A sequential conditional probability ratio test procedure for comparing diagnostic tests

In this paper, we derive sequential conditional probability ratio tests to compare diagnostic tests without distributional assumptions on test results. The test statistics in our method are nonparametric weighted areas under the receiver-operating characteristic curves. By using the new method, the decision of stopping the diagnostic trial early is unlikely to be reversed should the trials continue to the planned end. The conservatism reflected in this approach to have more conservative stopping boundaries during the course of the trial is especially appealing for diagnostic trials since the end point is not death. In addition, the maximum sample size of our method is not greater than a fixed sample test with similar power functions. Simulation studies are performed to evaluate the properties of the proposed sequential procedure. We illustrate the method using data from a thoracic aorta imaging study.

[1]  D. Jones,et al.  Group sequential methods. , 1979, British Journal of Cancer.

[2]  B. Freidlin,et al.  Data monitoring committees and interim monitoring guidelines. , 1999, Controlled clinical trials.

[3]  Xiaoping Xiong,et al.  Sequential Conditional Probability Ratio Tests for Normalized Test Statistic on Information Time , 2003, Biometrics.

[4]  Chengqing Wu,et al.  Nonparametric sequential evaluation of diagnostic biomarkers , 2008, Statistics in medicine.

[5]  D. Gladstone,et al.  In vivo identification of complicated upper thoracic aorta and arch vessel plaque by MR direct thrombus imaging in patients investigated for cerebrovascular disease. , 2006, AJR. American journal of roentgenology.

[6]  Sung C. Choi,et al.  Early decision in clinical trials when the treatment differences are small. Experience of a controlled trial in head trauma. , 1985, Controlled clinical trials.

[7]  D. Spiegelhalter,et al.  Monitoring clinical trials: conditional or predictive power? , 1986, Controlled clinical trials.

[8]  Mitchell H. Gail,et al.  A family of nonparametric statistics for comparing diagnostic markers with paired or unpaired data , 1989 .

[9]  T. Shiga,et al.  Diagnostic accuracy of transesophageal echocardiography, helical computed tomography, and magnetic resonance imaging for suspected thoracic aortic dissection: systematic review and meta-analysis. , 2006, Archives of internal medicine.

[10]  J. Hanley,et al.  The meaning and use of the area under a receiver operating characteristic (ROC) curve. , 1982, Radiology.

[11]  Xiao-Hua Zhou,et al.  Statistical Methods in Diagnostic Medicine , 2002 .

[12]  Xiaoping Xiong,et al.  A Class of Sequential Conditional Probability Ratio Tests , 1995 .

[13]  P. Costello,et al.  The diagnosis of thoracic aortic dissection by noninvasive imaging procedures. , 1993, The New England journal of medicine.

[14]  John A Butman,et al.  Comparison of MRI and CT for detection of acute intracerebral hemorrhage. , 2004, JAMA.

[15]  M Tan,et al.  Clinical trial designs based on sequential conditional probability ratio tests and reverse stochastic curtailing. , 1998, Biometrics.

[16]  E. DeLong,et al.  Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. , 1988, Biometrics.

[17]  Scott S Emerson,et al.  Nonparametric and Semiparametric Group Sequential Methods for Comparing Accuracy of Diagnostic Tests , 2008, Biometrics.

[18]  Choi Sc,et al.  Monitoring clinical trials based on predictive probability of significance. , 1989 .

[19]  E. Gumbel Bivariate Exponential Distributions , 1960 .

[20]  S. C. Choi,et al.  Monitoring clinical trials based on predictive probability of significance. , 1989, Biometrics.

[21]  Christopher Jennison,et al.  On group sequential tests for data in unequally sized groups and with unknown variance , 2001 .

[22]  Constantine A Gatsonis,et al.  Wilcoxon-based group sequential designs for comparison of areas under two correlated ROC curves. , 2008, Statistics in medicine.

[23]  M. Hareyama,et al.  Thoracic involvement of type A aortic dissection and intramural hematoma: diagnostic accuracy--comparison of emergency helical CT and surgical findings. , 2003, Radiology.