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多中心研究:抢先性药物遗传学检测的临床实施策略

Multisite investigation of strategies for the clinical implementation of pre-emptive pharmacogenetic testing.

机构信息

Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, University of Florida College of Pharmacy, Gainesville, FL, USA.

MedStar Health, Columbia, MD, USA.

出版信息

Genet Med. 2021 Dec;23(12):2335-2341. doi: 10.1038/s41436-021-01269-9. Epub 2021 Jul 19.

Abstract

PURPOSE

The increased availability of clinical pharmacogenetic (PGx) guidelines and decreasing costs for genetic testing have slowly led to increased utilization of PGx testing in clinical practice. Pre-emptive PGx testing, where testing is performed in advance of drug prescribing, is one means to ensure results are available at the time of prescribing decisions. However, the most efficient and effective methods to clinically implement this strategy remain unclear.

METHODS

In this report, we compare and contrast implementation strategies for pre-emptive PGx testing by 15 early-adopter institutions. We surveyed these groups, collecting data on testing approaches, team composition, and workflow dynamics, in addition to estimated third-party reimbursement rates.

RESULTS

We found that while pre-emptive PGx testing models varied across sites, institutions shared several commonalities, including methods to identify patients eligible for testing, involvement of a precision medicine clinical team in program leadership, and the implementation of pharmacogenes with Clinical Pharmacogenetics Implementation Consortium guidelines available. Finally, while reimbursement rate data were difficult to obtain, the data available suggested that reimbursement rates for pre-emptive PGx testing remain low.

CONCLUSION

These findings should inform the establishment of future implementation efforts at institutions considering a pre-emptive PGx testing program.

摘要

目的

临床药物遗传学(PGx)指南的可用性增加和基因检测成本的降低,使得 PGx 检测在临床实践中的应用逐渐增加。预先 PGx 检测是在开处方前进行的检测,可以确保在开处方决策时获得结果。然而,最有效和最有效的临床实施策略仍然不清楚。

方法

在本报告中,我们比较和对比了 15 个早期采用者机构的预先 PGx 检测实施策略。我们对这些团体进行了调查,收集了测试方法、团队组成和工作流程动态的相关数据,此外还收集了第三方报销率的估计数据。

结果

我们发现,尽管预先 PGx 测试模型在各个站点之间存在差异,但各机构存在一些共同之处,包括确定有资格进行测试的患者的方法、精准医学临床团队参与项目领导,以及实施有临床药物遗传学实施联合会指南的药物基因。最后,虽然难以获得报销率数据,但现有数据表明,预先 PGx 检测的报销率仍然很低。

结论

这些发现应该为考虑预先 PGx 检测计划的机构提供未来实施工作的信息。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef9f/8633054/766a0eb24ecb/nihms-1734682-f0001.jpg

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