Department of Biostatistics and Data Science, UTHealth School of Public Health, Houston, Texas, United States of America.
Department of Neurology, UTHealth, Houston, Texas, United States of America.
PLoS One. 2021 Jan 15;16(1):e0243603. doi: 10.1371/journal.pone.0243603. eCollection 2021.
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.
由于可能对数据质量和人员安全产生影响，大多数临床研究在 COVID 期间停止。我们旨在评估 COVID 对在大流行期间继续招募患者的急性中风临床试验的影响。BEST-MSU 是一项正在进行的移动中风单元（MSU）与 tPA 合格的急性中风患者在院前环境中接受标准治疗的比较研究。MSU 人员包括通过远程医疗的血管神经科医生，以及一名护士、CT 技师、护理人员和急诊医学技术员。在 COVID 期间，通过电话而不是亲自获得同意、90 天改良 Rankin 量表（mRS）和 EQ5D，但管理的其他方面与 COVID 前时期相似。我们比较了 COVID 期间和 COVID 前时期患者的人口统计学、研究指标和研究人员的感染情况。在 COVID 期间，6 个 BEST-MSU 站点中的 5 个继续招募患者。在 COVID 期间（n = 57）和 COVID 前（n = 869）招募的 tPA 合格患者的年龄、性别、种族（38.6% vs 38.0%黑人）、民族（15.8% vs 18.6%西班牙裔）或 NIHSS（中位数 11 分 vs 9 分）无差异。筛选后入组和经判定符合 tPA 标准的患者比例从 13.6%下降至 6.6%（p<.001）；研究入组与当地居家令和重新开放令相关。MSU 到达现场的警报时间和到达 tPA 的时间没有差异，但 MSU 现场时间延长了 5 分钟（p =.01）。ED 门到 CT、tPA 治疗或取栓穿刺时间、住院时间、出院处置或远程与亲自进行的 90 天 mRS 或 EQ5D 无差异。一名 MSU 护士检测呈阳性，但无需住院治疗。大流行期间，可准确安全地开展院前临床研究。tPA 合格人数减少，但患者人口统计学、研究流程恶化或研究人员严重感染方面无差异。试验注册：NCT02190500。
