Vach Werner, Gerke Oke
Department für Medizinische Biometrie und Medizinische Informatik, Universität Freiburg, Stefan Meier Str. 26, 79104, Freiburg, Deutschland,
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2015 Mar;58(3):256-62. doi: 10.1007/s00103-014-2111-4.
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.
如果治疗程序和诊断程序想要获得公共医疗保险的报销，就必须证明其与患者相关的益处。如果使用了恰当的结果指标，比较两种诊断程序的随机试验就能让我们直接评估这些益处。然而，由于这类研究普遍缺乏，现在也有必要采用“关联证据”方法，尝试从比较准确性研究的结果中预测与患者相关的益处。这种预测基于明确阐述我们对单个患者诊断改变后果的预期。我们讨论了这两种方法的基本特性，这些特性对于理解它们在诊断程序益处评估中可能发挥的作用至关重要。我们试图预测这两种方法未来的作用，并概述一些达成共识才能在益处评估中成功应用它们的问题。此外，我们指出了一些与个性化医疗范式相关的发展情况，这些发展可能会影响未来诊断研究益处评估的使用。
