Regulatory Issues in Electronic Health Records for Adolescent HIV Research: Strategies and Lessons Learned.

Background: Electronic health records (EHRs) are a cost-effective approach to provide the necessary foundations for clinical trial research. The ability to use EHRs in real-world clinical settings allows for pragmatic approaches to intervention studies with the emerging adult HIV population within these settings; however, the regulatory components related to the use of EHR data in multisite clinical trials poses unique challenges that researchers may find themselves unprepared to address, which may result in delays in study implementation and adversely impact study timelines, and risk noncompliance with established guidance.

Objective: As part of the larger Adolescent Trials Network (ATN) for HIV/AIDS Interventions Protocol 162b (ATN 162b) study that evaluated clinical-level outcomes of an intervention including HIV treatment and pre-exposure prophylaxis services to improve retention within the emerging adult HIV population, the objective of this study is to highlight the regulatory process and challenges in the implementation of a multisite pragmatic trial using EHRs to assist future researchers conducting similar studies in navigating the often time-consuming regulatory process and ensure compliance with adherence to study timelines and compliance with institutional and sponsor guidelines.

The Relation of Maternal Psychosocial Risk Factors to Infant Safe Sleep Practices.

Objectives: Sleep-related infant deaths are a common and preventable cause of infant mortality in the United States. Moreover, infants of color are at a greater risk of sleep-related deaths than are White infants. The American Academy of Pediatrics (AAP) published safe sleep guidelines to minimize the number of sleep-related infant deaths; however, many families face barriers to following these guidelines.

Direct and Indirect Care of Patients With Multiple Sclerosis: Burden on Providers and Impact of Portal Messages.

Background: Multiple sclerosis (MS) indirect patient-care time is often underreported and uncompensated. Data on time spent on indirect and direct care by MS providers is lacking.

Methods: A survey was designed to understand the practice patterns among MS providers in the United States, including time spent on direct and indirect patient care, as well as managing electronic medical record portal messages.

Health equity in pediatrics: Current concepts for the care of children in the 21st century (Dis Mon).

This is an analysis of important aspects of health equity in caring for children and adolescents written by a multidisciplinary team from different medical centers. In this discussion for clinicians, we look at definitions of pediatric health equity and the enormous impact of social determinants of health in this area. Factors involved with pediatric healthcare disparities that are considered include race, ethnicity, gender, age, poverty, socioeconomic status, LGBT status, living in rural communities, housing instability, food insecurity, access to transportation, availability of healthcare professionals, the status of education, and employment as well as immigration.

Obesity, gut microbiota, and multiple sclerosis: Unraveling the connection.

Obesity is associated with chronic mild-grade systemic inflammation and neuroinflammation. Obesity in early childhood and adolescence is also a significant risk factor for multiple sclerosis (MS) development. However, the underlying mechanisms that explain the link between obesity and MS development are not fully explored.

Suvorexant Acutely Decreases Tau Phosphorylation and Aβ in the Human CNS.

Objective: In Alzheimer's disease, hyperphosphorylated tau is associated with formation of insoluble paired helical filaments that aggregate as neurofibrillary tau tangles and are associated with neuronal loss and cognitive symptoms. Dual orexin receptor antagonists decrease soluble amyloid-β levels and amyloid plaques in mouse models overexpressing amyloid-β, but have not been reported to affect tau phosphorylation. In this randomized controlled trial, we tested the acute effect of suvorexant, a dual orexin receptor antagonist, on amyloid-β, tau, and phospho-tau.

An exploratory study of sleep habits in school-aged survivors of retinoblastoma.

Objective/background: Retinoblastoma is an ocular cancer diagnosed in early childhood. Previous research has indicated the impact of cancer treatment on sleep, but little is known about how sleep is impacted among survivors of retinoblastoma. The current study aimed to describe sleep habits of school-age survivors of retinoblastoma, to examine associations between sleep and quality of life, and to examine concordance between parent and child reports of sleep habits.

Acute sleep loss decreases CSF-to-blood clearance of Alzheimer's disease biomarkers.

Introduction: Sleep deprivation increases cerebrospinal fluid (CSF) amyloid beta (Aβ) and tau levels; however, sleep's effect on Aβ and tau in plasma is unknown.

Methods: In a cross-over design, CSF Aβ and tau concentrations were measured in five cognitively normal individuals who had blood and CSF collected every 2 hours for 36 hours during sleep-deprived and normal sleep control conditions.

Results: Aβ40, Aβ42, unphosphorylated tau threonine181 (T181), unphosphorylated tau threonine-217 (T217), and phosphorylated T181 (pT181) concentrations increased ∼35% to 55% in CSF and decreased ∼5% to 15% in plasma during sleep deprivation.

Psychologists' Role in a Multidisciplinary Approach to Pediatric Hematology and Oncology Care.

Pediatric cancer and hematological disorders affect a significant number of children and their families each year. The most impactful and effective patient care involves collaboration of medical providers and psychosocial services. Psychologists have a significant role on a patient's care team and can provide a multitude of services including brief intervention, psychotherapy, assessments, consultation, and additional support to the rest of the team.

Helping Physicians Collaborate with Psychologists.

Physicians have a lot of information to cover in a short amount of time. Over time, this creates burnout and compassion fatigue for physicians. However, psychologists are trained and have a unique skillset they can use to help decrease some of these difficulties.

Perspectives and experiences with COVID-19 vaccines in people with MS.

Background: People with MS may have unique perspectives on COVID-19 vaccines due to their condition and/or medications.

Objective: Assess perspectives and experiences with COVID-19 vaccination, and quantify variables impacting COVID-19 vaccine willingness in people with MS.

Methods: A survey captured demographics, MS characteristics, and COVID-19 infection and exposures data; opinions on COVID-19 vaccine safety, side effects, and efficacy; and experiences following vaccination.

Reduced antibody activity against SARS-CoV-2 B.1.617.2 delta virus in serum of mRNA-vaccinated individuals receiving tumor necrosis factor-α inhibitors.

Background: Although vaccines effectively prevent coronavirus disease 2019 (COVID-19) in healthy individuals, they appear to be less immunogenic in individuals with chronic inflammatory disease (CID) or receiving chronic immunosuppression therapy.

Methods: Here we assessed a cohort of 77 individuals with CID treated as monotherapy with chronic immunosuppressive drugs for antibody responses in serum against historical and variant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viruses after immunization with the BNT162b2 mRNA vaccine.

Findings: Longitudinal analysis showed the greatest reductions in neutralizing antibodies and Fc effector function capacity in individuals treated with tumor necrosis factor alpha (TNF-α) inhibitors (TNFi), and this pattern appeared to be worse against the B.

Multiple sclerosis diagnosis: Knowledge gaps and opportunities for educational intervention in neurologists in the United States.

Background: Few studies have addressed the results of educational efforts concerning proper use of McDonald criteria (MC) revisions outside multiple sclerosis (MS) subspecialty centers. Neurology residents and MS subspecialist neurologists demonstrated knowledge gaps for core elements of the MC in a recent prior study.

Objective: To assess comprehension and application of MC core elements by non-MS specialist neurologists in the United States who routinely diagnose MS.

Central vein sign: A diagnostic biomarker in multiple sclerosis (CAVS-MS) study protocol for a prospective multicenter trial.

The specificity and implementation of current MRI-based diagnostic criteria for multiple sclerosis (MS) are imperfect. Approximately 1 in 5 of individuals diagnosed with MS are eventually determined not to have the disease, with overreliance on MRI findings a major cause of MS misdiagnosis. The central vein sign (CVS), a proposed MRI biomarker for MS lesions, has been extensively studied in numerous cross sectional studies and may increase diagnostic specificity for MS.

Effect of Immunosuppression on the Immunogenicity of mRNA Vaccines to SARS-CoV-2 : A Prospective Cohort Study.

Background: Patients with chronic inflammatory disease (CID) treated with immunosuppressive medications have increased risk for severe COVID-19. Although mRNA-based SARS-CoV-2 vaccination provides protection in immunocompetent persons, immunogenicity in immunosuppressed patients with CID is unclear.

Objective: To determine the immunogenicity of mRNA-based SARS-CoV-2 vaccines in patients with CID.

Evaluation of a Safe Sleep Training for Home Visitors and Their Clients.

Sleep-related deaths are a common preventable cause of death, and such deaths occur disproportionately in families of color. Home visitors provide families with education about infant safe sleep guidelines; however, families face many barriers to engaging in safe sleep practices. This study evaluated the efficacy of a program to train home visitors to talk to clients about infant safe sleep using Motivational Interviewing and cultural sensitivity.

Integrated Behavioral Health Care: Reflections of the Past.

Humans have long sought to be provided with optimal health care, and the research continues in the twenty-first century. In the spirit of Galen from 19 centuries ago, empowering the patient's physician remains an important approach in health care. There is an emphasis on primary care and integration of behavioral consultation services in primary care.

Glucocorticoids and B Cell Depleting Agents Substantially Impair Immunogenicity of mRNA Vaccines to SARS-CoV-2.

Background: Individuals with chronic inflammatory diseases (CID) are frequently treated with immunosuppressive medications that can increase their risk of severe COVID-19. While novel mRNA-based SARS-CoV-2 vaccination platforms provide robust protection in immunocompetent individuals, the immunogenicity in CID patients on immunosuppression is not well established. Therefore, determining the effectiveness of SARS-CoV-2 vaccines in the setting of immunosuppression is essential to risk-stratify CID patients with impaired protection and provide clinical guidance regarding medication management.

Rapid transfer of knowledge for multiple sclerosis clinical care during COVID-19: ECHO MS.

Background: Healthcare providers caring for people with multiple sclerosis (MS) have had significant concerns about the intersection of MS and COVID-19. As a result, there has been an urgency to understand and share information about how to best provide MS clinical care during COVID-19. The Project ECHO model is well-suited for this challenge, as it provides a uniquely efficient and effective approach to sharing information in real-time using real cases.

Clinical and laboratory features distinguishing MOG antibody disease from multiple sclerosis and AQP4 antibody-positive neuromyelitis optica.

Background: Antibodies to myelin oligodendrocyte glycoprotein (MOG) are associated with a CNS inflammatory disorder distinct from multiple sclerosis (MS) and aquaporin-4 antibody-positive neuromyelitis optica (NMO). Knowledge of the clinical spectrum of MOG antibody disease (MOGAD) remains incomplete, particularly in comparison to two related inflammatory demyelinating diseases, MS and NMO.

Objective: Compare demographics, clinical characteristics, estimated disability, laboratory results, and treatment responses of a U.

Autism spectrum disorder: psychological and functional assessment, and behavioral treatment approaches.

There have been significant changes in the way Autism has been defined especially in the last decade. The changes encompass criteria over a spectrum rather than individual diagnoses based on clusters of criteria. With these changes, there has been a push for earlier screening and diagnosis to be made to ensure individual impacted by the deficits have ample time and opportunity to receive the services they need.