Moving the Needle on Diversity and Healthcare Disparities
April 2023 - Compass Newsletter
Using Predictive Digital Vascular Biomarkers to Identify Risk in Diverse Populations
Impaired vascular function may offer one explanation for why cardiovascular disease (CVD) disproportionately affects Black Americans when compared with whites, according to research published in the Journal of the American Heart Association.1 In the 2013 study, which involved 385 black and 470 white subjects, researchers used digital pulse amplitude tonometry (PAT) to measure reactive hyperemia index (or RHI, a measure of coronary endothelial dysfunction) and peripheral augmentation index (PAT-Alx). SphygmoCor® applanation tonometry was then used to measure central augmentation index (C-Alx) and pulse wave velocity (PWV) to determine wave reflection and arterial stiffness. Even after adjusting for differences in CVD risk profiles, researchers found higher levels of arterial stiffness, greater wave reflection and more impaired endothelial function in black men compared with white. Significantly, these same results were reproduced in a sub-analysis of healthy black men. This study proves that inherent racial differences in vascular function may put black Americans at higher risk for CVD, independent of traditional CVD risk factors. Since poor arterial elasticity and weak endothelial function increase the likelihood of worse long-term outcomes, the researchers concluded that non-invasive arterial analysis using digital vascular biomarkers are exceptionally useful tools for monitoring this high-risk population.
1Morris, A. et al.: Racial Differences in Arterial Stiffness and Microcirculatory Function Between Black and White Americans, J Am Heart Assoc. 2013;2: e002154.
Neighborhood Impacts on Healthcare Disparities
While the quality of healthcare is improving across the United States, significant healthcare disparities remain across communities, according to the 2021 National Healthcare Quality and Disparities Report. In fact, the World Health Organization (WHO) says social determinants such as economic status, education, environment, community, residence, and healthcare access can impact a whopping 80% of health outcomes.
In a 2016 study involving 3484 British men and women published in the journal, Hypertension, researchers used SphygmoCor® Pulse Wave Velocity (PWV) to determine baseline and changes in aortic (arterial) stiffness over a period of five years.1 Lower socioeconomic status was associated with higher cardiovascular (CVD) risk, according to the study. The 2023 Jackson Heart study and Morehouse-Emory Cardiovascular Center for Health Equity also explored the correlation between neighborhood environment and CVD risk in 2,000 black adults.2 These researchers employed SphygmoCor Pulse Wave Velocity (PWV) and Pulse Wave Analysis (PWA) to measure augmentation index (AIx), an indicator of arterial stiffness. The Jackson Heart Study found that less violence, more social structure and better access to food were associated with a lower pulse wave velocity and augmentation index, indicating better arterial elasticity. In other words, the better the neighborhood, the better the cardiovascular outcome.
1Trudel, X. et al.: Socioeconomic status, education, and aortic stiffness progression over 5 years: the Whitehall II prospective cohort study. J Hypertens. 2016; 34:2038–2044.
2Islam, S. et al.: (2022): Neighborhood characteristics and arterial stiffness among Black adults – Results from the Jackson Heart Study and Morehouse-Emory Cardiovascular Center for Health Equity. Vascular Medicine. 2023;0(0)
Diversity in FDA Clinical Trials Gets a Boost From New Legislation
Clinical trials have historically fallen short of consistently and adequately representing diverse populations across therapeutic areas. On average, 75% of clinical trial participants are white, 8% are Black or African America, 6% are Asian, and 11% are Hispanic, according to a 2020 Drug Trials Snapshots Summary Report from the U.S. Food and Drug Administration.
To address this ongoing inequity, the FDA recently enacted the Food and Drug Omnibus Reform Act (FDORA). Section 3601 of the legislation, which mandates drug and device companies increase diversity, requires sponsors to submit a strategic diversity action plan timed with the study protocol submission detailing how phase 3 trials and other pivotal drug studies (other than bioavailability or bioequivalence studies) will expand trial enrollment to a broader population.1 By increasing diversity in clinical trials, the FDA hopes to more closely align drug and/or medical device safety and effectiveness data with race and/or ethnicity, closing knowledge gaps on how these products would work in large segments of the population that were previously excluded from trials.2,3
1 Hyman, Phelps & McNamara, The FDA Law Blog, January 24, 2023: Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans (thefdalawblog.com).
2 November 2020 FDA guidance: Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry (fda.gov)
3 April 2022 FDA draft guidance: Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry (fda.gov)
Are Parkinson’s Disease Patients at a Higher Risk for Cardiovascular Disease?
In honor of Parkinson’s Disease (PD) Awareness Month, we are casting a spotlight on how clinicians and researchers are using digital vascular biomarkers to better understand the health implications of this devastating disease, which affects over one million Americans.1 What do vascular indices have in common with PD? Many are not aware that by monitoring indices such as augmentation index (Alx) or pulse pressure (PP), clinicians have a better chance of predicting whether a patient will experience a cardiovascular (CV) event, such as death due to a stroke. Investigators of a 2017 publication in the Journal of Movement Disorders focused on the prevalence of stroke and other CV events in patients with PD.2 The study found that peripheral and central pulse pressure was significantly lower in the Parkinson’s group than in the control group, which suggests that patients with PD are actually at lower risk of a cardiovascular event when compared to healthy individuals with a higher PP.
1https://www.parkinson.org/understanding-parkinsons/statistics
2Joong Hyun Park, Sang Won Han, Jong Sam Baik. J Mov Disord 2017;10(3):135-139.
The Essence of Usability in BioMeTs
The Digital Medicine Society (DiMe) recently invited ATCOR medical to join the Extending the V3 (Verification, analytical Validation, and clinical Validation) Framework that establishes consistent guidelines for evaluating the efficacy of novel biometric technologies (BioMeTs). Initially launched by DiMe in 2020, the V3 Framework has already been widely adopted across the industry, including by the European Medicines Agency (EMA). ATCOR and other industry partners are expanding the framework to include essential principles of human factors, human-centered design, and usability of BioMeTs for integration in decentralized clinical trials and healthcare.
“The expansion of the V3 Framework highlights the interoperability of digital patient data across healthcare and clinical research. ATCOR is excited to partner with other industry leaders on this influential DiMe project,” says Toni Hofhine, President of ATCOR Medical. DiMe is a global non-profit dedicated to driving scientific progress and broad acceptance in digital medicine to enhance public health.
About Us
ATCOR develops innovative medical devices and digital solutions that help identify and manage hypertension, cardiovascular disease (CVD), and other related vascular disorders such as Alzheimer’s and renal disease.
Using ATCOR's SphygmoCor® technology, researchers and clinicians are able to collect and assess clinically relevant digital vascular biomarkers to help facilitate better routine patient monitoring. These measurements also shed insight into subclinical changes in the arterial system that improve the efficacy of clinical trial therapies for chronic vascular diseases.
Read more about how our technological innovations can improve global health outcomes here.