Successful conduct of an acute stroke clinical trial during COVID.
Most clinical research stopped during COVID due to possible impact on data quality and personnel safety. We aimed to assess the impact of COVID on acute stroke clinical trial conduct at sites that continued to enroll patients during the pandemic. BEST-MSU is an ongoing study of Mobile Stroke Units (...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2021-01-01
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| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0243603 |
| _version_ | 1818741280114475008 |
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| author | Jose-Miguel Yamal Stephanie A Parker Asha P Jacob Suja S Rajan Ritvij Bowry Patti Bratina Mengxi Wang May Nour Jason Mackey Sarah Collins William Jones Brandi Schimpf David Ornelas Ilana Spokoyny Jenny Fung Im Greg Gilbert Michael Eisshofer James C Grotta |
| author_facet | Jose-Miguel Yamal Stephanie A Parker Asha P Jacob Suja S Rajan Ritvij Bowry Patti Bratina Mengxi Wang May Nour Jason Mackey Sarah Collins William Jones Brandi Schimpf David Ornelas Ilana Spokoyny Jenny Fung Im Greg Gilbert Michael Eisshofer James C Grotta |
| author_sort | Jose-Miguel Yamal |
| collection | DOAJ |
| description | Most clinical research stopped during COVID due to possible impact on data quality and personnel safety. We aimed to assess the impact of COVID on acute stroke clinical trial conduct at sites that continued to enroll patients during the pandemic. BEST-MSU is an ongoing study of Mobile Stroke Units (MSU) vs standard management of tPA-eligible acute stroke patients in the pre-hospital setting. MSU personnel include a vascular neurologist via telemedicine, and a nurse, CT technologist, paramedics and emergency medicine technicians on-board. During COVID, consent, 90-day modified Rankin Scale (mRS) and EQ5D were obtained by phone instead of in-person, but other aspects of management were similar to the pre-COVID period. We compared patient demographics, study metrics, and infection of study personnel during intra- vs pre-COVID eras. Five of 6 BEST-MSU sites continued to enroll during COVID. There were no differences in intra- (n = 57) vs pre- (n = 869) COVID enrolled tPA eligible patients' age, sex, race (38.6% vs 38.0% Black), ethnicity (15.8% vs 18.6% Hispanic), or NIHSS (median 11 vs 9). The percent of screened patients enrolled and adjudicated tPA eligible declined from 13.6% to 6.6% (p < .001); study enrollment correlated with local stay-at-home and reopening orders. There were no differences in alert to MSU arrival or arrival to tPA times, but MSU on-scene time was 5 min longer (p = .01). There were no differences in ED door to CT, tPA treatment or thrombectomy puncture times, hospital length of stay, discharge disposition, or remote vs in-person 90-day mRS or EQ5D. One MSU nurse tested positive but did not require hospitalization. Clinical research in the pre-hospital setting can be carried out accurately and safely during a pandemic. tPA eligibility rates declined, but otherwise there were no differences in patient demographics, deterioration of study processes, or serious infection of study staff. Trial registration: NCT02190500. |
| first_indexed | 2024-12-18T01:54:07Z |
| format | Article |
| id | doaj.art-22259344169b4b15a526383077e199fe |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-18T01:54:07Z |
| publishDate | 2021-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-22259344169b4b15a526383077e199fe2022-12-21T21:24:57ZengPublic Library of Science (PLoS)PLoS ONE1932-62032021-01-01161e024360310.1371/journal.pone.0243603Successful conduct of an acute stroke clinical trial during COVID.Jose-Miguel YamalStephanie A ParkerAsha P JacobSuja S RajanRitvij BowryPatti BratinaMengxi WangMay NourJason MackeySarah CollinsWilliam JonesBrandi SchimpfDavid OrnelasIlana SpokoynyJenny Fung ImGreg GilbertMichael EisshoferJames C GrottaMost clinical research stopped during COVID due to possible impact on data quality and personnel safety. We aimed to assess the impact of COVID on acute stroke clinical trial conduct at sites that continued to enroll patients during the pandemic. BEST-MSU is an ongoing study of Mobile Stroke Units (MSU) vs standard management of tPA-eligible acute stroke patients in the pre-hospital setting. MSU personnel include a vascular neurologist via telemedicine, and a nurse, CT technologist, paramedics and emergency medicine technicians on-board. During COVID, consent, 90-day modified Rankin Scale (mRS) and EQ5D were obtained by phone instead of in-person, but other aspects of management were similar to the pre-COVID period. We compared patient demographics, study metrics, and infection of study personnel during intra- vs pre-COVID eras. Five of 6 BEST-MSU sites continued to enroll during COVID. There were no differences in intra- (n = 57) vs pre- (n = 869) COVID enrolled tPA eligible patients' age, sex, race (38.6% vs 38.0% Black), ethnicity (15.8% vs 18.6% Hispanic), or NIHSS (median 11 vs 9). The percent of screened patients enrolled and adjudicated tPA eligible declined from 13.6% to 6.6% (p < .001); study enrollment correlated with local stay-at-home and reopening orders. There were no differences in alert to MSU arrival or arrival to tPA times, but MSU on-scene time was 5 min longer (p = .01). There were no differences in ED door to CT, tPA treatment or thrombectomy puncture times, hospital length of stay, discharge disposition, or remote vs in-person 90-day mRS or EQ5D. One MSU nurse tested positive but did not require hospitalization. Clinical research in the pre-hospital setting can be carried out accurately and safely during a pandemic. tPA eligibility rates declined, but otherwise there were no differences in patient demographics, deterioration of study processes, or serious infection of study staff. Trial registration: NCT02190500.https://doi.org/10.1371/journal.pone.0243603 |
| spellingShingle | Jose-Miguel Yamal Stephanie A Parker Asha P Jacob Suja S Rajan Ritvij Bowry Patti Bratina Mengxi Wang May Nour Jason Mackey Sarah Collins William Jones Brandi Schimpf David Ornelas Ilana Spokoyny Jenny Fung Im Greg Gilbert Michael Eisshofer James C Grotta Successful conduct of an acute stroke clinical trial during COVID. PLoS ONE |
| title | Successful conduct of an acute stroke clinical trial during COVID. |
| title_full | Successful conduct of an acute stroke clinical trial during COVID. |
| title_fullStr | Successful conduct of an acute stroke clinical trial during COVID. |
| title_full_unstemmed | Successful conduct of an acute stroke clinical trial during COVID. |
| title_short | Successful conduct of an acute stroke clinical trial during COVID. |
| title_sort | successful conduct of an acute stroke clinical trial during covid |
| url | https://doi.org/10.1371/journal.pone.0243603 |
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