Adapting an In-Home Randomized Intervention Trial Protocol for COVID-19 Precautions.
Adapting an In-Home Randomized Intervention Trial Protocol for COVID-19 Precautions.
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DOI：
10.3390/ijerph20031987
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发表时间：
2023-01-21
影响因子：
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通讯作者：
Brugge, Doug
中科院分区：
文献类型：
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作者：
Lerman Ginzburg, Shir;Vazquez-Dodero, Teresa;Mason, Chermaine;Hudda, Neelakshi;Meunier, Leigh;Sprague Martinez, Linda;Eliasziw, Misha;Brugge, Doug
背景：新冠肺炎大流行显著影响了美国临床试验的状况，要求研究人员重新考虑他们的研究方法。有鉴于此，我们讨论了我们对家庭空气过滤交通相关空气污染研究(HAFTRAP)研究方案的修改，这是一项针对主干道附近家庭空气过滤的随机交叉试验。资深作者在大流行之前设计了这项试验，并包括在参与者家中收集面对面的数据。由于大流行，我们推迟了试验的开始，以便修改我们的研究方案，以确保在家访期间参与者和工作人员的健康和福祉。据我们所知，在大流行期间，很少有关于试图继续在家里进行研究的报告。方法：当2020年3月实施与大流行相关的保护措施时，我们接近启动我们的试验。相反，我们推迟了招募，设定了从2020年9月开始的新目标，并在2020年夏天通过制定更多的安全预防措施来修改我们的方案。我们回顾了在研究参与者的家中安装便携式空气过滤装置的替代方法，以减少或消除进入家庭的情况。我们还制定了新冠肺炎安全计划，其中包括为保护现场团队工作人员和研究参与者而采取的预防措施。结果：我们的主要方法是在参与者的家中收集以下措施时尽量减少与他们的接触：(1)放置便携式空气过滤装置；(2)进行室内空气质量监测；(3)获取血样和血压测量；(4)在收集生物测量的同时进行筛查、同意和跟踪调查。调整我们的公共卫生试验导致了延迟，但也有助于确保道德和安全的研究实践。感知新冠肺炎感染的风险似乎是个人决定是否参加我们试验的主要因素，特别是在疫情开始时，当时人们对新冠肺炎知之甚少。结论：在与社区成员、IRB和大学合作时，我们需要灵活、有创意和冷静，同时反复调整，以适应不断变化的指南，因为我们确定了哪些对家庭数据收集有效，哪些对家庭数据收集无效。我们了解到，高质量的空气监测数据可以通过最少的面对面接触收集，而不会影响试验的完整性。此外，我们能够收集血压和静脉采血数据，将参与者的风险降至最低。
Background: The COVID-19 pandemic has significantly impacted the status of clinical trials in the United States, requiring researchers to reconsider their approach to research studies. In light of this, we discuss the changes we made to the protocol of the Home Air Filtration for Traffic-Related Air Pollution (HAFTRAP) study, a randomized crossover trial of air filtration in homes next to a major highway. The senior authors designed the trial prior to the pandemic and included in-person data collection in participants’ homes. Because of the pandemic, we delayed the start of our trial in order to revise our study protocol to ensure the health and well-being of participants and staff during home visits. To our knowledge, there have been few reports of attempts to continue in-home research during the pandemic. Methods: When pandemic-related protective measures were imposed in March 2020, we were close to launching our trial. Instead, we postponed recruitment, set a new goal of starting in September 2020, and spent the summer of 2020 revising our protocol by developing increased safety precautions. We reviewed alternative approaches to installing portable air filtration units in study participants’ homes, in order to reduce or eliminate entry into homes. We also developed a COVID-19 safety plan that covered precautionary measures taken to protect both field team staff and study participants. Results: Our primary approach was to minimize contact with participants when collecting the following measures in their homes: (1) placing portable air filtration units; (2) conducting indoor air quality monitoring; (3) obtaining blood samples and blood pressure measurements; and (4) administering screening, consent, and follow-up questionnaires that coincided with collection of biological measures. Adapting our public health trial resulted in delays, but also helped ensure ethical and safe research practices. Perceived risk of COVID-19 infection appeared to have been the primary factor for an individual in deciding whether or not to participate in our trial, particularly at the beginning of the pandemic, when less was known about COVID-19. Conclusions: We needed to be flexible, creative, and calm when collaborating with community members, the IRB, and the universities, while repeatedly adjusting to changing guidelines as we determined what worked and what did not for in-home data collection. We learned that high-quality air monitoring data could be collected with minimal in-person contact and without compromising the integrity of the trial. Furthermore, we were able to collect blood pressure and phlebotomy data with minimal risk to the participant.