In 2011 and 2012, the COPHES/DEMOCOPHES twin projects performed the first ever harmonized human biomonitoring survey in 17 European countries. In more than 1800 mother-child pairs, individual lifestyle data were collected and cadmium, cotinine and certain phthalate metabolites were measured in urine. Total mercury was determined in hair samples. While the main goal of the COPHES/DEMOCOPHES twin projects was to develop and test harmonized protocols and procedures, the goal of the current paper is to investigate whether the observed differences in biomarker values among the countries implementing DEMOCOPHES can be interpreted using information from external databases on environmental quality and lifestyle. In general, 13 countries having implemented DEMOCOPHES provided high-quality data from external sources that were relevant for interpretation purposes. However, some data were not available for reporting or were not in line with predefined specifications. Therefore, only part of the external information could be included in the statistical analyses. Nonetheless, there was a highly significant correlation between national levels of fish consumption and mercury in hair, the strength of antismoking legislation was significantly related to urinary cotinine levels, and we were able to show indications that also urinary cadmium levels were associated with environmental quality and food quality. These results again show the potential of biomonitoring data to provide added value for (the evaluation of) evidence-informed policy making.

• MeSH
• Biomarkers analysis   urine   MeSH
• Child MeSH
• Adult MeSH
• Data Interpretation, Statistical MeSH
• Cadmium analysis   urine   MeSH
• Cotinine urine   MeSH
• Smoking legislation & jurisprudence   urine   MeSH
• Environmental Pollutants analysis   urine   MeSH
• Humans MeSH
• Urban Population statistics & numerical data   MeSH
• Environmental Monitoring methods   statistics & numerical data   MeSH
• Seafood statistics & numerical data   MeSH
• Surveys and Questionnaires standards   MeSH
• Mercury analysis   urine   MeSH
• Rural Population statistics & numerical data   MeSH
• Government Regulation MeSH
• Hair chemistry   MeSH
• Environmental Exposure analysis   statistics & numerical data   MeSH
• Check Tag
• Child MeSH
• Adult MeSH
• Humans MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Geographicals
• Europe MeSH

BACKGROUND: By 2030, over 50% of individuals living with bipolar disorder (BD) are expected to be aged ≥50 years. However, older age bipolar disorder (OABD) remains understudied. There are limited large-scale prospectively collected data organized in key dimensions capable of addressing several fundamental questions about BD affecting this subgroup of patients. METHODS: We developed initial recommendations for the essential dimensions for OABD data collection, based on (1) a systematic review of measures used in OABD studies, (2) a Delphi consensus of international OABD experts, (3) experience with harmonizing OABD data in the Global Aging & Geriatric Experiments in Bipolar Disorder Database (GAGE-BD, n ≥ 4500 participants), and (4) critical feedback from 34 global experts in geriatric mental health. RESULTS: We identified 15 key dimensions and variables within each that are relevant for the investigation of OABD: (1) demographics, (2) core symptoms of depression and (3) mania, (4) cognition screening and subjective cognitive function, (5) elements for BD diagnosis, (6) descriptors of course of illness, (7) treatment, (8) suicidality, (9) current medication, (10) psychiatric comorbidity, (11) psychotic symptoms, (12) general medical comorbidities, (13) functioning, (14) family history, and (15) other. We also recommend particular instruments for capturing some of the dimensions and variables. CONCLUSION: The essential data dimensions we present should be of use to guide future international data collection in OABD and clinical practice. In the longer term, we aim to establish a prospective consortium using this core set of dimensions and associated variables to answer research questions relevant to OABD.

• MeSH
• Bipolar Disorder * diagnosis   epidemiology   therapy   MeSH
• Cognition MeSH
• Humans MeSH
• Prospective Studies MeSH
• Data Collection MeSH
• Aged MeSH
• Aging psychology   MeSH
• Check Tag
• Humans MeSH
• Aged MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Practice Guideline MeSH
• Systematic Review MeSH

Cílem sdílení genomických dat je umožnit bezpečný přístup k těmto údajům především za účelem výzkumu, personalizované zdravotní péče a tvorby zdravotních politik. Sdílení dat má potenciál urychlit výzkum a přinést významný pokrok v chápání zdraví a nemocí, avšak naráží na právní a etické problémy spojené s ochranou soukromí a důvěrnosti informací. Kromě mnohdy neintuitivní evropské legislativy vedoucí k různým právním interpretacím, existují v jednotlivých zemích Evropské unie další národní pravidla, která mohou nakládání s genomickými daty dále specifikovat. Tato různorodost komplikuje mezinárodní spolupráci a sdílení dat, a to nejenom v genetice, ale i v jiných oblastech biomedicínského výzkumu. Tato práce analyzuje základní právní rámec a jeho aplikaci umožňující sdílení genomických dat a objasňuje pojmy dalšího zpracování, sekundárního využití a účelu zpracování dat. Dále zdůrazňuje význam souhlasu subjektů údajů a specifických výjimek z obecného zákazu zpracování citlivých dat. Pro efektivní sdílení genomických dat je nezbytné dodržovat evropské a národní právní předpisy, včetně jasného stanovení účelu a právního základu zpracování. Mezinárodní spolupráce vyžaduje harmonizaci právních předpisů a důkladnou správu dat. Tento článek analyzuje základní dynamiku a zákonnost sdílení dat v oblasti genomického výzkumu.

The aim of genomic data sharing is to enable secure access to this data, primarily for research, personalized healthcare and health policy-making. Data sharing has the potential to accelerate research and bring about significant advances in the understanding of health and disease, but it faces legal and ethical issues related to the protection of privacy and confidentiality of information. In addition to the often counterintuitive European legislation leading to different legal interpretations, there are other national rules in individual European Union countries that can further specify the handling of genomic data. This diversity complicates international cooperation and data sharing, not only in genetics but also in other areas of biomedical research. This thesis analyzes the basic legal framework and its application enabling the sharing of genomic data and clarifies the concepts of further processing, secondary use and purpose of data processing. Furthermore, it stresses the importance of data subjects' consent and specific exceptions to the general ban on processing sensitive data. For effective sharing of genomic data, it is essential to comply with European and national legislation, including a clear definition of the purpose and legal basis of processing. International cooperation requires regulatory harmonization and robust data management. This paper analyzes the fundamental dynamics and legality of data sharing in the field of genomic research.

• MeSH
• Electronic Data Processing ethics   legislation & jurisprudence   MeSH
• Genomics * legislation & jurisprudence   MeSH
• Humans MeSH
• Liability, Legal MeSH
• Information Dissemination legislation & jurisprudence   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Research Support, Non-U.S. Gov't MeSH
• Review MeSH

BACKGROUND: Myasthenia gravis (MG) is a rare autoimmune disorder. Several new treatment concepts have emerged in recent years, but access to these treatments varies due to differing national reimbursement regulations, leading to disparities across Europe. This highlights the need for high-quality data collection by stakeholders to establish MG registries. A European MG registry could help bridge the treatment access gap across different countries, offering critical data to support regulatory decisions, foster international collaborations, and enhance clinical and epidemiological research. Several national MG registries already exist or are in development. To avoid duplication and ensure harmonization in data collection, a modified Delphi procedure was implemented to identify essential data elements for inclusion in national registries. RESULTS: Following a literature review, consultations with patient associations and pharmaceutical companies, and input from multiple European MG experts, 100 data elements were identified. Of these, 62 reached consensus for inclusion and classification, while only 1 item was agreed for exclusion. 30 items failed to reach the ≥ 80% agreement threshold and were excluded. Among the 62 accepted items, 21 were classified as mandatory data elements, 32 optional, and 9 items pertained to the informed consent form. CONCLUSIONS: Through a modified Delphi procedure, consensus was successfully achieved. This consensus-based approach represents a crucial step toward harmonizing MG registries across Europe. The resulting dataset will facilitate the sharing of knowledge and enhance European collaborations. Furthermore, the harmonized data may assist in regulatory or reimbursement decisions regarding novel therapies, as well as address treatment access disparities between European countries.

• MeSH
• Delphi Technique * MeSH
• Consensus MeSH
• Humans MeSH
• Myasthenia Gravis * therapy   diagnosis   MeSH
• Registries * MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Geographicals
• Europe MeSH

As one of the core elements of the European Human Biomonitoring Initiative (HBM4EU) a human biomonitoring (HBM) survey was conducted in 23 countries to generate EU-wide comparable HBM data. This survey has built on existing HBM capacity in Europe by aligning national or regional HBM studies, referred to as the HBM4EU Aligned Studies. The HBM4EU Aligned Studies included a total of 10,795 participants of three age groups: (i) 3,576 children aged 6-12 years, (ii) 3,117 teenagers aged 12-18 years and (iii) 4,102 young adults aged 20-39 years. The participants were recruited between 2014 and 2021 in 11-12 countries per age group, geographically distributed across Europe. Depending on the age group, internal exposure to phthalates and the substitute DINCH, halogenated and organophosphorus flame retardants, per- and polyfluoroalkyl substances (PFASs), cadmium, bisphenols, polycyclic aromatic hydrocarbons (PAHs), arsenic species, acrylamide, mycotoxins (deoxynivalenol (total DON)), benzophenones and selected pesticides was assessed by measuring substance specific biomarkers subjected to stringent quality control programs for chemical analysis. For substance groups analyzed in different age groups higher average exposure levels were observed in the youngest age group, i.e., phthalates/DINCH in children versus teenagers, acrylamide and pesticides in children versus adults, benzophenones in teenagers versus adults. Many biomarkers in teenagers and adults varied significantly according to educational attainment, with higher exposure levels of bisphenols, phthalates, benzophenones, PAHs and acrylamide in participants (from households) with lower educational attainment, while teenagers from households with higher educational attainment have higher exposure levels for PFASs and arsenic. In children, a social gradient was only observed for the non-specific pyrethroid metabolite 3-PBA and di-isodecyl phthalate (DiDP), with higher levels in children from households with higher educational attainment. Geographical variations were seen for all exposure biomarkers. For 15 biomarkers, the available health-based HBM guidance values were exceeded with highest exceedance rates for toxicologically relevant arsenic in teenagers (40%), 3-PBA in children (36%), and between 11 and 14% for total DON, Σ (PFOA + PFNA + PFHxS + PFOS), bisphenol S and cadmium. The infrastructure and harmonized approach succeeded in obtaining comparable European wide internal exposure data for a prioritized set of 11 chemical groups. These data serve as a reference for comparison at the global level, provide a baseline to compare the efficacy of the European Commission's chemical strategy for sustainability and will give leverage to national policy makers for the implementation of targeted measures.

• MeSH
• Acrylamides MeSH
• Arsenic * analysis   MeSH
• Biomarkers MeSH
• Biological Monitoring MeSH
• Child MeSH
• Fluorocarbons * analysis   MeSH
• Cadmium analysis   MeSH
• Environmental Pollutants * analysis   MeSH
• Humans MeSH
• Adolescent MeSH
• Young Adult MeSH
• Pesticides * analysis   MeSH
• Check Tag
• Child MeSH
• Humans MeSH
• Adolescent MeSH
• Young Adult MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Review MeSH

Despite the potential for patient-reported outcome measures (PROMs) and experience measures (PREMs) to enhance understanding of patient experiences and outcomes they have not, to date, been widely incorporated into renal registry datasets. This report summarizes the main points learned from an ERA-EDTA QUEST-funded consensus meeting on how to routinely collect PROMs and PREMs in renal registries in Europe. In preparation for the meeting, we surveyed all European renal registries to establish current or planned efforts to collect PROMs/PREMs. A systematic review of the literature was performed. Publications reporting barriers and/or facilitators to PROMs/PREMs collection by registries were identified and a narrative synthesis undertaken. A group of renal registry representatives, PROMs/PREMs experts and patient representatives then met to (i) share any experience renal registries in Europe have in this area; (ii) establish how patient-reported data might be collected by understanding how registries currently collect routine data and how patient-reported data is collected in other settings; (iii) harmonize the future collection of patient-reported data by renal registries in Europe by agreeing upon preferred instruments and (iv) to identify the barriers to routine collection of patient-reported data in renal registries in Europe. In total, 23 of the 45 European renal registries responded to the survey. Two reported experience in collecting PROMs and three stated that they were actively exploring ways to do so. The systematic review identified 157 potentially relevant articles of which 9 met the inclusion criteria and were analysed for barriers and facilitators to routine PROM/PREM collection. Thirteen themes were identified and mapped to a three-stage framework around establishing the need, setting up and maintaining the routine collection of PROMs/PREMs. At the consensus meeting some PROMs instruments were agreed for routine renal registry collection (the generic SF-12, the disease-specific KDQOL™-36 and EQ-5D-5L to be able to derive quality-adjusted life years), but further work was felt to be needed before recommending PREMs. Routinely collecting PROMs and PREMs in renal registries is important if we are to better understand what matters to patients but it is likely to be challenging; close international collaboration will be beneficial.

• MeSH
• Electronic Health Records MeSH
• Patient Outcome Assessment * MeSH
• Quality of Life MeSH
• Quality-Adjusted Life Years MeSH
• Humans MeSH
• Renal Replacement Therapy * MeSH
• Surveys and Questionnaires MeSH
• Registries * MeSH
• Renal Insufficiency therapy   MeSH
• Data Collection * MeSH
• Patient Satisfaction MeSH
• Quality Indicators, Health Care MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Consensus Development Conference MeSH
• Research Support, Non-U.S. Gov't MeSH
• Geographicals
• Europe MeSH

• MeSH
• Chemistry MeSH
• No-Observed-Adverse-Effect Level MeSH
• Pharmacokinetics MeSH
• Genetic Variation MeSH
• Risk Assessment standards   MeSH
• Specialty Uses of Chemicals MeSH
• Toxicity Tests MeSH
• Publication type
• Guideline MeSH

• Conspectus
• Chemie. Mineralogické vědy
• NML Fields
• chemie, klinická chemie
• NML Publication type
• publikace WHO

BACKGROUND: This study aims to evaluate the feasibility of generating pseudo-normal single photon emission computed tomography (SPECT) data from potentially abnormal images. These pseudo-normal images are primarily intended for use in an on-the-fly data harmonization technique. MATERIAL AND METHODS: The methodology was tested on brain SPECT with [123I]Ioflupane. The proposed model for generating a pseudo-normal image was based on a variational autoencoder (VAE) designed to process 2D sinograms of the brain [123I]-FP-CIT SPECT, potentially exhibiting abnormal uptake. The model aimed to predict SPECT sinograms with corresponding normal uptake. Training, validation, and testing datasets were created by SPECT simulator from 45 brain masks segmented from real patient's magnetic resonance (MR) scans, using various uptake levels. The training and validation datasets each comprised 612 and 360 samples, respectively, drawn from 36 brain masks. The testing dataset contained 153 samples based on 9 brain masks. VAE performance was evaluated through brain dimensions, Dice similarity coefficient (DSC) and specific binding ratio. RESULTS: Mean DSC was 80% for left basal ganglia and 84% for right basal ganglia. The proposed VAE demonstrated excellent consistency in predicting basal ganglia shape, with a coefficient of variation of DSC being less than 1.1%. CONCLUSIONS: The study demonstrates that VAE can effectively estimate an individualized pseudo-normal distribution of the radiotracer [123I]-FP-CIT SPECT from abnormal SPECT images. The main limitations of this preliminary research are the limited availability of real brain MR data, used as input for the SPECT data simulator, and the simplified simulation setup employed to create the synthetic dataset.

• MeSH
• Tomography, Emission-Computed, Single-Photon * MeSH
• Humans MeSH
• Brain * diagnostic imaging   MeSH
• Image Processing, Computer-Assisted * MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH

Background: Inter-organizational healthcare businesses are ruled by a huge set of policies: legal policies, organizational policies, medical policies, ethical policies, etc., which are quite static, patients policy and process, social and environmental conditions, which are highly dynamic. In the context of a business case, those diff erent policies must be harmonized to enable privilege management and access control decisions. Objectives: The authors off er a methodology to achieve interoperability through policies harmonization in a privilege management and access control solution for EHR systems, to be later on implemented in a cancer care network using HL7 specifications. Methods: To meet the objective, the authors make use of a system-theoretical, architecture-centric, ontology-based approach to formally representing the aforementioned polices for harmonization. Results: Because of its fl exibility and generality, a policydriven RBAC model is used to formally represent all the other access control models such as MAC, DAC, RBAC, ABAC, HL7 Data Segmentation and Labeling Services. All the policies deployed in the context of an inter-organizational collaboration for cancer care can be formalized and then harmonized. Conclusions: The authors provide an implementation independent methodology to enable policies harmonization in EHR systems. The methodology described in the paper is independent on the maturity of organizations’ privilege management and access control system. Furthermore, it does not hamper organizations progressing to more advanced solutions over the time. Even dynamic policies can be harmonized at run time, allowing advancement towards a patient-centered care.

• MeSH
• Electronic Health Records * standards   organization & administration   MeSH
• Health Level Seven MeSH
• Access to Information MeSH
• Computer Security MeSH

Deep learning (DL) methods have in recent years yielded impressive results in medical imaging, with the potential to function as clinical aid to radiologists. However, DL models in medical imaging are often trained on public research cohorts with images acquired with a single scanner or with strict protocol harmonization, which is not representative of a clinical setting. The aim of this study was to investigate how well a DL model performs in unseen clinical datasets-collected with different scanners, protocols and disease populations-and whether more heterogeneous training data improves generalization. In total, 3117 MRI scans of brains from multiple dementia research cohorts and memory clinics, that had been visually rated by a neuroradiologist according to Scheltens' scale of medial temporal atrophy (MTA), were included in this study. By training multiple versions of a convolutional neural network on different subsets of this data to predict MTA ratings, we assessed the impact of including images from a wider distribution during training had on performance in external memory clinic data. Our results showed that our model generalized well to datasets acquired with similar protocols as the training data, but substantially worse in clinical cohorts with visibly different tissue contrasts in the images. This implies that future DL studies investigating performance in out-of-distribution (OOD) MRI data need to assess multiple external cohorts for reliable results. Further, by including data from a wider range of scanners and protocols the performance improved in OOD data, which suggests that more heterogeneous training data makes the model generalize better. To conclude, this is the most comprehensive study to date investigating the domain shift in deep learning on MRI data, and we advocate rigorous evaluation of DL models on clinical data prior to being certified for deployment.

• MeSH
• Deep Learning * MeSH
• Humans MeSH
• Magnetic Resonance Imaging MeSH
• Brain diagnostic imaging   MeSH
• Neural Networks, Computer MeSH
• Reproducibility of Results MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Research Support, N.I.H., Extramural MeSH