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An RCT of a decision aid to support informed choices about taking aspirin to prevent colorectal cancer and other chronic diseases: a study protocol for the SITA (Should I Take Aspirin?) trial.一项关于决策辅助工具的 RCT,以支持关于服用阿司匹林预防结直肠癌和其他慢性疾病的知情选择:SITA(我应该服用阿司匹林吗?)试验的研究方案。
Trials. 2021 Jul 15;22(1):452. doi: 10.1186/s13063-021-05365-8.
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General practice's early response to the COVID-19 pandemic.全科医疗对新冠疫情的早期应对。
Aust Health Rev. 2020 Sep;44(5):733-736. doi: 10.1071/AH20157.
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Lancet. 2020 Aug 22;396(10250):523-524. doi: 10.1016/S0140-6736(20)31787-6.
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A Genomic Test for Colorectal Cancer Risk: Is This Acceptable and Feasible in Primary Care?结直肠癌风险的基因组检测:在初级保健中是否可接受和可行?
Public Health Genomics. 2020;23(3-4):110-121. doi: 10.1159/000508963. Epub 2020 Jul 20.
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Isolation and rapid sharing of the 2019 novel coronavirus (SARS-CoV-2) from the first patient diagnosed with COVID-19 in Australia.从澳大利亚首例被诊断为 COVID-19 的患者中分离并快速共享 2019 年新型冠状病毒(SARS-CoV-2)。
Med J Aust. 2020 Jun;212(10):459-462. doi: 10.5694/mja2.50569. Epub 2020 Apr 1.
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Benefits and harms of selective oestrogen receptor modulators (SERMs) to reduce breast cancer risk: a cross-sectional study of methods to communicate risk in primary care.选择性雌激素受体调节剂(SERMs)降低乳腺癌风险的获益与危害:初级保健中沟通风险方法的横断面研究。
Br J Gen Pract. 2019 Nov 28;69(689):e836-e842. doi: 10.3399/bjgp19X706841. Print 2019 Dec.
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The CRISP-P study: feasibility of a self-completed colorectal cancer risk prediction tool in primary care.CRISP-P 研究:在初级保健中使用自我完成的结直肠癌风险预测工具的可行性。
Fam Pract. 2019 Nov 18;36(6):730-735. doi: 10.1093/fampra/cmz029.
8
The use of a risk assessment and decision support tool (CRISP) compared with usual care in general practice to increase risk-stratified colorectal cancer screening: study protocol for a randomised controlled trial.在全科医疗中使用风险评估与决策支持工具(CRISP)与常规护理相比较,以增加风险分层的结直肠癌筛查:一项随机对照试验的研究方案。
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The CRISP-Q study: Communicating the risks and benefits of colorectal cancer screening.CRISP-Q 研究:结直肠癌筛查的风险和获益沟通。
Aust J Gen Pract. 2018 Mar;47(3):139-145. doi: 10.31128/AFP-04-17-4195.
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Improving chlamydia knowledge should lead to increased chlamydia testing among Australian general practitioners: a cross-sectional study of chlamydia testing uptake in general practice.提高衣原体知识水平应能促使澳大利亚全科医生增加衣原体检测:一项关于全科医疗中衣原体检测接受情况的横断面研究。
BMC Infect Dis. 2014 Nov 7;14:584. doi: 10.1186/s12879-014-0584-2.

评论:大流行期间的调整:针对 COVID-19 开发随机对照试验的新招募模型。

Commentary: Pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to COVID-19.

机构信息

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.

出版信息

Trials. 2021 Sep 8;22(1):605. doi: 10.1186/s13063-021-05567-0.

DOI:10.1186/s13063-021-05567-0
PMID:34496930
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8424147/
Abstract

BACKGROUND

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.

MAIN BODY

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.

CONCLUSION

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.

摘要

背景

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。

主要内容

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。

结论

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。