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Channeling Health Care Delivery and Implementation Science in Cardiology for Improved Outcomes

The opening session for AHA21 was nothing sort of inspirational. In the opening session, a quote by Dr. Keith Ferdinand, Professor of Medicine and Chair of Preventative Cardiology at Tulane University, really stuck with me. The topic was how is the field of medicine adjusting in the midst of the challenges faced and inequities uncovered by the COVID pandemic? The simple answer: while positive strides have been made, there is much room for improvement. He then went on to expound about the importance of implementation science, as the best science in the world will do you no good if patients are unable to implement physical activity/dietary guidelines, understand when to take the appropriate medications, or receive preventive vaccines in time.

From the American experience with COVID, part of the difficulty in reaching the average American seems to be the emotional gap between patients and either healthcare institutions or providers. The weight evidence from the trials on COVID vaccines are clear on the efficacy and safety, particularly of the mRNA vaccines. However, delivering the messaging in a way the public will accept remains frustrating in many parts of the country. As a result, only 59% of the US population is fully vaccinated, while 68% have received at least one dose, ranking 51st in the world (1). The way we consume information is drastically different from earlier decades. In 2020, a Pew Research poll revealed more than eight-in-ten U.S. adults (86%) received news from a digital device compared to TV (68%), with those under 50 heavily skewed towards digital news consumption.(2) In this same poll, approximately 50% of adults consumed news from social media.(2, 3)  In contrast, in 2015, 75% of American adults had a PCP, dropping to 64% among 30-year-olds.(4)  During the last true global pandemic, that PCP was more likely to make a house call rather than see a patient 1 to 4 times a year.

The common thread for successful interventions seems to be meeting people where they are. Several panelists on the FIT session on navigating misinformation on social media, noted that as many receive news on socia media, they were motivated to explain new studies and correct misinformation on those platforms where people are likely to spend time and digest information. Admittedly, this effect is hard to measure, and many studies thus far are qualitative in nature. More concretely, two exciting trials presented at #AHA21 seem to shed some light on how we can mobilize these neural structures to improve the rates of uptake of proven behavioral & therapeutic modalities, to yield the morbidity and mortality benefits. Simply, how do we get patients to successfully take their indicated medications?

Dr. Jiang He of Tulane University presented the results of the China Rural Hypertension Control Project, an intervention in rural China utilizing nonphysician community health workers (CHW) supervised by local primary care physicians. These CHW—village doctors—were provided with basic medical training (e.g. standardized BP measurement) and tasked to deliver protocolized antihypertensive medications and counsel patients on medication adherence and lifestyle modification (5, 6). Patients were followed monthly and received discounted or free medications and home BP monitors. After 18 months, this cluster-randomized trial, yielded a 37.1% increase in achievement of goal BP control (< 130/80 mm Hg) of subjects living in intervention villages (57%) compared with those living in control villages (19.9%) (P < 0.001). The average drop in BP in the intervention group was greater by 15/7 mm Hg. (6) The use of community health workers is not a new phenomenon in developing countries. They are often trusted community members who receive training to help address community problems. The first use of CHW with no prior formal training to address problems with rural health was in China in the 1930s.(7) This model later spread to Latin America and Southeast Asia in the 1960s with varying levels of success. Certain countries—including Brazil, Bangladesh, and Kenya—have learned from these early struggles to build sustainable successful CHW models (7-9). Our colleagues in infectious disease have successfully integrated CHW to help tackle lack of adherence to Tuberculosis medications causing resistance, by CHW directly observing patients taking their medicines (DOTS).(10) In the US, CHW was recognized as a standard job classification by the US Department of Labor (US Bureau of Labor Statistics, 2010) for the first time in the 2010 census and continue to be underutilized. If the work of Dr. He and colleagues, can be translated to a form suitable to the US health system, this can hold great promise for prevention of the myriad problems stemming from uncontrolled hypertensions.

Dr. Alexander Blood, of Brigham and Women’s Hospital, provides a glimpse of what this may look like. Based on prior work led by Dr. Benjamin Scirica at the same institution(11), the program uses “navigators” to communicate with patients (via phone, text, and email), pharmacists to prescribe and adjust medication as necessary, as well as an algorithm to help educate patients, integrate data, and coordinate care. (12, 13)  As a result, systolic blood pressure was reduced by 10 mm Hg and LDL cholesterol by 45 mg/dL in approximately 10,000 participants enrolled. In an interview with TCTMD, Dr. Blood compared this program to Warfarin management, where the physician writes the initial prescription and the Pharmacy and Warfarin clinic maintain patient’s INR on a weekly basis. It is unlikely that quarterly or biannual visits will yield effective control in patients with poor health literacy. For patients that needed higher intensity care, they were referred to their physician (12, 13). An important aspect of this trial is the results were consistent in populations typically underserved by the medical system–Blacks, Hispanics, and non-English speaking populations. Dr. Blood noted, “…if you structure the way you’re reaching out to patients, engaging them, and communicating with them—if you’re intentional and equitable in the way you make that type of outreach—it’s possible to engage, enroll, and help patients reach maintenance at similar rates across these subpopulations that are traditionally underserved in medicine.” (12)

In summary, while amazing new discoveries & technologies continue to reshape what is possible in cardiology, it is equally important to apply the same ingenuity to scaling up what we already know works and meet people where they are, in order to guide them to best health that science can offer.

 

References:

  1. Hannah Ritchie EM, Lucas Rodés-Guirao, Cameron Appel, Charlie Giattino, Esteban Ortiz-Ospina, Joe Hasell, Bobbie Macdonald, Diana Beltekian and Max Roser (2020) – “Coronavirus Pandemic (COVID-19)”. Published online at OurWorldInData.org. Retrieved from: ‘https://ourworldindata.org/coronavirus’ [Online Resource]. [Available from: https://ourworldindata.org/covid-vaccinations?country=USA.
  2. Shearer E. More than eight-in-ten Americans get news from digital devices2021. Available from: https://www.pewresearch.org/fact-tank/2021/01/12/more-than-eight-in-ten-americans-get-news-from-digital-devices/.
  3. Shearer E, Mitchell A. News Use Across Social Media Platforms in 20202021. Available from: https://www.pewresearch.org/journalism/2021/01/12/news-use-across-social-media-platforms-in-2020/.
  4. Levine DM, Linder JA, Landon BE. Characteristics of Americans With Primary Care and Changes Over Time, 2002-2015. JAMA Intern Med. 2020;180(3):463-6.
  5. Sun Y, Li Z, Guo X, Zhou Y, Ouyang N, Xing L, et al. Rationale and Design of a Cluster Randomized Trial of a Village Doctor-Led Intervention on Hypertension Control in China. Am J Hypertens. 2021;34(8):831-9.
  6. Neale T. Village-Level Intervention Nets Big BP Control Gains in Rural China. TCTMD. 2021. https://www.tctmd.com/news/village-level-intervention-nets-big-bp-control-gains-rural-china [Accessed November 14, 2021]
  7. Perry H. A Brief History of Community Health Worker Programs. https://www.mchip.net/: USAID; 2013. p. 14.
  8. Lehmann U, Sanders D. Community health workers: What do we know about them? The state of the evidence on programmes, activities, costs and impact on health outcomes of using community health workers. School of Public Health, University of the Western Cape, Evidence and Information for Policy DoHRfH; 2007.
  9. Rosenthal EL, Wiggins N, Ingram M, Mayfield-Johnson S, De Zapien JG. Community health workers then and now: an overview of national studies aimed at defining the field. J Ambul Care Manage. 2011;34(3):247-59.
  10. Farmer P, Kim JY. Community based approaches to the control of multidrug resistant tuberculosis: introducing “DOTS-plus”. BMJ. 1998;317(7159):671-4.
  11. Scirica BM, Cannon CP, Fisher NDL, Gaziano TA, Zelle D, Chaney K, et al. Digital Care Transformation: Interim Report From the First 5000 Patients Enrolled in a Remote Algorithm-Based Cardiovascular Risk Management Program to Improve Lipid and Hypertension Control. Circulation. 2021;143(5):507-9.
  12. O’Riordan M. Pharmacist-Led Intervention Slashes LDL and BP in 10,000 Patients. TCTMD. 2021. https://www.tctmd.com/news/pharmacist-led-intervention-slashes-ldl-and-bp-10000-patients?utm_source=TCTMD&utm_medium=email&utm_campaign=Newsletter111321 [Accessed November 14, 2021]
  13. Blood AJ CC, Gordon WJ, et al. Digital care transformation: report from the first 10,000 patients enrolled in a remote algorithm-based cardiovascular risk management program to improve lipid and hypertension control. Presented at: AHA 2021. November 13, 2021.
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CDC Guidelines for the Vaccinated Population

It has been more than a year since the World Health Organization declared COVID-19 as a pandemic. In the past year, more than 130 million people were diagnosed with COVID-19, and we have lost 3 million lives globally. Within a record time, several effective vaccines were developed. Given that the vaccinated population is rapidly increasing, the Centers for disease control and prevention (CDC) released new guidelines for the fully vaccinated population. (figure 1)

CDC recommendations for the fully vaccinated population:

  • You can gather indoors with fully vaccinated people without social distancing or wearing a mask.
  • You can gather indoors with unvaccinated people from 1 household without social distancing or wearing a mask. Unless they are considered to be at high risk for severe COVID infection.
  • For domestic travel, you do not need to get tested before or after travel or self-quarantine after travel.
  • You do NOT need to get tested before leaving the United States unless your destination requires it.
  • You still need to show a negative test result or documentation of recovery from COVID-19 before boarding a flight to the United States.
  • You should still get tested 3-5 days after international travel.
  • You do NOT need to self-quarantine after arriving in the United States.
  • If you’ve been around someone who has COVID-19, you do not need to stay away from others or get tested unless you have symptoms.

Based on solid data, we know that all three approved vaccines in the United States are very effective in preventing the disease, especially deaths and severe forms. However, there are a few questions that remain to be determined in the next few months.

  • What is the effectiveness of different vaccines on the various new COVID-19 variants?
  • Can fully vaccinate people spread the disease?
  • For how long is the vaccine effective?

Currently, in the United States, the average number of shots per day is 3 million. Earlier this week, the public health agency reported more than 4 million shots were administered in 1 day. According to the CDC, more than 60 million people are fully vaccinated and 104.2 million U.S. residents, or 31% of the population, have received at least one vaccine dose. With the current pace, vaccines will be available for every adult in the United States by the end of May. Since the beginning of this pandemic, we have faced a lot of challenges in different aspects but finally now as the number of cases is significantly decreasing and the vaccinated population is expanding, we are definitely heading in the right direction!

Figure 1:
CDC recommendations for fully vaccinated people

References:

  • https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

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Coronavirus Disease 2019 Vaccine

Coronavirus disease 2019 (Covid-19) has been declared a pandemic by the world health organization (WHO) on March 11, 2020. Since the outbreak, the WHO reported more than 70 million confirmed cases, and 1.5 million deaths globally. In the US, nearly 300,000 lost their lives and currently, we are facing another surge of cases with a record-breaking 3,124 new deaths in a single day last week. Over the past year, scientists, physicians, and pharmaceutical companies did phenomenal efforts to develop a safe and effective vaccine.

Finally, on December 11 2020, The Food and Drug Administration has issued an emergency use authorization (EUA) for Pfizer and BioNTech’s coronavirus vaccine (based on a 17 to 4 vote with one abstention). It is important to note that an EUA is not equivalent to FDA approval. As the latter requires safety data for at least six months. The FDA clearance occurred in a record-breaking time frame for a complicated process that usually takes years. This EUA makes the United States the sixth country to clear the vaccine after Bahrain, Canada, Saudi Arabia, Mexico, and the United Kingdom. In this blog, I will review the data behind the EUA.

The study behind the FDA’s EUA was a multinational, phase 2/3, Placebo-controlled, observer-blinded randomized trial. Between July 2020, and November 2020, 43,548 participants (16 years and older) who were healthy or had stable medical conditions underwent 1:1 randomization to receive vaccine or placebo (saline). Of which, 36,523 received two doses (21 days apart) and completed the 2 months follow up. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among the vaccine group and 162 cases among the placebo group. Hence the vaccine was 95% effective in preventing Covid-19. Moreover, among the 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in the placebo group and 1 in the vaccine group.

Figure 1: Efficacy of the vaccine against Covid-19 after the First Dose.

Each symbol represents Covid-19 cases starting on a given day; filled symbols represent severe Covid-19 cases. The inset shows the same data on an enlarged y-axis, through 21 days.

The noted side effects were short-term mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and similar in both groups (0.6% in the vaccine group and 0.5% in the placebo group).

Figure 2: Safety outcomes of the vaccine.

The Vaccine works simply as it contains a small piece of the virus’s mRNA that instructs cells in the body to produce the virus’s distinctive “spike” protein. After receiving the vaccine, the body will manufacture a piece of the COVID-19 virus named spike protein, which does not cause disease but triggers the immune system to learn to react defensively. Given the novel mechanism, theoretically, it carries no risk of infection, as it only codes for a piece of the virus. It is also important to note that currently, it is unclear how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.

Given the promising results and the EUA, Pfizer is planning on shipping 2.9 million doses over this week and 100 million doses of the vaccine by next March. The pharmaceutical giant has a deal with the U.S. government, under that agreement, the vaccines will be free to the public. Understandably, the distribution will be in phases with the most critical workers and vulnerable people being on top of the list. At this point, strict monitoring of any side effects will be enforced at all sites. Apart from the approved vaccine, Moderna’s vaccine utilized a similar technology and is currently under review by the FDA and could obtain an EUA soon. Other pharmaceutical companies such as Johnson & Johnson, Oxford, and AstraZeneca, are in late-stage trials and their vaccines could be authorized in the near future. This Vaccine is the light at the end of the tunnel which gives humanity hope to reach an endpoint to this pandemic. In the meantime, we must practice social distancing, trust the data, and get vaccinated!

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”