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[av_heading heading=’A new home for VALUE-Dx resources at ERS’s e-learning hub’ 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_dynamic=” link_target=” title_attr=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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After an impactful 5.5 years, the VALUE-Dx project has officially come to an end in September 2024, but its legacy continues. Thanks to the commitment of the European Respiratory Society (ERS), the knowledge and resources generated by VALUE-Dx remain accessible to healthcare professionals, researchers, and policymakers worldwide.

To ensure long-term accessibility, ERS has redesigned its e-learning environment with two dedicated entry points:

• Educational content: a newly structured VALUE-Dx webpage on the ERS virtual learning platform brings together all educational materials, including webinars and conference lectures, to help deepen understanding of diagnostic strategies in respiratory tract infections.
• Project resources: a separate VALUE-Dx document library on the ERS website hosts a wealth of additional materials, from project reports and scientific posters to newsletters and Expert Advisory Panel meeting summaries, all carefully organized for easy reference.

In the spirit of knowledge-sharing, all VALUE-Dx materials remain freely available without the need for registration.

A big thank you to the ERS advocacy team for making this possible! You are kindly invited to take full advantage of these invaluable resources and keep advancing diagnostic excellence in respiratory infections.

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[av_heading heading=’Concluding Interview’ 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_dynamic=” link_target=” title_attr=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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VALUE-Dx coordinator & project lead Em. Prof. Herman Goossens gives a concluding interview at the end of the project. He elaborates on its origin, discusses the achievements of the clinical trials and comments on the next steps.

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[av_heading heading=’Developing a Clinical Algorithm to support Etiological Diagnosis of CARTIs’ 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_dynamic=” link_target=” title_attr=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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The development of a clinical algorithm for diagnosing Community-Acquired Acute Respiratory Tract Infections (CA-ARTIs) in WP1 of VALUE-Dx is a critical advancement aimed at improving the accuracy and efficiency of diagnostic processes. The WP1 team systematically reviewed the effectiveness of point-of-care tests (POCTs) and leveraged their performance to create an algorithm to drive a diagnostic process. This algorithm integrates clinical signs and symptoms, biomarkers, imaging, rapid diagnostic tests, and nucleic acid amplification technology (NAAT). Two comprehensive reviews and meta-analyses were published in 2021 and 2022 and laid the groundwork for creating an optimal diagnostic decision structure.

Methodology

The clinical algorithm was built as a binary decision tree, where each node represents a single POCT and edges the POCTs’ results. The diagnostic pathways consider different clinical guidelines and POCT performance to predict bacterial or viral causes of respiratory infections. The algorithm was rigorously tested using patient-level data to identify the best-performing algorithms, thus offering a scalable and flexible approach that can be applied across varying clinical settings.

Results

The clinical algorithms use as many as 20 signs and symptoms, two biomarkers, two imagining techniques, eight Rapid Antigen or Antibody detection techniques, and 19 Nucleic-Acid-Amplification-based tests. The heuristic algorithms run to find the best clinical algorithms differed with the selection of the available POCTs to simulate different settings. The best-resulting algorithms had 87% accuracy (AUC) for the detection of bacterial aetiology and 66% for viral aetiology.

Reviewing existing clinical algorithms

A systematic review of 33 studies (1986-2021) revealed that existing clinical algorithms often lack comprehensive validation and are typically focused on a single condition, e.g., pneumonia, or aetiology, e.g., influenza. There is no consensus on the optimal features for diagnosis, with some algorithms relying on symptoms such as fever, cough, and gastrointestinal issues, while others incorporate biomarkers like C-reactive protein (CRP) or white blood cell counts. They almost exclusively utilise logistic regression analysis on the given closed clinical observational dataset. In contrast, the new approach developed by VALUE-Dx separates the derivation of the clinical algorithm from the clinical data, allowing for flexibility in adjusting the clinical algorithms to the novel pathogens, specific POCTs costs, local prevalence, settings, and populations.

Simulations and cost profiles

To evaluate the clinical algorithms, several simulations were conducted, exploring different combinations of POCTs and their costs. For instance, in Spain, a typical diagnostic pathway might begin with assessing symptoms, followed by biomarkers, imaging, and finally advanced tests like NAATs. The simulations highlighted that while the cost of diagnostic pathways varies widely (ranging from €0 to €500), there is no clear link between higher cost and better diagnostic performance. A subset of algorithms demonstrated high performance at relatively low costs, emphasizing the importance of optimizing the cost-performance ratio.

Meta-analysis automation

One of the challenges in maintaining an up-to-date clinical algorithm is the time-consuming nature of meta-analyses. To address this, the VALUE-Dx team developed an automated pipeline using Natural Language Processing (NLP) and Large Language Models (LLMs) to streamline the inclusion and extraction processes from scientific publications. This automated system significantly reduced manual work and ensured the clinical algorithm will remain adaptable to evolving diagnostic technologies.

Conclusion

The VALUE-Dx project introduced a novel approach to developing clinical algorithms for diagnosing CA-ARTIs. By integrating diverse POCTs, leveraging patient data, and automating the meta-analysis process, the project created a dynamic, performance-driven algorithm adaptable to different clinical settings. As POCTs continue to evolve, this algorithm offers a flexible framework for improving diagnostic accuracy, reducing unnecessary tests, and optimizing healthcare costs. Discussion is ongoing with relevant stakeholders and scientific Societies to support the sustainability of the clinical algorithms.

For interactive visualization of the clinical algorithm and meta-analysis results, visit https://ca-valuedx.ddsp.univr.it.
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[av_heading heading=’VALUE-Dx Closing Conference: celebrating 5.5 years of collaborative research’ 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_dynamic=” link_target=” title_attr=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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On 4 and 5 September 2024, the VALUE-Dx consortium gathered at the NH Valencia Center Hotel in Valencia, Spain, for their highly anticipated Closing Conference. This event provided a unique opportunity to reflect on the project’s journey and to discuss the final results, recommendations, and outcomes. With 83 attendees, including consortium members and invited stakeholders, the conference was a vibrant forum for sharing knowledge and ideas.

Key presentations covered a range of topics, including the clinical algorithm for diagnosing community-acquired acute respiratory infections (CA-ARTI), interoperability networks for AMR clinical research, and the findings from the two clinical studies, ADEQUATE and PRUDENCE. The social sciences team presented their qualitative research, while the health-economics teams delivered an economic evaluation of diagnostic tools for CA-ARTI. Lively panel discussions delved into the user requirement specifications and technical roadmap, as well as into the role of rapid diagnostic tests for CA-LRTI.

The dynamic debates were further enriched by some of the intriguing results from the clinical trials. A key takeaway from the conference was indeed that evaluating a point-of-care test involves much more than assessing a biological test; it also requires examining the behavioural interventions that surround its use.

The Closing Conference marked the conclusion of a remarkable 5.5-year project. Consortium members celebrated the successful collaboration between academia and industry, bringing together experts from diverse fields such as microbiology, infectious diseases, and health economics. While it took time to bridge these different perspectives, the result has been a strong, cohesive partnership that laid the groundwork for ongoing impactful research. The consortium is optimistic about continuing this important work and is eager to pursue more complex interventional studies, potentially in collaboration with the European Respiratory Society.
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[av_heading heading=’PRUDENCE and ADEQUATE-paediatric studies: the final steps’ 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=” title_attr=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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Recruitment for the VALUE-Dx studies, ADEQUATE-paediatric and PRUDENCE, was successfully concluded in January 2024. This marks the beginning of a whole new phase in VALUE-Dx that involves data cleaning, statistical analysis, microbiological analysis of samples and health-economic modelling.

About the studies

ADEQUATE aims to assess the impact of rapid syndromic diagnostic testing, BioFire® Respiratory Panel 2.1 plus (bioMérieux), in patients with acute respiratory tract infections (ARTI) at the emergency departments of hospitals on admission rates, antimicrobial prescriptions and clinical outcome. ADEQUATE enrolled 522 participants. From a subset of these participants, oropharyngeal swabs were collected on the day of randomisation and on day 30 , as part of a microbiology sub-study.

PRUDENCE aims to determine if point-of-care Community Acquired-ARTI diagnostic (CA-ARTI-Dx) tests could lead to more appropriate prescribing decisions for both upper and lower RTI in community care setting. The selected tests are Abbott AfinionTM CRP (Abbott) and BD VeritorTM System for Influenza A+B (Flu) and for Group A Streptococcus (GAS). PRUDENCE enrolled 2649 participants, with 2240 in the primary care arm and 209 in the long term care facility arm. From 112 participants nasopharyngeal swabs, stool samples and blood samples were taken for the microbiology-biomarker sub-study.

Next steps

The PRUDENCE and ADEQUATE data collection using electronic Case Report Forms (eCRFs) concluded on March 17, with a meticulous data cleaning process revealing minimal unresolved queries. Once all necessary queries have been resolved and all updates are completed, variables for unblinding will be added to final datasets upon confirmation from the study teams, with unblinded datasets subsequently uploaded to the Data Repository Environment (DRE).

Samples from the local sites to the central laboratory, where they will be further processed at the University of Antwerp (UA). The oropharyngeal swabs from ADEQUATE will be analysed using metagenomic sequencing to characterise the influence of antibiotic treatment on the composition of upper respiratory tract microbiome and antimicrobial resistance patterns. The swabs and stool samples of PRUDENCE will be analysed to assess whether selection of resistant pathogens occurs under antibiotic pressure.

Upon release of the unblinded datasets, statisticians in Oxford (UK) and Basel (Switzerland) will rigorously implement their Statistical Analysis Plans while the health-economics teams at UMC Groningen in The Netherlands and La Rioja University in Spain will use their custom-made models to provide valuable insights into the effectiveness (including projected long-term impact on antimicrobial resistance) and cost-effectiveness of a broader point-of-care testing strategy in the context of respiratory infections.
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[av_heading heading=’VALUE-Dx’s Closing Conference’ 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=” title_attr=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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VALUE-Dx officially ends on 30 September 2024, but until that time, project partners will continue to go to all lengths to generate ground-breaking and much needed insights into the value of diagnostics to improve antimicrobial prescription. These findings will be presented in a two-day Closing Conference in Valencia on 4 and 5 September 2024.

The outcomes of VALUE-Dx will be of particular interest for a wide range of stakeholders, including policy makers, public health officials, regulators and patient organisations. VALUE-Dx partners are therefore developing a tailored conference programme to translate the major study results in recommendations, concrete conclusions and food for thought. To stimulate interaction and dialogue, the conference will offer a balanced mixture of lectures and panel discussions. The programme will be finalized in the weeks to come, but here are already some of the highlights:

1. Main findings and implications for practice, policy and research of the PRUDENCE and ADEQUATE studies
2. Health economics analysis and implications of the clinical trials
3. Policy recommendations related to funding, pricing, and procurement to enhance the use of Point-of-Care Tests for CA-LRTI
4. Reflections and insights into the possible exploitation of the study results
5. Recommendations of VALUE-Dx on the role of rapid diagnostic tests for CA-LRTI
6. Panel discussion on the User Requirement Specifications and the Technical Roadmap
7. Interoperability of AMR data using OMOP: a Proof-of-Concept
8. VALUE-Dx’s clinical algorithm for community-acquired LRTI and the way forward

The conference will end with an open panel discussion on the role of rapid diagnostics for CA-LRTI.

On-site participation in the meeting will be limited to invited delegates, but the good news is that all sessions will be livestreamed and videorecorded. A detailed programme and registration details for the livestream will be available soon. Send an email to VALUE-Dx’s project manager at david.depooter@uantwerpen.be if you wish to be kept in the loop.
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Antimicrobial resistance (AMR) poses a significant global health threat, exacerbated by the irrational use of antibiotics, particularly in the treatment of respiratory tract infections in community care. Rapid Point-of-Care Tests (POCTs) can help mitigate overuse, but their adoption remains limited in most European countries. This VALUE-Dx paper explores the barriers and facilitators within health technology assessment (HTA), pricing, and funding policies that impact the use of POCTs for acute respiratory tract infections in outpatient practices.

Results

Expert interviews were conducted with representatives from five European countries: Austria, Estonia, France, Poland, and Sweden. The interviews provided comprehensive insights into HTA, funding, and pricing policies in the peri-launch phase. Barriers identified included a lack of evidence for diagnostics, limited transferability methods from medicines to diagnostics, and the absence of price regulation for studied diagnostics. Weak purchasing power due to regional procurement processes was also noted as a pricing-related obstacle. On the funding front, the coverage (reimbursement) of diagnostic tests and optimized remuneration for physicians were recognized as facilitators.

Conclusion

Diverse barriers and facilitators in the peri-launch phase for POCT uptake were identified, largely influenced by the country context and healthcare system. While the complex HTA process posed challenges, it wasn’t a barrier to POCT use in most countries.Free pricing was prevalent in all investigated countries, with substantial differences in funding for POCT application. Optimizing funding emerged as a key factor in increasing POCT uptake. Policymakers need to recognize that the non-adoption of peri-launch policies can impose long-term costs on the healthcare system and leave untapped potentials in pricing and funding. Measures against AMR should be integrated, acknowledging the interaction and impact of different policies. The implementation of national action plans against AMR can indirectly influence POCT uptake by addressing barriers related to funding.

Read the paper here. 
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[av_heading heading=’Progress and insights from the PRUDENCE and ADEQUATE trials’ 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=” title_attr=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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Antibiotic resistance is a growing concern. The PRUDENCE and ADEQUATE trials therefore aim to assess the impact of reducing antibiotic prescriptions on the emergence of resistant antimicrobials.

The PRUDENCE trial focuses on a comprehensive point-of-care testing strategy for CRP, strep A, influenza A+B, and SARS-CoV-2, targeting patients with lower or upper respiratory symptoms. The trial spans primary and long-term care across multiple countries with varying diagnostic practices. Unlike past studies, PRUDENCE considers patient recovery alongside antibiotic prescribing. Through this, we aim to provide valuable insights into the effectiveness and cost-effectiveness of a broader point-of-care testing strategy in the context of respiratory infections, addressing the shortcomings of previous studies.

Patient Recruitment and Progress Update

Launched in December 2021 with a goal of enlisting 2500 participants, the trial has successfully recruited 2159 patients, achieving over 86% of its target, with primary care currently at 2006 patients and long-term care at 153 patients. The teams in Georgia, Greece, Ireland and the UK have reached their network recruitment target already. Recruitment progress typically exhibits a seasonal trend, with a drop-off during Summer months. The trial includes a sampling sub-study, currently underway in long-term care and soon to be rolled out in Primary Care in the UK and Georgia. Despite challenges, including the impact of COVID-19 regulations and varying symptom presentations, the long-term care facility network is evolving positively. Trial recruitment will end in January.

The ADEQUATE trial aims to assess antibiotic prescription practices and hospitalization outcomes in pediatric emergency departments across Europe. The trial employs randomization to standard care and intervention arms, with patients presenting with lower respiratory tract infections. In the intervention arm, the Biofire respiratory panel assay is utilized, offering rapid testing for 24 pathogens, aiding clinical decisions without prescribing specific guidelines. The primary endpoints include antibiotic prescription rates and hospitalization duration, with a focus on generating immediately applicable evidence for routine settings.

Patient Recruitment and Progress Update

Six out of seven sites have been activated and have recruited patients, with the site in Thessaloniki, Greece being the top recruiter and have already reached its recruitment target. Currently at 85% recruitment, the trial plans to reach its goal of 520 participants. Recruitment fluctuations, influenced by seasonal patterns and the impact of the COVID-19 pandemic, are taken into account. The trial anticipates a surge in enrollment during the upcoming winter season, with a projected closure of all sites by February to March 2024.

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