Blood Lead Surveillance and Exposure Sources Among Alaska Children.

CONTEXT: Nationally, the child lead poisoning prevention strategy focuses on children in low-income communities living in old housing with lead paint. In Alaska, however, only about 3% of existing homes were built before 1950 and 38% were built during 1950-1979. As such, lead paint in old housing is a less frequent source of exposure for Alaska children with elevated blood lead levels (EBLLs). PROGRAM: The Alaska Department of Health and Social Services collects and maintains data for all blood lead level (BLL) tests in the state and is responsible for following up on EBLLs. IMPLEMENTATION: The Alaska Department of Health and Social Services conducts telephone interviews with parents of children with an EBLL to identify and remove possible sources of lead from the child's environment and prevent subsequent exposure. EVALUATION: This review summarizes the surveillance data on BLLs in Alaska children for 2011-2015 and describes the most commonly identified possible sources of childhood lead exposure statewide since 2011. DISCUSSION: While the proportion of children in Alaska who received a BLL test during these years is low compared with other states and EBLL prevalence is low among children tested, several possible sources of exposure were identified among children with EBLLs, including nonpaint sources. This report summarizes the challenges of combatting childhood lead exposure in a rural state where housing is a less common exposure source and describes ongoing work to prevent childhood lead exposure in Alaska.

Reporting of Demographics & Subgroup Analyses in Premarketing Studies of FDA Approved High-Risk Cardiovascular Devices, 2014-2022.

Background: Representation of diverse study populations in pivotal clinical trials for medical devices and subgroup analyses for demographic groups to explore differences in safety and effectiveness are essential to understanding the benefits and risks in diverse populations. The US Food and Drug Administration (FDA) has taken many steps to improve transparency and subgroup analyses over the past decade, but there has not been a recent evaluation of demographic reporting and subgroup analyses. Methods: We reviewed all FDA Premarket Approvals for high-risk cardiovascular devices from 2014 to 2022, focusing on pivotal studies supporting device approval. We abstracted detailed demographic data about the age, sex, race, ethnicity, and socioeconomic position of study participants. We also assessed the presence and results of subgroup analyses to understand the safety and effectiveness of devices across trial populations. Results: Analysis of 92 pivotal studies revealed that age and sex were reported in 96.7% of the studies, while race and ethnicity were reported in 71.7% and 58.7%, respectively. However, only 7.9% of studies explicitly detailed the participation of older adults (≥65 years) and no studies reported patients' socioeconomic position. Subgroup analyses by sex were conducted in 70.7% of studies, with 12.3% reporting significant differences. In contrast, analyses by race and ethnicity were performed in only 12.0% of the studies, with 9.1% reporting significant differences. Conclusion: Approximately one-third of pivotal studies for high-risk cardiovascular devices approved by the FDA from 2014 to 2022 did not report the race of study participants, nearly 40% did not report ethnicity, and more than 90% did not report the participation of older adults (≥65 years). Subgroup analyses were infrequently conducted by age or race and ethnicity. There is a need for better trial demographic reporting and conduct of subgroup analyses in premarketing studies to ensure the safety and effectiveness of medical devices for all patients.

An evaluation of off-label fenoldopam use in the neonatal intensive care unit.

We analyzed the effect of off-label fenoldopam (FDM) therapy on electrolyte balance, renal function, blood pressure, and urinary output in neonatal patients. We performed a retrospective review of 22 neonates treated with FDM in two neonatal intensive care units. Primary outcome compared physiological status 24 hours before FDM therapy to the first 24 hours of FDM therapy. Electrolytes, blood urea nitrogen (BUN), creatinine, fluid intake, respiratory support, blood pressure, and heart rate were also compared. FDM was used to treat oliguria and anasarca. Seven infants were supported with extracorporeal membrane oxygenation. Gestation ranged 24 to 39 weeks (median 37) and postnatal age, 1 to 89 days (median 10). FDM dose increased over time (median initial dose 0.10 microg/kg/min versus 0.20 at 48 hours). FDM therapy had no effect on serum creatinine, electrolytes, or cardiopulmonary function but was associated with a significant increase in BUN ( P = 0.008). Urine output did not increase significantly for the group as a whole (paired T test) but did significantly increase during the initial 24-hour infusion among oliguric infants. Low-dose FDM did not improve urine output in critically ill neonates as a whole. There were no apparent adverse cardiopulmonary or metabolic effects from FDM use in this limited population. Future FDM use in the context of a randomized prospective trial appears warranted in the early management of infants with oliguria.

The State of Alaska's early experience with institutionalization of health impact assessment.

BACKGROUND: Many nations routinely include health impact assessments (HIA) in public policy decisions. Institutionalization of HIA formally integrates health considerations into a governmental decision-making process. We describe an example of institutionalization in the United States through Alaska's early experience with institutionalization of HIA. LITERATURE REVIEW: HIA arose from a series of health conferences in the 1970s that affirmed the importance of "health for all." A number of key milestones eventually defined HIA as a unique field of impact assessment. There are several approaches to institutionalization, and one common approach in the United States is through the National Environmental Policy Act (NEPA). NEPA formed the basis for the earliest HIAs in Alaska. PROGRAM DESCRIPTION: Early HIAs in Alaska led to conferences, working groups, a state guidance document and the institutionalization of a HIA program within the Department of Health and Social Services in 2010. A medical epidemiologist staffs the program, which utilizes contractors to meet rising demand for HIA. The HIA program has sustainable funding from the state budget and from the state's natural resource permitting process. The HIA document is the main deliverable, but the program performs other tasks, including fieldwork and technical reviews. The HIA program works closely with a host of collaborative partners. CONCLUSION: Alaska's institutionalized HIA program benefits from sustainable funding that promotes continuous quality improvement and involves the program in the entire life cycle of a development project. The program structure adapts well to variations in workflow and supports a host of quality control activities. Currently, the program focuses on HIAs for natural resource development projects.