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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.
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COVID-19 , Pacientes Ambulatoriais , Adulto , Humanos , COVID-19/terapia , SARS-CoV-2 , Hospitalização , Anticorpos Monoclonais/uso terapêutico , Anticorpos NeutralizantesRESUMO
The Emergency Medicine Specimen Bank (EMSB) was developed to facilitate precision medicine in acute care. The EMSB is a biorepository of clinical health data and biospecimens collected from all adult English- or Spanish-speaking individuals who are able and willing to provide consent and are treated at the UCHealth-University of Colorado Hospital Emergency Department. The EMSB is the first acute care biobank that seeks to enroll all patients, with all conditions who present to the ED. Acute care biobanking presents many challenges that are unique to acute care settings such as providing informed consent in a uniquely stressful and fast-paced environment and collecting, processing, and storing samples for tens of thousands of patients per year. Here, we describe the process by which the EMSB overcame these challenges and was integrated into clinical workflow allowing for operation 24 hours a day, 7 days a week at a reasonable cost. Other institutions can implement this template, further increasing the power of biobanking research to inform treatment strategies and interventions for common and uncommon phenotypes in acute care settings.
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Bancos de Espécimes Biológicos/organização & administração , Serviço Hospitalar de Emergência/organização & administração , Medicina de Precisão/métodos , Manejo de Espécimes/normas , Adulto , Bancos de Espécimes Biológicos/economia , Humanos , Consentimento Livre e Esclarecido , Fluxo de TrabalhoRESUMO
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.
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Sistemas de Apoio a Decisões Clínicas/organização & administração , Serviço Hospitalar de Emergência/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Embolia Pulmonar/diagnóstico por imagem , Tomografia Computadorizada por Raios X/estatística & dados numéricos , Estudos Controlados Antes e Depois , Registros Eletrônicos de Saúde , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , RiscoRESUMO
Health care systems have utilized various process redesign methodologies to improve care delivery. This article describes the creation of a novel process improvement methodology, Rapid Process Optimization (RPO). This system was used to redesign emergency care delivery within a large academic health care system, which resulted in a decrease: (1) door-to-physician time (Department A: 54 minutes pre vs 12 minutes 1 year post; Department B: 20 minutes pre vs 8 minutes 3 months post), (2) overall length of stay (Department A: 228 vs 184; Department B: 202 vs 192), (3) discharge length of stay (Department A: 216 vs 140; Department B: 179 vs 169), and (4) left without being seen rates (Department A: 5.5% vs 0.0%; Department B: 4.1% vs 0.5%) despite a 47% increased census at Department A (34 391 vs 50 691) and a 4% increase at Department B (8404 vs 8753). The novel RPO process improvement methodology can inform and guide successful care redesign.
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Serviço Hospitalar de Emergência/organização & administração , Inovação Organizacional , Melhoria de Qualidade/organização & administração , Serviço Hospitalar de Emergência/normas , Humanos , Tempo de Internação , Desenvolvimento de Programas , Indicadores de Qualidade em Assistência à Saúde/estatística & dados numéricos , Fatores de TempoRESUMO
INTRODUCTION: Terrorism is a global public health burden. South Americans have been victims of terrorism for many decades. While the causes vary, the results are the same: death, disability, and suffering. The objective of this study was to perform a comprehensive, epidemiological, descriptive study of terrorist incidents in South America. METHODS: This is a cross-sectional, descriptive study. Data from January 1971 to July 2006 was selected using the RAND Terrorism Chronology 1968-1997 and RAND-Memorial Institute for Prevention of Terrorism (MIPT) Terrorism Incident database (1998-Present). Statistical significance was set at 0.05. RESULTS: The database reported a total of 2,997 incidents in South American countries that resulted in 3,435 victims with injuries (1.15 per incident) and 1,973 fatalities (0.66 per incident). The overall case fatality ratio (CFR) was 35.8%. Colombia had the majority of incidents with 57.9% (1,734 of 2,997), followed by Peru with 363 (12.1%), and Argentina with 267 (8.9%). The highest individual CFR occurred in Paraguay (83.3%), and the lowest in Chile with 4.8%. Of the total injuries and deaths, Colombia had 66.1% (2,269 of 2,997) of all injuries and 75.2% (1,443 out of 1,920) of all deaths. Living in the country of Colombia was associated with a 16 times greater likelihood of becoming a victim of terrorist violence [odds ratio (OR) 16.15; 95% CI 13.45 to 19.40; p < 0.0001]. The predominant method of choice for terrorist incidents was the use of conventional explosives with 2,543 of2,883 incidents (88.2%). CONCLUSIONS: Terrorist incidents in South America have accounted for nearly 2,000 deaths, with conventional explosive devices as the predominant method of choice. Understanding the nature of terrorist attacks and the medical consequences assist emergency preparedness and disaster management officials in allocating resources and preparing for potential future events.