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.