Month: November 2021

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[av_heading heading=’IMI Mid-Term Review meeting ‘ 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-kwlx1b9j’ custom_class=” admin_preview_bg=”][/av_heading]

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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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[av_heading heading=’PRUDENCE and ADEQUATE-Paediatric officially kicked off’ 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-kvawz4i3′ custom_class=” admin_preview_bg=”][/av_heading]

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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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[av_heading heading=’Health Economic Analyses of Diagnostics: Guidance on Design and Reporting’ 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-kvl1lcgr’ custom_class=” admin_preview_bg=”][/av_heading]

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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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