Interval Estimation of the Proportion Ratio in Repeated Binary Measurements Under a Stratified Randomized Clinical Trial with Noncompliance

REFERENCES

• Angrist , J. D. , Imbens , G. W. , Rubin , D. B. ( 1996 ). Identification of causal effects using instrumental variables . Journal of the American Statistical Association 91 : 444 – 456 .
   Web of Science ®Google Scholar
• Becher , H. (1992). The concept of residual confounding in regression models and some applications. Statistics in Medicine 11:1747–1758.
   PubMed Web of Science ®Google Scholar
• Bishop , Y. M. M. , Fienberg , S. E. , Holland , P. W. ( 1975 ). Discrete Multivariate Analysis: Theory and Practice . Cambridge , MA : MIT Press .
   Google Scholar
• Brunner , E. , Neumann , N. ( 1985 ). On the mathematical basis of Zelen's prerandomized designs . Methods of Information in Medicine 24 : 120 – 130 .
   PubMed Web of Science ®Google Scholar
• Casella , G. , Berger , R. L. ( 1990 ). Statistical Inference . Belmont , CA : Duxbury .
   Google Scholar
• Cochran , W. G. ( 1977 ). Sampling Techniques . New York : Wiley .
   Google Scholar
• Fleiss , J. L. ( 1981 ). Statistical Methods for Rates and Proportions, , 2nd ed. New York : Wiley .
   Google Scholar
• Frangakis , C. E. , Rubin , D. B. ( 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 .
   Web of Science ®Google Scholar
• Garrett , A. D. ( 2003 ). Therapeutic equivalence: fallacies and falsification . Statistics in Medicine 22 : 741 – 762 .
   PubMed Web of Science ®Google Scholar
• Greenland , S. , Robins , J. M. ( 1985 ). Estimation of a common effect parameter from sparse follow-up data . Biometrics 41 : 55 – 68 .
   PubMed Web of Science ®Google Scholar
• Greenland , S. , Robins , J. M. , Pearl , J. ( 1999 ). Confounding and collapsibility in causal inference . Statistical Science 14 : 29 – 46 .
   Web of Science ®Google Scholar
• Guo , J. , Geng , Z. ( 1995 ). Collapsibility of logistic regression coefficients . Journal of Royal Statistical Society Series B 57 : 263 – 267 .
   Google Scholar
• Jo , B. ( 2002 ). Statistical power in randomized intervention studies with noncompliance . Psychological Methods 7 : 178 – 193 .
   PubMed Web of Science ®Google Scholar
• Katz , D. , Baptista , J. , Azen , S. P. , Pike , M. C. ( 1978 ). Obtaining confidence intervas for the risk ratio in cohort studies . Biometrics 34 : 469 – 474 .
   Web of Science ®Google Scholar
• Lachin , J. M. ( 2000 ). Statistical Considerations in the intent-to-treat principle . Controlled Clinical Trials 21 : 167 – 189 .
   PubMedGoogle Scholar
• Laupacis , A. , Sackett , D. L. , Roberts , R. S. ( 1988 ). An assessment of clinically useful measures of the consequences of treatment . New England Journal of Medicine 318 : 1728 – 1733 .
   PubMed Web of Science ®Google Scholar
• Lui , K.-J. ( 2004 ). Statistical Estimation of Epidemiological Risk . New York : Wiley .
   Google Scholar
• Lui , K.-J. ( 2006 ). Risk ratio analysis . In: Encyclopedia of Biopharmaceutical Statistics , DOI: 10.1081/E-EBS-120041874 . New York : Marcel Dekker .
   Google Scholar
• Lui , K.-J. ( 2007a ). Interval estimation of the risk difference in non-compliance randomized trials with repeated binary measurements . Statistics in Medicine 26 : 3140 – 3156 .
   PubMed Web of Science ®Google Scholar
• Lui , K.-J. ( 2007b ). Correcting for non-compliance of repeated binary outcomes in randomized clinical trials: Randomized analysis approach . Statistics in Medicine (Letter to the Editor) 26 : 4679 – 4685 .
   PubMed Web of Science ®Google Scholar
• Lui , K.-J. ( 2007c ). Testing homogeneity of the risk ratio in stratified noncompliance randomized trials . Contemporary Clinical Trials 28 : 614 – 625 .
   PubMed Web of Science ®Google Scholar
• Lui , K.-J. ( 2008 ). Estimation of proportion ratio in non-compliance randomized trials with repeated measurements in binary data . Statistical Methodology 5 : 129 – 141 .
   Google Scholar
• Lui , K.-J. , Chang , K.-C. ( 2007 ). Five interval estimators for proportion ratio under a stratified randomized clinical trial with noncompliance . Biometrical Journal 49 : 613 – 626 .
   PubMed Web of Science ®Google Scholar
• Matsuyama , Y. ( 2002 ). Correcting for non-compliance of repeated binary outcomes in randomized clinical trials: Randomized analysis approach . Statistics in Medicine 21 : 675 – 687 .
   PubMed Web of Science ®Google Scholar
• Ohno , R. , Miyawaki , S. , Hatake , K. , Kuriyama , K. , Saito , K. , Kanamaru , A. , Kobayashi , T. , Kodera , Y. , Nishikawa , K. , Matsuda , S. , Yamada , O. , Omoto , E. , Takeyama , H. , Tsukuda , K. , Asou , N. , Tanimoto , M. , Shiozaki , H. , Tomonaga , M. , Masaoka , T. , Miura , Y. , Takaku , F. , Ohashi , Y. , Motoyoshi , K. ( 1997 ). Human urinary macrophage colony-stimulating factors reduces the incidence and duration of febrile neutropenia and shortens the period required to finish three courses of intensive consolidation therapy in acute myeloid leukemia: a double-blind controlled study . Journal of Clinical Oncology 15 : 2954 – 2965 .
   PubMed Web of Science ®Google Scholar
• Rothman , K. J. , Boice , J. D. (1979). Epidemiologic Analysis With a Programmable Calculator . NIH publication no. 79-1649. Washington , DC : US Government Printing Office.
   Google Scholar
• SAS Institute, Inc. ( 1990 ). SAS Language Version . Cary , NC : SAS Institute, Inc .
   Google Scholar
• Sato , T. ( 2001 ). A method for the analysis of repeated binary outcomes in randomized clinical trials with non-compliance . Statistics in Medicine 20 : 2761 – 2774 .
   PubMed Web of Science ®Google Scholar
• Sheps , M. C. ( 1958 ). Shall we count the living or the dead? New England Journal of Medicine 259 : 1210 – 1214 .
   PubMed Web of Science ®Google Scholar
• Sheps , M. C. ( 1959 ). An examination of some methods of comparing several rates or proportions . Biometrics 15 : 87 – 97 .
   Web of Science ®Google Scholar
• Sjölander , A. ( 2008 ). A note on ‘The method of handling non-compliance in clinical trials suggested by Sato/Matsuyama’ (Letter to the editor) . Statistics in Medicine 27 : 3920 – 3924 .
   PubMed Web of Science ®Google Scholar
• Sommer , A. , Zeger , S. L. ( 1991 ). On estimating efficacy from clinical trials . Statistics in Medicine 10 : 45 – 52 .
   PubMed Web of Science ®Google Scholar
• Tu , D. ( 1998 ). On the use of the ratio or the odds ratio of cure rates in establishing therapeutic equivalence of non-systemic drugs with binary clinical endpoints . Journal of Biopharmaceutical Statistics 8 : 263 – 282 .
   PubMedGoogle Scholar
• Tu , D. ( 2003 ). Odds ratio . In: Chow , S. C. , ed. Encyclopedia of Biopharmaceutical Statistics . New York : Taylor & Francis Group, Marcel Dekker .
   Google Scholar
• Walter , S. D. , Guyatt , G. , Montori , V. M. , Cook , R. , Prasad , K. ( 2006 ). A new preference-based analysis for randomized trials can estimate treatment acceptability and effect in compliant patients . Journal of Clinical Epidemiology 59 : 685 – 696 .
   PubMed Web of Science ®Google Scholar
• Wang , H. , Chow , S.-C. , Li , G. ( 2002 ). On sample size calculation based on odds ratio in clinical trials . Journal of Biopharmaceutical Statistics 12 : 471 – 483 .
   PubMedGoogle Scholar
• Zhou , X. H. , Li , S. M. ( 2006 ). ITT analysis of randomized encouragement design studies with missing data . Statistics in Medicine 25 : 2737 – 2761 .
   PubMed Web of Science ®Google Scholar