In this era of evidence-based medicine, diagnostic tests cannot escape close scrutiny of their effectiveness. Sensitivity and specificity have up till now played a central role in the evaluation of diagnostic tests. These terms are not without their shortcomings when it comes to the characterisation of a test's true worth for patients. Randomised clinical trials are increasingly used for evaluation of medical tests and outlining of strategy. The indirect relationship between test results and health outcome creates additional challenges for designers of such trials.
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