Creating dermatology guidelines for COVID-19: The pitfalls of applying evidence-based medicine to an emerging infectious disease

Abstract

To the Editor: We recently coauthored a piece in the JAAD about modifications the American Academy of Dermatology (AAD) implemented to enhance the rigor of evidence-based clinical practice guidelines.1Freeman E.E. McMahon D.E. Fitzgerald M. et al.Modernizing clinical practice guidelines for the American Academy of Dermatology.J Am Acad Dermatol. 2020; 82: 1487-1489Abstract Full Text Full Text PDF Scopus (7) Google Scholar Although we believe this change will serve the AAD well in the future, we must be flexible about guideline generation during the coronavirus disease-2019 (COVID-19) outbreak. Like the World Health Organization, the AAD already adopted a rapid-advice guidelines protocol, but this process relies on evaluating a body of evidence, which does not yet exist for COVID-19. To address this gap, the AAD established the COVID-19 Taskforce, which published interim guidance within 5 days of establishment. Although this advice is essential, it is by necessity made on limited and rapidly evolving evidence and must be tailored to individual patients. Issues include how to grade evidence from gray literature, risks and benefits of use of anecdotal experiences and indirect evidence, and harmonizing guidance simultaneously produced by other organizations. The harms of potentially issuing incorrect guidance must be balanced with the ethical risks of issuing no guidance at all.2Emanuel E.J. Persad G. Upshur R. et al.Fair allocation of scarce medical resources in the time of Covid-19.N Engl J Med. 2020; Crossref PubMed Scopus (1693) Google Scholar One example of this challenge is managing patients on immunosuppressives during COVID-19. A recent JAAD study examined the occurrence of upper respiratory infection (URI) for patients treated with various classes of biologic therapies for psoriasis as a proxy for risk of COVID-19 infection while on a biologic.3Lebwohl M. Rivera-Oyola R. Murrell D. Should biologics for psoriasis be interrupted in the era of COVID-19?.J Am Acad Dermatol. 2020; 82: 1217-1218Abstract Full Text Full Text PDF PubMed Scopus (120) Google Scholar Although we commend the authors for compiling these data, there are several issues with indirect evidence: (1) these trials compared biologics to placebo, (2) they were not powered for the outcome of URI, and (3) the similarity of COVID-19 to URI is unknown. Partly due to these concerns, the AAD COVID-19 Taskforce published interim guidance that did not distinguish among biologic classes. Dermatology societies are not struggling alone with creating interim guidelines. In cardiology, there has been concern over the use of angiotensin-converting enzyme inhibitors due to an observational study that many patients with hypertension admitted for COVID-19 were on angiotensin-converting enzyme inhibitors.4Fang L. Karakiulakis G. Roth M. Are patients with hypertension and diabetes mellitus at increased risk for COVID-19 infection?.Lancet Respir Med. 2020; 8: e21Abstract Full Text Full Text PDF PubMed Scopus (1827) Google Scholar In the face of uncertainty, societies, including the American College of Cardiology, took a stance to keep patients on angiotensin-converting enzyme inhibitors while they await more evidence.5Heart Failure Society of America Patients taking ACE-i and ARBs who contract COVID-19 should continue treatment, unless otherwise advised by their physician: statement from the American Heart Association, the Heart Failure Society of America and the American College of Cardiology.https://www.hfsa.org/patients-taking-ace-i-and-arbs-who-contract-covid-19-should-continue-treatment-unless-otherwise-advised-by-their-physician/Date: 2020Date accessed: March 31, 2020Google Scholar When guidelines can no longer 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. We need guidance not just on biologics but also on many topics, including scaling up teledermatology programs and managing patients with invasive skin cancers. These changes to dermatology guidelines do not exist in a vacuum. Important ethical implications include patient outcomes such as missed melanomas and the loss of employment for practice staff. With so much uncertainty in our medical practice, guidance is needed now more than ever. We should acknowledge the shift from evidence-based medicine to reliance on expert guidance and appreciate the potential for guideline reversal. But in a time of rapidly changing evidence, we must be willing to take on these risks to guide with the goal of maintaining the highest standard of patient care. The authors would like to acknowledge Dr Benjamin Stoff for his advice regarding the ethics of clinical practice guideline generation as well as Dr George Hruza and Dr Bruce Thiers for their comments on a preliminary draft of this manuscript. Modernizing clinical practice guidelines for the American Academy of DermatologyJournal of the American Academy of DermatologyVol. 82Issue 6PreviewThe American Academy of Dermatology is modernizing its clinical practice guidelines to be more timely and easily interpretable, while decreasing the influence of conflicts of interest in guideline generation. The main changes include the transition from SORT to GRADE methodology and the requirement that nonconflicted members of the guideline work groups remain nonconflicted throughout the entire guidelines process. Full-Text PDF