Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials.

The NIH Pragmatic Trials Collaboratory supports the design and conduct of 32 embedded pragmatic clinical trials, and many of these trials rely on data from the electronic health record (EHR) to monitor outcomes and/or use functionality provided by the EHR platform to deliver the intervention. Given the complexity and dynamic nature of EHR systems, study teams have encountered challenges in use of the EHR for these purposes, including challenges related to local implementation of trial interventions, rapid technology evolution, EHR updates, and transitions in EHR systems. In this article, we share case examples and lessons learned, and suggest that teams need to be aware of-and perhaps proactively investigate- possible changes to EHR systems and data that will affect the delivery of interventions and the integrity and safety of pragmatic clinical trials.

Patient-reported disease burden in the Accelerate Clinical Trials in Charcot-Marie-Tooth Disease Study.

Background And Aims: The Charcot-Marie-Tooth Disease Health Index (CMT-HI) is a disease-specific, patient-reported disease burden measure. As part of an international clinical trial readiness study, individuals with CMT1A (ages 18-75 years) underwent clinical outcome assessments (COAs), including the CMT-HI, to capture their longitudinal perspective on the disease burden.

Methods: Two hundred and fifteen participants underwent serial COAs including the CMT-HI, CMT Functional Outcome Measure (CMT-FOM), CMT Neuropathy Score (CMTNSv2R), and CMT Exam Score (CMTES/CMTES-R).

Practical Aspects of Nuclear Medicine Ventriculoperitoneal Shunt Evaluation.

The radionuclide ventriculoperitoneal shunt evaluation study is a simple test that involves injecting a small volume of radionuclide into the shunt reservoir and then observing its disappearance using dynamic γ-camera imaging. Although it seems simple, there are several potential pitfalls that can result in a misinterpreted or uninterpretable study. This paper is a detailed description of how to avoid the pitfalls and also how to interpret the results.

The National Clinical Care Commission Report to Congress: Leveraging Federal Policies and Programs to Improve Diabetes Treatment and Reduce Complications.

The Treatment and Complications subcommittee of the National Clinical Care Commission focused on factors likely to improve the delivery of high-quality care to all people with diabetes. The gap between available resources and the needs of people living with diabetes adversely impacts both treatment and outcomes. The Commission's recommendations are designed to bridge this gap.

The National Clinical Care Commission Report to Congress: Recommendations to Better Leverage Federal Policies and Programs to Prevent and Control Diabetes.

The National Clinical Care Commission (NCCC) was established by Congress to make recommendations to leverage federal policies and programs to more effectively prevent and treat diabetes and its complications. The NCCC developed a guiding framework that incorporated elements of the Socioecological and Chronic Care Models. It surveyed federal agencies and conducted follow-up meetings with representatives from 10 health-related and 11 non-health-related federal agencies.

Clinical approach to antibody-mediated rejection from the pediatric heart transplant society.

This document is designed to outline the definition, pathogenesis, diagnostic modalities and therapeutic measures to treat antibody-mediated rejection in children postheart transplant METHODS: Literature review was conducted by a Pediatric Heart Transplant Society (PHTS) working group to identify existing pediatric and adult studies on antibody-mediated rejection (AMR). In addition, the centers participating in PHTS were asked to submit their approach to diagnosis and management of pediatric AMR. This document synthesizes information gathered from both these sources to highlight a practical approach to diagnosing and managing a child with AMR postheart transplant.

The Hierarchical Taxonomy of Psychopathology (HiTOP) Is Not an Improvement Over the DSM.

In their response to our article (both in this issue), DeYoung and colleagues did not sufficiently address three fundamental flaws with the Hierarchical Taxonomy of Psychopathology (HiTOP). First, HiTOP was created using a simple-structure factor-analytic approach, which does not adequately represent the dimensional space of the symptoms of psychopathology. Consequently, HiTOP is not the empirical structure of psychopathology.

Congenital Neutropenia with Specific Granulocyte Deficiency Caused by Novel Double Heterozygous Mutations.

SMARCD2 (SWI/SNF-related, matrix-associated, actin-dependent regulator of chromatin, subfamily D, member 2) is critical for myelopoiesis. Recently, bi-allelic SMARCD2 mutations have been reported in five children, causing autosomal recessive congenital neutropenia with specific granulocytes deficiency (CN-SGD); a syndrome resulting in G-CSF resistant neutropenia, recurrent infections, and dysplastic myelopoiesis. We report a new case with CN-SGD caused by two novel heterozygous pathogenic variants in the SMARCD2 gene (c.

Associations of hiatus hernia with CT-based interstitial lung changes: the MESA Lung Study.

Background: Hiatus hernia (HH) is prevalent in adults with pulmonary fibrosis. We hypothesised that HH would be associated with markers of lung inflammation and fibrosis among community-dwelling adults and stronger among (rs35705950) risk allele carriers.

Methods: In the Multi-Ethnic Study of Atherosclerosis, HH was assessed from cardiac and full-lung computed tomography (CT) scans performed at Exam 1 (2000-2002, n=3342) and Exam 5 (2010-2012, n=3091), respectively.

Race Differences in Veteran's Affairs Emergency Department Utilization.

Introduction: African Americans (AAs) experience disparities in chronic pain care. This study aimed to identify the rates of emergency department (ED) utilization for visits associated with chronic pain diagnoses among AAs compared to Whites and to determine variables that accounted for any differences.

Methods: This retrospective observational study used national Veterans Affairs (Veteran's Health Administration) administrative data to identify Veterans with chronic pain diagnoses in 2018.

Physiological Roles of the Rapidly Activated Delayed Rectifier K Current in Adult Mouse Heart Primary Pacemaker Activity.

Robust, spontaneous pacemaker activity originating in the sinoatrial node (SAN) of the heart is essential for cardiovascular function. Anatomical, electrophysiological, and molecular methods as well as mathematical modeling approaches have quite thoroughly characterized the transmembrane fluxes of Na, K and Ca that produce SAN action potentials (AP) and 'pacemaker depolarizations' in a number of different in vitro adult mammalian heart preparations. Possible ionic mechanisms that are responsible for SAN primary pacemaker activity are described in terms of: (i) a Ca-regulated mechanism based on a requirement for phasic release of Ca from intracellular stores and activation of an inward current-mediated by Na/Ca exchange; (ii) time- and voltage-dependent activation of Na or Ca currents, as well as a cyclic nucleotide-activated current, I; and/or (iii) a combination of (i) and (ii).

A Framework for Patient-Centered Pathways of Care for Radiopharmaceutical Therapy: An ASTRO Consensus Document.

Radiopharmaceutical therapy (RPT) is an area of projected growth and importance with several agents in clinical use, new agents in late-phase clinical trials, and many others under testing and development. This article proposes a framework for developing pathways of care that can be broadly applied to all RPTs, representing the current status of RPT. It suggests foundational elements for many pathways of care for patients with cancer and concludes with areas in active development and the future horizon for RPT treatment centers.

Brain arteriovenous malformations: A review of natural history, pathobiology, and interventions.

Brain arteriovenous malformations (AVMs) are anomalous direct shunts between cerebral arteries and veins that convalesce into a vascular nidus. The treatment strategies for AVMs are challenging and variable. Intracranial hemorrhage and seizures comprise the most common presentations of AVMs.

Epidemiology and outcomes of clinically unsuspected venous thromboembolism in children: A systematic review.

Background: Clinically unsuspected venous thromboembolic events (uVTE) detected during routine imaging pose a management challenge due to limited knowledge about their clinical significance. Unsuspected VTE are often referred as "asymptomatic," "incidental," or "clinically silent/occult" VTE.

Objective: To understand the epidemiology, management, and outcomes of uVTE in children.

Dual specificity phosphatase 5 regulates perfusion recovery in experimental peripheral artery disease.

Peripheral artery disease (PAD) is caused by atherosclerotic occlusions of vessels outside the heart, particularly those of the lower extremities. Angiogenesis is one critical physiological response to vessel occlusion in PAD, but our understanding of the molecular mechanisms involved in angiogenesis is incomplete. Dual specificity phosphatase 5 (DUSP5) has been shown to play a key role in embryonic vascular development, but its role in post-ischemic angiogenesis is not known.

Society of Behavioral Medicine Position Statement: Congress should protect immigrants seeking health care.

According to the Migration Policy Institute (2019), as of 2017 the USA was home to approximately 44 million immigrants, the largest number of immigrants in the world. Most of these immigrants relocate from Mexico, India, China, the Philippines, El Salvador, Vietnam, Cuba, and the Dominican Republic. Since 2017, there have been increased reports of Immigrations and Customs Enforcement (ICE) interventions toward immigrants, especially at and near previously delineated "safe areas" such as medical facilities, as immigrants sought health care.

Effect of combined fish oil & Curcumin on murine skeletal muscle morphology and stress response proteins during mechanical unloading.

Skeletal muscle is a highly adaptable tissue capable of remodeling when dynamic stress is altered, including changes in mechanical loading and stretch. When muscle is subjected to an unloaded state (e.g.

Resident Competency and Proficiency in Combined Spinal-Epidural Catheter Placement Is Improved Using a Computer-Enhanced Visual Learning Program: A Randomized Controlled Trial.

Background: Physician educators must balance the need for resident procedural education with clinical time pressures as well as patient safety and comfort. Alternative educational strategies, including e-learning tools, may be beneficial to orient novice learners to new procedures and speed proficiency. We created an e-learning tool (computer-enhanced visual learning [CEVL] neuraxial) to enhance trainee proficiency in combined spinal-epidural catheter placement in obstetric patients and performed a randomized controlled 2-center trial to test the hypothesis that use of the tool improved the initial procedure performed by the anesthesiology residents.

Society of Behavioral Medicine (SBM) position statement: SBM urges Congress to preserve and extend funding for Medicaid services.

In May 2017, the Trump administration proposed steep cuts to Medicaid funding. This proposal was met with bipartisan criticism, as this program provides vital healthcare coverage for vulnerable children, adults, and families, including those living below the federal poverty line. In addition to the proposed funding cuts, federally authorized state restrictions to Medicaid access (e.

Society of Behavioral Medicine (SBM) position statement: SBM urges Congress to preserve and increase the financing of federally funded nutrition assistance programs and services.

Deep cuts have been proposed to federally funded nutrition assistance programs, including the Supplemental Nutrition Assistance Program (SNAP); the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC); and federally subsidized school breakfast and lunch programs. Yet, these programs help parents afford healthy meals for their families, pregnant and postpartum mothers access supplemental foods and health services for themselves and their infants and young children, and children obtain the nutrition necessary for optimal school performance. Participation in these programs is linked with reductions in perinatal morbidity and mortality, improved childhood growth trajectories, enhanced school performance, and reductions in food insecurity and poverty.