Analysis of Age, Race, Ethnicity, and Sex of Participants in Clinical Trials Focused on Disorders of Gut-Brain Interaction.
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SUBMITTER: Bar N
PROVIDER: S-EPMC9398929 | biostudies-literature | 2022 Sep
REPOSITORIES: biostudies-literature
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Analysis of Age, Race, Ethnicity, and Sex of Participants in Clinical Trials Focused on Disorders of Gut-Brain Interaction.
Bar Nir N Surjanhata Brian B Weeks Imani I Silver Julie K JK Burton Murray Helen H
Gastroenterology 20220607 3
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Project description:BackgroundWe examined associations between suicidality and genotypes that predict plasma efavirenz exposure among AIDS Clinical Trials Group study participants in the United States.MethodsFour clinical trials randomly assigned treatment-naive participants to efavirenz-containing regimens; suicidality was defined as reported suicidal ideation or attempted or completed suicide. Genotypes that predict plasma efavirenz exposure were defined by CYP2B6 and CYP2A6 polymorphisms. Associations were evaluated with weighted Cox proportional hazards models stratified by race/ethnicity. Additional analyses adjusted for genetic ancestry and selected covariates.ResultsAmong 1833 participants, suicidality was documented in 41 in exposed analyses, and 34 in on-treatment analyses. In unadjusted analyses based on 12 genotype levels, suicidality increased per level in exposed (hazard ratio, 1.11; 95% confidence interval, .96-1.27) and on-treatment 1.16; 1.01-1.34) analyses. In the on-treatment analysis, the association was strongest among white but nearly null among black participants. Considering 3 metabolizer levels (extensive, intermediate and slow), slow metabolizers were at increased risk. Results were similar after baseline covariate-adjustment for genetic ancestry, sex, age, weight, injection drug use history, and psychiatric history or recent psychoactive medication.ConclusionsGenotypes that predict higher plasma efavirenz exposure were associated with increased risk of suicidality. Strength of association varied by race/ethnicity.
| S-EPMC5853681 | biostudies-literature
Project description:BackgroundCOVID-19 quickly overwhelmed the world, but disproportionately affects certain communities, particularly minority groups. Despite overrepresentation among COVID-19 cases and death, minority groups were underrepresented in some of the early COVID-19 clinical trials.ObjectiveTo assess and compare the demographic characteristics of COVID-19 clinical trial participants to national COVID-19 data.MethodsPubMed was searched from December 1, 2019 to November 24, 2020, for randomized controlled trials evaluating a pharmacologic treatment for COVID-19 patients from one or more U.S. sites written in the English language following the PRISMA checklist. Descriptive statistics were calculated to characterize patient demographics enrolled in the included clinical trials, as well as for comparison with national COVID-19 data.ResultsA total of 4472 records were identified, of which 16 studies were included. The median number of participants was higher in studies of nonhospitalized patients compared to those of hospitalized patients (n = 452 [range 20-1062] vs n = 243 [152-2795]). Ten (63%) studies reported mean or median ages of 50 years or older among all study arms. Males comprised more than half of the study cohort in ten (63%) studies. Race and ethnicity were reported separately in four (25%) studies but were combined when reported in five (31%) studies, while six (38%) reported only race or ethnicity. Proportional representation based on age, sex, race, and ethnicity was evident in some trials, but not in others, when compared to national data.ConclusionOverall, participants often did not reflect the actual population with COVID-19 and demographic characteristics were inconsistently reported.
| S-EPMC9642036 | biostudies-literature
Project description:BackgroundIt is of paramount importance that clinical trials are designed with adequate health equity considerations to prevent disproportionate analyses of specific demographics.ObjectiveIn this study, we investigated the representation of sex, race, and ethnicity in pivotal clinical trials for drugs with dermatological disease indications approved by the U.S. Food and Drug Administration between 1995 and 2019.MethodsThirty-six novel drugs with indications to treat dermatological diseases, approved by the U.S. Food and Drug Administration between January 1995 and December 2019 were abstracted from Drugs@FDA. The drug approval label, statistical review, official record, and trial publication were reviewed for data on disease indication, approval year, pathway, number of participants, participant demographics (sex, race, and ethnicity), location, and sponsor type.ResultsThe overall female representation was 45.6% (n = 17,492 of 38,320). Adequate female representation was noted for five of six disease indications. Caucasians were predominantly overrepresented (80.4%; n = 28,065 of 34,890); Blacks (9.8%; n = 3242 of 33,240) and Asians (5.5%; n = 1535 of 27,696) were consistently underrepresented. Across sponsor types, there was a significant difference in the distribution of women (χ2 = 6.332; p = .042), as well as Caucasians (χ2 = 12.813; p = .002), Blacks (χ2 = 13.002; p = .002), and Hispanics/Latinos (χ2 = 7.747; p = .021).ConclusionPersistence of disparities disproportionately affect the quality of data behind therapies for certain demographics; as such, enrollment practices must continue to address the issue of underrepresentation. Efforts to facilitate demographic equity among clinical trial participants must be supported to ensure that safety and efficacy conclusions are drawn from representative population samples.
| S-EPMC8484973 | biostudies-literature
Project description:OBJECTIVES:Insufficient sleep has become recognized as a pervasive problem in modern society. Sleep debt is a novel measure of sleep adequacy that may be useful in describing those at risk for inadequate sleep. Our objective was to investigate factors that may be associated with sleep debt at the population level, as well as build upon previous data that showed that minority groups may be more likely to have sleep debt. DESIGN:A cross-sectional population phone survey included questions regarding amount of sleep required and amount of sleep achieved. Sleep debt was calculated by subtracting sleep achieved from sleep required. SETTING:This study was designed by the Philadelphia Health Management Corporation and conducted over landlines and cell phones. PARTICIPANTS:The Random Digit Dialing method was used to randomly choose 8,752 adults older than 18 years from several counties in and around Philadelphia to answer questions about sleep. MEASUREMENTS:Logistic regression was performed to test associations between sleep debt and various sociodemographic factors in different population subgroups to identify those at risk for sub-optimal sleep duration. RESULTS:Sleep debt was seen to decrease with age, a novel finding that is in contrast with literature suggesting that older adults have poor sleep. Greater sleep debt was also associated with female gender, Hispanic/Latino ethnicity, <40 years of age, self-reported poor health, and increased stress. CONCLUSIONS:Although older adults may sleep less as they age, they may also require less sleep to feel rested, resulting in less sleep debt. This and other demographic factors, such as female gender and Hispanic/Latino ethnicity, can be used to identify those at higher risk of inadequate sleep and potentially manage their sleep debt.
| S-EPMC6101976 | biostudies-literature
Project description:ObjectiveVulnerable populations, including women and racial and ethnic minorities, have been historically underrepresented in clinical trials. We, therefore, studied the demographics of patients enrolled in pivotal endovascular aortic device trials in the United States.MethodsWe queried the Food and Drug Administration (FDA) medical devices database for all FDA-approved endografts for the treatment of aortic aneurysms, transections, and dissections from September 1999 to November 2021. These included abdominal endovascular aortic repair (EVAR), thoracic EVAR (TEVAR), fenestrated EVAR (FEVAR) devices, and dissection stents. Multiple cases of approval for expanded indications were included separately. The primary outcomes included the proportion of trials reporting participant sex, race, and ethnicity and the proportion of enrolled participants across sex, racial, and ethnic groups.ResultsThe FDA provided 29 approvals from 29 trials of 24 devices: 15 EVAR devices (52%), 12 TEVAR devices (41%), 1 FEVAR device (3.4%), and 1 dissection stent (3.4%). These trials had included 4046 patients. Of the 29 trials, all had reported on the sex of the participants, and the median female enrollment was 21% (interquartile range [IQR], 11%-34%). The EVAR trials had the lowest female enrollment (11%; IQR, 8.7%-13%) compared with 41% (IQR, 27%-45%) in the TEVAR trials, 21% in the FEVAR trial, and 34% in the dissection stent trial (P < .01 for the difference). Only 52% of the trials had reported the three most common racial groups (White, Black, Asian), and only 48% had reported Hispanic ethnicity. The TEVAR trials were the most likely to report all three racial groups and Hispanic ethnicity (92% and 75%, respectively), while the EVAR trials had the lowest reporting rates (13% and 20%, respectively). Where reported, the median enrollment of racial and ethnic groups across the trials was as follows: Black patients, 9.8% (FEVAR, 0%; EVAR, 1.9%; TEVAR, 12%; dissection stent, 25%; P = .01); Asian patients, 2.4% (EVAR, 0.6%; FEVAR, 2.4%; TEVAR, 2.5%; dissection stent, 11%; P = .24); and Hispanic patients, 3.8% (EVAR, 1.3%; FEVAR, 2.4%; TEVAR, 3.9%; dissection stent, 4.1%; P = .75).ConclusionsRacial and ethnic minority groups were underrepresented and underreported in pivotal aortic device trials that led to FDA approval. Female patients were also underrepresented in these aortic trials, especially for EVAR. These data suggest the need for standardization of reporting practices and minimum thresholds for minority and female participation in pivotal trials to promote equitable representation.
| S-EPMC9613501 | biostudies-literature
Project description:The COVID-19 pandemic revealed the disproportionate risk of poor clinical outcomes among population subgroups. The study investigates length of stay (LOS), intensive care unit (ICU) admission, and in-hospital death across age, sex, and race among patients hospitalized with COVID-19. A pooled cross-sectional study analyzed hospital discharge data of state-licensed hospitals in Texas from April to December 2020. Of 98,879 patients, males accounted for 52.3%. The age distribution was 31.9% for the 65-79 age group, 29.6% for those aged 50-64, and 16.3% for those older than 79. Whites constituted the largest proportion (42.6%), followed by Hispanics (36.2%) and Blacks (13.1%). Higher in-hospital death rates were found among patients aged 80 and over (Adjusted Risk Ratio (aRR) 1.12, 95%CI 1.11-1.13) and patients aged 65-79 (aRR 1.08, 95%CI 1.07-1.09) compared to patients aged 19 and below. Hispanics (aRR 1.03, 95%CI 1.02-1.03) and other minorities (aRR 1.02, 95%CI 1.02-1.03) exhibited higher in-hospital death rates than whites, and these patients also had longer LOS and higher ICU admission rates. Patients aged 65-79, 50-64, and 80 and over all had longer hospital stays and higher ICU admission rates. Males experienced poor health outcomes in all assessed outcomes. Findings showed that disparities in clinical outcomes among population subgroups existed and remained throughout 2020. While the nation has to continue practicing public health measures to minimize the harm caused by the novel virus, serious consideration must be given to improving the health of marginalized populations during and beyond the pandemic.
| S-EPMC9133563 | biostudies-literature
Project description: Not available
| S-EPMC10844997 | biostudies-literature
Project description:Age, sex, and racial/ethnic disparities exist, but are understudied in pancreatic adenocarcinoma (PDAC). We used the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database to determine whether survival and treatment disparities persist after adjusting for demographic and clinical characteristics. Our study included PDAC patients diagnosed between 1992 and 2011. We used Cox regression to compare survival across age, sex, and race/ethnicity within early-stage and late-stage cancer subgroups, adjusting for marital status, urban location, socioeconomics, SEER region, comorbidities, stage, lymph node status, tumor location, tumor grade, diagnosis year, and treatment received. We used logistic regression to compare differences in treatment received across age, sex, and race/ethnicity. Among 20,896 patients, 84% were White, 9% Black, 5% Asian, and 2% Hispanic. Median age was 75; 56% were female and 53% had late-stage cancer. Among early-stage patients in the adjusted Cox model, older patient subgroups had worse survival compared with ages 66-69 (HR > 1.1, P < 0.01 for groups >69); no survival differences existed between sexes. Black (HR = 1.1, P = 0.01) and Hispanic (HR = 1.2, P < 0.01) patients had worse survival compared with White. Among late-stage cancer patients, patients over age 84 had worse survival than those aged 66-69 (HR = 1.1, P < 0.01), and males (HR = 1.08, P < 0.01) had worse survival than females; there were no racial/ethnic differences. Older age and minority race/ethnicity were associated with lower likelihood of receiving chemotherapy, radiation, and/or surgery. Age and racial/ethnic disparities in survival outcomes and treatment received exist for PDAC patients; these disparities persist after adjusting for differences in demographic and clinical characteristics.
| S-EPMC5806100 | biostudies-literature
Project description:BackgroundThe coexistence of chronic mental health conditions with somatic conditions (somatic-mental multimorbidity, or SMM) is common and has been associated with greater symptom burden and functional impairment, higher costs, and excess mortality. However, most existing literature focused on the co-occurrence of an index mental health condition with specific additional conditions. By contrast, we studied the prevalence and patterns of SMM more broadly considering 19 selected conditions, and we focused on differences by age, sex, and race/ethnicity.MethodsThe Rochester Epidemiology Project (REP) records-linkage system was used to identify all residents of Olmsted County, MN, on April 1, 2010. We identified individuals with each of 19 common chronic conditions, including 5 mental health conditions, using the International Classification of Diseases, ninth revision (ICD-9) codes received from any health care provider between April 1, 2005 and March 31, 2010.ResultsAmong the 138,858 residents of the county, 52.4% were women, and 7.9% had SMM. SMM increased steeply with older age, was 1.7 times more common in women, and was lower in Asians compared with whites. Of the 10,903 persons with SMM, 7,739 (71.0%) were younger than 65 years. Depressive and anxiety disorders were the most common conditions involved in SMM. The dyads that were observed more frequently or less frequently than expected by chance varied in composition by age and sex.ConclusionsSMM that reaches medical attention is highly prevalent across all age groups, is more frequent in women, is less frequent in Asians, and encompasses a wide range of conditions.
| S-EPMC5055644 | biostudies-literature
Project description:Millennials (ages 18-35) are now the largest living generation in the US, making it important to understand and characterize the rising trend of colorectal cancer incidence in this population, as well as other younger generations of Americans. Data from the New Jersey State Cancer Registry (n = 181 909) and Surveillance, Epidemiology, and End Results program (n = 448 714) were used to analyze invasive CRC incidence trends from 1979 to 2014. Age, sex, race, ethnicity, subsite, and stage differences between younger adults (20-49) and screening age adults (≥50) in New Jersey (NJ) were examined using chi-square; and, we compared secular trends in NJ to the United States (US). Whites, men, and the youngest adults (ages 20-39) are experiencing greater APCs in rectal cancer incidence. Rates among younger black adults, overall, were consistently higher in both NJ and the US over time. When compared to older adults, younger adults with CRC in NJ were more likely to be: diagnosed at the late stage, diagnosed with rectal cancer, male, non-white, and Hispanic. Invasive CRC incidence trends among younger adults were found to vary by age, sex, race, ethnicity, and subsite. Large, case-level, studies are needed to understand the role of genetics, human papillomavirus (HPV), and cultural and behavioral factors in the rise of CRC among younger adults. Provider and public education about CRC risk factors will also be important for preventing and reversing the increasing CRC trend in younger adults.
| S-EPMC6089150 | biostudies-literature