本文由小咖机器人翻译整理

期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.4088

摘要内容如下：

重要性

无论是现在还是将来，最佳卫生保健服务的提供都需要一个关于如何最好地提供护理的知识生成、传播和吸收的持续循环，不仅要确定哪些干预措施有效，还要确定如何最好地确保将它们提供给需要它们的人。随机临床试验（RCT）是确定什么在医疗保健中有效的最严格的工具。然而，临床试验企业的主要问题以及缺乏临床试验与医疗保健服务的整合损害了医学为社会提供最佳服务的能力。

观察

在大多数资源丰富的国家，临床试验和医疗保健提供企业作为独立的实体运作，具有孤立的目标、基础设施和激励机制。因此，随机对照试验往往与患者和负责提供护理的人员的需求缺乏相关性和响应性。与此同时，卫生保健提供系统往往脱离临床试验，无法迅速将随机对照试验产生的知识应用于实践。尽管这些问题由来已久，但考虑到从COVID-19大流行中吸取的教训、对难以获得最佳护理对弱势群体造成的不成比例的影响的认识提高，以及医疗保健领域的数字革命所带来的前所未有的改善机会，这些问题变得更加紧迫。必须改进四个主要方面。首先，特别是在美国，需要更大的透明度来确保对实施科学、质量改进、嵌入式临床试验和学习卫生系统的适当监管和监督。其次，需要更多地采用研究设计，以提高统计和后勤效率，降低参与者和临床医生的负担，使试验更智能、更安全、更快速。第三，如果随机对照试验与电子健康记录更好地整合，它们的响应能力和效率会大大提高。然而，这一进步首先需要更多地采用标准和流程，以确保健康数据足够可靠和准确，并能够在平台和组织之间负责任和高效地传输。第四，解决上述问题需要通过财政和非财政激励措施使临床试验和医疗保健提供企业中的利益相关者保持一致，这可以通过新的立法来实现。这些问题中的每一个都有解决方案，每一个都有成功的例子，但都未能以足够的规模实施。

结论和相关性

目前的医疗服务和可以提供的医疗服务之间的鸿沟可以说从未如此之大。一个关键的贡献者是知识产生和实施的两个分支——临床试验和医疗保健提供企业——像一个分开的房子一样运作。更好地整合这两个世界是加速改善医疗保健服务的关键。

英文原文如下：

Abstracts

Importance  Optimal health care delivery, both now and in the future, requires a continuous loop of knowledge generation, dissemination, and uptake on how best to provide care, not just determining what interventions work but also how best to ensure they are provided to those who need them. The randomized clinical trial (RCT) is the most rigorous instrument to determine what works in health care. However, major issues with both the clinical trials enterprise and the lack of integration of clinical trials with health care delivery compromise medicine's ability to best serve society.

Observations  In most resource-rich countries, the clinical trials and health care delivery enterprises function as separate entities, with siloed goals, infrastructure, and incentives. Consequently, RCTs are often poorly relevant and responsive to the needs of patients and those responsible for care delivery. At the same time, health care delivery systems are often disengaged from clinical trials and fail to rapidly incorporate knowledge generated from RCTs into practice. Though longstanding, these issues are more pressing given the lessons learned from the COVID-19 pandemic, heightened awareness of the disproportionate impact of poor access to optimal care on vulnerable populations, and the unprecedented opportunity for improvement offered by the digital revolution in health care. Four major areas must be improved. First, especially in the US, greater clarity is required to ensure appropriate regulation and oversight of implementation science, quality improvement, embedded clinical trials, and learning health systems. Second, greater adoption is required of study designs that improve statistical and logistical efficiency and lower the burden on participants and clinicians, allowing trials to be smarter, safer, and faster. Third, RCTs could be considerably more responsive and efficient if they were better integrated with electronic health records. However, this advance first requires greater adoption of standards and processes designed to ensure health data are adequately reliable and accurate and capable of being transferred responsibly and efficiently across platforms and organizations. Fourth, tackling the problems described above requires alignment of stakeholders in the clinical trials and health care delivery enterprises through financial and nonfinancial incentives, which could be enabled by new legislation. Solutions exist for each of these problems, and there are examples of success for each, but there is a failure to implement at adequate scale.

Conclusions and Relevance  The gulf between current care and that which could be delivered has arguably never been wider. A key contributor is that the 2 limbs of knowledge generation and implementation-the clinical trials and health care delivery enterprises-operate as a house divided. Better integration of these 2 worlds is key to accelerated improvement in health care delivery.

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