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Volumn 14, Issue 1, 2009, Pages 36-49

Intention to treat analysis, compliance, drop-outs and how to deal with missing data in clinical research: a review

Author keywords

COMPLIANCE; EFFECTIVENESS; EFFICACY; INTENTION TO TREAT ANALYSIS; MISSING DATA; RANDOMISED CLINICAL TRIALS; REVIEW

Indexed keywords


EID: 79958096534     PISSN: 10833196     EISSN: 1743288X     Source Type: Journal    
DOI: 10.1179/174328809X405928     Document Type: Review
Times cited : (260)

References (48)
  • 1
    • 0035901579 scopus 로고    scopus 로고
    • The revised CONSORT statement for reporting randomized trials: explanation and elaboration
    • Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Internal Med 2001; 134: 663–694.
    • (2001) Ann Internal Med , vol.134 , pp. 663-694
    • Altman, D.G.1    Schulz, K.F.2    Moher, D.3    Egger, M.4    Davidoff, F.5    Elbourne, D.6
  • 2
    • 0034621034 scopus 로고    scopus 로고
    • Intention to treat analysis is related to methodological quality
    • Ruiz-Canela M, Martinez-Gonzalez MA, De Irala-Estevez J. Intention to treat analysis is related to methodological quality. BMJ 2000; 320: 1007–1008.
    • (2000) BMJ , vol.320 , pp. 1007-1008
    • Ruiz-Canela, M.1    Martinez-Gonzalez, M.A.2    De Irala-Estevez, J.3
  • 4
    • 70149088007 scopus 로고    scopus 로고
    • Chapter 3: What constiutes evidence; What constitutes evidence about effects of interventions?
    • Herbert R., Jamtvedt G., Mead J., Birger Hagen K., (eds), In, editors, Edinburgh: Elsevier, p
    • Herbert R, Jamtvedt G, Mead J, Birger Hagen K. Chapter 3: What constiutes evidence; What constitutes evidence about effects of interventions? In: Herbert R, Jamtvedt G, Mead J, Birger Hagen K, editors. Practical evidence-based physiotherapy. Edinburgh: Elsevier; 2005. p. 20–34.
    • (2005) Practical evidence-based physiotherapy , pp. 20-34
    • Herbert, R.1    Jamtvedt, G.2    Mead, J.3    Birger Hagen, K.4
  • 5
    • 34447287864 scopus 로고    scopus 로고
    • General Issues
    • Machin D., Day S., Green S., (eds), In, editors, Chichester: John Wiley & Sons, Ltd, p
    • Machin D. General Issues. In: Machin D, Day S, Green S, editors. Textbook of Clinical Trials. Chichester: John Wiley & Sons, Ltd.; 2004. p. 11–44.
    • (2004) Textbook of Clinical Trials , pp. 11-44
    • Machin, D.1
  • 6
    • 85047692188 scopus 로고
    • Empirical evidence of bias: Dimensions of methodological quality associated with estimates of treatment effects in controlled trials
    • Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. J Amer Med Assoc 1995; 273: 408–412.
    • (1995) J Amer Med Assoc , vol.273 , pp. 408-412
    • Schulz, K.F.1    Chalmers, H.R.J.2    Altman, D.G.3
  • 7
    • 40949113623 scopus 로고    scopus 로고
    • Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: Meta- epidemiological study
    • Wood L, Egger M, Gluud LL, Schulz KF, Juni P, Altman DG, et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: Meta- epidemiological study. BMJ 2008; 336: 601–605.
    • (2008) BMJ , vol.336 , pp. 601-605
    • Wood, L.1    Egger, M.2    Gluud, L.L.3    Schulz, K.F.4    Juni, P.5    Altman, D.G.6
  • 9
    • 85053538802 scopus 로고
    • Intention to Treat in Clinical Trials
    • Peace K., (ed), In, editor, New York: Marcel Dekker, p
    • Fisher L. Intention to Treat in Clinical Trials. In: Peace K, editor. Statistical Issues in Drug Research and Development. New York: Marcel Dekker; 1990. p. 331–350.
    • (1990) Statistical Issues in Drug Research and Development , pp. 331-350
    • Fisher, L.1
  • 11
    • 0034061095 scopus 로고    scopus 로고
    • Statistical considerations in the intent-to-treat principle
    • Lachin JM. Statistical considerations in the intent-to-treat principle. Control Clin Trials 2000; 21: 167–189.
    • (2000) Control Clin Trials , vol.21 , pp. 167-189
    • Lachin, J.M.1
  • 12
    • 0030881070 scopus 로고    scopus 로고
    • Intention-to-treat analysis in randomized trials: Who gets counted?
    • Gibaldi M, Sullivan S. Intention-to-treat analysis in randomized trials: Who gets counted? J Clin Pharmacol 1997; 37: 667–672.
    • (1997) J Clin Pharmacol , vol.37 , pp. 667-672
    • Gibaldi, M.1    Sullivan, S.2
  • 13
    • 0032520209 scopus 로고    scopus 로고
    • The hope and the hazards of using compliance data in randomized controlled trials
    • Pocock SJ, Abdalla M. The hope and the hazards of using compliance data in randomized controlled trials. Stat Med 1998; 17: 303–317.
    • (1998) Stat Med , vol.17 , pp. 303-317
    • Pocock, S.J.1    Abdalla, M.2
  • 14
    • 84890613528 scopus 로고    scopus 로고
    • Chapter 16: Special topics in statistics
    • Higgins J., Green S., (eds), In, editors, [updated February, The Cochrane Collaboration, 2008. Available from, 2008
    • Higgins J, Deeks J, Altman D, Group obotCSM. Chapter 16: Special topics in statistics. In: Higgins J, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.0 [updated February 2008].: The Cochrane Collaboration, 2008. Available from www.cochrane-handbook.org; 2008.
    • (2008) Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.0
    • Higgins, J.1    Deeks, J.2    Altman, D.3
  • 15
    • 0345006938 scopus 로고
    • The analysis of data from clinical trials
    • Armitage P. The analysis of data from clinical trials. Statistician 1979; 28: 171–183.
    • (1979) Statistician , vol.28 , pp. 171-183
    • Armitage, P.1
  • 16
    • 0033546995 scopus 로고    scopus 로고
    • What is meant by intention to treat analysis? Survey of published randomised controlled trials
    • Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ 1999; 319: 670–674.
    • (1999) BMJ , vol.319 , pp. 670-674
    • Hollis, S.1    Campbell, F.2
  • 17
    • 0034534567 scopus 로고    scopus 로고
    • Efficacy, effectiveness, efficiency
    • Marley J., Editorial : Efficacy, effectiveness, efficiency. Aust Prescr 2000; 23: 114–115.
    • (2000) Aust Prescr , vol.23 , pp. 114-115
    • Editorial, M.J.1
  • 18
    • 0037151796 scopus 로고    scopus 로고
    • Post-randomisation exclusions: The intention to treat principle and excluding patients from analysis
    • Fergusson D, Aaron SD, Guyatt G, Hebert P. Post-randomisation exclusions: The intention to treat principle and excluding patients from analysis. BMJ 2002; 325: 652–654.
    • (2002) BMJ , vol.325 , pp. 652-654
    • Fergusson, D.1    Aaron, S.D.2    Guyatt, G.3    Hebert, P.4
  • 21
    • 0141849400 scopus 로고    scopus 로고
    • Intention-to-treat approach to data from randomized controlled trials: A sensitivity analysis
    • Wright CC, Sim J. Intention-to-treat approach to data from randomized controlled trials: A sensitivity analysis. J Clin Epidemiol 2003; 56: 833–842.
    • (2003) J Clin Epidemiol , vol.56 , pp. 833-842
    • Wright, C.C.1    Sim, J.2
  • 22
    • 0142260954 scopus 로고    scopus 로고
    • Inclusion of patients in clinical trial analysis: The intention-to-treat principle
    • Heritier SR, Gebski VJ, Keech AC. Inclusion of patients in clinical trial analysis: The intention-to-treat principle. Med J Aust 2003; 179: 438–440.
    • (2003) Med J Aust , vol.179 , pp. 438-440
    • Heritier, S.R.1    Gebski, V.J.2    Keech, A.C.3
  • 23
    • 0035046888 scopus 로고    scopus 로고
    • Does intention-to- treat analysis answer all questions in long-term mortality trials? Considerations on the basis of the ANZ trial
    • Tillmann HC, Sharpe N, Sponer G, Wehling M. Does intention-to- treat analysis answer all questions in long-term mortality trials? Considerations on the basis of the ANZ trial. Int J Clin Pharmacol Ther 2001; 39: 205–212.
    • (2001) Int J Clin Pharmacol Ther , vol.39 , pp. 205-212
    • Tillmann, H.C.1    Sharpe, N.2    Sponer, G.3    Wehling, M.4
  • 24
    • 20744445181 scopus 로고    scopus 로고
    • Violation of the intent-to-treat principle and rate of missing data in superiority trials assessing structural outcomes in rheumatic diseases
    • Baron G, Boutron I, Giraudeau B, Ravaud P. Violation of the intent-to-treat principle and rate of missing data in superiority trials assessing structural outcomes in rheumatic diseases. Arthr Rheuma 2005; 52: 1858–1865.
    • (2005) Arthr Rheuma , vol.52 , pp. 1858-1865
    • Baron, G.1    Boutron, G.B.2    Ravaud, P.3
  • 25
    • 0035977410 scopus 로고    scopus 로고
    • Intention-to-treat: Methods for dealing with missing values in clinical trials of progressively deteriorating diseases
    • Unnebrink K, Windeler J. Intention-to-treat: Methods for dealing with missing values in clinical trials of progressively deteriorating diseases. Stat Med 2001; 20: 3931–3946.
    • (2001) Stat Med , vol.20 , pp. 3931-3946
    • Unnebrink, K.1    Windeler, J.2
  • 27
    • 0029112615 scopus 로고
    • Improving the transition from basic efficacy research to effectiveness studies: Methodological issues and procedures
    • Clarke GN. Improving the transition from basic efficacy research to effectiveness studies: Methodological issues and procedures. J Consult Clin Psychol 1995; 63: 718–725.
    • (1995) J Consult Clin Psychol , vol.63 , pp. 718-725
    • Clarke, G.N.1
  • 28
    • 85047668937 scopus 로고    scopus 로고
    • Statistical power in randomized intervention studies with noncompliance
    • Jo B. Statistical power in randomized intervention studies with noncompliance. Psychol Meth 2002; 7: 178–193.
    • (2002) Psychol Meth , vol.7 , pp. 178-193
    • Jo, B.1
  • 29
    • 0036775090 scopus 로고    scopus 로고
    • ‘Intention-to-treat’ meets ‘missing data’: Implications of alternate strategies for analyzing clinical trials data
    • Nich C, Carroll KM. ‘Intention-to-treat’ meets ‘missing data’: Implications of alternate strategies for analyzing clinical trials data. Drug Alc Depend 2002; 68: 121–130.
    • (2002) Drug Alc Depend , vol.68 , pp. 121-130
    • Nich, C.1    Carroll, K.M.2
  • 30
    • 0003576014 scopus 로고
    • Chapter 12: Protocol Deviations
    • Pocock S., (ed), In, editor, New York: John Wiley & Sons Ltd, p
    • Pocock S. Chapter 12: Protocol Deviations. In: Pocock S, editor. Clinical Trials. New York: John Wiley & Sons Ltd.; 1983. p. 176–186.
    • (1983) Clinical Trials , pp. 176-186
    • Pocock, S.1
  • 31
    • 0000741850 scopus 로고    scopus 로고
    • Addressing complications of intention- to-treat analysis in the combined presence of all-or-none treatment- noncompliance and subsequent missing outcomes
    • Frangakis CE, Rubin DB. Addressing complications of intention- to-treat analysis in the combined presence of all-or-none treatment- noncompliance and subsequent missing outcomes. Biometrika 1999; 86: 365–379.
    • (1999) Biometrika , vol.86 , pp. 365-379
    • Frangakis, C.E.1    Rubin, D.B.2
  • 32
    • 0034762257 scopus 로고    scopus 로고
    • Intention-to-treat principle
    • Montori VM, Guyatt GH. Intention-to-treat principle. Can Med Assoc J 2001; 165: 1339–1341.
    • (2001) Can Med Assoc J , vol.165 , pp. 1339-1341
    • Montori, V.M.1    Guyatt, G.H.2
  • 34
    • 0017133178 scopus 로고
    • Inference and missing data
    • Rubin DB. Inference and missing data. Biometrika 1976; 63: 581–592.
    • (1976) Biometrika , vol.63 , pp. 581-592
    • Rubin, D.B.1
  • 35
    • 3042844143 scopus 로고    scopus 로고
    • Missing data: A review of current methods and applications in epidemiological research
    • Abraham WT, Russell DW. Missing data: A review of current methods and applications in epidemiological research. Curr Opin Psychiat 2004; 17: 315–321.
    • (2004) Curr Opin Psychiat , vol.17 , pp. 315-321
    • Abraham, W.T.1    Russell, D.W.2
  • 36
    • 0043198343 scopus 로고    scopus 로고
    • Modern statistical methods for handling missing repeated measurements in obesity trial data: Beyond LOCF
    • Gadbury GL, Coffey CS, Allison DB. Modern statistical methods for handling missing repeated measurements in obesity trial data: Beyond LOCF. Obes Rev 2003; 4: 175–184.
    • (2003) Obes Rev , vol.4 , pp. 175-184
    • Gadbury, G.L.1    Coffey, C.S.2    Allison, D.B.3
  • 37
    • 33744830564 scopus 로고    scopus 로고
    • Can one assess whether missing data are missing at random in medical studies?
    • Potthoff RF, Tudor GE, Pieper KS, Hasselblad V. Can one assess whether missing data are missing at random in medical studies? Stat Meth Med Res 2006; 15: 213–234.
    • (2006) Stat Meth Med Res , vol.15 , pp. 213-234
    • Potthoff, R.F.1    Tudor, G.E.2    Pieper, K.S.3    Hasselblad, V.4
  • 38
    • 0035436831 scopus 로고    scopus 로고
    • Intention to treat analysis in clinical trials when there are missing data
    • Streiner D, Geddes J. Intention to treat analysis in clinical trials when there are missing data. Evid Based Ment Health 2001; 4: 70–71.
    • (2001) Evid Based Ment Health , vol.4 , pp. 70-71
    • Streiner, D.1    Geddes, J.2
  • 39
    • 0037203136 scopus 로고    scopus 로고
    • Use of the mean, hot deck and multiple imputation techniques to predict outcome in intensive care unit patients in Colombia
    • Perez A, Dennis RJ, Gil JFA, Rondon MA, Lopez A. Use of the mean, hot deck and multiple imputation techniques to predict outcome in intensive care unit patients in Colombia. Stat Med 2002; 21: 3885–3896.
    • (2002) Stat Med , vol.21 , pp. 3885-3896
    • Perez, A.1    Dennis, R.J.2    Gil, J.F.A.3    Rondon, M.A.4    Lopez, A.5
  • 40
    • 0030460385 scopus 로고    scopus 로고
    • Intent-to-treat analysis for longitudinal studies with drop-outs
    • Little R, Yau L. Intent-to-treat analysis for longitudinal studies with drop-outs. Biometrics 1996; 52: 1324–1333.
    • (1996) Biometrics , vol.52 , pp. 1324-1333
    • Little, R.1    Yau, L.2
  • 42
    • 0037470266 scopus 로고    scopus 로고
    • Bias due to missing exposure data using complete-case analysis in the proportional hazards regression model
    • Demissie S, LaValley MP, Horton NJ, Glynn RJ, Cupples LA. Bias due to missing exposure data using complete-case analysis in the proportional hazards regression model. Stat Med 2003; 22: 545–557.
    • (2003) Stat Med , vol.22 , pp. 545-557
    • Demissie, S.1    LaValley, M.P.2    Horton, N.J.3    Glynn, R.J.4    Cupples, L.A.5
  • 43
    • 0242466086 scopus 로고    scopus 로고
    • Problems in dealing with missing data and informative censoring in clinical trials
    • Shih WJ. Problems in dealing with missing data and informative censoring in clinical trials. Curr Control Trials Cardiovasc Med 2002; 3.
    • (2002) Curr Control Trials Cardiovasc Med , vol.3
    • Shih, W.J.1
  • 44
    • 33749246253 scopus 로고    scopus 로고
    • Pragmatic randomised controlled trials in parenting research: The issue of intention to treat
    • Whittaker K, Sutton C, Burton C. Pragmatic randomised controlled trials in parenting research: The issue of intention to treat. J Epidemiol Commun Health 2006; 60: 858–864.
    • (2006) J Epidemiol Commun Health , vol.60 , pp. 858-864
    • Whittaker, K.1    Sutton, C.2    Burton, C.3
  • 45
    • 0032466012 scopus 로고    scopus 로고
    • The principle of intention to treat analysis in clinical studies: Its use and controversies
    • Hardin JM. The principle of intention to treat analysis in clinical studies: Its use and controversies. J Pharm Pract 1998; 11: 231–238.
    • (1998) J Pharm Pract , vol.11 , pp. 231-238
    • Hardin, J.M.1
  • 46
    • 33748475679 scopus 로고    scopus 로고
    • The intention-to-treat principle: A primer for the orthopaedic surgeon
    • Bubbar VK, Kreder HJ. The intention-to-treat principle: A primer for the orthopaedic surgeon. J Bone Joint Surg - Ser A 2006; 88: 2097–2099.
    • (2006) J Bone Joint Surg - Ser A , vol.88 , pp. 2097-2099
    • Bubbar, V.K.1    Kreder, H.J.2
  • 48
    • 33744775651 scopus 로고    scopus 로고
    • A new preference-based analysis for randomized trials can estimate treatment acceptability and effect in compliant patients
    • Walter SD, Guyatt G, Montori VM, Cook R, Prasad K. A new preference-based analysis for randomized trials can estimate treatment acceptability and effect in compliant patients. J Clin Epidemiol 2006; 59: 685–696.
    • (2006) J Clin Epidemiol , vol.59 , pp. 685-696
    • Walter, S.D.1    Guyatt, G.2    Montori, V.M.3    Cook, R.4    Prasad, K.5


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