An Appraisal of the Preventive Effect of Statins on the Development of Graves' Ophthalmopathy: A Hospital-Based Cohort Study.

Introduction: Graves' ophthalmopathy (GO) is an autoimmune inflammatory disorder observed in a substantial proportion of patients with Graves' disease (GD), with debilitating symptoms of disfiguring, periorbital pain, dry eyes, diplopia, and even visual disturbances. Previous studies involving Western populations have noted discrepancies in risk factors for GO. Therefore, this study aimed to determine the risk factors for GO development and the protective effect of statins in newly diagnosed patients with GD in Taiwan.

Quantitative bias analysis for external control arms using real-world data in clinical trials: a primer for clinical researchers.

Development of medicines in rare oncologic patient populations are growing, but well-powered randomized controlled trials are typically extremely challenging or unethical to conduct in such settings. External control arms using real-world data are increasingly used to supplement clinical trial evidence where no or little control arm data exists. The construction of an external control arm should always aim to match the population, treatment settings and outcome measurements of the corresponding treatment arm.

Olanzapine within steroid-sparing antiemetic regimen to prevent chemotherapy-induced nausea and vomiting in patients with acute leukemia receiving multi-day intensive chemotherapy.

Introduction: Olanzapine use for chemotherapy-induced nausea and vomiting (CINV) in hematological malignancies, for multi-day chemotherapy, and with a steroid-sparing antiemetic strategy is poorly understood. This study investigated if olanzapine is associated with improved prevention of CINV when added to a steroid-sparing antiemetic regimen in patients with acute leukemia receiving intensive, moderately emetogenic, multi-day chemotherapy.

Methods: This was a single-center, retrospective cohort study in patients with acute leukemia.

Transportability of Overall Survival Estimates From US to Canadian Patients With Advanced Non-Small Cell Lung Cancer With Implications for Regulatory and Health Technology Assessment.

Importance: The external validity of survival outcomes derived from clinical practice data from US patients with advanced non-small cell lung cancer (NSCLC) is not known and is of potential importance because it may be used to support regulatory decision-making and health technology assessment outside of the US.

Objective: To evaluate whether overall survival (OS) estimates for a selected group of patients with advanced NSCLC from a large US clinical practice database are transportable to Canadian patients receiving the same systemic therapies.

Design, Setting, And Participants: This retrospective multicenter cohort study used transportability analysis to assess whether adjustment for pretreatment characteristics of eligible patient cohorts could reliably approximate OS estimated from US-based samples to Canadian populations.

Predicting Progression of Oral Lesions to Malignancy Using Machine Learning.

Objective: To use large-scale electronic health record (EHR) data to develop machine learning models predicting malignant transformation of oral lesions.

Methods: A multi-institutional health system database was used to identify a retrospective cohort of patients with biopsied oral lesions. The primary outcome was malignant transformation.

Addressing challenges with real-world synthetic control arms to demonstrate the comparative effectiveness of Pralsetinib in non-small cell lung cancer.

As advanced non-small cell lung cancer (aNSCLC) is being increasingly divided into rare oncogene-driven subsets, conducting randomised trials becomes challenging. Using real-world data (RWD) to construct control arms for single-arm trials provides an option for comparative data. However, non-randomised treatment comparisons have the potential to be biased and cause concern for decision-makers.

Plant cytokinesis and the construction of new cell wall.

Cytokinesis in plants is fundamentally different from that in animals and fungi. In plant cells, a cell plate forms through the fusion of cytokinetic vesicles and then develops into the new cell wall, partitioning the cytoplasm of the dividing cell. The formation of the cell plate entails multiple stages that involve highly orchestrated vesicle accumulation, fusion and membrane maturation, which occur concurrently with the timely deposition of polysaccharides such as callose, cellulose and cross-linking glycans.

Association Between Smoking History and Overall Survival in Patients Receiving Pembrolizumab for First-Line Treatment of Advanced Non-Small Cell Lung Cancer.

Importance: There is a need to tailor treatments to patients who are most likely to derive the greatest benefit from them to improve patient outcomes and enhance cost-effectiveness of cancer therapies.

Objective: To compare overall survival (OS) between patients with a current or former history of smoking with patients who never smoked and initiated pembrolizumab monotherapy as first-line (1L) treatment for advanced non-small lung cancer (NSCLC).

Design, Setting, And Participants: This retrospective cohort study compared patients diagnosed with advanced NSCLC aged 18 or higher selected from a nationwide real-world database originating from more than 280 US cancer clinics.

Selection by design: Using job analysis to guide the selection of postgraduate pharmacy residents.

Purpose: To help ensure that we were accurately and consistently evaluating applicants to our postgraduate year 1 (PGY1) pharmacy residency program, we performed a job analysis to inform a redesign of our selection process.

Summary: A diverse panel of subject matter experts from our program was convened to develop a task inventory; a list of knowledge, skills, abilities, and other characteristics necessary for success in our program; and behavioral snapshots representing especially strong or weak resident performance (ie, critical incidents). After achieving a priori thresholds of consensus, these items were used to augment our application screening instrument (eg, development of anchored rating scales), build an online supplemental application consisting of a personality test and situational judgment test, develop a work sample consisting of a patient case presentation, and enhance the structure of our interviews (eg, by asking a consistent pattern of questions for all candidates).

Thromboelastography Changes of Whole Blood Compared to Blood Component Transfusion in Infant Craniosynostosis Surgery.

Surgical treatment of craniosynostosis with cranial vault reconstruction in infants is associated with significant blood loss. The optimal blood management approach is an area of active investigation. Thromboelastography (TEG) was used to examine changes in coagulation after surgical blood loss that was managed by transfusion with either whole blood or blood components.

Keeping it real: implications of real-world treatment outcomes for first-line immunotherapy in metastatic non-small-cell lung cancer.

Tweetable abstract Recent RWD studies suggest that the performance of immunotherapy in NSCLC is not as good as that seen in RCTs. However, analyses using RWD (and their interpretation) require careful appraisal and quantification of possible sources of bias.

EPX: An R package for the ensemble of subsets of variables for highly unbalanced binary classification.

Background And Objective: In binary classification problems with a rare class of interest, there is relatively little information available for the rare class to build a model. On the other hand, the number of useful variables to develop a model for classification can be high-dimensional. For example, in drug discovery, there are usually a very few bioactive compounds in a large chemical library, whereas thousands of potentially useful explanatory variables characterize a compound's chemical structure.

The Impact of Atherosclerotic Cardiovascular Risk on Graft Failure in Deceased-Donor Renal Transplantation.

Introduction: Pretransplant cardiovascular risk may be amplified after renal transplant, but little is known about its impact on graft outcomes.

Research Question: The purpose of this study was to determine if pretransplant cardiovascular risk was associated with graft outcomes.

Design: This retrospective study included deceased-donor renal transplant recipients from 2010-2015.

Pediatric airway management.

Purpose Of Review: Children are at risk of severe hypoxemia in the perioperative period owing to their unique anatomy and physiology. Safe and effective airway management strategies are therefore key to the practice of pediatric anesthesia. The goal of this review is to highlight recent publications (2019-2021) aimed to advance pediatric airway safety and to highlight a proposed simple, pediatric-specific, universal framework to guide clinical practice.

The Landscape of Emerging Randomized Clinical Trial Evidence for COVID-19 Disease Stages: A Systematic Review of Global Trial Registries.

Purpose: A multitude of randomized controlled trials (RCTs) have emerged in response to the novel coronavirus disease (COVID-19) pandemic. Understanding the distribution of trials among various settings is important to guide future research priorities and efforts. The purpose of this review was to describe the emerging evidence base of COVID-19 RCTs by stages of disease progression, from pre-exposure to hospitalization.

Reporting and design of randomized controlled trials for COVID-19: A systematic review.

Background: The novel coronavirus 2019 (COVID-19) pandemic has mobilized global research at an unprecedented scale. While challenges associated with the COVID-19 trial landscape have been discussed previously, no comprehensive reviews have been conducted to assess the reporting, design, and data sharing practices of randomized controlled trials (RCTs).

Purpose: The purpose of this review was to gain insight into the current landscape of reporting, methodological design, and data sharing practices for COVID-19 RCTs.

Independent risk factors associated with higher mortality rates and recurrence of brain abscesses from head and neck sources.

Objective: The aim of this study was to identify the features and independent risk factors associated with recurrence and mortality in patients with brain abscesses of head and neck origin.

Study Design: We designed a retrospective study of patients diagnosed with a brain abscess at the Massachusetts General Hospital between 1980 and 2017. Inclusion criteria were complete medical records, including medical and surgical history; and radiographic and microbiologic data.

Utilizing Bayesian predictive power in clinical trial design.

The Bayesian paradigm provides an ideal platform to update uncertainties and carry them over into the future in the presence of data. Bayesian predictive power (BPP) reflects our belief in the eventual success of a clinical trial to meet its goals. In this paper we derive mathematical expressions for the most common types of outcomes, to make the BPP accessible to practitioners, facilitate fast computations in adaptive trial design simulations that use interim futility monitoring, and propose an organized BPP-based phase II-to-phase III design framework.

How do I…Incorporate a two-sample blood type verification in a pediatric hospital?

Background: The AABB (American Association of Blood Banks) and the College of American Pathologists (CAP) regulations call on blood banks to address the risk of misidentification of a patient's blood type, which can result in transfusion of a mismatched product. Transfusion of mismatched blood product is potentially fatal due to acute hemolytic transfusion reaction and is considered a preventable event. CAP regulations outline options to reduce risk of mistransfusion by either documenting the ABO group of the intended recipient on a second sample collected at a separate phlebotomy, or utilizing a mechanical barrier system or electronic identification verification system that ensures the patient from whom the pretransfusion specimen was collected is the same patient who is about to be transfused.

The Pediatric Difficult Airway: Updates and Innovations.

Children have unique characteristics that make them particularly vulnerable to perioperative adverse events. Skilled airway management is a cornerstone of high-quality anesthetic management. The use of hybrid airway techniques is a critical tool for the pediatric anesthesiologist.

Antimicrobial Therapy in Septic Shock Is Conservative During Resuscitation and Maintenance Phases.

Maximal dosing of early antimicrobials with high loading and maintenance doses may optimize pharmacokinetic parameters to achieve and maintain therapeutic concentrations at the site of infection in septic shock. Little is known about the current practice of early antimicrobial dosing in septic shock. To characterize early antimicrobial dosing in patients in the resuscitation phase of septic shock.