injury: a randomised controlled trial. Lancet Neurol 6 (2007) 29-38
12. Lachin J.M. Worst-rank score analysis with informatively missing observations in clinical trials. Control Clin Trials 20 (1999) 408-422
13. Normand S.L., Rector T.S., Neaton J.D., Pina I.L., Lazar R.M., Proestel S.E., et al. Clinical and analytical considerations in the study of health status in device trials for heart failure. J Card Fail 11 (2005) 396-403
14. Moye L.A., Davis B.R., and Hawkins C.M. Analysis of a clinical trial involving a combined mortality and adherence dependent interval censored endpoint. Stat Med 11 (1992) 1705-1717
15. Finkelstein D.M., and Schoenfeld D.A. Combining mortality and longitudinal measures in clinical trials. Stat Med 18 (1999) 1341-1354
16. McMahon R.P., and Harrell F.E. Power calculation for clinical trials when the outcome is a composite ranking of survival and a nonfatal outcome. Control Clin Trials 21 (2000) 305-312
17. Maas A.I., and Murray G.D. Magnesium for neuroprotection after traumatic brain injury. Lancet Neurol 6 (2007) 20-21