Disparities In Enrollment Research Articles

The Black and African American Connections to Parkinson’s Disease (BLAAC PD) study protocol

Determining the genetic contributions to Parkinson’s disease (PD) across diverse ancestries is a high priority as this work can guide therapeutic development in a global setting. The genetics of PD spans the etiological risk spectrum, from rare, highly deleterious variants linked to monogenic forms with Mendelian patterns of inheritance, to common variation involved in sporadic disease. A major limitation in PD genomics research is lack of racial and ethnic diversity. Enrollment disparities have detrimental consequences on the generalizability of results and exacerbate existing inequities in care. The Black and African American Connections to Parkinson’s Disease (BLAAC PD) study is part of the Global Parkinson’s Genetics Program, supported by the Aligning Science Across Parkinson’s initiative. The goal of the study is to investigate the genetic architecture underlying PD risk and progression in the Black and/or African American populations. This cross-sectional multicenter study in the United States has a recruitment target of up to 2,000 individuals with PD and up to 2,000 controls, all of Black and/or African American ancestry. The study design incorporates several strategies to reduce barriers to research participation. The multifaceted recruitment strategy aims to involve individuals with and without PD in various settings, emphasizing community outreach and engagement. The BLAAC PD study is an important first step toward informing understanding of the genetics of PD in a more diverse population.

Automatic Enrollment in Patient Portal Systems Mitigates the Digital Divide in Healthcare: An Interrupted Time Series Analysis of an Autoenrollment Workflow Intervention

PurposeRacial and ethnic healthcare disparities require innovative solutions. Patient portals enable online access to health records and clinician communication and are associated with improved health outcomes. Nevertheless, a digital divide in access to such portals persist, especially among people of minoritized race and non-English-speakers. This study assesses the impact of automatic enrollment (autoenrollment) on patient portal activation rates among adult patients at the University of California, San Francisco (UCSF), with a focus on disparities by race, ethnicity, and primary language.Materials and methodsStarting March 2020, autoenrollment offers for patient portals were sent to UCSF adult patients aged 18 or older via text message. Analysis considered patient portal activation before and after the intervention, examining variations by race, ethnicity, and primary language. Descriptive statistics and an interrupted time series analysis were used to assess the intervention’s impact.ResultsAutoenrollment increased patient portal activation rates among all adult patients and patients of minoritized races saw greater increases in activation rates than White patients. While initially not statistically significant, by the end of the surveillance period, we observed statistically significant increases in activation rates in Latinx (3.5-fold, p = < 0.001), Black (3.2-fold, p = 0.003), and Asian (3.1-fold, p = 0.002) patient populations when compared with White patients. Increased activation rates over time in patients with a preferred language other than English (13-fold) were also statistically significant (p = < 0.001) when compared with the increase in English preferred language patients.ConclusionAn organization-based workflow intervention that provided autoenrollment in patient portals via text message was associated with statistically significant mitigation of racial, ethnic, and language-based disparities in patient portal activation rates. Although promising, the autoenrollment intervention did not eliminate disparities in portal enrollment. More work must be done to close the digital divide in access to healthcare technology.

Racial representation in multicenter clinical trials leading to drug approvals for gynecological cancer indications by the US Food and Drug Administration (FDA).

66 Background: Enrollment disparities in gynecologic (Gyn) cancer clinical trials in the United States (US) are well-documented. However, there is limited data evaluating how recruitment sites in international clinical trials contribute to racial representation, specifically in Gyn cancers. Here, we examined racial enrollment and geographic location in clinical trials that have led to approval for Gyn cancer applications. Methods: Agents approved by the FDA for Gyn cancer treatment and corresponding clinical trials were identified from the FDA Drug Approvals and Databases. Enrollment data were abstracted from ClinicalTrials.gov then cross-checked with published manuscripts and FDA labels. Using Gyn disease site prevalence from the 2021 SEER database, we calculated expected enrollment proportions by race and compared these to actual clinical trial enrollment data. The binomial test was used to compare expected vs. observed proportions with White patients as the reference group. Results: From 2014 to 2024, 9 drugs received 22 FDA approvals for ovarian (n=13), endometrial (n=4), or cervical cancer (n=5). These approvals were based on 28 clinical trials enrolling a total of 13,763 patients (75.7% White, 3.4% Black, 12.0% Asian, 8.9% Other/Unknown). These trials included 1 (3.6%) US only study, 3 (10.7%) non-US, primarily Europe-based studies (PAOLA-1, AURELIA, STUDY42 [Europe + Australia]), and 24 (85.7%) international studies across the US and 46 other countries. Considering the distribution of race (White: 86.3%, Black: 8.4%, Asian: 4.9%) of Gyn cancers in the US, Black patients had lower enrollment (45% of expected enrollment) vs. White patients (95% of expected enrollment, P&lt;0.0001). African countries were rarely included among the recruitment sites. Two international trials reported patient recruitment from South Africa (3.2% Black, 6/188 patients, 38% of expected enrollment).However, Asian patients had higher enrollment (269% of expected enrollment, P&lt;0.0001) compared to White patients. In 13 trials that included study sites in East Asia, Asian patients comprised 16% of the trial population (1310/8205 patients; 327% of expected enrollment) vs. 3.2% in trials that did not open in Asia (n=15) (181/5558 patients; 67% of expected enrollment). Conclusions: Black patients were underrepresented in pivotal trials that led to FDA approvals for Gyn cancers. Overrepresentation of Asian patients was likely due to international enrollment from East Asia. Post-marketing retrospective studies or additional studies focused on underrepresented groups are needed to assess true drug efficacy and safety in US populations that are disproportionately affected by Gyn cancer mortality.

S303 Assessing Enrollment Disparities by Demographics in Colorectal Cancer Clinical Trials Across the United States

S303 Assessing Enrollment Disparities by Demographics in Colorectal Cancer Clinical Trials Across the United States

Racial and ethnic representation of youth in type 1 diabetes interventional trials

BackgroundUnderrepresentation of racial and ethnic groups in clinical trials can limit generalizability of research findings and equitable access to treatment. This study evaluates racial and ethnic representation of youth in US-based interventional trials on childhood type 1 diabetes (T1D). MethodsThis cross-sectional study examined interventional trials of T1D conducted in the US and registered on ClinicalTrials.gov. Trials were included if completed as of June 6, 2023, began between years 2010 and 2022, and exclusively enrolled youth ≤19 years old. We assessed representation of racial and ethnic groups in T1D trials, estimated using the enrollment-prevalence difference (EPD). ResultsA total of 106 trials were eligible for inclusion. Of those eligible, 62 (58 %) trials reported participant race or ethnicity and were included in the analyses. Significant disparities in enrollment were observed for American Indian/Alaska Native, Asian/Pacific Islander, Black, and Hispanic youth compared to their respective contribution to disease burden among youth in the US. Disparities in trial enrollment were greatest for Black (EPD, −10.2; 95 % confidence interval [CI], −14.4 to −7.9) and Hispanic (EPD, −7.7; 95 % CI, −12.6 to −4.8) youth. EPDs of trials conducted prior to year 2017 did not differ significantly from those conducted as of year 2017. ConclusionsHistorically marginalized racial and ethnic youth were underrepresented in T1D trials. Strategies to improve recruitment of these populations are needed to reduce inequities in diabetes treatment and outcomes.

The consequences of the COVID-19 pandemic on human development, education and social welfare: A case of Central Visayas

This paper highlights the significant impact of the pandemic on the social sector. To curb infection spread, social and economic activities were limited, challenging human development. The study utilized an ecological design to analyze the situation of the social sector in Central Visayas, Philippines. Data from government and international organizations revealed strengths and vulnerabilities in these areas. Notably, disparities in enrollment and graduation rates before and during the pandemic indicate issues in retaining students. Poor performance, low cohort survival, and declining literacy rates suggest future societal challenges with less competent individuals. Additionally, increasing population density, teenage pregnancy, depression, and suicide rates compromise social welfare. The region requires improved access to quality education, responsive social safety nets, and strengthened physical and mental health programs to enhance human and social development and future-proof the sector.

Rural-urban disparity in community-based health insurance enrollment in Ethiopia: a multivariate decomposition analysis using Ethiopian Mini Demographic Health Survey 2019.

In sub-Saharan Africa, achieving universal health coverage (UHC) and protecting populations from health-related financial hardship remain challenging goals. Subsequently, community-based health insurance (CBHI) has gained interest in low and middle-income countries, such as Ethiopia. However, the rural-urban disparity in CBHI enrollment has not been properly investigated using multivariate decomposition analysis. Therefore, this study aimed to assess the rural-urban disparity of CBHI enrollment in Ethiopia using the Ethiopian Mini Demographic Health Survey 2019 (EMDHS 2019). This study used the latest EMDHS 2019 dataset. STATA version 17.0 software was used for analyses. The chi-square test was used to assess the association between CBHI enrollment and the explanatory variables. The rural-urban disparity of CBHI enrollment was assessed using the logit-based multivariate decomposition analysis. A p-value of <0.05 with a 95% confidence interval was used to determine the statistical significance. The study found that there was a significant disparity in CBHI enrollment between urban and rural households (p < 0.001). Approximately 36.98% of CBHI enrollment disparities were attributed to the compositional (endowment) differences of household characteristics between urban and rural households, and 63.02% of the disparities were due to the effect of these characteristics (coefficients). The study identified that the age and education of the household head, family size, number of under-five children, administrative regions, and wealth status were significant contributing factors for the disparities due to compositional differences between urban and rural households. The region was the significant factor that contributed to the rural-urban disparity of CBHI enrollment due to the effect of household characteristics. There were significant urban-rural disparities in CBHI enrollment in Ethiopia. Factors such as age and education of the household head, family size, number of under-five children, region of the household, and wealth status of the household contributed to the disparities attributed to the endowment, and region of the household was the contributing factor for the disparities due to the effect of household characteristics. Therefore, the concerned body should design strategies to enhance equitable CBHI enrollment in urban and rural households.

School Choice and Students With Disabilities: Evidence From Administrative Data

School choice has emerged as an alternative to traditional public education, allowing families to select schools outside their neighborhood. While extensive research has examined its impact on students overall, there is a need to focus on its specific effects on students with disabilities. This article addresses this gap by reviewing 39 quantitative studies analyzing this issue using administrative data. Twenty-eight focus on charter schools, and 18 compare differences in enrollment—usually referred to as the “SPED gap”—between sectors. However, few publications explore factors contributing to these disparities or variations in services provided and their impact on student outcomes. We propose future research should (a) explore outcomes beyond enrollment disparities, including both academic and non-academic aspects, as well as short and long-term consequences; (b) employ rigorous statistical methods; (c) broaden the scope of the investigation to encompass diverse states and contexts, as well as other choice policies.

Enrollment of underserved racial and ethnic populations in pediatric asthma clinical trials

BackgroundLimited data exist on enrollment trends of historically underserved racial and ethnic children in clinical trials. ObjectiveWe sought to evaluate documentation and representation of race and ethnicity in pediatric asthma clinical trials in the US. MethodsThis is a cross-sectional study of US-based interventional trials studying pediatric asthma completed between 2008 and 2022 and registered on ClinicalTrials.gov. Enrollment disparities were assessed using the enrollment prevalence difference (EPD) measure – the median difference between the proportion of participants enrolled and asthma prevalence in the US population by race and ethnicity. ResultsOf the 67 trials reviewed, 53 (79.2%) and 36 (53.7%) reported on race and ethnicity in ClinicalTrials.gov, respectively. Most participants were White (39.1%), Black (37.1%), and non-Hispanic (66.1%). Black, Hispanic, Multiracial, and White children were enrolled in expected proportions based on their contribution to asthma burden. However, American Indian or Alaska Native (AI/AN) (EPD: -1, 95% CI: -1, -1) and Asian children (EPD: -3, 95% CI: -3, -3) were underrepresented, relative to disease burden in these respective groups. Fewer Black children were enrolled in drug or device trials (β=-0.80; 95% CI -1.60, -0.01) than in other trials. Fewer Hispanic children were enrolled in early phase than late phase trials (β=-2.42; 95% CI -3.66, -1.19). ConclusionsEnrollment in pediatric asthma trials conducted in the US was commensurate with the demographics of children affected by asthma for most racial and ethnic groups, but AI/AN and Asian children were underrepresented. Concerted efforts are needed to promote inclusion of these underserved groups in future trials.

Investigating racial and gender disparities in virtual randomized clinical trial enrollment: Insights from the BE ACTIVE study

Randomized clinical trials (RCTs) often suffer from a lack of representation from historically marginalized populations, and it is uncertain whether virtual RCTs (vRCTs) enhance representativeness or if elements of their consent and enrollment processes may instead contribute to underrepresentation of these groups. In this study, we aimed to identify disparities in enrollment demographics in a vRCT, the BE ACTIVE study, which recruited patients within a single health system. We discovered that the proportions of eligible patients who were randomized differed significantly by gender and race/ethnicity (men 1.2%, women 2.0%, P < .001; White 1.8%, Black 1.3%, Hispanic 0.7%, Asian 0.9%; P < .001), and compared with White patients, non-White patients were less likely to have a valid email address on file and were less likely to click on the email link to the study webpage and begin enrollment.

Sex, racial, and ethnic disparities in motor neuron disease: clinical trial enrolment

Objective Motor neuron disease (MND) is a group of neurological diseases, the majority being amyotrophic lateral sclerosis (ALS), with varying clinical presentations across demographics. Clinical trial enrollment reflecting global disease burden improves understanding of diverse presentations and aids personalized therapy development. We assessed the sex, racial, and ethnic composition of MND/ALS clinical trial participants relative to global disease burdens. Methods We searched ‘motor neuron disease OR amyotrophic lateral sclerosis’ on ClinicalTrials.gov from 02/2000–04/2024. We extracted trial (start year, study site, sponsor location, phase, masking, intervention) and demographic data (sex, race, ethnicity) from randomized interventional studies. We obtained sex-based MND/ALS disease burden estimates from the Global Burden of Disease database. For females, we calculated pooled participation-to-prevalence ratio (PPR) with 95% confidence intervals (CIs), with PPR of 0.8–1.2 indicating adequate enrollment. We used Kruskal–Wallis tests to compare demographic groups across trial characteristics. Results Of 85 trials, females comprised 37.47% (n = 5011) of 13,372 participants; the pooled female PPR was 0.97 (95% CI: 0.77–1.16). Of 41 trials (9340 participants) reporting race, 121 (1.30%) participants were Black or African American, 16 (0.17%) American Indian or Alaskan Native, and 6 (0.06%) Native Hawaiian or Other Pacific Islander. 24 trials (595 participants) reported ethnicity, with a minority of Hispanic participants (n = 153; 2.57%). Conclusions MND/ALS clinical trials had adequate female enrollment relative to global disease burdens. Race and ethnicity data were underreported. However, there were enrollment disparities of racial and ethnic groups. Increased trial leadership diversity, equitable enrollment policies, and addressing barriers to participation could improve enrollment diversity.

Investigating disparities in enrollment of patients in lung cancer clinical trials that led to FDA approval for immunotherapies between 2015 and 2023: A comparison with the US population.

e23104 Background: Registrational clinical trials have led to the FDA approval of numerous immunotherapy (IO) agents in the treatment of non-small cell lung cancer (NSCLC) since 2015. Given the historical lack of adequate representation of the US population with cancer in clinical trials, we aimed to analyze disparities in race and ethnicity reporting and enrollment in lung cancer clinical trials that led to FDA-approved immunotherapies between 2015-2023. Methods: The FDA archives and database were queried to review all FDA drug approvals for IO approved to treat NSCLC between 2015 to 2023. Enrollment data were obtained from FDA labels, ClinicalTrials.gov, and corresponding journal manuscripts. The enrollment incidence ratio (EIR) and enrollment mortality ratio (EMR) were calculated as the proportion of patients of a particular race among clinical trial participants in approval studies divided by the estimated proportion of patients of that particular race diagnosed or dying of lung cancer, respectively, among the US population. Results: Among 27 trials with a total of 15,878 subjects, distribution by race shows that 77.5% were White, 16.7% Asian, 8.8% Hispanic, 1.63% Black, 0.33% American Indian Alaska Native (AIAN), and 0.07% were Native Hawaiian and Other Pacific Islander (NHOPI). 67.4% were males while 32.6% were females. The EIR for Non-Hispanic White, Non-Hispanic Black, Asian, and Hispanic patients was 0.99, 0.13, 3.56, and 0.85 respectively. The EMR for Non-Hispanic White, Non-Hispanic Black, Asian, and Hispanic patients was 0.99, 0.12, 4.23, and 0.96 respectively. Racial demographics were reported in 65% of journal manuscripts, 65% of ClinicalTrials.gov pages, and 92% of FDA labels while ethnicity demographics were reported in 0% of journal manuscripts, 42% of ClinicalTrials.gov pages, and 15% of FDA labels. Conclusions: Black, AIAN and female patients are severely underrepresented in lung cancer trials that lead to approval for IO based therapy. Asian patients were overrepresented. Less than half of the trials reported data on ethnicity. Further research is needed to see if regulatory initiatives to increase clinical trial diversity result in more equitable clinical trial enrollment in pivotal trials.

Gender disparity in enrollment in clinical trials for hairy cell leukemia (HCL) in the last 40 years.

e19024 Background: Hairy Cell Leukemia (HCL) is a B-cell lymphoproliferative disorder characterized by infiltration of the bone marrow, liver, and spleen by malignant B cells with hairy cell cytoplasmic projections(1). There is a significant predominance of HCL in males, with a male-to-female ratio of 4:1, especially in Western countries. Differences have been found in the role of gender influencing the severity of the disease. The latest data had identified better outcomes in females with HCL(2). In the last 40 years of HCL research a distinct gender participation gap has surfaced, favoring males in the enrollment of clinical trials. Our study aims to investigate the contributing factors to this imbalance, such as physio-pathological reasons, socio-demographic characteristics, accessibility barriers, and awareness limitations. Methods: In this descriptive, retrospective study, we searched EMBASE, PUBMED, and ClinicalTrials.gov from January 1983 to December of 2023 for publications on randomized clinical trials (RCT) in Hairy Cell Leukemia. The number of participants in clinical trials, their gender, the country where the trial was conducted, year of publication was recorded and descriptive statistical analysis of all the variables was performed. Results: We identified 57 studies comprising 4595 individuals with different subtypes of HCL. Of the total RCT, 79.10% of the patients were male and 20.89% were female. 49.12% of the studies were performed in the United States, 38.59% in Western Europe, 5.26% in Eastern Europe, and the remaining in Japan, Australia, and Iran. 36.84% of RCT were performed between 2000 and 2010. The male-to-female ratio was 7.92 for RTC performed between 1983 to 1989, 3.81 for RCT performed between 1991 to 1999 and 3.36 for RCT performed between 2000 and 2010. Conclusions: Female patients with HCL were recently shown to have a significantly longer progression free survival than male patients. Our retrospective analysis confirms that there is smaller than expected percentage of female participants enrolled in HCL clinical trials published over the last four decades. When examining the male-to-female ratio over different time periods there was a notable decrease from RCTs performed in the 1980s compared to RTCs performed after 2000. The gender disparity observed in clinical trials where males may be overrepresented could be attributed to the predominantly higher prevalence of both newly diagnosed and relapsed HCL in males, making them more likely to be eligible for the RCT. Bridging this gender gap in trials is crucial to accurately reflect the efficacy of novel therapies in both males and females, enabling improved treatment design and better outcomes for all.

End of life (EOL) care in head and neck squamous cell carcinoma (HNSCC) compared to other solid tumors (OST) in Washington (WA) State.

11147 Background: Real world data describing EOL care in HNSCC is limited. We performed a retrospective study evaluating EOL in HNSCC vs OST in a population-based sample of patients in WA. Methods: We used a database linking WA state cancer registry records with claims records from Medicare, Medicaid, and two large commercial insurers. Patients with HNSCC (oral cavity, oropharynx, hypopharynx, or larynx) were compared to OST (any solid tumor diagnosis). Adults with AJCC stage II-IV or SEER stage Regional/Distant who died in 2011-2021 with continuous insurance enrollment 6 months before death were included. We compared proportions of patients with &gt;1 ED visits in the last 30 days of life, ICU admission in the last 30 days of life, chemotherapy in the last 14 days of life, and hospice enrollment at least 3 days prior to death. We performed multivariate regression analysis to determine factors associated with hospice enrollment. Results: 1,389 patients with HNSCC and 41,412 patients with OST were identified. Demographics for HNSCC vs OST included median age 68 vs 73, white race 91.5% vs 90.1%, stage IV 57.5% vs 45.3%. Insurance types for HNSCC vs OST were commercial 8.4% vs 9.8%, Medicaid 16.6% vs 8.8%, Medicare 59.1% vs 65.5%, multiple 15.8% vs 15.9% (p&lt;0.0001). HNSCC patients had lower rates of &gt;1 ED visits compared to OST (14.1% vs 16.4%, p=0.02); there was no significant difference in ICU admission (25.1% vs 24.0%, p=0.3) or chemotherapy receipt (6.3% vs 5.1%, p=0.056). Hospice enrollment was significantly lower in HNSCC patients (49.0% vs 56.4%, p&lt;0.0001). A stratified analysis limited to stage IV patients yielded consistent findings in all categories. HNSCC patients died more at home and less in hospice (20.2% vs 12.7% and 41.5% vs 52.0%, p&lt;0.0001). In a multivariate regression analysis (Table) HNSCC, black race, living with a partner, or living in neighborhoods with higher area deprivation index (ADI) was associated with lower hospice enrollment. Patients with Medicare or multiple insurance types were more likely to enroll in hospice; AJCC stage was not significant. Conclusions: In this population-based sample, compared to OST, a greater proportion of HNSCC patients were insured by Medicaid at EOL and were less likely to enroll in hospice prior to death. The reasons driving these observed disparities in hospice enrollment warrant further study to optimize EOL care among patients with HNSCC. [Table: see text]

Real-world assessment of treatment-related symptoms and associated burden among African American and Caucasian patients receiving chemotherapy in the US.

11102 Background: In the treatment of breast cancer, research has identified racial differences in the ability to receive the full dose of prescribed chemotherapy which may be due in part to cancer-treatment symptom burden. In clinical trials, evaluation by race is challenging due to enrollment disparities, with African Americans (AA) accounting for 7% of trial participants, but comprising 12% of the US total population. The objective of this study is to evaluate treatment-related symptoms and treatment burden among patients treated with chemotherapy through an electronic remote symptom monitoring system, and explore whether there were any racial differences. Methods: Patients (pts) diagnosed with multiple myeloma, breast, ovarian, or lung cancer in academic cancer practices were enrolled in Carevive’s Patient Reported Outcomes Mobile Platform (Carevive PROmpt) between September 2020 and June 2023. A total of 1000 pts received chemotherapy alone or in combination. PRO-CTCAE-derived weekly surveys assessed severity, frequency, and interference for 16 symptoms: anxiety, constipation, cough, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth/throat sores, muscle pain, nausea, numbness and tingling, rash, sadness, shortness of breath, and vomiting. The GP5 assessed weekly overall burden from treatment. Results: The mean age of pts was 60.9 (SD=12.8) years, with 75% female, and 20% AA. At the time of enrollment, fatigue was reported by roughly 48% of AA and Caucasian (C) pts. Muscle pain was noted in 38% of AA pts, followed by general pain (33%), and anxiety (30%), with constipation, decreased appetite, insomnia, nausea, and numbness/tingling occurring in over 20% of pts. A different pattern was observed in C pts, with anxiety occurring in 38%, followed by cough, decreased appetite, general pain, insomnia, muscle pain, nausea, and numbness/tingling present in 20% of pts. The proportion of pts at least “somewhat” bothered by the side effects of treatment were similar (44% AA, 45% C). Conclusions: This study enabled evaluation of symptom burden in cancer in a population closer in racial representation to the real world than in clinical trials; with AA representation being three-fold that seen in clinical trials. Consistent with a qualitative study of AA breast cancer pts, fatigue was identified as the most frequent symptom among those treated with chemotherapy either alone or in combination in the real world. Racial differences in the proportions of pts reporting pain (muscle or general) and anxiety suggest that treating physicians should consider these symptoms to ensure they do not interfere with patients’ ability to receive full chemotherapy courses. Additionally, the levels of anxiety reported in patients highlights the importance of considering concomitant psycho-oncology treatments in cancer therapy.

Racial differences in genomic profiles and targeted treatment use in ER+ HER2- metastatic breast cancer.

1017 Background: Despite well-documented disparities in survival between patients (pts) with Black and White racial backgrounds, there are limited data on racial equity of targeted treatment use for pts with estrogen receptor positive, HER2 negative (ER+/HER2-) metastatic breast cancer (MBC). We evaluated differences in circulating tumor DNA (ctDNA) genomic alterations in Black and White pts with ER+/HER2- MBC. Methods: This retrospective cohort study analyzed a database of 1327 pts with MBC who were treated at Washington University in St. Louis, Massachusetts General Hospital, and Northwestern University and had ctDNA testing through the commercially available Guardant360 assay. Progesterone receptor (PR) status of the ER+/HER2- pts was identified to categorize pts as ER+/PR+/HER2- (N=60 Black, N=435 White) and ER+/PR-/HER2- (N=24 Black, N=237 White). Pts were evaluated by self-reported race and use of PIK3CA, CDK4/6, and mTOR inhibitors, either through clinical trial enrollment or after FDA approval. A multivariate logistic analysis was performed to determine genomic and prognostic differences by race. Overall survival (OS) from time of first ctDNA testing was determined by subgroup. Results: Black pts with PIK3CA single nucleotide variants (SNVs) were significantly less likely to receive targeted therapy than White pts (5.9%, 1/17 pts vs. 28.8%, 45/156 pts, Fisher’s exact test p=0.045), while there was no difference in use of CDK4/6 or mTOR inhibitors. None of the Black pts with PIK3CA mutations were enrolled in clinical trials vs. 11.5% of White pts. Black pts with ER+/PR+/HER2- tumors were more likely to have CCND1 copy number variation (cnv) (odds ratio (OR) 2.4, 95% confidence interval (CI) 1.1-5.4, p=0.030) when compared with White pts. Black pts with PR- tumors were more likely to have de novo metastatic disease (OR 3.4, 95% CI 1.1-10.8, p=0.034) and GATA3SNV (OR 3.5, 95% CI 1.04-11.6, p=0.044). KRAS cnv was more common in White PR- pts (HR 2.9, CI 1.02-8.3, p=0.045). There were significant differences in OS between Black and White pts with ER+/PR+/HER2- tumors (median OS of 25 vs. 32 months, respectively) and for Black and White pts with ER+/PR-/HER2- MBC, (median OS of 9.1 vs. 21 months, respectively, log-rank test p=0.00093). Conclusions: To our knowledge, this is the largest clinicogenomic dataset comparing genomic alterations and targeted treatment use by race in MBC. We identified significant disparities in the use of PI3K inhibitors for Black pts while other drugs that do not require genomic profiling were similarly utilized. OS and clinical trial enrollment disparities are consistent with prior findings and must continue to be addressed. Further research is needed to validate these findings, elucidate the factors contributing to these disparities, and explore interventions to improve racial disparities in use of precision medicine therapies and enrollment in clinical trials.

Enhancing College Access in Zimbabwe: Impact of Student Loans and Grants

This study explores how government interventions, grants, and loans influence college access in Zimbabwe, focusing on understanding the factors affecting college access and retention rates. The research aims to inform evidence-based decision-making regarding college access through a mixed research approach integrating qualitative and quantitative methods. Combining both qualitative and quantitative methods to ensure the validity and reliability of the findings. It analyses secondary data sources, such as literature, reports, and statistical datasets, to explore aspects like college access, enrollment trends, poverty rates, financial aid programs, and student loan systems in Zimbabwe. Triangulation techniques enhance the credibility of the study's findings by integrating evidence from various sources and employing diverse data collection and analysis methods, enriching perspectives and strengthening the validity and reliability of the study's conclusions. Key findings suggest that grants and loans significantly contribute to increasing college enrollment rates, particularly among economically disadvantaged groups. However, enrollment disparities persist, especially among marginalized populations like women. Despite a modest increase in government spending on education, concerns arise due to a slowdown in overall enrollment growth. Barriers to student loan uptake include complex application processes, concerns about debt burdens, and uncertainties regarding post-graduation employment prospects. The study emphasizes the importance of comprehensive policy interventions to simplify eligibility criteria, enhance financial literacy, and promote employment pathways. Using human capital and open systems theories, the research lays a groundwork for evidence-based decision-making to enhance access to higher education in Zimbabwe.

Diversity in enrollment to clinical trials for cataract medicine and surgery: meta-analysis.

To investigate sex, racial, and ethnic disparities in patient enrollment across cataract trials registered in the United States. Participants enrolled in high-quality (reduced risk of bias), U.S.-registered (on ClinicalTrials.gov ), cataract-related randomized controlled trials (RCTs). RCTs must be completed, have used double or greater masking, and have published results through the registry or a scholarly journal. Cross-sectional database study. Trial (study sponsor country, study site location, trial initiation year, study phase, and study masking) and demographic data (sex, race, and ethnicity according to U.S. reporting guidelines) were collected. The Global Burden of Disease database provided sex-based cataract disease burdens. Pooled participation-to-prevalence ratios (PPRs) with 95% CIs were calculated for female sex, with values between 0.8 and 1.2 constituting sufficient study enrollment. Kruskal-Wallis tests (α = 0.05) with subsequent post hoc comparisons were used to evaluate demographic representations stratified by trial characteristics. From 864 records, 100 clinical trials (N = 67 874) were identified, of which 97 (N = 67 697) reported sex demographics with a pooled female PPR of 0.89 (95% CI, 0.85-0.94). Of the 67 697 total participants, the absolute female enrollment was 19 062 (28.16%). Ethnicity and race were reported in 9 (N = 1792) and 26 trials (N = 23 181), respectively. Among trials that reported race, most were White (N = 19 574; 84.44%). High-quality, U.S.-registered, cataract trials enrolled acceptable proportions of women. However, the absolute number of female and racialized participants was low. Race and ethnicity were underreported. Disparity trends predominately held across secondary variables. To promote generalizability, future trials should pursue equitable demographic enrollment.

Use of Electronic Patient Messaging by Pregnant Patients Receiving Prenatal Care at an Academic Health System: Retrospective Cohort Study.

The COVID-19 pandemic accelerated telemedicine and mobile app use, potentially changing our historic model of maternity care. MyChart is a widely adopted mobile app used in health care settings specifically for its role in facilitating communication between health care providers and patients with its messaging function in a secure patient portal. However, previous studies analyzing portal use in obstetric populations have demonstrated significant sociodemographic disparities in portal enrollment and messaging, specifically showing that patients who have a low income and are non-Hispanic Black, Hispanic, and uninsured are less likely to use patient portals. The study aimed to estimate changes in patient portal use and intensity in prenatal care before and during the pandemic period and to identify sociodemographic and clinical disparities that continued during the pandemic. This retrospective cohort study used electronic medical record (EMR) and administrative data from our health system's Enterprise Data Warehouse. Records were obtained for the first pregnancy episode of all patients who received antenatal care at 8 academically affiliated practices and delivered at a large urban academic medical center from January 1, 2018, to July 22, 2021, in Chicago, Illinois. All patients were aged 18 years or older and attended ≥3 clinical encounters during pregnancy at the practices that used the EMR portal. Patients were categorized by the number of secure messages sent during pregnancy as nonusers or as infrequent (≤5 messages), moderate (6-14 messages), or frequent (≥15 messages) users. Monthly portal use and intensity rates were computed over 43 months from 2018 to 2021 before, during, and after the COVID-19 pandemic shutdown. A logistic regression model was estimated to identify patient sociodemographic and clinical subgroups with the highest portal nonuse. Among 12,380 patients, 2681 (21.7%) never used the portal, and 2680 (21.6%), 3754 (30.3%), and 3265 (26.4%) were infrequent, moderate, and frequent users, respectively. Portal use and intensity increased significantly over the study period, particularly after the pandemic. The number of nonusing patients decreased between 2018 and 2021, from 996 of 3522 (28.3%) in 2018 to only 227 of 1743 (13%) in the first 7 months of 2021. Conversely, the number of patients with 15 or more messages doubled, from 642 of 3522 (18.2%) in 2018 to 654 of 1743 (37.5%) in 2021. The youngest patients, non-Hispanic Black and Hispanic patients, and, particularly, non-English-speaking patients had significantly higher odds of continued nonuse. Patients with preexisting comorbidities, hypertensive disorders of pregnancy, diabetes, and a history of mental health conditions were all significantly associated with higher portal use and intensity. Reducing disparities in messaging use will require outreach and assistance to low-use patient groups, including education addressing health literacy and encouraging appropriate and effective use of messaging.

Racial and ethnicassociations with comprehensive cancer center access and clinical trial enrollment for acute leukemia.

Clinical trial participation at Comprehensive Cancer Centers (CCC) is inequitable for minoritized racial and ethnic groups with acute leukemia. CCCs care for a high proportion of adults with acute leukemia. It is unclear if participation inequities are due to CCC access, post-access enrollment, or both. We conducted a retrospective cohort study of adults with acute leukemia (2010-2019) residing within Massachusetts, the designated catchment area of the Dana-Farber/Harvard Cancer Center (DF/HCC). Individuals were categorized as non-Hispanic Asian (NHA), Black (NHB), White (NHW), Hispanic White (HW), or Other. Decomposition analyses assessed covariate contributions to disparities in (1) access to DF/HCC care and (2) post-access enrollment. Of 3698 individuals with acute leukemia, 85.9% were NHW, 4.5% HW, 4.3% NHB, 3.7% NHA, and 1.3% Other. Access was lower for HW (age- and sex-adjusted OR = 0.64, 95% CI = 0.45 to 0.90) and reduced post-access enrollment for HW (aOR = 0.54, 95% CI =0.34 to 0.86) and NHB (aOR = 0.60, 95% CI = 0.39 to 0.92) compared to NHW. Payor and socioeconomic status (SES) accounted for 25.2% and 21.2% of the +1.1% absolute difference in HW access. Marital status and SES accounted for 8.0% and 7.0% of the -8.8% absolute disparity in HW enrollment; 76.4% of the disparity was unexplained. SES and marital status accounted for 8.2% and 7.1% of the -9.1% absolute disparity in NHB enrollment; 73.0% of the disparity was unexplained. A substantial proportion of racial and ethnic inequities in acute leukemia trial enrollment at CCCs are from post-access enrollment, the majority of which was not explained by sociodemographic factors.