Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN.
Research Systems Operations, Mayo Clinic, Scottsdale, AZ.
Mayo Clin Proc. 2021 Sep;96(9):2332-2341. doi: 10.1016/j.mayocp.2021.06.022. Epub 2021 Jul 5.
To assess the impact of the COVID-19 pandemic on clinical research and the use of electronic approaches to mitigate this impact.
We compared the utilization of electronic consenting, remote visits, and remote monitoring by study monitors in all research studies conducted at Mayo Clinic sites (Arizona, Florida, and Minnesota) before and during the COVID-19 pandemic (ie, between May 1, 2019 and December 31, 2020). Participants are consented through a participant-tracking system linked to the electronic health record.
Between May 2019, and December 2020, there were 130,800 new consents across every modality (electronic and paper) to participate in a non-trial (107,176 [82%]) or a clinical trial (23,624 [18%]). New consents declined from 5741 in February 2020 to 913 in April 2020 but increased to 11,864 in November 2020. The mean (standard deviation [SD]) proportion of electronic consent increased from 22 (2%) before to 45 (20%) during the pandemic (P=.001). Mean (SD) remote electronic consenting increased from 0.3 (0.5%) to 29 (21%) (P<.001). The mean (SD) number of patients with virtual visits increased from 3.5 (2.4%) to 172 (135%) (P=.003) per month between pre-COVID (July 2019 to February 2020) and post-COVID (March to December 2020) periods. Virtual visits used telemedicine (68%) or video (32%). Requests for remote monitor access to complete visits increased from 44 (17%) per month between May 2019 and February 2020 to 111 (74%) per month between March and December 2020 (P=.10).
After a sharp early decline, the enrollment of new participants and ongoing study visits recovered during the COVID-19 pandemic. This recovery was accompanied by the increased use of electronic tools.
评估 COVID-19 大流行对临床研究的影响，并评估采用电子方法来减轻这种影响。
我们比较了梅奥诊所（亚利桑那州、佛罗里达州和明尼苏达州）在 COVID-19 大流行（即 2019 年 5 月 1 日至 2020 年 12 月 31 日）前后所有研究中电子知情同意、远程访问和研究监查员远程监测的使用情况。参与者通过与电子健康记录相关联的参与者跟踪系统进行知情同意。
在 2019 年 5 月至 2020 年 12 月期间，有 130800 人通过各种模式（电子和纸质）新同意参与非试验（107176[82%]）或临床试验（23624[18%]）。新同意数从 2020 年 2 月的 5741 人下降到 4 月的 913 人，但在 2020 年 11 月增加到 11864 人。电子知情同意的平均（标准差[SD]）比例从大流行前的 22（2%）增加到 45（20%）（P<.001）。远程电子知情同意的平均（SD）从 0.3（0.5%）增加到 29（21%）（P<.001）。每月虚拟就诊患者的平均（SD）人数从大流行前（2019 年 7 月至 2020 年 2 月）的 3.5（2.4%）增加到 172（135%）（P=.003）。虚拟就诊使用远程医疗（68%）或视频（32%）。从 2019 年 5 月至 2020 年 2 月，每月要求远程监测访问以完成就诊的次数从 44（17%）增加到 2020 年 3 月至 12 月的 111（74%）（P=.10）。
在最初急剧下降后，COVID-19 大流行期间新参与者的入组和正在进行的研究访问量有所恢复。这种恢复伴随着电子工具使用的增加。
