Developing Real-world Evidence-Ready Datasets: Time for Clinician Engagement.

Developing Real-world Evidence-Ready Datasets: Time for Clinician Engagement.
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DOI:
10.1007/s11912-020-00904-z
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发表时间:
2020-04-16
影响因子:
4.7
通讯作者:
Poisson LM
Poisson LM
中科院分区:
医学2区
文献类型:
--
作者:
Snyder JM;Pawloski JA;Poisson LM

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支持学习卫生系统和实用临床试验的医疗保健中的真实世界数据(RWD)应用正在获得动力,这主要是由于立法支持药物审批的真实世界证据(RWE)。临床记录被认为是RWD应用的基石,特别是对于有效治疗有限的疾病、从其他疾病外推治疗或异质性疾病生物学和临床表型。在这里,我们讨论了当前应用在床旁捕获的RWD的问题,并为临床医生提供了一个框架,以参与RWD收集。为了获得有临床意义的结果,必须在我们的患者描述中使用一致的术语可靠地捕获RWD。RWD通过告知结果的普遍性,产生新的假设,并为科学发现创建大型数据网络,补充了传统的临床试验和研究。临床医生有效参与RWD应用程序的开发对于该领域的持续进步是必要的。
Real-world data (RWD) applications in healthcare that support learning health systems and pragmatic clinical trials are gaining momentum, largely due to legislation supporting real-world evidence (RWE) for drug approvals. Clinical notes are thought to be the cornerstone of RWD applications, particularly for conditions with limited effective treatments, extrapolation of treatments from other conditions, or heterogenous disease biology and clinical phenotypes. Here, we discuss current issues in applying RWD captured at the point-of-care and provide a framework for clinicians to engage in RWD collection. To achieve clinically meaningful results, RWD must be reliably captured using consistent terminology in the description of our patients. RWD complements traditional clinical trials and research by informing the generalizability of results, generating new hypotheses, and creating a large data network for scientific discovery. Effective clinician engagement in the development of RWD applications is necessary for continued progress in the field.
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