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題名 Simultaneous non-inferiority test of sensitivity and specificity for two diagnostic procedures in the presence of a gold standard
作者 薛慧敏;Chen J. J.;Liu J. P.
James J. Chen;Hsueh, Huey-miin Hsueh;Liu, Jen-pei
關鍵詞 Accuracy;Correlated binary endpoints;Diagnostic procedure or screening test;One-sided equivalence test;Sample size
日期 2003-01
上傳時間 19-Dec-2008 14:51:11 (UTC+8)
摘要 Sensitivity and specificity have traditionally been used to assess the performance of a diagnostic procedure. Diagnostic procedures with both high sensitivity and high specificity are desirable, but these procedures are frequently too expensive, hazardous, and/or difficult to operate. A less sophisticated procedure may be preferred, if the loss of the sensitivity or specificity is determined to be clinically acceptable. This paper addresses the problem of simultaneous testing of sensitivity and specificity for an alternative test procedure with a reference test procedure when a gold standard is present. The hypothesis is formulated as a compound hypothesis of two non-inferiority (one-sided equivalence) tests. We present an asymptotic test statistic based on the restricted maximum likelihood estimate in the framework of comparing two correlated proportions under the prospective and retrospective sampling designs. The sample size and power of an asymptotic test statistic are derived. The actual type I error and power are calculated by enumerating the exact probabilities in the rejection region. For applications that require high sensitivity as well as high specificity, a large number of positive subjects and a large number of negative subjects are needed. We also propose a weighted sum statistic as an alternative test by comparing a combined measure of sensitivity and specificity of the two procedures. The sample size determination is independent of the sampling plan for the two tests.
關聯 Biometrical Journal, 45(1), 47-60
資料類型 article
DOI http://dx.doi.org/10.1002/bimj.200290015
dc.creator (作者) 薛慧敏;Chen J. J.;Liu J. P.zh_TW
dc.creator (作者) James J. Chen;Hsueh, Huey-miin Hsueh;Liu, Jen-pei-
dc.date (日期) 2003-01en_US
dc.date.accessioned 19-Dec-2008 14:51:11 (UTC+8)-
dc.date.available 19-Dec-2008 14:51:11 (UTC+8)-
dc.date.issued (上傳時間) 19-Dec-2008 14:51:11 (UTC+8)-
dc.identifier.uri (URI) https://nccur.lib.nccu.edu.tw/handle/140.119/18151-
dc.description.abstract (摘要) Sensitivity and specificity have traditionally been used to assess the performance of a diagnostic procedure. Diagnostic procedures with both high sensitivity and high specificity are desirable, but these procedures are frequently too expensive, hazardous, and/or difficult to operate. A less sophisticated procedure may be preferred, if the loss of the sensitivity or specificity is determined to be clinically acceptable. This paper addresses the problem of simultaneous testing of sensitivity and specificity for an alternative test procedure with a reference test procedure when a gold standard is present. The hypothesis is formulated as a compound hypothesis of two non-inferiority (one-sided equivalence) tests. We present an asymptotic test statistic based on the restricted maximum likelihood estimate in the framework of comparing two correlated proportions under the prospective and retrospective sampling designs. The sample size and power of an asymptotic test statistic are derived. The actual type I error and power are calculated by enumerating the exact probabilities in the rejection region. For applications that require high sensitivity as well as high specificity, a large number of positive subjects and a large number of negative subjects are needed. We also propose a weighted sum statistic as an alternative test by comparing a combined measure of sensitivity and specificity of the two procedures. The sample size determination is independent of the sampling plan for the two tests.-
dc.format application/en_US
dc.language enen_US
dc.language en-USen_US
dc.language.iso en_US-
dc.relation (關聯) Biometrical Journal, 45(1), 47-60en_US
dc.subject (關鍵詞) Accuracy;Correlated binary endpoints;Diagnostic procedure or screening test;One-sided equivalence test;Sample size-
dc.title (題名) Simultaneous non-inferiority test of sensitivity and specificity for two diagnostic procedures in the presence of a gold standard-
dc.type (資料類型) articleen
dc.identifier.doi (DOI) 10.1002/bimj.200290015en_US
dc.doi.uri (DOI) http://dx.doi.org/10.1002/bimj.200290015en_US