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Volumn 23, Issue 6, 2013, Pages 1352-1371

Analysis of longitudinal trials with protocol deviation: A framework for relevant, accessible assumptions, and inference via multiple imputation

Author keywords

Clinical trial; De facto estimand; De jure estimand; Intention to treat; Missing data; Multiple imputation; Protocol deviation; Sensitivity analysis

Indexed keywords

BUDESONIDE; PLACEBO;

EID: 84887005678     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543406.2013.834911     Document Type: Article
Times cited : (196)

References (28)
  • 1
    • 2442736478 scopus 로고    scopus 로고
    • Small-sample degrees of freedom with multiple imputation
    • Barnard, J., Rubin, D. (1999). Small-sample degrees of freedom with multiple imputation. Biometrika 86:948-955
    • (1999) Biometrika , vol.86 , pp. 948-955
    • Barnard, J.1    Rubin, D.2
  • 2
    • 0031958895 scopus 로고    scopus 로고
    • Budesonide delivered by Turbuhaler is effective in a dose-dependent fashion when used in the treatment of adult patients with chronic asthma
    • DOI 10.1016/S0091-6749(98)70353-7
    • Busse, W. W., Chervinsky, P., Condemi, J., Lumry, W. R., Petty, T. L., Rennard, S., Townley, R. G. (1998). Budesonide delivered by Turbuhaler is effective in a dosedependent fashion when used in the treatment of adult patients with chronic asthma. Journal of Allergy and Clinical Immunology 101:457-463 (Pubitemid 28208248)
    • (1998) Journal of Allergy and Clinical Immunology , vol.101 , Issue.4 , pp. 457-463
    • Busse, W.W.1    Chervinsky, P.2    Condemi, J.3    Lumry, W.R.4    Petty, T.L.5    Rennard, S.6    Townley, R.G.7
  • 4
    • 78649584235 scopus 로고    scopus 로고
    • Committee for Medicinal Products for Human Use (CHMP) London, UK: European Medicines Agency
    • Committee for Medicinal Products for Human Use (CHMP). (2010). Guideline on Missing Data in Confirmatory Clinical Trials. London, UK: European Medicines Agency
    • (2010) Guideline on Missing Data in Confirmatory Clinical Trials
  • 5
    • 0012803122 scopus 로고    scopus 로고
    • Committee for Proprietary Medicinal Products (CPMP) London, UK: European Agency for the Evaluation of Medicinal Products Available at (accessed January 10, 2006)
    • Committee for Proprietary Medicinal Products (CPMP). (2001). Points to Consider on Missing Data. London, UK: European Agency for the Evaluation of Medicinal Products. Available at: www.emea.eu.int (accessed January 10, 2006)
    • (2001) Points to Consider on Missing Data
  • 8
    • 0033546995 scopus 로고    scopus 로고
    • What is meant by intention to treat analysis? Survey of published randomised controlled trials
    • Hollis, S., Campbell, F. (1999). What is meant by intention to treat analysis? Survey of published randomised controlled trial. British Medical Journal 319:670-674 (Pubitemid 29423954)
    • (1999) British Medical Journal , vol.319 , Issue.7211 , pp. 670-674
    • Hollis, S.1    Campbell, F.2
  • 9
    • 0033566769 scopus 로고    scopus 로고
    • Statistical principles for clinical trials: ICH harmonised tripartite guideline
    • ICH E9 Expert Working Group
    • ICH E9 Expert Working Group. (1999). Statistical principles for clinical trials: ICH harmonised tripartite guideline. Statistics in Medicine 18:1905-1942
    • (1999) Statistics in Medicine , vol.18 , pp. 1905-1942
  • 10
    • 63049088583 scopus 로고    scopus 로고
    • Multiple imputation
    • Davidian M., Fitzmaurice, G., eds. Chichester, UK Wiley
    • Kenward, M. G., Carpenter, J. R. (2009). Multiple imputation. In A Handbook of Modern Statistical Methods. Davidian, M., Fitzmaurice, G., eds. Chichester, UK: Wiley, pp. 477-500
    • (2009) A Handbook of Modern Statistical Methods , pp. 477-500
    • Kenward, M.G.1    Carpenter, J.R.2
  • 11
    • 0030880605 scopus 로고    scopus 로고
    • Small sample inference for fixed effects from restricted maximum likelihood
    • DOI 10.2307/2533558
    • Kenward, M. G., Roger, J. H. (1997). Small sample inference for fixed effects from restricted maximum likelihood. Biometrics 53:983-997 (Pubitemid 27391027)
    • (1997) Biometrics , vol.53 , Issue.3 , pp. 983-997
    • Kenward, M.G.1    Roger, J.H.2
  • 14
    • 0030460385 scopus 로고    scopus 로고
    • Intent-to-treat analysis for longitudinal studies with dropouts
    • Little, R. J. A., Yau, L. (1996). Intent-to-treat analysis for longitudinal studies with dropouts. Biometrics 52:471-483
    • (1996) Biometrics , vol.52 , pp. 471-483
    • Little, R.J.A.1    Yau, L.2
  • 16
    • 84886993421 scopus 로고    scopus 로고
    • National Institute for Clinical Excellence Available at accessed October 17 2011
    • National Institute for Clinical Excellence. (2011). Glossary. Available at: http://www.nice. org.uk/website/glossary/glossary.jsp (accessed October 17, 2011)
    • (2011) Glossary
  • 17
    • 79952576381 scopus 로고    scopus 로고
    • National Research Council Committee on National Statistics, Division of Behavioral and Social Sciences and Education. Washington DC: National Academies Press
    • National Research Council. (2010). The Prevention and Treatment of Missing Data in Clinical Trials. Panel on Handling Missing Data in Clinical Trials. Committee on National Statistics, Division of Behavioral and Social Sciences and Education. Washington, DC: National Academies Press
    • (2010) The Prevention and Treatment of Missing Data in Clinical Trials. Panel on Handling Missing Data in Clinical Trials
  • 18
    • 78650651199 scopus 로고    scopus 로고
    • Missing data: Discussion points from the PSI missing data expert group
    • on behalf of the PSI Expert Group
    • Philips, A. on behalf of the PSI Expert Group. (2010). Missing data: Discussion points from the PSI missing data expert group. Pharmaceutical Statistics 9:288-297
    • (2010) Pharmaceutical Statistics , vol.9 , pp. 288-297
    • Philips, A.1
  • 19
    • 0017042882 scopus 로고
    • Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design
    • Peto, R., Pike, M. C., Armitage, P., Breslow, N. E., Cox, D. R., Howard, S. V., Mantel, N., McPherson, K., Peto, J., Smith, P. G. (1976a). Design and analysis of randomised clinical trials requiring prolonged observation of each patient. I. Introduction and design. British Journal of Cancer 34:585-612 (Pubitemid 8004970)
    • (1976) British Journal of Cancer , vol.34 , Issue.6 , pp. 585-612
    • Peto, R.1    Pike, M.C.2    Armitage, P.3
  • 23
    • 0032960273 scopus 로고    scopus 로고
    • Multiple imputation: A primer
    • DOI 10.1191/096228099671525676
    • Schafer, J. L. (1999). Multiple imputation: A primer. Statistical Methods in Medical Research 8:3-15 (Pubitemid 29222784)
    • (1999) Statistical Methods in Medical Research , vol.8 , Issue.1 , pp. 3-15
    • Schafer, J.L.1
  • 24
    • 0014115513 scopus 로고
    • Explanatory and pragmatic attitudes in therapeutic trials
    • Schwartz, D., Lelouch J. (1967). Explanatory and pragmatic attitudes in therapeutic trials. Journal of Chronic Diseases 20:637-648
    • (1967) Journal of Chronic Diseases , vol.20 , pp. 637-648
    • Schwartz, D.1    Lelouch, J.2
  • 26
    • 34249281320 scopus 로고    scopus 로고
    • Eliciting and using expert opinions about dropout bias in randomized controlled trials
    • DOI 10.1177/1740774507077849
    • White, I. R., Carpenter, J. R., Evans, S. J., Schroter, S. (2007). Eliciting and using expert opinions about non-response bias in randomised controlled trials. Clinical Trials 4:125-139 (Pubitemid 46814848)
    • (2007) Clinical Trials , vol.4 , Issue.2 , pp. 125-139
    • White, I.R.1    Carpenter, J.2    Evans, S.3    Schroter, S.4
  • 27
    • 79955417678 scopus 로고    scopus 로고
    • Strategy for intention to treat analysis in randomised trials with missing outcome data
    • White I. R., Horton, N. J., Carpenter, J. R., Pocock, S. J. (2011). Strategy for intention to treat analysis in randomised trials with missing outcome data. British Medical Journal 342:d40
    • (2011) British Medical Journal , vol.342
    • White, I.R.1    Horton, N.J.2    Carpenter, J.R.3    Pocock, S.J.4
  • 28
    • 78651256743 scopus 로고    scopus 로고
    • Multiple imputation using chained equations: Issues and guidance for practice
    • White, I. R., Royston, P., Wood, A. M. (2011). Multiple imputation using chained equations: Issues and guidance for practice. Statistics in Medicine 30:377-399
    • (2011) Statistics in Medicine , vol.30 , pp. 377-399
    • White, I.R.1    Royston, P.2    Wood, A.M.3


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