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J Neurointerv Surg ; 12(9): 831-835, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-626369

ABSTRACT

To assess the impact of COVID-19 on neurovascular research and deal with the challenges imposed by the pandemic. METHODS: 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. RESULTS: 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. CONCLUSION: 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.


Subject(s)
Betacoronavirus , Brain Ischemia/therapy , Coronavirus Infections/therapy , Pneumonia, Viral/therapy , Randomized Controlled Trials as Topic/methods , Stroke/therapy , Surveys and Questionnaires , Brain Ischemia/diagnosis , Brain Ischemia/epidemiology , COVID-19 , Coronavirus Infections/diagnosis , Coronavirus Infections/epidemiology , Endovascular Procedures/methods , Endovascular Procedures/trends , Female , Forecasting , Humans , Male , Pandemics , Pneumonia, Viral/diagnosis , Pneumonia, Viral/epidemiology , SARS-CoV-2 , Stroke/diagnosis , Stroke/epidemiology
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