ABSTRACT
Rationale: COVID-19 hospitalizations continue to surge rapidly throughout the world. Given the high morbidity and mortality and prolonged duration of illness experienced by patients with respiratory failure due to COVID-19, shortages of ventilators are expected. In New York State, the Crisis Standards of Care guidelines were codified by the New York State Taskforce on Life and the Law in the 2015 Ventilator Triage Guidelines (NYS guidelines). These guidelines outline clinical criteria for triage, including exclusion criteria and stratification of patients using the Sequential Organ Failure Assessment (SOFA) score. We aimed to estimate the excess mortality that would be associated with implementation of triage processes using this protocol. Methods: We included all 5,028 patients who were admitted with COVID-19 in three acute care hospitals at a single academic medical center in the Bronx from March 1, 2020 to May 27, 2020 during the peak of the pandemic surge in New York City. Importance sampling was used to estimate the likelihood of patient trajectories under the NYS guidelines and estimate survival rates. Pessimistic and optimistic estimations were derived to account for potential unobserved confounders. Overall estimated survival was then calculated over a range of hypothetical ventilator shortages (e.g. if it has not been possible to acquire the additional ventilators that were procured in the Spring) from 85-100% availability of the total ventilator capacity of these facilities. Results: The average age of the sample was 64.2 (SD 16.2) and 47% were female. The observed survival rate was 74.16%. A total of 721 patients (14%) required mechanical ventilation during admission. If there has been a ventilator shortfall with ventilator capacity at 85% and the NYS guidelines were enacted in this setting, the estimated survival would be between 70.3% (pessimistic estimation) and 71.5% (optimistic estimation) (Figure 1). Conclusions: A shortfall of ventilators at 85% ventilator capacity requiring implementation of the NYS guidelines triage protocol would have resulted in 2.7-3.9% excess mortality in hospitalized patients with COVID-19 during the pandemic surge, or 134-194 additional deaths. This study is limited by the exclusion of COVID-19 negative patients, who would be in the triage pool in an actual triage situation. Future directions include using this data set to compare NYS guideline performance to other triage strategies including first-come first-served and random allocation to better understand the utility of SOFA score-based triage strategies.
ABSTRACT
RATIONALE: COVID-19 activity continues to cause a high disease burden, and hospitals are vulnerable to ventilator scarcity. Crisis standards of care aim to maximize lives saved and to minimize clinician distress from bedside rationing. 26 states have allocation guidelines. 15 use the Sequential Organ Failure Assessment (SOFA) score. SOFA predicts mortality in hospitalized patients and provides objective data to reduce the risk of introducing bias. We use data from the COVID-19 surge in New York City (NYC) to model performance of a protocol based on SOFA scores and NY State guidelines. Although these guidelines were not implemented, we estimate the hypothetical outcomes had they been required. METHODS: This is a chart review of a random sample (205) of all intubated patients (1002) in three NYC hospitals between 25 March 2020 and 29 April 2020. Patients with and without COVID-19 were included. SOFA scores were calculated upon intubation, 48-, and 120-hours post-intubation. We calculated mortality and proportion of patients categorized into four groups: blue (ventilator not offered or removed), red (highest priority), yellow (intermediate priority), and green (weaned or ventilation not indicated) at each interval. RESULTS: 65 (32%) patients survived to discharge (Figure). 117 patients (57%) were categorized blue at least once;28 (24%) of those ultimately survived hospitalization. Patients ever in blue category had higher mortality (76%) compared with those never categorized blue (58%;p<0.01). Of expired patients, 89 (63%) were ever categorized as blue. CONCLUSIONS: Since over half of all patients met exclusion criteria at one or more time points, clinical judgment may still be needed to decide which patients would be excluded first. This re-introduces bias and moral distress;issues effective triage protocols should address. More specific scoring systems, such as 4C mortality score, may improve performance. Alternative strategies including first-come, first-served, randomization, clinician judgement, and triage committees lack empirical data and have ethical shortcomings. Our findings differ from a recent retrospective cohort study, which found few patients outside of the pandemic met New York State guideline blue category criteria among more than 40,000 ICU admissions. Our sample more closely reflects the acuity of pandemic conditions when this allocation guideline would be activated. The data from this preliminary study suggest that the SOFA score offers limited utility in triage, raising the question of whether sufficient ethical justification exists to impose a life-ending decision on a subset of patients to offer potential benefit to a modest number of others.