Mental Health Emergency Department Visits by Children Before and During the COVID-19 Pandemic.

OBJECTIVES: To describe pediatric mental health emergency department (ED) visit rates and visit characteristics before and during the COVID-19 pandemic. METHODS: We conducted a cross-sectional study of ED visits by children 5-17 years old with a primary mental health diagnosis from March 2018 to February 2021 at a 10-hospital health system and a children's hospital in the Chicago area. We compared demographic and clinical characteristics of children with mental health ED visits before and during the pandemic. We conducted an interrupted time series analysis to determine changes in visit rates. RESULTS: We identified 8,127 pediatric mental health ED visits (58.5% female, 54.3% White, Not Hispanic/Latino and 42.4% age 13-15). During the pandemic, visits for suicide or self-injury increased 6.69% (95% CI 4.73, 8.65), and visits for disruptive, impulse control, conduct disorders increased 1.94% (95% CI 0.85, 3.03). Mental health ED visits by children with existing mental health diagnoses increased 2.29% (95% CI 0.34, 4.25). Mental health ED visits that resulted in medical admission increased 4.32% (95% CI 3.11, 5.53). The proportion of mental health ED visits at community hospitals increased by 5.49% (95% CI 3.31, 7.67). Mental health ED visit rates increased at the onset of the pandemic (adjusted incidence rate ratio [aIRR] 1.27, 95% CI 1.06, 1.50), followed by a monthly increase thereafter (aIRR 1.04, 95% CI 1.02, 1.06). CONCLUSION: Mental health ED visit rates by children increased during the COVID-19 pandemic. Changes in mental health ED visit characteristics during the pandemic may inform interventions to improve children's mental health.

Design and rationale of GUARDD-US: A pragmatic, randomized trial of genetic testing for APOL1 and pharmacogenomic predictors of antihypertensive efficacy in patients with hypertension.

RATIONALE AND OBJECTIVE: APOL1 risk alleles are associated with increased cardiovascular and chronic kidney disease (CKD) risk. It is unknown whether knowledge of APOL1 risk status motivates patients and providers to attain recommended blood pressure (BP) targets to reduce cardiovascular disease. STUDY DESIGN: Multicenter, pragmatic, randomized controlled clinical trial. SETTING AND PARTICIPANTS: 6650 individuals with African ancestry and hypertension from 13 health systems. INTERVENTION: APOL1 genotyping with clinical decision support (CDS) results are returned to participants and providers immediately (intervention) or at 6 months (control). A subset of participants are re-randomized to pharmacogenomic testing for relevant antihypertensive medications (pharmacogenomic sub-study). CDS alerts encourage appropriate CKD screening and antihypertensive agent use. OUTCOMES: Blood pressure and surveys are assessed at baseline, 3 and 6 months. The primary outcome is change in systolic BP from enrollment to 3 months in individuals with two APOL1 risk alleles. Secondary outcomes include new diagnoses of CKD, systolic blood pressure at 6 months, diastolic BP, and survey results. The pharmacogenomic sub-study will evaluate the relationship of pharmacogenomic genotype and change in systolic BP between baseline and 3 months. RESULTS: To date, the trial has enrolled 3423 participants. CONCLUSIONS: The effect of patient and provider knowledge of APOL1 genotype on systolic blood pressure has not been well-studied. GUARDD-US addresses whether blood pressure improves when patients and providers have this information. GUARDD-US provides a CDS framework for primary care and specialty clinics to incorporate APOL1 genetic risk and pharmacogenomic prescribing in the electronic health record. TRIAL REGISTRATION: ClinicalTrials.govNCT04191824.

Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases.

The literature thoroughly describes the challenges of pediatric drug development for rare diseases. This includes (1) generating interest from sponsors, (2) small numbers of children affected by a particular disease, (3) difficulties with study design, (4) lack of definitive outcome measures and assessment tools, (5) the need for additional safeguards for children as a vulnerable population, and (6) logistical hurdles to completing trials, especially with the need for longer term follow-up to establish safety and efficacy. There has also been an increasing awareness of the need to engage patients and their families in drug development processes and to address inequities in access to pediatric clinical trials. The year 2020 ushered in yet another challenge-the COVID-19 pandemic. The pediatric drug development ecosystem continues to evolve to meet these challenges. This article will focus on several key factors including recent regulatory approaches and public health policies to facilitate pediatric rare disease drug development, emerging trends in product development (biologics, molecularly targeted therapies), innovations in trial design/endpoints and data collection, and current efforts to increase patient engagement and promote equity. Finally, lessons learned from COVID-19 about building adaptable pediatric rare disease drug development processes will be discussed.

Electronic Health Record Network Research in Infectious Diseases.

With the marked increases in electronic health record (EHR) use for providing clinical care, there have been parallel efforts to leverage EHR data for research. EHR repositories offer the promise of vast amounts of clinical data not easily captured with traditional research methods and facilitate clinical epidemiology and comparative effectiveness research, including analyses to identify patients at higher risk for complications or who are better candidates for treatment. These types of studies have been relatively slow to penetrate the field of infectious diseases, but the need for rapid turnaround during the COVID-19 global pandemic has accelerated the uptake. This review discusses the rationale for her network projects, opportunities and challenges that such networks present, and some prior studies within the field of infectious diseases.