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題名 Tests for equivalence or non-inferiority for paired binary data
作者 薛慧敏
Liu, Jen-pei ;
     Hsueh, Huey-miin ;
     Hsieh, Eric ;
     Chen, James J.
關鍵詞 asymptotic test;
     correlated binary endpoints;
     confidence interval;
     diagnostic tests;
     two one-sided tests
日期 2001-12
上傳時間 19-十二月-2008 14:54:16 (UTC+8)
摘要 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.
關聯 Statistics in Medicine 21(2),231-245
資料類型 article
DOI http://dx.doi.org/10.1002/sim.1012
dc.creator (作者) 薛慧敏zh_TW
dc.creator (作者) Liu, Jen-pei ;
     Hsueh, Huey-miin ;
     Hsieh, Eric ;
     Chen, James J.		-
dc.date (日期) 2001-12en_US
dc.date.accessioned 19-十二月-2008 14:54:16 (UTC+8)-
dc.date.available 19-十二月-2008 14:54:16 (UTC+8)-
dc.date.issued (上傳時間) 19-十二月-2008 14:54:16 (UTC+8)-
dc.identifier.uri (URI) https://nccur.lib.nccu.edu.tw/handle/140.119/18191-
dc.description.abstract (摘要) 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.-
dc.format application/en_US
dc.language enen_US
dc.language en-USen_US
dc.language.iso en_US-
dc.relation (關聯) Statistics in Medicine 21(2),231-245en_US
dc.subject (關鍵詞) asymptotic test;
     correlated binary endpoints;
     confidence interval;
     diagnostic tests;
     two one-sided tests		-
dc.title (題名) Tests for equivalence or non-inferiority for paired binary dataen_US
dc.type (資料類型) articleen
dc.identifier.doi (DOI) 10.1002/sim.1012en_US
dc.doi.uri (DOI) http://dx.doi.org/10.1002/sim.1012en_US