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10.1136/neurintsurg-2020-016502

http://scihub22266oqcxt.onion/10.1136/neurintsurg-2020-016502
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32606103!7371488!32606103
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suck abstract from ncbi


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pmid32606103      J+Neurointerv+Surg 2020 ; 12 (9): 831-835
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  • Neuroendovascular clinical trials disruptions due to COVID-19 Potential future challenges and opportunities #MMPMID32606103
  • Rai AT; Leslie-Mazwi TM; Fargen KM; Pandey AS; Dabus G; Hassan AE; Fraser JF; Hirsch JA; Gupta R; Hanel R; Yoo AJ; Bozorgchami H; Fiorella D; Mocco J; Arthur AS; Zaidat O; Siddiqui AH
  • J Neurointerv Surg 2020[Sep]; 12 (9): 831-835 PMID32606103show ga
  • 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.
  • |*Betacoronavirus[MESH]
  • |*Surveys and Questionnaires[MESH]
  • |Brain Ischemia/diagnosis/epidemiology/*therapy[MESH]
  • |COVID-19[MESH]
  • |Coronavirus Infections/diagnosis/epidemiology/*therapy[MESH]
  • |Endovascular Procedures/methods/trends[MESH]
  • |Female[MESH]
  • |Forecasting[MESH]
  • |Humans[MESH]
  • |Male[MESH]
  • |Pandemics[MESH]
  • |Pneumonia, Viral/diagnosis/epidemiology/*therapy[MESH]
  • |Randomized Controlled Trials as Topic/*methods[MESH]
  • |SARS-CoV-2[MESH]


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