Regulatory considerations for successful implementation of digital endpoints in clinical trials for drug development.

Regulatory acceptance of Digital Health Technology (DHT) -derived endpoints can be a long, multifaceted and costly process. Success relies on establishing a global strategy as part of the development program including health authority consultations to ensure alignment with regulatory requirements. In this manuscript, the authors provide stepwise guidance for successful implementation of DHT-derived endpoints in clinical trials for drug development.

Quantitative environmental radiologic assessment of oil and gas exploration activities using Ra concentration to estimate Po and Pb dose.

Exploration activities of hydrocarbon reservoirs have resulted in the release of naturally occurring radioactive material (NORM) into the environment, exposing them to workers and members of the public. Radium-226 and its progeny (Rn, Pb and Po) in the U-series and Ra in the Th-series are key isotopes that are released into the environment. Excessive radiation derived from oil and natural gas activities can potentially result in adverse health effects and increased cancer risk; thus, this study is focused on the evaluation of radiation exposure in Southern Pennsylvania, where large-scale conventional drilling and newer technologies have been carried out for over a century.

Strengths for Helping Professionals Exposed to Secondary Trauma: A Scoping Review.

Helping professionals working with people who have experienced trauma are at risk of developing psychological distress. To date, most studies exploring psychological distress among helping professionals have focused on risk factors associated with the development of adverse reactions to secondary trauma, and few have identified strengths or protective factors, which may buffer and/or alleviate distress. Therefore, this scoping review uses the Resilience Portfolio Model (Grych et al.

Novel pacing maneuvers for mapping the upstream insertion of unidirectional accessory pathways.

Background: Anatomic characterization of unidirectional accessory pathways (APs) is inherently limited to the localization of the downstream insertion site. The inability to define the full anatomic course of unidirectional pathways can limit the safety and effectiveness of ablation in the setting of complex pathways, slanted pathways, unstable catheter positioning at downstream insertions, or insertions near the conduction system.

Objective: We aimed to develop novel pacing maneuvers to localize upstream insertions of unidirectional APs.

Development and Validation of Natural Language Processing Algorithms in the ENACT National Electronic Health Record Research Network.

Electronic health record (EHR) data are a rich and invaluable source of real-world clinical information, enabling detailed insights into patient populations, treatment outcomes, and healthcare practices. The availability of large volumes of EHR data are critical for advancing translational research and developing innovative technologies such as artificial intelligence. The Evolve to Next-Gen Accrual to Clinical Trials (ENACT) network, established in 2015 with funding from the National Center for Advancing Translational Sciences (NCATS), aims to accelerate translational research by democratizing access to EHR data for all Clinical and Translational Science Awards (CTSA) hub investigators.

Medical Spanish Vital Signs Educational Module for Healthcare Students.

Background: With a growing number of Spanish-speaking patients in the United States, it is crucial for clinicians to communicate effectively with their patients. However, the number of Spanish-speaking clinicians is disproportionately low. Our module aims to provide healthcare students with a practical foundation of basic Spanish for taking vital signs.

Temporal stability and lack of variance in microbiome composition and functionality in fit recreational athletes.

Human gut microbiome composition and function is influenced by environmental and lifestyle factors, including exercise and fitness. We studied the composition and functionality of the faecal microbiome of recreational (non-elite) runners (n = 62) with serial shotgun metagenomics, at 4 time points over a 7-week period. Gut microbiome composition and function was stable over time.

Home cage-based insights into motor learning and strategy adaptation in a Huntington disease mouse model.

Huntington disease (HD) is a genetic neurodegenerative disorder characterized by progressive motor dysfunction, cognitive decline, and neuropsychiatric symptoms. Assessing early motor skill deficits in HD mouse models is challenging with traditional behavioral tasks. This study uses a home cage-based lever-pulling task, PiPaw2.

Shared pathway of WDFY4-dependent cross-presentation of immune complexes by cDC1 and cDC2.

Priming CD8+ T cells against tumors or viral pathogens results largely from cross-presentation of exogenous antigens by type 1 conventional dendritic cells (cDC1s). Although monocyte-derived DCs and cDC2s can cross-present in vitro, their physiological relevance remains unclear. Here, we used genetic models to evaluate the role of cDC subsets in presentation of cell-associated and immune complex antigens to CD4+ and CD8+ T cells in vivo.

Utilisation of nursing home care before and after the 2015 Dutch national reform: an interrupted time series analysis.

Background: The Netherlands introduced abrupt, large-scale, long-term care (LTC) reforms in 2015 that promoted ageing-in-place. However, there has been no comprehensive population-level study evaluating how these reforms have impacted nursing home (NH) utilisation. This study examines the association between the 2015 reforms with national monthly rates of NH admissions and survival time amongst newly admitted older adults.

Incident Heart Failure in Atherosclerotic Renal Artery Stenosis: A Post Hoc Analysis of the CORAL Trial.

Rationale & Objective: Although renal artery stenosis (RAS) and heart failure (HF) have been linked, the incidence and predictors of HF among patients with RAS are not well described.

Study Design: Post hoc analysis of the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) multicenter, open-label, randomized controlled trial (RCT).

Settings And Participants: Patients with atherosclerotic RAS and elevated blood pressure, chronic kidney disease, or both, and without a history of HF at enrollment.

"If there was a quick and easy way to participate": The engagement of United Kingdom radiotherapy and diagnostic imaging departments in research strategy.

Introduction: Research strategies support professionals to create a shared vision and work towards common objectives which can enhance workforce satisfaction, retention and patient experience. Our research aimed to capture the current number of United Kingdom (UK) radiotherapy and diagnostic imaging departments that have a local discipline specific research strategy in place. We also sought to understand the contributing factors to their development, with the aim of generating models of support to enhance future local research strategies.

Neurocognitive Functioning in Tourette Syndrome: From Research Findings to Clinical Implementation.

Individuals living with Tourette syndrome (TS) may benefit from cognitive assessment, as it may elucidate specific difficulties for which someone could receive accommodation and highlight relative strengths to build upon. Eventually, cognitive assessment could help predicting symptom trajectory or treatment outcome. However, the literature on cognition in TS is often equivocal, which may be at least partly attributed to small samples, inconsistent consideration of co-occurring conditions, psychotropic medication, and developmental influence.

Preclinical use of a clinically-relevant scAAV9/SUMF1 vector for the treatment of multiple sulfatase deficiency.

Background: Multiple Sulfatase Deficiency (MSD) is a rare inherited lysosomal storage disorder characterized by loss of function mutations in the SUMF1 gene that manifests as a severe pediatric neurological disease. There are no available targeted therapies for MSD.

Methods: We engineered a viral vector (AAV9/SUMF1) to deliver working copies of the SUMF1 gene and tested the vector in Sumf1 knock out mice that generally display a median lifespan of 10 days.

Ophthalmic Outcomes in Children With Spina Bifida Myelomeningocele in Ireland.

Purpose: To investigate the ophthalmic complications associated with spina bifida myelomeningocele (SBM) in Irish children and to evaluate the impact of spinal lesion levels and shunt status on visual outcomes.

Methods: A retrospective audit was conducted on 129 children with SBM, examining visual acuity, refractive errors, strabismus, papilledema, optic atrophy, and cortical visual impairment (CVI). The median age of participants was 6.

Feasibility of In-Hospital Administration of a Tool to Predict Persistent Post-ICU Functional Impairment Among Older ICU Survivors: A Pilot Study.

Background: A recent international consensus conference called for the development of risk prediction models to identify ICU survivors at increased risk of each of the post-ICU syndrome domains. We previously developed and validated a risk prediction tool for functional impairment after ICU admission among older adults.

Research Question: In this pilot study, we assessed the feasibility of administering the risk prediction tool in the hospital to older adults who had just survived critical illness.

Burnout in Military Orthopedic Surgeons: A Multicenter, Cross-Sectional Study.

Background: High rates of burnout are prevalent in U.S. physicians with evidence that the rates are increasing.

Assessing the Nutrient Composition of a Carnivore Diet: A Case Study Model.

Background/objectives: The rise in chronic metabolic diseases has led to the exploration of alternative diets. The carnivore diet, consisting exclusively of animal products, has gained attention, anecdotally, for imparting benefit for inflammatory conditions beyond that possible by other restrictive dietary approaches. The aim was to assess the micronutrient adequacy of four versions of the carnivore diet against national nutrient reference values (NRVs).

All Suture Biceps Tenodesis Has Greater Biomechanical Strength Than Metal Button Fixation.

Purpose: To evaluate the maximal load to failure, cyclic displacement, stiffness, and modes of failure of onlay subpectoral biceps tenodesis with an intramedullary unicortical metal button (MB) versus an inlay, all-suture Caspari-Weber (CW) technique.

Methods: Sixteen matched paired human cadaveric proximal humeri were randomly allocated for subpectoral BT with either CW or MB using a high-strength suture (N = 16; 8 male, 8 female, mean age = 82.5 years, range 62-99 years).

Benchmarking performance in Targhee sheep in development of a genetic reference flock.

The Targhee breed is important to range sheep production in the Western United States. The objective of this research was to integrate industry sires participating in national genetic evaluation through the National Sheep Improvement Program (NSIP) into the U.S.

The association between adverse childhood experiences and adult cardiac function in the UK Biobank.

Aims: The importance of early life factors in determining health in later adulthood is increasingly recognized. This study evaluated the association of adverse childhood experiences (ACEs) with cardiovascular magnetic resonance (CMR) phenotypes.

Methods And Results: UK Biobank participants who had completed CMR and the self-reported questionnaire on traumatic childhood experiences were included.

Improved Adherence to Lipid Screening in the Pediatric Cardiology Clinic: A Quality Improvement Project.

Introduction: Lipid screening identifies at-risk patients to facilitate cardiovascular risk reduction. National pediatric guidelines recommend universal lipid screening between 9-11 and 17-21 years of age. We aimed to improve adherence to lipid screening for all age-appropriate outpatient pediatric cardiology visits from a baseline of 35% to 90% between November 2021 and July 2023.

Impacts of birth season and production system on gastrointestinal parasitism and growth in Katahdin lambs.

Gastrointestinal nematode (GIN) infection adversely affects the performance and well-being of forage-based sheep throughout the world. The study objectives were to estimate longitudinal differences between birth seasons and production systems for lamb postweaning growth and indicators of GIN infection. Data were collected on Katahdin lambs within a single flock from 2006 to 2022.

VACStent closure of oesophageal defects by covered stent and endoscopic vacuum therapy: initial use and clinical outcomes.

Endoscopic management of transmural oesophageal defects following esophagectomy or spontaneous perforations, such as Boerhaave's syndrome, is often complicated by stent migration and luminal occlusion [1]. The Vacuum-Assisted Closure (VAC) stent, which integrates a covered stent with endoscopic vacuum therapy, aims to address these issues by providing functional drainage and promoting wound healing [2]. This case series presents our initial experience with VACStent therapy in four patients treated between February 2023 and April 2024.