Multi-diagnostic chest-worn patch to detect obstructive sleep apnea and cardiac arrhythmias.

Study Objectives: Evaluate the performance of the SANSA device to simultaneously assess obstructive sleep apnea (OSA) and cardiac arrhythmias.

Methods: Participants suspected or known to have OSA underwent polysomnography (PSG) while wearing SANSA. SANSA's algorithm was trained using 86 records and tested on 67 to evaluate training bias.

Comparison of in-clinic assessment of 6MWT by conventional method and using wearable sensors for patients with ATTR-CM.

Introduction: The 6-minute walk test (6MWT) is used to assess submaximal exercise capacity in clinical trials. Conducting the 6MWT can be challenging when patients cannot visit the clinic due to physical/travel limitations. This pilot study assessed the feasibility of conducting the 6MWT using wearable sensors for patients with transthyretin amyloid cardiomyopathy.

Instance maps as an organising concept for complex experimental workflows as demonstrated for (nano)material safety research.

Nanosafety assessment, which seeks to evaluate the risks from exposure to nanoscale materials, spans materials synthesis and characterisation, exposure science, toxicology, and computational approaches, resulting in complex experimental workflows and diverse data types. Managing the data flows, with a focus on provenance (who generated the data and for what purpose) and quality (how was the data generated, using which protocol with which controls), as part of good research output management, is necessary to maximise the reuse potential and value of the data. Instance maps have been developed and evolved to visualise experimental nanosafety workflows and to bridge the gap between the theoretical principles of FAIR (Findable, Accessible, Interoperable and Re-usable) data and the everyday practice of experimental researchers.

ALS Motor Observational Telemedicine Objective Rasch-Built Assessment: A Quantitative Scale for the Era of Teleneurology.

Background And Objectives: Telemedicine has become a mainstay of ALS clinical care, but there is currently no standardized approach for assessing and tracking changes to the neurologic examination in this format. The goal of this study was to create a standardized telemedicine-based motor examination scale to objectively and reliably track ALS progression and use Rasch methodology to validate the scale and improve its psychometric properties.

Methods: A draft telemedicine examination scale with 25 items assessing movement in the bulbar muscles, neck, trunk, and extremities was created by an ALS expert panel, incorporating input from patient advisors.

Impact of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors on Lipoprotein(a): A Meta-Analysis and Meta-Regression of Randomized Controlled Trials.

Background: Lipoprotein(a) [Lp(a)] has been independently associated with increased cardiovascular risk.

Objectives: The authors examined the effect of monoclonal antibody proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9is) on plasma Lp(a) levels across multiple trials.

Methods: Studies were retrieved comparing the effect of PCSK9i vs placebo on Lp(a) levels.

SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocols.

Unlabelled: Transparent and accurate reporting in early phase dose-finding (EPDF) clinical trials is crucial for informing subsequent larger trials. The SPIRIT statement, designed for trial protocol content, does not adequately cover the distinctive features of EPDF trials. Recent findings indicate that the protocol contents in past EPDF trials frequently lacked completeness and clarity.

CONSORT-DEFINE explanation and elaboration: recommendations for enhancing reporting quality and impact of early phase dose-finding clinical trials.

Unlabelled: Early phase dose-finding (EPDF) trials are key in the development of novel therapies, with their findings directly informing subsequent clinical development phases and providing valuable insights for reverse translation. Comprehensive and transparent reporting of these studies is critical for their accurate and critical interpretation, which may improve and expedite therapeutic development. However, quality of reporting of design characteristics and results from EPDF trials is often variable and incomplete.

Sepsis in Northern Tanzania: A Prospective Observational Study of Clinical Characteristics, Management, and Outcomes for Adolescents and Adults With Sepsis.

Background: Despite a high burden of sepsis in Sub-Saharan Africa, clinical data for adolescent and adult sepsis in this setting are limited. We sought to describe clinical characteristics, management, and outcomes in adolescents and adults with sepsis in northern Tanzania. We also assessed for clinical associations with in-hospital mortality.

Quality of care delivery in patients with acute heart failure: insights from the international REPORT-HF registry.

Background: Heart Failure (HF) quality of care (QoC) is associated with clinical outcomes. Therefore, we investigated differences in HF QoC across worldwide regions (with differing national income) and the association of quality indicators with outcomes.

Methods: We examined the quality of care (QoC) in acute heart failure (HF) patients across different regions using quality indicators (QIs) from the European Society of Cardiology (ESC) and the American Heart Association (AHA) to evaluate QoC.

Achievement of guideline-based lipid goals among very-high-risk patients with atherosclerotic cardiovascular disease and type 2 diabetes: results in 213,380 individuals from the cvMOBIUS2 registry.

Objective: Lowering lipid to reach guideline-indicated goals significantly reduces cardiovascular outcomes in very-high-risk (VHR) patients with atherosclerotic cardiovascular disease (ASCVD) and type 2 diabetes (DM2). How well VHR patients currently achieve these goals in community practice is unknown.

Methods: VHR patients with ASCVD and DM2 were identified across 14 US healthcare systems using electronic health records between 1/1/2021-12/31/2022.

Safety and efficacy of outpatient versus inpatient adult brachial plexus surgery.

Purpose: Outpatient orthopedic surgery is becoming more common as a method of providing safe and cost-effective medical care. The purpose of this study was to compare outcomes between adult patients undergoing outpatient versus inpatient brachial plexus surgery.

Methods: A single institution database was queried for patients with brachial plexus injuries undergoing brachial plexus exploration with or without concomitant reconstructive procedures from 2010 to 2022.

A comparison study of 90-day readmission and emergency department visitation after outpatient versus inpatient pediatric pollicization surgery.

Introduction: Transition to outpatient surgery has grown with an emphasis on delivery of safe, high-quality medical care. The purpose of this study is to compare 90-day emergency department (ED) visits, readmissions, and complications between patients undergoing outpatient versus inpatient pollicization surgery.

Methods: A single institution database was queried for primary thumb pollicization from 2010 to 2022 in patients under 18 years of age.

Context-specific eQTLs provide deeper insight into causal genes underlying shared genetic architecture of critically ill COVID-19 and idiopathic pulmonary fibrosis.

Most genetic variants identified through genome-wide association studies (GWAS) are suspected to be regulatory in nature, but only a small fraction colocalize with expression quantitative trait loci (eQTLs, variants associated with expression of a gene). Therefore, it is hypothesized but largely untested that integration of disease GWAS with context-specific eQTLs will reveal the underlying genes driving disease associations. We used colocalization and transcriptomic analyses to identify shared genetic variants and likely causal genes associated with critically ill COVID-19 and idiopathic pulmonary fibrosis.

Practical management of adverse events in patients receiving tarlatamab, a delta-like ligand 3-targeted bispecific T-cell engager immunotherapy, for previously treated small cell lung cancer.

Tarlatamab is a bispecific T-cell engager immunotherapy targeting delta-like ligand 3 (DLL3) and the cluster of differentiation 3 (CD3) molecule. In the phase 2 DeLLphi-301 trial of tarlatamab for patients with previously treated small cell lung cancer, tarlatamab 10 mg every 2 weeks achieved durable responses and encouraging survival outcomes. Analyses of updated safety data from the DeLLphi-301 trial demonstrated that the most common treatment-emergent adverse events were cytokine release syndrome (53%), pyrexia (38%), decreased appetite (36%), dysgeusia (32%), and an emia (30%).

Robotic Versus Open Placement of Hepatic Artery Infusion Pumps.

Background: A growing number of centers offer hepatic artery infusion pump (HAIP) chemotherapy for advanced liver malignancies. While small series have demonstrated feasibility of robotic HAIP placement, comparison of outcomes with open placement is lacking. We compared outcomes after robotic versus open HAIP placement.

A morphometric signature to identify ductal carcinoma in situ with a low risk of progression.

Ductal carcinoma in situ (DCIS) may progress to ipsilateral invasive breast cancer (iIBC), but often never will. Because DCIS is treated as early breast cancer, many women with harmless DCIS face overtreatment. To identify features associated with progression, we developed an artificial intelligence-based DCIS morphometric analysis pipeline (AIDmap) on hematoxylin-eosin-stained (H&E) tissue sections.

Imaging-based prediction of early recurrence and neoadjuvant therapy outcomes for resectable beyond Milan HCC.

Purpose: To develop and validate an MRI-based model for predicting postoperative early (≤2 years) recurrence-free survival (RFS) in patients receiving upfront surgical resection (SR) for beyond Milan hepatocellular carcinoma (HCC) and to assess the model's performance in separate patients receiving neoadjuvant therapy for similar-stage tumors.

Method: This single-center retrospective study included consecutive patients with resectable BCLC A/B beyond Milan HCC undergoing upfront SR or neoadjuvant therapy. All images were independently evaluated by three blinded radiologists.

Association between chiropractic spinal manipulation for sciatica and opioid-related adverse events: A retrospective cohort study.

Background: Patients receiving chiropractic spinal manipulation (CSM) for spinal pain are less likely to be prescribed opioids, and some evidence suggests that these patients have a lower risk of any type of adverse drug event. We hypothesize that adults receiving CSM for sciatica will have a reduced risk of opioid-related adverse drug events (ORADEs) over a one-year follow-up compared to matched controls not receiving CSM.

Methods: We searched a United States (US) claims-based data resource (Diamond Network, TriNetX, Inc.

Mental health challenges and perceptions of stigma among youth living with HIV in Tanzania.

Youth living with HIV (YLWH) face psychosocial challenges and HIV-related stigma, which impact adherence to antiretroviral therapy (ART). This study was designed to understand better the change in mental health symptoms and experiences with stigma among YLWH in Tanzania who completed the original pilot Sauti ya Vijana (SYV), a mental health and life skills group intervention. YLWH who completed SYV and demonstrated a change of ≥2 points in either direction on their Patient Health Questionnaire PHQ-9 (depression screener) from baseline to 18 months were purposively sampled.

What Next for the Science of Patient Preference? Interoperability, Standardization, and Transferability.

Using patient preference information (PPI) to incorporate patient voices into the drug development lifecycle can help align therapies with the needs and values of patients. However, several barriers have limited the use of PPI, including a lack of clarity on its use by decision-makers, a need for greater decision-maker trust in PPI, and a lack of time, budgets, and access to specialist expertise. The value proposition for PPI could be enhanced by making it FAIR: Findable, Accessible, Interoperable, and Reusable.

Combining Hyperpolarized Xe MR Imaging and Spectroscopy to Non-Invasively Estimate Pulmonary Vascular Resistance.

Hyperpolarized Xe MRI/MRS enables quantitative mapping of function in lung airspaces, membrane tissue, and red blood cells (RBCs) within the pulmonary capillaries. The RBC signal also exhibits cardiogenic oscillations that are reduced in pre-capillary pulmonary hypertension (PH). This effect is obscured in patients with concomitant defects in transfer from airspaces to RBCs, which increase RBC oscillation amplitudes.

Near-universal prevalence of central adiposity in heart failure with preserved ejection fraction: the PARAGON-HF trial.

Background And Aims: An expansion of fat mass is an integral feature of patients with heart failure and preserved ejection fraction (HFpEF). While body mass index (BMI) is the most common anthropometric measure, a measure of central adiposity-the waist-to-height ratio (WHtR)-focuses on body fat content and distribution; is not distorted by bone or muscle mass, sex, or ethnicity; and may be particularly relevant in HFpEF.

Methods: The PARAGON-HF trial randomized 4796 patients with heart failure and ejection fraction ≥45% to valsartan or sacubitril/valsartan.