Lessons From the COVID-19 Pandemic: Clinical Guidance and Respect for Science
“Everything is theoretically impossible until it is done.”—Robert A. Heinlen (1)
Unknown clinical scenarios frequently pose challenges to the everyday practice of medicine. These challenges can be both stressful and stimulating, forcing clinicians to navigate ambiguity and uncertainty while also introducing new and continuous opportunities for learning.
Modern day clinicians, having trained in the era of evidence-based medicine, read the literature, understand data, and ultimately try to make decisions on the basis of the science available. However, clinical challenges, particularly those without clear-cut guidelines or new and emerging evidence, pose a dilemma with regard to how to provide the highest quality of care.
The unprecedented nature of the coronavirus disease-2019 (COVID-19) pandemic amplified this challenge, leaving clinicians quickly trying to manage and treat patients—some critically ill and many at the greatest risk of the novel virus—with little evidence-based information, let alone enough time or long-term data to allow for the critical review necessary to create clinical guidelines.
With little scientific evidence, clinicians worldwide have had to practice clinical judgment in the face of uncertainty. They have worked hard to share information and best practices and stay up to date on the latest research in order to develop and adapt practice and/or hospital protocols and create pathways to standardize care for patients with COVID. They have also learned to be discerning with what they read and “avoid the cognitive biases introduced by anecdote, sensationalism, and fear” that Kodadek et al (2) cautioned about in an October 2020 commentary published in the Journal of Patient Safety and Risk Management.
One of the biggest lessons reinforced by the pandemic was that no anecdotal experience or promising report can substitute for rigorous science. However, to gather scientific evidence, patients have to be enrolled in clinical trials and cohort studies and data have to be collected—none of which happens overnight, and all of which was made even harder by social distancing requirements and stay-at-home orders.
Guidance like the American College of Cardiology’s (ACC) early Health Policy Statement on Cardiovascular Disease Considerations for COVID-19 Vaccine Prioritization, as well as the comprehensive COVID-19 Hub with links to the latest published research, expert commentary, health policy updates, and more, served as alternative resources for clinicians. To date, >3 million people have accessed the Hub and its contents since its inception in April 2020. As we slowly start to emerge from the pandemic, it is important to reflect on the use of clinical guidance in the absence of guidelines and find ways to pass on lessons learned to the next generation of trainees.
Guidance vs Guidelines
Providing cardiovascular professionals with the best clinical guidance and ultimately guidelines on how to succeed in delivering the most appropriate, equitable, and cost-effective care is at the fundamental core of the College’s mission, vision, and values.
Recognizing the need to help clinicians provide appropriate care where evidence is new, limited, and/or changing and evolving, the ACC has increasingly striven to find new ways to provide clinical guidance based on the best available evidence. While clinical guidelines guide what to do, the College has developed “Solution Sets” that build off the Bethesda Conference models of the 1980s and 1990s and are designed to “marry knowledge with action” (3) (Figure 1).
Solution Sets are organized around specific clinical topic areas and can include a variety of tools like stakeholder roundtables, Expert Consensus Decision Pathways (ECDPs), Health Policy Statements, mobile applications, Appropriate Use Criteria, and/or Patient Engagement materials. Typically, these tools involve minimal text and actionable algorithms and figures with the goal of helping clinicians make sense of quickly evolving scientific evidence and optimize frontline care delivery on the basis of best practices. Recent examples include ECDPs on the management of atherosclerotic cardiovascular disease (ASCVD) risk reduction in patients with persistent hypertriglyceridemia, optimization of heart failure treatment, and same-day discharge after percutaneous coronary intervention. Focused CardioSmart patient education around COVID-19 tied to the College’s related Health Policy Statement is another great example of timely Solution Set tools.
Building on clinical guidance, the ACC and American Heart Association (AHA) have worked together over the last 40 years to create clinical practice guidelines providing evidence-based recommendations for prevention, diagnosis, and treatment across the spectrum of cardiovascular disease.
Each guideline is based on systematic methods of evaluating, reviewing, and classifying the latest clinical evidence—methods that have evolved and continue to evolve to meet the needs of clinicians in light of changing technologies and the accelerated and constant pace of new research. Since the first guideline developed in 1980, the ACC and AHA have developed >30 guidelines addressing topics ranging from arrhythmias to vascular disease. The most recent guidelines, released in 2021, provide recommendations involving the evaluation and diagnosis of chest pain, as well as the treatment of patients with significant coronary artery disease undergoing coronary revascularization.
In 2012, as a result of the ACC/AHA Clinical Practice Guideline Methodology Summit, several changes were implemented, including formal evidence reviews and an expanded peer-review process; movement away from procedure-centric guidelines toward condition-centric guidelines; development of a standardized guideline format; and implementation of changes to the guideline recommendation classification system (4-6). Additionally, the policies and procedures regarding relationships with industry, including updating the guideline writing committee selection process to account for the need to include trained methodologists and health economists, were updated. (7)
Learning from technology companies like Apple and Google to harness big data and improve upon or develop new intuitive and easy-to-use user interfaces, as well as from innovation start-ups who have ideas for using machine learning and artificial intelligence to quickly distil information into usable algorithms or decision-making tools, the ACC and AHA have worked to further optimize the entire clinical guideline process from the very first step of preproduction review to final dissemination over the last 2 years. The goal: to create guidelines that are more concise, timely, accessible, patient-centered, and applicable to cardiovascular clinicians worldwide.
This guideline optimization work is reflected in recent guidelines pertaining to hypertrophic cardiomyopathy, valvular heart disease, chest pain, and coronary revascularization. For example, the new Chest Pain Guideline specifically makes use of a new modular format that breaks the guideline into “knowledge chunks” that include a table of recommendations, a brief synopsis, recommendation-specific supportive text and, when appropriate, flow diagrams or additional tables (6). Additionally, each of the recent guidelines also offer cost-value considerations with a focus on social determinants of health, where appropriate.
Interactive tools are also an important part of guideline implementation, helping to support clinical decision making in a way that makes it is easier to consume, share, and integrate recommendations at the point of care. Recent examples include the JACC interactive genetic testing tool tied to the Hypertrophic Cardiomyopathy Guideline, the ACC’s updated ManageMR mobile app that incorporates the 2020 Valvular Heart Disease Guideline recommendations and the College’s overarching Guideline Clinical app that incorporates recommendations across all existing guidelines into 1 mobile tool. The ACC’s ASCVD Risk Estimator Plus app, as well as the Multilingual ASCVD Risk Estimator available in 6 languages, are examples of other innovative mobile apps that provide easy access to recommendations specific to calculated risk estimates and include readily accessible ACC/AHA primary prevention guideline reference information for both providers and patients related to therapy, monitoring, and lifestyle.
Patient education continues to be another area of growth, particularly over the last several years. Focused CardioSmart infographics, curated condition centers, and detailed action plans are developed for each guideline. With the value of shared decision making underscored in nearly every new guideline, the patient materials are an important element of ensuring patients not only understand their respective disease and treatment options but are able to engage with their care providers regarding their care.
A continued desire to harmonize guidelines with other organizations in the United States and abroad to minimize confusion and enhance adherence to recommendations is also an important goal. Over the last 2 decades, more and more partner cardiovascular societies have partnered on the guidelines, providing important perspectives and insights into the guideline development and peer-review process, as well as furthering the reach and dissemination of the guidelines upon publication. These efforts will only continue as we look to the future, as they are vital to the shared goal of all societies in improving outcomes for patients around the world.
The tremendous power of science has been demonstrated during the pandemic. It was through science that tools were developed to combat the pandemic, from sequencing the severe acute respiratory syndrome coronavirus 2 genome, figuring out host factors involved in viral entry, characterizing the modes of transmission and spread, and continuing surveillance of new viral variants. It is science with research and evidence that continues to give us hope in the face of ongoing uncertainties.
Hence, there is no better time than now to hold science in high regard and promote scientific culture by believing in, respecting, and loving science. In battling COVID-19, it is also clear that science has limitations. It requires time and ideally needs a collective effort and scientific collaboration on a global scale to make possible therapies from bench to bedside. While the COVID-19 pandemic is not over and the emergence of new variants may delay its ending, we will only prevail by remembering what we have all experienced and endured over these past 2 years.
Author Leo Buscaglia said: “Change is the end result of all true learning” (8). Going forward, we must think about how to combat future viral epidemics. This will require embracing science with research funding for surveillance programs, making efforts to better understand our immune system, continuing to develop new vaccines or other combative strategies, and, last, improving on communication strategies to enhance public trust and engagement and manage misinformation.
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2. "Guidance vs. guidelines: the role of evidence-based medicine in the COVID-19 pandemic.” Journal of Patient Safety and Risk Management". https://journals.sagepub.com/doi/10.1177/2516043520965844. Accessed
October 27, 2020.
3. "Solution sets to generate actionable knowledge for cardiovascular care". J Am Coll Cardiol 2019;73:3349-3351.
4. "ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures". J Am Coll Cardiol 2014;63:2304-2322.
5. "Recent innovations, modifications, and evolution of ACC/AHA clinical practice guidelines: an update for our constituencies". J Am Coll Cardiol 2019;73:1990-1998.
6. "Further evolution of the ACC/AHA clinical practice guideline recommendation classification system: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines". J Am Coll Cardiol 2016;67:1572-1574.
7. "Relationships with Industry and Other Entities: ACC/AHA Policies and Procedures for Development of Guidelines, Performance Measures and Data Standards". https://www.acc.org/guidelines/about-guidelines-and-clinical-documents/relationships-with-industry-policy. Accessed
November 3, 2021.
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