Category: News

  • VALUE-Dx real-time inclusions

    VALUE-Dx real-time inclusions

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    [av_heading heading=’VALUE-Dx real-time inclusions’ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-desktop-font-size-title=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-desktop-font-size=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-desktop-font-size-1=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ av-desktop-margin=” av-desktop-margin_sync=’true’ av-medium-margin=” av-medium-margin_sync=’true’ av-small-margin=” av-small-margin_sync=’true’ av-mini-margin=” av-mini-margin_sync=’true’ headline_padding=” headline_padding_sync=’true’ av-desktop-headline_padding=” av-desktop-headline_padding_sync=’true’ av-medium-headline_padding=” av-medium-headline_padding_sync=’true’ av-small-headline_padding=” av-small-headline_padding_sync=’true’ av-mini-headline_padding=” av-mini-headline_padding_sync=’true’ padding=’10’ av-desktop-padding=” av-medium-padding=” av-small-padding=” av-mini-padding=” icon_padding=’10’ av-desktop-icon_padding=” av-medium-icon_padding=” av-small-icon_padding=” av-mini-icon_padding=” link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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    Recently, two real-time graphs were added to the VALUE-Dx website, as an easy tool to track the inclusion progress of the PRUDENCE and ADEQUATE trails. This information is crucial because at the start of these trials, a target number of patients was set that has to be included for the trials to have statistical “power”. If these targets aren’t met, there is a risk that the studies will be considered unsuccessful because the research questions couldn’t be answered with enough certainty. 

    The graphs are updated on a daily basis and show how many patients are recruited per site or per country. Thanks to this data, it becomes clear which sites or countries are recruiting well and which are lagging behind the inclusion schedule. These sites or countries are then approached to see how they can be supported in order to reach the target. 

    PRUDENCE (Primary Care)

    The PRUDENCE graph indicates the number of patients per setting and country. It is split up into patients in primary care and in long-term facility care. Within this trial, a country can have several sites, for example multiple GP offices in Primary Care. 

    ADEQUATE (Emergency Rooms)

    The ADEQUATE graph is also split up into two parts, the left part shows the number of paediatric patients enrolled per site and the right one the total number. 

    The inclusion graphs have been created by the VALUE-Dx Data Management & Analytics team at the UMC Utrecht. The inclusion graphs are just one example of the team’s output. Other graphs are crucial tools to monitor data quality and the data cleaning process. 

    About the trials

    The PRUDENCE trial researches whether having a community-acquired acute respiratory tract infections 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.

    The ADEQUATE trial is a randomised controlled trial of rapid syndromic diagnostic testing for enhancing the quality of antibiotic prescribing for community acquired acute respiratory tract infection (CA-ARTI) in emergency rooms in Europe.
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  • VALUE-Dx paper BJGP Number 1 Most Read Article

    VALUE-Dx paper BJGP Number 1 Most Read Article

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    [av_heading heading=’VALUE-Dx paper in BJGP Top 10′ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-desktop-font-size-title=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-desktop-font-size=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-desktop-font-size-1=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ av-desktop-margin=” av-desktop-margin_sync=’true’ av-medium-margin=” av-medium-margin_sync=’true’ av-small-margin=” av-small-margin_sync=’true’ av-mini-margin=” av-mini-margin_sync=’true’ headline_padding=” headline_padding_sync=’true’ av-desktop-headline_padding=” av-desktop-headline_padding_sync=’true’ av-medium-headline_padding=” av-medium-headline_padding_sync=’true’ av-small-headline_padding=” av-small-headline_padding_sync=’true’ av-mini-headline_padding=” av-mini-headline_padding_sync=’true’ padding=’10’ av-desktop-padding=” av-medium-padding=” av-small-padding=” av-mini-padding=” icon_padding=’10’ av-desktop-icon_padding=” av-medium-icon_padding=” av-small-icon_padding=” av-mini-icon_padding=” link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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    We are proud to announce that one of VALUE-Dx’s publications is the number one most read paper in the BJGP Open in 2022! Our paper on Point-of-care testing, antibiotic prescribing and prescribing confidence for respiratory tract infections in primary care: a prospective audit in 18 European countries tops their Top 10 Most Read Research articles, a wonderful achievement.

    The aim of the study was to describe between-country differences in RTI management, particularly diagnostic testing and antibiotic prescribing, and investigate which factors relate to antibiotic prescribing and GPs’ prescribing confidence. Read the paper here.
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  • WHO AWaRe Antibiotic Book

    WHO AWaRe Antibiotic Book

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    [av_heading heading=’WHO AWaRe Antibiotic Book’ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-desktop-font-size-title=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-desktop-font-size=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-desktop-font-size-1=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ av-desktop-margin=” av-desktop-margin_sync=’true’ av-medium-margin=” av-medium-margin_sync=’true’ av-small-margin=” av-small-margin_sync=’true’ av-mini-margin=” av-mini-margin_sync=’true’ headline_padding=” headline_padding_sync=’true’ av-desktop-headline_padding=” av-desktop-headline_padding_sync=’true’ av-medium-headline_padding=” av-medium-headline_padding_sync=’true’ av-small-headline_padding=” av-small-headline_padding_sync=’true’ av-mini-headline_padding=” av-mini-headline_padding_sync=’true’ padding=’10’ av-desktop-padding=” av-medium-padding=” av-small-padding=” av-mini-padding=” icon_padding=’10’ av-desktop-icon_padding=” av-medium-icon_padding=” av-small-icon_padding=” av-mini-icon_padding=” link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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    In December 2022, the World Health Organisation (WHO) released the WHO AWaRe Antibiotic Book. AWaRe (which stands for access, watch and reserve) is a concise, evidence-based guide for choosing antibiotics, doses, routes of administration and duration of treatment for more than 30 of the most common clinical infections in children and adults, in both primary health care and hospital settings. For ease of use, the book is also available in the form of infographics and an online web application, which provides a quick-reference guide for health care professionals at the point of care.

    Up until now, easily accessible, evidence-based guidance from trusted sources has been lacking for many common infections in many countries, especially in low- and middle-income settings. The AWaRe antibiotic book is expected to be of particular value in those settings where WHO guidance might be the only high-quality information source available.

    Through the Global Action Plan on AMR, WHO is working to improve the surveillance of antimicrobial resistance and reduce inappropriate antibiotic consumption. VALUE-Dx shares WHO’s concern that antimicrobial resistance poses a threat to public health globally, and contributes to the fight against AMR by validating diagnostics to optimize antibiotic use. Find out more here.
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    [/av_one_fifth][av_one_fifth min_height=” vertical_alignment=” space=” custom_margin=” margin=’0px’ row_boxshadow=” row_boxshadow_color=” row_boxshadow_width=’10’ link=” linktarget=” link_hover=” title_attr=” alt_attr=” padding=’0px’ highlight=” highlight_size=” border=” border_color=” radius=’0px’ column_boxshadow=” column_boxshadow_color=” column_boxshadow_width=’10’ background=’bg_color’ background_color=” background_gradient_color1=” background_gradient_color2=” background_gradient_direction=’vertical’ src=” background_position=’top left’ background_repeat=’no-repeat’ animation=” mobile_breaking=” mobile_display=” av_uid=’av-1gk3g’]

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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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  • VALUE-Dx gives recommendations for CA-ARTI diagnostics in new report

    VALUE-Dx gives recommendations for CA-ARTI diagnostics in new report

    [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=’#08b4a0′ background_gradient_color1=” background_gradient_color2=” background_gradient_direction=’vertical’ src=” attachment=” attachment_size=” attach=’parallax’ position=’top center’ repeat=’stretch’ video=” video_ratio=’16:9′ overlay_opacity=’0.5′ overlay_color=’#08b4a0′ overlay_pattern=” overlay_custom_pattern=” av_element_hidden_in_editor=’0′ av_uid=’av-jzkylawd’ custom_class=”]
    [av_heading heading=’VALUE-Dx gives recommendations for CA-ARTI diagnostics in new report’ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-desktop-font-size-title=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-desktop-font-size=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-desktop-font-size-1=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ av-desktop-margin=” av-desktop-margin_sync=’true’ av-medium-margin=” av-medium-margin_sync=’true’ av-small-margin=” av-small-margin_sync=’true’ av-mini-margin=” av-mini-margin_sync=’true’ headline_padding=” headline_padding_sync=’true’ av-desktop-headline_padding=” av-desktop-headline_padding_sync=’true’ av-medium-headline_padding=” av-medium-headline_padding_sync=’true’ av-small-headline_padding=” av-small-headline_padding_sync=’true’ av-mini-headline_padding=” av-mini-headline_padding_sync=’true’ padding=’10’ av-desktop-padding=” av-medium-padding=” av-small-padding=” av-mini-padding=” icon_padding=’10’ av-desktop-icon_padding=” av-medium-icon_padding=” av-small-icon_padding=” av-mini-icon_padding=” link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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    Antimicrobial resistance (AMR) is a global public health threat which is the cause of numerous deaths and medical complications. One major driver for AMR is the inappropriate use of antibiotics, such as in the treatment of community-acquired acute respiratory tract infections (CA-ARTI).

    In November 2022, Work Package 5 of VALUE-Dx published a report on their 5.4 Deliverable. The aim of the study was to develop recommendations for fit-for-purpose policies in funding and pricing to improve the uptake of CA-ARTI point-of-care testing (POCT) in the outpatient sector. The report presents such policy recommendations, which are supplemented by some additional advice on health technology assessments (HTA) and overarching considerations. 

    One of the goals of Work Package 5 is to review and analyse the current policy environment in Europe and identify good practices for the assessment of innovative diagnostics. WP5 also strives to develop proposals for fit-for-purpose policies, to accelerate market entry of and accessibility to cost-effective diagnostics with the potential to be applied to reduce AMR.

    In the report, a total of fifteen recommendations targeted at policy-makers are proposed. Ten of them have been clustered in the policy areas of HTA, pricing and procurement, and funding. Five additional recommendations refer to overarching aspects that are conducive to the successful implementation of peri-launch policies. Read the report here.

     
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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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  • Does diagnostic testing always decrease antibiotics prescriptions?

    Does diagnostic testing always decrease antibiotics prescriptions?

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    [av_heading heading=’Does diagnostic testing always decrease antibiotics prescriptions?’ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ padding=’10’ icon_padding=’10’ headline_padding=” headline_padding_sync=’true’ link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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    [av_one_full first min_height=” vertical_alignment=’av-align-top’ space=” margin=’0px’ margin_sync=’true’ row_boxshadow_color=” row_boxshadow_width=’10’ link=” linktarget=” link_hover=” title_attr=” alt_attr=” padding=’50px,5%,50px,5%’ highlight_size=’1.1′ border=” border_color=” radius=’0px’ radius_sync=’true’ column_boxshadow_color=” column_boxshadow_width=’10’ background=’bg_color’ background_color=” background_gradient_color1=” background_gradient_color2=” background_gradient_direction=’vertical’ src=” attachment=” attachment_size=” background_position=’top left’ background_repeat=’no-repeat’ animation=” mobile_breaking=” mobile_display=” av_uid=’av-k0i4yzrj’ custom_class=”]

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    In August 2022, VALUE-Dx published a new article in the European Journal of Health Economics with the following title: ‘Does diagnostic testing always decrease antibiotics prescriptions?’. The conclusion of this scientific paper is that we should be very careful when we assert that point-of-care diagnostic testing (POCT) reduces antibiotics prescriptions as there are situations in which the opposite effect occurs.

    Why POCT?
    Empiric prescription as a treatment for infectious diseases in community care settings has caused antibiotics to be overprescribed, resulting in an increase of antimicrobial resistance (AMR). In order to reduce antibiotics prescription, point-of-care diagnostic testing (POCT) has been suggested.

    In this new VALUE-Dx article, a stylised static theoretical economic model was used to analyse whether POCT always decreases antibiotics prescriptions. The interaction of a group of doctors who differ in their level of concern about AMR when prescribing with a firm selling a POCT was taken into consideration. The price set by the manufacturer and doctors’ decision to employ POCT was characterised.

    Results of the study
    It is widely accepted that the use of diagnostic testing to guide antibiotics prescription in community care settings reduces the number of antibiotics prescriptions. However, the model used in this article shows that we should be very careful with recommending the use of POCT to reduce antibiotics prescriptions as we may end up with the opposite result.

    In fact, the number of antibiotics prescriptions is not always lower. It depends on the distribution of the doctors’ concern about AMR as there is a proportion of doctors who use POCT and then prescribe antibiotics, while other doctors change their prescribing behaviour after using POCT. They stop giving antibiotics to patients who do not benefit from them. When the proportion of patients who need antibiotic treatment is higher than the proportion of doctors who use POCT and stop prescribing unnecessary antibiotics, the number of antibiotics prescriptions is larger.

    These analyses convey the message that we should be very careful when we assert that POCT reduces antibiotics prescriptions as there are situations in which the contrary effect is produced.

    You can read the publication here.

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  • WAAW 2022 theme announced

    WAAW 2022 theme announced

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    [av_heading heading=’WAAW 2022 theme announced ‘ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ padding=’10’ icon_padding=’10’ headline_padding=” headline_padding_sync=’true’ link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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    This year’s World of Antimicrobial Awareness Week (WAAW) theme is ‘Preventing antimicrobial resistance together’. It was announced by the Quadripartite organisations, which includes the Food and Agriculture Organisation of the United Nations (FAO), the United Nations Environment Programme (UNEP), the World Health Organisation (WHO), and the World Organisation for Animal Health (WOAH, founded as OIE).

    The WAAW takes place every year from 18 to 24 November. The 2022 topic focuses on a One Health approach and inspires collaboration across sectors. AMR is a threat to humans, animals, plants and the environment  and fighting it is a global endeavour. 

    Discover more here
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  • Ecraid press release on European response to monkeypox virus outbreak

    Ecraid press release on European response to monkeypox virus outbreak

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    [av_heading heading=’Ecraid press release on European response to monkeypox virus outbreak’ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ padding=’10’ icon_padding=’10’ headline_padding=” headline_padding_sync=’true’ link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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    Utrecht, 7 July 2022 – Ecraid is assessing its readiness to respond in the event the monkeypox outbreak spreads further in Europe. These preparations are proportionate to the current relatively low risk of this infection for European citizens. Ecraid is currently operating in outbreak response mode 2 (mobilisation) for adults, and in outbreak response mode 1 (preparedness) for children, the second and first of three response modes.

    Outbreak

    Early May 2022 a multi-country outbreak of monkeypox virus (MPXV) started affecting the United Kingdom (UK), the EU/EEA, Asia, the Americas, and Australia. The virus spreading outside of the known enzootic countries in the African region has been designated clade 3 MPXV. Cases that are thought to be linked to this outbreak have been reported from 31 countries and areas throughout the European region, and other countries. Most recognized infections are in men with high-risk exposure for transmission (men who have sex with men), and disease transmission outside this population is still rare, but there is some concern that expansion of the risk group is possible if the outbreak continues to evolve. The clinical manifestations of clade 3 MPXV infections are usually mild, and most people in the current outbreak have recovered within weeks. More severe disease has been reported in studies from African countries with enzootic presence of monkeypox, with outbreaks with clade 3 MPXV with a case-fatality rate up to 3% in Nigeria. The highest case fatality rates have been reported for children and young adults, as well as immunocompromised individuals.

    Treatment for monkeypox is mostly symptomatic. Tecovirimat was approved by the European Medicines Agency (EMA) for treatment of monkeypox throughout the EU on 6 January 2022. Tecovirimat has been authorised under ‘exceptional circumstances’, as it has not been possible to obtain complete information about tecovirimat efficacy and safety in human monkeypox due to the rarity of the disease. Persons with severe disease, immunocompromised patients, children younger than 8 years, and pregnant individuals could be considered for antiviral treatment.

    Although the exact extent of the outbreak remains to be established, these events have triggered an assessment of the level of preparedness of clinical research networks in Europe for possible deployment in case of further spread. The EU has invested in the development of these European clinical networks over many years to ensure preparedness for delivering clinical research in response to new infectious disease outbreaks. These networks include Ecraid: The European Clinical Research Alliance for Infectious Diseases (With the support of funding provided by the EU, Europe is now much better prepared to speed up the processes of clinical research to the extent that findings are generated in real time to inform practice when it is most useful, in the midst of an outbreak, rather than once the threat has passed.

    How Ecraid is responding

    Information on Ecraid’s response modes and implications can be found here. Activities are planned and conducted in close collaboration with our partner networks (EU-RESPONSE and VACCELERATE) and the European Union and in alignment with those of WHO, ECDC and EMA. The preparations made by Ecraid as part of its mode 1 and 2 responses are briefly summarised below.

    Ecraid participates in the MOSAIC study (led by University of Oxford as the sponsor and ANRS/Inserm representant of the sponsor in Europe). This is an observational study of the natural history of monkeypox disease in children and adults. With its collaborative network, Ecraid will identify study sites for participation in MOSAIC in those countries not yet participating. Together with its partners ANRS/Inserm, University of Oxford and UMC Utrecht, the alliance also participates in the preparation of a randomized controlled trial evaluating the effectiveness of tecovirimat. Moreover, Ecraid offers countries access to serology and sequencing capacity in its network (e.g., Erasmus MC).

    Through its partners with expertise in pediatric infections (PENTA-ID, UMC Utrecht and Erasmus MC), Ecraid will develop a scientific research agenda in the event that monkeypox infections emerge in children. The first initiatives for preparation have focused on the use of Imvanex in adults and children as Post-Exposure Prophylaxis or Pre-Exposure Prophylaxis. Imvanex is not licensed for children under 18 years but is used off-label for exposed children. There is no standardized protocol for follow-up of these children and the possibilities of a cohort study looking at immunogenicity, break-through infections and adverse events is being explored with several European countries. Study developments will be discussed with EMA, and execution will be aligned with VACCELERATE.

    The standing Ecraid Outbreak Mode Committee (Prof. Marion Koopmans of the Erasmus Medical Center in Rotterdam, Prof. Peter Horby of the University of Oxford, Prof. Herman Goossens of the University of Antwerp, Prof. Yazdan Yazdanpanah and Prof. Marc Bonten, University Medical Center) continue to follow the events closely to ensure Ecraid’s clinical research response remains aligned with the risk to health and security of European citizens.

    Quotes

    Prof. Marc Bonten (UMC Utrecht and CEO of Ecraid): “Ecraid has been established to enhance our capacity in Europe to mount a rapid clinical research response to any new infectious disease threat. Monkeypox may become such a threat, and that’s why we have started preparations for clinical studies now.”

    Prof. Yazdan Yazdanpannah (ANRS/Inserm): “Threats related to new emerging pathogens or re-emerging infectious diseases appear regularly and the frequency of their occurrence is increasing. This is again illustrated by the unprecedented and unexpected outbreak of human monkeypox cases across Europe, the Americas, and Australia. A United Europe of Research is key to respond to epidemics/pandemics. Research infrastructures such as Ecraid and its partner networks EU-RESPONSE and VACCELERATE are very important tools of response.”

    Prof. Peter Horby (Oxford University): “The unanticipated emergence of monkeypox outside of Africa is a perfect case-study of how threats anywhere can become threats everywhere and exemplifies the need to work as a global community to identify and counter all infectious disease problems, wherever they occur and whomever they affect.”

    Prof. Marion Koopmans (Erasmus MC, Rotterdam): “While we do not foresee a surge of monkeypox cases in the near future, preparedness does require scenario thinking and preparing for those scenarios. In Ecraid, we do that for possible trajectories that may evolve if the current public health response does not lead to containment of the outbreak.”

    Prof. Herman Goossens (Antwerp University): “The European clinical trial networks, expanded during the COVID-19 pandemic thanks to significant EU funding, are providing the sustainable infrastructures for the response to the monkeypox threat.”

    About Ecraid

    The European Clinical Research Alliance for Infectious Diseases (Ecraid) is a not-for profit foundation that advances clinical research in the field of infectious diseases by establishing a long-term, financially self-sustainable, clinical research network in Europe. Headquartered in Utrecht, the Netherlands, Ecraid is the first network of its kind in Europe to offer a single point of access to a pan-European clinical research network for infectious diseases and spans 1,100 clinical sites and 900 laboratories across 42 countries. For more information, please visit www.ecraid.eu.

    ECRAID PRESS RELEASE
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  • POC Diagnostics in General Practice: the Effects on Antimicrobial Resistance

    POC Diagnostics in General Practice: the Effects on Antimicrobial Resistance

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    [av_one_full first min_height=” vertical_alignment=’av-align-top’ space=” margin=’0px’ margin_sync=’true’ row_boxshadow_color=” row_boxshadow_width=’10’ link=” linktarget=” link_hover=” title_attr=” alt_attr=” padding=’50px,5%,50px,5%’ highlight_size=’1.1′ border=” border_color=” radius=’0px’ radius_sync=’true’ column_boxshadow_color=” column_boxshadow_width=’10’ background=’bg_color’ background_color=” background_gradient_color1=” background_gradient_color2=” background_gradient_direction=’vertical’ src=” attachment=” attachment_size=” background_position=’top left’ background_repeat=’no-repeat’ animation=” mobile_breaking=” mobile_display=” av_uid=’av-k0i4yzrj’ custom_class=”]

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    In June 2022, VALUE-Dx contributed to a new publication titled ‘The Opportunity of Point-of-Care Diagnostics in General Practice: Modelling the Effects on Antimicrobial Resistance’, that appeared in the open-access journal PharmacoEconomics. The aim of the study was to quantify the investments required for a large-scale rollout of point-of-care (POC) diagnostic testing in Dutch primary care, as well as the impact on antimicrobial resistance (AMR) due to reduced use of antibiotics. 

    AMR is a public health threat that is mainly caused by unnecessary use of antibiotics. Community-acquired acute respiratory tract infections (CA-ARTIs) are a major driver of antibiotic consumption in primary care. It is estimated that each year more than 650.000 infections and 30.000 attributable deaths in Europe or 1.27 million deaths worldwide are caused by resistant organisms. 

    An individual-based model was developed to simulate CA-ARTI consultations at Dutch GP practices. It compared a scenario where GPs test all CA-ARTI patients with a hypothetical diagnostic strategy to a scenario where the current standard-of-care is continued for the years 2020-2030. Differences in costs and future AMR rates were estimated. 

    Results of the study

    The results show that improved diagnostics may reduce AMR in the next decade, but that there also are major costs associated. When comparing the current standard-of-care to the diagnostic algorithm, the latter increases the total costs of GP consultations for CA-ARTI by 9% and 19%, when priced at €5 and €10. The hypothetical diagnostic strategy can partly restrain the forecast increase in Streptococcus pneumoniae resistance against penicillins from 3.8 to 3.5% in 2023, albeit with considerable uncertainty.       

    Conclusions

    The results show that the costs of consultations increase, while antibiotic consumption and AMR decrease when implementing a hypothetical diagnostic strategy for all CA-ARTI patients in primary care. Interventions with limited gains for individual patients, but considerable potential related to antibiotic consumption and AMR, can require novel health-economic methods to assess and communicate the potential benefits related to AMR.   

    You can read the publication here
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  • Diagnostics for AMR: Building back better from the COVID-19

    Diagnostics for AMR: Building back better from the COVID-19

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    The VALUE-Dx project encouraged all relevant stakeholders to partake in a Massive Open Online Course (MOOC) on Diagnostics for AMR: Building back better from the COVID-19 pandemic, developed by the London School of Hygiene & Tropical Medicine in partnership with Becton, Dickinson and Company (BD).

    This free three-week course provided valuable insight into how COVID-19 has affected country AMR programmes and how countries can explore the lessons and benefits that the responses to the COVID-19 pandemic hold for AMR. You were able to learn at your own pace with a faculty of leading experts in COVID-19 and AMR and be part of the largest community of AMR professionals on the cutting edge of new information.

    • You learned about diagnostic technology innovations and diagnostic capacity increases developed in response to the COVID-19 pandemic and how they can be applied to the AMR response.
    • You learned about the importance of quality and data systems for AMR diagnostics and AMR data sharing to strengthen surveillance and reporting, and opportunities for professional development as part of a culture of continuous learning.
    • You got the opportunity to join discussion forums to share your knowledge and views with colleagues and benefit from the experiences of other learners from around the world.

    How can the COVID-19 pandemic help us defeat Antimicrobial Resistance?

    Having the latest data for COVID-19 allows policy makers, clinicians, and the public to do their part in the fight against this pandemic. Many countries still lack sufficient data on antimicrobial resistance (AMR) trends to develop national and local treatment guidelines and policies. “Without data, you are just a person who has another opinion…with data, you can convince people there is an issue”, says Dr. Amal Saif Al-Maani, AMR expert from Oman.

    In addition, we have made numerous investments in science, diagnostic testing capacity, and innovations in data systems we can leverage to do better with AMR before it’s too late. “Now is the time to learn more about the diagnostic technology innovations and diagnostic capacity increases that developed in response to COVID-19, and how they can be applied to the AMR response”, says Professor Rosanna Peeling, Director and Chair of Diagnostics at the International Diagnostics Centre at the London School of Hygiene and Tropical Medicine.

    COURSE SYLLABUS

    Week 1 – Updates on the AMR response and the impact of the COVID-19 pandemic

    Week 2 – Better diagnosis, surveillance and reporting for AMR

    Week 3 – Building back better for a robust and sustainable AMR response
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  • VALUE-Dx supported participation in Ecraid webinar

    VALUE-Dx supported participation in Ecraid webinar

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    [av_heading heading=’VALUE-Dx supported participation in Ecraid webinar’ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ padding=’10’ icon_padding=’10’ headline_padding=” headline_padding_sync=’true’ link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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    The VALUE-Dx project encouraged all relevant stakeholders to attend the Ecraid educational webinar “Clinical case discussion: How clinical trials inform antibiotic stewardship”, organized by VALUE-Dx partners ERS and ESCMID. The webinar took place on 19 January, 2022 from 13:00–14:30 CET.

    The aim of this webinar was to provide an overview of data from clinical trials in the management of complicated urinary tract infections and pneumonia, and how this information may be incorporated into stewardship activities.

    Following the webinar, participants were able to discern the relevance of microbiological tests and their interpretation for the aetiological diagnosis of pneumonia, and the evidence-based principles for antibiotic treatment of complicated UTIs and community-acquired pneumonia.

    About Ecraid

    The European Clinical Research Alliance for Infectious Diseases – Ecraid – advances clinical research in the field of infectious diseases by establishing a long-term, financially self-sustainable, clinical research network in Europe. This network encompasses more than 2,000 sites in 40+ European countries. It includes primary care settings (general practitioners), hospital settings (emergency rooms and intensive care units), paediatric care settings, clinical laboratories, and long-term care facilities. The VALUE-Dx project and clinical studies are at the heart of the Ecraid network.
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