There is a shift from evidence-based medicine to reliance on expert guidance which must be balanced with the ethical risks of issuing no guidance at all during the coronavirus disease-2019 (COVID-19) pandemic, according to a letter to the editor published in the Journal of the American Academy of Dermatology.
The authors discuss the need for flexibility about guideline generation during the COVID-19 outbreak. The American Academy of Dermatology (AAD) implemented a rapid advice guidelines protocol, however, this a process relying on assessing a body of evidence that currently does not exist for COVID-19. Although the AAD’s COVID-19 task force offered guidance within 5 days of its establishment, it was based on limited and quickly evolving evidence, the authors pointed out. Issues factored include how to grade evidence from unclear literature, benefits and risks for use of anecdotal experiences, and indirect evidence and being consistent with guidance created by other organizations.
In the current uncertain times, the authors suggest that it is crucial to weigh the harm of potentially issuing incorrect guidance with the ethical risks of providing no direction. The challenges of indirect evidence were noted when giving an example of managing patients on immunosuppressives during COVID-19. The issues included a) clinical trials compared biologic agents with placebo b) not correctly powered for outcome of disease and c) the similarity of COVID-19 to the disease was unknown. The authors acknowledge that if current guidance cannot be based on the “highest level of evidence, then indirect studies, gray literature, case reports, and expert consensus may be the only tools left in our arsenal.”
The authors conclude that guidance is urgently required on biologic agents, scaling up teledermatology programs, and managing patients with invasive skin cancers. In order to meet the urgency, they recommend that certain risks need to be taken with the goal of maintaining the highest standard of patient care.
Freeman EE, McMahon DE. Creating dermatology guidelines for COVID-19: The pitfalls of applying evidence based medicine to an emerging infectious disease (published online April 9, 2020). J Am Acad Dermatol. 2020 Apr 9. doi: 10.1016/j.jaad.2020.04.002