Periodic Reporting for period 3 - VALUE-Dx (The value of diagnostics to combat antimicrobial resistance by optimising antibiotic use) Período documentado: 2021-04-01 hasta 2022-03-31 Resumen del contexto y de los objetivos generales del proyecto VALUE-Dx is focused on demonstrating the value of diagnostics to combat antimicrobial resistance by optimizing antibiotic use within Europe. If we want to tackle anti-microbial resistance (AMR), we need to ensure that antibiotics are only used when absolutely necessary. However, data shows that in Europe, 30-50% of antibiotics are prescribed unnecessarily. Greater use of diagnostic tests could help to bring this figure down by ensuring that doctors only prescribe antibiotics when absolutely necessary. However, the wider use of diagnostic tests in healthcare is hampered by a lack of insight into their medical, technological and health economical value. In addition, our knowledge about the barriers to their use remains limited. The goal of VALUE-Dx is to generate evidence on the medical, economic, and public health value of diagnostics in treating AMR. To that end, VALUE-Dx will focus its research on community care, which includes medical clinics (including general practice, urgent care centres, accident and emergency and other acute services in hospitals, paediatric care centres, and rehabilitation and long-term care facilities), both in and out of office hours care. lnnovative diagnostics could indeed transform clinical care, especially in community care settings where the majority of antibiotics are prescribed, by reducing uncertainty about potential benefit antibiotics may offer to individuals. Though VALUE-Dx will focus on diagnostic strategies relevant to reducing AMR in Community-Acquired Acute Respiratory Tract lnfections (CA-ARTI), the project’s findings are likely to be relevant for other common infections, including urinary tract infections, blood stream infections, and respiratory tract infections acquired in hospitals. Ultimately, VALUE-Dx should help to transform medical practice by making it easier for doctors to deliver personalized, evidence-based antibiotic prescriptions thanks to the use of innovative diagnostic strategies. Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha Clinical Algorithm finalizedA 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 TrialsPRUDENCEDue 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 modelMERIAM (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. Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha) The delivery of a working technology demonstration (POC1) represents an over-achievement, since at the outset of the project it was not considered feasible that a working demonstration of capabilities could be delivered. World Antibiotic Awareness Week Campaign World Antibiotic Awarenes Week 2021
