Human-important outcomes and EBM during the COVID-19 pandemic

Roman Jaeschke, James Douketis, Malgorzata Nowaczyk, Gordon Guyatt

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A PDF of the online-first version of the article can be accessed free of charge through the website of Polish Archives of Internal Medicine.


Evidence-based medicine (EBM) includes a guiding principle that “evidence does not make decisions, people do.” Another key principle is that evidence may be high or low quality, but either way people must make decisions. The initial paucity of high, moderate, or sometimes even low quality evidence [during the coronavirus disease 2019, or COVID-19, pandemic] and the very rapid cycle of information has generated situations where we had to make decisions based on preliminary data, prepublication manuscripts, and societal pressure.

We became familiar with “surges,” “flattening of the curve,” mean differences for remdesivir and relative risks for dexamethasone, and the proper donning and doffing of personal protective equipment. Unfortunately, we have also became familiar with a pursuit to rapidly “publish something” regardless of underlying confidence in the findings, familiar with lowering of the methodological rigor of scientific papers up to the point of retracting articles published in prominent journals, and familiar with changing or conflicting clinical practice guidelines. […]

The pandemic brought with it an entire new realm of human suffering that is only indirectly related to disease itself—it relates to the societies’ ways of dealing with the illness. […] We propose that when making decisions about health-care interventions during this and during future pandemics, those “human-important outcomes” (HIO) are carefully considered.

Our aim is not to downplay the role of interventions designed to limit the spread of COVID-19, such as restricting visits to hospitals and long-term care institutions or constraining public gatherings and interactions. Those interventions are important or even crucial, especially in environments of high risk (high prevalence of the disease). At the same time, those interventions brought a new category of outcomes, outcomes that we should not ignore, especially in the environments of low prevalence of COVID-19. We are asking to consider the balance of pros and cons of specific interventions.

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