Introduction
What is new?
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In diagnostic research, decision models form a valuable alternative when randomized clinical trials (RCTs) are infeasible by integrating the best available evidence.
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Decision-analytic models should be increasingly used to evaluate clinical outcome including cost-effectiveness of fast developing diagnostic techniques.
To date, consensus on the methodology to evaluate new diagnostic tests is lacking [1]. Moreover, with rapid technical advances, especially in the field of imaging, diagnostic techniques undergoing evaluation may be already outdated before diagnostic and clinical values are established [2], [3].
Similar to therapeutic research, a hierarchy can be discerned within diagnostic research [1], [2], [4], [5], [6], [7]. The first step is the assessment of test characteristics of a new test. The next step is the evaluation of its added value [8]. The third step is the assessment of the effect on clinical outcome, and the final step comprises a cost-effectiveness analysis [7]. For evaluation of clinical outcome and cost-effectiveness of tests, randomized clinical trials (RCTs) are often not feasible.
We will shortly review each step of diagnostic research and discuss decision analysis as a useful alternative methodology for critical assessment of clinical value and efficient use of resources.