Centre for Health Economics, The University of York, York, Yorkshire, UK.
Med Decis Making. 2018 May;38(4):495-508. doi: 10.1177/0272989X17749829. Epub 2018 Mar 13.
In recent years, Health Technology Assessment (HTA) processes specific to diagnostics and prognostic tests have been created in response to the increased pressure on health systems to decide not only which tests should be used in practice but also the best way to proceed, clinically, from the information they provide. These technologies differ in the way value is accrued to the population of users, depending critically on the value of downstream health care choices. This paper defines an analytical framework for establishing the value of diagnostic and prognostic tests for HTA in a way that is consistent with methods used for the evaluation of other health care technologies. It assumes a linked-evidence approach where modeling is required, and incorporates considerations regarding several different areas of policy, such as personalized medicine. We initially focus on diagnostic technologies with dichotomous results, and then extend the framework by considering diagnostic tests that provide more complex information, such as continuous measures (for example, blood glucose measurements) or multiple categories (such as tumor classification systems). We also consider how the methods of assessment differ for prognostic information or for diagnostics without a reference standard. Throughout, we propose innovative graphical ways of summarizing the results of such complex assessments of value.
近年来，为了应对医疗系统面临的压力，不仅需要决定在实践中应使用哪些检测，还需要决定如何根据检测提供的信息进行临床决策，因此出现了专门针对诊断和预后检测的卫生技术评估 (Health Technology Assessment, HTA) 流程。这些技术在为用户群体带来价值的方式上有所不同，这主要取决于下游医疗保健选择的价值。本文定义了一个分析框架，用于以与其他医疗保健技术评估方法一致的方式为 HTA 确定诊断和预后检测的价值。它假设采用链接证据方法，需要进行建模，并考虑了政策的几个不同领域的因素，例如个性化医疗。我们最初关注具有二分结果的诊断技术，然后通过考虑提供更复杂信息的诊断检测（例如，连续测量值（例如血糖测量值）或多个类别（例如肿瘤分类系统））来扩展框架。我们还考虑了预后信息或没有参考标准的诊断检测的评估方法有何不同。自始至终，我们提出了创新的图形方法来总结此类复杂价值评估的结果。
