New predictors of cardiovascular outcomes are widely sought in research settings, and predictive tests are commonly recommended for routine use in cardiovascular clinical care. A number of multivariable scoring systems are in use around the world for assessment of a patient’s risk. While such scoring systems are often recommended for clinical use in medical practice guidelines, their actual use in medical care falls short of recommendations. Limitations in the predictive capacity of existing predictive models are recognized, including lack of predictive accuracy, lack of ability to separate those who develop events from those who do not, and risks and costs of the testing modalities. Biomarker research is actively developing new testing strategies trying to improve upon current approaches, but it is often unclear how to assess the incremental prognostic information that a new test provides. In this report, we discuss the statistical approaches that can be used to evaluate additive predictive value of new tests. We also consider clinical research examples to put this information into a practical context.

中文翻译：

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评估新的心血管生物标志物的预后价值。


在研究环境中广泛寻求心血管结果的新预测因子，并且通常建议在心血管临床护理中常规使用预测测试。世界各地正在使用许多多变量评分系统来评估患者的风险。虽然此类评分系统经常在医疗实践指南中被推荐用于临床，但它们在医疗保健中的实际使用却达不到建议的要求。人们认识到现有预测模型的预测能力存在局限性，包括缺乏预测准确性、缺乏将发生事件的人和没有发生事件的人区分开的能力，以及测试方式的风险和成本。生物标志物研究正在积极开发新的测试策略，试图改进当前的方法，但通常不清楚如何评估新测试提供的增量预后信息。在本报告中，我们讨论了可用于评估新测试的附加预测价值的统计方法。我们还考虑临床研究示例，将这些信息应用到实际环境中。