The assessment of diagnostic tests. A survey of current medical research

S. B. Sheps and M. T. Schechter

To study current diagnostic test evaluation, 129 recent articles were assessed against several well-known methodological criteria. Only 68% employed a well-defined "gold standard." Test interpretation was clearly described in only 68% and was stated to be "blind" in only 40%. Approximately 20% used the terms sensitivity and specificity incorrectly. Predictive values were considered in only 31% and the influence of disease prevalence and study setting was considered in only 19%. Overall, 74% failed to demonstrate more than four of seven important characteristics and there was an increased proportion of high specificities reported in this group. Articles assessing new tests reported high sensitivities and specificities significantly more often than articles assessing existing tests. These results indicate a clear need for greater attention to accepted methodological standards on the part of researchers, reviewers, and editors.

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Systematic reviews of diagnostic tests in cancer: review of methods and reporting
Mallett et al.
BMJ 2006;333:413.
ABSTRACT | FULL TEXT  

Accuracy of Helical Computed Tomography and [18F] Fluorodeoxyglucose Positron Emission Tomography for Identifying Lymph Node Mediastinal Metastases in Potentially Resectable Non-Small-Cell Lung Cancer
Pozo-Rodriguez et al.
JCO 2005;23:8348-8356.
ABSTRACT | FULL TEXT  

Challenges in Systematic Reviews of Diagnostic Technologies
Tatsioni et al.
ANN INTERN MED 2005;142:1048-1055.
ABSTRACT | FULL TEXT  

The STARD Statement for Reporting Studies of Diagnostic Accuracy: Explanation and Elaboration
Bossuyt et al.
ANN INTERN MED 2003;138:W1-W12.
ABSTRACT | FULL TEXT  

The STARD Statement for Reporting Studies of Diagnostic Accuracy: Explanation and Elaboration
Bossuyt et al.
Clin. Chem. 2003;49:7-18.
ABSTRACT | FULL TEXT  

Spectrum Bias or Spectrum Effect? Subgroup Variation in Diagnostic Test Evaluation
Mulherin and Miller
ANN INTERN MED 2002;137:598-602.
ABSTRACT | FULL TEXT  

Evidence base of clinical diagnosis: Evaluation of diagnostic procedures
Knottnerus et al.
BMJ 2002;324:477-480.
FULL TEXT  

Examining Diagnostic Tests: An Evidence-Based Perspective
Fritz and Wainner
ptjournal 2001;81:1546-1564.
ABSTRACT | FULL TEXT  

Pleural Fluid pH as a Predictor of Pleurodesis Failure* : Analysis of Primary Data
Heffner et al.
Chest 2000;117:87-95.
ABSTRACT | FULL TEXT  

To test or not to test?
Holloway and Feasby
Neurology 1999;53:1905-1905.
FULL TEXT  

Clinical Epidemiological Quality in Molecular Genetic Research: The Need for Methodological Standards
Bogardus et al.
JAMA 1999;281:1919-1926.
ABSTRACT | FULL TEXT  

Bayesian Analysis in the Diagnostic Process
Velanovich
American Journal of Medical Quality 1994;9:158-161.
ABSTRACT  

Reliability of ultrasonography in identification of reflux nephropathy in children
Stokland et al.
BMJ 1994;309:235-239.
ABSTRACT | FULL TEXT  

A Randomized Trial of Test Result Sequencing in Patients With Suspected Multiple Sclerosis
O'Connor et al.
Arch Neurol 1994;51:53-59.
ABSTRACT  

How Much Routine Preoperative Laboratory Testing Is Enough?
Velanovich
American Journal of Medical Quality 1993;8:145-151.
ABSTRACT  

Local versus Global Measures of Accuracy: An Important Distinction for Diagnostic Imaging
Black and Dwyer
Med Decis Making 1990;10:266-273.
ABSTRACT  

Clinical Neuroepidemiology: I. Diagnosis
Longstreth et al.
Arch Neurol 1987;44:1091-1099.
ABSTRACT  

Cost-Effectiveness of Computerized Tomography and Magnetic Resonance Imaging in Dementia
Simon and Lubin
Med Decis Making 1985;5:335-351.