Background: The ATHENA COVID-19 study was set up to recruit a cohort of patients with linked health information willing to be recontacted in future to participate in clinical trials and also to investigate the outcomes of people with COVID-19 in Queensland, Australia, using consent. This report describes how patients were recruited, their primary care data extracted, proportions consenting, outcomes of using the recontact method to recruit to a study, and experiences interacting with general practices requested to release the primary care data.

Methods: Patients diagnosed with COVID-19 from 1 January 2020 to 31 December 2020 were systematically approached to gain consent to have their primary healthcare data extracted from their general practice into a Queensland Health database and linked to other datasets for ethically approved research. Patients were also asked to consent to allow future recontact to discuss participation in clinical trials and other research studies. Patients who consented to recontact were later approached to recruit to a long-COVID study. Patients' general practices were contacted to export the patient files. All patient and general practice interactions were recorded. Outcome measures were proportions of patients consenting to data extraction and research, permission to recontact, proportions of general practices agreeing to participate. A thematic analysis was conducted to assess attitudes regarding export of healthcare data, and the proportions consenting to participate in the long-COVID study were also reported.

Results: Of 1212 patients with COVID-19, contact details were available for 1155; 995 (86%) were successfully approached, and 842 (85%) reached a consent decision. Of those who reached a decision, 581 (69%), 615 (73%) and 629 (75%) patients consented to data extraction, recontact, and both, respectively. In all, 382 general practices were contacted, of whom 347 (91%) had an electronic medical record compatible for file export. Of these, 335 (88%) practices agreed to participate, and 12 (3%) declined. In total, 526 patient files were exported. The majority of general practices supported the study and accepted electronic patient consent as legitimate. For the long-COVID study, 376 (90%) of those patients recontacted agreed to have their contact details passed onto the long-COVID study team and 192 (53%) consented to take part in their study.

Conclusion: This report describes how primary care data were successfully extracted using consent, and that the majority of patients approached gave permission for their healthcare information to be used for research and be recontacted. The consent-to-recontact concept demonstrated its effectiveness to recruit to new research studies. The majority of general practices were willing to export identifiable patient healthcare data for linkage provided consent had been obtained.

Keywords: ATHENA COVID-19; General practice; attitudes; clinical trial; consent; data linkage; primary care; recontact; sharing.

背景： ATHENA COVID-19 研究旨在招募一群愿意在未来参与临床试验并提供联系信息的患者，同时利用知情同意书来调查澳大利亚昆士兰州新冠患者的预后。本报告描述了如何招募患者、提取其初级保健数据、签署同意的比例以及使用重新接触方法进行研究招募的结果和经验。

方法： 从2020年1月1日至2020年12月31日期间，对所有被诊断为新冠的患者进行了系统性的联系以获得他们的初级保健数据（从其家庭医生处提取并链接到昆士兰州健康数据库中进行伦理批准的研究）的同意。同时要求这些患者同意在未来再次被联系以讨论参与临床试验和其他研究的可能性。对于同意重新接触的患者，后来又被邀请参加长期新冠研究。患者的全科诊所被联系以导出病历文件。所有患者和诊所之间的互动都被记录下来。指标包括签署数据提取和研究同意的比例、允许再联系的权限比例以及诊所愿意合作的比例。进行了主题分析来评估关于健康数据导出的态度，并报告了参与长期新冠研究的同意比例。

结果： 在1212名新冠患者中，有1155人提供了联系方式；其中995人（86%）成功进行了联系，并且842人（85%）做出了同意决定。做出决定的患者中有581人（69%）、615人（73%）和629人（75%）分别同意了数据提取、重新接触以及两者都同意。总共有382个全科诊所被联系，其中347家（91%）的电子病历系统与导出文件兼容。在这当中，有335家（88%）诊所同意参与，并且有12家（3%）拒绝了。总的来说，共导出了526份患者档案。大多数全科诊所以及接受者都支持这项研究并认可电子病历的合法性。对于长期新冠研究，重新联系到的那些患者中有376人（90%）同意将他们的联系方式传递给长期新冠研究团队，并且有192人（53%）同意参与该研究。

结论： 本报告描述了如何通过知情同意成功提取初级保健数据，以及大多数被接触的患者都允许使用其健康信息进行研究并同意再次联系。重新接触概念证明其在招募新研究中的有效性，并且大多数全科诊所愿意导出可识别患者的医疗数据以供链接，前提是已经获得患者的许可。

关键词： ATHENA COVID-19；全科诊所；态度；临床试验；同意；数据关联；初级保健；重新联系；共享