ABSTRACT
BACKGROUND: Early in the coronavirus disease 2019 (COVID-19) pandemic, there was minimal data to guide treatment, and we lacked understanding of how clinicians translated this limited evidence base for potential therapeutics to bedside care. Our objective was to systematically determine how emerging data about COVID-19 treatments was implemented by analyzing institutional treatment protocols. METHODS: Treatment protocols from North American healthcare facilities and recommendations from guideline-issuing bodies were collected. Qualitative data on treatment regimens and their applications were extracted using an adapted National Institutes of Health/US Food and Drug Administration experimental therapeutics framework. Structured data on risk factor and severity of illness scoring systems were extracted and analyzed using descriptive statistics. RESULTS: We extracted data from 105 independent protocols. Guideline-issuing organizations published recommendations after the initial peak of the pandemic in many regions and generally recommended clinical trial referral, with limited additional guidance. Facility-specific protocols favored offering some treatment (96.8%, N = 92 of 95), most commonly, hydroxychloroquine (90.5%), followed by remdesivir and interleukin-6 inhibitors. Recommendation for clinical trial enrollment was limited largely to academic medical centers (19 of 52 vs 9 of 43 community/Veterans Affairs [VA]), which were more likely to have access to research studies. Other themes identified included urgent protocol development, plans for rapid updates, contradictory statements, and entirely missing sections, with section headings but no content other than "in process." CONCLUSIONS: In the COVID-19 pandemic, emerging information was rapidly implemented by institutions into clinical practice and, unlike recommendations from guideline-issuing bodies, heavily favored administering some form of therapy. Understanding how and why evidence is translated into clinical care is critical to improve processes for other emerging diseases.
ABSTRACT
Importance: Decision-making in the timing of tracheostomy in patients with coronavirus disease 2019 (COVID-19) has centered on the intersection of long-standing debates on the benefits of early vs late tracheostomy, assumptions about timelines of infectivity of the novel coronavirus, and concern over risk to surgeons performing tracheostomy. Multiple consensus guidelines recommend avoiding or delaying tracheostomy, without evidence to indicate anticipated improvement in outcomes as a result. Objective: To assess outcomes from early tracheostomy in the airway management of patients with COVID-19 requiring mechanical ventilation. Design, Setting, and Participants: A retrospective medical record review was completed of 148 patients with reverse transcriptase-polymerase chain reaction-confirmed COVID-19 requiring mechanical ventilation at a single tertiary-care medical center in New York City from March 1 to May 7, 2020. Interventions: Open or percutaneous tracheostomy. Main Outcomes and Measures: The primary outcomes were time from symptom onset to (1) endotracheal intubation, (2) tracheostomy; time from endotracheal intubation to tracheostomy; time from tracheostomy to (1) tracheostomy tube downsizing, (2) decannulation; total time on mechanical ventilation; and total length of stay. Results: Participants included 148 patients, 120 men and 28 women, with an overall mean (SD) age of 58.1 (15.8) years. Mean (SD; median) time from symptom onset to intubation was 10.57 (6.58; 9) days; from symptom onset to tracheostomy, 22.76 (8.84; 21) days; and from endotracheal intubation to tracheostomy, 12.23 (6.82; 12) days. The mean (SD; median) time to discontinuation of mechanical ventilation was 33.49 (18.82; 27) days; from tracheostomy to first downsize, 23.02 (13.76; 19) days; and from tracheostomy to decannulation, 30.16 (16.00; 26) days. The mean (SD; median) length of stay for all patients was 51.29 (23.66; 45) days. Timing of tracheostomy was significantly associated with length of stay: median length of stay was 40 days in those who underwent early tracheostomy (within 10 days of endotracheal intubation) and 49 days in those who underwent late tracheostomy (median difference, -8; 95% CI, -15 to -1). In a competing risks model with death as the competing risk, the late tracheostomy group was 16% less likely to discontinue mechanical ventilation (hazard ratio, 0.84; 95% CI, 0.55 to 1.28). Conclusions and Relevance: This cohort study from the first 2 months of the pandemic in New York City provides an opportunity to reconsider guidelines for tracheostomy for patients with COVID-19. Findings demonstrated noninferiority of early tracheostomy and challenges recommendations to categorically delay or avoid tracheostomy in this patient population. When aligned with emerging evidence about the timeline of infectivity of the novel coronavirus, this approach may optimize outcomes from tracheostomy while keeping clinicians safe.