Multicentre study conducted across centres in the USA, Europe and Australia to assess the safety and effectiveness of a bilateral hypoglossal nerve stimulation system for the treatment of obstructive sleep apnoea in adults: a protocol for a pivotal, multicentre, open-label, single-arm study.

Introduction: Obstructive sleep apnoea (OSA) is characterised by blood oxygen desaturations and sleep disruptions manifesting undesirable consequences. Existing treatments including oral appliances, positive airway pressure (PAP) therapy and surgically altering the anatomy of the pharynx have drawbacks including poor long-term adherence or often involving irreversible, invasive procedures. Bilateral hypoglossal nerve stimulation (HNS) is a new treatment for managing OSA, and this study is intended to determine whether an HNS system is a safe and effective treatment option for adults with OSA.

CANBERRA: A Phase II Randomized Clinical Trial to Test the Therapeutic Potential of Oral Vicasinabin in Diabetic Retinopathy.

Objective: Nonproliferative diabetic retinopathy (NPDR) is a progressive disease that can lead to blindness. Current therapies for NPDR are invasive and not extensively used or accessible until the disease progresses, pointing to the need for an early noninvasive treatment. The objective of CANBERRA was to assess the safety, tolerability, and efficacy of oral administration of vicasinabin (RG7774) on the severity of diabetic retinopathy (DR) in participants with moderately severe to severe NPDR and good vision.

Quantifying absolute treatment effect heterogeneity for time-to-event outcomes across different risk strata: divergence of conclusions with risk difference and restricted mean survival difference.

Background: Risk-based analyses are increasingly popular for understanding heterogeneous treatment effects (HTE) in clinical trials. For time-to-event analyses, the assumption that high-risk patients benefit most on the clinically important absolute scale when hazard ratios (HRs) are constant across risk strata might not hold. Absolute treatment effects can be measured as either the risk difference (RD) at a given time point or the difference in restricted mean survival time (ΔRMST) which aligns more closely with utilitarian medical decision-making frameworks.

Use of Intraoperative Hemostatic Checklists for Blood Management in Patients Undergoing Cardiac Surgery: A Scoping Review.

Background: Using intraoperative hemostatic checklists may improve rates of surgical re-exploration and utilization of allogenic blood products in patients undergoing cardiac surgery. In this review, the authors explore the current evidence describing the impact of using intraoperative hemostatic checklists on reducing rates of surgical bleeding and perioperative blood product transfusion in this group of patients.

Methods: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, electronic information was obtained via sources that included Scopus, MEDLINE, EMBASE, and the Cochrane Library.

Prioritizing US Geological Survey science on salinization and salinity in candidate and selected priority river basins.

The US Geological Survey (USGS) is selecting and prioritizing basins, known as Integrated Water Science basins, for monitoring and intensive study. Previous efforts to aid in this selection process include a scientifically defensible and quantitative assessment of basins facing human-caused water resource challenges (Van Metre et al. in Environmental Monitoring and Assessment, 192(7), 458 2020).

A Framework for Considering the Value of Race and Ethnicity in Estimating Disease Risk.

Background: Accounting for race and ethnicity in estimating disease risk may improve the accuracy of predictions but may also encourage a racialized view of medicine.

Objective: To present a decision analytic framework for considering the potential benefits of race-aware over race-unaware risk predictions, using cardiovascular disease, breast cancer, and lung cancer as case studies.

Design: Cross-sectional study.

A Programming Algorithm for Optimizing Hypoglossal Nerve Stimulator Respiratory Entrainment.

Hypoglossal nerve stimulation (HNS) is a surgical treatment for obstructive sleep apnea that activates in a phasic manner. The most widely available HNS device has respiratory entrainment programming settings that are not widely utilized. We present an algorithm for office-based respiratory sensing adjustments to optimize HNS respiratory entrainment.

Correlation of sub-centennial-scale pulses of initial Central Atlantic Magmatic Province lavas and the end-Triassic extinctions.

The end-Triassic extinction (ETE) on land was synchronous with the initial lavas of the Central Atlantic Magmatic Province (CAMP) and occurred just after the brief 26 thousand year (kyr) reverse geomagnetic polarity Chron E23r that can be used for global correlation. Lava-by-lava paleomagnetic secular variation data, previously reported from Morocco and northeastern United States combined with our data for the North Mountain Basalt from the Fundy Basin of Canada show that the initial phase of CAMP volcanism occurred in only five directional groups or pulses each occupying less than a century. The first four directional groups occur during a ~40 kyr period based on available astrochronology and U-Pb geochronology.

Guidance for unbiased predictive information for healthcare decision-making and equity (GUIDE): considerations when race may be a prognostic factor.

Clinical prediction models (CPMs) are tools that compute the risk of an outcome given a set of patient characteristics and are routinely used to inform patients, guide treatment decision-making, and resource allocation. Although much hope has been placed on CPMs to mitigate human biases, CPMs may potentially contribute to racial disparities in decision-making and resource allocation. While some policymakers, professional organizations, and scholars have called for eliminating race as a variable from CPMs, others raise concerns that excluding race may exacerbate healthcare disparities and this controversy remains unresolved.

New Brunswick HEARS: outcomes of a community-delivered hearing intervention adapted for older adults in Atlantic Canada.

Objective: To assess acceptability and benefit of a community-based hearing intervention delivered at no cost to lower-income older adults with untreated hearing loss in New Brunswick, Canada.

Design: Mixed method pre-post intervention study investigating aspects of communication function and social support at baseline and three months post-intervention.

Study Sample: 124 of 175 independent-living older adults screened at the study site and in local community centres in low-income neighbourhoods were recruited into the study.

Returning individual research results to participants: Values, preferences, and expectations.

Background/objective: Disclosing individual research results to participants is not standard practice. The return of individual research results to participants may increase recruitment, retention, and engagement in research. This study's objective was to explore the preferences, expectations, and experiences of research participants receiving individual research results.

Racial and ethnic differences in the receipt of continuous positive airway pressure treatment for obstructive sleep apnea.

Objective: To examine the pattern of health services access and utilization that may contribute to racial/ethnic disparities in receiving continuous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA).

Methods: This cross-sectional study used a national sample from the All of Us Research Program, which included over 80 % of participants from underrepresented populations in biomedical research. Study participants included adults aged 18 years and older diagnosed with OSA (N = 8518).

Evaluation of an OSA Risk Screening Smartphone App in a General, Non-Symptomatic Population Sample (ESOSA).

: Obstructive Sleep apnea (OSA) is a prevalent sleep disorder, risk factor for cardiovascular disease and imposes a substantial global socioeconomic and health burden. OSA is insufficiently diagnosed as it often presents with unspecific or no symptoms. This study compares the effectiveness of a smartphone-based screening method to polysomnography (PSG) in a general, non-symptomatic population sample.

Cystatin C as a Marker of Kidney Function in Children.

This review examines the reliability of cystatin C as a biomarker for kidney function in paediatric populations. Chronic kidney disease (CKD) affects a significant number of children globally, leading to severe health complications such as anaemia, hypertension, and growth disorders. Traditionally, kidney function has been assessed using the estimated glomerular filtration rate derived from serum creatinine, though this method is flawed due to variability in muscle mass, age, gender, and diet.

Comparison of Home Sleep Devices and Sleep Study Testing in Hypoglossal Nerve Stimulation Patients.

Objective: Hypoglossal nerve stimulation (HGNS) is an implantable therapy for obstructive sleep apnea (OSA). Therapy efficacy is currently confirmed by a formal sleep study after empiric adjustment by the patient at home based on their subjective experience with the device. Home-based longitudinal apnea hypopnea index (AHI) measurements have the potential to refine HGNS therapeutic amplitude selection with objective data.

Turmoil.

Description I painted this picture after tearing up over the phone with her parents. "I think she's passing away," I had told them, "You'd better come up to the hospital." Inexperienced as a brand new physician, I felt like I was drowning in my responsibility over the care of my patients.

Reduction of Z alpha-1 antitrypsin polymers in human iPSC-hepatocytes and mice by LRRK2 inhibitors.

Background: Alpha-1 antitrypsin deficiency (A1ATD) is a life-threatening condition caused by the inheritance of the serpin family A member 1 "Z" genetic variant driving alpha-1 antitrypsin (AAT) protein misfolding in hepatocytes. There are no approved medicines for this disease.

Methods: We conducted a high-throughput image-based small molecule screen using patient-derived induced pluripotent stem cell-hepatocytes (iPSC-hepatocytes).

Percutaneous Approaches to Hypoglossal Nerve Stimulation: A Pilot Study During Drug-Induced Sleep Endoscopy.

Hypoglossal nerve stimulation (HNS) is a surgical treatment option for select patients with obstructive sleep apnea that currently requires intraoperative dissection of the hypoglossal nerve (HGN) for implantation of an electrode array. Most HNS strategies target select HGN protrusor muscle branches and exclude undesirable retractor branches. We hypothesized that the target HGN branches could instead be selectively stimulated with a percutaneously delivered electrode array under ultrasound guidance via several anatomic approaches.

Derivation of an Annualized Claims-Based Major Adverse Cardiovascular Event Estimator in Type 2 Diabetes.

Background: Major adverse cardiovascular events (MACE) are a leading cause of morbidity and mortality among adults with type 2 diabetes. Currently, available MACE prediction models have important limitations, including reliance on data that may not be routinely available, narrow focus on primary prevention, limited patient populations, and longtime horizons for risk prediction.

Objectives: The purpose of this study was to derive and internally validate a claims-based prediction model for 1-year risk of MACE in type 2 diabetes.