Representation of Older Adults in Cardiovascular Disease Trials Since the Inclusion Across the Lifespan Policy.
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ABSTRACT:
SUBMITTER: Nanna MG
PROVIDER: S-EPMC7489390 | biostudies-literature | 2020 Nov
REPOSITORIES: biostudies-literature
Publications
Representation of Older Adults in Cardiovascular Disease Trials Since the Inclusion Across the Lifespan Policy.
Nanna Michael G MG Chen Sean T ST Nelson Adam J AJ Navar Ann Marie AM Peterson Eric D ED
JAMA internal medicine 20201101 11
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Project description:Background Although disproportionately affected by cardiovascular disease, Black adults remain underrepresented in clinical trials. The National Institutes of Health recommends that studies define goals for recruitment of underrepresented populations. However, the extent to which cardiovascular trials incorporate evidence-based recruitment strategies in their protocols is understudied. Methods and Results We systematically reviewed National Institutes of Health-funded cardiovascular clinical trials registered in ClinicalTrials.gov between 2000 and 2019. Based on publicly available or requested protocols, we focused on enrollment of Black adults as well as the following recruitment strategies: community-based, electronic medical record-based, and provider-based recruitment. A total of 100 clinical trials focused on cardiovascular disease were included in our analysis, of which 62% had published protocols, and 46% of trials had enrolled populations that were <25% Black. In our analysis of available trial protocols, 21% of trials defined a recruitment target for underrepresented groups; however, only one study reported achieving its enrollment goal. While 13% of trial protocols referenced community-based recruitment strategies, 5% explicitly mentioned involving community members in the trial design process. Defining recruitment targets was associated with higher enrollment of Black participants. Conclusions Black adults are underrepresented in National Institutes of Health-funded cardiovascular trials, and the majority of these trials did not specify a Black enrollment target, did not meet targets, and largely did not report specific plans to enroll Black adults in their studies. Future interventions should target trial design and planning phases before study initiation to address these enrollment disparities.
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Project description:ImportanceCardiovascular health (CVH), defined by the American Heart Association as Life's Simple 7 to promote a healthy lifestyle and manage vascular risk factors, has been associated with a low risk of Alzheimer disease and less vascular dementia. However, the association between CVH and biomarkers of neurodegeneration remains less understood.ObjectiveTo investigate the association of CVH with serum biomarkers of neurodegeneration, including neurofilament light chain (NfL) and total tau (t-tau).Design, setting, and participantsThis cohort study was conducted within the biracial, population-based Chicago Health and Aging Project (CHAP) of adults aged 65 years or older between 1993 and 2012. Participants who had measured serum NfL and t-tau levels and data on all components of the CVH score were included. The statistical analysis was conducted from April 10 to September 26, 2024.ExposureThe CVH score includes 7 components: a healthy diet; regular exercise; normal body mass index; nonsmoking status; and the absence of dyslipidemia, diabetes, and hypertension. The scores were divided into 3 groups from lowest to highest CVH (0-6 points, 7-9 points, and 10-14 points).Main outcomes and measuresThe main outcome was the association of CVH score with serum biomarkers of NfL and t-tau as measured using linear regression and mixed-effects models.ResultsA total of 1018 CHAP participants were included in the analysis (mean [SD] age, 73.1 [6.1] years; 625 female [61.4%]; 610 Black or African American [59.9%] and 408 White [40.1%]). Participants with a high CVH score (ie, 10-14 points) were predominantly White (151 [64.3%]) and had a higher education (mean [SD], 13.6 [3.7] years). Compared with participants with low CVH scores (ie, 0-6 points), those with CVH scores of 10 to 14 points had significantly lower serum levels of NfL (relative difference, -18.9%; β = -0.091; SE, 0.025). A higher CVH score was associated with a slower annual increase in NfL levels as participants aged (relative difference in rate, -1.7%; β = -0.008; SE, 0.004). Cardiovascular health was not associated with serum levels of t-tau.Conclusions and relevanceThese findings suggest that promoting CVH in older adults may help alleviate the burden of neurodegenerative diseases, particularly among Black adults, who are known to experience a higher prevalence of cardiovascular disease.
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2023-08-16 | GSE237817 | GEO