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2019年冠状病毒病大流行对麻醉学临床试验中止的影响:横断面分析

Influence of the COVID-19 Pandemic on Clinical Trial Discontinuation in Anesthesiology: Cross-sectional Analysis.

作者信息

Traxler Brett D, Rucker Brayden M, Greenough Mary C, Sajjadi Nicholas B, Hartwell Micah

机构信息

Office of Medical Student Research, College of Osteopathic Medicine, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States.

Office for Research Development and Scholarly Activity, School of Community Medicine, University of Oklahoma, Tulsa, OK, United States.

出版信息

JMIR Perioper Med. 2022 Apr 5;5(1):e34936. doi: 10.2196/34936.

Abstract

BACKGROUND

The COVID-19 pandemic drastically altered perioperative medical practice owing to safety concerns, postponing elective or nonemergent procedures, supply chain shortages, and reallocating perioperative staff to care for patients with COVID-19. However, the impact of the pandemic on the conduct on anesthesiology clinical research is unknown.

OBJECTIVE

The primary objective was to quantify the magnitude of the COVID-19 pandemic's impact on anesthesiology clinical research.

METHODS

We performed a systematic search using ClinicalTrials.gov to identify clinical trials related to the practice of anesthesiology. We screened trials with status updates from January 1, 2020, through October 1, 2021, to capture trials potentially affected by the COVID-19 pandemic by the time of our search. Investigators screened for relevant studies and extracted trial characteristics along with the reason for discontinuation reported on the clinical trial registry.

RESULTS

A total of 823 clinical trials met inclusion criteria, and 146 clinical trials were discontinued within the designated date range. In total, 24 (16.4%) of the 146 clinical trials were halted explicitly owing to the COVID-19 pandemic. A significant association existed between trial enrollment numbers and the likelihood of discontinuation due to the COVID-19 pandemic, as larger trials were more likely to be disrupted (z=-2.914, P=.004).

CONCLUSIONS

The COVID-19 pandemic is reportedly associated with the discontinuation of anesthesiology-related clinical trials. With the uncertain course of the COVID-19 pandemic, developing anesthesia trial protocols to help minimize social interaction and prevent premature trial disruption are imperative.

摘要

背景

由于安全担忧、推迟择期或非紧急手术、供应链短缺以及将围手术期工作人员重新分配以照顾新冠病毒疾病患者,新冠疫情极大地改变了围手术期医疗实践。然而,疫情对麻醉学临床研究开展的影响尚不清楚。

目的

主要目的是量化新冠疫情对麻醉学临床研究的影响程度。

方法

我们使用美国国立医学图书馆临床试验数据库(ClinicalTrials.gov)进行系统检索,以识别与麻醉学实践相关的临床试验。我们筛选了2020年1月1日至2021年10月1日有状态更新的试验,以获取在我们检索时可能受新冠疫情影响的试验。研究人员筛选相关研究,并提取试验特征以及临床试验登记处报告的终止原因。

结果

共有823项临床试验符合纳入标准,146项临床试验在指定日期范围内终止。在这146项临床试验中,共有24项(16.4%)因新冠疫情而明确暂停。试验入组人数与因新冠疫情而终止的可能性之间存在显著关联,因为规模较大的试验更有可能被中断(z=-2.914,P=0.004)。

结论

据报道,新冠疫情与麻醉学相关临床试验的终止有关。鉴于新冠疫情的发展态势尚不确定,制定麻醉试验方案以尽量减少社交互动并防止试验过早中断势在必行。

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