ABC Study registry to examine the outpatient treatment of COVID-19 Infections
Dendrite Clinical Systems and the Institute for Health Research (IGES) in Berlin, Germany, have initiated the Outpatient Treatment of COVID-19 Infections (ABC-19) study, to record data on the treatment of COVID-19 patients and discover more about the outpatient course of the disease, the individual risk factors of patients that contribute to severe COVID-19 courses and the procedures of general practitioners (GPs). It is hoped the study will help establish evidence-based guidelines for the outpatient treatment of COVID-19 patients, leading to improved outcomes and prevent unnecessary hospital admissions. The long-term effects of CVOID- are also being observed in the study.
"This online registry study collects data from GPs and crucially, from patients using their smartphone or tablets - via our e-PROMS module (patient-reported outcome measures). This allows patients who are isolating to remotely enter their data directly into the registry at their own convenience,” said Dr Peter Walton, Managing Director of Dendrite Clinical Systems.
Dendrite’s intuitive Web-Registry platform now includes more than 30 different validated instruments as part of the system’s innovative e-PROMS module. The flexible module can be adapted to include bespoke PROMS instruments across the whole spectrum of clinical scenarios, whilst maintaining patient anonymity and confidentiality, ensuring data validation, increasing efficiency and simplifying the data collection process.
The PROMS for the ABC Study includes questions on the current symptoms experienced by the patient (e.g. exhaustion, cough, shortness of breath, etc), as well as enabling patients to enter data such as their blood pressure, blood sugar levels and body temperature etc. Importantly, patients can also report any additional symptoms or usual activities, whether they were experiencing pain/discomfort and anxiety/depression, as well as complete a self-assessed quality of life score.
The ABC study, which was started in Berlin and Brandenburg, is being rolled out throughout Germany. Any doctor, in public and private practice, who regularly look after a certain number of COVID-19 patients are being invited to participate in the study. If a patient agrees to participate in the study, their medical findings and personal pseudonymised form (identifiable information fields within a data record are replaced by one or more artificial pseudonyms to prevent identification), evaluated and, if necessary, passed on. The data is only collected, stored, evaluated and passed on if the patient agrees. The patient’s consent can be revoked at any time without giving reasons.
“The ABC Study is the latest in a series of COVID registries developed by Dendrite and we are proud to be playing our part in facilitating the recording and reporting of the different treatment strategies to help patients and healthcare systems overcome this devastating virus,” Dr Walton added.
The ABC Study is funded by Faculty of Health Sciences Brandenburg (FGW) and the first data are expected to be reported at the end of the second quarter of 2021.