Department of Health Sciences, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Department of Economics and Business, University of La Rioja, Logroño, Spain.
Pharmacoeconomics. 2021 Dec;39(12):1355-1363. doi: 10.1007/s40273-021-01104-8. Epub 2021 Nov 1.
Cost-effectiveness analyses (CEAs) can be used to assess the value of diagnostics in clinical practice. Due to the introduction of the European in vitro diagnostic and medical devices regulations, more clinical data on new diagnostics may become available, which may improve the interest and feasibility of performing CEAs. We present eight recommendations on the reporting and design of CEAs of diagnostics. The symptoms patients experience, the clinical setting, locations of test sampling and analysis, and diagnostic algorithms should be clearly reported. The used time horizon should reflect the time horizon used to model the treatment after the diagnostic pathway. Quality-adjusted life-years (QALYs) or disability-adjusted life-years (DALYs) should be used as the clinical outcomes but may be combined with other relevant outcomes, such as real options value. If the number of tests using the same equipment can vary, the economy of scale should be considered. An understandable graphical representation of the various diagnostic algorithms should be provided to understand the results, such as an efficiency frontier. Finally, the budget impact and affordability should be considered. These recommendations can be used in addition to other, more general, recommendations, such as the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) or the reference case for economic evaluation by the international decision support initiative.
成本效益分析（CEA）可用于评估诊断在临床实践中的价值。由于欧洲体外诊断和医疗器械法规的出台，更多关于新诊断的临床数据可能会变得可用，这可能会提高进行 CEA 的兴趣和可行性。我们提出了关于诊断 CEA 报告和设计的八项建议。应明确报告患者的症状、临床环境、检测采样和分析地点以及诊断算法。使用的时间范围应反映用于对诊断途径后的治疗进行建模的时间范围。应使用质量调整生命年（QALY）或残疾调整生命年（DALY）作为临床结果，但可与其他相关结果（如实物期权价值）结合使用。如果使用同一设备的检测数量可能会有所不同，则应考虑规模经济。应提供各种诊断算法的易于理解的图形表示，以了解结果，例如效率前沿。最后，应考虑预算影响和负担能力。这些建议可以与其他更一般的建议（如卫生保健经济评估报告标准（CHEERS）或国际决策支持倡议的经济评估参考案例）一起使用。
