Centre for Cancer Research, University of Melbourne, Level 10, 305 Grattan Street, Melbourne, VIC, 3000, Australia.
Department of General Practice, University of Melbourne, Melbourne, Australia.
Trials. 2021 Sep 8;22(1):605. doi: 10.1186/s13063-021-05567-0.
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.
2020 年,许多非 COVID-19 试验受到干扰,要么难以招募参与者,要么完全停止招募。2019 年 12 月,也就是大流行之前,我们获得了一项资助,在澳大利亚维多利亚州开展一项随机对照试验,即 SITA 试验。维多利亚州是 2020 年澳大利亚 COVID-19 疫情最严重的州。
我们最初将 SITA 试验的招募方法建模为之前的试验,参与者在普通诊所候诊室被接触和招募。COVID-19 改变了普通诊所的工作方式,远程医疗咨询显著增加,限制了现场候诊人数。这促使我们调整我们的招募方法以适应这种新环境,以减少对参与者和工作人员的潜在风险,同时将任何招募偏差最小化。我们设计了一种新颖的远程试验模型,该模型涉及在参与者的全科医生预约之前致电他们,以检查他们的资格。我们通过虚拟和面对面的方式提供试验,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试验模型,使我们能够以较高的速度完成招募。随着我们继续应对 COVID-19 大流行的影响,远程试验模型现在正在我们的其他初级保健试验中使用。