Better Safe Than Sorry. A Scoping Review of Monitoring for Negative Effects in Preregistrations of Psychological Interventions.

Although negative effects of psychological interventions are suspected to be common, they are rarely investigated. Experts and international guidelines agree that monitoring for negative effects in clinical studies is needed to make psychological interventions safer and to empower patients before they give their consent to participate. Therefore, monitoring should already be considered during planning and preregistration of a study. The aim of this scoping review was to find out how frequently studies on psychological interventions monitor their negative effects according to preregistrations and to investigate reasons why monitoring is not carried out. Preregistrations of psychological interventions on ClinicalTrials.gov were scrutinized for information on monitoring of negative effects and other study characteristics. In a survey, researchers of studies where no monitoring was reported were asked for reasons for not doing so. Overall, 2231 preregistrations of psychological interventions were found; of these, only 3.4% included explicit information on monitoring for negative effects. In the survey, more researchers reported having conducted monitoring, although the type of monitoring was often inadequate. The type of monitoring varied widely, and specific monitoring measurements were rarely used repeatedly. Monitoring for negative effects was more prevalent in studies investigating treatments versus low-threshold interventions, in studies conducted in Europe versus other continents and in more recent studies. Researchers reported lack of knowledge as the most frequent reason for not monitoring negative effects. Our results imply a lack of monitoring and inconsistent information on negative effects in preregistrations, with inconsistent use of the term monitoring and measurements, and a lack of knowledge among researchers. Improved knowledge and a standardized approach, starting with an adequate preregistration, would be helpful to routinely examine negative effects in psychological interventions to make them safer and better.

Increase transparency and reproducibility of real-world evidence in rare diseases through disease-specific Federated Data Networks.

PURPOSE: In rare diseases, real-world evidence (RWE) generation is often restricted due to small patient numbers and global geographic distribution. A federated data network (FDN) approach brings together multiple data sources harmonized for collaboration to increase the power of observational research. In this paper, we review how to increase reproducibility and transparency of RWE studies in rare diseases through disease-specific FDNs. METHOD: To be successful, a multiple stakeholder scientific FDN collaboration requires a strong governance model in place. In such a model, each database owner remains in full control regarding the use of and access to patient-level data and is responsible for data privacy, ethical, and legal compliance. Provided that all this is well documented and good database descriptions are in place, such a governance model results in increased transparency, while reproducibility is achieved through data curation and harmonization, and distributed analytical methods. RESULTS: Leveraging the OHDSI community set of methods and tools, two rare disease-specific FDNs are discussed in more detail. For multiple myeloma, HONEUR-the Haematology Outcomes Network in Europe-has built a strong community among the data partners dedicated to scientific exchange and research. To advance scientific knowledge in pulmonary hypertension (PH) an FDN, called PHederation, was established to form a partnership of research institutions with PH databases coming from diverse origins.

Risk Prediction for Sudden Cardiac Death in the General Population: A Systematic Review and Meta-Analysis.

Objective: Identification of SCD risk is important in the general population from a public health perspective. The objective is to summarize and appraise the available prediction models for the risk of SCD among the general population. Methods: Data were obtained searching six electronic databases and reporting prediction models of SCD risk in the general population. Studies with duplicate cohorts and missing information were excluded from the meta-analysis. Results: Out of 8,407 studies identified, fifteen studies were included in the systematic review, while five studies were included in the meta-analysis. The Cox proportional hazards model was used in thirteen studies (96.67%). Study locations were limited to Europe and the United States. Our pooled meta-analyses included four predictors: diabetes mellitus (ES = 2.69, 95%CI: 1.93, 3.76), QRS duration (ES = 1.16, 95%CI: 1.06, 1.26), spatial QRS-T angle (ES = 1.46, 95%CI: 1.27, 1.69) and factional shortening (ES = 1.37, 95%CI: 1.15, 1.64). Conclusion: Risk prediction model may be useful as an adjunct for risk stratification strategies for SCD in the general population. Further studies among people except for white participants and more accessible factors are necessary to explore.

Epidemic intelligence in Europe: a user needs perspective to foster innovation in digital health surveillance.

BACKGROUND: European epidemic intelligence (EI) systems receive vast amounts of information and data on disease outbreaks and potential health threats. The quantity and variety of available data sources for EI, as well as the available methods to manage and analyse these data sources, are constantly increasing. Our aim was to identify the difficulties encountered in this context and which innovations, according to EI practitioners, could improve the detection, monitoring and analysis of disease outbreaks and the emergence of new pathogens. METHODS: We conducted a qualitative study to identify the need for innovation expressed by 33 EI practitioners of national public health and animal health agencies in five European countries and at the European Centre for Disease Prevention and Control (ECDC). We adopted a stepwise approach to identify the EI stakeholders, to understand the problems they faced concerning their EI activities, and to validate and further define with practitioners the problems to address and the most adapted solutions to their work conditions. We characterized their EI activities, professional logics, and desired changes in their activities using NvivoⓇ software. RESULTS: Our analysis highlights that EI practitioners wished to collectively review their EI strategy to enhance their preparedness for emerging infectious diseases, adapt their routines to manage an increasing amount of data and have methodological support for cross-sectoral analysis. Practitioners were in demand of timely, validated and standardized data acquisition processes by text mining of various sources; better validated dataflows respecting the data protection rules; and more interoperable data with homogeneous quality levels and standardized covariate sets for epidemiological assessments of national EI. The set of solutions identified to facilitate risk detection and risk assessment included visualization, text mining, and predefined analytical tools combined with methodological guidance. Practitioners also highlighted their preference for partial rather than full automation of analyses to maintain control over the data and inputs and to adapt parameters to versatile objectives and characteristics. CONCLUSIONS: The study showed that the set of solutions needed by practitioners had to be based on holistic and integrated approaches for monitoring zoonosis and antimicrobial resistance and on harmonization between agencies and sectors while maintaining flexibility in the choice of tools and methods. The technical requirements should be defined in detail by iterative exchanges with EI practitioners and decision-makers.

Preact to lower the risk of falling by customized rehabilitation across Europe: the feasibility study protocol of the PRECISE project in Italy.

Introduction: Falls are a major worldwide health problem in older people. Several physical rehabilitation programs with home-based technologies, such as the online DigiRehab platform, have been successfully delivered. The PRECISE project combines personalized training delivered through the application with an artificial intelligence-based predictive model (AI-DSS platform) for fall risk assessment. This new system, called DigiRehab, will enable early identification of significant risk factors for falling and propose an individualized physical training plan to attend to these critical areas. Methods: The study will test the usability of the DigiRehab platform in generating personalized physical rehabilitation programs at home. Fifty older adults participants will be involved, 20 of them testing the beta version prototype, and 30 participants testing the updated version afterwards. The inclusion criteria will be age ≥65, independent ambulation, fall risk (Tinetti test), Mini Mental State Examination ≥24, home residents, familiarity with web applications, ability and willingness to sign informed consent. Exclusion criteria will be unstable clinical condition, severe visual and/or hearing impairment, severe impairment in Activities of Daily Living and absence of primary caregiver. Discussion: The first part of the screening consists in a structured questionnaire of 10 questions regarding the user's limitations, including the risk of falling, while the second consists in 10 physical tests to assess the functional status. Based on the results, the program will help define the user's individual profile upon which the DSS platform will rate the risk of falling and design the personalized exercise program to be carried out at home. All measures from the initial screening will be repeated and the results will be used to optimize the predictive algorithms in order to prepare the tool in its final version. For the usability assessment, the System Usability Scale will be administered. The follow-up will take place after the 12-week intervention at home. A semi-structured satisfaction questionnaire will also be administered to verify whether the project will meet the needs of older adults and their family caregiver. Conclusion: We expect that personalized training prescribed by DigiRehab platform could help to reduce the need for care in older adults subjects and the care burden.Clinical trial registration: [https://clinicaltrials.gov/], identifier [NCT05846776].

An assessment of the state of conservation planning in Europe.

Expanding and managing current habitat and species protection measures is at the heart of the European biodiversity strategy. A structured approach is needed to gain insights into such issues is systematic conservation planning, which uses techniques from decision theory to identify places and actions that contribute most effectively to policy objectives given a set of constraints. Yet culturally and historically determined European landscapes make the implementation of any conservation plans challenging, requiring an analysis of synergies and trade-offs before implementation. In this work, we review the scientific literature for evidence of previous conservation planning approaches, highlighting recent advances and success stories. We find that the conceptual characteristics of European conservation planning studies likely reduced their potential in contributing to better-informed decisions. We outline pathways towards improving the uptake of decision theory and multi-criteria conservation planning at various scales, particularly highlighting the need for (a) open data and intuitive tools, (b) the integration of biodiversity-focused conservation planning with multiple objectives, (c) accounting of dynamic ecological processes and functions, and (d) better facilitation of entry-points and co-design practices of conservation planning scenarios with stakeholders. By adopting and improving these practices, European conservation planning might become more actionable and adaptable towards implementable policy outcomes. This article is part of the theme issue 'Ecological novelty and planetary stewardship: biodiversity dynamics in a transforming biosphere'.

Predicting the responses of European grassland communities to climate and land cover change.

European grasslands are among the most species-rich ecosystems on small spatial scales. However, human-induced activities like land use and climate change pose significant threats to this diversity. To explore how climate and land cover change will affect biodiversity and community composition in grassland ecosystems, we conducted joint species distribution models (SDMs) on the extensive vegetation-plot database sPlotOpen to project distributions of 1178 grassland species across Europe under current conditions and three future scenarios. We further compared model accuracy and computational efficiency between joint SDMs (JSDMs) and stacked SDMs, especially for rare species. Our results show that: (i) grassland communities in the mountain ranges are expected to suffer high rates of species loss, while those in western, northern and eastern Europe will experience substantial turnover; (ii) scaling anomalies were observed in the predicted species richness, reflecting regional differences in the dominant drivers of assembly processes; (iii) JSDMs did not outperform stacked SDMs in predictive power but demonstrated superior efficiency in model fitting and predicting; and (iv) incorporating co-occurrence datasets improved the model performance in predicting the distribution of rare species. This article is part of the theme issue 'Ecological novelty and planetary stewardship: biodiversity dynamics in a transforming biosphere'.

UK dog fighting ring had cross-Channel reach.

Josh Loeb reports on the conviction of a criminal gang involved in dog fighting in the UK and Europe.

The global impact of SARS-CoV-2 variant BA.2.86: a comprehensive analysis with the latest developments and transmission trends - an epidemiological study.

OBJECTIVE: The variant BA.2.86 of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is causing concern globally. The virus contains a large number of mutations, and transmission trends are rapidly changing globally. This study investigates the global epidemiological and transmission trends of SARS-CoV-2 new variant BA.2.86 in various continents and countries. MATERIALS AND METHODS: The data were recorded using key terms, including SARS-CoV-2, Omicron, BA.2.86, epidemiology, occurrence, incidence, prevalence, and transmission trends. The data on SARS-CoV-2 variant BA.2.86 were searched by the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), the Global Initiative on Sharing All Influenza Data (GSIAD), PubMed, and Web of Science. Initially, 40 documents were identified, and finally, 8 documents were included for the data analysis and discussion. The analysis of findings on transmission trends was based on the data from August 14, 2023, to February 28, 2024. RESULTS: The SARS-CoV-2, novel variant BA.2.86, crossed the international borders of 6 continents and 89 countries and infected 19,532 people. In Europe, 32 countries are affected and involved 12,667 people (64.85%), North and South America 18 countries with 3,515 cases (17.99%), Asia 27 countries with 2,063 people (10.56%), Oceania 2 countries with 689 cases (3.52%), and Africa 10 countries with 598 (3.06%) cases. The BA.2.86 rapidly spread and mainly affected the people in the United Kingdom 3,228 (16.52%), Sweden 2,380 (12.18%), USA 1,929 (9.87%), Denmark 1,621 (8.29%), Canada 1,516 (7.67%), France 833 (4.26%), Japan 810 (4.14%), Netherlands 725 (3.71%), Germany 681 (3.48%), Spain 665 (3.40%), South Korea 556 (2.84%), and Australia 512 (2.62%). CONCLUSIONS: The SARS-CoV-2, novel variant BA.2.86, spread over six continents and 89 countries and affected 19,532 people worldwide. The disease is more prevalent in the United Kingdom, United States of America, and European countries. The detection of the disease in multiple continents and countries suggests some degree of transmissibility. Global health authorities need to rethink their policies and implement strict strategies to eradicate emerging variants and minimize the global disease burden.

Strategic choices of migrants and smugglers in the Central Mediterranean sea.

The sea crossing from Libya to Italy is one of the world's most dangerous and politically contentious migration routes, and yet over half a million people have attempted the crossing since 2014. Leveraging data on aggregate migration flows and individual migration incidents, we estimate how migrants and smugglers have reacted to changes in the border enforcement regime, namely the rise in interceptions by the Libyan Coast Guard starting in 2017 and the corresponding decrease in the probability of rescue to Europe. We find support for a deterrence effect in which attempted crossings along the Central Mediterranean route declined, and a diversion effect in which some migrants substituted to the Western Mediterranean route. At the same time, smugglers adapted their tactics. Using a strategic model of the smuggler's choice of boat size, we estimate how smugglers trade off between the short-run payoffs to launching overcrowded boats and the long-run costs of making less successful crossing attempts under different levels of enforcement. Taken together, these analyses shed light on how the integration of incident- and flow-level datasets can inform ongoing migration policy debates and identify potential consequences of changing enforcement regimes.

Sex differences in cognitive decline among middle-aged and older adults: a cohort study in Europe.

OBJECTIVES: Previous studies on sex differences in cognitive decline provide inconsistent findings, with many European countries being underrepresented. We determined the association between sex and cognitive decline in a sample of Europeans and explored differences across birth cohorts and regions. METHODS: Participants 50+ years old enrolled in the Survey of Health, Ageing and Retirement in Europe had their cognition measured by tests of immediate recall, delayed recall and verbal fluency biennially up to 17 years of follow-up (median 6, interquartile range 3-9 years). We used linear mixed-effects models to assess the relationship between sex and the rate of cognitive decline, adjusting for sociodemographic and health-related characteristics. RESULTS: Of 66,670 participants (mean baseline age 63.5 ± standard deviation 9.4), 55% were female. Males and females had similar rates of decline in the whole sample in immediate recall (beta for interaction sex × time B = 0.002, 95% CI -0.001 to 0.006), delayed recall (B = 0.000, 95% CI -0.004 to 0.004), and verbal fluency (B = 0.008, 95% CI -0.005 to 0.020). Females born before World War II had a faster rate of decline in immediate recall and delayed recall compared to males, while females born during or after World War II had a slower rate of decline in immediate recall. Females in Central and Eastern Europe had a slower rate of cognitive decline in delayed recall compared to males. DISCUSSION: Our study does not provide strong evidence of sex differences in cognitive decline among older Europeans. However, we identified heterogeneity across birth cohorts and regions.

[The review of the monograph "Ambroise Paré. The first surgeon of the Kingdom" by E. E. Berger].

The review considers the approach placing famous French surgeon A. Paré into more general European context of European Renaissance of XVI century and into local context of intellectual life of Paris of this period. The refutation of widespread in history of medicine opinion about strict separation of university medicine from artisan surgery in Medieval Europe is discussed.

Investigating the Cost-Effectiveness of Telemonitoring Patients With Cardiac Implantable Electronic Devices: Systematic Review.

BACKGROUND: Telemonitoring patients with cardiac implantable electronic devices (CIEDs) can improve their care management. However, the results of cost-effectiveness studies are heterogeneous. Therefore, it is still a matter of debate whether telemonitoring is worth the investment. OBJECTIVE: This systematic review aims to investigate the cost-effectiveness of telemonitoring patients with CIEDs, focusing on its key drivers, and the impact of the varying perspectives. METHODS: A systematic review was performed in PubMed, Web of Science, Embase, and EconLit. The search was completed on July 7, 2022. Studies were included if they fulfilled the following criteria: patients had a CIED, comparison with standard care, and inclusion of health economic evaluations (eg, cost-effectiveness analyses and cost-utility analyses). Only complete and peer-reviewed studies were included, and no year limits were applied. The exclusion criteria included studies with partial economic evaluations, systematic reviews or reports, and studies without standard care as a control group. Besides general study characteristics, the following outcome measures were extracted: impact on total cost or income, cost or income drivers, cost or income drivers per patient, cost or income drivers as a percentage of the total cost impact, incremental cost-effectiveness ratios, or cost-utility ratios. Quality was assessed using the Consensus Health Economic Criteria checklist. RESULTS: Overall, 15 cost-effectiveness analyses were included. All studies were performed in Western countries, mainly Europe, and had primarily a male participant population. Of the 15 studies, 3 (20%) calculated the incremental cost-effectiveness ratio, 1 (7%) the cost-utility ratio, and 11 (73%) the health and cost impact of telemonitoring. In total, 73% (11/15) of the studies indicated that telemonitoring of patients with implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy ICDs was cost-effective and cost-saving, both from a health care and patient perspective. Cost-effectiveness results for telemonitoring of patients with pacemakers were inconclusive. The key drivers for cost reduction from a health care perspective were hospitalizations and scheduled in-office visits. Hospitalization costs were reduced by up to US $912 per patient per year. Scheduled in-office visits included up to 61% of the total cost reduction. Key drivers for cost reduction from a patient perspective were loss of income, cost for scheduled in-office visits and transport. Finally, of the 15 studies, 8 (52%) reported improved quality of life, with statistically significance in only 1 (13%) study (P=.03). CONCLUSIONS: From a health care and patient perspective, telemonitoring of patients with an ICD or a cardiac resynchronization therapy ICD is a cost-effective and cost-saving alternative to standard care. Inconclusive results were found for patients with pacemakers. However, telemonitoring can lead to a decrease in providers' income, mainly due to a lack of reimbursement. Introducing appropriate reimbursement could make telemonitoring sustainable for providers while still being cost-effective from a health care payer perspective. TRIAL REGISTRATION: PROSPERO CRD42022322334; https://tinyurl.com/puunapdr.

Assessing watercourse quality using results-based indicators in an agri-environment scheme.

Small watercourses are essential contributors to catchment water quality, but they continue to suffer degradation across Europe. A results-based agri-environment scheme, aimed at improving watercourse quality in Ireland, developed a rapid drainage assessment to identify point source risks. The assessment uses a scoring system based on visual indicators of nutrient and sediment risk, linking the outcomes to farmer payments. To understand how this novel drainage risk assessment relates to instream watercourse quality, we used three macroinvertebrate-based biotic indices (Q-value, Small Stream Impact Score and Proportion of Sediment Sensitive Invertebrates). Macroinvertebrate kick-sampling and physiochemical analysis were completed in May and July 2021 for 12 'At Risk' and 12 'Not at Risk' small watercourses as identified by the results-based scheme. Results show that the scheme's drainage risk assessment can identify point source risks but we found it does not directly reflect local instream quality as assessed by the biotic indices. Unexpectedly, the biotic indices showed watercourse degradation in 58% of the upstream (control) sampling points, indicating impacts not captured by the drainage risk assessment. Small watercourses displayed high heterogeneity, with significant species turnover between the sampling months. The Small Stream Impact Score was less influenced by temporal change than the Q-value index. There was a significant relationship between instream watercourse quality and sedimentation, as quantified by the Proportion of Sediment Sensitive Invertebrates. Including a measurement of instream sedimentation in the drainage assessments would improve the identification of risks and management. These results show that by linking farmer payments to the drainage risk assessments results-based payment schemes could positively contribute to improving catchment scale watercourse quality, but further work is required to capture wider sources of freshwater impacts.

Multi-hazard assessment of climate-related hazards for European coastal cities.

The assessment of risk posed by climate change in coastal cities encompasses multiple climate-related hazards. Sea-level rise, coastal flooding and coastal erosion are important hazards, but they are not the only ones. The varying availability and quality of data across cities hinders the ability to conduct holistic and standardized multi-hazard assessments. Indeed, there are far fewer studies on multiple hazards than on single hazards. Also, the comparability of existing methodologies becomes challenging, making it difficult to establish a cohesive understanding of the overall vulnerability and resilience of coastal cities. The use of indicators allows for a standardized and systematic evaluation of baseline hazards across different cities. The methodology developed in this work establishes a framework to assess a wide variety of climate-related hazards across diverse coastal cities, including sea-level rise, coastal flooding, coastal erosion, heavy rainfall, land flooding, droughts, extreme temperatures, heatwaves, cold spells, strong winds and landslides. Indicators are produced and results are compared and mapped for ten European coastal cities. The indicators are meticulously designed to be applicable across different geographical contexts in Europe. In this manner, the proposed approach allows interventions to be prioritized based on the severity and urgency of the specific risks faced by each city.

PFAS Contamination in Europe: Generating Knowledge and Mapping Known and Likely Contamination with "Expert-Reviewed" Journalism.

While the extent of environmental contamination by per- and polyfluoroalkyl substances (PFAS) has mobilized considerable efforts around the globe in recent years, publicly available data on PFAS in Europe were very limited. In an unprecedented experiment of "expert-reviewed journalism" involving 29 journalists and seven scientific advisers, a cross-border collaborative project, the "Forever Pollution Project" (FPP), drew on both scientific methods and investigative journalism techniques such as open-source intelligence (OSINT) and freedom of information (FOI) requests to map contamination across Europe, making public data that previously had existed as "unseen science". The FPP identified 22,934 known contamination sites, including 20 PFAS manufacturing facilities, and 21,426 "presumptive contamination sites", including 13,745 sites presumably contaminated with fluorinated aqueous film-forming foam (AFFF) discharge, 2911 industrial facilities, and 4752 sites related to PFAS-containing waste. Additionally, the FPP identified 231 "known PFAS users", a new category for sites with an intermediate level of evidence of PFAS use and considered likely to be contamination sources. However, the true extent of contamination in Europe remains significantly underestimated due to a lack of comprehensive geolocation, sampling, and publicly available data. This model of knowledge production and dissemination offers lessons for researchers, policymakers, and journalists about cross-field collaborations and data transparency.

Effects of methane emissions on multiple myeloma-related mortality rates: A World Health Organization perspective.

In this research, it was aimed to evaluate effects of methane emissions on multiple myeloma related mortality rates. Two countries in Europe (Germany and Netherlands) and 1 country for each region (Turkey, USA, Brazil, Egypt, and Australia) were selected within The World Health Organization Database. Multiple myeloma mortality rates of countries between 2009 and 2019 were used as dependent variable of the research. Methane emission level and agriculture methane levels of countries were used as independent variables from The World Bank Database. Current health expenditure and healthy life expectancy were used as controlling variables. Multiple myeloma-related mortality rate was the highest in the USA, followed by Germany, Brazil, Turkey, Australia, Netherlands, and Egypt. Difference analysis results were significant (P < .05). Methane and agriculture methane emissions were the highest in the USA. Multiple myeloma mortality was positively correlated with methane emissions (R = 0.504; P < .01), agricultural methane emissions (R = 0.705; P < .01), and current health expenditure (R = 0.528; P < .01). According to year and country controlled correlation analysis results, multiple myeloma mortality (MMM) was positively correlated with methane emissions (R = 0.889; P < .01), agricultural methane emissions (R = 0.495; P < .01), and current health expenditure (R = 0.704; P < .01). Methane emission (B = 0.01; P < .05), Germany (B = 9010.81; P < .01), the USA (B = 26516.77; P < .01), and Brazil (B = 4886.14; P < .01) had significant effect on MMM. Nonagricultural methane production has an increasing effect on MMM. Therefore, by looking at the differences between agricultural methane emissions and general methane emissions, studies can be conducted that allow for more effective global comparisons.

Per- and polyfluoroalkyls used as cosmetic ingredients - Qualitative study of 765 cosmetic products.

Per- and polyfluoroalkyl substances (PFAS) form a vast family comprising more than 4700 synthetic compounds. Their molecules contain a terminal functional group and a hydrophobic carbon tail (alkyl group) at which the hydrogen atoms are totally (in the case of perfluorinated compounds) or partially (in the case of polyfluorinated compounds) replaced by fluorine atoms. Due to the very specific properties of their structure, they have been used in a vast range of applications over the last 70 years. These substances are considered to be of concern for the environment. Their effects on human health are still poorly understood because studies are still too rare, but the cutaneous route could be a significant pathway of penetration. In this context, we made a qualitative study to assess the presence of PFAS in various cosmetics such as hygiene products, skin care products, make-up and perfumes. Among the 765 products studied, we found 11 different PFAS. Polytetrafluoroethylene (PTFE) and perfluorodecalin, present in 25.9% and 22.2% of products containing it, respectively, were the most frequent. Although the presence of this type of ingredient seems to be limited in Europe, make-up appears to be the type of product most likely to contain PFAS.

Unlocking the genomic landscape: Results of the Beyond 1 Million Genomes (B1MG) pilot in Belgium towards Genomic Data Infrastructure (GDI).

Genomic medicine has great potential to offer insights into how humans' genetic variation can affect their health, prevention options and treatment responses. The Beyond 1 Million Genomes (B1MG) project was kicked off in 2020 with the aim of building a federated network of genomic data in Europe, in which Belgium took part as a piloting country. B1MG developed a framework to enable all interested countries to self-evaluate the level of maturity of national genomic medicine practices following a common matrix, called Maturity Level Model (MLM), that contained 49 indicators across eight domains: I. Governance and strategy; II. Investment and economic model; III. Ethics, legislation and policy; IV. Public awareness and acceptance; V. Workforce skills and organisation; VI. Clinical organisation, infrastructure and tools; VII. Clinical genomics guidelines and infrastructure; and VIII. Data management, standards and infrastructure. The ongoing Genomic Data Infrastructure (GDI) project aims to capitalise on the experience of B1MG piloting countries and their MLM results. In this paper, we present the qualitative and quantitative outcomes of B1MG MLM assessment in Belgium and discuss their relevance to GDI. The insights gained from this study can be helpful for steering future policy directions and interventions on genomics in Belgium and beyond.