Empirical Evidence of Design-Related Bias in Studies of Diagnostic Tests

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Abstract
During recent decades, the number of available diagnostic tests has been rapidly increasing. As for all new medical technologies, new diagnostic tests should be thoroughly evaluated prior to their introduction into daily practice. The number of test evaluations in the literature is increasing but the methodological quality of these studies is on average poor. A survey of the diagnostic literature (1990-1993) showed that only 18% of the studies satisfied 5 of the 7 methodological standards examined.1 Different guidelines have been written to help physicians with the critical appraisal of the diagnostic literature consisting of lists of criteria for the assessment of study quality.2-4 Criteria enable readers to check whether studies fulfill methodological criteria on study design, data collection, and methods of reporting the results.