Periodic Reporting for period 3 - VALUE-Dx (The value of diagnostics to combat antimicrobial resistance by optimising antibiotic use)
Berichtszeitraum: 2021-04-01 bis 2022-03-31
A clinical algorithm (CA) for diagnosing the aetiology of the community-acquired acute respiratory tract infections (CA-ARTIs) is necessary to limit inappropriate antibiotic prescribing in primary care and consequently curb antibiotic resistance emergence. The VALUE-Dx heuristic algorithm is designed to be able to select an optimal CA for any particular out-patients setting, i.e. list of available point of care diagnostic tests, their performance and cost, and disease prevalence.
Clinical Trials
PRUDENCE
Due to the changing COVID-19 pandemic situation across Europe, variations in vaccination programmes and availability of SARS-CoV-2 testing, optional SARS-CoV-2 testing (GP choice) has been included as part of the PRUDENCE clinical algorithm. While we had planned to open the majority of networks prior to the end of 2021, we encountered unexpected delays with contracts and regulatory approvals in some networks, in addition to the ongoing COVID-19 pandemic. By 31st March, however, the trial was open to recruitment in 7 (out of 10) Primary Care Networks and 2 (out of 6) Long Term Care Facility Networks, with 276 participants having been randomised at that date.
ADEQUATE
The COVID-19 pandemic continued to affect timelines, where initially all focus was needed to provide medical care to the high amount of COVID-19 infected patients in all countries, the pandemic now changed logistics at ER and in some countries the device became part of clinical routine.
The Steering Committee, however, agreed take all possible actions to ensure reaching the overall recruitment targets. Site startup was continued over Summer. This way sites have the time to implement and get used to the study procedures and can be fully up and running by the Winter season. Towards the end of the first Winter season, month 35, site selection was reopened.
Development of a health-economic model
MERIAM (Modelling the Economics of Respiratory tract Infections and AMr) is a model built to assess the long-term health-economic effects of improved diagnostics for community-acquired acute respiratory tract infections at the first point of care. MERIAM has three compartments: the demographic model, the consultation model, and the antimicrobial resistance (AMR) model. In the past year, the demographic model has been adapted to incorporate all countries included in the ADEQUATE and PRUDENCE trials. The consultation model depends on the trial data, so will be finalized as soon as the first results come in. The AMR model has been further developed and has been capable of producing publication-ready AMR forecasts since year 3 of VALUE-Dx. Work is underway to link AMR reductions forecast from the diagnostic interventions to QALYs gains in the future. The model is now publicly available under an open-source license.
Other activities that started during the third year of VALUE-Dx:
1. We have designed the Health Economic Framework that can assess and demonstrate the value of diagnostics for public health. The HEF is ready to accept the input from the ADEQUATE and PRUDENCE trials, which will be used to assess the value for individual patients and to further refine the reduced antibiotic use.
2. We are developing a roadmap to provide recommendations for future development, implementation, and increased uptake of CA-ARTI diagnostics.
3. We developed a systematic review and meta-analysis on diagnostic accuracy of all available point-of-care-tests for outpatients with CA-ARTI.
4. As a means of raising awareness on unnecessary prescription and use of antibiotics during the COVID-19 pandemic, a VALUE-Dx communication campaign was held during the World Antibiotic Awareness Week in November 2021.