Duration of Time Intervals for Risk Minimization Measure Effectiveness Studies.

Insights into the time needed for evaluation of risk minimization measures' (RMMs) effectiveness might identify areas for improvement. We assessed the duration of time intervals between regulatory milestones for RMM effectiveness studies assessed by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA). We included completed RMM effectiveness post-authorization safety studies (PASSs) assessed by PRAC between 2016 and 2022.

Participatory Action Research to Enhance Patient-Centred Goal Setting in Geriatric Rehabilitation: A Nursing Team's Quest.

Aim: The aim of this study was to provide insights into how, through exploring goal-setting interventions, a nursing team in geriatric rehabilitation might refine their patient-centred strategies.

Design: The study design was participatory action research (PAR).

Method: Team members and nursing students, under the guidance of a facilitator, performed two PAR cycles.

The fundamentals of eye tracking part 2: From research question to operationalization.

In this article, we discuss operationalizations and examples of experimental design in eye-tracking research. First, we distinguish direct operationalization for entities like saccades, which are closely aligned with their original concepts, and indirect operationalization for concepts not directly measurable, such as attention or mind-wandering. The latter relies on selecting a measurable proxy.

Postoperative accuracy quantification of corrective osteotomies: standardisation of Q3D-CT methodology.

Purpose: Currently, no gold standard exists for 3D analysis of virtually planned surgery accuracy postoperatively. The aim of this study was to present a new, validated and standardised methodology for 3D postoperative assessment of surgical accuracy in patients undergoing 3D virtually planned and guided corrective osteotomies.

Methods: All patients who underwent 3D planned corrective osteotomy in 2021-2022 at our center with a postoperative CT were included.

Implant irritation and removal rates in operatively treated multiple rib fractures: a 49-month follow-up study.

Purpose: Little is known about the prevalence, impact and change of the symptoms after implant removal due to irritation in multiple rib fractures. This study aims to explore these aspects to improve treatment decision-making.

Methods: Data was collected from two hospitals in the Netherlands and Switzerland.

Revealing catalyst restructuring and composition during nitrate electroreduction through correlated operando microscopy and spectroscopy.

Electrocatalysts alter their structure and composition during reaction, which can in turn create new active/selective phases. Identifying these changes is crucial for determining how morphology controls catalytic properties but the mechanisms by which operating conditions shape the catalyst's working state are not yet fully understood. In this study, we show using correlated operando microscopy and spectroscopy that as well-defined CuO cubes evolve under electrochemical nitrate reduction reaction conditions, distinct catalyst motifs are formed depending on the applied potential and the chemical environment.

Genome-wide association analysis of composite sleep health scores in 413,904 individuals.

Recent genome-wide association studies (GWASs) of several individual sleep traits have identified hundreds of genetic loci, suggesting diverse mechanisms. Moreover, sleep traits are moderately correlated, so together may provide a more complete picture of sleep health, while illuminating distinct domains. Here we construct novel sleep health scores (SHSs) incorporating five core self-report measures: sleep duration, insomnia symptoms, chronotype, snoring, and daytime sleepiness, using additive (SHS-ADD) and five principal components-based (SHS-PCs) approaches.

Defining Hyperphagia for Improved Diagnosis and Management of MC4R Pathway-Associated Disease: A Roundtable Summary.

Purpose Of Review: Hyperphagia is a condition associated with rare obesity-related diseases, presenting as a pathologic, insatiable hunger accompanied by abnormal food-seeking behaviors. In October 2023, a group of researchers and clinicians with expert knowledge on hyperphagia convened at the annual ObesityWeek meeting to discuss the need for a unified definition of hyperphagia and key items necessary to improve the identification, assessment, and treatment of hyperphagia in patients with melanocortin 4 receptor (MC4R) pathway-associated diseases.

Recent Findings: The definition of hyperphagia proposed by this group is a pathologic, insatiable hunger accompanied by abnormal food-seeking behaviors.

Mechanistic insights into Wnt-β-catenin pathway activation and signal transduction.

In multicellular organisms, Wnt proteins govern stem and progenitor cell renewal and differentiation to regulate embryonic development, adult tissue homeostasis and tissue regeneration. Defects in canonical Wnt signalling, which is transduced intracellularly by β-catenin, have been associated with developmental disorders, degenerative diseases and cancers. Although a simple model describing Wnt-β-catenin signalling is widely used to introduce this pathway and has largely remained unchanged over the past 30 years, in this Review we discuss recent studies that have provided important new insights into the mechanisms of Wnt production, receptor activation and intracellular signalling that advance our understanding of the molecular mechanisms that underlie this important cell-cell communication system.

Patient-specific implants combined with 3D-printed drilling guides for corrective osteotomies of multiplanar tibial and femoral shaft malunions leads to more accurate corrections.

Purpose: The aim of this study was to evaluate the feasibility of using patient-specific implants (PSI) for complex shaft corrective osteotomies in multiplanar deformities of long bones in the lower extremities. Additionally, it aimed to investigate the added value of these implants by quantifying surgical accuracy on postoperative CT, comparing their outcomes to two commonly used techniques: 3D virtual visualizations and 3D-printed surgical guides.

Methods: Six tibial and femoral shaft corrective osteotomies were planned and performed on three Thiel embalmed human specimen.

A network of interacting ciliary tip proteins with opposing activities imparts slow and processive microtubule growth.

Cilia are motile or sensory organelles present on many eukaryotic cells. Their formation and function rely on axonemal microtubules, which exhibit very slow dynamics, but the underlying mechanisms are largely unexplored. Here we reconstituted in vitro the individual and collective activities of the ciliary tip module proteins CEP104, CSPP1, TOGARAM1, ARMC9 and CCDC66, which interact with each other and with microtubules and, when mutated in humans, cause ciliopathies such as Joubert syndrome.

Patient flow problems affecting in-patient spinal cord injury rehabilitation in the Netherlands.

Study Design: Prospective cohort study.

Objectives: To describe barriers to admission to and discharge from an inpatient rehabilitation unit for patients with newly acquired spinal cord injury or disease (SCI/D) and to identify modifiable factors whereby patient flow can be optimized.

Setting: Netherlands.

Type B ankle fractures with additional medium-sized posterior fragment: mid-term functional and radiological outcome after fixation versus no fixation of the posterior fragment.

Purpose: Guidelines for treatment of medium-sized posterior fragments in trimalleolar fractures are scarce and show varying advice. Recent trials comparing fixation and no fixation of posterior fragments, show no difference in outcomes one year postoperatively. This study compares functional outcome and development of osteoarthritis in patients with fixation of a posterior malleolar fracture to patients without fixation of the posterior malleolus fracture.

Prevalence, incidence, and complications of malnutrition in severely injured patients.

Background: Severely injured patients may suffer from acute disease-related or injury-related malnutrition involving a marked inflammatory response. This study investigated the prevalence and incidence of malnutrition and its relation with complications in severely injured patients admitted to the intensive care unit (ICU).

Methods: This observational prospective cohort study included severely injured patients (Injury Severity Score ≥ 16), admitted to the ICU of five level-1 trauma centers in the Netherlands and United States.

The severely injured older patient: identifying patients at high risk for mortality using the Dutch National Trauma Registry.

Purpose: The incidence of severely injured older trauma patients is increasing globally, portraying high mortality rates. Exploring the demographics and clinical outcomes of this subgroup is essential to further improve specialised care at the right place. This study was performed to identify severely injured older patients at high risk for mortality by examining their characteristics and identifying prognostic factors contributing to mortality.

V3+ extends the V3 framework to ensure user-centricity and scalability of sensor-based digital health technologies.

We propose the addition of usability validation to the extended V3 framework, now "V3+", and describe a pragmatic approach to ensuring that sensor-based digital health technologies can be used optimally at scale by diverse users. Alongside the original V3 components (verification; analytical validation; clinical validation), usability validation will ensure user-centricity of digital measurement tools, paving the way for more inclusive, reliable, and trustworthy digital measures within clinical research and clinical care.

The interface of depression and diabetes: treatment considerations.

This state-of-the-art review explores the relationship between depression and diabetes, highlighting the two-way influences that make treatment challenging and worsen the outcomes of both conditions. Depression and diabetes often co-occur and share genetic, lifestyle, and psychosocial risk factors. Lifestyle elements such as diet, physical activity, and sleep patterns play a role on the development and management of both conditions, highlighting the need for integrated treatment strategies.

Zinc absorption from maize-based meals enriched with edible house crickets: a randomized crossover stable-isotope study in Kenyan pre-school children.

Edible insects have been proposed as a novel and sustainable source of protein and other essential nutrients for human consumption but nutrient absorption efficiency is still uncertain. We investigated zinc absorption from house crickets (Acheta domesticus) in a single-center and single-blinded cross-over study with children aged 24-36 months old in Kenya from September-November 2021. For this, children were randomized to consume two different experimental meals labeled with stable isotopes of zinc (Zn) at two different days, separated by a wash-out period of one month.

Palbociclib Is Safe for Breast Cancer Patients With Mild Hepatic Impairment: A Multicenter Retrospective Study Using Real-World Data.

The liver is crucial for metabolizing the anticancer drug palbociclib, but limited information is available on the impact of hepatic impairment on its toxicity and efficacy, with no real-world data available. This study aims to evaluate how hepatic impairment affects hematological toxicity and progression-free survival (PFS) of palbociclib in advanced hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer, using the National Cancer Institute scoring system, in a large real-world dataset. This multicenter retrospective observational study included female patients treated with palbociclib between August 2017 and February 2024.

Advances in digital camera-based phenotyping of Botrytis disease development.

Botrytis cinerea is an important generalist fungal plant pathogen that causes great economic losses. Conventional detection methods to identify B. cinerea infections rely on visual assessments, which are error prone, subjective, labor intensive, hard to quantify, and unsuitable for artificial intelligence (AI) and machine learning (ML) applications.

Distillation for in situ recovery of volatile fermentation products.

Many fermentation products inhibit their own microbial production, which complicates industrial-scale fermentation development for these products. When a product is volatile, this inhibition can be circumvented by removing product during fermentation through evaporation in a loop around the bioreactor. Microbes can survive this loop if its temperature is reduced using vacuum.

Effect of Cariprazine on Outcomes in Older-aged and Younger-aged Patients with Bipolar I Disorder: A Post-hoc Analysis.

Objectives: To evaluate cariprazine in adults with older- and younger-age bipolar I disorder (OABD-I and YABD-I) and compare treatment effects between them.

Design And Setting: Pooled post-hoc analysis of studies in depressive or acute manic/mixed episodes associated with bipolar I disorder.

Participants: 475/1383 patients (34.

A Call for a Neoadjuvant Kidney Cancer Consortium: Lessons Learned from Other Cancer Types.

Neoadjuvant systemic treatment strategies have improved outcomes in several solid tumour types. This success has not yet been replicated in renal cell carcinoma (RCC). A consensus and international collaboration are urgently needed for the development of adaptive perioperative immunotherapy strategies for patients with RCC at high risk of recurrence.

Cracking the Code of Calcification: How Presence and Burden among Intracranial Arteries Influence Stroke Incidence and Recurrence.

Background: Intracranial atherosclerosis accounts for about 8% of all strokes in Western societies but the influence of arterial calcification on plaque instability is a topic on ongoing debate.

Purpose: Explore the association between the presence and burden of calcium in atherosclerotic plaques among intracranial arteries with the risk of clinical or silent stroke events through a systematic review and meta-analysis.

Data Sources: Adhering to PRISMA guidelines, studies from PubMed and Embase were analyzed up to May 2024.