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The Quality of Reporting in Diagnostic Test Research: Getting Better, Still Not Optimal

¹ Academic Medical Center, University of Amsterdam, Amsterdam, NA 1105 AZ The Netherlands, Fax 31-31-20-6912683, E-mail p.m.bossuyt@amc.uva.nl

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In this era of evidence-based medicine, clinicians and other decision-makers turn to the scientific literature for high-quality evidence about the usefulness, precision, and accuracy of diagnostic tests. Such evidence is needed more than ever because the list of diagnostic tests is growing exponentially, and even more biomarkers, proteomics, and applications of gene expression profiling will be added in the years to come.

Studies of diagnostic accuracy can provide the necessary data. Rigorous methodologic standards in research about diagnostic tests have been slower to develop than standards for therapy studies. During the past decade, our knowledge about study design features that are associated with bias and lack of applicability in diagnostic studies has grown. Diagnostic studies with deficiencies in specific design features have been shown to be associated with biased, optimistic estimates of diagnostic accuracy compared with studies without such deficiencies (1).

Given this potential for bias, it is of paramount importance that study reports include a proper description of the study methods, in particular those design features that have been most clearly associated with bias. Within the spirit of evidence-based medicine, readers should take these features into account when examining a study and its results, pondering the decision on whether to implement changes in practice based on conclusions from the study.

Unfortunately, the quality . . . [Full Text of this Article]