Racial-ethnic Minority Research Articles

Uptake of Peritoneal Dialysis (PD) by Minoritized Patients: The Role of Modality Education.

In a cohort of patients with late-stage kidney disease who completed dialysis modality education and who self-identified as racial ethnic minorities, we studied characteristics of those choosing PD, and perception of usefulness of the education session in modality selection. In this study of individuals with kidney failure cared for by nephrologists at Montefiore Medical Center, Bronx, NY, who were referred for modality education, we: 1-tested the association of patient characteristics with modality selection in 113 patients from 2021-2023, and 2-examined patient perception of the quality of modality education from 13 semi-structured interviews. We compared sociodemographic, clinical attributes, and patient responsiveness to attempts made by staff among those who selected and initiated PD to those who a-did not select PD, or b-initiated on HD urgently . We performed qualitative analysis of interviews to reach consensus on theoretical domain framework concepts and how they fit events in the kidney failure trajectory. Compared to individuals who required urgent HD, those who selected, and were initiated on, PD were younger (54 yrs vs 66 yrs), had fewer comorbidities, and did not require as many attempts to schedule modality education. Qualitative analysis of interviews showed that experience with staff and quality of information conveyed during education was generally positive, but the following gaps were identified: lack of support for the emotional trauma of kidney failure diagnosis, inability to address structural barriers to PD specific to the patient population, and the lack of a deliberate program to lessen anxiety about the responsibility of PD. Incorporation of tailored content that addresses clinical comorbidity, structural barriers to care and emotional trauma constitute aspects of modality education that can be improved to increase PD uptake among minoritized patients.

The Viability, Needs, and Acceptability of Text Message Group Therapy Among Racial-Ethnic Minority Mothers with Low Income: A Qualitative Exploratory Study

The Viability, Needs, and Acceptability of Text Message Group Therapy Among Racial-Ethnic Minority Mothers with Low Income: A Qualitative Exploratory Study

Skin cancer treatment environment and survivorship resources among sexual and gender minority patients: results of the OUT National Cancer Survey.

Sexual and gender minority (SGM) cancer survivors face unmet care needs in accessing cancer health information and social support despite high satisfaction with treatment. SGM patients often delay care due to concerns of discrimination in healthcare settings, though the care experiences of SGM skin cancer survivors are less known. SGM individuals, particularly sexual minority men, report higher skin cancer prevalence and related risk behaviors than heterosexual men. This study aims to describe SGM skin cancer survivors' perceptions of the care environment and availability of SGM-specific survivorship resources. We conducted a secondary analysis of data from the OUT: National Cancer Survey conducted from September 2020 to March 2021. Among 2,528 survey respondents, 96 self-reported a history of skin cancer, with 33% having keratinocyte carcinomas (KC) only and 67% having melanoma. While 69% reported treatment in welcoming environments, 91% noted the absence of welcoming cues. Only 23% used social support specific to cancer survivorship, despite 62% valuing access to LGBTQI+-inclusive survivorship support. KC survivors reported less access to SGM-specific cancer information compared to melanoma survivors. These findings highlight gaps in dermatologic care for SGM skin cancer survivors. Dermatologists can address these needs by developing targeted health education resources, integrating identity-affirming information into care plans, and establishing inclusive environments through visible LGBTQI + cues and training staff in identity-affirming care. While limited by a small sample size, underrepresentation of gender and racial-ethnic minorities, and reliance on unvalidated survey tools, this study highlights the significant lack of data on SGM skin cancer survivors' experiences. We provide valuable insights into the unmet care needs of SGM skin cancer survivors. Future research should build on this foundational evidence to further examine differences in care experiences across skin cancer types and treatment settings, aiming to optimize support for SGM patients.

Addressing Health Care Disparities and COVID-19: Mental Illness Prevention in Communities of Color.

As the COVID-19 pandemic emerged in March 2020, the New York State Office of Mental Health received funding from the Federal Emergency Management Agency to implement the agency's Crisis Counseling Assistance and Training Program statewide. Because COVID-19 infections were disproportionately affecting minority communities of color, engagement strategies that prioritized contracting with community agencies that were already well established in the most highly affected racial-ethnic minority neighborhoods were used. This approach to outreach successfully made engagement and counseling support available to Black and Hispanic citizens, at levels significantly exceeding their proportional representation in the state population. These efforts identify an opportunity for a postpandemic paraprofessional workforce to address general medical health and mental health inequities in underresourced racial-ethnic minority communities.

Examining Systemic and Interpersonal Bias in Violence Risk Assessments of Patients in Acute Psychiatric Care.

The assessment and management of inpatient risk for violence in acute psychiatric care are challenges that introduce the potential for bias. This study aimed to examine inequities based on social determinants of health (SDoH) (e.g., race-ethnicity, gender, or mode of admission to acute care) that may lead to unfair assessment of psychiatric patients. The authors analyzed electronic health records of 7,424 acute care patients across 12,650 stays (2016-2022) at a large Canadian psychiatric hospital. Risk ratios (RRs) were calculated by SDoH for staff assessments of high risk (perceived risk), for violent incidents (actual risk), and for potentially biased risk assessment (particularly when a patient was assessed as high risk but did not become violent). In univariate analyses, patients assessed as high risk who did not become violent were more likely to be male than female and to be Black, Indigenous, or Middle Eastern than White. When RRs were mutually adjusted for all variables, the associations for gender and race-ethnicity were attenuated or were no longer statistically significant. Associations with potentially biased risks that remained significant included most psychiatric diagnoses (vs. a depressive or anxiety disorder), supportive or unstable housing (vs. owning a home), and admission by police (vs. self-admission; RR=2.14, 95% CI=1.92-2.40). Systemic factors, such as admission by police and housing status, and having severe mental illness were the primary drivers of observed inequities in risk assessments of patients from racial-ethnic minority groups. Addressing these systemic factors might be key to improving acute psychiatric care.

Racial/Ethnic Disparities in Oncology Clinical Trial Participation: Investigator Attitudes, Needs, and Motivation to Improve.

The perspective of all stakeholders involved in clinical trials is critical to addressing disparities in racial/ethnic minority (REM) clinical trial participation. Little is known about clinical trial investigator perspectives. To our knowledge, there are no published studies assessing differences in investigator perspectives on the basis of their primary role in clinical trials (ie, principal investigator [PI] or subinvestigator [sub-I]). Differences likely exist in investigator perspectives on the basis of having a more design-oriented (PI) or recruitment-oriented (sub-I) role. We conducted a cross-sectional, anonymous, pilot survey of 107 oncology clinical trial investigators at an academic center. The survey assessed five domains about disparities in REM clinical trial participation. We performed a subgroup analysis of mid- and late-career investigators (≥10 years of experience) comparing PIs (opened ≥one clinical trial in the past year) with sub-Is (did not). Among 60 respondents, a majority (83%) strongly agreed disparities exist in REM clinical trial participation and that this is problematic (75%). Notably, 45% agreed they cannot directly address this problem. In the subgroup analysis, PIs were more likely to have received training about barriers/facilitators to REM clinical trial participation and strategies to increase participation. They were also more likely to endorse wanting help in this area. Our results suggest clinical trial investigators are aware of disparities in REM clinical trial participation but do not feel they can address them. PIs are more likely to have received previous training on this topic and to want help to improve their ability to address disparities. More studies are needed to inform targeted interventions and structural improvements to enhance investigators' self-efficacy for improving REM participation in oncology clinical trials.

Competence Perceptions at the Intersection of Gender and Race-Ethnicity

Competence perceptions represent a fundamental dimension of human perception and have wide-ranging consequences for social interaction. Therefore, it is no surprise that multiple prominent social psychological theories emphasize the role of competence perceptions. We know that both a person’s gender and race-ethnicity influence assumptions about their competence, but we have only a few studies examining the intersections of these factors. Using a large survey experiment (N = 1,219), I examine competence perceptions at the intersection of 2 gender and 13 racial-ethnic categories. Results show large effects of both gender and race-ethnicity and also highly intersectional stereotypes; that is, there is no one overarching effect of gender or race-ethnicity but instead contingent effects. By oversampling racial-ethnic minorities, I also test the assumption of consensus for competence perceptions. Results show highly consensual perceptions, suggesting we all recognize society’s stereotypes even if we do not agree with them.

Social factors related to gun violence in urban United States

IntroductionGun violence (GV), acknowledged as a public health crisis, disproportionately affects urban centers in the United States. However, the precise connections between social factors and GV are not fully understood. This study, leveraging the Cardiff Model approach, evaluates whether there is a statistical and geospatial relationship between social vulnerability index (SVI) and GV. MethodsIn this cross-sectional study, we combined Gun Violence Archive (GVA), a dataset of firearm violence (2019–2023), with corresponding census tract level SVIs for three selected cities—Atlanta, GA; St. Louis, MO; and Washington, DC. The GVA was created, due to gaps in government-based data, from daily public records and media by an independent data collection group. Also, the SVI, derived from a place-based index from Centers for Disease Control (CDC), was originally used to evaluate the resiliency of communities to recover from socio-environmental stressors. GV data from these three cities, representative of major urban centers in the United States, were used to conduct various analyses. We used Poisson regression to assess whether nine of the sixteen SVI measures were statistically associated with GV incidents. Furthermore, we examined whether spatial relationships between SVI and GV differ by level of concentrated disadvantage in urban neighborhoods. ResultsOut of all GV incidents (10,442), corresponding to 488 census tracts, teenagers ages 12–17 were found to have higher GV rates in St. Louis (12 %) than Atlanta (7.6 %) and Washington DC (10.5 %). Children, ages 0–11, in St. Louis (3.1 %) were involved in more GV incidents than the other two (Washington DC-1.2 % and Atlanta-2.3 %) cities. In the composite model, census tract-level SVIs were statistically significantly associated with GV. Some of the most prominent SVIs, viewed as predictors of GV, included racial-ethnic minority [Incidence Rate Ratio (IRR): 1.02, 95 % CI: 1.01–1.02, p<0.001], 150 % of Federal Poverty Level (FPL) [IRR: 1.00, 95 % CI: 1.00–1.01, p<0.001], and unemployment (IRR: 1.01, p<0.001). Also, many of the SVI variables were found to be significantly associated with GV incidents in each of the three selected cities. ConclusionsIn this original study, we found that there was a strong statistically significant association between SVI-related disadvantaged neighborhoods and increased GV incidents. Additionally, we found that the geospatial distribution of GV incidents were more concentrated in neighborhoods with increased vulnerability throughout the three (Atlanta, GA; St. Louis, MO; and Washington, DC) selected cities than those neighborhoods with decreased vulnerability. Unique approaches such as integration of the SVI with gun control legislation, which informs ownership, use, and access to firearms, provides a better strategy to inform the implementation of an interdisciplinary approach such as the Cardiff Model. GV policy reform, from the public health and criminology lens, would help reduce the prevalence of GV through the promotion of social resilience within communities.

7525 Impact of Medicaid Policy Change on CGM Uptake in a Federally Qualified Health Center

Abstract Disclosure: W. Solorzano: None. L. Scarlett: None. K.P. Santiago Mangual: None. J. Borrell: None. B. Brumley: None. M. Tavares: None. C. Santana: None. T. Moin: None. E.M. Everett: None. Background: Despite the numerous benefits of CGMs in diabetes management, studies have consistently reported inequities in CGM use in racial-ethnic minorities, lower socioeconomic status, and with public insurance. In January 2022, a new California Medicaid policy switched coverage of CGMs from a Durable Medical Equipment benefit to a pharmacy benefit, creating less stringent insurance related criteria for CGM approval. We aim to evaluate the utilization of CGM use after the aforementioned policy change in an urban, multi-centered, federally qualified health center. Methods: We performed a retrospective study of patients with diabetes seen by diabetes NPs in three different clinics from January 1, 2022, through June 30, 2023. We excluded patients not managed on insulin. Patients were stratified by CGM status (current user, former user, never user). We used descriptive statistics to report patient demographics and clinical characteristics. Chi-squared test was used to evaluate differences between groups. We performed multivariate logistic regression to evaluate predictors of never using CGM. Results: We identified 239 patients who met inclusion criteria. They were primarily between the ages of 45-64 (60%), female (57%), Hispanic (84%), Spanish speaking (70%), and on Medicaid insurance (63%). Majority had a diagnosis of type 2 diabetes (93%) and managed on basal insulin plus other antidiabetic medication(s) (48%) with a mean HbA1c ≥ 10% (31%). At the end of the study period, 37% were current CGM users, 13% were former users and 51% were never users. Almost all (98%) of those who used CGMs started after January 2022.There was a statistically significant difference between CGM groups and treatment regimen (p = 0.000), insurance type (p = 0.000), type of diabetes (p = 0.000), and clinic site (p = 0.029). There was no statistically significant association between age, birth sex, race, primary language, or mean Hba1c. Most current and former users were/are on Freestyle Libre 2 (61% and 93%, respectively). Among never users, 55% had no discussion about CGM use documented in their charts. In an adjusted analysis, insurance type was the strongest predictor of never using CGM. Those without insurance on a county program, My Health LA (OR 15.5, 95% CI 3.7-65.6) or self-pay (OR 10.0, 95% CI 1.77-56.3) were more likely to be a never user. Conclusion: In an underserved population with diabetes, insurance status was the primary barrier to CGM use as demonstrated by the large uptake of CGM use after the policy change and that insurance status was the largest predictor of use. Additional studies are needed to evaluate other barriers impacting CGM uptake and adherence, clinical impact of CGM use, and patient experience. This will improve the utilization and adherence of this diabetes technology in this patient population who historically experiences more challenges with diabetes and obtaining optimal glycemic control. Presentation: 6/1/2024

Self-Guided Behavioral Activation Using an Online Single-Session Intervention: Content and Lexical Analyses of Activity Scheduling

The Common Elements Toolbox (COMET) is a self-guided online single-session intervention (SSI) containing cognitive-behavioral elements, including behavioral activation (BA). Little is known about the process of activity scheduling in BA. Using data from an 8-week randomized controlled trial of COMET with 409 online workers with a history of psychopathology, two raters coded the types of activities individuals scheduled during the intervention. Additionally, we compared the activities to a BA dictionary developed from therapist-led psychotherapy. We explored baseline clinical and demographic variables that were predictive of the activity category scheduled and explored the scheduled activity category as a predictor of depression, anxiety, and well-being post-intervention. Results yielded 9 different activity types, most commonly sedentary hobbies (41%), physical activity (29%), and active hobbies (18%). We found a small overlap (17%) between the self-guided BA activities in our COMET sample and those in the existing BA dictionary. Demographic variables were predictive of activity category, but clinical variables were not. The type of activity scheduled was not predictive of post-intervention outcomes. In self-guided BA, individuals, particularly men, less educated participants, and racial-ethnic minorities, tend to pick sedentary activities. Findings underscore the need for adaptive and personalized interventions.

Children of immigrants' behavioral trajectories and family processes: Using an integrative developmental model.

Using an integrative developmental model, this study revisited the "immigrant paradox" in early behavioral development, differentiating immigrant background from race and examining the role of family processes (family structure, stability, racial/ethnic socialization) in disparities between immigrant and U.S.-origin children. Growth-curve analyses on a sample of children aged 5-7 (N = 12,520) from the Early Childhood Longitudinal Study-Kindergarten class of 2010-2011 data set revealed distinct behavioral trajectories based on parental country of origin. Some groups outperformed the racially matched U.S.-origin peers by improving faster (internalizing behaviors: Salvadoran) or maintaining their advantages (internalizing: Mexican, Dominican; externalizing: Mexican, Salvadoran, Guatemalan, South American, and Dominican), while others faced continued challenges (externalizing behaviors: Japanese, Thai) or exhibited a nuanced pattern such as beginning with an advantage but deteriorating faster (internalizing: Cuban). The time-varying, country-of-origin-specific family processes fully or partly explained some disparities (except for Asian), emphasizing the need for a sociocultural understanding of the distinct strengths and limitations in racial-ethnic minority families. This contextualized knowledge is crucial for promoting healthy child development. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Positive Feedback as a Lever to Boost Students' STEM Outcomes.

Although many college students intend to major in Science, Technology, Engineering, and Mathematics (STEM), dropout from these fields is high, especially among members of historically underrepresented groups, such as women and racial-ethnic minorities. We propose a minimal, yet potentially powerful intervention to broaden participation in STEM: giving positive feedback to students in STEM. Studies 1 and 2 found that giving positive feedback is less normative in math (vs. English) courses, and instructors' feedback-giving practices and students' experiences mirror these norms. However, students who received positive (vs. only objective) feedback on introductory-level college calculus exams showed greater belonging and self-efficacy in math, which predicted better STEM outcomes (i.e., increased interest in STEM and higher final math course grades, respectively, Study 3). These findings were especially strong for racial-ethnic minority students. Giving positive (vs. only objective) feedback is thus a potentially transformative tool that boosts student outcomes, especially for underrepresented groups.

“Imagine Growing Up Thinking the US is the Best Opportunity”: Immigrant Origin Youth of Color Supporting the Black Lives Matter Movement on Twitter

Immigrant origin youth are among the largest growing population in the United States of America (U.S.), and are important political agents for social change. This study examines how these youth engage in interracial solidarity, particularly in digital spaces. This study used reflexive thematic analysis to analyze the Twitter posts of 36 immigrant origin youth (ages 18–23; 62.5% women) from African/Afro-Latine, Latine, and Asian origins. We examined their posts about the Black Lives Matter (BLM) movement and racial justice for Black Americans in 2020. We found that immigrant origin youths’ identities as racial-ethnic minorities informed their support of BLM. Further, we found racial differences in digital action such that African-origin youth focused on celebrating Blackness and calling in peers of all races, while non-African origin youth strategically amplified the work of U.S.-origin Black Americans and called in allyship in their racial-ethnic communities. Lastly, we found that African-origin youth viewed their positionality within the BLM movement differently compared to their U.S.-born Black peers due to their different relationship to chattel slavery and anti-Blackness. This study suggests that scholars and practitioners can support immigrant origin youths’ sociopolitical development by incorporating an intersectional analysis of inequities to promote collective identification and mass mobilization.

Beyond the 10%: Unraveling the genetic diversity in Turkish cystic fibrosis patients not eligible for CFTR modulators.

Cystic fibrosis (CF) is an autosomal recessive disease caused by variants of CFTR gene. Over 2000 variants have been identified, and new drugs called CFTR modulators have been developed to target specific defects in the CFTR protein. However, these drugs are only suitable for patients with certain variants of CFTR, and eligibility rates vary depending on race and geographical region. This study aimed to reveal the detailed genotype and clinical characteristics of people with CF (pwCF) at our center in Turkey, a developing country, who are not eligible for CFTR modulators. A total of 445 pwCF followed up at Marmara University were reviewed retrospectively. Variants of the patients ineligible to CFTR modulators were classified based on American College of Medical Genetics guidelines, CFTR classification, the change in the encoded protein, and the variant type. The study revealed that 139 (31.2%) patients weren't eligible for CFTR modulators. There were 60 different variants in the 276 alleles, as two were missing. The majority of patients had missense or nonsense variants, and that the most common variant was c.1545_1546del, which can be said unique to this geography. The study highlights the importance of detecting the variants of ineligible patients in detail to guide future approaches for more targeted and effective interventions in CF care. Testing the effectiveness of CFTR modulators for rare or newly occurring variants is crucial to ensure equal access for pwCF to these therapies from different racial backgrounds and ethnic minorities.

Electronic Patient-Reported Outcome-Driven Symptom Management by Oncology Pharmacists in a Majority-Minority Population: An Implementation Study.

There is a lack of systematic solutions to manage supportive care issues in racial/ethnic minorities (REM) receiving treatment for cancer. We developed and implemented an electronic patient-reported outcome (ePRO)-driven symptom management tool led by oncology pharmacists in a majority-minority cancer center located in Southern California. This study was designed to evaluate the implementation outcomes of our multilevel intervention. This was a prospective, pragmatic, implementation study conducted between July 2021 and June 2023. Newly diagnosed adult patients with cancer receiving intravenous anticancer therapies completed symptom screening using ePRO that consists of the Patient-Reported Outcomes Measurement Information System measures at each infusion visit during the study. ePRO results were presented to an oncologist pharmacist for personalized symptom management and treatment counseling. The RE-AIM framework was used to guide implementation outcomes. Differences in symptom trajectories and clinical outcomes between groups were tested using generalized estimating equations. We screened 388 patients of whom 250 were enrolled (acceptance rate: 64.4%), with 564 assessments being completed. The sample consisted of non-Hispanic White (NHW, 42.4%), Hispanic/Latinx (H/L, 30.8%), and non-Hispanic Asian (20.4%), with one (21.6%) of five participants preferring speaking Spanish. Compared with NHW, H/L participants had greater odds of reporting mild to severe pain interference (odds ratio [OR], 1.91 [95% CI, 1.18 to 3.08]; P = .008) and nausea and vomiting (OR, 2.08 [95% CI, 1.21 to 3.58]; P = .008), and higher rates of urgent care utilization (OR, 1.92 [95% CI, 1.04 to 3.61]; P = .04) within 30 days. Nausea and vomiting (n = 131, 23.2%), pain (n = 91, 16.1%), and fatigue (n = 72, 12.8%) were most likely to be intervened, with 90% of the participants expressing satisfaction across all visits. Our multilevel ePRO-driven intervention led by oncology pharmacists helps facilitate symptom assessments and management and potentially reduce health disparities among REM.

Impact of the Early COVID-19 Pandemic on Incidence and Outcomes of Hepatocellular Carcinoma in the United States.

Access to hepatocellular carcinoma (HCC) surveillance and treatments were disrupted during the coronavirus disease 2019 (COVID-19) pandemic. We aimed to characterize the impact of the pandemic on HCC incidence and mortality rates, treatment, and outcomes in the United States. Two nationwide databases, the United States Cancer Statistics and the National Vital Statistics System, were used to investigate HCC incidence and mortality between 2001 and 2020. Trends in age-adjusted incidence rate (aIR) and adjusted mortality rate (aMR) were assessed using joinpoint analysis. The 2020 aIR and aMR were projected based on the prepandemic data and compared with actual values to assess the extent of underdiagnosis. We assessed differences in HCC characteristics, treatment, and overall survival between 2020 and 2018-2019. The aIR of HCC in 2020 was significantly reduced compared with 2019 (5.22 vs 6.03/100K person-years [PY]), representing a 12.2% decrease compared with the predicted aIR in 2020 (5.94/100K PY). The greatest extent of underdiagnosis was observed in Black (-14.87%) and Hispanic (-14.51%) individuals and those with localized HCC (-15.12%). Individuals staged as regional or distant HCC were also less likely to receive treatment in 2020. However, there was no significant difference in short-term overall survival in 2020 compared with 2018-2019, with HCC mortality rates remaining stable (aMR: 2.76 vs 2.73/100K PY in 2020 vs 2019). The COVID-19 pandemic resulted in underdiagnosis of HCC, particularly early stage disease and racial ethnic minorities, and underuse of HCC-directed treatment. Longer follow-up is needed to determine the impact of the COVID-19 pandemic on HCC-related mortality.

Differences in Perioperative Metrics by Race and Ethnicity and Insurance After Pelvic Fracture: A Nationwide Study.

Disparities in orthopedic trauma care have been reported for racial-ethnic minority and socially disadvantaged patients. We examined differences in perioperative metrics by patient race and ethnicity and insurance after pelvic fracture in a national sample in the United States. The 2016-2019 National Inpatient Sample was queried for White, Black, and Hispanic patients 18 to 64 years old with private, Medicaid, or self-pay insurance who underwent non-elective pelvic fracture surgery. Associations between combined race and ethnicity and insurance subgroups and perioperative metrics (time to surgery, length of stay, inhospital complications, institutional discharge) were assessed using multivariable generalized linear and logistic regression models. Adjusted percent differences or odds ratios (ORs) were reported. A weighted total of 14,375 surgeries were included (68.8% in White patients, 16.1% in Black patients, and 15.1% in Hispanic patients; 60.0% private insurance, 26.3% Medicaid, and 13.7% self-pay). Compared with White patients with private insurance, all Black insurance subgroups had longer length of stay (+15.38% to +38.78%, P≤.001), as did Hispanic patients with Medicaid (+28.03%, P<.001), White patients with Medicaid (+13.08%, P<.001), and White patients with self-pay (+9.47%, P=.04). Additionally, compared with White patients with private insurance, decreased odds of institutional discharge were observed for all patients with self-pay (OR, 0.24-0.37, P<.001) as well as White patients with Medicaid (OR, 0.70, P=.003) and Hispanic patients with Medicaid (OR, 0.57, P=.002). There were no significant adjusted associations between race and ethnicity and insurance subgroups and in-hospital complications or time to surgery. These differences in perioperative metrics, primarily for Black patients and patients with self-pay insurance, warrant further examination to identify whether they reflect disparities that should be addressed to promote equitable orthopedic trauma care. [Orthopedics. 2024;47(5):e233-e240.].

Impact of eligibility criteria discordance on clinical trial accrual in diffuse large B-cell lymphoma (DLBCL).

e13707 Background: Excessively stringent clinical trial eligibility criteria may hinder trial accrual, differentially exclude racial-ethnic minority groups, and limit generalizability. This study reviewed the association between trial accrual and concordance of eligibility criteria with known drug safety data in DLBCL clinical trials. Methods: Eligibility criteria and accrual of completed phase II/III clinical trials for DLBCL that opened in the US between 2010-2020 were abstracted from ClinicalTrials.gov. Trials missing posted results or studying cellular therapy / transplant were excluded. Concordance with known safety data was assessed by comparing study eligibility criteria for QTc, renal, hepatic, and cardiac function to FDA labels and phase I safety signals of study drugs. Excessively strict discordant criteria (ExSDC) were defined as eligibility criteria without supporting safety signals. Logistic regression +/- dispersion was used for analysis. Results: 58 trials met criteria for inclusion, accruing 6,232 participants. 88% of studies involved a non-FDA-approved agent, 74% were multicenter, 55% were industry sponsored, 66% only accrued in the US, and 86% were phase II. Eligibility criteria were highly variable (Table). Discordance of renal, hepatic, cardiac function, and QTc criteria from known safety data occurred in 31%, 26%, 41%, and 29% of studies, respectively. Race and ethnicity data were not reported in 22% and 45% of studies, respectively. Trials after 2015 were more likely to report race (p=0.04) and ethnicity (p=0.01). In a multivariable model adjusted for international study sites, greater number of ExSDC was associated with a lower proportion of black patients in the trial (OR 0.45, CI 0.29-0.71, p=0.001). ExSDC in cardiac function were most associated with reduced accrual of this minority group (OR 0.17, CI 0.05-0.58, p=0.007). 11 studies (19%) had early termination for lack of accrual (ETLA). In multivariable analysis, greater number of ExSDC was independently associated with ETLA (OR 3.53, CI 1.45-8.64, p=0.006), while multicenter status protected against ETLA (OR 0.05, CI 0.01-0.31, p=0.002). Industry sponsor and concordance of cardiac criteria protected against ETLA in univariable analysis only. Other eligibility criteria were not associated. Conclusions: Eligibility criteria in DLBCL trials varied widely and were often discordant with known safety data. Higher number of ExSDC was associated with lower accrual of black patients and higher risk of ETLA. Optimizing concordance of eligibility criteria with safety data may improve trial accrual and diversity. [Table: see text]

#2348 Paradoxical association of pre-donation estimated glomerular filtration rate with kidney function decline in living kidney donors

Abstract Background and Aims Living kidney donors (LKD) are at risk for chronic kidney disease (CKD). Whether differences in pre-donation estimated glomerular filtration rates (eGFR) are associated with differences in the rate of post-donation eGFR decline is unclear. We aim to examine the association between pre-donation eGFR and the risk of kidney function decline post-donation. Method A retrospective cohort study using the Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR) database included LKD with pre- and early post-donation eGFR as well as eGFR at 6, 12, and 24 months after donation. The association between the quartile (Q) of pre-donation eGFR and time to ≥35% decline in post-donation eGFR compared to pre-donation eGFR was examined by competing-risks survival regression with death serving as a competing risk variable. Results Of 129,943 LKD ≥18 years old undergoing donation between October 1987 and September 2022, mean ± SD age was 42 ± 12 years and 61% were female. Mean overall pre-donation eGFR was 95.76 ± 29.80 mL/min/1.732 and mean pre-donation eGFR of LKD in Q1, 2, 3, and 4 were 63.50 ± 8.86, 83.05 ± 4.53, 100.30 ± 5.72, and 136.22 ± 23.69 mL/min.1.73 m2, respectively (Ptrend &amp;lt;0.001). Compared to pre-donation eGFR, the mean eGFR at early post-donation was significantly decreased to 53.56 ± 39.81 mL/min.1.73 m2 (mean eGFRpost-pre −43.38 mL/min.1.73 m2; P &amp;lt; 0.001), but mean post-donation eGFR at 6, 12, and 24 months continued trending up to 57.58 ± 45.37, 59.28 ± 43.25, and 61.05 ± 42.51 mL/min.1.73 m2, respectively which were significantly greater than early post-donation eGFR (mean eGFR 6mo-post 4.28, eGFR12mo-post 6.01, and eGFR24mo-post 7.82 mL/min.1.73 m2; P &amp;lt; 0.001; Fig. 1). Median survival for ≥35% decline in post-donation eGFR was 6.43 months (5.50, 11.30) with an incidence rate of 0.08 person-months. Among 75,220 LKD with follow-up data, 58,985 (78%) had the event and 15 (0.02%) died. Compared to LKD with pre-donation eGFR in Q1, LKD in other Q had a significantly higher risk for ≥35% decline in post-donation eGFR with a positively graded association (HR (95% CI)Q2 1.28 (1.23, 1.32); HRQ3 1.41 (1.36, 1.46); and HRQ4 1.60 (1.55, 1.65)). After adjusting for age, gender, race, body mass index, history of hypertension, diabetes, U.S. citizen status, education, and the interaction term between the quartile pre-donation eGFR and race, the magnitude of the association increased but the direction remained (HR (95%C I)Q2 1.41 (1.36, 1.47) HRQ3 1.72 (1.65, 1.79), and HRQ4 2.11 (2.02, 2.20). In addition, race was identified as an effect modifier with an increased risk for ≥35% decline in post-donation eGFR observed in Hispanic/Latino LKD (Pinteraction Q 2, Q3, Q4 0.025, 0.005, and &amp;lt;0.001). Conclusion Higher pre-donation eGFR is associated with a greater risk for post-donation eGFR decline especially among Hispanic/Latino LKD. Candidacy for living kidney donation should not be declined based only on eGFR; while some racial-ethnic minorities may be at greater risk even having higher pre-donation eGFR.

Collaborative Care for Depression and Anxiety: Racial-Ethnic Differences in Treatment Engagement and Outcomes.

This study aimed to examine racial-ethnic differences in engagement with and clinical outcomes of a collaborative care model (CoCM) implemented in primary care outpatient clinics in an urban academic medical center. Adult patients (N=4,911) who screened positive for symptoms of depression, anxiety, or both on the Patient Health Questionnaire-9 or the Generalized Anxiety Disorder-7 scale and who identified as non-Hispanic Black, Hispanic, or non-Hispanic White were offered participation in a CoCM implementation. The primary outcome was treatment engagement, defined as receipt of any follow-up visit, minimally adequate 4-week follow-up (at least one visit), and minimally adequate 16-week follow-up (at least three visits) after initial assessment. Secondary outcomes were response and remission of depression or anxiety. After adjustment of analyses for sociodemographic covariates, Black and Hispanic participants were significantly less likely than White participants to have received any or minimally adequate follow-up. Black and Hispanic participants who received any or minimally adequate 16-week follow-up were more likely than White participants to demonstrate depression symptom response and remission of anxiety symptoms. This CoCM implementation appears to have been effective in treating depression and anxiety among Black and Hispanic patients. However, significant disparities in receipt of follow-up care were observed. Efforts must be made to improve the retention of patients from racial-ethnic minority groups in collaborative care.