Feasibility and lessons learned on remote trial implementation from TestBoston, a fully remote, longitudinal, large-scale COVID-19 surveillance study.
Feasibility and lessons learned on remote trial implementation from TestBoston, a fully remote, longitudinal, large-scale COVID-19 surveillance study.
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DOI：
10.1371/journal.pone.0269127
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发表时间：
2022
期刊：
影响因子：
3.7
通讯作者：
中科院分区：
文献类型：
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作者：
纵向临床研究传统上需要亲自进行研究访问，这些访问有很好的记录，对参与构成障碍，并对招募代表性样本构成挑战。远程试验模式可以减少研究参与的障碍，提高保留率，并达到更具代表性的队列。随着COVID-19大流行后远程试验变得越来越普遍，对这种方法进行批判性评估对于优化研究中的这种范式转变至关重要。TestBoston研究旨在通过完全远程的家庭测试模型了解大波士顿地区COVID-19感染的流行率和风险因素。参与者（成年人，在马萨诸塞州波士顿45英里范围内）是从布莱根妇女医院的患者登记处和公众中远程招募的。参与者每月和“按需”在家中使用鼻拭子和干血斑自我采集试剂盒进行SARS-CoV-2 RT-PCR和抗体检测，并通过在线仪表板进行电子调查，以评估COVID-19的症状和风险因素。在2020年10月至2021年1月期间，我们招募了10，289名参与者，反映了马萨诸塞州的人口普查数据。平均年龄为47岁（范围18-93岁），5855例（56.9%）在出生时被指定为女性，7181例（69.8%）报告为非西班牙裔白色白人，952例（9.3%）西班牙裔/拉丁裔，925例（9.0%）黑人，889例（8.6%）亚裔，342例（3.3%）其他和/或多个人种。黑人和西班牙裔/拉丁裔个人的初始入学率较低，需要采取适应性的招聘方法，利用与医疗系统的联系，再加上社区合作伙伴关系，以确保具有代表性的队列。纵向保留是较高的参与者谁是白色非西班牙裔，老年人，远程工作，社会经济脆弱性较低。实施强调了远程试验模式的关键差异，因为参与者独立导航研究里程碑，需要专门的参与者支持团队和强大的技术平台，以减少入组障碍，促进保留，并确保科学严谨性和数据质量。远程临床试验模型提供了巨大的潜力，可以吸引代表性队列，扩大生物医学研究，并通过减少传统试验设计中常见的障碍来促进可访问性。在不同的人口统计学群体中，远程试验中的障碍和负担可能不成比例地存在。为了最大限度地提高参与度和保留率，研究人员应该优先考虑密集的参与者支持，对技术基础设施的投资和适应性方法，以最大限度地提高参与度和保留率。
Longitudinal clinical studies traditionally require in-person study visits which are well documented to pose barriers to participation and contribute challenges to enrolling representative samples. Remote trial models may reduce barriers to research engagement, improve retention, and reach a more representative cohort. As remote trials become more common following the COVID-19 pandemic, a critical evaluation of this approach is imperative to optimize this paradigm shift in research. The TestBoston study was launched to understand prevalence and risk factors for COVID-19 infection in the greater Boston area through a fully remote home-testing model. Participants (adults, within 45 miles of Boston, MA) were recruited remotely from patient registries at Brigham and Women’s Hospital and the general public. Participants were provided with monthly and “on-demand” at-home SARS-CoV-2 RT-PCR and antibody testing using nasal swab and dried blood spot self-collection kits and electronic surveys to assess symptoms and risk factors for COVID-19 via an online dashboard. Between October 2020 and January 2021, we enrolled 10,289 participants reflective of Massachusetts census data. Mean age was 47 years (range 18–93), 5855 (56.9%) were assigned female sex at birth, 7181(69.8%) reported being White non-Hispanic, 952 (9.3%) Hispanic/Latinx, 925 (9.0%) Black, 889 (8.6%) Asian, and 342 (3.3%) other and/or more than one race. Lower initial enrollment among Black and Hispanic/Latinx individuals required an adaptive approach to recruitment, leveraging connections to the medical system, coupled with community partnerships to ensure a representative cohort. Longitudinal retention was higher among participants who were White non-Hispanic, older, working remotely, and with lower socioeconomic vulnerability. Implementation highlighted key differences in remote trial models as participants independently navigate study milestones, requiring a dedicated participant support team and robust technology platforms, to reduce barriers to enrollment, promote retention, and ensure scientific rigor and data quality. Remote clinical trial models offer tremendous potential to engage representative cohorts, scale biomedical research, and promote accessibility by reducing barriers common in traditional trial design. Barriers and burdens within remote trials may be experienced disproportionately across demographic groups. To maximize engagement and retention, researchers should prioritize intensive participant support, investment in technologic infrastructure and an adaptive approach to maximize engagement and retention.
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影响因子：
3.7
作者：
Boughey JC;Snyder RA;Kantor O;Zheng L;Chawla A;Nguyen TT;Hillman SL;Hahn OM;Mandrekar SJ;Roland CL
通讯作者：
Roland CL
影响因子：
1.7
作者：
Lai, Byron;Chiu, Chia-Ying;Rimmer, James
通讯作者：
Rimmer, James
影响因子：
4.2
作者：
Clark, Luther T;Watkins, Laurence;Regnante, Jeanne M
通讯作者：
Regnante, Jeanne M
影响因子：
2.2
作者：
Mahoney MC;Park E;Schlienz NJ;Duerr C;Hawk LW
通讯作者：
Hawk LW
DOI：
10.1080/15265161.2018.1431322
发表时间：
2018-04
期刊：
The American journal of bioethics : AJOB
影响因子：
--
作者：
Kraft SA;Cho MK;Gillespie K;Halley M;Varsava N;Ormond KE;Luft HS;Wilfond BS;Soo-Jin Lee S
通讯作者：
Soo-Jin Lee S