TY - JOUR
T1 - Sensitivity and specificity of a diagnostic test determined by repeated observations in the absence of an external standard
AU - Schulzer, Michael
AU - Anderson, Douglas R.
AU - Drance, Stephen M.
N1 - Funding Information:
Acknowledgements-This study was supported in part by the Foundation for Glaucoma Research, San Francisco, Califoria; in part by National Glaucoma Research, a program of American Health Assistance Foundation, Rockville, Maryland; and in part by a Senior Scientific Investigators Award to Dr Anderson by Research to Prevent Blindness, Inc., New York.
Copyright:
Copyright 2014 Elsevier B.V., All rights reserved.
PY - 1991
Y1 - 1991
N2 - Traditionally, the sensitivity and specificity of a new diagnostic test are derived from its application to two groups of individuals known to have or not to have met the criterion to be detected as judged by means of a "gold standard", some external time-honored test. In this study, a test with unknown accuracy parameters was used to detect an end-point criterion in an ongoing ophthalmological clinical trial. Since no external test method was available to assess the accuracy of this test, equations were derived relating the unknown sensitivity and specificity of the test to data frequencies based on replicate measurements. The solutions to these equations also provided estimates of the incidence rate of the criterion under investigation in the group tested, and of the predictive values of the test. The validity of this method of estimation is discussed, and applications to other situations are suggested.
AB - Traditionally, the sensitivity and specificity of a new diagnostic test are derived from its application to two groups of individuals known to have or not to have met the criterion to be detected as judged by means of a "gold standard", some external time-honored test. In this study, a test with unknown accuracy parameters was used to detect an end-point criterion in an ongoing ophthalmological clinical trial. Since no external test method was available to assess the accuracy of this test, equations were derived relating the unknown sensitivity and specificity of the test to data frequencies based on replicate measurements. The solutions to these equations also provided estimates of the incidence rate of the criterion under investigation in the group tested, and of the predictive values of the test. The validity of this method of estimation is discussed, and applications to other situations are suggested.
KW - Incidence predictive values
KW - Multivariate binomial distribution
KW - Sensitivity
KW - Specificity
KW - Test criterion
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U2 - 10.1016/0895-4356(91)90149-4
DO - 10.1016/0895-4356(91)90149-4
M3 - Article
C2 - 1789861
AN - SCOPUS:0026056282
VL - 44
SP - 1167
EP - 1179
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
SN - 0895-4356
IS - 11
ER -