Ravindran Rizani, Szadkowski Leah, Lovblom Leif Erik, Clarke Rosemarie, Huang Qian Wen, Manase Dorin, Parente Laura, Walmsley Sharon
University Health Network, Toronto General Hospital Research Institute, Toronto, Ontario, Canada.
Biostatistics Research Unit; University Health Network; University of Toronto, Toronto, Ontario, Canada.
PLOS Digit Health. 2023 May 9;2(5):e0000242. doi: 10.1371/journal.pdig.0000242. eCollection 2023 May.
The Covid-19 pandemic required many clinical trials to adopt a decentralized framework to continue research activities during lock down restrictions. The STOPCoV study was designed to assess the safety and efficacy of Covid-19 vaccines in those aged 70 and above compared to those aged 30-50 years of age. In this sub-study we aimed to determine participant satisfaction for the decentralized processes, accessing the study website and collecting and submitting study specimens. The satisfaction survey was based on a Likert scale developed by a team of three investigators. Overall, there were 42 questions for respondents to answer. The invitation to participate with a link to the survey was emailed to 1253 active participants near the mid-way point of the main STOPCoV trial (April 2022). The results were collated and answers were compared between the two age cohorts. Overall, 70% (83% older, 54% younger cohort, no difference by sex) responded to the survey. The overall feedback was positive with over 90% of respondents answering that the website was easy to use. Despite the age gap, both the older cohort and younger cohort reported ease of performing study activities through a personal electronic device. Only 30% of the participants had previously participated in a clinical trial, however over 90% agreed that they would be willing to participate in future clinical research. Some difficulties were noted in refreshing the browser whenever updates to the website were made. The feedback attained will be used to improve current processes and procedures of the STOPCoV trial as well as share learning experiences to inform future fully decentralized research studies.
新冠疫情使得许多临床试验采用分散式框架,以便在封锁限制期间继续开展研究活动。“STOPCoV研究”旨在评估新冠疫苗在70岁及以上人群中与30至50岁人群相比的安全性和有效性。在这项子研究中,我们旨在确定参与者对分散式流程、访问研究网站以及收集和提交研究样本的满意度。满意度调查基于由三名研究人员组成的团队开发的李克特量表。总体而言,共有42个问题供受访者回答。在“STOPCoV”主要试验的中途(2022年4月),向1253名活跃参与者发送了包含调查问卷链接的参与邀请邮件。对结果进行了整理,并比较了两个年龄组的答案。总体而言,70%(老年组83%,年轻组54%,性别无差异)的人回复了调查。总体反馈是积极的,超过90%的受访者表示该网站易于使用。尽管存在年龄差距,但老年组和年轻组都表示通过个人电子设备开展研究活动很容易。只有30%的参与者此前参加过临床试验,然而超过90%的人同意他们愿意参加未来的临床研究。在网站进行更新时,刷新浏览器存在一些困难。所获得的反馈将用于改进“STOPCoV试验”的当前流程和程序,并分享经验教训,为未来完全分散式的研究提供参考。