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Not only therapeutic procedures, but also diagnostic procedures, have to demonstrate their patient-relevant benefits if they are to be reimbursed by public health insurance. Randomized trials comparing two diagnostic procedures allow us to assess these benefits directly if appropriate outcomes are used. However, owing to the widespread lack of such studies, it is now necessary to use the "linked evidence" approach as well, trying to predict the patient-relevant benefits from the results of comparative accuracy studies. Such a prediction is based on explicitly specifying our expectations with regard to the consequences of a change in diagnosis at the level of a single patient. We discuss the basic properties of these two approaches, which are relevant to the understanding of their possible role in the benefit assessment of diagnostic procedures. We try to predict the future roles of the two approaches and outline some of the issues on which a consensus is required to allow their successful use in benefit assessment. Furthermore, we indicate some of the developments related to the paradigm of individualized care that may influence the use of benefit assessments for diagnostic studies in the future.

Objectives: The European HeartScore has traditionally differentiated between low and high-risk countries. Until 2012 Germany and Denmark were considered to be high-risk countries but have now been defined as low-risk countries. In this survey we aim to address the consequences of this downgrading., Methods: A screening of 3932 randomly selected (mean age 56 years, 46% male) individuals from Germany and Denmark free of cardiovascular disease was performed. Traditional risk factors were determined, and the HeartScore was measured using both the low-risk and the high-risk country models. A non-contrast Cardiac-CT scan was performed to detect coronary artery calcification (CAC)., Results: Agreement of HeartScore risk groups with CAC groups was poor, but higher when applying the algorithm for the low-risk compared to the high-risk country model (agreement rate: 77% versus 63%, and weighted Kappa: 0.22 versus 0.15). However, the number of subjects with severe coronary calcification (CAC score ≥400) increased in the low and intermediate HeartScore risk group from 78 to 147 participants (from 2.7 % to 4.2 %, p = 0.001), when estimating the risk based on the algorithm for low-risk countries., Conclusion: As a consequence of the reclassification of Germany and Denmark as low-risk countries more people with severe atherosclerosis will be classified as having a low or intermediate risk of fatal cardiovascular disease., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)