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DAPA-CKD: Is SGLT2i the ANSWER? Will the guidelines change?

Over the past years, series of clinical trials prove the beneficial effect of glucose cotransporter 2 (SGLT2) inhibitors in reducing the risk of cardiovascular events in people with type 2 diabetes mellitus. The results from these trials were consistent, significant, and demonstrated a considerable reduction in heart failure hospitalization among patients who used SGLT2 inhibitors, whereas the benefit on atherothrombotic events such as myocardial infarction and stroke was moderate.

Similar findings from The Canagliflozin and Renal Events in Diabetes With Established Nephropathy Clinical Evaluation trial (CREDENCE) were obtained for patients with type 2 diabetes mellitus and chronic kidney disease who are exceptionally at higher risk for cardiovascular disease. In CREDENCE trial, Canagliflozin reduced the risk of chronic kidney disease, cardiovascular death or hospitalization, myocardial infarction, and stroke. Although diabetes is not the only cause of chronic kidney disease, and people with chronic kidney disease are still at increased risk for cardiovascular disease, regardless if they had a preexisting history of cardiovascular disease or not. Therefore, its essential to implement guidelines that recommend the use of certain therapeutics as routine treatment for primary and secondary prevention of cardiovascular disease in patients with chronic kidney disease, regardless of their diabetes status.

During #AHA20, I enjoyed attending the online session by Dr. John McMurray, where he shared scientific breakthrough results from the Dapagliflozin And Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) Mega-Trial. The session reported the results of the effect of dapagliflozin on prespecified kidney and cardiovascular outcomes in patients with chronic kidney disease with and without diabetes. The DAPA-CKD trial was a randomized, double-blind, placebo-controlled, multicenter trial, where adults with or without type 2 diabetes, with estimated glomerular filtration rate (eGFR) between 25 and 75 ml/min/1.73 m2, and a urinary albumin-to-creatinine ratio (UACR) between 200 and 5000 mg/g were eligible for DAPA-CKD trial. In this trial, patients were randomized to dapagliflozin 10 mg once daily or placebo with follow up at 2 weeks, 2,4, and 8 months and at 4 months intervals thereafter. The primary composite outcome was the time to the first occurrence of any of the following: > 50% decline in eGFR, onset of end-stage renal disease, or death from kidney or cardiovascular disease. Moreover, secondary outcomes were: 1) kidney composite outcome identical to the primary endpoint with the exception of death from cardiovascular death 2)( a cardiovascular composite outcome consisting of hospitalization for heart failure or death from cardiovascular  causes; and 3) death from any cause.

 

Effects of dapagliflozin on prespecified clinical outcomes according to the baseline history of cardiovascular disease.

 The DAPA-CKD trial found that among patients with cardiovascular disease who received dapagliflozin, the primary composite outcome occurred in 11.2% participants, while the primary outcome occurred in 17.2% in participants who were in the placebo group, (HR 0.61; 95% CI, 0.47-0.79) and the corresponding numbers in people without cardiovascular disease were 7.9% and 12.9% respectively, (HR 0.61; 0.48-0.78).

The DAPA-CKD trial also found that for both the primary and secondary prevention patients, the event rates favored dapagliflozin for all components of the primary and secondary outcomes, although reduction in cardiovascular risk was not statistically significant.

DAPA-CKD Figure

Additionally, among patients with cardiovascular disease, cardiovascular death or hospitalization for heart failure occurred in 9.3% of participants in the dapagliflozin group and 12.8% of participants in the placebo group, (HR 0.7; 0.52-0.94) and the corresponding numbers for patients without cardiovascular disease were 1.8% and 2.7% respectively, (HR 0.67; 0.40-1.13). The observed reduction in cardiovascular risk for these two groups was driven by reduction in heart failure hospitalization which occurred in 4.1% of participants in the dapagliflozin group and 7.3% participants in the placebo group with cardiovascular disease and the corresponding numbers for patients without cardiovascular disease were 0.3% and 1.0% (HR, 0.31; 0.10-0.94) respectively. These results show that dapagliflozin reduced the risk of adverse kidney outcomes irrespective of baseline cardiovascular disease status. Moreover, the mortality benefit from dapagliflozin as demonstrated from the DAPA-CKD study supports the findings of the DAPA-HF trial. In summary, dapagliflozin reduced the risk of kidney failure, death from cardiac disease or hospitalization for heart failure, furthermore, it prolonged survival, in people with chronic kidney disease, irrespective of the presence of a concomitant cardiovascular disease.

 

What is next?

The data from DAPA-CKD trial for dapagliflozin effect on patients with cardiovascular disease and chronic kidney disease is clear, but we have so much work to do. Is Dapagliflozin the answer? How would this change the guideline directed medical therapy (GDMT) for the care of patients with an increased heart failure, cardiovascular or chronic kidney disease risk, regardless of their glycemic status?

 

References:

  1. Effect of Dapagliflozin on Clinical Outcomes in Patients with Chronic Kidney Disease, With and Without Cardiovascular Disease. John J.V. McMurray , David C. Wheeler , Bergur V. Stefánsson , Niels Jongs , Douwe Postmus , Ricardo Correa-Rotter , Glenn M. Chertow , Tom Greene , Claes Held , Fan Fan Hou , Johannes F.E. Mann , Peter Rossing , C. David Sjöström , Robert D. Toto , Anna Maria Langkilde , and Hiddo J.L. Heerspink for the DAPA-CKD Trial Committees and Investigators
  2. Presented by Dr. John J. V. McMurray at the American Heart Association Virtual Scientific Sessions, November 13, 2020.
  3. Heerspink HJ, Stefánsson BV, Correa-Rotter R, et al., on behalf of the DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients With Chronic Kidney Disease.N Engl J Med 2020;383:1436-46.
  4. Presented by Dr. Hiddo J.L. Heerspink at the European Society of Cardiology Virtual Congress, August 30, 2020.
  5. Rationale and protocol:Heerspink HJ, Stefansson BV, Chertow GM, et al., on behalf of the DAPA-CKD Investigators. Rationale and protocol of the Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial. Nephrol Dial Transplant 2020;35:274-82.

“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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WELLNESS MATTERS

American Heart Association Early Career Guest Blog

Sherry-Ann Brown MD PhD FAHA

WELLNESS

The World Health Organization defines wellness as “a state of complete physical, mental, and social well-being, and not merely the absence of disease or infirmity”. The terms in this definition inspire similar words such as continuous (state), whole (complete), tangible (physical) and intangible (mental), as well as togetherness or community (social).

 PANDEMIC WELLNESS

Indeed, during the pandemic, we often say or hear, “We are all in this together”. The global community has rallied around each other to get through the coronavirus disease of 2019 (COVID-19) well. In the midst of a nation in turmoil with pandemics juxtaposed (coronavirus and racial and ethnic inequities), we find ourselves in the middle of it all as physicians.

SAFETY & WELLNESS

Along with everyone else in medical authority, we encourage those around us and all we serve to distance physically more so than socially. We want people to remain social, to enhance wellness. Yet, we need that socialization to be safe and physically distant, to foster tangible wellness.

 WELLNESS NOT CANCELLED

We encourage everyone to recognize that conversations, relationships, love, songs, reading, hope, joy, getting outdoors, music, family, and self-care should not and will not be canceled. This is the good stuff. The intangible components of wellness.

WELLNESS HEROES

So many of us in health care are sacrificing this period of our lives or in fact our very lives so that our patients can be whole. This altruism that led us here is continuous and indestructible by the #rona. Many of us turn to visual wellness inspired by COVID-19 to help capture the essence and sentiments of these challenging times. Art and other forms of creative expression of what’s inside of us or in society can motivate us to see more, be more, and serve more.

These matters at hand are crucial to help maintain our state of complete physical, mental, and social well-being. If we are honest with ourselves, we recognize that most of us live at best in a state of incomplete well-being. Yet, we can stand together against cancellation of our will and empower each other on this journey to wellness. It’s never been a destination. It’s always been a process that we continue to learn daily.

 

“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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Lessons I’ve Learned as Chair

Being a recent graduate just entering the professional stage of one’s career is an especially turbulent time. This is magnified for ones that had a prolonged academic journey, such as advanced medical training, pursuing master’s/doctoral degrees, and any other unique situation that can lead to a long journey of being an official student on paper (because unofficially we’re all students of life, until the end!).

However long and winding road one takes, there comes a time when the stage is set to exit being a student and enter the professional field. This stage is simply known as Early Career (using the naming convention most widely used, including at the American Heart Association). This part of a career journey has the uniqueness of blending learning many new life skills, and professionally performing up to the standards expected from achieving the academic endpoint one has reached (MD, PhD, or any other).

One way a young professional can advance their learning curve and become professionally savvy and focused is by seeking and actively participating in committees within organizations related to their working field. Committees provide a platform where members interact regularly, discuss and plan actions related to the work environment, provide community-building opportunities, and essentially expose their members to a variety of learning experiences that are highly beneficial, both directly and indirectly, in progressing their early career professional journey.

Here I present my personal experience as an example. I have recently concluded my term as Chair of the trainee committee in my institute, and have recently been granted full employment status as part of the reorganization of the employment structure here. I’m now exactly placed in the “Early Career Professional” stage of my journey.  Being part of a committee provided me with many extra layers of understanding on how everything functions within the institution. My long academic stage provided me with skills and experiences within the realm of science, laboratory research and academic scholarship, but precious few glimpses of structures and professional actions outside the lab and classroom settings.

(Image from Pixabay.com CC0)

Working within a committee, and chairing a committee in my personal example, comes with its own learning curve, which can be a daunting thought for an already overwhelmed young professional (or senior student or trainee). But the rewards are plenty, and the effort is worth it at the end. Committee membership can be a rich source for personal and professional education. Some lessons are generalized for everyone to gain, other lessons are more individually centered, for each person to uniquely grow from. Some of the many lessons I’ve learned recently I’ll share here.

I’ve learned how a budget in an institutional structure is managed (which is different from how a personal household budget is done). I’ve learned the names of so many other professionals within the organization outside of my daily interactions. I’ve learned more about the administrative structure of the place where I work in. I sat in meetings that shape the direction of the future of the institution. I learned about leadership, and even more about teamwork. I learned the great value and appreciation for creating a close-knit community within a professional organization. As human beings, we have been creating and living in villages for thousands of years, and nowadays the professional network one works in can be part of that village. Here as well is where one can find opportunities to increase the equity, diversity, and inclusiveness of the professional community within the institution or organization. I had first-hand experience in this. Providing support and a platform for the under-represented can create an entry point for the larger effort required within the whole organization, institution and wider society. We should use all the tools at our disposal (and create new tools when necessary) to continuously provide better results for members of our community that are under-represented or marginalized.

My pitch here at the end to you is to seek out, create when possible, and accept opportunities, to be active in your work organization, and professional societies, during your early career stage (and moving forward). My personal endorsement goes to being an active member of a committee at your institution, and then to expand into national and international societies that exist in your professional field. There is much to learn, a community to join, to build, and a lot to gain towards advancing your professional path, and maybe, the society as a whole.

“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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Taking a public stand for social justice

My heart is broken after the recent events and the loss of George Floyd’s life in Minneapolis, my beloved home over the last couple of years, along with many other recent tragedies that highlight the racial injustices in the United States. Like many, I hope that these events will lead to fundamental changes and improvements in our society.

I admire the institutions, organizations, companies, leaders, and my colleagues who are making public statements in support of efforts to lead to social justice. I think that it is important to acknowledge that as a society, we are now expecting many organizations, institutions, companies, and leaders (political, academic, organizational, etc.) to take a public stand against racism, a topic that many organizations and businesses previously shied away from making public comments on. This is a positive shift in our culture. One of the initial ways to lead to long-lasting change is to acknowledge that there is a problem. My home institution, the University of Minnesota was quick to make a public statement condemning racism and social injustices after George Floyd’s death. As researchers and healthcare providers, we know that there are health inequities, magnified by the COVID-19 pandemic which my fellow AHA blogger, Dr. Anika Hines (@DrAnikaLHines) recently discussed.

Furthermore, as healthcare providers and researchers, we are often leaders in our communities and are able to provide a voice to those who are disadvantaged. Another fellow blogger, Dr. Elizabeth Knight (@TheKnightNurse) recently wrote about the importance of advocacy by healthcare providers. Racism and social inequalities are public health issues. Many organizations that we are a part of have made public statements for social justice. The American Heart Association and American College of Cardiology have made a joint statement with the Association of Black Cardiologists against racism and social inequities. Similarly, the American Medical Association and Association of American Medical Colleges have also made public statements condemning racism and advocating for change. Additionally, many healthcare providers across the country have kneeled and protested for #WhiteCoatsforBlackLives over the last couple of days. When the organizations and institutions that we are a part of take a public stand against racism and social injustices, we then feel supported in our efforts.

I encourage trainees to pay attention to which organizations and institutions are making statements against racism and social injustices and are committed to making changes.

Be an active ally. Listen and learn. Be kind. Be safe.

“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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Scientific Sessions during the pandemic

I didn’t know what to expect when I logged in to the American Heart Association’s Quality of Care and Outcomes Research Scientific Sessions earlier this month but having attended I’m definitely a fan of this new virtual format. As a trainee, the largest barriers to attending conferences are usually finding the funding and arranging the time off from work. Not having to worry about missing work on Friday and the cost of a roundtrip flight and hotel for the weekend was a huge positive.

In the couple of weeks since the conference, it’s also been great having access to sessions I missed. With so much going on during the live scientific session, it’s easy to miss a lot of really interesting new research being presented. Being able to go back a couple of weeks later and look through the content has made it much more digestible and eased any fear of missing out I had.

It did take me a little bit to get comfortable navigating the HeartHub (https://www.hearthubs.org/qcor), but then again I usually get turned around at in-person conferences too. Once I was in virtual sessions, I was surprised by how interactive the chats were and how relaxed they felt. Not sure why it felt less formal than an in-person conference but “attending” while having a coffee in my living room, rather than wearing a suit in a conference room sure didn’t add any stress.

Looking forward to #AHA20 online!

“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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The Importance of Maintaining the Public’s Trust in Science and Medicine

Often, and especially during the COVID-19 pandemic, there is a plethora of misinformation that is spread. We have all probably seen at least one scientific publication, news article, social media post, or YouTube video that is spreading information that is not accurate. Every day, I am bombarded by conspiracy theories or unfounded scientific claims while skimming through social media. During a time when information is rapidly disseminated through the internet, it is often difficult to extinguish a lie.

Sometimes, misinformation is inadvertently spread by well-meaning individuals who have not had the time or energy to confirm or critically appraise the information shared. “Liking”, “retweeting”, and/or sharing a post from a colleague/friend/relative is facile. We have all probably “retweeted” or shared certain articles and posts that we did not completely critically assess before sharing. Sometimes dissecting truth from fallacy is difficult, especially when information is disseminated widely. Our current technological advances with the internet and social media magnify opinions, good and bad. Occasionally, one may think, if multiple people I know and/or respect are sharing certain information and the number of posts about the false information outnumber those on the truth, then the misinformation must be true.

Occasionally, misinformation about science or medicine is shared by members of our own scientific and/or medical communities, which can sometimes be more damaging to our profession. For example, more assumed credibility may be given to a scientist or healthcare provider, even if his/her expertise is not in the area that is commented on. Conspiracy theorists may continually reference these “experts” to support their arguments. Sometimes, refuting incorrect information requires massive efforts but may never eliminate the long-lasting negative effects of the misinformation. For example, Andrew Wakefield’s infamous, now retracted scientific article that was published in The Lancet and falsely claimed an association between the measles, mumps, and rubella vaccine with autism is unfortunately still being referenced to support arguments against vaccinations even though multiple studies have overwhelmingly refuted the claims made in the retracted article.

With less malicious intent, some misinformation may be spread by the media or others in reference to research articles. Certain conclusions of research papers are sometimes not justified by the data presented due to inadequate sample size, biases, issues with the experimental design, etc. During a pandemic, since rapid dissemination of scientific and medical information is needed, there is frequently a tradeoff with the scientific rigor and reproducibility of the results. Since access to papers in preprint servers are available to the public, the media and public figures may tout certain research findings as truth when they have not been vetted by the peer-review process. A fellow AHA early career blogger, Dr. Allison Webel (@allisonwebelPhD), recently wrote an outstanding blog discussing the importance of the peer-review process (https://earlycareervoice.professional.heart.org/in-defense-of-peer-review/). Of note, even peer-reviewed articles are not free from research misconduct and incorrect conclusions. There are many articles retracted from high impact journals. Before the development of the internet and social media, critiques and feedback of research findings were typically only discussed at scientific meetings or at other selective venues (e.g., local conferences/presentations, journals typically not viewed by lay people, etc.). Now, these debates occur in the public arena with beneficial and negative aspects and frequently with nonexperts. These public debates may dilute the truth when unfounded comments are perpetuated.

What should we do about the spread of misinformation? Propaganda and false information are always going to be spread but we should try to mitigate their breadth and potential damage. On an individual level, researchers should thoroughly assess their results and determine whether their data are valid and whether the claims they make in publications are justified by the data before presenting the findings to the public. Limit overreaching conclusions. Scrutiny of results by authors and the research community is essential to the scientific process. Developments and advances in science often occur when findings are reproduced either within a specific lab/group or by other labs/groups and this is especially important to realize during a time when a deluge of single-center, small sample size papers are published about the COVID-19 pandemic. Dr. Elizabeth Knight (@TheKnightNurse), another fellow AHA early career blogger, recently calls to attention the scientific lessons learned from the current pandemic (https://earlycareervoice.professional.heart.org/evidence-whats-good-whats-good-enough-whats-dangerous-lessons-for-now-and-later/).

How do we influence other people’s opinions? Internal changes are often easier to make than changing other people’s opinions. However, we are all likely an influential source of information within our own social circles and networks. We may feel more comfortable directly communicating with people we know to correct misinformation. Altering the opinions of people who we do not personally know is more challenging. At minimum, as researchers and healthcare providers, we should not intentionally try to deceive the public. Flagrant dishonesty from researchers and/or healthcare providers may erode the public’s trust in our profession, possibly to a greater extent than a nonexpert’s comments. We all make mistakes and honest misunderstandings and misinterpretations can affect all of us. However, deliberately lying and abusing the influence of one’s position as a scientist or healthcare professional is more offensive. I do not know how best to address colleagues who blatantly mislead the public. If an individual we personally know is deceiving others, we can directly communicate with him/her about the impact of the misinformation. Depending on the extent of the damage created by an individual in our professional community who is propagating false information, should we review his/her ability to maintain as a member of our profession?

What are your thoughts on how we can preserve the public’s trust in science and medicine?

“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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Evidence: What’s good, What’s good enough, What’s dangerous? Lessons for now and later.

COVID-19 has created a complex environment for health research. In an evidence vacuum with a clinical imperative to act, we have few choices. They include relying on analogues (such as SARS or MERS), trying treatments based on theoretical biological plausibility, relying on anecdotal evidence and case reports, and rushing evidence from small studies that may have significant limitations into print. There is a need for answers that are definitive but also rapid: a condition that science as we currently practice it can’t satisfy. Additionally, peer review relies on content-area experts, which are hard to find for a rapidly evolving area when potential experts are also stretched thin with clinical and research roles. The result is that evidence may look different from what we are accustomed to.

Some healthcare practitioners and scientists have reacted with alarm when low-quality studies have been published by normally meticulous journals. Are we abandoning the RCT, they ask? Is appropriate statistical analysis no longer required? Does the name of a prestige journal no longer guarantee rigor? Is low-quality evidence worse than no evidence at all? Is it wise to publish clinical observations in a newspaper rather than a medical journal? Who is responsible when a public (or public official) not equipped to recognize the limits of early evidence spreads misinformation? Are resulting adverse events or medication shortages partially the responsibility of the publication? The researcher?

These are debates worth having, and there will be compelling arguments on both sides. No matter your stance, though, there will be an impact on the future of science.

Lessons include:

  • Critically reading studies and understanding their strengths and limitations remains a valuable skill. Just because something is in print doesn’t mean it should be in practice. Scientific education in all disciplines needs to continue to focus on this skill.
  • Perhaps the standard glacial pace of evidence dissemination can, in fact, improve. Faced with undeniable urgency, the mechanisms of publication are adapting. Turnaround time measured in days or weeks rather than months or years is possible.
  • Lots of content related to COVID-19 from academic and lay publications alike is open-access— because it is seen as for the public good. Perhaps that perception can broaden, and alternative payment structures will make science more accessible.
  • The translation of basic science to clinical application (bench to bedside) can move rapidly when needed. As my fellow blogger Sasha Prisco has noted, there are currently administrative barriers that hinder this work, and their long-term necessity may need to be reevaluated.
  • Real-time information sharing and collaboration occurs through multiple channels beyond academic journals, including social media sites.

Have you considered the potential impact of this pandemic on the future of scientific publication and knowledge dissemination? Has it changed your ideas about publishing, research, evidence-based practice?

“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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In defense of peer review

The generation of knowledge, through rigorous, established systematic methods has informed much of our progress in the past few centuries. Science guides all aspects of healthcare today including how we develop the new medications, therapeutic procedures, and non-pharmacological interventions that have improved the quality and duration of human life. Many of the crucial gates in the scientific journey- funding, ethical approval, and dissemination- are guarded by the process of peer review; a process that is increasing under attack in our current hyper-reactive, digital, media cycle.

Peer review is the critical appraisal of a scientific work by those who have requisite knowledge to evaluate one or more aspects of the work. It is a panel of experts in the related field who understand the importance and novelty of the questions under consideration and the rigor and trustworthiness of the methods proposed or employed to answer that question.

Peer review takes time. Time to find agreeable reviewers with the right expertise, time to review and think about the science, and time to determine how to weigh those critiques against the community’s need for information. From the early days of the novel coronavirus pandemic, this balance of time needed for peer review and unquenchable public thirst for rigorous information has been dominating the conversations at leading medical and scientific journals around the world. To better understand how these decisions are made and what we as clinicians, scientists, and health care consumers need to consider when reading and sharing emerging science, I spoke with Dr. Joseph Hill, the Editor in Chief of Circulation one of 12 AHA Journals.

Even though peer review is an established practice, it is important to start by questioning why we should even do it. Unquestionably, the value of thoughtful peer review is that it enhances the quality of the science. “We [the AHA journals)\] handle approximately 20,000 manuscripts a year and with extraordinarily rare exceptions, the paper always gets better with peer review”.

Having now published many of my own scientific manuscripts, I know the pain of peer review well. “They” missed that detail on line 176. “They” clearly lack the expertise to evaluate my work. “They” kept this manuscript for 8 months before sending their disposition! However, I also know that some of the best revisions to my papers have come from generous peer reviewers. Reviewers who volunteered to spend their time reading my papers and think deeply about my findings in the context of larger literature. While painful, the constant assessment and evaluation of our science is critical to improving the quality and impact of our work.

Prior to the coronavirus outbreak, up to 10 experts, including peer reviewers, statisticians, and editors, would review a manuscript for Circulation. But the need for up-to-date information about the epidemiology, pathophysiology, and treatment of COVID-19 challenged Circulation’s editorial team to move fast. While recognizing that it’s “hard to do good science in a war zone”, the quality of published science cannot be compromised in times of crisis. Dr. Hill continues, “We are walking a fine line between trying to get the information out as quickly as possible but we recognize that [in clinical science] we could make it worse and could do harm. So we have to maintain our high standards but function at a high velocity.”

High velocity seems an understatement. After an initial call for high-quality COVID-19 related papers, the editorial team has done over 300 fast track reviews, contributed to a curated coronavirus and cardiovascular disease collection, and conducted 17 interviews with experts working on the front line around the world. All in the past month. This work is exhausting but done with great energy by a team inspired to advance “cardiovascular science for the good of humanity, especially during these times of urgent challenge, anxiety, and forthright resolve.”

Peer review is the best process we have for evaluating science; but peer review is done by peers- busy, human, distractible peers- who will make mistakes. This is why many reputable journals require an editorial screen and at least two peer reviews before it can make a decision on a manuscript. Scientific volunteers do this work. Which brings us to what you, as an early career professional can do. Peer review relies on us—all of us—to sign up to review, accept the invitation to review, and spend the time carefully doing the review. You may wonder if you have the expertise to peer review for Circulation or another AHA Journal; you likely do and you should. Dr. Hill remarked that “some of the best reviews I’ve seen are from early-career scientists”.  If you are interested in helping to contribute to peer review and the sharing of good cardiovascular science, considering signing up to be a journal reviewer in your AHA Science Volunteer Form or emailing Dr. Hill your interest in reviewing for Circulation.

 

“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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COVID-19 Pandemic: 5 lessons about the way we (should) debate in medicine

In my previous blog, I shared five lessons about the way we practice medicine, which I believe were highlighted by the unprecedented circumstances of the COVID-19 pandemic. I would like to share five more COVID-19-inspired reflections, but this time it’s about the way we, as physicians, debate our medical opinions and the thought processes through which we form these opinions to begin with. While these thoughts came as a result of following scientific debates on social media, I believe they apply to all sorts of debates in other contexts as well:

  1. Opinions are not principles.  Principles are ethical codes we live by and cherish for our whole life. Opinions, on the other hand, are impressions and ideas that we make as we go, based on information that is available to us (with some emotional influences as well). That being said, while it might take a major life event for someone to change their principles; opinions can, and should, change quite often. There is nothing wrong about changing one’s opinion based on new information or on changing circumstances. In fact, this only reflects a healthy and dynamic thought process. Keeping that in mind makes it easy for us to admit when we’re wrong and to accept that others are allowed to change their position without being accused of hypocrisy.
  2. Debate is not an aim. With the urge to prove our point and support our convictions, we often forget the real aim of any debate; reaching the truth through exploring alternative interpretations. Social media has opened unprecedented venues for endless debate, and the field of medicine has remarkably caught up to this. Unfortunately, we sometimes forget that proving our point often gets in the way of actually finding the truth.
  3. Absence of evidence is not evidence of absence. As physicians, we adopt a scientific thought process. We always strive to find evidence to support any medical claim. Nonetheless, it is important to remember that just because something is not supported by evidence, it does not necessarily mean that it’s not true. It often only means that “we don’t know”. In the midst of scientific debates, we tend to forget this simple fact and start to proclaim that a certain medical intervention doesn’t work simply because it hasn’t yet been assessed by clinical trials. The more accurate way to address this is to say that we don’t know if it works or not, otherwise, we would be committing the same error we were criticizing in the first place.
  4. Bias is vulnerability. Bias and prejudice are human flaws. And we are all human. We tend to be a lot less rigorous in our scrutiny of the methodology and the validity of the results of an article (scientific or otherwise) when the findings are consistent with our own bias. We tend to drop our most important defense mechanism against gullibility—our ability to think systematically and to critically appraise the evidence. This becomes particularly obvious on social media where we are quick to enthusiastically share (and sometimes praise) studies that support our viewpoints, without properly examining the content. Eliminating this bias requires a conscious effort when assessing data that align with our opinions to be even more careful.
  5. We know very little, so be humble. Every day, nature shows us that no matter how much our medical knowledge increases over time, we still know relatively very little about the world we live in. COVID-19 is just another reminder. It’s true that some of us know more than others, but in the big scheme of things, none of us is in a position to brag or be condescending. So no matter whom or what we’re debating, let’s remember to be humble, be kind, and be respectful.

 

“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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How a Pandemic Worsens Overall Cardiovascular Health in the U.S.

The novel coronavirus pandemic, currently holding the global population hostage in their homes, has killed over 150,000 people and infected over 2 million. The US leads all nations in both categories. One only needs to look out the window, or visit the local grocery store, to understand the overwhelming sentiment amongst the people.

Afraid.

Lonely.

Stressed.

In a pre-COVID blog post, I reviewed a paper by Brewer et al. that investigates the deleterious affects of chronic stress, minor stresses and major life events on one´s overall cardiovascular health, as determined by the AHA´s Life´s Simple 7 initiative.1 In summary, the authors found that the study participants performed worst in diet, BMI, physical activity and smoking metrics. They reference research studies of depression, CVH and smoking when proposing a theory as to why this profound correlation exists. The studies identify binge eating and smoking to be adverse behavioral responses to psychosocial stress, as well as decrease in physical activity.

The current pandemic is an acute stressor, and major life event, for us all. Unemployment claims in the U.S. have topped 20 million, stock prices are 40% lower than their 2019 highs, one third of the world´s school-aged children are home, local and international businesses are closed, flights are grounded and this graduation/wedding season will be like none we´ve ever witnessed. Psychiatric telehealth consultations are at an all-time high because this is not our steady state; we are social by nature. The current pandemic´s acute stress on our society will inevitably affect its overall cardiovascular health.

I like this illustration of the effects of psychosocial stress on the hypothalamic-pituitary-adrenal axis, and how that translates to increased cortisol level and the subsequent worsening of many cardiovascular risk factors.2

When juxtaposed with the graphic below, illustrating AHA´s Life´s Simple 7, it is quite clear that our current state of stress is antithetic to our goals of reducing cardiovascular death and improving cardiovascular health by 20% by the end of 2020.

With no clear end in sight, but promising figures showing flattening of the disease curve, we must begin tackle the deleterious effects of this acute but soon to be chronic stress on our patient population. Otherwise, we will awake from this pandemic with clinics full of less healthy patients at higher risk of succumbing to an already deadly disease.

At home strategies for exercising, healthy eating, meditation etc will be discussed in my next blog post. For now, be safe, stay home and keep hope alive!

References:

1) Brewer LC, Redmond N, Slusser JP, Scott CG, Chamberlain AM, Djousse L, Patten CA, Roger VL, Sims M. Stress and Achievement of Cardiovascular Health Metrics: The American Heart Association Lifes Simple 7 in Blacks of the Jackson Heart Study. Journal of the American Heart Association, 7(11). doi:10.1161/jaha.118.008855

2) Iob, Eleonora & Steptoe, Andrew. (2019). Cardiovascular Disease and Hair Cortisol: a Novel Biomarker of Chronic Stress. Current Cardiology Reports. 21. 10.1007/s11886-019-1208-7.

“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.”