A team of doctors has published a correspondence article in the American Journal of Respiratory Cell and Molecular Biology warning that novel approaches to treating COVID-19 may do more harm than good.
The team, from the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, argues that doctors should rely on tried and tested, evidence-based intensive care practices rather than novel therapies.
The rapid emergence and expansion of Sars-CoV-2, the virus that causes COVID-19, has had an unprecedented effect on social and cultural practices across the world.
It has also had a significant impact on the medical staff and other health workers who are treating people who are severely ill with COVID-19. Public health systems are under strain due to the sudden increase in patients requiring intensive care.
Researchers and clinicians have been working hard to understand the virus so that they can determine the most effective treatments and therapies to help save lives and ease the pressure on intensive care units.
The team from Northwestern University has observed an increase in the use of untested therapies and treatments and those where scant evidence or rationale for their effectiveness exists.
The authors note that COVID-19 does not perfectly match some definitions of other Acute Respiratory Distress Syndromes (ARDS), such as viral pneumonia. As a consequence, COVID-19 has received a designation as a variant of an ARDS.
The authors argue that this designation has encouraged some doctors to use novel therapies instead of standard ARDS treatments when treating COVID-19.
The authors believe this is a mistake and note that ARDS is a syndrome, and, as such, is heterogeneous. This means it can present in diverse ways.
The authors agree that standard ARDS therapies are effective even when used on COVID-19 patients who present with a variety of non-standard issues.
They highlight a trial that looked at low tidal volume ventilation and another that looked at prone positioning, both of which “exhibited myriad etiologies, compliances, and shunt fractions but, nevertheless, benefited from the targeted interventions.”
It may, therefore, be unwarranted to disregard standard therapies.
The authors argue that while some of the novel therapies that some doctors are trying may be biologically plausible, this is not a good enough reason to implement them in a clinical context.
They note that throughout the history of intensive care practices, numerous therapies that appeared biologically plausible had no positive effect or were actively harmful.
The authors stress that this does not mean that doctors should never use novel therapies. However, what concerns them is the routine use of novel therapies for COVID-19, particularly those that have not produced convincing results in trials.
What accounts for this deviation from standard clinical practice? Dr. Benjamin D. Singer and his co-authors suggest that “[e]motion, stress, fatigue, and political proclamations amplify our innate desire to help our patients and try something — anything — that might provide benefit and provide hope to providers and patients alike.”
However, the authors still have significant have issues with this approach. For example, if a patient recovers after treatment with a novel therapy, a doctor may suppose that the recovery was due to the novel therapy. This might encourage other doctors to make use of it.
However, without a randomized, controlled trial to confirm this outcome, it is not possible to draw such a conclusion. It may be a coincidence that the person got better, or perhaps they were lucky not to experience any adverse effects. The next patient may not be so fortunate.
For the authors, biases mean that people are quick to apply cause to things they want to work — known as confirmation bias. People are similarly quick to overlook the adverse effects that their attempts to help may result in.
For Dr. Singer and his co-authors, “The only known strategy to overcome these biases lies in the scientific method and the application of controlled trials to determine whether an agent is effective and the degree to which it is harmful.” They conclude:
“Pending data from ongoing clinical trials, we must resist the innate human desire to act on emotion and instead rely on our creed: first, do no harm.”
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