An exact test for comparing two predictive values in small-size clinical trials.
negative predictive value
permutation test
positive predictive value
small-size clinical trial
Journal
Pharmaceutical statistics
ISSN: 1539-1612
Titre abrégé: Pharm Stat
Pays: England
ID NLM: 101201192
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
received:
24
08
2018
revised:
10
06
2019
accepted:
11
07
2019
pubmed:
24
10
2019
medline:
15
12
2020
entrez:
24
10
2019
Statut:
ppublish
Résumé
Positive and negative predictive values describe the performance of a diagnostic test. There are several methods to test the equality of predictive values in paired designs. However, these methods were premised on large sample theory, and they may not be suitable for small-size clinical trials because of inflation of the type 1 error rate. In this study, we propose an exact test to control the type 1 error rate strictly for conducting a small-size clinical trial that investigates the equality of predictive values in paired designs. In addition, we execute simulation studies to evaluate the performance of the proposed exact test and existing methods in small-size clinical trials. The proposed test can calculate the exact P value, and as a result of simulations, the empirical type 1 error rate for the proposed test did not exceed the significance level regardless of the setting, and the empirical power for the proposed test is not much different from the other methods based on large-sample theory. Therefore, it is considered that the proposed exact test is useful when the type 1 error rate needs to be controlled strictly.
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
31-43Informations de copyright
© 2019 John Wiley & Sons, Ltd.
Références
Altman DG, Bland JM. Diagnostic test 2: predictive values. BMJ. 1994;309:102.
Guggenmoos-Holzman I, van Houselingen HC. The (in)validity of sensitivity and specificity. Stat Med. 2000;19:1783-1792.
Pepe MS. The Statistical Evaluation of Medical Tests for Classification and Prediction. New York: Oxford University Press; 2004;22.
Zhou X, Obuchowski NA, McClish DK. Statistical Methods in Diagnostic Medicine, Second Edition. New York: John Wiley & Sons; 2011;47.
Leisenring W, Alonzo T, Pepe MS. Comparisons of predictive values of binary medical diagnostic tests for paired designs. Biometrics. 2000;56:345-351.
Moskowitz CS, Pepe MS. Comparing the predictive values of diagnostic tests: sample size and analysis for paired study designs. Clin Trials. 2006;3:272-279.
Wang W, Davis CS, Soong S. Comparison of predictive values of two diagnostic tests from the same sample of subjects using weighted least squares. Stat Med. 2006;25:2215-2229.
Roldán Nofuentes JA, Luna del Castillo JD, Montero Alonso MA. Global hypothesis test to simultaneously compare the predictive values of two binary diagnostic tests. Comput Stat Data Anal. 2012;56:1161-1173.
Kosinski AS. A weighted generalized score statistic for comparison of predictive values of diagnostic tests. Stat Med. 2013;32:964-977.
Weiner DA, Ryan TJ, McCabe CH, et al. Exercise stress testing - Correlations among history of angina, st-segment response and prevalence of coronary-artery disease in the Coronary-Artery Surgery Study (CASS). N Engl J Med. 1979;301:230-235.