Cardiovascular disease (CVD) is the leading cause of death in women globally.¹ BHF-funded research suggests that over a 10-year period, more than 8,200 women’s lives were needlessly lost in England and Wales because they didn’t receive the same standard of care as men.²

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Decades of research have improved cardiac care and treatment, but women continue to have worse outcomes than men. Multiple factors are thought to contribute to this problem, including misconceptions that CVD is a ‘man’s disease’, a higher likelihood of initial misdiagnosis and reduced or delayed access to life-saving treatments and care.

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With recent advances in digital health, we’ve never been in a better position to address the inequalities women face in awareness, treatment and care.

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Empowering patients and practitioners

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Traditional care pathways depend on women being able to spot symptoms and seek treatment. But we know that women are less likely to recognise they are suffering from a cardiac event.

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Remote patient monitoring can remove the pressure on patients to recognise signs and monitor their own health. Huma’s ‘hospital at home’ technology prompts patients to continually share their symptoms, but it’s the clinical team who makes the decision on when they need to get in touch. Our patient app can also provide educational content about symptoms, care and treatment to improve patient awareness of their condition.

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Our technology helps clinicians to gather more detailed insights and review a wider range of symptoms. This means they don't just have to rely on snapshots of patients on a particular day.

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In collaboration with Cwm Taf and Betsi Cadwaladr University Health Boards we used our ‘hospital at home’ technology to help manage heart failure conditions. The project showed that our technology can support clinical teams to monitor patient progress, identify patients who needed extra care and optimise patients faster.

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“Part of what we do is to teach patients if their symptoms are deteriorating or improving, and tell them to get in touch if they think they’re heading in the wrong direction,” explains Viki Jenkins, Community Nursing at BCUHB who was involved in the project. “However, we’re relying on them to engage with their health, and we find that some patients worry that they’re bothering us and are reluctant to get in touch.

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“With Huma’s technology, it’s easy for us to spot when a patient’s signs and symptoms are heading in the wrong direction. This allows us to respond sooner.”

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Improving research participation

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Historically, women have been underrepresented in research, which means that most of our existing clinical evidence comes from studies largely conducted in men.

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A recent review of over 700 cardiovascular clinical trials³ found that women account for roughly 38% of the total participants. So why are women underrepresented in cardiovascular trials? According to a report from the American College of Cardiology Cardiovascular Disease in Women Committee⁴, barriers to participation include:

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• Logistical issues- Barriers relating to financial and caregiver requirements may disproportionately affect women.
• Age- Women with CVD are generally older and more likely to have comorbidities than men. This can mean they are excluded from trials.
• Lower rates of referral- Women are less likely to be referred to cardiologists or tertiary care services and as a result could have a lower chance of meeting clinicians recruiting for clinical trials.

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Decentralized clinical trials can lift barriers to participation, allowing participants to take part wherever they are in the world, and when it suits them. This could be particularly important for women in employment and those with caring responsibilities so they don’t have to take time off or schedule care, or for women who are older or have comorbidities that may find it difficult to travel for onsite visits.

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To include older patients, or those with comorbidities, in decentralized clinical trials, platforms need to provide good assurance that they can safely monitor these high-risk patients remotely. This is where having real-world healthcare experience of monitoring complex patients becomes important. Work we’ve done with Royal Brompton and Harefield hospitals has shown that our platform can safely monitor hundreds of at-risk cardiac patients with almost 90 per cent specificity.

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Digital tools enable researchers to access larger, more diverse participant pools and could help counteract gender differences in cardiac referral rates. Our project with Bayer, Stanford Medicine and the Stanford Center for Digital Health to deliver a scalable, fully decentralized cardiovascular intervention trial for participants with atrial fibrillation shows digital-first recruitment strategies are a viable option. We were able to recruit 94% of participants in just 12 days.⁵

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When it comes to improving equity in research, we’re starting to see progress in the right direction. One of our recent studies, which was picked up by over 2000 media outlets, covered a population that was 57.9% female⁶. But we must continue to ensure that the people we really need to contribute to scientific research are able and empowered to do so.

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Our commitment to understanding bias

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Unfortunately all research comes with some bias. If we don’t recognise and understand what biases there are in research, we’ll never be able to fully address them and ensure that the evidence we generate is relevant to everyone across society.

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As we move towards digital-first research we need to identify any bias that exists with these approaches too. That’s why at Huma we’re working with the University of Cambridge on a unique study that will help us understand the bias in decentralized clinical trials. Our platform is being used to remotely collect data from nearly 2,500 participants from the Fenland cohort to help researchers understand the progression of COVID-19 infection and build predictive models for pre-symptomatic infection.

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By embedding our technology in an existing traditional research study, we can get valuable insights into who takes part in digital research, how they engage and understand what we can do to encourage them. We hope that when we publish our results it’ll provide useful information for the whole industry to ensure we bring everyone along with the digital revolution.

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References

1. GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.
2. Wilkinson C et al. Sex differences in quality indicator attainment for myocardial infarction: a nationwide cohort study Heart 2019; 105:516-523
3. Jin X et al. Women's Participation in Cardiovascular Clinical Trials From 2010 to 2017. Circulation. 2020 Feb 18;141(7):540-548. doi: 10.1161/CIRCULATIONAHA.119.043594. Epub 2020 Feb 17. PMID: 32065763.
4. Cho L et al. Cardiovascular Disease in Women Committee Leadership Council. Increasing Participation of Women in Cardiovascular Trials: JACC Council Perspectives. J Am Coll Cardiol. 2021 Aug 17;78(7):737-751. doi: 10.1016/j.jacc.2021.06.022. PMID: 34384555.
5. Publication in production.
6. Shahram Nikbakhtian et al. Accelerometer-derived sleep onset timing and cardiovascular disease incidence: a UK Biobank cohort study, European Heart Journal - Digital Health 2021 Volume 2, Issue 4, Pages 658–666

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