Cross-Sectional Analysis of Clinical Trial Availability and North Carolina Neighborhood Social Vulnerability.

PURPOSE: Residents of communities facing social vulnerability (eg, poverty) have limited access to clinical trials, leaving them susceptible to experiencing poor health outcomes. We examined the association between North Carolina county-level social vulnerability and available multiple myeloma (MM) trials. METHODS: Using a novel data linkage between ClinicalTrials.gov, the 2019 American Community Survey, and the Centers for Disease Control and Prevention's Social Vulnerability Index, we investigated at the county level (1) availability of MM trial sites and (2) the relationship between Social Vulnerability Index and MM trial site availability using logistic regression. RESULTS: Between 2002 and 2021, 229 trials were registered across 462 nonunique trial sites in 34 counties. Nearly 50% of trial sites were in academic medical centers, 80% (n = 372) of all trials were industry-sponsored, 60% (n = 274) were early-phase, and 50% (n = 232) were for patients with relapsed or refractory MM. Counties with low as opposed to high poverty rates had six times greater odds of having ≥ 1 MM trial sites (odds ratio [OR], 5.60; 95% CI, 1.85 to 19.64; P = .004). Counties with the lowest percentage of Black Indigenous Persons of Color and non-native English speakers had 77% lower odds (OR, 0.23; 95% CI, 0.07 to 0.69; P = .011) of having ≥ 1 trial sites. The effect remained significant after accounting for the presence of five academic medical centers (n = 95; OR, 0.18; 95% CI, 0.05 to 0.6; P = .008) and adjustment for metropolitan, suburban, or rural status (OR, 0.25; 95% CI, 0.07 to 0.81; P = .025). CONCLUSION: Counties with the lowest poverty rates had more MM trial sites, whereas those with the lowest percentage of Black Indigenous Persons of Color populations had fewer MM trial sites. Multilevel efforts are needed to improve the availability and access to trials for socially vulnerable populations.

Neuropathology of murine Sanfilippo D syndrome.

Sanfilippo D syndrome (mucopolysaccharidosis type IIID) is a lysosomal storage disorder caused by the deficiency of N-acetylglucosamine-6-sulfatase (GNS). A mouse model was generated by constitutive knockout of the Gns gene. We studied affected mice and controls at 12, 24, 36, and 48 weeks of age for neuropathological markers of disease in the somatosensory cortex, primary motor cortex, ventral posterior nuclei of the thalamus, striatum, hippocampus, and lateral and medial entorhinal cortex. We found significantly increased immunostaining for glial fibrillary associated protein (GFAP), CD68 (a marker of activated microglia), and lysosomal-associated membrane protein-1 (LAMP-1) in Sanfilippo D mice compared to controls at 12 weeks of age in all brain regions. Intergroup differences were marked for GFAP and CD68 staining, with levels in Sanfilippo D mice consistently above controls at all age groups. Intergroup differences in LAMP-1 staining were more pronounced in 12- and 24-week age groups compared to 36- and 48-week groups, as control animals showed some LAMP-1 staining at later timepoints in some brain regions. We also evaluated the somatosensory cortex, medial entorhinal cortex, reticular nucleus of the thalamus, medial amygdala, and hippocampal hilus for subunit c of mitochondrial ATP synthase (SCMAS). We found a progressive accumulation of SCMAS in most brain regions of Sanfilippo D mice compared to controls by 24 weeks of age. Cataloging the regional neuropathology of Sanfilippo D mice may aid in understanding the disease pathogenesis and designing preclinical studies to test brain-directed treatments.

Analysis of Social Determinants and the Utilization of Pediatric Tele-Urgent Care During the COVID-19 Pandemic: Cross-sectional Study.

BACKGROUND: Telehealth is increasingly used to provide specialty consultations to infants and children receiving care. However, there is uncertainty if the COVID-19 pandemic has influenced the use of telehealth among vulnerable populations. OBJECTIVE: This research aims to compare the overall use of tele-urgent care visits for pediatric patients before and after the pandemic, especially among vulnerable populations. METHODS: We conducted a cross-sectional analysis of pediatric tele-urgent care visits at a virtual care center at a southeastern health care center. The main outcome of this study was the use of pediatrics tele-urgent visits across geographical regions with different levels of social disparities and between 2019 and 2020. RESULTS: Of 584 tele-urgent care visits, 388 (66.4%) visits occurred in 2020 during the pandemic compared to 196 (33.6%) visits in 2019. Among 808 North Carolina zip codes, 181 (22%) consisted of a high concentration of vulnerable populations, where 17.7% (56/317) of the tele-urgent care visits originated from. The majority (215/317, 67.8%) of tele-urgent care visits originated from zip codes with a low concentration of vulnerable populations. There was a significant association between the rate of COVID-19 cases and the concentration level of social factors in a given Zip Code Tabulation Area. CONCLUSIONS: The use of tele-urgent care visits for pediatric care doubled during the COVID-19 pandemic. The majority of the tele-urgent care visits after COVID-19 originated from regions where there is a low presence of vulnerable populations. In addition, our geospatial analysis found that geographic regions with a high concentration of vulnerable populations had a significantly higher rate of COVID-19-confirmed cases and deaths compared to regions with a low concentration of vulnerable populations.