政大機構典藏-National Chengchi University Institutional Repository(NCCUR):Item 140.119/18191

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政大機構典藏 > 商學院 > 統計學系 > 期刊論文 > Item 140.119/18191

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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:	2008-12-19 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 連結:	http://dx.doi.org/10.1002/sim.1012
DOI:	10.1002/sim.1012
顯示於類別:	[統計學系] 期刊論文

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