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[av_heading heading=’Webinar with the Expert Advisory Panel on September 30′ tag=’h3′ link_apply=” link=’manually,http://’ link_target=” style=’blockquote modern-quote modern-centered’ size=” subheading_active=’subheading_below’ subheading_size=’15’ margin=” margin_sync=’true’ padding=’10’ color=” custom_font=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-kejx7tvu’ custom_class=” admin_preview_bg=”][/av_heading]

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Within VALUE-Dx, WP5 aims to develop new health-economic models to determine the short and long-term clinical, public health and economic impact of diagnostics in the fight against AMR, and develop a new framework to accelerate market entry and accessibility to cost-effective diagnostics able to reduce AMR.

To achieve such aims, it is pivotal that both WP5 and the overall VALUE-Dx consortium have appropriate opportunities to take into consideration the perspectives of key healthcare system stakeholders. This will allow project partners to make sure the outputs VALUE-Dx delivers are as likely to be of interest and useful for these stakeholders as possible. Therefore, in task 5.1 we have established an External Advisory Panel (EAP) comprised of key stakeholders who are world-leaders on regulatory-HTA-payer systems, supplemented by international leading clinical experts in the use of diagnostics to fight AMR, able to provide the consortium with the necessary insights to ensure that VALUE-Dx activities and outputs are meaningful for regulators, HTA bodies, payers, and clinical practitioners.

On 30 September 2020, a 3-hours webinar panel session with the Expert Advisory Panel will take place at 01:30 PM UK time. The webinar will include:

• An introduction to the project and its progress
• Strategic discussion on the context of VALUE-Dx in the current regulatory/HTA and payer to VALUE-Dx based around questions posed by the Consortium
• Feedback and discussion from the panel to specific operational questions posed by VALUE-Dx members for deliverables.

Task 5.1 would like to invite all interested VALUE-Dx members to register in advance for this webinar through the link that the Project Manager will separately share by email. Please contact David De Pooter (David.DePooter@uantwerpen.be) if you haven’t received this email. After registering, you will receive a confirmation email containing information about joining the webinar.
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[av_heading heading=’Evaluating the clinical and cost-effectiveness of CA-ARTI diagnostics through PRUDENCE trial’ tag=’h3′ link_apply=” link=’manually,http://’ link_target=” style=’blockquote modern-quote modern-centered’ size=” subheading_active=’subheading_below’ subheading_size=’15’ margin=” margin_sync=’true’ padding=’10’ color=” custom_font=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-kbw4ue5u’ custom_class=” admin_preview_bg=”][/av_heading]

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The invention of antimicrobials was a major breakthrough in medical science that saved millions of lives. Antimicrobials are used to treat illness caused by bacteria. Development of these medicines meant that illnesses, like pneumonia, which were once often fatal, could now usually be successfully treated. But effectiveness of antimicrobials is now decreasing because they are being overused.

Microorganisms that are being exposed to antimicrobials change genetically over time, making it harder for the antimicrobials to work against them. As a result, “superbugs” are developing. We have no effective treatment for some of these “superbugs”. The development of resistance to antimicrobials is a major public health concern worldwide. Unhelpful, clinically unwarranted variation in care is a major contributor. Point-of-care testing that is proven to be cost-effective in clinical trials could help improve the quality of care and thus patient outcomes. This is especially true for community-acquired acute respiratory tract infections (CA-ARTI), the most common acute reasons for consulting health services in community care setting and for antimicrobial use.

The aim of Platform Randomised controlled trial of point of care Diagnostics for Enhancing the quality of aNtibiotic prescribing for Community acquired acute respiratory tract infection (CA-ARTI) in ambulatory care in Europe (PRUDENCE) is to determine if having a CA-ARTI diagnostic (CA-ARTI-Dx) test result available when a clinician is considering, or plans to prescribe an antimicrobial, leads to more appropriate prescribing decisions, without causing harm to patients. PRUDENCE is a multi-country, prospective, individually randomised, platform clinical trial in community care with a nested process evaluation. The trial is a diagnostic strategy intervention study to evaluate the use of clinical algorithms that include a CA-ARTI-Dx, compared to usual clinical care without CA-ARTI-Dx.

The PRUDENCE trial is managed by the University of Oxford, University Medical Centre Utrecht, Abbott and BD, and it will involve up to 10 primary care networks in Europe. Designed as a flexible platform trial, it has the capability of including additional interventions without having to start a new trial each time a new intervention emerges. It will also involve a mixed-methods process evaluation to capture data to understand how point-of-care tests are used and viewed by clinicians and patients to inform recommendations on implementation.

Read the main objectives of PRUDENCE here.
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[av_heading heading=’RECOVER builds on the work of VALUE-Dx to combat COVID-19 pandemic’ tag=’h3′ link_apply=” link=’manually,http://’ link_target=” style=’blockquote modern-quote modern-centered’ size=” subheading_active=’subheading_below’ subheading_size=’15’ margin=” margin_sync=’true’ padding=’10’ color=” custom_font=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-kbw114sj’ custom_class=” admin_preview_bg=”][/av_heading]

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On 11 March 2020, the University of Antwerp has launched Rapid European COVID-19 Emergency Research response (RECOVER), in collaboration with 9 international partners. The launch comes in response to the impact of the novel Coronavirus (COVID-19) pandemic in Europe. This project was selected for funding by the European Union under the Horizon 2020 research framework and builds on many years of investment by the European Commission in clinical research preparedness for epidemic response. The overall goal of RECOVER is to understand the COVID-19 pandemic through clinical research in order to transform patient care and public health responses.

RECOVER’s Primary Care Studies are leveraging the work done by the VALUE-Dx Work Package (WP) 4, such as the Point Prevalence Audit Survey (PPAS). This research aims to contribute to informing the planning, policy, communication, and clinical management of the COVID-19 pandemic.

VALUE-Dx is currently conducting an Extended PPAS in 16 countries to capture information from consultations and care provided to patients presenting in primary care with symptoms of an acute respiratory tract infection during the COVID-19 pandemic. This work is drawing on the first PPAS that was done in January and February 2020, as part of VALUE-Dx WP4 work in 18 European countries.
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[av_heading heading=’Review and analysis of diagnostic test accuracy for CA-ARTI ‘ tag=’h3′ link_apply=” link=’manually,http://’ link_target=” style=’blockquote modern-quote modern-centered’ size=” subheading_active=’subheading_below’ subheading_size=’15’ margin=” margin_sync=’true’ padding=’10’ color=” custom_font=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-kc36fi2p’ custom_class=” admin_preview_bg=”][/av_heading]

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VALUE-Dx is working on identifying the optimal tests that can diagnose reliably all patients with specific Community-Acquired Acute Respiratory Tract Infections (CA-ARTIs). WP1 conducted a systematic review and meta-analysis of point-of-care diagnostic test accuracy (DTA) for CA-ARTI including Rapid Antigen Detection Technique (RADTs), Nucleic acids amplification tests, imaging techniques, signs and symptoms, and host biomarkers. The performance of several pathogen-based RADTs to define the aetiology of CA-ARTI was investigated. Influenza virus, Respiratory Syncytial virus (RSV) and group A Streptococcus (GAS) RADTs showed a good DTA with an AUC >80%. Sensitivity and specificity differed depending on patient population (children and adults), brand name and test type; in particular, immunochromatographic assays were the most represented with a high DTA (AUC >87%). No significant heterogeneity rises for subgroup analysis by type of setting (community care, ED, LCTF). PCR tests proved very useful to exclude the diagnosis of CA-ARTIs with a very good sensitivity (80-98%) and high specificity (94-99%) and to reduce inappropriate antibiotic usage. Lung ultrasound showed also excellent diagnostic efficiency tool for the diagnosis of bacterial CAP (AUC 94%).

In addition, WP1 is involved in developing a roadmap to provide recommendations for future development, implementation, and increased uptake of CA-ARTI diagnostics. The roadmap will address short-term and long-term goals and aims to provide key information to help diagnostic innovators and funders prioritize investment decisions. To improve antibiotic use in CA-ARTI by diagnostics, it is essential that these tests meet the user requirements. WP1 is therefore also developing user requirement specifications in line with ongoing and published global efforts to determine Target Product Profiles for diagnostics addressing the antibiotic resistance challenge.
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[av_heading heading=’Enhancing the quality of antibiotic prescribing for CA-ARTI in Emergency Rooms through ADEQUATE trial’ tag=’h3′ link_apply=” link=’manually,http://’ link_target=” style=’blockquote modern-quote modern-centered’ size=” subheading_active=’subheading_below’ subheading_size=’15’ margin=” margin_sync=’true’ padding=’10’ color=” custom_font=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-kbi09k3d’ custom_class=” admin_preview_bg=”][/av_heading]

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Community-acquired acute respiratory tract infections (CA-ARTI) are among the most frequent infectious diseases worldwide. Uncomplicated ARTI is the most frequent cause of inappropriate antibiotic use, and there is a need of more judicious antibiotic prescribing to prevent exposure to drug-related adverse events, selection of antibiotic resistance and emergence of opportunistic pathogens that substitute the indigenous microbiota. Antibiotic resistance rates are related to antibiotic use in any setting, but opportunities to decrease unnecessary treatments are probably most apparent in primary care and emergency departments.

Optimal clinical management of CA-ARTI is hampered because of diagnostic delays and suboptimal test sensitivity, leading to incorrect or missing etiologic diagnosis, and empiric overprescription of antibiotics.

There is a need to assess the impact of rapid syndromic diagnostic testing in patients with CA-ARTI presenting to Emergency Rooms on clinical decision making related to hospitalization and antibiotics prescribing. At the same time it must be determined whether the decisions guided by the rapid syndromic diagnostic testing results do not compromise patient safety.

ADEQUATE (Advanced Diagnostics for Enhanced QUality of Antibiotic prescription in respiratory Tract infections in Emergency rooms) is a randomized controlled trial of Rapid Syndromic Diagnostic testing versus current local Standard Of Care for enhancing the quality of antibiotic prescribing for CA-ARTI in Emergency Rooms in Europe. The ADEQUATE trial is managed by the University Medical Centre Utrecht and bioMérieux

ADEQUATE aims to assess the impact of rapid syndromic diagnostic testing (bioMérieux) in patients with Acute Respiratory Tract Infection (ARTI) at the emergency department, on (1) hospital admission rates and (2) antimicrobial prescriptions (days of treatment) and the non-inferiority in terms of clinical outcome.

The ADEQUATE protocol has been aligned with the different WPs of the VALUE-Dx project and is getting ready to be implemented in secondary care in the next winter season by starting the regulatory procedures. ADEQUATE is in close communication with WP5 on the design of a health-economic framework to assess and demonstrate the value of diagnostics both for individual patients and for public health impact by reducing antibiotic use and subsequent antibiotic resistance among patients.

The objective to establish a sustainable European Standardised Care Network adequately trained and resourced to conduct clinical trials evaluating the value of diagnostics is materializing by the initiation of the Site selection for hospital care study at different geographical areas in Europe in the context of CLIN-Net and PENTA networks.

In addition, social sciences have been implemented in the ADEQUATE protocol as part of the objectives in order to explore, define and resolve the psychological, ethical and social barriers which prevent the more widespread adoption of diagnostics delivering healthcare to the population.

Read the main objectives of ADEQUATE in the WP4 page.
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Why would patients, doctors, health insurers and governments pay for tests that are six times more expensive than the accompanying treatment? That is the question that we try to unravel within VALUE-Dx. To take the Netherlands as an example, the reference price (excluding pharmacy fees) for a 3-day course amoxicillin is €0.69, while this is €4.07 for a C-reactive protein test. Clearly, just giving all patients an antibiotic is much cheaper than testing them and provide an antibiotic in case of a positive result. Core to VALUE-Dx is the reduction of therapeutically inappropriate antibiotic prescriptions and, related to that, antimicrobial resistance (AMR) on the long term. Hence, quantifying the societal costs of AMR is one of the main issues in our research. Another issue is more general, which is the economic appraisal of diagnostics. Compared to pharmaceuticals, methods for economic evaluations and rules for reimbursement are much less developed in this field.

Finding answers to above questions and solutions for improvement of underlying mechanisms requires an interdisciplinary approach: our work on Economic Value, Policies and Innovative Funding Models therefore integrates a variation of tasks and viewpoints, distributed over various organizations: academic institutions (with UMCG leading the WP), governmental agencies, and companies (with bioMérieux co-leading the WP). Although most groups are ongoing in the research process, we have already two milestones to celebrate. Firstly, NICE has established the Expert Advisory Panel (EAP), a group of 10 experts that will provide input on the appraisal process of diagnostics. Secondly, the University of La Rioja and the UMCG have finished the first deliverable of WP5: a systematic review of health-economic approaches for diagnostic-driven antibiotic use, in which best practises are discussed to develop health-economic models for VALUE-Dx. One of the findings of the review was that opportunities for economic models of infectious disease diagnostics, mainly lie in the inclusion of generic quality-of-life outcomes, as opposed to (disease-)specific outcomes, and in the inclusion of time in the analyses, mainly in assessing more extensive time horizons (over 10 years).

Below are updates on the progress of the different tasks:

Task 5.1 Establishment, maintenance and management of a WP5 regulatory-HTA-payer EAP (NICE; GÖG, UMCG, bioMérieux)
The organisation and structure for the EAP has been developed and set in place. Following successful recruitment, a first session in parallel with the Bologna meeting was being planned. However, due to the COVID-19 pandemic this has unfortunately been delayed. The first meeting is now expected in the autumn and will provide key advice and input into other tasks and across work packages.

Task 5.2: Review of the current HTA environment and methodologies, inclusive health-economic frameworks and models, used for valuing diagnostics and analysing antibiotic resistance (UNIRIOJA, UMCG; NICE, GÖG, bioMérieux)
The first version of the systematic review was finished in April. Currently, preparations are taking place to disseminate the findings in a scientific paper as well as to search for articles to be included in the 2021 update.

Task 5.3 Trial-based health-economic analysis of (rapid, localised) diagnostics strategies in close collaboration with WP4 (UNIRIOJA; UA, NICE, bioMérieux)
As the protocols of the clinical trials of WP4 are being finished, the team of task 5.3 (as well as the team of task 5.4) has been readily involved with making sure the right data are analysed in the trial to be able to perform rigorous economic evaluations as soon as the first results come in. The models used to perform the economic analyses of the diagnostic strategies are being prepared.

Task 5.4 Development of a health-economic model for cost-effectiveness of diagnostics beyond the trial-based setting (UMCG; OECD, NICE, UA, UMCU, bioMérieux, BD, Accelerate, Janssen)
The first year of VALUE-Dx was mainly a year to rethink, on a fundamental level, how to assess the broad, long-term public health and economic impact of implementing point-of-care diagnostics and how to model this. Now, the first prototype is being developed using data from demographic databases, scientific literature, and the point-prevalence survey of WP4.

Task 5.5 Analysis of existing and potential innovative policies applied to include new diagnostics in the care systems of European countries with a view of identifying good practice and a proposal for enhancing fit-for purpose policy frameworks related to HTA, pricing and funding mechanisms (GÖG; NICE, UMCG, UNIRIOJA, bioMérieux)
This task will gather very useful information on the funding policies for diagnostics within many European countries. Data from a literature search (which is being executed right now), will be used to populate a survey (currently almost finished) that will be sent out later this year. The survey will provide essential insight to be able to adapt the health-economic models to the various countries included in VALUE-Dx, as well as provide recommendations on how to improve funding mechanisms in Europe.

Task 5.6 Transferability of health-economic approaches and results of such transfers between countries, notably to H2020 Associated Countries (OECD; UNIRIOJA, BU, bioMérieux)
Task 5.6 translates the findings from the economic analyses (tasks 5.3 and 5.4) to countries outside the trial. The model used will be closely aligned with the model developed in task 5.4 and the OECD SPHeP-AMR model, which are both are under active development right now.

Task 5.7 Interviewing stakeholders on policy and regulatory factors (UOXF, UA; UNIRIOJA, GÖG)
This qualitative research project will provide valuable insights on the facilitators and barriers of adapting or implementing novel diagnostics in community care, by interviewing policy and decision makers of certain member states. Due to the COVID-19 crisis and subsequent changes to delivery of care in community care settings we are postponing interviews until policy makers have better availability, hopefully later this year or the beginning of next year. From an administrative viewpoint, everything is good to go.
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[av_heading heading=’VALUE-Dx gets ready for clinical trials’ tag=’h3′ link_apply=” link=’manually,http://’ link_target=” style=’blockquote modern-quote modern-centered’ size=” subheading_active=’subheading_below’ subheading_size=’15’ margin=” margin_sync=’true’ padding=’10’ color=” custom_font=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-kc36bewb’ custom_class=” admin_preview_bg=”][/av_heading]

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WP2 encompasses microbiology work performed on clinical samples obtained from WP4 clinical trials, as well as biobanking. As the clinical trials have not started yet, no actionable results have been obtained so far. However, the WP2 team has been working on the optimization of the methods to be used once the samples are received.

Specifically, work has been performed on the aetiology elucidation from clinical samples based on next generation sequencing (NGS) techniques. Especial focus has been put into the detection of Streptococcus pneumoniae from clinical samples as one of the primary pathogens causing CA-ARTI, but other pathogens, such as viruses, will also be detected. Furthermore, work has been performed on direct detection of antimicrobial resistance (AMR) in bacterial pathogens by correlating phenotypic and genotypic data. This will allow to predict AMR directly from raw sequencing data.

The WP2 team has collected publicly available and in-house generated S. pneumoniae WGS sequences and built a Hidden Markov Model (HMM) based serotyping database for S. pneumoniae. This in-house developed database will be used along with phenotypic data, which will enable us to delineate and identify the serotypes, especially novel serotypes, from metagenomics data. This database, the first of its kind for S. pneumoniae, will be made publicly available in the near future.

All these methods will be applied in the metagenomics study, which allows defining the microbial community present in a sample, as well as studying the resistome, that is the whole set of antimicrobial resistance genes present in that sample. The clinical trial has not started yet, but the optimization of this protocol is ongoing. The protocol to perform shotgun metagenomics on a short-read sequencing platform (Illumina MiSeq) is optimized, while the protocol for long-read 16S sequencing (PacBio Sequel) is almost complete.

Additionally, work is undergoing for the development of the bioinformatics pipeline to be used to remove host DNA and analyze the sequencing results. This pipeline includes a first step to removing host reads, and then several analyses are performed (assembly of the metagenome, detection of antimicrobial resistance genes and virulence factors, the taxonomic classification of the bacterial community).

Biomarker detection will proceed by mesoscale discovery (MSD) wherein the instrument is available and the protocols are being optimized. Research will begin when clinical samples are received.

Biobanking will be the next step.
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[av_heading heading=’Extended PPAS during COVID-19 pandemic’ tag=’h3′ link_apply=” link=’manually,http://’ link_target=” style=’blockquote modern-quote modern-centered’ size=” subheading_active=’subheading_below’ subheading_size=’15’ margin=” margin_sync=’true’ padding=’10’ color=” custom_font=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-k9ig5395′ custom_class=” admin_preview_bg=”][/av_heading]

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The point prevalence audit survey (PPAS) was extended to capture presentation and management of patients with acute respiratory tract infection during the COVID-19 pandemic.

This registration additionally focuses on the organisation of primary care during the pandemic and what additional testing and (preventive) measures were taken and advised to patients.

The chart below shows in real-time the inclusion of patients across different countries in Europe. Keep checking this page for more information.
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[av_heading heading=’Headway made for Point Prevalence Audit Survey in primary and long-term care settings’ tag=’h3′ link_apply=” link=’manually,http://’ link_target=” style=’blockquote modern-quote modern-centered’ size=” subheading_active=’subheading_below’ subheading_size=’15’ margin=” margin_sync=’true’ padding=’10’ color=” custom_font=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-k588rl65′ custom_class=” admin_preview_bg=”][/av_heading]

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We are happy to announce that significant headway has been made in the inclusion of patients in primary care and long-term care settings across different countries for the point prevalence audit survey (PPAS) that is a part of Work Package 4a.

Currently, a total of 375 patients have been included in the PPAS across 9 countries in primary care settings whilst a total of 5 patients have been included in long-term care settings across 2 countries.

The goals for each setting and each country are 240 patients to be included.

This PPAS aims to record information about patients who seek healthcare for CA-ARTI, helping researchers to benchmark patterns of testing and antibiotic prescribing in different European healthcare settings by observing current routine care practices.

The chart below shows in real-time the inclusion of patients across different countries in Europe. Keep checking this page for more information.
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[av_heading heading=’IMI article – Technology, not instinct, should guide antibiotic prescribing. A Q&A with Herman Goossens’ tag=’h3′ link_apply=” link=’manually,http://’ link_target=” style=’blockquote modern-quote modern-centered’ size=” subheading_active=’subheading_below’ subheading_size=’15’ margin=” margin_sync=’true’ padding=’10’ color=” custom_font=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-k38ojp8b’ custom_class=” admin_preview_bg=”][/av_heading]

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Quick tests for bacterial infections are out there, but insurers won’t cover them and doctors are reluctant to use them. Prof. Dr. Herman Goossens, VALUE-Dx project coordinator, tells us that cutting down on unnecessary prescriptions of antibiotics would help reduce rates of antibiotic resistance. But even though the technology exists, it’s not in widespread use. The VALUE-Dx project set out to find out how much these diagnostic tests would be worth to society in the long run.

Read the full article written by IMI
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