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Volumn 5, Issue 1, 2010, Pages

A novel method to adjust efficacy estimates for uptake of other active treatments in long-term clinical trials

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANGIOTENSIN II ANTAGONIST; ANTITHROMBOCYTIC AGENT; ATORVASTATIN; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM CHANNEL BLOCKING AGENT; CARDIOVASCULAR AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; FENOFIBRATE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; PLACEBO; PRAVASTATIN; SIMVASTATIN;

EID: 77649145926     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0008580     Document Type: Article
Times cited : (21)

References (38)
  • 1
    • 24944468294 scopus 로고    scopus 로고
    • Uses and limitations of randomization-based efficacy estimators
    • White IR (2005) Uses and limitations of randomization-based efficacy estimators. Stat Methods Med Res 14: 327.
    • (2005) Stat Methods Med Res , vol.14 , pp. 327
    • White, I.R.1
  • 2
    • 62249208742 scopus 로고    scopus 로고
    • Analysing direct effects in randomized trials with secondary interventions: An application to human immunodeficiency virus prevention trials
    • Rosenblum M, Jewell NP, van der Laan M, Shiboski S, Van der Straten A, et al. (2009) Analysing direct effects in randomized trials with secondary interventions: an application to human immunodeficiency virus prevention trials. J R Stat Soc A172: 443-465.
    • (2009) J R Stat Soc , vol.A172 , pp. 443-465
    • Rosenblum, M.1    Jewell, N.P.2    van der Laan, M.3    Shiboski, S.4    Van der Straten, A.5
  • 3
    • 3242749893 scopus 로고    scopus 로고
    • Adjusting for differential proportions of secondline treatment in cancer clinical trials. Part I: Structural nested models and marginal structural models to test and estimate treatment arm effects
    • Yamaguchi T, Ohashi Y (2004) Adjusting for differential proportions of secondline treatment in cancer clinical trials. Part I: Structural nested models and marginal structural models to test and estimate treatment arm effects. Stat Med 23: 1991-2003.
    • (2004) Stat Med , vol.23 , pp. 1991-2003
    • Yamaguchi, T.1    Ohashi, Y.2
  • 4
    • 0142260954 scopus 로고    scopus 로고
    • Inclusion of patients in clinical trial analysis: The intention-to-treat principle
    • Heritier SR, Gebski VJ, Keech AC (2003) Inclusion of patients in clinical trial analysis: the intention-to-treat principle. Med J Aust 179: 438-440.
    • (2003) Med J Aust , vol.179 , pp. 438-440
    • Heritier, S.R.1    Gebski, V.J.2    Keech, A.C.3
  • 5
    • 0028817457 scopus 로고
    • Intention-to-treat analysis and the goal of clinical trials
    • Sheiner LB, Rubin DB (1995) Intention-to-treat analysis and the goal of clinical trials. Clin Pharmacol Ther 56: 6-10.
    • (1995) Clin Pharmacol Ther , vol.56 , pp. 6-10
    • Sheiner, L.B.1    Rubin, D.B.2
  • 6
    • 85183083095 scopus 로고    scopus 로고
    • FIELD Study Investigators (2005) Effects of long-term fenofibrate therapy on cardiovascular events among 9795 people with type 2 diabetes mellitus (the FIELD study): a randomised controlled trial. Lancet 366: 1849-1861.
    • FIELD Study Investigators (2005) Effects of long-term fenofibrate therapy on cardiovascular events among 9795 people with type 2 diabetes mellitus (the FIELD study): a randomised controlled trial. Lancet 366: 1849-1861.
  • 7
    • 12444318777 scopus 로고    scopus 로고
    • The need for a large-scale trial of fibrate therapy in diabetes: The rationale and design of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. ISRCTN64783481
    • FIELD study investigators
    • FIELD study investigators (2004) The need for a large-scale trial of fibrate therapy in diabetes: the rationale and design of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. ISRCTN64783481. Cardiovasc Diabetol 3: 9.
    • (2004) Cardiovasc Diabetol , vol.3 , pp. 9
  • 8
    • 0034734141 scopus 로고    scopus 로고
    • Estimating treatment effect in randomized clinical trials in the presence of non-compliance
    • Nagelkerke N, Fidler V, Bernsen R, Borgdor M (2000) Estimating treatment effect in randomized clinical trials in the presence of non-compliance. Stat Med 19: 1849-1864.
    • (2000) Stat Med , vol.19 , pp. 1849-1864
    • Nagelkerke, N.1    Fidler, V.2    Bernsen, R.3    Borgdor, M.4
  • 9
    • 66949128919 scopus 로고    scopus 로고
    • A comparison of methods for estimating the causal effect of a treatment in randomized clinical trials subject to noncompliance
    • Little RJ, Long Q, Lin X (2009) A comparison of methods for estimating the causal effect of a treatment in randomized clinical trials subject to noncompliance. Biometrics 65: 640-649.
    • (2009) Biometrics , vol.65 , pp. 640-649
    • Little, R.J.1    Long, Q.2    Lin, X.3
  • 10
    • 33947102051 scopus 로고    scopus 로고
    • Instrumental variables and interactions in the causal analysis of a complex clinical trial
    • Bond SJ, White IR, Walker AS (2007) Instrumental variables and interactions in the causal analysis of a complex clinical trial. Stat Med 26: 1473-1496.
    • (2007) Stat Med , vol.26 , pp. 1473-1496
    • Bond, S.J.1    White, I.R.2    Walker, A.S.3
  • 11
    • 0035767377 scopus 로고    scopus 로고
    • Estimating the efficacy of receiving treatment in randomized clinical trials with noncompliance
    • Marcus SM, Gibbons RD (2001) Estimating the efficacy of receiving treatment in randomized clinical trials with noncompliance. Health Serv Outcomes Res Methodol 2: 247-258.
    • (2001) Health Serv Outcomes Res Methodol , vol.2 , pp. 247-258
    • Marcus, S.M.1    Gibbons, R.D.2
  • 12
    • 26844579239 scopus 로고    scopus 로고
    • Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study, a randomized, placebocontrolled trial: Baseline characteristics and short-term effects of fenofibrate
    • FIELD Study Investigators
    • FIELD Study Investigators (2005) Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study, a randomized, placebocontrolled trial: baseline characteristics and short-term effects of fenofibrate. Cardiovasc Diabetol 4: 13.
    • (2005) Cardiovasc Diabetol , vol.4 , pp. 13
  • 13
    • 0037065502 scopus 로고    scopus 로고
    • Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients
    • Antithrombotic Trialists' Collaboration
    • Antithrombotic Trialists' Collaboration (2002) Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ 324: 71-86.
    • (2002) BMJ , vol.324 , pp. 71-86
  • 14
    • 0038165393 scopus 로고    scopus 로고
    • A strategy to reduce cardiovascular disease by more than 80%
    • Wald NJ, Law MR (2003) A strategy to reduce cardiovascular disease by more than 80%. BMJ 326: 1419-1427.
    • (2003) BMJ , vol.326 , pp. 1419-1427
    • Wald, N.J.1    Law, M.R.2
  • 15
    • 0025347391 scopus 로고
    • Blood pressure, stroke and coronary heart disease. Part 2: Short-term reductions in blood pressure: overview of randomised drug trials in their epidemiological context
    • Collins R, Peto R, MacMahon S, Hebert P, Fiebach NH, et al. (1990) Blood pressure, stroke and coronary heart disease. Part 2: short-term reductions in blood pressure: overview of randomised drug trials in their epidemiological context. Lancet 335: 827-838.
    • (1990) Lancet , vol.335 , pp. 827-838
    • Collins, R.1    Peto, R.2    MacMahon, S.3    Hebert, P.4    Fiebach, N.H.5
  • 16
    • 0021909115 scopus 로고
    • Beta blockade during and after myocardial infarction: Overview of randomized trials
    • Yusuf S, Peto R, Lewis J, Collins R, Sleight P (1985) Beta blockade during and after myocardial infarction: overview of randomized trials. Prog Cardiovascular Dis 27: 335-371.
    • (1985) Prog Cardiovascular Dis , vol.27 , pp. 335-371
    • Yusuf, S.1    Peto, R.2    Lewis, J.3    Collins, R.4    Sleight, P.5
  • 17
    • 0023694811 scopus 로고
    • Overview of results of randomized clinical trials in heart disease. I. Treatments following myocardial infarction
    • Yusuf S, Wittes J, Friedman L (1988) Overview of results of randomized clinical trials in heart disease. I. Treatments following myocardial infarction. JAMA 260: 2088-2093.
    • (1988) JAMA , vol.260 , pp. 2088-2093
    • Yusuf, S.1    Wittes, J.2    Friedman, L.3
  • 18
    • 0034627183 scopus 로고    scopus 로고
    • Effects of ACE inhibitors, calcium antagonists, and other blood pressure lowering drugs: Results of prospectively designed overviews of randomised trials
    • Blood Pressure Lowering Treatment Trialists' Collaboration
    • Blood Pressure Lowering Treatment Trialists' Collaboration (2000) Effects of ACE inhibitors, calcium antagonists, and other blood pressure lowering drugs: results of prospectively designed overviews of randomised trials. Lancet 355: 1955-1964.
    • (2000) Lancet , vol.355 , pp. 1955-1964
  • 19
    • 0037490085 scopus 로고    scopus 로고
    • Value of low dose combination treatment with blood pressure lowering drugs: Analysis of 354 randomised trials
    • Law MR, Wald NJ, Morris JK, Jordan R (2003) Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials. BMJ 326: 1427-1431.
    • (2003) BMJ , vol.326 , pp. 1427-1431
    • Law, M.R.1    Wald, N.J.2    Morris, J.K.3    Jordan, R.4
  • 20
    • 0028306578 scopus 로고
    • Blood pressure, antihypertensive drug treatment and the risks of stroke and coronary heart disease
    • Collins R, MacMahon S (1994) Blood pressure, antihypertensive drug treatment and the risks of stroke and coronary heart disease. Br Med Bull 50: 272-298.
    • (1994) Br Med Bull , vol.50 , pp. 272-298
    • Collins, R.1    MacMahon, S.2
  • 21
    • 37749003775 scopus 로고    scopus 로고
    • Maximising secondary prevention therapies in patients with coronary heart disease
    • Capewell S, O'Flaherty M (2008) Maximising secondary prevention therapies in patients with coronary heart disease. Heart 94: 8-9.
    • (2008) Heart , vol.94 , pp. 8-9
    • Capewell, S.1    O'Flaherty, M.2
  • 22
    • 85183083610 scopus 로고    scopus 로고
    • Cholesterol Treatment Trialists' (CTT) Collaborators (2005) Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90 056 participants in 14 randomised trials of statins. Lancet 366: 1267-1278.
    • Cholesterol Treatment Trialists' (CTT) Collaborators (2005) Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90 056 participants in 14 randomised trials of statins. Lancet 366: 1267-1278.
  • 23
    • 38049033935 scopus 로고    scopus 로고
    • Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: A meta-analysis
    • Kearney PM, Blackwell L, Collins R, Keech A, Simes J, et al. (2008) Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lancet 71: 117-125.
    • (2008) Lancet , vol.71 , pp. 117-125
    • Kearney, P.M.1    Blackwell, L.2    Collins, R.3    Keech, A.4    Simes, J.5
  • 24
    • 0037490080 scopus 로고    scopus 로고
    • Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: Systematic review and meta-analysis
    • Law MR, Wald NJ, Rudnicka A (2003) Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis. BMJ 326: 1423-1427.
    • (2003) BMJ , vol.326 , pp. 1423-1427
    • Law, M.R.1    Wald, N.J.2    Rudnicka, A.3
  • 26
    • 0000336139 scopus 로고
    • Regression methods of life tables (with discussion)
    • Cox DR (1972) Regression methods of life tables (with discussion). J R Stat Soc B 34: 187-220.
    • (1972) J R Stat Soc B , vol.34 , pp. 187-220
    • Cox, D.R.1
  • 28
    • 0023757376 scopus 로고
    • Explanatory and pragmatic estimates of the treatment effect when deviations from allocated treatment occur
    • Newcombe RG (1988) Explanatory and pragmatic estimates of the treatment effect when deviations from allocated treatment occur. Stat Med 7: 1179-1186.
    • (1988) Stat Med , vol.7 , pp. 1179-1186
    • Newcombe, R.G.1
  • 29
    • 0026444054 scopus 로고
    • Meta-analysis adjusting for non-compliance: The example of breast cancer screening
    • Glasziou PP (1992) Meta-analysis adjusting for non-compliance: the example of breast cancer screening. J Clin Epidemiol 45: 1251-1256.
    • (1992) J Clin Epidemiol , vol.45 , pp. 1251-1256
    • Glasziou, P.P.1
  • 30
    • 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 (1999) Addressing complications of intention-to-treat analysis in the combined presence of all-or-none treatment-noncompliance and subsequent missing outcomes. Biometrika 86: 365-379.
    • (1999) Biometrika , vol.86 , pp. 365-379
    • Frangakis, C.E.1    Rubin, D.B.2
  • 31
    • 21844517537 scopus 로고
    • Adjusting for differential rates of prophylaxis therapy for PCP in high- versus low-dose AZT treatment arms in an AIDS randomized trial
    • Robins JM, Greenland S (1994) Adjusting for differential rates of prophylaxis therapy for PCP in high- versus low-dose AZT treatment arms in an AIDS randomized trial. J Am Stat Assoc 89: 737-749.
    • (1994) J Am Stat Assoc , vol.89 , pp. 737-749
    • Robins, J.M.1    Greenland, S.2
  • 32
    • 0031005036 scopus 로고    scopus 로고
    • Adjusting for non-compliance and contamination in randomized clinical trials
    • Cuzick JK, Edwards R, Segnan N (1997) Adjusting for non-compliance and contamination in randomized clinical trials. Stat Med 16: 1017-1029.
    • (1997) Stat Med , vol.16 , pp. 1017-1029
    • Cuzick, J.K.1    Edwards, R.2    Segnan, N.3
  • 33
    • 0035922441 scopus 로고    scopus 로고
    • Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy
    • Brenner BM, Cooper ME, de Zeeuw D, Keane WF, Mitch WE, et al. (2001) Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med 345: 861-869.
    • (2001) N Engl J Med , vol.345 , pp. 861-869
    • Brenner, B.M.1    Cooper, M.E.2    de Zeeuw, D.3    Keane, W.F.4    Mitch, W.E.5
  • 34
    • 3843078519 scopus 로고    scopus 로고
    • The Study on Cognition and Prognosis in the Elderly (SCOPE); outcomes in patients not receiving add-on therapy after randomization
    • Lithell H, Hansson L, Skoog I, Elmfeldt D, Hofman A, et al. (2004) The Study on Cognition and Prognosis in the Elderly (SCOPE); outcomes in patients not receiving add-on therapy after randomization. J Hypertens 22: 1605-1612.
    • (2004) J Hypertens , vol.22 , pp. 1605-1612
    • Lithell, H.1    Hansson, L.2    Skoog, I.3    Elmfeldt, D.4    Hofman, A.5
  • 35
    • 34247379373 scopus 로고    scopus 로고
    • Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): A randomised, open-label, blinded endpoint morbidity-mortality study
    • Mochizuki S, Dahlöf B, Shimizu M, Ikewaki K, Yoshikawa M, et al. (2007) Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study. Lancet 369: 1431-149.
    • (2007) Lancet , vol.369 , pp. 1431-2149
    • Mochizuki, S.1    Dahlöf, B.2    Shimizu, M.3    Ikewaki, K.4    Yoshikawa, M.5
  • 36
    • 34548420712 scopus 로고    scopus 로고
    • Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): A randomised controlled trial
    • ADVANCE Collaborative Group
    • ADVANCE Collaborative Group (2007) Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial. Lancet 370: 829-840.
    • (2007) Lancet , vol.370 , pp. 829-840
  • 37
    • 0035899289 scopus 로고    scopus 로고
    • Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation
    • Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators
    • Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators (2001) Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med 345: 494-502.
    • (2001) N Engl J Med , vol.345 , pp. 494-502
  • 38
    • 34250785602 scopus 로고    scopus 로고
    • Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: Design and methods
    • ACCORD Study Group
    • ACCORD Study Group (2007) Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methods. Am J Cardiol 99(S): 21i-33i.
    • (2007) Am J Cardiol , vol.99 , Issue.S


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