Author: Leandra

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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-kmx42r8e’ custom_class=” admin_preview_bg=”][/av_heading]

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Clinical management of Community-Acquired acute Respiratory Tract Infections (CA-ARTI) is suboptimal in emergency departments, needing a more judicious antibiotic prescribing. It is hampered because of diagnostic delays and suboptimal test sensitivity, leading to incorrect or missing etiologic diagnosis, and overprescription of antibiotics. 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 for enhancing the quality of antibiotic prescribing for CA-ARTI in Emergency Rooms in Europe.

ADEQUATE aims to assess the impact of rapid syndromic diagnostic testing 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 Study consists of an adult and a pediatric protocol. The ADEQUATE protocol has been aligned with the different WPs of the VALUE-Dx project. ADEQUATE has designed a data collection process in close communication with WP3 and WP5 to build 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. In collaboration with WP2, the pediatric sites will collect the right samples to complement the biological studies. 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.

During 2020, 8 adult sites and 6 pediatric sites have been selected, covering different geographical areas in Europe (Germany, Serbia, Hungary, UK, Switzerland, Greece, Spain, Israel, France, Belgium) in the context of CLIN-Net and PENTA networks. Ethical Committee submissions have been completed for the first sites and first approvals are being received. First sites start-up is planned for patient enrolment as of March-April 2021

Read the main objectives of ADEQUATE here.
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[av_heading heading=’PRUDENCE trial will start in Autumn 2021′ 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-krvp85ar’ custom_class=” admin_preview_bg=”][/av_heading]

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In February 2021, WP4a has re-opened the Point Prevalence Audit Survey (PPAS) in approximately 15 primary care networks to record patient management towards the end of the second COVID-19 wave. In addition to the PPAS, the PRUDENCE Trial is currently being set up. This is a platform randomised controlled trial of point of care diagnostics for enhancing the quality of antibiotic prescribing for CA-ARTI in ambulatory care in Europe. It will include participants recruited by primary care clinicians and in long-term care facility (LTCF). The following networks will participate: the UK, Greece, Georgia, Ireland, Poland, Germany, Belgium, Hungary, Spain, France, Italy, Switzerland, and Israel.

The University of Oxford has agreed to act as trial Sponsor. The Sponsor letter, confirmation of insurance, protocol and associated documents have been sent to the networks for translation and submission to their national regulatory agencies. By the end of 2020, the UK, Georgia and Hungary had received all regulatory approvals and executed the contractual agreements to enable them to start in January 2021.

However, the PRUDENCE Trial Management Group (TMG) met on the 22nd December 2020 to discuss postponement of the trial. Due to the pressures on primary care with the continuing COVID-19 pandemic, the vaccine roll-out and lack of flu circulating, the TMG and VALUE-Dx Executive Board agreed to the postponement of PRUDENCE until Autumn 2021.
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[av_heading heading=’The third point prevalence audit survey captures information on care delivery and patient management 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-kmuf166j’ custom_class=” admin_preview_bg=”][/av_heading]

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The delivery of primary health care, especially for patients with symptoms of a respiratory tract infection, has been highly affected by the COVID-19 pandemic. Preventive measures, frequently changing advice and guidelines, implementation of diagnostic testing by general practices and later by routine community surveillance, changed consultation behaviours because of fear for COVID-19 and not wanting to unnecessarily use health care resources urged for constant adaptations in care delivery.

The first point prevalence audit survey (PPAS1) registered characteristics of patients seeking care for a respiratory tract infection and their management with respect to diagnostic testing, medication prescribing and advice they received from their general practitioner just before the COVID-19 pandemic (Jan-Feb 2020). PPAS1 was implemented in 18 European countries and registered 4995 patients. PPAS2 captured care delivery for 3401 patients with a respiratory tract infection in the beginning of the first wave of the COVID-19 pandemic in 16 countries (March-June 2020) and highlighted profound differences in the delivery of care and patient management between those countries.

In March 2021, countries are dealing with the 3^rd pandemic wave, routine surveillance is implemented, and in some countries care for patients with respiratory tract infection is provided at separate locations. The PPAS3, which started beginning of March 2021, will capture information on care delivery and patient management in 17 countries during hopefully the final stage of the COVID-19 pandemic.

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[av_heading heading=’VALUE-Dx assesses diagnostic accuracy of point-of-care tests in community settings for lower 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-kmuasrsj’ custom_class=” admin_preview_bg=”][/av_heading]

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WP1 successfully concluded a systematic review and meta-analysis to assess the diagnostic accuracy of point-of-care tests (POCTs) in community settings for lower community-acquired, acute respiratory tract infections (CA-ARTI). For this purpose, 11,326 articles were screened and 393 studies were finally analysed. Our results show that the accuracy of stand-alone signs and symptoms or biomarkers is really poor. Interestingly, lung ultrasound, which can be easily implemented with fast training in community settings, shows sensitivity and specificity (90% for both) for the diagnosis of bacterial pneumonia higher than chest-X-ray. Rapid antigen based diagnostic tests for influenza, respiratory syncytial virus, human metapneumovirus, SARS-CoV-2, and Streptococcus pneumoniae have sub-optimal sensitivity (range, 49% – 84%) but high specificity (>80%). As for the molecular test, their diagnostic performance is higher compared to that of rapid diagnostic tests for all the diagnostics and pathogen analysed. These results stratified by age and settings (emergency rooms versus long term care facilities versus community ambulatory) are currently under review for publication. Based on the evidence and applying a machine learning approach the team built clinical algorithms for children and adults assessed in different settings for determining the aetiology of CA-ARTI which is now under validation with real life big database including patients assessed outside the hospitals.

In addition, WP1 finalised the User Requirement Specification and the first version of the Technical Roadmap for diagnostic of CA-ARI which are currently under international experts and EFPIA assessment and review.

During the COVID-19 pandemic the team of University of Verona, Rambam Health Care Campus in Haifa and EFPIA contributed to the evidence of diagnostic for CA-ARTI with a systematic review on SARS-CoV-2. 51 studies including more than 10,000 patients show major limitations of molecular diagnostics in SARS-CoV-2 infection and that on average 10% of patients with coronavirus infections might be missed with PCR tests (CMI 2020). The WP1 team also developed, using a multi criteria decision analysis methodology, priority criteria to rapidly identify COVID-19 patients in need of hospitalization in low-resource settings with hospital-bed shortage (IJID 2020).
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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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[av_heading heading=’VALUE-Dx at Virtual ISPOR Europe 2020′ 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-khm2mecs’ custom_class=” admin_preview_bg=”][/av_heading]

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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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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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[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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