York Health Economics Consortium, University of York, York, UK.
Test Evaluation Research Group, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
Int J Technol Assess Health Care. 2023 Feb 21;39(1):e14. doi: 10.1017/S0266462323000065.
To identify which international health technology assessment (HTA) agencies are undertaking evaluations of medical tests, summarize commonalities and differences in methodological approach, and highlight examples of good practice.
A methodological review incorporating: systematic identification of HTA guidance documents mentioning evaluation of tests; identification of key contributing organizations and abstraction of approaches to all essential HTA steps; summary of similarities and differences between organizations; and identification of important emergent themes which define the current state of the art and frontiers where further development is needed.
Seven key organizations were identified from 216 screened. The main themes were: elucidation of claims of test benefits; attitude to direct and indirect evidence of clinical effectiveness (including evidence linkage); searching; quality assessment; and health economic evaluation. With the exception of dealing with test accuracy data, approaches were largely based on general approaches to HTA with few test-specific modifications. Elucidation of test claims and attitude to direct and indirect evidence are where we identified the biggest dissimilarities in approach.
There is consensus on some aspects of HTA of tests, such as dealing with test accuracy, and examples of good practice which HTA organizations new to test evaluation can emulate. The focus on test accuracy contrasts with universal acknowledgment that it is not a sufficient evidence base for test evaluation. There are frontiers where methodological development is urgently required, notably integrating direct and indirect evidence and standardizing approaches to evidence linkage.
确定哪些国际卫生技术评估（HTA）机构正在对医学检测进行评估，总结方法学方法的异同，并突出良好实践的范例。
采用方法学综述，包括：系统识别提到检测评估的 HTA 指导文件；确定主要参与组织，并提取所有必要的 HTA 步骤的方法；总结组织之间的相似性和差异性；以及确定当前技术现状和需要进一步发展的前沿领域的重要新兴主题。
从 216 篇筛选文献中确定了 7 个关键组织。主要主题包括：阐明检测益处的主张；对临床有效性的直接和间接证据（包括证据链接）的态度；搜索；质量评估；以及健康经济评估。除了处理检测准确性数据外，方法主要基于一般的 HTA 方法，很少有针对检测的具体修改。在检测主张的阐明和对直接和间接证据的态度方面，我们发现方法上存在最大的差异。
在测试评估方面，HTA 有一些方面存在共识，例如处理测试准确性，以及 HTA 机构可以借鉴的良好实践范例。对测试准确性的关注与普遍承认的事实形成对比，即准确性不是测试评估的充分证据基础。在某些方面，方法学发展迫切需要，特别是整合直接和间接证据，并标准化证据链接的方法。
