Roberts James R, Chervinskiy Sheva K, McCulloh Russell, Snowden Jessica, Darden Paul M, Phan Thao-Ly T, Dawley Erin, Reynolds Victoria, Lim Crystal S, Pyles Lee, Hubberd DeAnn, Baldner Jaime, Lawrence Lora, Davis Ann M
Medical University of South Carolina, Charleston, SC, USA.
University of Arkansas for Medical Sciences, Little Rock, AR, USA.
J Clin Transl Sci. 2022 Aug 25;6(1):e115. doi: 10.1017/cts.2022.453. eCollection 2022.
BACKGROUND/OBJECTIVE: Prior to the COVID-19 pandemic, our research group initiated a pediatric practice-based randomized trial for the treatment of childhood obesity in rural communities. Approximately 6 weeks into the originally planned 10-week enrollment period, the trial was forced to pause all study activity due to the COVID-19 pandemic. This pause necessitated a substantial revision in recruitment, enrollment, and other study methods in order to complete the trial using virtual procedures. This descriptive paper outlines methods used to recruit, enroll, and manage clinical trial participants with technology to obtain informed consent, obtain height and weight measurements by video, and maintain participant engagement throughout the duration of the trial.
The study team reviewed the IRB records, protocol team meeting minutes and records, and surveyed the site teams to document the impact of the COVID-19 shift to virtual procedures on the study. The IRB approved study changes allowed for flexibility between clinical sites given variations in site resources, which was key to success of the implementation.
All study sites faced a variety of logistical challenges unique to their location yet successfully recruited the required number of patients for the trial. Ultimately, virtual procedures enhanced our ability to establish relationships with participants who were previously beyond our reach, but presented several challenges and required additional resources.
Lessons learned from this study can assist other study groups in navigating challenges, especially when recruiting and implementing studies with rural and underserved populations or during challenging events like the pandemic.
背景/目的：在新冠疫情大流行之前，我们的研究小组启动了一项基于儿科实践的随机试验，用于治疗农村社区的儿童肥胖症。在原计划的10周入组期进行了约6周后，由于新冠疫情大流行，该试验被迫暂停所有研究活动。这次暂停使得有必要对招募、入组及其他研究方法进行大幅修订，以便使用虚拟程序完成试验。这篇描述性论文概述了利用技术招募、入组和管理临床试验参与者的方法，包括获取知情同意书、通过视频测量身高和体重，以及在整个试验期间保持参与者的参与度。
研究团队查阅了机构审查委员会（IRB）记录、方案团队会议记录，并对各研究点团队进行了调查，以记录新冠疫情转向虚拟程序对该研究的影响。IRB批准的研究变更考虑到了各临床研究点资源的差异，允许研究点之间具有灵活性，这是实施成功的关键。
所有研究点都面临着因各自地理位置而产生的各种后勤挑战，但都成功招募到了试验所需数量的患者。最终，虚拟程序增强了我们与之前难以接触到的参与者建立关系的能力，但也带来了一些挑战，并且需要额外的资源。
从本研究中吸取的经验教训可以帮助其他研究小组应对挑战，特别是在招募和实施针对农村及服务不足人群的研究时，或者在像疫情这样的挑战性事件期间。
