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Volumn 7, Issue 4, 2012, Pages

Designing and analyzing clinical trials with composite outcomes: Consideration of possible treatment differences between the individual outcomes

Author keywords

[No Author keywords available]

Indexed keywords

BETA ADRENERGIC RECEPTOR BLOCKING AGENT; PLACEBO;

EID: 84859840957     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0034785     Document Type: Article
Times cited : (40)

References (32)
  • 1
    • 0037031257 scopus 로고    scopus 로고
    • Lessons learned from recent cardiovascular clinical trials: Part I. Circulation
    • DeMets D, Califf R, (2002) Lessons learned from recent cardiovascular clinical trials: Part I. Circulation 106: 746-751.
    • (2002) , vol.106 , pp. 746-751
    • DeMets, D.1    Califf, R.2
  • 2
    • 34247503838 scopus 로고    scopus 로고
    • Problems with use of composite end points in cardiovascular trials: Systematic review of randomized controlled trials
    • British Medical Journal
    • Ferreira-Gonzalez I, Busse J, Heels-Ansdell D, Montori V, Akl E, et al. (2007) Problems with use of composite end points in cardiovascular trials: Systematic review of randomized controlled trials. British Medical Journal.
    • (2007)
    • Ferreira-Gonzalez, I.1    Busse, J.2    Heels-Ansdell, D.3    Montori, V.4    Akl, E.5
  • 5
    • 32944459943 scopus 로고    scopus 로고
    • How should clinicians interpret results reflecting the effect of an intervention on composite endpoints: Should I dump this lump?
    • Montori V, Busse J, Permanyer-Miralda G, Ferreira-Gonzalez I, Guyatt G, (2005) How should clinicians interpret results reflecting the effect of an intervention on composite endpoints: Should I dump this lump? ACP Journal Club 143: A8-A9.
    • (2005) ACP Journal Club , vol.143
    • Montori, V.1    Busse, J.2    Permanyer-Miralda, G.3    Ferreira-Gonzalez, I.4    Guyatt, G.5
  • 6
    • 2442461297 scopus 로고    scopus 로고
    • Multiple analyses in clinical trials
    • New York, Springer
    • Moye, LA, (2003) Multiple analyses in clinical trials. New York Springer.
    • (2003)
    • Moye, L.A.1
  • 7
    • 26844517347 scopus 로고    scopus 로고
    • Key issues in end point selection from heart failure trials: Composite end points
    • Neaton J, Gray G, Zuckerman B, Konstam M, (2005) Key issues in end point selection from heart failure trials: Composite end points. Journal of Cardiac Failure 11: 567-575.
    • (2005) Journal of Cardiac Failure , vol.11 , pp. 567-575
    • Neaton, J.1    Gray, G.2    Zuckerman, B.3    Konstam, M.4
  • 8
    • 0030778697 scopus 로고    scopus 로고
    • A reviewer's perspective on multiple endpoint issues in clinical trials
    • Huque M, Sankoh A, (1997) A reviewer's perspective on multiple endpoint issues in clinical trials. Journal of Biopharmaceutical Statistics 7: 545-564.
    • (1997) Journal of Biopharmaceutical Statistics , vol.7 , pp. 545-564
    • Huque, M.1    Sankoh, A.2
  • 9
    • 33645227163 scopus 로고    scopus 로고
    • Some issues with composite endpoints
    • Chi G, (2005) Some issues with composite endpoints. Fundamental & Clinical Pharmacology 19: 609-619.
    • (2005) Fundamental & Clinical Pharmacology , vol.19 , pp. 609-619
    • Chi, G.1
  • 10
    • 0141617402 scopus 로고    scopus 로고
    • Efficacy endpoint selection and multiplicity adjustment methods in clinical trials with inherent multiple endpoint issues
    • Sankoh A, D'Agostino R Sr, Huque M, (2003) Efficacy endpoint selection and multiplicity adjustment methods in clinical trials with inherent multiple endpoint issues. Statistics in Medicine 22: 3133-3150.
    • (2003) Statistics in Medicine , vol.22 , pp. 3133-3150
    • Sankoh, A.1    D'Agostino Sr., R.2    Huque, M.3
  • 11
    • 0037108235 scopus 로고    scopus 로고
    • Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems
    • Pocock S, Assmann S, Enos L, Kasten L, (2002) Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Statistics in Medicine 21: 2917-2930.
    • (2002) Statistics in Medicine , vol.21 , pp. 2917-2930
    • Pocock, S.1    Assmann, S.2    Enos, L.3    Kasten, L.4
  • 13
    • 0035892613 scopus 로고    scopus 로고
    • Approaches to heterogeneity in meta-analysis
    • Petitti D, (2001) Approaches to heterogeneity in meta-analysis. Statistics in Medicine 20: 3625-3633.
    • (2001) Statistics in Medicine , vol.20 , pp. 3625-3633
    • Petitti, D.1
  • 14
    • 44349168172 scopus 로고    scopus 로고
    • Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial
    • Devereaux P, Yang H, Yusuf S, Guyatt G, Leslie K, et al. (2008) Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. The Lancet 371: 1839-1847.
    • (2008) The Lancet , vol.371 , pp. 1839-1847
    • Devereaux, P.1    Yang, H.2    Yusuf, S.3    Guyatt, G.4    Leslie, K.5
  • 15
    • 0003663926 scopus 로고
    • Generalized Linear Models
    • London, Chapman and Hall
    • McCullagh, P, Nelder, JA, (1989) Generalized Linear Models. London Chapman and Hall.
    • (1989)
    • McCullagh, P.1    Nelder, J.A.2
  • 16
    • 77649173768 scopus 로고
    • Longitudinal data analysis using generalized linear models
    • Liang K, Zeger S, (1986) Longitudinal data analysis using generalized linear models. Biometrika 73: 13-22.
    • (1986) Biometrika , vol.73 , pp. 13-22
    • Liang, K.1    Zeger, S.2
  • 17
    • 0029807710 scopus 로고    scopus 로고
    • for the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stroke Trial Study Group. Use of a global test for multiple outcomes in stroke trials with application to the National Institute of Neurological Disorders and Stroke t-PA Trial
    • Tilley B, Marler J, Geller N, Lu M, Legler J, et al. (1996) for the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stroke Trial Study Group. Use of a global test for multiple outcomes in stroke trials with application to the National Institute of Neurological Disorders and Stroke t-PA Trial. Stroke 27: 2136-2142.
    • (1996) Stroke , vol.27 , pp. 2136-2142
    • Tilley, B.1    Marler, J.2    Geller, N.3    Lu, M.4    Legler, J.5
  • 18
    • 0027053029 scopus 로고
    • An overview of methods for the analysis of longitudinal data
    • Zeger S, Liang K, (1992) An overview of methods for the analysis of longitudinal data. Statistics in Medicine 11: 1825-1839.
    • (1992) Statistics in Medicine , vol.11 , pp. 1825-1839
    • Zeger, S.1    Liang, K.2
  • 19
    • 77954970861 scopus 로고    scopus 로고
    • Testing for heterogeneity among the components of a binary composite outcome in a clinical trial
    • Pogue J, Thabane L, Devereaux P, Yusuf S, (2010) Testing for heterogeneity among the components of a binary composite outcome in a clinical trial. BMC Medical Research Methodology 10.
    • (2010) BMC Medical Research Methodology , vol.10
    • Pogue, J.1    Thabane, L.2    Devereaux, P.3    Yusuf, S.4
  • 20
    • 0023248602 scopus 로고
    • Adjustment to the Mantel-Haenszel chi-squared statistic and odds ratio estimator when the data are clustered
    • Donald A, Donner A, (1987) Adjustment to the Mantel-Haenszel chi-squared statistic and odds ratio estimator when the data are clustered. Statistics in Medicine 6: 491-499.
    • (1987) Statistics in Medicine , vol.6 , pp. 491-499
    • Donald, A.1    Donner, A.2
  • 21
    • 0026629087 scopus 로고
    • A simple method for the analysis of clustered binary data
    • Rao J, Scott A, (1992) A simple method for the analysis of clustered binary data. Biometrics 48: 577-585.
    • (1992) Biometrics , vol.48 , pp. 577-585
    • Rao, J.1    Scott, A.2
  • 22
    • 84891398833 scopus 로고    scopus 로고
    • The Frailty Model
    • New York, Springer Science
    • Duchateau L, Janssen, P, (2008) The Frailty Model. New York Springer Science.
    • (2008)
    • Duchateau, L.1    Janssen, P.2
  • 23
    • 79953752268 scopus 로고
    • Regression analysis of multivariate incomplete failure time data by modeling marginal distributions
    • Wei L, Lin D, Weissfeld L, (1989) Regression analysis of multivariate incomplete failure time data by modeling marginal distributions. Journal of the American Statistical Association 84: 1065-1073.
    • (1989) Journal of the American Statistical Association , vol.84 , pp. 1065-1073
    • Wei, L.1    Lin, D.2    Weissfeld, L.3
  • 24
    • 1842293418 scopus 로고    scopus 로고
    • An overview of statistical methods for multiple failure time data in clinical trials
    • Wei L, Glidden D, (1997) An overview of statistical methods for multiple failure time data in clinical trials. Statistics in Medicine 16: 833-839.
    • (1997) Statistics in Medicine , vol.16 , pp. 833-839
    • Wei, L.1    Glidden, D.2
  • 25
    • 84859810191 scopus 로고    scopus 로고
    • Testing for treatment heterogeneity between the individual outcomes within a composite outcome [dissertation]
    • McMaster University
    • Pogue, J, (2012) Testing for treatment heterogeneity between the individual outcomes within a composite outcome [dissertation]. McMaster University.
    • (2012)
    • Pogue, J.1
  • 27
    • 84950438424 scopus 로고
    • Linear regression analysis for multivariate failure time observations
    • Lin D, Wei L, (1992) Linear regression analysis for multivariate failure time observations. Journal of the American Statistical Association 87: 1091-1097.
    • (1992) Journal of the American Statistical Association , vol.87 , pp. 1091-1097
    • Lin, D.1    Wei, L.2
  • 28
    • 84863304598 scopus 로고    scopus 로고
    • R A language and environment for statistical computing., version 2.11.1 [computer program]
    • R Development Core Team, Vienna, Austria, R Foundation for Statistical Computing
    • R Development Core Team (2008) R A language and environment for statistical computing., version 2.11.1 [computer program]. Vienna, Austria R Foundation for Statistical Computing.
    • (2008)
  • 31
    • 0034712491 scopus 로고    scopus 로고
    • Subgroup analysis and other (mis)uses of baseline data in clinical trials
    • Assman S, Pocock S, Enos L, Kasten L, (2000) Subgroup analysis and other (mis)uses of baseline data in clinical trials. The Lancet 355: 1064-1069.
    • (2000) The Lancet , vol.355 , pp. 1064-1069
    • Assman, S.1    Pocock, S.2    Enos, L.3    Kasten, L.4
  • 32
    • 0003463572 scopus 로고
    • Introduction to Linear Regression Analysis
    • New York, John Wiley & Sons
    • Montgomery, DC, Peck, EA, (1982) Introduction to Linear Regression Analysis. New York John Wiley & Sons.
    • (1982)
    • Montgomery, D.C.1    Peck, E.A.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.