“I hope you are doing well in these uncertain times.”
It’s a phrase I use repeatedly in correspondences with students, colleagues, family, and friends. Although it feels a bit overused, it could not be more appropriate given the circumstances. So many questions remain unanswered in our lives — when will the economy recover, when will schools reopen, when will there be social stability in this country, is this our “new normal?”
One area that many people haven’t considered is the COVID-19 pandemic’s impact on evidence-based medicine, which is defined as medical practice on the basis of findings from the best, most up-to-date research.
This approach ensures that there is critical consideration of existing data and an application of that science to each patient’s unique characteristics. The strongest evidence is derived from randomized controlled trials designed to minimize the risk that outcomes are related to chance and not a direct result of the intervention. They provide insight on whether therapies are safe and effective in a large, representative patient population as compared with placebo or a standard of care.
In the absence of strong research, some clinicians may find themselves practicing based on personal experiences with their own recent patients or even based on stories relayed by individuals on the internet.
The risk that these anecdotal observations are due to chance is high. In this pandemic, anecdotal medicine is overriding our traditional reliance on rigorous clinical trials.
Based on evidence
When most people think of pharmacists like me, it brings to mind the friendly face at their local community pharmacy. I am friendly, but I spend my days as a clinical pharmacist in a medical intensive care unit at a top-notch academic medical center. I collaborate with physicians, nurses, and other health care professionals to take care of very sick patients, including those hospitalized with COVID-19.
I thrive in this fast-paced environment, staying abreast of the latest developments in treatment options to ensure that our team is making strong, evidence-based decisions for our patients.
Our interprofessional team meets daily for patient rounds, discussing the diagnosis, prognosis, and treatment plan. I routinely provide suggestions to optimize therapy, with a focus on medications. I typically offer recommendations based on a recent study or on my synthesis of the risks versus the benefits of the medications under consideration.
There would then be a discussion about the pros and cons of the different options, and we would proceed on these evidence-based, patient-centered considerations.
But in these uncertain times, my traditional role as the medication expert is challenged. I don’t have strong opinions about drug therapies for the coronavirus because the evidence impacting our decisions is still unfolding.
The results of the first robust, randomized controlled trial of therapies for COVID-19 showing a positive effect were released a few weeks ago. The time to recovery (i.e., patient discharge from the hospital) was 11 days with remdesivir versus 15 days in patients receiving placebo.
This is one strong clinical trial; we still have so many unanswered questions about therapeutics for COVID-19. Patients with the severest elements of the disease and multiple organ failure may be experiencing the effect of the body’s immune system in overdrive. There may be a role for medications that abate this response.
We are also seeing that patients with COVID-19 may have a predisposition to blood clots, which may contribute to organ failure. There may be a role for blood thinners.
Treatment algorithms have been created to address these issues based on extrapolation from other disease states and anecdotal experiences. Publications about the theoretical benefits of therapies for COVID-19 are rampant but the clinical evidence to support their use is not yet available.
Adaptive trials, or trials that are preemptively designed to modify interventions based on data analyses at different times points (e.g., the recent remdesivir study) are the key to getting our scientific questions answered more efficiently given the time crunch. There is certainly an urgency to do something when patients need help.
To ensure a future that is evidence-based, clinicians must enroll patients in clinical trials and not jump to the newest trend making headlines.
The science will come, but strong science will take time.
Mojdeh Heavner is an assistant professor of pharmacy practice and science at the University of Maryland School of Pharmacy.