Category: News

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[av_heading heading=’VALUE-Dx developed sample collection and management manuals for 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-kmq561dk’ custom_class=” admin_preview_bg=”][/av_heading]

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WP2 has been working on the set-up of the VALUE-Dx biobank and continuing the optimisation of the protocols in preparation for the imminent start of WP4 clinical trials.

Thanks to the expertise of LAB-Net members, the sample collection and management manuals for both trials have been developed. These manuals describe in depth how to collect samples for the microbiology sub-studies and how to process and store them until shipment to the VALUE-Dx UA/UZA biobank in Antwerp. Additionally, the preparation of kits to be sent to the sites for the sample collection has begun, starting with kits to store the leftover samples from the diagnostic intervention implemented in the paediatric arm of the ADEQUATE trial.

Regarding the optimisation of metagenomics protocols, the focus has been on the bioinformatics protocols that will be used to analyse the generated shotgun metagenomics data, as the wet lab protocols for sequencing are optimised for Illumina and PacBio. The pipeline will include tools for quality control and host reads removal, after which taxonomical classification, functional characterisation and assemblies will be performed. Furthermore, antimicrobial resistance genes and mutations will be studied with different tools, and S. pneumoniae serotypes will be identified if present in the sample. Validation of this pipeline is being done in shotgun metagenomics data from other studies, and will be further extended with a metagenome reconstruction step implemented by Bioaster.

Concerning the biomarker sub-studies, specific manuals for sample collection and processing have been developed. These manuals describe how to collect, process and store plasma (EDTA and heparin) and RNA samples prior to their shipment to the UA/UZA biobank in Antwerp. The kits required for blood collection and processing are being assembled for their subsequent use in the PRUDENCE trial. Additionally, the cytokine and chemokine analysis is being optimised, starting with the selection of the most relevant and promising biomarkers. Cytokine and chemokine panels are currently being designed. Also, we tested and recommended a double-spin plasma separation protocol to be utilised within the PRUDENCE trial, which will improve the quality of collected samples.
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[av_heading heading=’Federated Research Data Infrastructure in the fight against AMR’ 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-kmoowx1z’ custom_class=” admin_preview_bg=”][/av_heading]

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Good data management is extremely important in clinical research and in the fight against AMR. All relevant data, from diagnostic test results to patient records, must be available and collected from various sources and systems in a timely, accurate and efficient manner. Next to that it needs to be able to be shared with concerned stakeholders, in a standardized and easily accessible way.

As part of VALUE-Dx WP3, co-lead by the University Medical Center Utrecht and bioMérieux, aims to develop and implement a data management architecture capable for the storage, curation and reporting of the data generated within the project. Interoperability is fundamental in these types of systems. Data is produced in different countries, with different languages and IT systems. In order for it to be aggregated with each other, a common data vocabulary has to be used. In addition, the European GDPR imposes strict constraints on how to handle patient sensitive health data.

In VALUE-Dx, task 3.4, led by FIND, has innovated and showcased (via a Proof of Concept POC1) the use of federated networks, using the ODHSI open source technology stack. In a federated architecture, the data reside at the data provider location and are queried from a central “observatory” location. This POC showed how interoperability and data analysis can be orchestrated across an international network of participating laboratories, without the need for individual laboratories to share sensitive patient identifiable data. All that is shared is the query (analytical question) and the aggregated result.

Task 3.4 has exceeded its expectations; not only has it proposed and tested the feasibility of enhancements to ODHSI (in order to allow the platform to work with AMR data) but has also provided an example of the technology working with sample AMR data from different sources.
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[av_heading heading=’ESCMID Policy Statement: addressing the lack of availability of existing antibiotics’ 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-khylpwse’ custom_class=” admin_preview_bg=”][/av_heading]

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ESCMID, the largest European society active in the field of infection and VALUE-Dx partner, has recently released a Policy Statement addressing the lack of availability of existing antibiotics, and what ESCMID can do to contribute to tackling this issue.

In particular, ESCMID plans to lead, in collaboration with relevant stakeholders, activities aiming at identifying the existing antibiotics (including for pediatric use) that are essential and should at all times be available in all countries in Europe and including them in ESCMID guidelines and EUCAST testing recommendation. To this end, a consensus paper listing the current unmet needs regarding the repositioning of existing antibiotics will also be developed.

Finally, ESCMID would be willing to bring its scientific expertise and network to contribute to ongoing or future work done on this topic, at European or international level.

For more information, you can read the Policy Statement here.
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VALUE-Dx is proud to present a workshop at the Virtual ISPOR Europe 2020 conference entitled ‘Assessing the Value of Point-of-Care Diagnostics: Economic Analyses and Appraisals’. The Professional Society for Health Economics and Outcomes Research (ISPOR) virtual conference is taking place 16-19 November with a theme ‘Improving Health: Establishing Incentives and Sharing Value’. The conference will question the fundamental conventions around value, risk, rewards, and the role of public and private sectors.

About the workshop

Purpose

Diagnostic testing is an essential part of modern medicine, but only recently, due to the COVID-19 outbreak, did it gain substantial attention among the general public. VALUE-Dx is an IMI-funded consortium with the objective to assess and demonstrate the value of diagnostic-driven treatment of community-acquired acute respiratory tract infections (CA-ARTI) for both individual patients and public health. Within this consortium, academic, private and (inter)governmental institutions collaborate in many scientific fields: ranging from microbiology and economics to sociology and data science.

Inappropriate prescribing of antibiotics can lead to greater antimicrobial resistance of infectious pathogens. More rapid and accurate diagnoses can reduce inappropriate prescribing and thereby combat antimicrobial resistance. The workshop will focus on the current state of economic models and the appraisal of point-of-care (POC) diagnostics, as well as provide practical guidance for modellers, in vitro diagnostic companies, and appraisal agencies to value diagnostic innovations.

Description

The workshop will cover the full process of assessing a new POC diagnostic:

1. The appraisal of POC diagnostic tests, reflecting on what NICE have learned about the challenges of assessing the value of POC testing in the UK setting.
2. The specific elements to consider when conceptualizing a health-economic model for POC diagnostics of infectious disease, based on a review of the literature;
3. An example of a health-economic model to value POC diagnostics for CA-ARTI, which explains how the considerations of B were used to develop a flexible, individual-based model applicable to several European countries;
4. The assessment of broader public health and economic benefits with respect to antimicrobial resistance over the medium- to long-term using advanced modelling techniques. During the workshop, the audience will be asked questions using live polling, which will also be used to inform ongoing research of the VALUE-Dx project.

Discussion Leaders

• Colm Leonard, MD, National Institute for Health and Care Excellence, Manchester, UK
• Paula Rojas, MA, Dept of Economics, University of La Rioja, Logroño, Spain
• Simon Van der Pol, PharmD, Health Sciences, University of Groningen, University Medical Center Groningen, Groningen, Netherlands
• Isabelle Feldhaus, MSPH, PhD, The Organisation for Economic Co-operation and Development (OECD), Paris, France

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[av_heading heading=’Antimicrobial Resistance Survey – Joint Action by JPIAMR and VALUE-Dx’ 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-kfz4g1i3′ custom_class=” admin_preview_bg=”][/av_heading]

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In the antimicrobial resistance (AMR) field, we currently lack a comprehensive overview with accurate information about available resources and services, where to find them, how they compare to one another, and ways to assess their fitness for reuse in new research. To close this gap, the international consortia JPIAMR and VALUE-Dx bundled their strengths and set out a survey with the ultimate aim to get an overview of existing resources and services that are relevant for AMR research and development. The overview could become a central source of information, ready to take up information on future resources and services as well.

This public report describes the steps taken to set up this survey, presents the results, and the future steps that will be taken. With the survey presented in this report, information was collected on a highly aggregated level. It is an important first step in creating a dynamic overview of AMR-related resources and services. The AMR community will benefit from this initiative, as it will expand options for innovative research and development and may result in new strategies to tackle the global challenge of AMR.

More information here.

The results are also presented in an interactive dashboard that can be used by the entire AMR research community. Make sure to check it out!

Another survey will be set out to collect more detailed information about individual resources and services, and to address issues related to their findability, reuse, sustainability, and quality. For the next survey we strive to use a machine-readable metadata scheme, ensuring that the input is documented according to a standardised & community-agreed description, is interoperable, and remains up-to-date!

This is an initiative by ZonMw (the Netherlands Organisation for Health Research and Development) on behalf of the consortia JPIAMR and VALUE-Dx.

Contact: jpiamr@zonmw.nl (please use heading ‘AMR survey’)
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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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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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