Building a vertically integrated genomic learning health system: The biobank at the Colorado Center for Personalized Medicine.

Precision medicine initiatives across the globe have led to a revolution of repositories linking large-scale genomic data with electronic health records, enabling genomic analyses across the entire phenome. Many of these initiatives focus solely on research insights, leading to limited direct benefit to patients. We describe the biobank at the Colorado Center for Personalized Medicine (CCPM Biobank) that was jointly developed by the University of Colorado Anschutz Medical Campus and UCHealth to serve as a unique, dual-purpose research and clinical resource accelerating personalized medicine. This living resource currently has more than 200,000 participants with ongoing recruitment. We highlight the clinical, laboratory, regulatory, and HIPAA-compliant informatics infrastructure along with our stakeholder engagement, consent, recontact, and participant engagement strategies. We characterize aspects of genetic and geographic diversity unique to the Rocky Mountain region, the primary catchment area for CCPM Biobank participants. We leverage linked health and demographic information of the CCPM Biobank participant population to demonstrate the utility of the CCPM Biobank to replicate complex trait associations in the first 33,674 genotyped individuals across multiple disease domains. Finally, we describe our current efforts toward return of clinical genetic test results, including high-impact pathogenic variants and pharmacogenetic information, and our broader goals as the CCPM Biobank continues to grow. Bringing clinical and research interests together fosters unique clinical and translational questions that can be addressed from the large EHR-linked CCPM Biobank resource within a HIPAA- and CLIA-certified environment.

ED-based COVID-19 vaccination campaign finds higher vaccination rates for individuals from racial and ethnic minority groups compared with clinic setting.

BACKGROUND: Emergency department visits associated with Coronavirus Disease 2019 (COVID-19) continue to indicate racial and ethnic inequities. We describe the sociodemographic characteristics of individuals receiving COVID-19 vaccination in the emergency department and compare with an outpatient clinic population and emergency department (ED) patients who were eligible but not vaccinated. METHODS: We conducted a retrospective analysis of electronic health record data at an urban academic ED from May to July 2021. The primary aim was to characterize the ED-vaccinated population, compared with ED patients who were eligible but unvaccinated and the physically adjacent outpatient vaccination clinic population. RESULTS: A total of 627 COVID-19 vaccinations were administered in the ED. Overall, 49% of ED patients during that time had already received at least one vaccine dose prior to ED arrival. Hispanic, non-Hispanic Black patients, and patients on non-commercial insurance had higher odds of being vaccinated in the ED as compared with outpatient clinic setting. Among eligible ED patients, men and patients who were uninsured/self-pay were more likely to accept ED vaccination. CONCLUSIONS: This ED COVID-19 vaccination campaign demonstrated a higher likelihood to vaccinate individuals from racial/ethnic minority groups, those with high social vulnerability, and non-commercial insurance, when compared with a co-located outpatient vaccination clinic.

Real-World Evidence of the Neutralizing Monoclonal Antibody Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients.

BACKGROUND: It is not known whether sotrovimab, a neutralizing monoclonal antibody (mAb) treatment authorized for early symptomatic coronavirus disease 2019 (COVID-19) patients, is also effective in preventing the progression of severe disease and mortality following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Delta variant infection. METHODS: In an observational cohort study of nonhospitalized adult patients with SARS-CoV-2 infection, 1 October 2021-11 December 2021, using electronic health records from a statewide health system plus state-level vaccine and mortality data, we used propensity matching to select 3 patients not receiving mAbs for each patient who received outpatient sotrovimab treatment. The primary outcome was 28-day hospitalization; secondary outcomes included mortality and severity of hospitalization. RESULTS: Of 10 036 patients with SARS-CoV-2 infection, 522 receiving sotrovimab were matched to 1563 not receiving mAbs. Compared to mAb-untreated patients, sotrovimab treatment was associated with a 63% decrease in the odds of all-cause hospitalization (raw rate 2.1% vs 5.7%; adjusted odds ratio [aOR], 0.37; 95% confidence interval [CI], .19-.66) and an 89% decrease in the odds of all-cause 28-day mortality (raw rate 0% vs 1.0%; aOR, 0.11; 95% CI, .0-.79), and may reduce respiratory disease severity among those hospitalized. CONCLUSIONS: Real-world evidence demonstrated sotrovimab effectiveness in reducing hospitalization and all-cause 28-day mortality among COVID-19 outpatients during the Delta variant phase.

The Case for Virtual Sepsis Surveillance and Intervention.

Study Objective:To determine whether deployment of an integrated virtual sepsis surveillance program could improve time to antibiotics and mortality in a longitudinal cohort of non-present on admission (NPOA) sepsis cases.Methods:We used an uncontrolled pre- and poststudy design to compare time to antibiotics and mortality between a time-based cohort of NPOA sepsis cases separated by the deployment of a virtual sepsis surveillance program.Results:A total of 566 NPOA sepsis cases were included in this study. Three hundred and thirty-five cases compromised the preintervention arm, whereas the postintervention cohort included 231 cases. After deployment of the virtual sepsis surveillance program, median time to antibiotics improved from 92 to 59 min (p < 0.001). Mortality was reduced from 30% to 21% (p = 0.015).Conclusion:Deployment of a virtual sepsis surveillance program resulted in a decreased time to antibiotics and an overall reduction in NPOA sepsis mortality.

How alternative payment models in emergency medicine can benefit physicians, payers, and patients.

While there has been considerable effort devoted to developing alternative payment models (APMs) for primary care physicians and for episodes of care beginning with inpatient admissions, there has been relatively little attention by payers to developing APMs for specialty ambulatory care, and no efforts to develop APMs that explicitly focus on emergency care. In order to ensure that emergency care is appropriately integrated and valued in future payment models, emergency physicians (EPs) must engage with the stakeholders within the broader health care system. In this article, we describe a framework for the development of APMs for emergency medicine and present four examples of APMs that may be applicable in emergency medicine. A better understanding of how APMs can work in emergency medicine will help EPs develop new APMs that improve the cost and quality of care, and leverage the value that emergency care brings to the system.

Process Improvement Tools, Commitment to Change Lead to Serious Turnaround.

The ED at the University of Colorado Hospital (UCH) has undergone a dramatic transformation in recent years, doubling in size while also using process improvement methods to dramatically reduce wait times, eliminate ambulance diversion, and boost patient satisfaction. Throughout this period, volume has continued to increase while the cost per patient and avoidable hospital admissions have experienced steady declines. Guiding the effort has been a series of core principles, with a particular focus on making sure that all processes are patient-centered. . To begin the improvement effort, ED leaders established a leadership team, and hired a process improvement chief with no previous experience in healthcare to provide fresh, outside perspective on processes. . In addition to mandating that all processes be patient-centered, the other guiding principles included a commitment to use and track data, to speak with one voice, to value everyone's perspective, to deliver high-quality care to all patients, and to set a standard for other academic medical centers. . To get points on the board early and win approval from staff, one of the first changes administrators implemented was to hire scribes for every physician so they wouldn't be bogged down with data input. The approach has essentially paid for itself. . Among the biggest changes was the elimination of triage, a process that improvement teams found no longer added value or quality to the patient experience. . Leadership also has moved to equilibrate the size and staff of the various zones in the ED so that they are more generic and less specialized. The move has facilitated patient flow, enabling patients in zones with resuscitation bays to connect with providers quickly.

Implementation of a Front-End Split-Flow Model to Promote Performance in an Urban Academic Emergency Department.

BACKGROUND: In an urban academic emergency department (ED), a front-end split-flow model, which entailed deployment of an attending-physician intake model, implementation of a 16-bed clinic decision unit, expanded point-of-care (POC) testing, and dedicated ED transportation services, was created. METHODS: A retrospective, observational, pre-post intervention comparison study was conducted at a large academic urban hospital with 74,000 ED annual visits that serves as a Level 2 Trauma Center. The new flow model was implemented in April 2013, coincident with the opening of a new ED space. RESULTS: During the six-month pre- (July 2012-December 2012) and postimplementation (July 2013-December 2013) periods, there were 17,307 and 27,443, respectively, walk-in encounters during the intake times. Despite this 59% increase and a 35% increase in overall ED patient census, implementation of the innovative novel process redesign resulted in a clinically meaningful reduction (median minutes pre vs. post and one-year post) in (1) overall length of stay (LOS) for all walk-ins (220 vs. 175 and 140), discharged (216 vs. 170 and 140), and inpatient admissions (249 vs. 217 and 181); (2) door-to-physician time (minutes) (54 vs. 15 and 12); and (3) left without being seen (LWBS) rates (5.5% vs. 0.5% and 0.0%). The left before visit complete (LBVC) rates were 0.8% vs. 1.1% and 0.6%. The average total relative value unit (RVU) per patient discharged from intake was 2.31. During the pre-post analysis periods, no significant increase in reported safety events were identified (10 vs. 9 per 1,000 patient encounters). CONCLUSION: Implementation of a novel multifaceted process redesign including an attending physician-driven intake model had a clinically positive impact on ED flow. Validation of this model should be conducted in other practice settings.

Predictors of patients who present to the emergency department with sepsis and progress to septic shock between 4 and 48 hours of emergency department arrival.

OBJECTIVES: Approximately one in every four patients who present to the emergency department with sepsis progresses to septic shock within 72 hours of arrival. In this study, we describe key patient characteristics present within 4 hours of emergency department arrival that are associated with developing septic shock between 4 and 48 hours of emergency department arrival. DESIGN AND SETTING: This study was a retrospective chart review study of all patients hospitalized from the emergency department with two or more systemic inflammatory response syndrome criteria present within 4 hours of emergency department arrival from September 2010 to February 2011 at two large academic institutions. Patients were excluded if they presented with a ST-elevation myocardial infarction, acute stroke, or trauma; had a cardiac arrest prior to arrival; were pregnant; or admitted from the emergency department psychiatric unit or transferred from an outside hospital. We identified patients with within 4 hours of emergency department arrival and identified those with septic shock at 48 hours after emergency department arrival, using a standard set of guidelines. The primary objective was identifying the number of patients who present with sepsis and progress to septic shock between 4 and 48 hours of emergency department arrival. As to the second objective, we used multivariate logistic regression analysis to identify patient factors associated with the progression of sepsis to septic shock for the aforementioned population. MEASUREMENTS AND MAIN RESULTS: A total of 18,100 patients were admitted from the emergency department, of which 3,960 patients had two or more systemic inflammatory response syndrome criteria, and 1,316 patients had sepsis within 4 hours of emergency department arrival. Although 50 patients presented to the emergency department with septic shock within 4 hours of arrival, 111 patients with sepsis (8.4%) progressed to septic shock between 4 and 48 hours of emergency department arrival. Characteristics associated with the progression of septic shock between 4 and 48 hours of emergency department arrival included female gender (odds ratio, 1.59; 95% CI, 1.02-2.47), nonpersistent hypotension (odds ratio, 6.24; 95% CI, 3.58-10.86), bandemia at least 10% (odds ratio, 2.60; 95% CI, 1.50-4.51), lactate at least 4.0 mmol/L (odds ratio, 5.30; 95% CI, 2.59-10.84), and past medical of coronary artery disease (odds ratio, 2.01; 95% 1.26-3.44). CONCLUSION: Approximately 12% of septic emergency department patients develop shock within 48 hours of presentation, and more than half of these patients develop shock after the first 4 hours of emergency department arrival. Over a third of patients who have sepsis within 4 hours of emergency department arrival and develop septic shock between 4 and 48 hours of emergency department arrival are not admitted to an ICU.

National study of health insurance type and reasons for emergency department use.

BACKGROUND: The rates of emergency department (ED) utilization vary substantially by type of health insurance, but the association between health insurance type and patient-reported reasons for seeking ED care is unknown. OBJECTIVE: We evaluated the association between health insurance type and self-perceived acuity or access issues among individuals discharged from the ED. DESIGN, PATIENTS: This was a cross-sectional analysis of the 2011 National Health Interview Survey. Adults whose last ED visit did not result in hospitalization (n = 4,606) were asked structured questions about reasons for seeking ED care. We classified responses as 1) perceived need for immediate evaluation (acuity issues), or 2) barriers to accessing outpatient services (access issues). MAIN MEASURES: We analyzed survey-weighted data using multivariable logistic regression models to test the association between health insurance type and reasons for ED visits, while adjusting for sociodemographic characteristics. KEY RESULTS: Overall, 65.0% (95% CI 63.0-66.9) of adults reported ≥ 1 acuity issue and 78.9% (95% CI 77.3-80.5) reported ≥ 1 access issue. Among those who reported no acuity issue leading to the most recent ED visit, 84.2% reported ≥ 1 access issue. Relative to those with private insurance, adults with Medicaid (OR 1.05; 95% CI 0.79-1.40) and those with Medicare (OR 0.98; 95% CI 0.66-1.47) were similarly likely to seek ED care due to an acuity issue. Adults with Medicaid (OR 1.50; 95% CI 1.06-2.13) and Medicaid + Medicare (dual eligible) (OR 1.94; 95% CI 1.18-3.19) were more likely than those with private insurance to seek ED care for access issues. CONCLUSION: Variability in reasons for seeking ED care among discharged patients by health insurance type may be driven more by lack of access to alternate care, rather than by differences in patient-perceived acuity. Policymakers should focus on increasing access to alternate sites of care, particularly for Medicaid beneficiaries, as well as strategies to increase care coordination that involve ED patients and providers.

Effectiveness of subcutaneous monoclonal antibody treatment in emergency department outpatients with COVID-19.

Objectives: To evaluate whether subcutaneous neutralizing monoclonal antibody (mAb) treatment given in the emergency department (ED) setting was associated with reduced hospitalizations, mortality, and severity of disease when compared to nontreatment among mAb-eligible patients with coronavirus disease 2019 (COVID-19). Methods: This retrospective observational cohort study of ED patients utilized a propensity score-matched analysis to compare patients who received subcutaneous casirivimab and imdevimab mAb to nontreated COVID-19 control patients in November-December 2021. The primary outcome was all-cause hospitalization within 28 days, and secondary outcomes were 90-day hospitalization, 28- and 90-day mortality, and ED length of stay (LOS). Results: Of 1340 patients included in the analysis, 490 received subcutaneous casirivimab and imdevimab, and 850 did not received them. There was no difference observed for 28-day hospitalization (8.4% vs. 10.6%; adjusted odds ratio [aOR] 0.79, 95% confidence intervals [CI] 0.53-1.17) or 90-day hospitalization (11.6% vs. 12.5%; aOR 0.93, 95% CI 0.65-1.31). However, mortality at both the 28-day and 90-day timepoints was substantially lower in the treated group (28-day 0.6% vs. 3.1%; aOR 0.18, 95% CI 0.08-0.41; 90-day 0.6% vs. 3.9%; aOR 0.14, 95% CI 0.06-0.36). Among hospitalized patients, treated patients had shorter hospital LOS (5.7 vs. 11.4 days; adjusted rate ratio [aRR] 0.47, 95% CI 0.33-0.69), shorter intensive care unit LOS (3.8 vs. 10.2 days; aRR 0.22, 95% CI 0.14-0.35), and the severity of hospitalization was lower (aOR 0.45, 95% CI 0.21-0.97) compared to untreated. Conclusions: Among ED patients who presented for symptomatic COVID-19 during the Delta variant phase, ED subcutaneous casirivimab/imdevimab treatment was not associated with a decrease in hospitalizations. However, treatment was associated with lower mortality at 28 and 90 days, hospital LOS, and overall severity of illness.

The effect of an ambulance diversion ban on emergency department length of stay and ambulance turnaround time.

STUDY OBJECTIVE: Massachusetts became the first state in the nation to ban ambulance diversion in 2009. It was feared that the diversion ban would lead to increased emergency department (ED) crowding and ambulance turnaround time. We seek to characterize the effect of a statewide ambulance diversion ban on ED length of stay and ambulance turnaround time at Boston-area EDs. METHODS: We conducted a retrospective, pre-post observational analysis of 9 Boston-area hospital EDs before and after the ban. We used ED length of stay as a proxy for ED crowding. We compared hospitals individually and in aggregate to determine any changes in ED length of stay for admitted and discharged patients, ED volume, and turnaround time. RESULTS: No ED experienced an increase in ED length of stay for admitted or discharged patients or ambulance turnaround time despite an increase in volume for several EDs. There was an overall 3.6% increase in ED volume in our sample, a 10.4-minute decrease in length of stay for admitted patients, and a 2.2-minute decrease in turnaround time. When we compared high- and low-diverting EDs separately, neither saw an increase in length of stay, and both saw a decrease in turnaround time. CONCLUSION: After the first statewide ambulance diversion ban, there was no increase in ED length of stay or ambulance turnaround time at 9 Boston-area EDs. Several hospitals actually experienced improvements in these outcome measures. Our results suggest that the ban did not worsen ED crowding or ambulance availability at Boston-area hospitals.

A comparison of the speed, success rate, and retention of rescue airway devices placed by first-responder emergency medical technicians: a high-fidelity human patient simulation study.

BACKGROUND: Current airway management for most first-responder basic emergency medical technicians (EMT-Bs) does not include the use of blind-advanced-airway devices. OBJECTIVE: To compare the speed, success rates, and skill retention with which EMT-Bs providers can place three blind-advanced-airway devices. METHODS: Prospective study of 43 EMT-Bs trained in the use of the Esophageal-Tracheal-Combitube(®) (ETC), King LT(®) (KLT), and Laryngeal Mask Airway(™) (LMA). The time it took each participant to place each device correctly and ventilate a human patient simulator was assessed. Primary outcome measures were the success rate of proper insertion for each device and time interval from initiation of mouth insertion to initiation of chest rise. To assess skill retention, at 3 months the providers were reassessed under exact conditions. RESULTS: At Day 1, time required to place an ETC, LMA, and KLT were 32.7 ± 12.3, 19.2 ± 6.2, and 20.1 ± 6.6 s, respectively. Using paired t-tests, LMA and KLT were faster than ETC, p < 0.0001. At 3 months, pair-wise comparisons showed the ETC took longer to place than the KLT and LMA, p < 0.0001; and the LMA took longer to place than the KLT, p = 0.0034 (36.4 ± 13.1 ETC, 24.8 ± 12.4 LMA, 19.0 ± 6.9 KLT). There was no statistical difference of failures in placing any device. CONCLUSIONS: Comparison of three rescue airway devices placed by EMT-Bs providers showed that it takes significantly longer to place an ETC compared to an LMA and KLT both on Day 1 and 3 months later. Three-month retention studies revealed that it took significantly longer to place an LMA compared to the KLT.

Expedited electronic entry: a new way to manage mass-casualty radiology order workflow.

One of the important tenets of emergency preparedness is that planning for disaster response should resemble standard operating procedure whenever possible. Electronic order entry has become part of the standard operating procedures of most institutions but many of these systems are either too cumbersome for use during a surge or can even be rendered non-functional during a sudden patient surge such as a mass-casualty incident (MCI). Presented here is an experience with delayed radiology order entry during a recent MCI and the after action programming of the system based on this real experience. In response to the after action analysis of the MCI, a task force was assigned to solve the MCI radiology order entry problem and a solution to streamline disaster image ordering was devised. A "browse page" was created that lists every x-ray and every CT scan that might be needed in such an event with all required information defaulted to "Disaster." This created a way to order multiple images for any one patient, with 40% time saving over standard electronic order entry. This disaster radiology order entry solution is an example of the surge preparedness needed to promote patient safety and efficient care delivery as the widespread deployment of electronic health records and order entry continues across the United States.

Real-World Evidence of Neutralizing Monoclonal Antibodies for Preventing Hospitalization and Mortality in COVID-19 Outpatients.

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.

Effect of computerized clinical decision support on the use and yield of CT pulmonary angiography in the emergency department.

PURPOSE: To determine the effect of evidence-based clinical decision support (CDS) on the use and yield of computed tomographic (CT) pulmonary angiography for acute pulmonary embolism (PE) in the emergency department (ED). MATERIALS AND METHODS: Institutional review board approval was obtained for this HIPAA-compliant study, which was performed between October 1, 2003, and September 30, 2009, at a 793-bed quaternary care institution with 60,000 annual ED visits. Use (number of examinations per 1000 ED visits) and yield (percentage of examinations positive for acute PE) of CT pulmonary angiography were compared before and after CDS implementation in August 2007. The authors included all adult patients presenting to the ED and developed and validated a natural language processing tool to identify acute PE diagnoses. Linear trend analysis was used to assess for variation in CT pulmonary angiography use. Logistic regression was used to determine variation in yield after controlling for patient demographic and clinical characteristics. RESULTS: Of 338,230 patients presenting to the ED, 6838 (2.0%) underwent CT pulmonary angiography. Quarterly CT pulmonary angiography use increased 82.1% before CDS implementation, from 14.5 to 26.4 examinations per 1000 patients (P<.0001) between October 10, 2003, and July 31, 2007. After CDS implementation, quarterly use decreased 20.1%, from 26.4 to 21.1 examinations per 1000 patients between August 1, 2007, and September 30, 2009 (P=.0379). Overall, 686 (10.0%) of the CT pulmonary angiographic examinations performed during the 6-year period were positive for PE; subsequent to CDS implementation, yield by quarter increased 69.0%, from 5.8% to 9.8% (P=.0323). CONCLUSION: Implementation of evidence-based CDS in the ED was associated with a significant decrease in use, and increase in yield, of CT pulmonary angiography for the evaluation of acute PE.

The Role of Academic Health Systems in Leading the "Third Wave" of Digital Health Innovation.

Investors, entrepreneurs, health care pundits, and venture capital firms all agree that the health care sector is awaiting a digital revolution. Steven Case, in 2016, predicted a "third wave" of innovation that would leverage big data, artificial intelligence, and machine learning to transform medicine and finally achieve reduced costs, improved efficiency, and better patient outcomes. Academic medical centers (AMCs) have the infrastructure and resources needed by digital health intrapreneurs and entrepreneurs to innovate, iterate, and optimize technology solutions for the major pain points of modern medicine. With large unique patient data sets, strong research programs, and subject matter experts, AMCs have the ability to assess, optimize, and integrate new digital health tools with feedback at the point of care and research-based clinical validation. As AMCs begin to explore digital health solutions, they must decide between forming internal teams to develop these innovations or collaborating with external companies. Although each has its drawbacks and benefits, AMCs can both benefit from and drive forward the digital health innovations that will result from this journey. This viewpoint will provide an explanation as to why AMCs are ideal incubators for digital health solutions and describe what these organizations will need to be successful in leading this "third wave" of innovation.

COVID-19 Vaccine Clinic Real-Time Throughput Analysis: Development and Implementation of an Innovative Data Collection Tool.

BACKGROUND: The novel coronavirus disease 2019 (COVID-19) pandemic has presented the healthcare system with a plethora of challenges, including implementation of an efficient vaccination strategy. Mass vaccinations have been used during previous pandemics; however, the associated data have largely been limited to theoretical simulations and post hoc analysis. METHODS: An innovative data collection tool was created to deliver real-time data analysis during a drive-through mass vaccination. Patients were assigned unique identification numbers at the clinic entrance. Using these identification numbers, and the web-based spreadsheet, patients were tracked throughout the vaccination process. Static timestamps corresponding to the entry and exit at each checkpoint were recorded in real time. RESULTS: Data were collected on a total of 3,744 vehicles over five clinic days. Total time was collected, from entry to exit, on 2,860 vehicles. Registration and vaccination times were collected on 3,111 vehicles. Of the vehicles sampled, 1,588 (42%) had data points associated with all checkpoints. CONCLUSIONS: This open-source, innovative data collection tool was successfully implemented in our mass vaccination clinic for tracking patients in real time providing actionable data on overall throughput efficiency. This cost-effective tool can be used on a variety of healthcare-related projects to provide data-driven evaluation on the efficiency of care.

Machine Learning-Based Exploratory Clinical Decision Support for Newly Diagnosed Patients With Acute Myeloid Leukemia Treated With 7 + 3 Type Chemotherapy or Venetoclax/Azacitidine.

PURPOSE: There are currently limited objective criteria to help assist physicians in determining whether an individual patient with acute myeloid leukemia (AML) is likely to do better with induction with either standard 7 + 3 chemotherapy or targeted therapy with venetoclax plus azacitidine. The study goal was to address this need by developing exploratory clinical decision support methods. PATIENTS AND METHODS: Univariable and multivariable analysis as well as comparison of a range of machine learning (ML) predictors were performed using cohorts of 120 newly diagnosed 7 + 3-treated AML patients compared with 101 venetoclax plus azacitidine-treated patients. RESULTS: A variety of features in the two patient cohorts were identified that may potentially correlate with short- and long-term outcomes, toxicities, and other considerations. A subset of these diagnostic features was then used to develop ML-based predictors with relatively high areas under the curve of short- and long-term outcomes, hospital stays, transfusion requirements, and toxicities for individual patients treated with either venetoclax/azacitidine or 7 + 3. CONCLUSION: Potential ML-based approaches to clinical decision support to help guide individual patients with newly diagnosed AML to either 7 + 3 or venetoclax plus azacitidine induction therapy were identified. Larger cohorts with separate test and validation studies are necessary to confirm these initial findings.

Real World Evidence of Neutralizing Monoclonal Antibodies for Preventing Hospitalization and Mortality in COVID-19 Outpatients.

BACKGROUND: Neutralizing monoclonal antibodies (mAbs) are authorized for early symptomatic COVID-19 patients. Whether mAbs are effective against the SARS-CoV-2 Delta variant, among vaccinated patients, or for prevention of mortality remains unknown. OBJECTIVE: To evaluate the effectiveness of mAb treatment in preventing progression to severe disease during the Delta phase of the pandemic and based on key baseline risk factors. DESIGN SETTING AND PATIENTS: Observational cohort study of non-hospitalized adult patients with SARS-CoV-2 infection from November 2020-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 mAbs. EXPOSURE: Neutralizing mAb treatment under emergency use authorization. MAIN OUTCOMES: The primary outcome was 28-day hospitalization; secondary outcomes included mortality and severity of hospitalization. RESULTS: Of 36,077 patients with SARS-CoV-2 infection, 2,675 receiving mAbs were matched to 6,677 not receiving mAbs. Compared to 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%). Relative effectiveness was similar in preventing hospitalizations during the Delta variant phase (adjusted OR 0.35, 95%CI 0.25-0.50) and across subgroups. Lower number-needed-to-treat (NNT) to prevent hospitalization were observed for subgroups with higher baseline risk of hospitalization (e.g., multiple comorbidities (NNT=17) and not fully vaccinated (NNT=24) vs. no comorbidities (NNT=88) and fully vaccinated (NNT=81). CONCLUSION: Real-world evidence demonstrated mAb effectiveness in reducing hospitalization among COVID-19 outpatients, including during the Delta variant phase, and conferred an overall 89% reduction in 28-day mortality. Early outpatient treatment with mAbs should be prioritized, especially for individuals with highest risk for hospitalization.

Real World Evidence of the Neutralizing Monoclonal Antibody Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients.

Background: It is not known whether sotrovimab, a neutralizing monoclonal antibody (mAb) treatment authorized for early symptomatic COVID-19 patients, is effective against the SARS-CoV-2 Delta variant to prevent progression to severe disease and mortality. Methods: Observational cohort study of non-hospitalized adult patients with SARS-CoV-2 infection from October 1 st 2021 - December 11 th 2021, using electronic health records from a statewide health system plus state-level vaccine and mortality data. We used propensity matching to select 3 patients not receiving mAbs for each patient who received outpatient sotrovimab treatment. The primary outcome was 28-day hospitalization; secondary outcomes included mortality and severity of hospitalization. Results: Of 10,036 patients with SARS-CoV-2 infection, 522 receiving sotrovimab were matched to 1,563 not receiving mAbs. Compared to mAb-untreated patients, sotrovimab treatment was associated with a 63% decrease in the odds of all-cause hospitalization (raw rate 2.1% versus 5.7%; adjusted OR 0.37, 95% CI 0.19-0.66) and an 89% decrease in the odds of all-cause 28-day mortality (raw rate 0% versus 1.0%; adjusted OR 0.11, 95% CI 0.0-0.79), and may reduce respiratory disease severity among those hospitalized. Conclusion: Real-world evidence demonstrated sotrovimab effectiveness in reducing hospitalization and all-cause 28-day mortality among COVID-19 outpatients during the Delta variant phase.