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政大典藏 > College of Commerce > Department of Statistics > Periodical Articles > Item 140.119/18191

Please use this identifier to cite or link to this item: https://nccur.lib.nccu.edu.tw/handle/140.119/18191

Title:	Tests for equivalence or non-inferiority for paired binary data
Authors:	薛慧敏 Liu, Jen-pei;Hsueh, Huey-miin;Hsieh, Eric;Chen, James J.
Keywords:	asymptotic test;correlated binary endpoints;confidence interval;diagnostic tests;two one-sided tests
Date:	2001-12
Issue Date:	2008-12-19 14:54:16 (UTC+8)
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.
Relation:	Statistics in Medicine 21(2),231-245
Data Type:	article
DOI link:	http://dx.doi.org/10.1002/sim.1012
DOI:	10.1002/sim.1012
Appears in Collections:	[Department of Statistics] Periodical Articles

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