Annals of Emergency Medicine
Volume 55, Issue 5 , Pages 408-411 , May 2010

Are We Looking for Superiority, Equivalence, or Noninferiority? Asking the Right Question and Answering It Correctly

  • Amy H. Kaji, MD, PhD

      Affiliations

    • Corresponding Author InformationAddress for correspondence: Amy H. Kaji, MD, PhD, Department of Emergency Medicine, Harbor–UCLA Medical Center, 1000 West Carson St, Box 21, Torrance, CA 90509; 310-222-3500, fax 310-782-1763
    • ,
  • Roger J. Lewis, MD, PhD

References 

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  2. Young KD, Lewis RJ. What is confidence? Part 1: the use and interpretation of confidence intervals. Ann Emerg Med. 1997;30:307–310
  3. Young KD, Lewis RJ. What is confidence? Part 2: detailed definition and determination of confidence intervals. Ann Emerg Med. 1997;30:311–318
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  6. Tamayo-Sarver JH, Albert JM, Tamayo-Sarver M, et al. Advanced statistics: how to determine whether your intervention is different, at least as effective as, or equivalent: a basic introduction. Acad Emerg Med. 2005;12:536–542
  7. Altman DG, Bland JM. Absence of evidence is not evidence of absence. BMJ. 1995;311:485
  8. Flemming TR. Design and interpretation of equivalence trials. Am Heart J. 2000;139:S171–S176
  9. Laster LL, Johnson MF. Non-inferiority trials: the “at least as good as” criterion. Stat Med. 2003;22:883–899
  10. Pigeot I, Schafer J, Rohmel J, et al. Assessing non-inferiority of a new treatment in a three-arm clinical trial including a placebo. Stat Med. 2003;22:883–899
  11. Jones B, Jarvis P, Lewis JA, et al. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996;313:36–39
  12. Greene WL, Concato J, Feinstein AR. Claims of equivalence in medical research: are they supported by the evidence?. Ann Intern Med. 2000;132:715–722
  13. Siegel JP. Equivalence and non-inferiority trials. Am Heart J. 2000;139:S166–S170
  14. D'Agostino RB, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues—the encounters of academic consultants in statistics. Stat Med. 2003;22:169–186
  15. Piaggio G, Elbourne DR, Altman DG, et al. CONSORT Group Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA. 2006;295:1152–1160

 Supervising editor: Steven M. Green, MD

 Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. The authors have stated that no such relationships exist. See the Manuscript Submission Agreement in this issue for examples of specific conflicts covered by this statement.

 Publication date: Available online February 20, 2010.

 Reprints not available from the authors.

PII: S0196-0644(10)00047-8

doi: 10.1016/j.annemergmed.2010.01.024

Annals of Emergency Medicine
Volume 55, Issue 5 , Pages 408-411 , May 2010

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