Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests ; Draft Guidance for Industry and FDA Reviewers Draft Guidance-Not for Implementation

[1]  M S Pepe,et al.  Using a combination of reference tests to assess the accuracy of a new diagnostic test. , 1999, Statistics in medicine.

[2]  B Bunnag,et al.  Comparing new and old screening tests when a reference procedure cannot be performed on all screenees. Example of automated cytometry for early detection of cervical cancer. , 1987, American journal of epidemiology.

[3]  D M Hawkins,et al.  Some issues in resolution of diagnostic tests using an imperfect gold standard , 2001, Statistics in medicine.

[4]  L. A. Thibodeaul.  Evaluating Diagnostic Tests , 1981 .

[5]  J. Gart,et al.  Comparison of a screening test and a reference test in epidemiologic studies. II. A probabilistic model for the comparison of diagnostic tests. , 1966, American journal of epidemiology.

[6]  W. Miller,et al.  Bias in discrepant analysis: when two wrongs don't make a right. , 1998, Journal of clinical epidemiology.

[7]  P M Vacek,et al.  The effect of conditional dependence on the evaluation of diagnostic tests. , 1985, Biometrics.

[8]  A. V. Pollock.  How to Report Statistics in Medicine , 2001 .

[9]  C. Black,et al.  Evaluation of Bias in Diagnostic-Test Sensitivity and Specificity Estimates Computed by Discrepant Analysis , 1998, Journal of Clinical Microbiology.

[10]  X H Zhou,et al.  Correcting for verification bias in studies of a diagnostic test's accuracy , 1998, Statistical methods in medical research.

[11]  S D Walter,et al.  Effects of dependent errors in the assessment of diagnostic test performance. , 1997, Statistics in medicine.

[12]  M. Shoukri.  Agreement, Measurement of† , 2005 .

[13]  W. Miller.  Can we do better than discrepant analysis for new diagnostic test evaluation? , 1998, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[14]  A. Tenenbein.  A Double Sampling Scheme for Estimating from Binomial Data with Misclassifications: Sample size Determination , 1971 .

[15]  A. Saah,et al.  Sensitivity and Specificity Reconsidered: The Meaning of These Terms in Analytical and Diagnostic Settings , 1997, Annals of Internal Medicine.

[16]  M Staquet,et al.  Methodology for the assessment of new dichotomous diagnostic tests. , 1981, Journal of chronic diseases.

[17]  J. Sellors,et al.  Bias in the evaluation of DNA-amplification tests for detecting Chlamydia trachomatis. , 1998, Statistics in medicine.

[18]  P N Valenstein,et al.  Evaluating diagnostic tests with imperfect standards. , 1990, American journal of clinical pathology.

[19]  I. Bross.  Misclassification in 2 X 2 Tables , 1954 .

[20]  C B Begg,et al.  Biases in the assessment of diagnostic tests. , 1987, Statistics in medicine.

[21]  S. Hui,et al.  Evaluation of diagnostic tests without gold standards , 1998, Statistical methods in medical research.

[22]  A. McAdam,et al.  Discrepant Analysis: How Can We Test a Test? , 2000, Journal of Clinical Microbiology.

[23]  H. Lipman,et al.  Quantifying the bias associated with use of discrepant analysis. , 1998, Clinical chemistry.

[24]  S D Walter,et al.  Estimation of test error rates, disease prevalence and relative risk from misclassified data: a review. , 1988, Journal of clinical epidemiology.

[25]  A Hadgu,et al.  Discrepant analysis: a biased and an unscientific method for estimating test sensitivity and specificity. , 1999, Journal of clinical epidemiology.