Making Clinical Practice Guidelines Pragmatic: How Big Data and Real World Evidence Can Close the Gap.
Making Clinical Practice Guidelines Pragmatic: How Big Data and Real World Evidence Can Close the Gap.
复制标题
使临床实践指南更加务实：大数据和现实世界证据如何缩小差距。
DOI：
10.47102/annals-acadmedsg.v47n12p523
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发表时间：
2018
期刊：
影响因子：
--
通讯作者：
D. Matchar
中科院分区：
文献类型：
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作者：
S. Y. Chew;M. S. Koh;C. Loo;J. Thumboo;S. Shantakumar;D. Matchar
临床实践指南 (CPG) 已在当今医学的各个领域变得无处不在，但在实施和改善健康结果方面取得的成功有限。指南主要基于传统随机对照试验（RCT）的结果，这些试验采用高度选择性的过程，以最大限度地提高干预措施证明疗效的机会，因此具有较高的内部效度，但缺乏外部效度。因此，基于这些随机对照试验的指南常常存在试验效果与现实世界效果之间的差距，这也是导致医生未能遵守指南的常见原因之一。 “真实世界证据”(RWE) 可以补充 CPG 开发中的随机对照试验。 RWE——以综合电子健康记录数据的形式——代表了一线医生和患者丰富多样的集体经验。 RWE 有潜力通过平衡有关测试或治疗是否有效的信息（有效性）与其在现实世界实践中如何发挥作用的数据（有效性）来填补当前指南的空白。 RWE 还可以通过让一线利益相关者参与务实的生物标志物研究来推进日常实践中的精准医学议程。这将使指南制定者不仅能够更准确地确定是否建议进行临床测试或治疗，还可以确定针对谁以及何时建议进行临床测试或治疗。新加坡处于有利地位，能够驾驭大数据和 RWE 浪潮，因为我们拥有高度数字互联、综合国家电子健康记录 (NEHR) 以及政府以智能国家计划形式提供的支持等优势。
Clinical practice guidelines (CPGs) have become ubiquitous in every field of medicine today but there has been limited success in implementation and improvement in health outcomes. Guidelines are largely based on the results of traditional randomised controlled trials (RCTs) which adopt a highly selective process to maximise the intervention's chance of demonstrating efficacy thus having high internal validity but lacking external validity. Therefore, guidelines based on these RCTs often suffer from a gap between trial efficacy and real world effectiveness and is one of the common reasons contributing to poor guideline adherence by physicians. "Real World Evidence" (RWE) can complement RCTs in CPG development. RWE-in the form of data from integrated electronic health records-represents the vast and varied collective experience of frontline doctors and patients. RWE has the potential to fill the gap in current guidelines by balancing information about whether a test or treatment works (efficacy) with data on how it works in real world practice (effectiveness). RWE can also advance the agenda of precision medicine in everyday practice by engaging frontline stakeholders in pragmatic biomarker studies. This will enable guideline developers to more precisely determine not only whether a clinical test or treatment is recommended, but for whom and when. Singapore is well positioned to ride the big data and RWE wave as we have the advantages of high digital interconnectivity, an integrated National Electronic Health Record (NEHR), and governmental support in the form of the Smart Nation initiative.