The ETS transcription factor ERG is aberrantly expressed in approximately 50% of prostate tumors due to chromosomal rearrangements such as TMPRSS2/ERG. The ability of ERG to drive oncogenesis in prostate epithelial cells requires interaction with distinct coactivators, such as the RNA-binding protein EWS. Here, we find that ERG has both direct and indirect interactions with EWS, and the indirect interaction is mediated by the poly-A RNA-binding protein PABPC1.
View Article and Find Full Text PDFImportance: After US Food and Drug Administration (FDA) approval of a new drug, sponsors can submit additional clinical data to obtain supplemental approval for use for new indications.
Objective: To characterize pivotal trials supporting recent supplemental new indication approvals of drugs and biologics by the FDA and to compare them with pivotal trials that supported these therapeutics' original indication approvals.
Design, Setting, And Participants: This is a cross-sectional study characterizing pivotal trials supporting supplemental indication approvals by the FDA between 2017 and 2019 and pivotal trials that supported these therapeutics' original indication approvals.
Little and ring finger carpometacarpal joints (CMCJs) injuries are commonly missed due to misinterpretation of radiographs. We aimed to determine the sensitivity and specificity of four different radiographic views. Radiographs (posteroanterior [PA], lateral [LAT], pronated oblique [POL], and supinated oblique [SOL] views) showing normal findings or little/ring finger CMCJ injuries were shown to two cohorts of orthopaedic trainees and a cohort of emergency nurse practitioners.
View Article and Find Full Text PDFWe report six cases of complications from use of a thermal wand at wrist arthroscopy. Complications included skin necrosis, extensor tendon lesions and thermal articular cartilage damage, one with a catastrophic outcome. Thermal wands have the potential for substantial soft tissue damage causing severe harm to patients.
View Article and Find Full Text PDFImportance: Since the introduction of the Fast Track designation in 1988, the number of special regulatory programs available for the approval of new drugs and biologics by the US Food and Drug Administration (FDA) has increased, offering the agency flexibility with respect to evidentiary requirements.
Objective: To characterize pivotal efficacy trials supporting the approval of new drugs and biologics during the past 3 decades.
Design, Setting, And Participants: This cross-sectional study included 273 new drugs and biologics approved by the FDA for 339 indications from 1995 to 1997, from 2005 to 2007, and from 2015 to 2017.
Objective: In 2001, Chinese guidelines for the care of acute myocardial infarction (AMI) included a new recommendation against the routine use of magnesium. We studied temporal trends and institutional variation in the use of intravenous magnesium sulfate in nationally representative samples of individuals hospitalised with AMI in China between 2001 and 2015.
Methods: In an observational study (China PEACE-Retrospective Study) of AMI care, we used a two-stage, random sampling strategy to create a nationally representative sample of 28 208 patients with AMI at 162 Chinese hospitals in 2001, 2006, 2011 and 2015.
Background: Racial inequities for patients with heart failure (HF) have been widely documented. HF patients who receive cardiology care during a hospital admission have better outcomes. It is unknown whether there are differences in admission to a cardiology or general medicine service by race.
View Article and Find Full Text PDFImportance: Although studies have described differences in hospital outcomes by patient race and socioeconomic status, it is not clear whether such disparities are driven by hospitals themselves or by broader systemic effects.
Objective: To determine patterns of racial and socioeconomic disparities in outcomes within and between hospitals for patients with acute myocardial infarction, heart failure, and pneumonia.
Design, Setting, And Participants: Retrospective cohort study initiated before February 2013, with additional analyses conducted during the peer-review process.
Objectives: To characterise postmarketing studies for drugs that were newly approved by the US Food and Drug Administration and the European Medicines Agency.
Design And Setting: Cross-sectional analysis of postmarketing studies registered in ClinicalTrials.gov until September 2014 for all novel drugs approved by both regulators between 2005 and 2010.
Circ Cardiovasc Qual Outcomes
November 2017
Background: In response to urban-rural disparities in healthcare resources, China recently launched a healthcare reform with a focus on improving rural care during the past decade. However, nationally representative studies comparing medical care and patient outcomes between urban and rural areas in China during this period are not available.
Methods And Results: We created a nationally representative sample of patients in China admitted for ST-segment-elevation myocardial infarction in 2001, 2006, and 2011, using a 2-stage random sampling design in 2 urban and 3 rural strata.
Eur Heart J Qual Care Clin Outcomes
October 2017
Aims: ST-segment elevation myocardial infarctions (STEMI) in China and other low- and middle-income countries outnumber non-ST-segment elevation myocardial infarctions (NSTEMI). We hypothesized that the STEMI predominance was associated with lower biomarker use and would vary with hospital characteristics.
Methods And Results: We hypothesized that the STEMI predominance was associated with lower biomarker use and would vary with hospital characteristics.
Post-marketing research in oncology has rarely been described. We aimed to characterize post-marketing trials for a consistent set of anticancer agents over a long period. We performed a cross-sectional analysis of post-marketing trials registered at ClinicalTrials.
View Article and Find Full Text PDFEur Heart J Qual Care Clin Outcomes
January 2017
Public reporting of measures of hospital performance is an important component of quality improvement efforts in many countries. However, it can be challenging to provide an overall characterization of hospital performance because there are many measures of quality. In the United States, the Centers for Medicare and Medicaid Services reports over 100 measures that describe various domains of hospital quality, such as outcomes, the patient experience and whether established processes of care are followed.
View Article and Find Full Text PDFBackground: China has gaps in the quality of care provided to patients with ST-elevation myocardial infarction, but little is known about how quality varies between hospitals.
Methods And Results: Using nationally representative data from the China PEACE-Retrospective AMI Study, we characterized the quality of care for ST-elevation myocardial infarction at the hospital level and examined variation between hospitals. Two summary measures were used to describe the overall quality of care at each hospital and to characterize variations in quality between hospitals in 2001, 2006, and 2011.
Importance: Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making.
Objectives: To characterize the frequency of postmarket safety events among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic characteristics known at the time of FDA approval were associated with increased risk.
To characterize the prospective controlled clinical studies for all novel drugs that were initially approved by the Food and Drug Administration on the basis of limited evidence. Systematic review. Drugs@FDA database and PubMed.
View Article and Find Full Text PDFBackground: Hyperglycemia on admission has been found to elevate risk for mortality and adverse clinical events after acute myocardial infarction (AMI), but there are evidences that the relationship of blood glucose and mortality may differ between diabetic and nondiabetic patients. Prior studies in China have provided mixed results and are limited by statistical power. Here, we used data from a large, nationally representative sample of patients hospitalized with AMI in China in 2001, 2006, and 2011 to assess if admission glucose is of prognostic value in China and if this relationship differs depending on the presence or absence of diabetes.
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