Development of a P magnetic resonance spectroscopy technique to quantify NADH and NAD at 3 T.

NADH and NAD act as electron donors and acceptors and NAD was shown to stimulate mitochondrial biogenesis and metabolic health. We here develop a non-invasive Phosphorous Magnetic Resonance Spectroscopy (P-MRS) method to quantify these metabolites in human skeletal muscle on a clinical 3 T MRI scanner. This new MR-sequence enables NADH and NAD+ quantification by suppressing α-ATP signal, normally overlapping with NADH and NAD.

Can hemophilia be cured? It depends on the definition.

Over the years, the palette of treatment options for hemophilia has grown extensively, leading to an increased life expectancy and quality of life for people living with hemophilia. Nonetheless, it is frequently emphasized that none of the current treatment modalities provides a "cure." It is therefore hoped that innovative treatments such as gene therapy may bridge this void.

A Flow-based Truncated Denoising Diffusion Model for super-resolution Magnetic Resonance Spectroscopic Imaging.

Magnetic Resonance Spectroscopic Imaging (MRSI) is a non-invasive imaging technique for studying metabolism and has become a crucial tool for understanding neurological diseases, cancers and diabetes. High spatial resolution MRSI is needed to characterize lesions, but in practice MRSI is acquired at low resolution due to time and sensitivity restrictions caused by the low metabolite concentrations. Therefore, there is an imperative need for a post-processing approach to generate high-resolution MRSI from low-resolution data that can be acquired fast and with high sensitivity.

Inferior and Superior Vena Cava Reconstruction.

Obstructions of the superior and inferior vena cava are prevalent etiologies of deep venous obstruction, presenting a spectrum of clinical manifestations ranging from life-threatening conditions to asymptomatic states. The etiological diversity inherent to these central venous obstructions necessitates a subtle approach to their diagnosis and management. This discrepancy in clinical presentations emphasizes the importance of a differentiated diagnostic and therapeutic strategy, tailored to the specific form of vena cava obstruction encountered.

Systematic scoping review of cluster randomised trials conducted exclusively in low-income and middle-income countries between 2017 and 2022.

Objective: Cluster randomised trials (CRTs) are used for evaluating health-related interventions in low-income and middle-income countries (LMICs) but raise complex ethical issues. To inform the development of future ethics guidance, we aim to characterise CRTs conducted exclusively in LMICs by examining the types of clusters, settings, author affiliations and primary clinical focus and to evaluate adherence to trial registration and ethics reporting requirements over time.

Design: A systematic scoping review using the Preferred Reporting Items for Systematic Review and Meta-Analyses Extension for Scoping Reviews.

High-quality lipid suppression and B0 shimming for human brain H MRSI.

Magnetic Resonance Spectroscopic Imaging (MRSI) is a powerful technique that can map the metabolic profile in the brain non-invasively. Extracranial lipid contamination and insufficient B homogeneity however hampers robustness, and as a result has hindered widespread use of MRSI in clinical and research settings. Over the last six years we have developed highly effective extracranial lipid suppression methods with a second order gradient insert (ECLIPSE) utilizing inner volume selection (IVS) and outer volume suppression (OVS) methods.

An ethics framework for the transition to an operational learning healthcare system.

Introduction: While Learning Healthcare Systems (LHSs) have received increasing attention in health care and research, the amount of operational LHSs remains limited. Given the investment of resources in these projects, a moral responsibility to pursue the transition toward an LHS falls on projects and their participating stakeholders. This paper provides an ethics framework for projects that have taken steps toward building an LHS and are in the position to transition to an operational LHS.

Comparison of the Response to an Electronic Versus a Traditional Informed Consent Procedure in Terms of Clinical Patient Characteristics: Observational Study.

Background: Electronic informed consent (eIC) is increasingly used in clinical research due to several benefits including increased enrollment and improved efficiency. Within a learning health care system, a pilot was conducted with an eIC for linking data from electronic health records with national registries, general practitioners, and other hospitals.

Objective: We evaluated the eIC pilot by comparing the response to the eIC with the former traditional paper-based informed consent (IC).

Indirect H-[C] MRS of the human brain at 7 T using a C-birdcage coil and eight transmit-receive H-dipole antennas with a 32-channel H-receive array.

The neuronal tricarboxylic acid and glutamate/glutamine (Glu/Gln) cycles play important roles in brain function. These processes can be measured in vivo using dynamic H-[C] MRS during administration of C-labeled glucose. Proton-observed carbon-edited (POCE) MRS enhances the signal-to-noise ratio (SNR) compared with direct C-MRS.

Cardiac organoids do not warrant additional moral scrutiny.

Certain organoid subtypes are particularly sensitive. We explore whether moral intuitions about the heartbeat warrant unique moral consideration for newly advanced contracting cardiac organoids. Despite the heartbeat's moral significance in organ procurement and abortion discussions, we argue that this significance should not translate into moral implications for cardiac organoids.

Unfair knowledge practices in global health: a realist synthesis.

Unfair knowledge practices easily beset our efforts to achieve health equity within and between countries. Enacted by people from a distance and from a position of power ('the centre') on behalf of and alongside people with less power ('the periphery'), these unfair practices have generated a complex literature of complaints across various axes of inequity. We identified a sample of this literature from 12 journals and systematized it using the realist approach to explanation.

The TOPOS study.

: We aimed to study the long-term safety and efficacy of oblique venous stents for post-thrombotic syndrome (PTS) with iliac vein compression. : In the multinational, prospective, single-arm TOPOS study, PTS patients scheduled for endovascular therapy with the sinus-Obliquus stent and optional distal extension with the sinus-Venous or sinus-XL Flex stent were enrolled at eight European vascular centres between October 2016 and December 2020. The primary outcome was primary stent patency at 24 months, and secondary outcomes included the clinical course of PTS (Villalta score, revised Venous Clinical Severity Score [rVCSS], Visual Analog Scale [VAS] of pain), quality of life changes (Chronic Venous Insufficiency Quality of Life Questionnaire, CIVIQ-20), and device-related complications.

Overcoming ethical and legal obstacles to data linkage in health research: stakeholder perspectives.

Introduction: Data linkage for health research purposes enables the answering of countless new research questions, is said to be cost effective and less intrusive than other means of data collection. Nevertheless, health researchers are currently dealing with a complicated, fragmented, and inconsistent regulatory landscape with regard to the processing of data, and progress in health research is hindered.

Aim: We designed a qualitative study to assess what different stakeholders perceive as ethical and legal obstacles to data linkage for health research purposes, and how these obstacles could be overcome.

Building a Sustainable Learning Health Care System for Pregnant and Lactating People: Interview Study Among Data Access Providers.

Background: In many areas of health care, learning health care systems (LHSs) are seen as promising ways to accelerate research and outcomes for patients by reusing health and research data. For example, considering pregnant and lactating people, for whom there is still a poor evidence base for medication safety and efficacy, an LHS presents an interesting way forward. Combining unique data sources across Europe in an LHS could help clarify how medications affect pregnancy outcomes and lactation exposures.

The toolbox of acute DVT intervention.

Although the thrombectomy system is very important, there are many other devices and supportive tools that build the foundation for a successful interventional procedure. We suggest a toolbox of acute DVT intervention to aid in all likely strategies to effectively remove thrombus from the deep venous vasculature.

Learning healthcare systems in cardiology: A qualitative interview study on ethical dilemmas of a learning healthcare system.

Background: Implementation of an LHS in cardiology departments presents itself with ethical challenges, including ethical review and informed consent. In this qualitative study, we investigated stakeholders' attitudes toward ethical issues regarding the implementation of an LHS in the cardiology department.

Methods: We conducted a qualitative study using 35 semi-structured interviews and 5 focus group interviews with 34 individuals.

Ethical aspects of hemophilia gene therapy: a qualitative interview study with stakeholders.

Background: There are great expectations for the potential role of gene therapy in the treatment of hemophilia. At the same time, developments in the field of hemophilia gene therapy have always raised ethical issues. It remains unknown how these ethical issues are perceived by stakeholders, particularly regarding the most recent developments in the field.

Risk factors of chronic course of anxiety and depressive disorders: a 3-year longitudinal study in the general population.

Background: Risk factors of a chronic course of anxiety and depressive disorders were previously studied using a limited definition of recovery, i.e. remission of the index disorder.

Parallel detection of multi-contrast MRI and Deuterium Metabolic Imaging (DMI) for time-efficient characterization of neurological diseases.

Deuterium Metabolic Imaging (DMI) is a novel method that can complement traditional anatomical magnetic resonance imaging (MRI) of the brain. DMI relies on the MR detection of metabolites that become labeled with deuterium (H) after administration of a deuterated substrate and can provide images with highly specific metabolic information. However, clinical adoption of DMI is complicated by its relatively long scan time.

The economic burden of mental disorders: results from the Netherlands mental health survey and incidence study-2.

Objective: Currently, there is a paucity of up-to-date estimates of the economic burden caused by mental disorders. Such information could provide vital insight into one of the most serious and costly-yet to some extent preventable-health challenges facing the world today.

Method: Data from a national psychiatric-epidemiological cohort study (NEMESIS-2, N = 6506) were used to provide reliable, relevant, and up-to-date cost estimates (in 2019 Euro) regarding healthcare costs, productivity losses, and patient and family costs associated with DSM-IV mental disorders both at individual level, but also in the general population and in the workforce of the Netherlands (per 1 million population).

Specific measures for data-intensive health research without consent: a systematic review of soft law instruments and academic literature.

It is a common misunderstanding of current European data protection law that when consent is not being used as lawful basis, the processing of personal data is prohibited. Article 9(2)(j) of the European General Data Protection Regulation (GDPR) permits Member States to establish a legal basis in national law that allows for the processing of personal data for scientific research purposes without consent. However, the European legislator has formulated this "research exemption" as an opening clause, rendering the GDPR not specific as to what measures exactly are required to comply with the research exemption.

Residential Treatment Exclusively for Tobacco Use Disorder: A Narrative Review.

Introduction: Tobacco use disorder is a major public health issue, and novel smoking cessation approaches are urgently needed. Residential treatment programs have been suggested as a potentially effective treatment for tobacco use disorder. However, there is limited literature on residential treatment programs for patients who are exclusively dependent on nicotine.