Consent to Recontact for Future Research Using Linked Primary Healthcare Data: Outcomes and General Practice Perceptions from the ATHENA COVID-19 Study

Abstract

Background: The ATHENA COVID-19 (ACV19) study was set up to recruit a cohort of patients with linked health information willing to be re-contacted 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 January 1, 2020, to December 31, 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 also reported. Results: Out 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. 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. Conclusions: This report describes how primary care data was 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.