Pediatric and Congenital Cardiology Department, M3C Regional Reference Centre, Clinical Investigation Centre, University Hospital, Montpellier, France.
Pediatric and Congenital Cardiology Department, M3C Regional Reference Centre, Clinical Investigation Centre, University Hospital, Montpellier, France; PhyMedExp, CNRS, INSERM, University of Montpellier, Montpellier, France.
Arch Pediatr. 2022 Jul;29(5):347-353. doi: 10.1016/j.arcped.2022.03.004. Epub 2022 Apr 20.
COVID-19 triggered an unprecedented crisis affecting society at every level. Research in pediatric and congenital cardiology is currently in full development and may have been disrupted. The aim of the study was to determine the impact of COVID-19 on pediatric and congenital cardiology clinical research and to analyze decision-making and adaptation processes, from a panel of ongoing academic and industry-sponsored research at the time of the pandemic.
This observational study was carried out in April 2020, from a CHD clinical research network involving five tertiary care pediatric and congenital cardiology centers. Investigators and clinical research assistants from each participating research center completed an online survey questionnaire, and each principal investigator underwent a 1-h web-based videoconference interview.
A total of 34 study questionnaires were collected, reporting that 18 studies were totally suspended. Upon the investigator's decision, after discussion on ethical issues and with facilitating support from health authorities, 16 studies were resumed. The rate of study suspension in interventional research (53%) was similar to that in non-interventional research (56%). Logistical problems were predominantly reported in both continued and suspended trials. Research protocols were adapted, largely thanks to telemedicine, which in some cases even improved the course of the study.
The impact of the COVID-19 pandemic on clinical research in pediatric and congenital cardiology has been limited by a rapid adaptation of all research structures and an extensive use of telemedicine at all stages of the studies.
COVID-19 引发了一场前所未有的危机，影响了社会的各个层面。儿科和先天性心脏病学的研究目前正在全面发展，但可能已经受到了干扰。本研究旨在确定 COVID-19 对儿科和先天性心脏病学临床研究的影响，并分析当时正在进行的学术和行业资助研究的决策和适应过程。
本观察性研究于 2020 年 4 月进行，涉及五个三级儿科和先天性心脏病学中心的 CHD 临床研究网络。每个参与研究中心的调查员和临床研究助理完成了在线问卷调查，每位主要研究者都接受了 1 小时的网络视频会议采访。
共收集了 34 份研究问卷，报告称有 18 项研究完全暂停。在调查员决定后，经过对伦理问题的讨论，并在卫生当局的协助下，有 16 项研究得以恢复。介入性研究（53%）和非介入性研究（56%）的研究暂停率相似。在继续进行和暂停的试验中，主要报告了后勤问题。研究方案进行了调整，主要得益于远程医疗，在某些情况下甚至改善了研究进程。
COVID-19 大流行对儿科和先天性心脏病学临床研究的影响有限，这得益于所有研究结构的快速适应以及在研究的各个阶段广泛使用远程医疗。
