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Evidence-informed health: post COVID-19 lessons

During COVID-19 pandemic, evidence became a daily discussion matter not only for healthcare professionals but also for the general society. How could healthcare agencies take this opportunity to shift from EBM to evidence informed decision-making (EIDM) in health?

Válter Fonseca

December 20, 2022 · 12 min read

Article co-authored by David Rodrigues and Eduardo Freire Rodrigues
The COVID-19 pandemic has challenged the practice of high-quality evidence-based medicine (EBM) due to two major reasons: uncertainty due to the lack of evidence available, and the sense of urgency that emerged. How could healthcare agencies take this opportunity to shift from EBM to evidence informed decision-making (EIDM) in health? Which role do clinical standards and real-world evidence play in this shift?
Clinical standards aim to ensure that every patient receives high quality and adequate care. This is usually achieved through agreed guidelines that support physicians and healthcare workers to improve the quality and safety of care. Additionally, health standards are the basis of an objective evaluation process that can help healthcare organizations measure, assess, and improve performance, through key performance indicators.1 Considering Archie Cochrane’s distinction between efficiency and efficacy in healthcare, clinical standards take on both purposes: setting the ideal conditions to maximize the beneficial change of a given intervention in the most inexpensive way.2
Clinical standards are one of the available instruments to disseminate evidence-based medicine (EBM), which is currently defined as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients”.3 The two principles that rule EBM sustain that:
  1. Not all evidence is the same and a set of principles can identify the most reliable;
  2. Evidence alone is not enough, meaning that decision-makers should assess the risks and benefits of alternative management strategies in the context of patients’ values, social context, and available resources.4

COVID-19: the urgency to find hybrid models for evidence production and translation into clinical standards

Traditional knowledge translation models, understood as “the exchange, synthesis, and effective communication of reliable and relevant research results (…) so that effective interventions are used more widely”,5 typically take many years of research. In a pandemic, which by its very nature develops and evolves rapidly, the great challenge is how to speed up this process, which is not at all compatible with the classical methodologies, not only because of speed but also because of uncertainty.
With the advent of the COVID-19 pandemic, health authorities – used to produce clinical standards based on robust and reliable evidence and methodologies – came across a new reality: evidence production was, at the very beginning, sparse, and, later, massive. However, due to the expedited thirst for information, still presenting wide differences in terms of scientific quality.6
Therefore, the COVID-19 pandemic has challenged our understanding and the use of EBM: the complex systems theory has been recently proposed to reflect epidemics as biosocial events,7 composed of complex and dynamic relationships in the real world which need to be addressed by a variety of methods, going beyond clinical trials, and dealing with information that is systematically more fragile and temporary.
FDA defines real-world evidence (RWE) as data about potential benefits or risks of a medical product derived from analysis of real-world data (RWD), such as big data, patient-generated data, data from registries, or electronic health records. RWE advocates state that this approach reflects more accurately what happens outside a controlled research environment. However, Schünemann outlines some risks that should not be neglected:8
  1. Systematic errors (bias) by emphasizing directness;
  2. Extrapolation;
  3. Lack of transparency when analyzing data.
The future – and already the present – belongs to hybrid models, able to incorporate distinct types of evidence:9 scientific (codified) evidence – both from clinical trial and RWE-, tacit (also known as colloquial evidence, since it often includes opinions, expertise, lessons learned, organizational tradition of policymakers, clinicians, patients, or citizens), global and local evidence. A structured assessment is still required as the basis for EIDM, but it is not enough. Development of living guidelines incorporating RWD/RWE, and data on values, available resources (including digital) and organizational factors are a way forward to face rapidly evolving scientific knowledge and a critical need to ensure compliance.

Reimagining clinical standards’ target: engaging civil society in evidence-based behaviors at post COVID-19

In relation to the people for which clinical standards are suitable, the pandemic caused two different effects. On one hand, healthcare professionals changed their perspective on clinical standards, and on the other hand, new (lay) audiences become aware of clinical standards’ importance.
Often left making critical diagnostic and treatment decisions in the absence of unambiguous evidence, as reported by Simon Carley, - “the nature of a pandemic is to push clinicians into a position where they must make decisions that are both time-critical and information light”10 - healthcare professionals changed the lenses through which they look at clinical standards, from a purely economic perspective bounding individual decision-making to a useful tool to approach a new condition surrounded by uncertainty. 
Moreover, COVID-19 demonstrated that these recommendations should overtake the physical frontiers of healthcare providers to guide social behaviors and drive political decisions. Perhaps like no other major event in recent memory, the pandemic has exposed synergies between science and policy, as scientists have played a key role in providing scientific advice to national and local governments on what to do at each moment. Usually in the background, epidemiologists were leading actors throughout the pandemic, since public authorities needed information on a real-time basis to track the incidence evolution, disease severity and health system impact, and the potential effect of interventions – e.g. testing strategies, vaccination rollout, nationwide lockdown, circulation restrictions, occupancy limits in public transport or cultural events.
Therefore, the COVID-19 pandemic brought to the fore evidence-based policymaking (EBP),11 as a discourse of methods that inform the policy process, advocates a more rigorous, and systematic approach, on the premise that policy decisions should be better informed by available evidence and should include rational analysis. On this matter, a Global Commission on Evidence to Address Societal Challenges12 led by McMaster University made a wakeup call for decisive action by multiple stakeholders to ensure that evidence is consistently used to address societal challenges.
Finally, it should not go unnoticed that the success of many pandemic-related policies also depended on the public’s compliance with clinical standards. Evidence became a daily discussion matter not only for healthcare professionals but also for the general society. This represents another transformational shift, aligned with Huber et al. definition of health as:

“The ability to adapt and to self manage, in the face of social, physical and emotional challenges” 13

This perspective stresses the traditional doctor-patient relationship and perceives citizens as active agents of change capable of navigating the health system.
Clinical standards should therefore evolve to establish the cornerstones for self-management support interventions, defined as “the care taken by individuals towards their own health and wellbeing: it comprises the actions they take to lead a healthy lifestyle; to meet their social, emotional and psychological needs; to care for their long-term condition; and to prevent further illness or accidents”.14 It may include patient education, support for decision-making, self-monitoring, and psychological and social support and has the potential to improve the efficiency of health services by reducing unnecessary primary care or hospital visits.

Clinical standards supporting the shift from evidence-based medicine to evidence-informed decision

Despite the information disorder phenomenon, the rise of “anecdotal medicine”,15 and the challenges imposed on the two distinctive domains of the evidence ecosystem - evidence creation and evidence application - both from a public health perspective and direct clinical care - scientific response to the pandemic has been remarkable. In an article for Nature, Helen Pearson stressed out that:

“Medical advances based on rigorous evidence have helped to chart a route out of the pandemic. The rapid trials of vaccines were spectacular successes, and well-run trials of possible treatments have shown, for instance, that some steroids help to fight COVID-19, but the drug hydroxychloroquine does not. Many physicians point to the United Kingdom’s RECOVERY trial as archetypal in showing how quick action and simple protocols make it possible to conduct a large clinical trial in a crisis. And researchers have launched ‘living’ systematic reviews that are constantly updated as research emerges — essential in a fast-moving disease outbreak.” 16

During health emergencies, when time is limited, scientific uncertainties and political pressures are high, and irrefutable evidence to support a decision may be lacking, decision-makers must consider the scientific evidence together with other political and social imperatives, such as the need to maintain the national economy, security, education, and the need of individuals to work to meet their daily needs.17 However, as health emergencies are fortunately non-routine events, training for this kind of decision making is usually lacking.

What's for the future?

In this regard, the pandemic emphasized the need to switch from evidence-based medicine to evidence-informed decision-making. That is to say, decisions should be made putting together research evidence with public health expertise, resources, and knowledge about community health issues and local context, to make policy and programming decisions. In other words, policymaking – and not only clinical decisions – is made considering the most relevant, high-quality qualitative or quantitative evidence available, among other dimensions such as: community health status reports to determine the magnitude of a particular health issue in the local setting, the needs and interests of community members, the current political climate, and the financial and human resources available.18
The lessons learned from people engaged with decision making for the COVID-19 pandemic need to be disseminated as a heritage for future public health emergencies. In this article, we focused on clinical standards as a tool to support evidence-informed decision, which asks for a revision of their development and dissemination process intending to:
  • Address different targets and needs;
  • Adopt responsive and continuously updated models as new evidence becomes available;
  • Embrace digital, interactive, and user-friendly formats able to enhance its applicability;
  • Support local and coordinated solutions, engaging health, scientific and political authorities;
  • Ensure individuals' navigability within healthcare systems to establish the cornerstones for self-management support interventions.
Talk to us to discover more on how UpHill has been providing evidence-based clinical pathways to help the medical community and the work done during COVID-19 pandemic to support citizens self-management.

References

  1. About our standards. The Joint Commission. (n.d.). Retrieved May 9, 2022, from https://www.jointcommission.org/standards/about-our-standards/
  2. Cochrane AL (1972) Effectiveness and Efficiency: Random Reflections on Health Services. Nuffield Provincial Hospitals Trust, London.
  3. Sackett DL , Rosenberg WM , Gray JA , et al . Evidence based medicine: what it is and what it isn't. BMJ 1996;312:71 2. doi:10.1136/bmj.312.7023.71 pmid:http://www.ncbi.nlm.nih.gov/pubmed/8555924
  4. Guyatt G, Djulbegovic B. Evidence-based medicine and the theory of knowledge. In: Guyatt G, Rennie D, Meade MO, Cook DJ. Users’ guides to the medical literature: A manual for evidence-based clinical practice. 3rd ed. Chicago, New York; JAMA/McGraw-Hill Education; 2019.
  5. World Health Organization. (‎2004)‎. World report on knowledge for better health: strengthening health systems. World Health Organization. https://apps.who.int/iris/handle/10665/43058
  6. Lee, C. K., Merriam, L. T., Pearson, J. C., Lipnick, M. S., McKleroy, W., & Kim, E. Y. (2022). Treating COVID-19: Evolving approaches to evidence in a pandemic. Cell reports. Medicine, 3(3), 100533. https://doi.org/10.1016/j.xcrm.2022.100533
  7. Colman E, Wanat M, Goossens H, et al Following the science? Views from scientists on government advisory boards during the COVID-19 pandemic: a qualitative interview study in five European countries BMJ Global Health 2021;6:e006928.
  8. Schünemann, H. J. (2019, April 1). All evidence is real world evidence. BMJ. Retrieved May 9, 2022, from https://blogs.bmj.com/bmj/2019/03/29/holger-j-schunemann-all-evidence-is-real-world-evidence/
  9. World Health Organization. (‎2021)‎. Evidence, policy, impact: WHO guide for evidence-informed decision-making. World Health Organization. https://apps.who.int/iris/handle/10665/350994.
  10. Carley S, Horner D, Body R, et al Evidence-based medicine and COVID-19: what to believe and when to change. Emergency Medicine Journal 2020;37:572-575.
  11. Sutcliffe S.; Court, J. 2005. Evidence-based policymaking: What is it? How does it work? What relevance for developing countries? London: Overseas Development Institute. Retrieved from: https://www.odi.org/sites/odi.org.uk/files/odi-assets/publications-opinion-files/3683.pdf
  12. Global Commission on Evidence to Address Societal Challenges. The Evidence Commission report: A wake-up call and path forward for decision makers, evidence intermediaries, and impact-oriented evidence producers. Hamilton: McMaster Health Forum, 2022. ISBN 978-1-927565-31-5 Available online: https://www.mcmasterforum.org/networks/evidence-commission/report/english
  13. Huber M, Knottnerus JA, Green L et al. . How should we define health? BMJ 2011;343:d4163 10.1136/bmj.d4163
  14. Clark N, Becker M, Janz N, Lorig K, Rawkowski W, Anderson L. Self management of chronic disease by older adults: a review and questions for research. J Aging Health. 1991;3:3–27. doi: 10.1177/089826439100300101
  15. Cheryl K. Lee, Louis T. Merriam, Jeffrey C. Pearson, Michael S. Lipnick, William McKleroy, Edy Y. Kim, Treating COVID-19: Evolving approaches to evidence in a pandemic, Cell Reports Medicine, Volume 3, Issue 3, 2022, 100533, ISSN 2666-3791, https://doi.org/10.1016/j.xcrm.2022.100533.
  16. Pearson, H. (2021, May 12). How covid broke the evidence pipeline. Nature News. Retrieved May 9, 2022, from https://www.nature.com/articles/d41586-021-01246-x
  17. European Centre for Disease Prevention and Control. e use of evidence in decision-making during public health emergencies. Stockholm: ECDC; 2019. Available from: https://www.ecdc.europa.eu/sites/default/files/documents/use-of-evidence-in-decision-making-during-public-health-emergencies_0.pdf
  18. National Collaborating Centre for Methods and Tools. (revised 2012). A Model for Evidence-Informed Decision-Making in Public Health. [fact sheet]. Retrieved from https://www.nccmt.ca/uploads/media/media/0001/01/d9f5cec8637db62f8edda6a6a2551b293a053ede.pdf

Válter Fonseca

Head of Medical Decision and Health Quality

M.D., Lisbon Faculty of Medicine, 2010. Ph.D., Medicine/Immunology, Lisbon Faculty of Medicine, 2018. PGDip., Health Management, Católica Lisbon School of Business and Economics, 2019. Internal Medicine Specialist. Assistant Professor, Lisbon Faculty of Medicine. Director, Health Quality Department, Directorate-General of Health, 2018-2022. Chair, COVID-19 National Immunization Technical Advisory Group, 2020-2022. Author of more than 100 communications, articles, and book chapters.

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