By Zack Dumont

In a past edition of Critical Links we talked about the value of using a common research tool — PICO — to help critically app raise science news. With this tool, a reader can think skeptically/critically about the following:

  • P – Was this a patient/population of interest? Who is included? Who is excluded? Who will this study truly apply to? Specificity is very important in answering these questions.
  • I – Was this an intervention of interest? What exactly does the new intervention include? What else could they have studied?
  • C – Did they use a good comparator/control? Did they use a control group? Or, in the setting of having pre-existing treatments, did they compare the new intervention to the old/gold standard that we’d usually use?
  • O – Did they measure outcomes that should matter to patients? Did they study actual outcomes that patients care about, or did they study surrogates (i.e., compelling numbers — think blood pressure — that people might be persuaded to care about but may not actually matter)?

In a highly touted research paper very recently published in the New England Journal of Medicine, we see a blatant violation of the C from PICO. This paper is a perfect example of why the C is so critical. Did some patients get better in the study while on the medication? Yes, absolutely. Would they have gotten better without the medication? We have no idea! There was no control group, believe it or not.

Yet, we do know that some probably would have gotten better without the drug, some might have gotten worse with the drug, and in the end we hardly know any more than before we had this paper available. Without a control group — one likely receiving a placebo since there’s no known treatments for COVID-19 — we don’t know if this new antimalarial medication is better or worse than doing nothing. However, the publicity alone will garner pressure directed at governments for approval, which will ultimately lead to medication sales. The fact that remdesivir is being studied more properly in other trials almost does not matter at this point.

Let this be a reminder that we always need critical thinking and skepticism . A pandemic is not the time to abandon evidence-based medicine.

This article appears in the May 2020 version of Critical Links.