Inconsistent Reporting and Definitions of Time-to-Event Endpoints in CAR T Clinical Trials: A Review.

Clinical trials evaluating chimeric antigen receptor T-cell therapy (CAR T) commonly report time-to-event (TTE) endpoints. However, definitions are not necessarily comparable across studies and variability can lead to misinterpretation of results or inappropriate comparisons across products and studies. Amid the rapidly increasing number of published CAR T trials-many of which were used for regulatory approval-this study aims to summarize the variation in the use and reporting of TTE endpoints in CAR T trials.

Global and Community Health: Neurologic Care and a Case Study for Immigrants and Refugees in West Philadelphia.

Philadelphia is a diverse city that has experienced an increasing immigrant and refugee population in recent decades. Although many academic medical centers also call Philadelphia their home, lack of accessibility and difficulty with insurance limit access to health care for many of its newest residents. The Social Health and Medical Services (SHAMS) Free Health Clinic was started to help address some of these disparities, especially for immigrant and refugee populations.

Impact of Non-Alcoholic Fatty Liver Disease on Sepsis Inpatient Outcomes: A Nationwide Sample Analysis (2000-2019).

Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) are reported to have an increased risk of developing severe infections, leading to hospitalizations with sepsis. However, data regarding the impact of comorbid NAFLD on in-hospital outcomes of patients with sepsis is scarce. This nationwide retrospective observational study using discharge data from the National Inpatient Sample (NIS), Healthcare Cost and Utilization Project (HCUP), and Agency for Healthcare Research and Quality included 21,057,911 adult patients who were admitted to hospitals in the United States between 2000 and 2019 with a primary discharge diagnosis of sepsis.

Is Postoperative Voice Rest Unnecessary? A Systematic Review and Meta-analysis of Voice Rest Recommendation Outcomes.

Background: Voice rest (VR) is widely recommended after microlaryngeal surgery to facilitate recovery and improve voice outcomes. Our study is the first systematic review and meta-analysis summarizing the impact of postoperative absolute voice rest (AVR) and no voice rest (NVR) instructions on voice outcomes.

Methods: PubMed, Embase, and Cochrane Library databases were searched using "voice rest laryngeal surgery" and "postoperative voice rest" for articles published before December 2022.

The Recovery of Consciousness via Evidence-Based Medicine and Research (RECOVER) Program: A Paradigm for Advancing Neuroprognostication.

Background: Neuroprognostication for disorders of consciousness (DoC) after severe acute brain injury is a major challenge, and the conventional clinical approach struggles to keep pace with a rapidly evolving literature. Lacking specialization, and fragmented between providers, conventional neuroprognostication is variable, frequently incongruent with guidelines, and prone to error, contributing to avoidable mortality and morbidity.

Recent Findings: We review the limitations of the conventional approach to neuroprognostication and DoC care, and propose a paradigm entitled the Recovery of Consciousness Via Evidence-Based Medicine and Research (RECOVER) program to address them.

Altered Mental Status at the Extreme: Behavioral Evaluation of Disorders of Consciousness.

Disorders of consciousness represent altered mental status at its most severe, comprising a continuum between coma, the vegetative state/unresponsive wakefulness syndrome, the minimally conscious state, and emergence from the minimally conscious state. Patients often transition between these levels throughout their recovery, and determining a patient's current level can be challenging, particularly in the acute care setting. Although healthcare providers have classically relied on a bedside neurological exam or the Glasgow Coma Scale to aid with assessment of consciousness, studies have identified multiple limitations of doing so.

Advances in Bone Marrow Evaluation.

Evaluation of bone marrow aspirate smear and trephine biopsy specimens is critical to the diagnosis of benign and malignant hematologic conditions. Digital pathology has the potential to revolutionize bone marrow assessment through implementation of artificial intelligence for assisted and automated evaluation, but there remain many barriers toward this implementation. This article reviews the current state of digital evaluation of bone marrow aspirate smears and trephine biopsies, recent research using machine learning models for automated specimen analysis, an outline of the advantages and barriers facing clinical implementation of artificial intelligence, and a potential vision of artificial intelligence-associated bone marrow evaluation.

Reducing Central Line-Associated Bloodstream Infections With a Multipronged Nurse-Driven Approach.

Background: Despite implementation of central catheter bundles, central line [catheter]-associated bloodstream infections (CLABSIs) remain a preventable hospital-acquired infection.

Local Problem: A new population of patients with pulmonary artery catheters was introduced to the cardiac progressive care unit, increasing central catheter days, device use, and CLABSI rate.

Methods: A quality improvement project was conducted.

Dose optimization of second window indocyanine green in meningioma patients.

Objective: Surgery remains the first line treatment for meningiomas and can benefit from fluorescence-guided surgical techniques such as second-window indocyanine green (SWIG). In the current study, we compared the use of the standard SWIG dose of 5.0 mg/kg relative to 2.

How Might Antibiotic Stewardship Programs Influence Clinicians' Autonomy and Organizations' Liability?

Federal and state governments mandate some health care organizations to implement antibiotic stewardship programs (ASPs). Some early adopters developed model ASPs that have helped set industry standards; other benchmarks will likely be forged in subsequent regulation, legislation, and jurisprudence. This article considers how ASP designs can affect professional autonomy, especially of frontline antibiotic stewards who are usually physicians and pharmacists.

Should Antimicrobial Resistance Limit Access to an Organ Transplant?

Burkholderia cenocepacia (B cenocepacia) is a gram-negative bacteria associated with significant morbidity and mortality following lung transplantation. Most US transplant programs consider B cenocepacia colonization to be an absolute contraindication to transplantation. This article argues that, if clinicians have good clinical reasons to expect poor outcomes for patients with B cenocepacia, then offering transplantation anyway is an abrogation of clinicians' fiduciary duties.

Associations between Present-on-Admission Do-Not-Resuscitate Orders and Short-Term Outcomes in Patients with Pneumonia.

Objectives: Do-not-resuscitate DNR) orders are used to express patient preferences for cardiopulmonary resuscitation. This study examined whether early DNR orders are associated with differences in treatments and outcomes among patients hospitalized with pneumonia.

Methods: This is a retrospective cohort study of 768,015 adult patients hospitalized with pneumonia from 2010 to 2015 in 646 US hospitals.

Whole Exome Sequencing Uncovers the Genetic Complexity of Bicuspid Aortic Valve in Families with Early Onset Complications.

Bicuspid Aortic Valve (BAV) is the most common adult congenital heart lesion with an estimated population prevalence of 1%. We hypothesize that early onset complications of BAV (EBAV) are driven by specific impactful genetic variants. We analyzed whole exome sequences (WES) to identify rare coding variants that contribute to BAV disease in 215 EBAV families.

Failing to Make the Grade: Conventional Cardiac Allograft Rejection Grading Criteria Are Inadequate for Predicting Rejection Severity.

Background: Cardiac allograft rejection is the leading cause of early graft failure and is a major focus of postheart transplant patient care. While histological grading of endomyocardial biopsy samples remains the diagnostic standard for acute rejection, this standard has limited diagnostic accuracy. Discordance between biopsy rejection grade and patient clinical trajectory frequently leads to both overtreatment of indolent processes and delayed treatment of aggressive ones, spurring the need to investigate the adequacy of the current histological criteria for assessing clinically important rejection outcomes.

The FXYD1 protein plays a protective role against pulmonary hypertension and arterial remodeling via redox and inflammatory mechanisms.

Pulmonary hypertension (PH) consists of a heterogenous group of diseases that culminate in increased pulmonary arterial pressure and right ventricular (RV) dysfunction. We sought to investigate the role of FXYD1, a small membrane protein that modulates Na-K-ATPase function, in the pathophysiology of PH. We mined online transcriptome databases to assess FXYD1 expression in PH.

Wait Time Advantage for Transplant Candidates With HIV Who Accept Kidneys From Donors With HIV Under the HOPE Act.

Background: Kidney transplant (KT) candidates with HIV face higher mortality on the waitlist compared with candidates without HIV. Because the HIV Organ Policy Equity (HOPE) Act has expanded the donor pool to allow donors with HIV (D + ), it is crucial to understand whether this has impacted transplant rates for this population.

Methods: Using a linkage between the HOPE in Action trial (NCT03500315) and Scientific Registry of Transplant Recipients, we identified 324 candidates listed for D + kidneys (HOPE) compared with 46 025 candidates not listed for D + kidneys (non-HOPE) at the same centers between April 26, 2018, and May 24, 2022.

Rare Genomic Copy Number Variants Implicate New Candidate Genes for Bicuspid Aortic Valve.

Bicuspid aortic valve (BAV), the most common congenital heart defect, is a major cause of aortic valve disease requiring valve interventions and thoracic aortic aneurysms predisposing to acute aortic dissections. The spectrum of BAV ranges from early onset valve and aortic complications (EBAV) to sporadic late onset disease. Rare genomic copy number variants (CNVs) have previously been implicated in the development of BAV and thoracic aortic aneurysms.