Race and ethnicity do not impact eligibility for remdesivir: A single-center experience.
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ABSTRACT:
SUBMITTER: Pischel L
PROVIDER: S-EPMC8101938 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:AbstractUnderrepresentation of racial and ethnic subgroups in cancer clinical trials remains a persistent challenge. Restrictive clinical trial eligibility criteria have been shown to exacerbate this problem. We previously identified that up to 24% of patients treated with standard immunochemotherapy would have been excluded from recent first-line trials in diffuse large B-cell lymphoma (DLBCL) based on 5 laboratory-based criteria. These ineligible patients had worse clinical outcomes and increased deaths related to lymphoma progression, suggesting the potential exclusion of patients who could have benefited most from the novel therapies being evaluated. Using data from the prospectively enrolled Lymphoma Epidemiology Outcomes cohort study, with demographics broadly similar to the US patients diagnosed with lymphoma, we evaluated the impact of laboratory eligibility criteria from recent first-line DLBCL trials across various racial and ethnic backgrounds. There were significant differences in the baseline laboratory values by race/ethnicity with Black/African American (AA) patients having the lowest mean hemoglobin and highest creatinine clearance. Based on recent clinical trial eligibility criteria, AA and Hispanic patients had higher rates of laboratory-based ineligibility than non-Hispanic White patients. The largest gap in the clinical outcomes between eligible and noneligible patients was noted within AA patients with an overall survival hazard ratio based on POLARIX clinical trial criteria of 4.09 (95% confidence interval, 1.83-9.14). A thoughtful approach to the utility of each criterion and cutoffs for eligibility needs to be evaluated in the context of its differential impact across various racial/ethnic groups.
| S-EPMC11375257 | biostudies-literature
Project description:The 21st Century Cures Act permitted people with end-stage renal disease (ESRD) to enroll in Medicare Advantage (MA) effective January 2021. It is imperative to understand the breadth of dialysis facility networks across MA contracts because most patients with ESRD need thrice-weekly dialysis to survive. In 2020 MA contracts' networks included a mean of 51 percent of dialysis facilities in their service areas. MA contracts with plans in a single state, with not-for-profit status, and with higher proportions of dually eligible enrollees with ESRD were significantly more likely to include less than or equal to 25 percent of dialysis facilities in their service area in network ("narrow networks") than contracts with plans in multiple states, with for-profit status, and with lower proportions of dually eligible enrollees with ESRD (by 12.9, 13.0, and 11.7 percentage points, respectively). Hispanic, Asian/Pacific Islander, and American Indian/Alaska Native people with ESRD were enrolled in contracts with narrow networks of dialysis facilities at markedly higher rates than non-Hispanic White people with ESRD. In contrast, Black people with ESRD were less likely to be enrolled in a narrow-network contract. Policy makers should monitor and address the adequacy of dialysis facility networks in MA contracts, as well as disparities in enrollment in narrow-network plans.
| S-EPMC10837791 | biostudies-literature
Project description:BackgroundCriteria for low-dose CT scan lung cancer screening vary across guidelines. Knowledge of the eligible pool across demographic groups can enable policy and programmatic decision-making, particularly for disproportionately affected populations.Research questionWhat are the eligibility rates for low-dose CT scan screening according to sex and race or ethnicity and how do these rates relate to corresponding lung cancer incidence rates?Study design and methodsThis was a cross-sectional study using data from the 2015 National Health Interview Survey adult and cancer control supplement files. In addition to eligibility rates, the ratio of the eligibility rate to the lung cancer incidence rate in a given population group (eligibility to incidence [E-I] ratio) also was determined. Guidelines assessed were: Centers for Medicare and Medicaid Services, National Comprehensive Cancer Network, and US Preventive Services Task Force current or with expansion of age and smoking or quit thresholds. We also assessed a risk model (PLCOM2012 risk model).ResultsTotal numbers eligible based on current guidelines ranged from 8.3 to 13.3 million, representing 8.3% to 13.4% of the US population 50 to 80 years of age, and up to 17.5 million with expanded criteria. Overall eligibility rates on average were about 10 percentage points higher for men than women. For both men and women, and both overall and among ever smokers, non-Hispanic Whites had the highest eligibility rates across all guidelines, followed generally by non-Hispanic Blacks, and then Asians and Hispanics. Among both men and women, non-Hispanic Whites had the highest E-I ratios across all guidelines; non-Hispanic Black men had higher lung cancer incidence, but 30% to 50% lower E-I ratios, than non-Hispanic White men.InterpretationScreening eligibility rates vary widely across guidelines, with disparities evident in E-I ratios, including among non-Hispanic Black men, despite higher lung cancer burden. Consideration of smoking duration in risk assessment criteria may address current disparities.
| S-EPMC8411441 | biostudies-literature
Project description:ImportanceUsing race and ethnicity in clinical prediction models can reduce or inadvertently increase racial and ethnic disparities in medical decisions.ObjectiveTo compare eligibility for lung cancer screening in a contemporary representative US population by refitting the life-years gained from screening-computed tomography (LYFS-CT) model to exclude race and ethnicity vs a counterfactual eligibility approach that recalculates life expectancy for racial and ethnic minority individuals using the same covariates but substitutes White race and uses the higher predicted life expectancy, ensuring that historically underserved groups are not penalized.Design, setting, and participantsThe 2 submodels composing LYFS-CT NoRace were refit and externally validated without race and ethnicity: the lung cancer death submodel in participants of a large clinical trial (recruited 1993-2001; followed up until December 31, 2009) who ever smoked (n = 39 180) and the all-cause mortality submodel in the National Health Interview Survey (NHIS) 1997-2001 participants aged 40 to 80 years who ever smoked (n = 74 842, followed up until December 31, 2006). Screening eligibility was examined in NHIS 2015-2018 participants aged 50 to 80 years who ever smoked. Data were analyzed from June 2021 to September 2022.ExposureIncluding and removing race and ethnicity (African American, Asian American, Hispanic American, White) in each LYFS-CT submodel.Main outcomes and measuresBy race and ethnicity: calibration of the LYFS-CT NoRace model and the counterfactual approach (ratio of expected to observed [E/O] outcomes), US individuals eligible for screening, predicted days of life gained from screening by LYFS-CT.ResultsThe NHIS 2015-2018 included 25 601 individuals aged 50 to 80 years who ever smoked (2769 African American, 649 Asian American, 1855 Hispanic American, and 20 328 White individuals). Removing race and ethnicity from the submodels underestimated lung cancer death risk (expected/observed [E/O], 0.72; 95% CI, 0.52-1.00) and all-cause mortality (E/O, 0.90; 95% CI, 0.86-0.94) in African American individuals. It also overestimated mortality in Hispanic American (E/O, 1.08, 95% CI, 1.00-1.16) and Asian American individuals (E/O, 1.14, 95% CI, 1.01-1.30). Consequently, the LYFS-CT NoRace model increased Hispanic American and Asian American eligibility by 108% and 73%, respectively, while reducing African American eligibility by 39%. Using LYFS-CT with the counterfactual all-cause mortality model better maintained calibration across groups and increased African American eligibility by 13% without reducing eligibility for Hispanic American and Asian American individuals.Conclusions and relevanceIn this study, removing race and ethnicity miscalibrated LYFS-CT submodels and substantially reduced African American eligibility for lung cancer screening. Under counterfactual eligibility, no one became ineligible, and African American eligibility increased, demonstrating the potential for maintaining model accuracy while reducing disparities.
| S-EPMC10507484 | biostudies-literature
Project description:ObjectiveTo assess the impact of the Medicare Shared Savings Program (MSSP) ACOs on mental health and substance use services utilization and racial/ethnic disparities in care for these conditions.Data sourcesFive percent random sample of Medicare claims from 2009 to 2016.Study designWe compared Medicare beneficiaries in MSSP ACOs to non-MSSP beneficiaries, stratifying analyses by Medicare eligibility (disability vs age 65+). We estimated difference-in-difference models of MSSP ACOs on mental health and substance use visits (outpatient and inpatient), medication fills, and adequate care for depression adjusting for age, sex, race/ethnicity, region, and chronic medical and behavioral health conditions. To examine the differential impact of MSSP on our outcomes by race/ethnicity, we used a difference-in-difference-in-differences (DDD) design.Data collection/extraction methodsNot applicable.Principal findingsMSSP ACOs were associated with small reductions in outpatient mental health (Coeff: -0.012, P < .001) and substance use (Coeff: -0.001, P < .01) visits in the disability population, and in adequate care for depression for both the disability- and age-eligible populations (Coeff: -0.028, P < .001; Coeff: -0.012, P < .001, respectively). MSSP ACO's were also associated with increases in psychotropic medications (Coeff: 0.007 and Coeff: 0.0213, for disability- and age-eligible populations, respectively, both P < .001) and reductions in inpatient mental health stays (Coeff:-0.004, P < .001, and Coeff:-0.0002, P < .01 for disability- and age-eligible populations, respectively) and substance use-related stays for disability-eligible populations (Coeff:-0.0005, P<.05). The MSSP effect on disparities varied depending on type of service.ConclusionsWe found small reductions in outpatient and inpatient stays and in rates of adequate care for depression associated with MSSP ACOs. As MSSP ACOs are placed at more financial risk for population-based treatment, it will be important to include more robust behavioral health quality measures in their contracts and to monitor disparities in care.
| S-EPMC8313953 | biostudies-literature
Project description:BackgroundThe US Food and Drug Administration issued an Emergency Use Authorization for remdesivir use in patients with severe COVID-19.MethodsWe utilized data from 2 quaternary acute care hospitals. The outcomes of interest were the impact of remdesivir on in-hospital death by day 28 and time to recovery, clinical improvement, and discharge. We utilized Cox proportional hazards models and stratified log-rank tests.ResultsTwo hundred twenty-four patients were included in the study. The median age was 59 years; 67.0% were male; 17/125 patients (13.6%) who received supportive care and 7/99 patients (7.1%) who received remdesivir died. The unadjusted risk for 28-day in-hospital death was lower for patients who received remdesivir compared with patients who received supportive care (hazard ratio [HR], 0.42; 95% CI, 0.16-1.08). Although this trend remained the same after adjusting for age, sex, race, and oxygen requirements on admission (adjusted HR [aHR], 0.49; 95% CI, 0.19-1.28), as well as chronic comorbidities and use of corticosteroids (aHR, 0.44; 95% CI, 0.16-1.23), it did not reach statistical significance. The use of remdesivir was not associated with an increased risk of acute kidney injury (AKI) or liver test abnormalities. Although not statistically significant, the rate ratios for time to recovery, clinical improvement, and discharge were higher in women and black or African American patients.ConclusionsPatients on remdesivir had lower, albeit not significant, all-cause in-hospital mortality, and the use of remdesivir did not increase the risk for AKI. Promising signals from this study need to be confirmed by future placebo-controlled randomized clinical trials.
| S-EPMC7454852 | biostudies-literature
Project description:BackgroundRemdesivir is a monophosphoramidate prodrug of an adenosine analog, and it has a broad-spectrum antiviral activity against paramyxoviruses, flaviviruses, and coronaviruses. Remdesivir is associated with decreased hospital stay and improved outcomes in coronavirus- disease 2019 (COVID-19).MethodologyOf 846 suspected COVID-19 patients admitted to the hospital, 612 SARS-CoV-2 nasopharyngeal RT-PCR positive patients were evaluated for enrollment in this prospective cohort study. 159 RT-PCR positive patients were given remdesivir. Their clinical, biochemical parameters, hospital stay, and outcomes related to morbidity and mortality were followed.ResultsOut of the 159 patients, 141 recovered after remdesivir use. The Chi-square test for independence examined the relation between the day of the first dose, dose of remdesivir, and clinical outcome. The standardized case fatality ratio (CFR) in the 453 hospitalized patients who did not receive remdesivir was 32.89% (N = 149) as compared to 11.32% (N = 18) in the patients who received remdesivir. These findings are in keeping with the therapeutic value of remdesivir in symptomatic SARS-CoV-2 infection of varying severity.ConclusionThe use of remdesivir is associated with a decrease in the severity of the SARS-CoV-2 infection. Its use is also associated with a decreased length of hospital stay and lower mortality than the patients who did not receive remdesivir.
| S-EPMC8823973 | biostudies-literature
Project description:OBJECTIVE:Insulin sensitivity affects plasma triglyceride concentration and both differ by race/ethnicity. The purpose of this study was to provide a comprehensive assessment of the variation in insulin sensitivity and its relationship to hypertriglyceridaemia between five race/ethnic groups. RESEARCH DESIGN AND METHODS:In this cross-sectional study, clinical data for 1025 healthy non-Hispanic White, Hispanic White, East Asian, South Asian and African American individuals were analysed. Insulin-mediated glucose disposal (a direct measure of peripheral insulin sensitivity) was measured using the modified insulin suppression test. Statistical analysis was performed using analysis of co-variance. RESULTS:Of the study participants, 63% were non-Hispanic White, 9% were Hispanic White, 11% were East Asian, 11% were South Asian and 6% were African American. Overall, non-Hispanic Whites and African Americans displayed greater insulin sensitivity than East Asians and South Asians. Triglyceride concentration was positively associated with insulin resistance in all groups, including African Americans. Nevertheless, for any given level of insulin sensitivity, African Americans had the lowest triglyceride concentrations. CONCLUSION:Insulin sensitivity, as assessed by a direct measure of insulin-mediated glucose disposal, and its relationship to triglyceride concentration vary across five race/ethnic groups. Understanding these relationships is crucial for accurate cardiovascular risk stratification and prevention.
| S-EPMC6713231 | biostudies-literature
Project description:This cross-sectional study aimed to assess the impact of epilepsy, myasthenia gravis (MG), and multiple sclerosis (MS) on pregnancy and family planning decision-making in a cohort of Saudi women. Women with epilepsy, MG, and MS were recruited consecutively at the time of their follow-up visits at a neurology clinic. Data were collected using 3 standardized questionnaires, and presented using descriptive statistics. A logistic regression was performed to determine variables associated with decisions regarding abstaining from pregnancy and encouraging other women to conceive. A total of 272 (83 epilepsy, 69 MG, and 120 MS) women with a mean age of 29.9 ± 8.0 years participated. The proportion of women who abstained from or postponed pregnancy was 41.2% and 31.4%, respectively. The concerns mentioned most often were disease worsening during pregnancy, peripartum and postpartum, side effects of medications on the unborn child, and inability to care for the child. Older age was independently associated with the decision to abstain from pregnancy (odds ratio [OR] 1.14, 95% confidence interval [CI] 1.04 - 1.25). Higher knowledge levels were independently associated with encouraging other women to have children (OR 1.3, 95% CI 1.11-1.53). Over 50% of women reported that they were not counseled on issues related to pregnancy and childbirth. In conclusion, we identified a major influence of epilepsy, MG, and MS on pregnancy and family planning. Comprehensive counseling programs are needed to help women with these neurological diseases make informed family-planning decisions.
| S-EPMC7598843 | biostudies-literature
Project description:AimDetermine changes in rapid response team (RRT) activations and describe institutional adaptations made during a surge in hospitalizations for coronavirus disease 2019 (COVID-19).MethodsUsing prospectively collected data, we compared characteristics of RRT calls at our academic hospital from March 7 through May 31, 2020 (COVID-19 era) versus those from January 1 through March 6, 2020 (pre-COVID-19 era). We used negative binomial regression to test differences in RRT activation rates normalized to floor (non-ICU) inpatient census between pre-COVID-19 and COVID-19 eras, including the sub-era of rapid COVID-19 census surge and plateau (March 28 through May 2, 2020).ResultsRRT activations for respiratory distress rose substantially during the rapid COVID-19 surge and plateau (2.38 (95% CI 1.39-3.36) activations per 1000 floor patient-days v. 1.27 (0.82-1.71) during the pre-COVID-19 era; p = 0.02); all-cause RRT rates were not significantly different (5.40 (95% CI 3.94-6.85) v. 4.83 (3.86-5.80) activations per 1000 floor patient-days, respectively; p = 0.52). Throughout the COVID-19 era, respiratory distress accounted for a higher percentage of RRT activations in COVID-19 versus non-COVID-19 patients (57% vs. 28%, respectively; p = 0.001). During the surge, we adapted RRT guidelines to reduce in-room personnel and standardize personal protective equipment based on COVID-19 status and risk to providers, created decision-support pathways for respiratory emergencies that accounted for COVID-19 status uncertainty, and expanded critical care consultative support to floor teams.ConclusionIncreased frequency and complexity of RRT activations for respiratory distress during the COVID-19 surge prompted the creation of clinical tools and strategies that could be applied to other hospitals.
| S-EPMC8096179 | biostudies-literature