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为“适应性试验”一词赋予新含义:2019年冠状病毒病大流行期间开展临床研究的挑战及对实施科学的启示

Bringing New Meaning to the Term "Adaptive Trial": Challenges of Conducting Clinical Research During the Coronavirus Disease 2019 Pandemic and Implications for Implementation Science.

作者信息

Branch-Elliman Westyn, Elwy A Rani, Monach Paul

机构信息

VA Boston Healthcare System, Department of Medicine, Boston, Massachussetts, USA.

Harvard Medical School, Boston, Massachussetts, USA.

出版信息

Open Forum Infect Dis. 2020 Oct 19;7(11):ofaa490. doi: 10.1093/ofid/ofaa490. eCollection 2020 Nov.

Abstract

Although implementation of evidence-based practices takes an average of 17 years, in the context of the global pandemic, coronavirus disease 2019 (COVID-19) interventions were adopted in a greatly compressed time frame. This rapid uptake creates major challenges for conducting COVID-19 clinical research studies, because quickly evolving standards make it difficult to adapt in real time. The rapid dissemination and implementation of COVID-19 interventions is the realization of goals long pursued by the implementation science community. However, the downside of the rapid implementation is that low-quality evidence with little to no scientific vetting may be quickly integrated into clinical care, resulting in lost opportunities to advance our scientific understanding about how to manage infected patients. In the future, novel adaptive designs embedded into electronic health records (Embedded Quantified, Integrated-into-Practice Trial [EQuIPT] designs) that allow for easier and better access to clinical trials may simultaneously improve care and advance healthcare innovations.

摘要

尽管循证实践的实施平均需要17年,但在全球大流行的背景下,2019冠状病毒病(COVID-19)干预措施在极短的时间内就被采用了。这种迅速采用给开展COVID-19临床研究带来了重大挑战,因为快速演变的标准使得实时适应变得困难。COVID-19干预措施的迅速传播和实施实现了实施科学领域长期追求的目标。然而,快速实施的不利之处在于,几乎没有经过科学审查的低质量证据可能会迅速融入临床护理,从而失去了推进我们对如何管理感染患者的科学理解的机会。未来,嵌入电子健康记录的新型适应性设计(嵌入式量化、融入实践试验[EQuIPT]设计),可使临床试验更容易、更好地进行,这可能同时改善护理并推动医疗创新。

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