Testing for heterogeneity among the components of a binary composite outcome in a clinical trial

BMC Medical Research Methodology

Volumn 10, Issue , 2010, Pages

  Pogue, Janice ^a   Thabane, Lehana ^a   Devereaux, P J ^a   Yusuf, Salim ^a  

^a MCMASTER UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL; CLINICAL TRIAL (TOPIC); HUMAN; OUTCOME ASSESSMENT; STATISTICAL ANALYSIS; STATISTICAL MODEL; STATISTICS;

CLINICAL TRIALS AS TOPIC; DATA INTERPRETATION, STATISTICAL; HUMANS; LOGISTIC MODELS; OUTCOME ASSESSMENT (HEALTH CARE);

EID: 77954970861     PISSN: None     EISSN: 14712288     Source Type: Journal    
DOI: 10.1186/1471-2288-10-49     Document Type: Article

References (31)

1. Localized intracoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting. MB Leon PS Teirstein JW Moses P Tripuranenin AJ Lansky S Jani SC Wong D Fish S Ellis DR Holmes D Kerieakes RE Kuntz, The New England Journal of Medicine 2001 344 250 6 10.1056/NEJM200101253440402 11172151
2. How should clinicians interpret results reflecting the effect of an intervention on composite endpoints: Should I dump this lump? VM Montori JW Busse G Permanyer-Miralda I Ferreira GH Guyatt, ACP Journal Club 2005 143 -8 9
3. Validity of composite outcomes in clinical trials. VM Montori G Permanyer-Miralda I Ferreira-Gonzalez JW Busse V Pacheco-Huergo D Bryant J Alonso EA Akl A Domingo-Salvany E Mills P Wu HJ Schunemann R Jaeschke GH Guyatt, British Medical Journal 2005 330 594 6 10.1136/bmj.330.7491.594 15761002
4. Problems with use of composite end points in cardiovascular trials: systematic review of randomized controlled trials. I Ferreira-Gonzalez JW Busse Heels-Ansdell VM Montori EA Akl DM Bryant P Alonso-Coello J Alonso A Worster S Upadhye R Jaeschke HJ Schunemann G Permanyer-Miralda V Pacheco-Huergo A Domingo-Salvany P Wu EJ Mills GH Guyatt, British Medical Journal 2007 334 7597 786 10.1136/bmj.39136.682083.AE 17403713
5. Lessons learned from recent cardiovascular clinical trials: Part I. DL DeMets RM Califf, Circulation 2002 106 746 51 10.1161/01.CIR.0000023219.51483.66 12163438
6. Key issues in end point selection for heart failure trials: Composite end points. JD Neaton G Gray BD Zuckerman MA Konstam, Journal of Cardiac Failure 2005 11 567 75 10.1016/j.cardfail.2005.08.350 16230258
7. LA Moye, Multiple analyses in clinical trials New York: Springer 2003
8. Evaluating surgical outcomes. S Bergman LS Feldman JS Barkun, Surgical Clinics of North America 2006 86 129 49 10.1016/j.suc.2005.10.007 16442425
9. Left ventricular ejection fraction may not be useful as an end point of thrombolytic therapy comparative trials. RM Califf L Harrelson-Woodlief EJ Topol, Circulation 1990 82 1847 53 2225381
10. An approach to evaluating thrombolytic therapy in acute myocardial infarction. The 'unsatisfactory outcome' end point. E Braunwald CP Cannon CH McCabe, Circulation 1992 86 683 7 1638732
11. Endpoints and regulatory issues in HIV vaccine clinical trials. D Follmann A Duerr S Tabet P Gilber Z Moddie P Fast M Cardinali S Self, Journal of Acquired Immune Deficiency Syndrome 2007 44 49 60 10.1097/01.qai.0000247227. 22504.ce (Pubitemid 46052220)
12. Evolution of endpoints for renal transplant outcome. S Hariharan MA McBride EP Cohen, American Journal of Transplantation 2003 3 933 41 10.1034/j.1600-6143.2003.00176.x 12859527
13. Statistical approaches to effectiveness measurement and outcome-driven re-randomizations in the clinical antipsychotic trials of intervention effectiveness (CATIE) studies. SM Davis GG Koch CE Davis LM LaVange, Schizophrenia Bulletin 2003 29 73 80 12908662
14. Powering our way to the elusive side effect: A composite outcome 'basket' of predefined designated endpoints in each organ system should be included in all controlled trials. P Tugwell MG Judd JF Fries G Singh GA Wells, Journal of Clinical Epidemiology 2005 58 785 90 10.1016/j.jclinepi.2004.11.028 16018913
15. Composite outcomes in randomized clinical trial: arguments for and against. S Ross, American Journal of Obstetrics & Gynecology 2007 196 119e1 e6
16. A reviewer's perspective on multiple endpoint issues in clinical trials. MF Huque AJ Sankoh, Journal of Biopharmaceutical Statistics 1997 7 545 64 10.1080/10543409708835206 9358328
17. Efficacy endpoint selection and multiplicity adjustment methods in clinical trials with inherent multiple endpoint issues. AJ Sankoh RB D'Argostina Sr MF Huque, Statistics in Medicine 2003 22 3133 50 10.1002/sim.1557 14518019
18. Improving the information content of categorical clinical trials endpoints. V Berger, Controlled Clinical Trials 2002 23 502 14 10.1016/S0197-2456(02)00233-7 12392864
19. A method of assigning scores to the components of a composite outcome: An example from the MITI trial. AP Hallstrom PE Litwin WD Weaver, Controlled Clinical Trials 1992 13 148 55 10.1016/0197-2456(92)90020-Z 1316829
20. Rule-based ranking schemes for antiretroviral trials. LE Bjorling JS Hodges, Statistics in Medicine 1997 16 1175 91 10.1002/(SICI)1097-0258(19970530) 16:10<1175::AID-SIM5223.0.CO;2-G 9179982
21. Detecting and describing heterogeneity in meta-analysis. RJ Hardy SG Thompson, Statistics in Medicine 1998 17 841 56 10.1002/(SICI)1097- 0258(19980430)17:8<841::AID-SIM7813.0.CO;2-D 9595615
22. SAS Institute, SAS version 9.1 SAS Institute, Cary, NC
23. MM Shoukri MA Chaudhary, Analysis of Correlated Data with SAS and R London, Chapman & Hall 3 2007
24. Adjustment to the Mantel-Haenszel chi-squared statistic and odds ratio estimator when the data are clustered. A Donald A Donner, Statistics in Medicine 1987 6 491 9 10.1002/sim.4780060408 3629050
25. A simple method for the analysis of clustered binary data. JNK Rao AJ Scott, Biometrics 1992 48 577 85 10.2307/2532311 1637980
26. Longitudinal data analysis using generalized linear models. KY Liang SL Zeger, Biometrika 1986 73 13 22 10.1093/biomet/73.1.13
27. P McCullagh JA Nelder, Generalized Linear Models London: Chapman and Hall 1989
28. Effect of an angiotensin-converting-enzyme inhibitor, ramipril on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation (HOPE) Study Investigators, The New England Journal of Medicine 2000 342 145 53 10.1056/NEJM200001203420301 10639539
29. A simple method for generating correlated binary variates. CG Park T Park DW Shin, The American Statistician 1996 50 306 10 10.2307/2684925
30. A comparison of the statistical power of different methods for the analysis of cluster randomization trials with binary outcomes. PC Austin, Statistics in Medicine 2007 26 3550 65 10.1002/sim.2813 17238238
31. DW Hosmer S Lemeshow, Applied Logistic Regression New York: John Wiley & Sons, Inc 2000