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The STARD Initiative and the Reporting of Studies of Diagnostic Accuracy

¹ Department of Pathology, Box 800214, University of Virginia Medical School

^aE-mail dbruns@virginia.edu

The first 300 words of the full text of this article appear below.

With the current public attention on medical tests (1), it is appropriate that we publish (2) this month, simultaneously with other journals,¹ the first result of an international project to improve the reporting of studies of the diagnostic accuracy of medical tests. The report(2) on Standards for Reporting Diagnostic Accuracy (STARD) reflects a multidisciplinary effort, 3 years in the making, that involved close collaboration of scores of clinicians, clinical investigators, clinical chemists, radiologists, clinical microbiologists, methodologists, and others. I review here some of the evidence that studies of diagnostic accuracy of medical tests need improving and I suggest that the STARD report(2) is a step in the right direction.

What Is Diagnostic Accuracy?

"Diagnostic accuracy" refers to the ability of a test to identify a condition of interest. In studies of diagnostic accuracy, the results of one or more tests are compared with a reference ("gold") standard in a group of patients suspected of having the condition of interest. The term "accuracy" in this context thus refers to the amount of agreement between the studied test(s) and the reference standard.

Studies of diagnostic accuracy are distinct from studies of analytical characteristics of a test, such as analytical accuracy, and distinct from studies of nonanalytical factors, such as within-person biological variation. Both of these types of studies provide essential information about tests, but they are not the focus here. Similarly, studies of diagnostic accuracy must be distinguished from studies of outcomes related to testing (such as improvements in health) and from studies of cost-effectiveness of testing. Quantitative understanding of the diagnostic accuracy of a test is critical both in deciding on its potential to improve outcomes and in assessing the results of a test in an individual patient.

The term diagnostic accuracy is sometimes used in a . . . [Full Text of this Article]

The Need for Improvement

Efforts to Improve Reporting of Studies in Clinical Chemistry

The STARD Initiative

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