國家衛生研究院 NHRI:Item 3990099045/1778
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    Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/1778


    Title: Tests for equivalence or non-inferiority for paired binary data
    Authors: Liu, JP;Hsueh, HM;Hsieh, E;Chen, JJ
    Contributors: Division of Biostatistics and Bioinformatics
    Abstract: Assessment of therapeutic equivalence or non-inferiority between two medical diagnostic procedures often involves comparisons of the response rates between paired binary endpoints. The commonly used and accepted approach to assessing equivalence is by comparing the asymptotic confidence interval on the difference of two response rates with some clinical meaningful equivalence limits. This paper investigates two asymptotic test statistics, a Wald-type (sample-based) test statistic and a restricted maximum likelihood estimation (RMLE-based) test statistic, to assess equivalence or non-inferiority based on paired binary endpoints. The sample size and power functions of the two tests are derived. The actual type I error and power of the two tests are computed by enumerating the exact probabilities in the rejection region. The results show that the RMLE-based test controls type I error better than the sample-based test. To establish an equivalence between two treatments with a symmetric equivalence limit of 0.15, a minimal sample size of 120 is needed. The RMLE-based test without the continuity correction performs well at the boundary point 0. A numerical example illustrates the proposed procedures.
    Keywords: Mathematical & Computational Biology;Public, Environmental & Occupational Health;Medical Informatics;Medicine, Research & Experimental;Statistics & Probability
    Date: 2002-01-30
    Relation: Statistics in Medicine. 2002 Jan;21(2):231-245.
    Link to: http://dx.doi.org/10.1002/sim.1012
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0277-6715&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000173217200006
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=0037196214
    Appears in Collections:[Jen-Pei Liu(1998-2002)] Periodical Articles

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