CLIN CHEM LAB MED:临床生物标记物的创新?

2019-11-03 gladiator MedSci原创

选择用于进一步研究和开发的生物标志物检测,不仅关系到诊断的准确性,而且关系到后续的临床和经济效益。

选择用于进一步研究和开发的生物标志物检测,不仅关系到诊断的准确性,而且关系到后续的临床和经济效益。早期健康经济建模是评估生物标志物创新的潜在影响和支持决策的重要技术手段。

我们将早期健康经济模型应用于难治性高血压患者原发性醛固酮增多症的诊断。使用马尔科夫队列状态转移模型模拟了一组患者。使用headroom方法,将当前使用的醛甾酮-肾素比率与一种具有完美诊断性能的假设新测试进行比较,以确定基于质量调整寿命年(quality-adjusted life-years, QALYs)和成本的headroom,然后进行阈值分析,以确定具有最低诊断准确性的低成本产品。

我们的模型表明,完善的诊断测试将产生0.027 QALYs,并使每位患者的费用增加€43 在每QALY 20,000欧元的成本效益阈值下,此完美测试具有成本效益的最高价格为498欧元(95%置信区间[CI]275–808欧元)。 完美测试的价值受当前生物标记测试灵敏度的最大影响。阈值分析表明,新的检测需要至少0.9的灵敏度和至少0.7的特异性才能具有成本效益。

在对开发,临床研究和实施进行大量投资之前,我们基于模型的方法评估了临床生物标志物创新的附加价值。 我们得出的结论是,在实验室中优先考虑生物标志物创新时,早期的健康经济建模可能是有价值的工具。

原始出处:

Anouck KluytmansJaap DeinumClinical biomarker innovation: when is it worthwhile?

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    2020-09-15 wjywjy
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