RESUMO
BACKGROUND: Neutralizing monoclonal antibodies (mAbs) were authorized for the treatment of COVID-19 outpatients based on clinical trials completed early in the pandemic, which were underpowered for mortality and subgroup analyses. Real-world data studies are promising for further assessing rapidly deployed therapeutics. RESEARCH QUESTION: Did mAb treatment prevent progression to severe disease and death across pandemic phases and based on risk factors, including prior vaccination status? STUDY DESIGN AND METHODS: This observational cohort study included nonhospitalized adult patients with SARS-CoV-2 infection from November 2020 to October 2021 using electronic health records from a statewide health system plus state-level vaccine and mortality data. Using propensity matching, we selected approximately 2.5 patients not receiving mAbs for each patient who received mAb treatment under emergency use authorization. The primary outcome was 28-day hospitalization; secondary outcomes included mortality and hospitalization severity. RESULTS: Of 36,077 patients with SARS-CoV-2 infection, 2,675 receiving mAbs were matched to 6,677 patients not receiving mAbs. Compared with mAb-untreated patients, mAb-treated patients had lower all-cause hospitalization (4.0% vs 7.7%; adjusted OR, 0.48; 95% CI, 0.38-0.60) and all-cause mortality (0.1% vs 0.9%; adjusted OR, 0.11; 95% CI, 0.03-0.29) to day 28; differences persisted to day 90. Among hospitalized patients, mAb-treated patients had shorter hospital length of stay (5.8 vs 8.5 days) and lower risk of mechanical ventilation (4.6% vs 16.6%). Results were similar for preventing hospitalizations during the Delta variant phase (adjusted OR, 0.35; 95% CI, 0.25-0.50) and across subgroups. Number-needed-to-treat (NNT) to prevent hospitalization was lower for subgroups with higher baseline risk of hospitalization; for example, multiple comorbidities (NNT = 17) and not fully vaccinated (NNT = 24) vs no comorbidities (NNT = 88) and fully vaccinated (NNT = 81). INTERPRETATION: Real-world data revealed a strong association between receipt of mAbs and reduced hospitalization and deaths among COVID-19 outpatients across pandemic phases. Real-world data studies should be used to guide practice and policy decisions, including allocation of scarce resources.
Assuntos
COVID-19 , Pacientes Ambulatoriais , Adulto , Humanos , COVID-19/terapia , SARS-CoV-2 , Hospitalização , Anticorpos Monoclonais/uso terapêutico , Anticorpos NeutralizantesRESUMO
OBJECTIVE: The objective was to evaluate the impact of evidence-based clinical decision support tools integrated directly into provider workflow in the electronic health record on utilization of computed tomography (CT) brain, C-spine, and pulmonary embolism (PE). METHODS: Validated, well-accepted scoring tools for head injury, C-spine injury, and PE were embedded into the electronic health record in a manner minimally disruptive to provider workflow. This was a longitudinal, before/after study in five emergency departments (EDs) in a healthcare system with a common electronic health record. Attending ED physicians practicing during the entire study period were included. The main outcome measure was proportion of CTs ordered by provider (total number of CT scans of a given type divided by total patients seen by that provider) in aggregate in the pre- and post intervention period. RESULTS: There were 235,858 total patient visits analyzed in this study with an absolute decrease of 6,106 CT scan ordering for the three studies. Across all sites, there was greater than 6% decrease in utilization of CT brain and CT C-spine (-10%, 95% CI = -13% to -7%, p < 0.001; and -6%, 95% CI =-11% to -1%, p = 0.03, respectively). The use of CT PE also decreased but was not significant (-2%, 95% CI = -9% to +5%, p = 0.42). For all CT types, high utilizers in the pre-intervention period decreased usage over 14% in the post-intervention period with CT brain (-18%, 95% CI = -22% to -15%, p < 0.001), CT C-spine (-14%, 95% CI = -20% to -8%, p = 0.001), and CT PE (-23%, 95% CI = -31% to -14%, p < 0.001). For all three studies, the average utilizers did not change their usage practices. For CT brain, the low utilizers also did not increase usage but for CT C-spine and CT PE usage was increased (+29%, 95% CI = 10% to 52%, p = 0.003; and +46%, 95% CI = 26% to 70%, p < 0.001, respectively). CONCLUSION: Embedded clinical decision support is associated with decreased overall utilization of high-cost imaging, especially among higher utilizers. It also affected low utilizers, increasing their usage consistent with improved adherence to guidelines, but this effect did not offset the overall decreased utilization for CT brain or CT C-spine. Thus, integrating clinical decision support into the provider workflow promotes usage of validated tools across providers, which can standardize the delivery of care and improve compliance with evidence-based guidelines.