Equivalence and noninferiority testing in regression models and repeated-measures designs

Anesthesia and Analgesia

Volumn 112, Issue 3, 2011, Pages 678-687

  Mascha, Edward J ^a   Sessler, Daniel I ^a  

^a LERNER RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DATA ANALYSIS; EQUIVALENCE TRIAL TEST; HUMAN; INTERMETHOD COMPARISON; LINEAR REGRESSION ANALYSIS; NONINFERIORITY TRIAL TEST; NORMAL DISTRIBUTION; PRIORITY JOURNAL; PROBABILITY SAMPLE; REFERENCE VALUE; REPEATED MEASURE DESIGN; SAMPLE SIZE; STATISTICAL ANALYSIS; STATISTICAL MODEL; STUDY DESIGN; SURGICAL PATIENT; TEMPERATURE MEASUREMENT; TREATMENT OUTCOME;

EID: 79952444336     PISSN: 00032999     EISSN: None     Source Type: Journal    
DOI: 10.1213/ANE.0b013e318206f872     Document Type: Article

References (38)

1. O'Connor AB. Building comparative efficacy and tolerability into the FDA approval process. JAMA 2010;303:979-80
2. Malozowski S. Comparative efficacy: what we know, what we need to know, and how we can get there. Ann Intern Med 2008;148:702-3 (Pubitemid 351669115)
3. Altman DG, Bland JM. Absence of evidence is not evidence of absence. Biometrical J 1995;311:485
4. Wellek S. Testing Statistical Hypotheses of Equivalence. Boca Raton, FL: Chapman and Hall/CRC Press LCC, 2003
5. Blackwelder W. "Proving the null hypothesis" in clinical trials. Control Clin Trials 1982;3:345-53 (Pubitemid 13113168)
6. Laster LL, Johnson MF. Non-inferiority trials: the 'at least as good as' criterion. Stat Med 2003;22:187-200 (Pubitemid 36163580)
7. 2) comparably maintain normothermia during open abdominal surgery. Anesth Analg 2011;112:608-14
8. Mascha EJ. Equivalence and noninferiority testing in anesthe-siology research. Anesthesiology 2010;113:779-81
9. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJW, for the CG. Reporting of noninferiority and equivalence ran-domized trials: an extension of the CONSORT statement. JAMA 2006;295:1152-60 (Pubitemid 43352345)
10. Christensen E. Methodology of superiority vs. equivalence trials and non-inferiority trials. J Hepatol 2007;46:947-54 (Pubitemid 46546604)
11. Tunes da Silva G, Logan BR, Klein JP. Methods for equivalence and noninferiority testing. Biol Blood Marrow Transplant 2008;15:120-7
12. Tamayo-Sarver J, Albert JM, Tamayo-Sarver M, Cydulka R. Advanced statistics: how to determine whether your interven-tion is different, at least as effective as, or equivalent: a basic introduction. J Academic Emergency Med 2005;12:536-42 (Pubitemid 40732338)
13. Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. Biometrical J 1996;313:36-9 (Pubitemid 26229889)
14. Ebbutt AF, Frith L. Practical issues in equivalence trials. Stat Med 1998;17:1691-701 (Pubitemid 28409925)
15. Schuirmann D. A comparison of the two one-sided tests procedure and the power approach for assessing the equiva-lence of coverage bioavailability. J Pharmacokinet Biopharm 1987;15:657-80
16. Pocock SAS, Enos L, Kasten L. Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Stat Med 2002;21:2917-30
17. Burns DR, Elswick RK. Equivalence testing with dental clinical trials. J Dent Res 2001;80:1513-7
18. Tango T. Equivalence test and confidence interval for the difference in proportions for the paired-sample design. Stat Med 1998;17:891-908 (Pubitemid 28185167)
19. Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics 1982;38:963-74
20. Henderson CR. Applications of Linear Models in Animal Breeding. Guelph, Ontario, Canada: University of Guelph, 1984
21. Littell RC, Milliken GA, Stroup WW, Wolfinger RD, Schaben-berber O. SAS for Mixed Models. 2nd ed. Cary, NC: SAS Institute Inc., 2006
22. Krueger C, Tian L. A comparison of the general linear mixed model and repeated measures ANOVA using a dataset with multiple missing data points. Biolog Res Nurs 2004;6:151-7 (Pubitemid 44005145)
23. Holm S. A simple sequentially rejective multiple test proce-dure. Scand J Statistics 1979;6:65-70
24. Laster L, Johnson MF, Kotler ML. Non-inferiority trials: the 'at least as good as' criterion with dichotomous data. Stat Med 2006;25:1115-30
25. Wellek S. Statistical methods for the analysis of two-arm non-inferiority trials with binary outcomes. Biometrical J 2005;47:48-61 (Pubitemid 40390438)
26. Chow SC, Liu J. Design and Analysis of Bioavailability and Bioequivalence Studies. New York: Marcel Dekker, 1992
27. Com-Nougue C, Rodary C, Patte C. How to establish equiva-lence when data are censored: a randomized trial of treatments for B non-Hodgkin lymphoma. Stat Med 1993;12:1353-64 (Pubitemid 23230837)
28. Liang K-Y, Zeger SL. Longitudinal data analysis using gener-alized linear models. Biometrika 1986;73:13-22
29. Zeger SL, Liang K-Y. Longitudinal data analysis for discrete and continuous outcomes. Biometrics 1986;42:121-30
30. Vonesh EF, Chinchilli VM. Linear and Nonlinear Models for the Analysis of Repeated Measurements. New York: Marcel Dekker, 1997
31. Snapinn SM. Noninferiority trials (Commentary). Curr Control Trials Cardiovasc Med 2000;1:19-21
32. Farrington CP, Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med 1990;9:1447-54
33. Verbeke G, Molenberghs G. Linear mixed models for longitu-dinal data. New York: Springer, 2000
34. Dahmen G, Rochon J, König IR, Ziegler A. Sample size calculations for controlled clinical trials using generalized estimating equations (GEE). Methods Inf Med 2004;43:451-6 (Pubitemid 40040323)
35. Hou Y. Issues on the selection of non-inferiority margin in clinical trials. Chinese Medical J 2009;122:466-70
36. Wiens BL. Choosing an equivalence limit for noninferiority or equivalence studies. Control Clin Trials 2002;23:2-14 (Pubitemid 34164354)
37. Lange S, Freitag G. Special invited papers section: therapeutic equivalence\clinical issues and statistical methodology in noninferiority trials. Biometrical J 2005;47:12-27
38. Kaji A, Lewis R. Are we looking for superiority, equivalence, or noninferiority? Asking the right question and answering it correctly. Ann Emerg Med 2010;55:408-11