A systematic literature review of real-world evidence (RWE) on post-market assessment of medical devices.

The increasing use of real-world evidence (RWE) and real-world data (RWD) to assess post-market medical devices (MDs) might satisfy the urgent need for data sharing and traceability. This study sought to (i) get an overview of current practice in post-market assessments of MDs reporting on RWE/RWD; (ii) draw policy recommendations for governments and health organisations and identify a research agenda for scholars.A systematic review was undertaken until February 2024 following the PRISMA guidelines.

Visualizing Cancer Heterogeneity at the Molecular and Cellular Levels: Lessons from Rosetta.

Understanding tumor heterogeneity is a major challenge that was recognized as one of the first Cancer Grand Challenges, with a call to provide solutions to visualize tumor heterogeneity. The Rosetta team took on this challenge, exploiting advances in spatial-omics approaches centered around mass spectrometry imaging to map tumor heterogeneity at the cellular and molecular scales with different levels of resolution. See related article by Bressan et al.

Overweight, obesity, and cardiovascular disease in heterozygous familial hypercholesterolaemia: the EAS FH Studies Collaboration registry.

Background And Aims: Overweight and obesity are modifiable risk factors for atherosclerotic cardiovascular disease (ASCVD) in the general population, but their prevalence in individuals with heterozygous familial hypercholesterolaemia (HeFH) and whether they confer additional risk of ASCVD independent of LDL cholesterol (LDL-C) remains unclear.

Methods: Cross-sectional analysis was conducted in 35 540 patients with HeFH across 50 countries, in the EAS FH Studies Collaboration registry. Prevalence of World Health Organization-defined body mass index categories was investigated in adults (n = 29 265) and children/adolescents (n = 6275); and their association with prevalent ASCVD.

Impact of age-related changes in buccal epithelial cells on pediatric epigenetic biomarker research.

Cheek swabs, heterogeneous samples consisting primarily of buccal epithelial cells, are widely used in pediatric DNA methylation studies and biomarker creation. However, the decrease in buccal proportion with age in adults remains unexamined in childhood. We analyzed cheek swabs from 4626 typically developing children 2-months to 20-years-old.

Ethnic and racial discrimination in maternal health care in Mexico: a neglected challenge in the search for universal health coverage.

Background: Ethnic and racial discrimination in maternal health care has been overlooked in academic literature and yet it is critical for achieving universal health coverage (UHC). There is a lack of empirical evidence on its impact on the effective coverage of maternal health interventions (ECMH) for Indigenous women in Mexico. Documenting progress in reducing maternal health inequities, particularly given the disproportionate impact of the Covid-19 pandemic on ethnic minorities, is essential to improving equity in health systems.

Point of view: Challenges in implementation of new immunotherapies for Alzheimer's disease.

The advancement of disease-modifying treatments (DMTs) for Alzheimer's disease (AD), along with the approval of three amyloid-targeting therapies in the US and several other countries, represents a significant development in the treatment landscape, offering new hope for addressing this once untreatable chronic progressive disease. However, significant challenges persist that could impede the successful integration of this class of drugs into clinical practice. These challenges include determining patient eligibility, appropriate use of diagnostic tools and genetic testing in patient care pathways, effective detection and monitoring of side effects, and improving the healthcare system's readiness by engaging both primary care and dementia specialists.

Maintaining level of modifiable dementia risk scores is associated with better cognitive outcomes than increasing risk scores: A population-based prospective cohort study.

Background: A brain healthy lifestyle, consisting of good cardiometabolic health and being cognitively and socially active in midlife, is associated with a lower risk of cognitive decline years later. However, it is unclear whether lifestyle changes over time also affect the risk for mild cognitive impairment (MCI)/dementia, and rate of cognitive decline.

Objectives: To investigate if lifestyle changes over time are associated with incident MCI/dementia risk and rate of cognitive decline.

Key considerations for combination therapy in Alzheimer's clinical trials: Perspectives from an expert advisory board convened by the Alzheimer's drug discovery foundation.

There is growing consensus in the Alzheimer's community that combination therapy will be needed to maximize therapeutic benefits through the course of the disease. However, combination therapy raises complex questions and decisions for study sponsors, from preclinical research through clinical trial design to regulatory, statistical, and operational considerations. In January 2024, the Alzheimer's Drug Discovery Foundation convened an expert advisory board to discuss the key considerations in each of these areas.

Blarcamesine for the treatment of Early Alzheimer's Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial.

Background: There are no approved oral disease-modifying treatments for Alzheimer's disease (AD).

Objectives: The objective of this study was to assess efficacy and safety of blarcamesine (ANAVEX®2-73), an orally available small-molecule activator of the sigma-1 receptor (SIGMAR1) in early AD through restoration of cellular homeostasis including autophagy enhancement.

Design: ANAVEX2-73-AD-004 was a randomized, double-blind, placebo-controlled, 48-week Phase IIb/III trial.

Whole body vibrations and lower back pain: a systematic review of the current literature.

Introduction: Whole body vibration (WBV) is thought to be associated with low back pain (LBP). To mitigate against this the International Organisation for Standardisation (ISO) have created the ISO 2631 standard, recommending safe dose limits. The aim of this research is to conduct a systematic review of available literature addressing the question, is WBV associated with LBP?

Methods: A literature search was performed from January 1970 until April 2022, including studies focusing on LBP and sciatica in association with WBV, looking specifically for ones reporting on military populations.

A qualitative exploration of the barriers and facilitators to early lower limb assessment and onward referral for specialist treatment for patients with venous ulceration.

Guidance for venous leg ulceration (VLU) recommends compression therapy and early referral for specialist vascular assessment within two weeks. Few patients receive timely assessment and referral. Reasons for this are unclear.

In-depth Computational Analysis Reveals The Significant Dysregulation of Key Gap Junction Proteins (GJPs) Driving Thoracic Aortic Aneurysm Development.

Objective: Thoracic Aortic Aneurysm (TAA) represents an aortic pathology that is caused by the deranged integrity of the three layers of the aortic wall, and is related to severe morbidity and mortality. Consequently, it is crucial to identify the biomarkers implicated in the pathogenesis and biology of TAA. The aim of the current computational study was to assess the differential gene expression profile of the gap junction proteins (GJPs) in patients with TAA in order to identify novel potential biomarkers for the diagnosis and treatment of this disease.

Relationships between Chronic Cough and Asthma Control and Quality-of-Life in Patients with Severe Asthma: A 6-Month Longitudinal Analysis.

Background: The prevalence and clinical implications of chronic cough (CC) in patients with severe asthma receiving asthma treatment remain relatively unknown.

Objective: This study aimed to evaluate the relationships between CC and asthma control and quality-of-life (QoL) in patients with severe asthma through longitudinal analysis.

Methods: Baseline and 6-month follow-up data from the Korean Severe Asthma Registry were analyzed.

Whole examination AI estimation of fetal biometrics from 20-week ultrasound scans.

The current approach to fetal anomaly screening is based on biometric measurements derived from individually selected ultrasound images. In this paper, we introduce a paradigm shift that attains human-level performance in biometric measurement by aggregating automatically extracted biometrics from every frame across an entire scan, with no need for operator intervention. We use a neural network to classify each frame of an ultrasound video recording.

Efgartigimod efficacy and safety in refractory myasthenia gravis: UK's first real-world experience.

Background: We report our experience of patients with generalised myasthenia gravis (gMG) treated with efgartigimod, an neonatal Fc receptor antagonist, under the Early Access to Medicine Scheme (EAMS) in the UK.

Methods: Data from all UK patients treated with efgartigimod under the EAMS July 2022 to July 2023 were collected retrospectively. Efgartigimod was administered as per the ADAPT protocol (consisting of a treatment cycle of four infusions at weekly intervals with further cycles given according to clinical need).

Pragmatic algorithm for visual assessment of 4-Repeat tauopathies in [F]PI-2620 PET Scans.

Aim: Standardized evaluation of [F]PI-2620 tau-PET scans in 4R-tauopathies represents an unmet need in clinical practice. This study aims to investigate the effectiveness of visual evaluation of [F]PI-2620 images for diagnosing 4R-tauopathies and to develop a straight-forward reading algorithm to improve objectivity and data reproducibility.

Methods: A total of 83 individuals with [F]PI-2620 PET scans were included.

Clinical Outcomes With Immune Checkpoint Inhibitors in Patients With FGFR2/3, MTAP or ERBB2 Genomic Alterations in Advanced Urothelial Carcinoma.

Background: FGFR2/3, MTAP and ERBB2 genomic alterations have treatment targets in advanced urothelial carcinoma (aUC). These alterations may affect tumor microenvironment and outcomes with immune checkpoint inhibitors (ICIs) in aUC.

Patients And Methods: We identified patients with available genomic data in our multi-institution cohort of patients with aUC treated with ICI.

Rising cardiovascular mortality among obstructive sleep apnea patients: United States epidemiological trends (1999-2019).

Background: Obstructive sleep apnea (OSA) prevalence has risen significantly, affecting millions globally and posing a major healthcare burden. OSA is strongly associated with cardiovascular diseases (CVD) such as heart failure, stroke, and ischemic heart disease. However, trends in CVD-related mortality among individuals with OSA remain underexplored.

Neural invasion severity is a strong predictor of local recurrence in pancreatic ductal adenocarcinoma.

Background: In pancreatic ductal adenocarcinoma, neural invasion is being increasingly recognized as an unfavorable predictor of patient outcomes. Neural invasion severity seems to have a stronger clinical impact on patient prognosis than neural invasion status alone. Therefore, this study aims to assess the impact of severity of neural invasion on overall survival and disease-free survival in pancreatic ductal adenocarcinoma.

Ovarian cancer staging and follow-up: updated guidelines from the European Society of Urogenital Radiology female pelvic imaging working group.

Objective: To provide up-to-date European Society of Urogenital Radiology (ESUR) guidelines for staging and follow-up of patients with ovarian cancer (OC).

Methods: Twenty-one experts, members of the female pelvis imaging ESUR subcommittee from 19 institutions, replied to 2 rounds of questionnaires regarding imaging techniques and structured reporting used for pre-treatment evaluation of OC patients. The results of the survey were presented to the other authors during the group's annual meeting.

Indications for the addition of a patellofemoral joint arthroplasty following a previous unicondylar knee arthroplasty- a literature review and Delphi consensus.

Introduction: The aim of this study was to establish an international consensus statement on the indications for the addition of a patellofemoral joint arthroplasty (PFJA) in patients with a unicondylar knee arthroplasty (UKA) and symptomatic progression of patellofemoral compartment osteoarthritis.

Materials And Methods: A systematic review of the literature was conducted, and the results used to inform the development of a statement by an expert working group. This was then evaluated and modified, using a Delphi process, by members of the European Knee Society (EKS).

EBSA at 40 - an updated history.

The European Biophysical Societies' Association (EBSA) is an association of 32 biophysical societies in Europe dedicated to the promotion of excellence in biophysics. Through cooperation and collaborative activities, EBSA makes a major and positive impact on the European and International biophysics community. Biennial congresses at various European locations, organized by host societies, are a major activity that engages biophysicists with the wider international scientific community.