Category: News

  • IMI Mid-Term Review meeting

    IMI Mid-Term Review meeting

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    VALUE-Dx’s Mid-Term Review meeting was held on 13 October 2021 and brought together VALUE-Dx’s Executive Board members, IMI’s Scientific Officer and three external reviewers to monitor and discuss project progress.
    In a full day remote meeting, Executive Board members presented progress and achievements to date as well as planned activities for the coming months and years. Constructive and very interactive Q&A sessions provided the expert panellists with detailed project information. While the reviewers’ consensus report is confidential, the experts concluded that VALUE-Dx will likely provide results with significant immediate or potential impact in the years to come. Concrete suggestions and recommendations to further enhance the output of the project will be implemented.

    The sets of slides that were presented during the meeting are available on the Members Area of the VALUE-Dx website.
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  • PRUDENCE and ADEQUATE-Paediatric officially kicked off

    PRUDENCE and ADEQUATE-Paediatric officially kicked off

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    On 17 and 18 September 2021, an online Network Training meeting has officially kicked off PRUDENCE, a clinical trial aiming to assess effectiveness of CA-ARTI diagnostics in terms of both reductions in antimicrobial prescribing, and patient recovery.

    During this meeting, the sites were trained by the study team on all the aspects of the trial, from patient recruitment to performance of the diagnostic test and completion of the eCRF. Specifically, the LAB-Net team (the laboratory network within COMBACTE and Ecraid) has trained the long term care facilities (LTCF) on sample collection and management for the Microbiology-Biomarker study embedded in PRUDENCE. After almost a year’s delay due to the COVID-19 pandemic, this online session represents finally the start of PRUDENCE.

    ADEQUATE-Paediatric aims to assess the impact of rapid syndromic diagnostic testing in patients with ARTI at the emergency department. As of 1 October 2021, nine patients were enrolled in ADEQUATE-Paediatric and four (Germany, Switzerland, Greece, and Spain) of the six sites were trained by the study team during virtual site initiation visits (SIVs).
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  • Health Economic Analyses of Diagnostics: Guidance on Design and Reporting

    Health Economic Analyses of Diagnostics: Guidance on Design and Reporting

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    Over the past decades, policy makers in the healthcare sector have tried to control the rising costs of pharmaceuticals in different ways. To assess the value of diagnostic interventions in clinical practice, cost-effectiveness analyses can be used; however, we previously identified some gaps in the design and reporting of these studies. Compared with pharmaceutical interventions, assessing the cost effectiveness of diagnostic strategies can be more challenging, as various diseases or treatment options may be important to consider. The new VALUE-Dx publication provides eight recommendations on the reporting and design of CEAs of diagnostics, which can be used in addition to more general guidelines.

    The first recommendation is to specify the target population of the test, including the symptoms patients experience and other relevant determinants that may influence the clinician when diagnosing patients. Clearly state whether the aim of the intervention is to screen, diagnose or monitor patients. The second recommendation is to specify the clinical setting in which the clinician operates, and where the diagnostic test is performed. Next to that you should specify the diagnostic algorithm, including clinicians’ decision processes (decision to perform the test), the diagnostic tests (including brand, type and frequency), and the relevant treatment options (the outcome of the diagnostic algorithm). It is also important that the assessed time horizon should be similar to the time horizon over which costs and consequences of treatment following the diagnostic process are typically evaluated.

    The fifth recommendation is to include either QALYs or DALYs when assessing the cost effectiveness of diagnostics. Consider the economy (or diseconomy) of scale related to collecting, transporting and performing more (or fewer) tests on the same equipment, as opposed to a fixed price per test. Use an efficiency frontier to visualize the incremental costs and outcomes of the different strategies, if several diagnostic algorithms are assessed simultaneously. Finally, define the perspective of the economic evaluation and identify which payers are included in the budget impact analysis. Calculate the budget impact of implementing the assessed diagnostic algorithm within the overall clinical care pathway and consider setting-specific reimbursement regulations

    These recommendations can be used in addition to other, more general, recommendations, such as the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) or the reference case for economic evaluation by the international decision support initiative. Although we expect the issues raised in the paper to be generalizable to diagnostics or all disease areas, some issues relevant for specific disease areas may not have been included. However, this research could be used as a starting point for a follow-up project to further develop diagnostic-specific guidelines or a reference case for diagnostic CEAs.

    Read the full article
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    [/av_one_fifth][/av_section][av_section min_height=” min_height_pc=’25’ min_height_px=’500px’ padding=’default’ shadow=’no-border-styling’ bottom_border=’no-border-styling’ bottom_border_diagonal_color=’#333333′ bottom_border_diagonal_direction=” bottom_border_style=” custom_margin=’0px’ custom_margin_sync=’true’ custom_arrow_bg=” id=” color=’main_color’ background=’bg_color’ custom_bg=’#1b7ca4′ background_gradient_color1=” background_gradient_color2=” background_gradient_direction=’vertical’ src=” attachment=” attachment_size=” attach=’scroll’ position=’top left’ repeat=’no-repeat’ video=” video_ratio=’16:9′ overlay_opacity=’0.5′ overlay_color=” overlay_pattern=” overlay_custom_pattern=” av_element_hidden_in_editor=’0′ av_uid=’av-k0i590fy’ custom_class=”]
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  • Point-of-care diagnostic testing (POCT) improves the quality of antibiotic prescription

    Point-of-care diagnostic testing (POCT) improves the quality of antibiotic prescription

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    [av_heading heading=’Point-of-care diagnostic testing (POCT) improves the quality of antibiotic prescription’ 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-ksioskw8′ custom_class=” admin_preview_bg=”][/av_heading]

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    In August 2021, the VALUE-Dx Consortium has published a new article in the journal Health Economics Review on the use of point-of-care diagnostic testing for improved antibiotic prescription.

    Antimicrobial resistance (AMR) is one of the top 10 global public health threats facing humanity. Antibiotics have been over-prescribed to treat infectious diseases and have generated antimicrobial resistances that reduce their effectiveness. Point-of-care diagnostic testing (POCT) can improve the quality of antibiotic prescription with the aim of reducing AMR.

    In order to understand whether this recommendation is valid, the VALUE-Dx researchers created a theoretical economic model to determine under which conditions the expected benefits of using POCT to guide antibiotic prescription are greater than for empiric prescription. The researchers considered the interaction of a group of physicians who express differing levels of uncertainty when prescribing with a firm selling a diagnostic device, and analysed the firm’s pricing policy and the physicians’ prescribing decisions. The physicians were allowed to internalize the external costs of antimicrobial resistances.

    The results showed that the use of POCT reduces the number of antibiotic prescriptions. The reduction in antibiotic prescriptions is higher when physicians internalise the costs of antimicrobial resistances. Physicians with relatively high levels of uncertainty use POCT as they are uncertain about the right treatment for a large proportion of patients. Physicians with low levels of uncertainty prefer to prescribe empirically. The segmentation in the population of physicians regarding the uptake of POCT depends on the distribution of levels of uncertainty across physicians. For each test, the firm charges the marginal production costs of the inputs needed to administer the test, and makes its profit from the sales of the testing devices.

    From a theoretical perspective, these findings corroborate the fact that POCT improve the quality of antibiotic prescription and reduce the number of prescriptions. Nevertheless, their use is not always recommended as empiric therapy may be preferred when uncertainty is low.

    Read the full article
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  • VALUE-Dx investigates HTA, Reimbursement and Pricing of Diagnostic Tests for CA-ARTI

    VALUE-Dx investigates HTA, Reimbursement and Pricing of Diagnostic Tests for CA-ARTI

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    [av_heading heading=’VALUE-Dx investigates HTA, Reimbursement and Pricing of Diagnostic Tests 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-knr9eayp’ custom_class=” admin_preview_bg=”][/av_heading]

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    In January 2021, the VALUE-Dx project produced a report that aims to map policies related to Health Technology Assessment (HTA), pricing and reimbursement of diagnostics for CA-ARTI in Europe.

    The study indicates that the overall level of policy implementation in pricing and reimbursement for diagnostics is rather low. In addition, it is shown that HTA as a supportive tool to inform pricing and reimbursement decisions at national levels is rarely used in the study countries. Diagnostics for CA-ARTI constitute a valuable instrument to ensure rational antibiotic prescribing and thus to tackle antimicrobial resistance (AMR). Pricing and reimbursement policies, supported by HTA, can contribute to patient access and uptake of health products, such as diagnostics for CA-ARTI. Further research will be conducted in the course of the VALUE-Dx project.

    In its fight against AMR, VALUE-Dx seeks to investigate the economic value, policies and innovative funding models. One of the goals of Work Package 5 is to review and analyze the current policy environment in Europe and identify good practices for the assessment of diagnostics.

    The successful implementation and long-term viability of rapid diagnostic testing does not solely depend on developing, selling, and marketing these kind of medical devices. It is also important to demonstrate the economic value – especially from a long-term societal perspective – and to incentivize the uptake of rapid diagnostic tests through appropriate policies with regards to pricing, reimbursement (funding), and HTA.

    Read the report
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  • Funding models and health economics of diagnostics

    Funding models and health economics of diagnostics

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    WP5 is researching the funding models and health economics of diagnostics. What does exactly make these innovative diagnostics valuable and what are the barriers for healthcare providers and policy makers to start adopting them? These questions can only be answered using an interdisciplinary approach across disciplines such as microbiology, sociology, epidemiology, and economics; but it is also vital to combine the views from governmental organisations, industry, and academics.

    WP5 comprises of seven tasks:

    The task 5.1 team continues to work on preparing for the second Expert Advisory Panel meeting scheduled on 11 March 2021. This will provide expert input into the ongoing work on developing the economic models as well as other tasks in VALUE-Dx.

    In task 5.2, we are focussing on updating the literature review on the economic modelling of diagnostics and therapies for infectious diseases, and on three scientific articles derived from the literature review (respiratory tract infections, gastro-intestinal infections, and sepsis).

    Task 5.3 is collecting cost data from different sources to populate the economic evaluation models, which will be elaborated from the Prudence and Adequate trials.

    Task 5.4’s focus is on the long-term value of diagnostics to prescribe antibiotics more appropriately and we are now working on antimicrobial resistance forecasts, which will allow the model to incorporate future trends and costs related to resistance.

    Task 5.5 has reached deliverable 5.2 and we finalised the corresponding report on “HTA, Reimbursement and Pricing of Diagnostic Tests for CA-ARTI: An international overview of policies”. The next step will be the analysis of key facilitators and barriers for the adequate reimbursement of diagnostic tests for community-acquired respiratory infections.

    Task 5.6 is continuing model development and validation. Task 5.7 will explore stakeholders’ views and experiences of supporting the adoption of new diagnostic tests in European community care to manage community acquired respiratory tract infections. We have identified stakeholders  from different health care organisations, policy departments and diagnostic companies. Interviews will start in March 2021 and we aim to finish data collection by autumn 2021.
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    [/av_one_fifth][/av_section][av_section min_height=” min_height_pc=’25’ min_height_px=’500px’ padding=’default’ shadow=’no-border-styling’ bottom_border=’no-border-styling’ bottom_border_diagonal_color=’#333333′ bottom_border_diagonal_direction=” bottom_border_style=” custom_margin=’0px’ custom_margin_sync=’true’ custom_arrow_bg=” id=” color=’main_color’ background=’bg_color’ custom_bg=’#1b7ca4′ background_gradient_color1=” background_gradient_color2=” background_gradient_direction=’vertical’ src=” attachment=” attachment_size=” attach=’scroll’ position=’top left’ repeat=’no-repeat’ video=” video_ratio=’16:9′ overlay_opacity=’0.5′ overlay_color=” overlay_pattern=” overlay_custom_pattern=” av_element_hidden_in_editor=’0′ av_uid=’av-k0i590fy’ custom_class=”]
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  • Enhancing the quality of antibiotic prescribing for CA-ARTI in Emergency Rooms through ADEQUATE trial

    Enhancing the quality of antibiotic prescribing for CA-ARTI in Emergency Rooms through ADEQUATE trial

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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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  • PRUDENCE trial will start in the summer of 2021

    PRUDENCE trial will start in the summer of 2021

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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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  • The third PPAS captures information on care delivery and patient management during COVID-19 pademic

    The third PPAS captures information on care delivery and patient management during COVID-19 pademic

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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 3rd 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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  • VALUE-Dx assesses diagnostic accuracy of point-of-care tests in community settings for lower CA-ARTI

    VALUE-Dx assesses diagnostic accuracy of point-of-care tests in community settings for lower CA-ARTI

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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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