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Commentary: Pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to COVID-19
Trials ( IF 2.5 ) Pub Date : 2021-09-08 , DOI: 10.1186/s13063-021-05567-0
Shakira Milton 1, 2 , Jennifer McIntosh 2, 3 , Lucy Boyd 1, 2 , Napin Karnchanachari 1, 2 , Finlay Macrae 4, 5 , Jon David Emery 1, 2, 6
Affiliation  

Many non-COVID-19 trials were disrupted in 2020 and either struggled to recruit participants or stopped recruiting altogether. In December 2019, just before the pandemic, we were awarded a grant to conduct a randomised controlled trial, the Should I Take Aspirin? (SITA) trial, in Victoria, the Australian state most heavily affected by COVID-19 during 2020. We originally modelled the SITA trial recruitment method on previous trials where participants were approached and recruited in general practice waiting rooms. COVID-19 changed the way general practices worked, with a significant increase in telehealth consultations and restrictions on in person waiting room attendance. This prompted us to adapt our recruitment methods to this new environment to reduce potential risk to participants and staff, whilst minimising any recruitment bias. We designed a novel teletrial model, which involved calling participants prior to their general practitioner appointments to check their eligibility. We delivered the trial both virtually and face-to-face with similar overall recruitment rates to our previous studies. We developed an effective teletrial model which allowed us to complete recruitment at a high rate. The teletrial model is now being used in our other primary care trials as we continue to face the impacts of the COVID-19 pandemic.

中文翻译:

评论:大流行期间的转变:为应对 COVID-19 的随机对照试验开发新的招募模式

许多非 COVID-19 试验在 2020 年中断,要么难以招募参与者,要么完全停止招募。2019 年 12 月,就在大流行之前,我们获得了一项赠款,用于进行一项随机对照试验,我应该服用阿司匹林吗?(SITA) 试验,在 2020 年受 COVID-19 影响最严重的澳大利亚州维多利亚州进行。我们最初在之前的试验中模拟了 SITA 试验招募方法,在这些试验中,参与者在全科诊所候诊室进行接触和招募。COVID-19 改变了一般做法的工作方式,远程医疗咨询显着增加,并限制亲自到候诊室出勤。这促使我们调整我们的招聘方法以适应这种新环境,以降低参与者和员工的潜在风险,同时最大限度地减少任何招聘偏见。我们设计了一种新颖的远程审讯模型,该模型涉及在预约全科医生之前致电参与者以检查他们的资格。我们进行了虚拟和面对面的试验,总体招募率与我们之前的研究相似。我们开发了一种有效的远程审判模型,使我们能够以高速度完成招聘。随着我们继续面临 COVID-19 大流行的影响,远程审判模型现在正在我们的其他初级保健试验中使用。
更新日期:2021-09-08
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