Diagnostic Accuracy Studies

The medical community often assumes that the tests we use to diagnose various diseases are accurate, safe, and effective. However, the study designs traditionally used to determine whether such a diagnostic test is indeed accurate, safe, and effective are often at a higher risk of bias and are of lower methodological quality than those evaluating efficacy of therapeutic interventions. Several designs can be used to study diagnostic tests such as diagnostic accuracy cross-sectional studies, diagnostic accuracy case-control studies, and diagnostic accuracy comparative studies. Clinicians, researchers, and policy-makers may wish to consider moving toward higher quality study designs when studying new diagnostic modalities prior to their implementation in routine practice and diagnostic randomized trials are one such alternative.