COVID-19 employer conundrum - Sound Science vs. Art in clinical decision support: Clinicians have long prided themselves in making population health decisions based on sound science, in the form of peer-reviewed literature and guidance from a handful of regulatory and public health institutes. An unfortunate by-product of this pandemic has seen the regulatory environment around COVID-19 get more and more murky. In any given week most of us feel as if HHS, FDA, CDC, WHO, the White House and individual state/municipal regulatory agencies are at odds with one another – sometimes issuing contradicting guidance across similar issues in parallel, only to be changed days later depending on the interpretation and incorporation of guidance from a ‘sister’ regulatory agency or institute. For public health professionals and employers alike, trying to keep up on the constant change is nearly impossible. And the peer-review process just wasn’t set up to be operational amidst a fast-moving pandemic. As clinical experts, we have often found ourselves balancing sound science with some periodic ‘art’ thrown in to help guide practical decisions which employers can react to and build businesses around. 

Regulatory (mis) guidance: Just this past week, the CDC issued guidance against any asymptomatic COVID-19 testing, only to walk back those recommendations merely days later casting decision making into a whirlwind for public health officials and employers alike  Last month, the CDC adopted the practical approach already taken by many employers, to leverage a more lenient symptoms-based return-to-work strategy amidst lack of access to testing. Previously, an impractical, dual-negative test framework had been suggested. Even amidst the changes, it took nearly a month for some public health institutes and even the CDC itself, to align other guidance within certain vulnerable populations such as employers, health care workers or long-term care facilities, making it difficult for business leaders to interpret and pivot decision-making. 

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Proactive Testing: If you are among those employers looking to be proactive in periodic surveillance testing of employees to better identify pre or asymptomatic workers before they have a chance to infect others in the workplace, where would you turn for guidance on a testing protocol? Unless you happen to run a long-term care or assisted living facility, you won’t find any US regulatory body or public health institute providing guidance around building a proactive testing protocol.  Those regulatory bodies argue today that the science just isn’t available….yet. But is such a novel approach so risky amidst the scientific uncertainty that we shouldn’t try in the right situations? 

Turn-around-time trumps accuracy: Throughout this pandemic PCR tests have been held up as the go-to, gold standard for COVID testing due to their accuracy (high sensitivity and specificity). And many platforms spanning a variety of different specimen collection mechanisms (nasal swabs, saliva, et al) have received Emergency Use Authorization from a regulatory standpoint. But what if you can’t get test results for 5 days or even 14? At what point is the ‘gold standard’ PCR test no longer actionable from a clinical or even return-to-work context? A handful of experts including Michael Mina at the Harvard T.H. Chan School of Public health as well those led by Raj Shah at Rockefeller Foundation are arguing for a new strategy – one focused on Rapid Antigen testing which delivers results in 15 minutes. Imagine you are the CEO of a urban tour operator once the pandemic begins to wane in the months to come and you are faced with an infection exposure incidence your staff. Should you rely on self-administered PCR tests which take days to return results? Or can you invest now in inexpensive rapid antigen tests which will enable decisions as to who goes to quarantine and who continues at work in 15 minutes. These experts aren’t setting aside science in favor of art – they are just flexing their instincts around artful interpretation and what tools are most practical to protect health and keep businesses running. 

We believe that leadership from businesses, armed with key insights from leading scientists, will lead us out of this pandemic.  Amidst the steady stream of changing guidance and expertise in a fluid situation, we find ourselves incorporating more ‘art’ than ever before – but at its core, the science must be sound. If you’d like help interpreting the right amount of ‘art’ to help balance your science in these unprecedented times, our CMO panel is here to help.