Cardiovascular surgery trials in the United States: representation of women and minorities.
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ABSTRACT:
SUBMITTER: Luc JGY
PROVIDER: S-EPMC10711410 | biostudies-literature | 2023 Nov
REPOSITORIES: biostudies-literature
Publications
Cardiovascular surgery trials in the United States: representation of women and minorities.
Luc Jessica G Y JGY Moon Marc R MR Preventza Ourania O
Annals of cardiothoracic surgery 20230728 6
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Project description:Gender and ethnicity are factors affecting the incidence and severity of vascular disease as well as subsequent treatment outcomes. Although well studied in other fields, balanced enrollment of patients with relevant demographic characteristics in vascular surgery randomized controlled trials (RCTs) is not well known. This study describes the reporting of gender and ethnicity data in vascular surgery RCTs and analyzes whether these studies adequately represent our diverse patient population.We conducted a retrospective review of United States-based RCTs from 1983 through 2007 for three broadly defined vascular procedures: aortic aneurysm repair (AAR), carotid revascularization (CR), and lower extremity revascularization (LER). Included studies were examined for gender and ethnicity data, study parameters, funding source, and geographic region. The Nationwide Inpatient Sample (NIS) database was analyzed to obtain group-specific procedure frequency as an estimate of procedure frequency in the general population.We reviewed 77 studies, and 52 met our inclusion criteria. Only 85% reported gender, and 21% reported ethnicity. Reporting of ethnicity was strongly associated with larger (>280 participants), multicenter, government-funded trials (P < .001 for all). Women are disproportionately under-represented in RCTs for all procedure categories (AAR, 9.0% vs 21.5%; CR, 30.0% vs 42.9%; LER, 22.4% vs 41.3%). Minorities are under-represented in AAR studies (6.0% vs 10.7%) and CR studies (6.9% vs 9.5%) but are over-represented in LER studies (26.0% vs 21.8%, P < .001 for all).Minority ethnicity and female gender are under-reported and under-represented in vascular surgery RCTs, particularly in small, non-government-funded and single-center trials. The generalizability of some trial results may not be applicable to these populations. Greater effort to enroll a balanced study population in RCTs may yield more broadly applicable results.
| S-EPMC2759770 | biostudies-literature
Project description:BackgroundRepresentation trends of women, older adults, and ethnic/racial minorities in randomized controlled trials (RCTs) of atrial fibrillation (AF) are uncertain.MethodsWe systematically reviewed 134 AF related RCTs (phase II and III) encompassing 149,162 participants using Medline and ClinicalTrials.gov through April 2019 to determine representation trends of women, older patients (≥75 years), and ethnic/racial minorities. Weighted data on the prevalence of AF from epidemiological studies were used to compare the representation of the studied groups of interest in AF RCTs to their expected burden of the disease.ResultsOnly 18.7% of the RCTs reported proportion of older patients, and 12.7% RCTs reported ethnic/racial minorities. The proportions of women in RCTs versus general population were 35.2% and 35.1%, of Hispanics were 11.9% and 5.2%, of Blacks were 1.2% and 5.7%, of American Indian/Alaskans were 0.2% and 0.2%, of Asians were 14.2% and 2.4%, of native Hawaiian/Pacific Islanders were 0.05% and 0.1% and of non-Whites were 19.5% and 22.5%, respectively. The weighted mean age (SD) across the trials was 65.3 (3.2) years which was less than the corresponding weighted mean age of 71.1 (4.5) years in the comparative epidemiological data.ConclusionThe reporting of older patients and ethnic/racial minorities was poor in RCTs of AF. The representation of women and American Indian/Alaskan natives matched their expected population share of disease burden. Hispanics and Asians were over-represented and Blacks, native Hawaiian/Pacific Islanders and non-Whites were under-represented in RCTs of AF.
| S-EPMC8404149 | biostudies-literature
Project description:ObjectiveDescribe the demographic profile of US participants in Amgen clinical trials over a 10-year period and variations across therapeutic areas, indications, and geographies.MethodsCross-sectional retrospective study including participants enrolled (2005-2020) in phase 1-3 trials completed between January 1, 2012 and June 30, 2021.ResultsAmong 31,619 participants enrolled across 258 trials, one-fifth represented racial minority populations (Asian, 3%; Black or African American, 17%; American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, multiracial, each < 1%); fewer than one-fifth (16%) represented an ethnic minority population (Hispanic or Latino). Compared with census data, representation of racial and ethnic groups varied across US states. Across most therapeutic areas (bone, cardiovascular, hematology/oncology, inflammation, metabolic disorders, neuroscience) except nephrology, participants were predominantly White (72-81%). A similar proportion of males and females were enrolled between 2005 and 2016; male representation was disproportionately higher than female between 2016 and 2020. Across most medical indications, the majority of participants were 18-65 years of age.Conclusions and relevanceWhile the clinical research community is striving to achieve diversity and proportional representation across clinical trials, certain populations remain underrepresented. Our data provide a baseline assessment of the diversity and representation of US participants in Amgen-sponsored clinical trials and add to a growing body of evidence on the importance of diversity in clinical research. These data provide a foundation for strategies aimed at supporting more equitable and representative research, and a baseline from which to assess the impact of future strategies to advance health equity.
| S-EPMC11480170 | biostudies-literature
Project description:Background Women have traditionally been underrepresented in randomized clinical trials (RCTs). We performed a systematic evaluation of the inclusion of women in cardiac surgery RCTs published in the past 2 decades. Methods and Results MEDLINE, EMBASE, and the Cochrane Library were searched (2000 to July 2020) for RCTs written in English, comparing ≥2 adult cardiac surgical procedures. The percentage of women enrolled and its association with year of publication, sample size, mean age, funding source, geographic location, number of sites involved, and interventions tested were analyzed using a meta-analytic approach. Fifty-one trials were included. Of 25 425 total patients, 5029 were women (20.8%; 95% CI, 17.6-24.4; range, 0.5%-57.9%). The proportion of women dropped significantly during the study period (29.6% in 2000 versus 13.1% in 2019, P<0.001). Women were significantly more represented in European trials (26.2%; 95% CI, 21.2-31.9), and less represented in trials of coronary bypass surgery versus other interventions (16.8%; 95% CI, 12.3-22.7 versus 33.6%; 95% CI, 27.4-40.5; P=0.0002) and in trials enrolling younger patients (P=0.009); the percentage of women was higher in industry-sponsored versus non-industry sponsored trials (31.7%; 95% CI, 27.2-36.6 versus 15.5%; 95% CI, 10.0-23.2; P=0.0004) and was not associated with trial sample size (P=0.52) or study design (multicenter versus monocenter: P=0.22). After exclusion of trials conducted at Veteran Affairs centers, women representation was 24.4% (95% CI, 21.1-28.0; range, 10.4%-57.9%), with no significant changes during the study period. Conclusions The proportion of women in cardiac surgery trials is low and likely inadequate to provide meaningful estimates of the treatment effect.
| S-EPMC8475035 | biostudies-literature
Project description:ObjectiveTo determine policy-associated changes over time in 1) the enrollment of women and minorities in National Institute of Neurological Disorders and Stroke (NINDS)-funded clinical trials and 2) the trial publication reporting of race/ethnicity and gender.MethodsAll NINDS-funded phase III trials published between 1985 and 2008 were identified. Percent of African Americans, Hispanic Americans, and women enrolled in the trials was calculated for those trials with available data. Z tests were used to compare reporting and enrollment data from before (period 1) and after (period 2) 1995 when NIH enacted their policies regarding race, ethnicity, and gender. Percent of main trial publications reporting enrollment of African Americans, Hispanic Americans, and women was also calculated.ResultsOf the 56 trials identified, 100%, 48%, and 25% reported enrollment by gender, race, and ethnicity. Women constituted 42.1% of the trial population. Enrollment of women increased over time (36.9% period 1; 49.0% period 2, p < 0.001). African Americans constituted 19.8% of the enrollees in trials with available data and enrollment increased over time (11.6% period 1; 30.7% period 2, p < 0.001). Hispanic Americans constituted 5.8% of subjects in trials with available data and enrollment decreased over time (7.4% period 1; 5.0% period 2, p < 0.001).ConclusionsImprovements in reporting of race/ethnicity in publications and enrollment of Hispanics in NINDS trials are needed. While African American representation is above population levels, Hispanic Americans are underrepresented in NINDS trials and representation is declining despite Hispanics' increasing representation in the US population.
| S-EPMC3034419 | biostudies-literature
Project description:ObjectiveTo examine Hispanic/Latino representation in diabetes cardiovascular outcomes trials for novel antidiabetic drugs.Research design and methodsWe compared Hispanic/Latino representation, age, gender and body mass index in diabetes cardiovascular outcomes trials published from January 2008 to October 2018 to Hispanic adults with diabetes in the National Health Examination and Nutrition Survey over the same time period.ResultsHispanics/Latinos comprised 18.5 % of trial subjects, which was similar to the proportion of US adults with diabetes who identify as Hispanic. Trial subjects were significantly younger, more likely to be female, and more obese than US Hispanics/Latinos. At least 10 different Latin American countries and territories were represented across the 10 trials.ConclusionsUS Hispanics/Latinos differ from subjects in diabetes cardiovascular outcomes trials, which may limit generalizability of trial results.
| S-EPMC6557465 | biostudies-literature
Project description:BackgroundOver the past decade, suicide rates have increased among certain racial/ethnic minority groups in the United States. To better understand suicide vulnerability among people of color, studies have examined the relations between social risk factors-such as discrimination-and suicidal thoughts and behaviors. However, the literature has been inconsistent, calling for more population studies.MethodsThis study analyzed data from two surveys: (1) The National Survey of American Life; and (2) The National Latino and Asian American Survey, which taken together are representative of Black, Latino, and Asians in the United States. Multivariable logistic regression models were used to examine the association between levels of discrimination on the Everyday Discrimination Scale and suicidal thoughts and behaviors. Additional models tested for effect modification by race and by psychiatric diagnosis.ResultsWe found that individuals who reported the highest levels of discrimination had greater odds of reporting lifetime suicidal thoughts, plans, and attempts, when compared with people who did not report discrimination, after adjusting for socio-demographic characteristics. Notably, discrimination increased odds of reporting an unplanned suicide attempt and a suicide attempt without the intent to die. Adjusting for psychiatric diagnoses attenuated these effects. We found no evidence of effect modification by race or by psychiatric diagnosis.LimitationsData were cross-sectional, which did not allow for causal inferences.ConclusionsFuture translational research can explore how screening for discrimination may help identify individuals and groups of racial/ethnic minorities at risk for suicidal thoughts and behaviors.
| S-EPMC6351183 | biostudies-literature
Project description:BackgroundTransgender women (TW) are disproportionately affected by both HIV and cardiovascular disease (CVD).ObjectivesWe aim to quantify prevalence of elevated predicted CVD risk for TW compared to cisgender women (CW) and cisgender men (CM) in HIV care and describe the impact of multiple operationalizations of CVD risk score calculations for TW.DesignWe conducted a cross-sectional analysis of patients engaged in HIV care between October 2014 and February 2018.SettingThe Centers for AIDS Research Network of Integrated Clinical Systems, a collaboration of 8 HIV clinical sites in the United States contributed data for this analysis.Patients221 TW, 2983 CW, and 13467 CM.MeasurementsThe measure of interest is prevalence of elevated 10-year cardiovascular disease risk based on ACC/AHA Pooled Cohort Risk Assessment equations (PCE) and the Framingham Risk Score (FRS), calculated for TW by: birth-assigned sex (male); history of exogenous sex hormone use (female/male); and current gender (female).ResultsUsing birth-assigned sex, the adjusted prevalence ratio (aPR) was 2.52 (95% CI: 1.08,5.86) and 2.58 (95% CI: 1.71,3.89) comparing TW to CW, by PCE and FRS, respectively. It was 1.25 (95% CI: 0.54,2.87) and 1.25 (95% CI: 0.84,1.86) comparing TW to CM, by PCE and FRS, respectively. If TW were classified according to current gender versus birth-assigned sex, their predicted CVD risk scores were lower.LimitationsPCE and FRS have not been validated in TW with HIV. Few adjudicated CVD events in the data set precluded analyses based on clinical outcomes.ConclusionsAfter adjustment for demographics and history of HIV care, prevalence of elevated CVD risk in TW was similar to CM and equal to or higher than in CW, depending operationalization of the sex variable. Future studies with CVD outcomes are needed to help clinicians accurately estimate CVD risk among TW with HIV.
| S-EPMC7371206 | biostudies-literature
Project description:Background Suboptimal cardiovascular health (CVH) and social determinants of health (SDOH) have a significant impact on maternal morbidity and mortality. We aimed to evaluate the association of SDOH with suboptimal CVH among pregnant women in the United States. Methods and Results We examined cross-sectional data of pregnant women aged 18 to 49 years from the National Health Interview Survey (2013-2017). We ascertained optimal and suboptimal CVH based on the presence of 0 to 1 and ≥2 risk factors (hypertension, diabetes, hyperlipidemia, current smoking, obesity, and insufficient physical activity), respectively. We calculated an aggregate SDOH score representing 38 variables from 6 domains (economic stability; neighborhood, physical environment, and social cohesion; community and social context; food; education; and healthcare system) and divided into quartiles. We used Poisson regression model to evaluate the association of SDOH with suboptimal CVH and risk factors. Our study included 1433 pregnant women (28.8±5.5 years, 13% non-Hispanic Black). Overall, 38.4% (95% CI, 33.9-43.0) had suboptimal CVH versus 51.7% (95% CI, 47.0-56.3) among those in the fourth SDOH quartile. Risk ratios of suboptimal CVH, smoking, obesity, and insufficient physical activity were 2.05 (95% CI, 1.46-2.88), 8.37 (95% CI, 3.00-23.43), 1.54 (95% CI, 1.17-2.03), and 1.19 (95% CI, 1.01-1.42), respectively among those in the fourth SDOH quartile compared with the first quartile. Conclusions Over 50% of pregnant women with the highest SDOH burden had suboptimal CVH, highlighting the public health urgency for interventions in socially disadvantaged pregnant women with renewed strategies toward improving modifiable risk factors, especially smoking and insufficient physical activity.
| S-EPMC9238529 | biostudies-literature
Project description:ObjectiveEating disorders (EDs) were once conceptualized as primarily affecting affluent, White women, a misconception that informed research and practice for many years. Abundant evidence now discredits this stereotype, but it is unclear if prevailing "evidence-based" treatments have been evaluated in samples representative of the diversity of individuals affected by EDs. Our goal was to evaluate the reporting, inclusion, and analysis of sociodemographic variables in ED psychotherapeutic treatment randomized controlled trials (RCTs) in the US through 2020.MethodsWe conducted a systematic review of ED psychotherapeutic treatment RCTs in the US and examined the reporting and inclusion of gender identity, age, race/ethnicity, sexual orientation, and socioeconomic status (SES) of enrolled participants, as well as recruitment methods, power analyses, and discussion of limitations and generalizability.ResultsOur search yielded 58 studies meeting inclusion criteria dating back to 1985. Reporting was at times incomplete, absent, or centered on the racial/gender majority group. No studies reported gender diverse participants, and men and people of color were underrepresented generally, with differences noted across diagnoses. A minority of papers considered sociodemographic variables in analyses or acknowledged limitations related to sample characteristics. Some progress was made across the decades, with studies increasingly providing full racial and ethnic data, and more men included over time. Although racial and ethnic diversity improved somewhat, progress appeared to stall in the last decade.DiscussionWe summarize findings, consider context and challenges for RCT researchers, and offer suggestions for researchers, journal editors, and reviewers on improving representation, reporting, and analytic practices.Public significanceRandomized controlled trials of eating disorder psychotherapeutic treatment in the US are increasingly reporting full race/ethnicity data, but information on SES is inconsistent and sexual orientation absent. White women still comprise the overwhelming majority of participants, with few men and people of color, and no gender-diverse individuals. Findings underscore the need to improve reporting and increase representation to ensure evidence-based treatments are effective across and within diverse groups.
| S-EPMC8988395 | biostudies-literature