Interventional Neuroradiology, West Virginia University Rockefeller Neuroscience Institute, Morgantown, West Virginia, USA
Department of Neurosurgery, Massachusetts General Hospital, Boston, Massachusetts, USA.
J Neurointerv Surg. 2020 Sep;12(9):831-835. doi: 10.1136/neurintsurg-2020-016502. Epub 2020 Jun 30.
To assess the impact of COVID-19 on neurovascular research and deal with the challenges imposed by the pandemic.
A survey-based study focused on randomized controlled trials (RCTs) and single-arm studies for acute ischemic stroke and cerebral aneurysms was developed by a group of senior neurointerventionalists and sent to sites identified through the clinical trials website (https://clinicaltrials.gov/), study sponsors, and physician investigators.
The survey was sent to 101 institutions, with 65 responding (64%). Stroke RCTs were being conducted at 40 (62%) sites, aneurysm RCTs at 22 (34%) sites, stroke single-arm studies at 37 (57%) sites, and aneurysm single-arm studies at 43 (66%) sites. Following COVID-19, enrollment was suspended at 51 (78%) sites-completely at 21 (32%) and partially at 30 (46%) sites. Missed trial-related clinics and imaging follow-ups and protocol deviations were reported by 27 (42%), 24 (37%), and 27 (42%) sites, respectively. Negative reimbursements were reported at 17 (26%) sites. The majority of sites, 49 (75%), had put new trials on hold. Of the coordinators, 41 (63%) worked from home and 20 (31%) reported a personal financial impact. Remote consent was possible for some studies at 34 (52%) sites and for all studies at 5 (8%) sites. At sites with suspended trials (n=51), endovascular treatment without enrollment occurred at 31 (61%) sites for stroke and 23 (45%) sites for aneurysms. A total of 277 patients with acute ischemic stroke and 184 with cerebral aneurysms were treated without consideration for trial enrollment.
Widespread disruption of neuroendovascular trials occurred because of COVID-19. As sites resume clinical research, steps to mitigate similar challenges in the future should be considered.
评估 COVID-19 对神经血管研究的影响，并应对大流行带来的挑战。
一组资深神经介入医师开发了一项基于调查的研究，重点关注急性缺血性脑卒中 (AIS) 和脑动脉瘤的随机对照试验 (RCT) 和单臂研究，并通过临床试验网站 (https://clinicaltrials.gov/)、研究赞助商和医师研究者确定的地点发送该调查。
该调查共发送至 101 个机构，其中 65 个机构做出回应（64%）。40 个（62%）地点正在进行脑卒中 RCT，22 个（34%）地点进行动脉瘤 RCT，37 个（57%）地点进行脑卒中单臂研究，43 个（66%）地点进行动脉瘤单臂研究。COVID-19 之后，51 个（78%）地点暂停入组，其中 21 个（32%）完全暂停，30 个（46%）部分暂停。27 个（42%）、24 个（37%）和 27 个（42%）地点分别报告错过了与试验相关的门诊和影像学随访以及方案偏离。17 个（26%）地点报告出现负补偿。大多数（49 个）地点（75%）搁置了新试验。在协调员中，41 个（63%）在家工作，20 个（31%）报告个人经济受到影响。34 个（52%）地点的一些研究可以进行远程知情同意，5 个（8%）地点的所有研究都可以进行远程知情同意。在暂停试验的 51 个地点（n=51），31 个（61%）地点对 AIS 进行了血管内治疗而未入组，23 个（45%）地点对动脉瘤进行了血管内治疗而未入组。共有 277 例急性缺血性脑卒中患者和 184 例脑动脉瘤患者在未考虑试验入组的情况下接受了治疗。
COVID-19 导致神经介入试验广泛中断。随着各地点恢复临床研究，应考虑采取措施减轻未来类似的挑战。
