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1.
Crit Care Explor ; 6(7): e1122, 2024 Jul 01.
Article in English | MEDLINE | ID: mdl-39023121

ABSTRACT

IMPORTANCE: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has evolved through multiple phases in the United States, with significant differences in patient centered outcomes with improvements in hospital strain, medical countermeasures, and overall understanding of the disease. We describe how patient characteristics changed and care progressed over the various pandemic phases; we also emphasize the need for an ongoing clinical network to improve the understanding of known and novel respiratory viral diseases. OBJECTIVES: To describe how patient characteristics and care evolved across the various COVID-19 pandemic periods in those hospitalized with viral severe acute respiratory infection (SARI). DESIGN: Severe Acute Respiratory Infection-Preparedness (SARI-PREP) is a Centers for Disease Control and Prevention Foundation-funded, Society of Critical Care Medicine Discovery-housed, longitudinal multicenter cohort study of viral pneumonia. We defined SARI patients as those hospitalized with laboratory-confirmed respiratory viral infection and an acute syndrome of fever, cough, and radiographic infiltrates or hypoxemia. We collected patient-level data including demographic characteristics, comorbidities, acute physiologic measures, serum and respiratory specimens, therapeutics, and outcomes. Outcomes were described across four pandemic variant periods based on a SARS-CoV-2 sequenced subsample: pre-Delta, Delta, Omicron BA.1, and Omicron post-BA.1. SETTING: Multicenter cohort of adult patients admitted to an acute care ward or ICU from seven hospitals representing diverse geographic regions across the United States. PARTICIPANTS: Patients with SARI caused by infection with respiratory viruses. MAIN OUTCOMES AND RESULTS: Eight hundred seventy-four adult patients with SARI were enrolled at seven study hospitals between March 2020 and April 2023. Most patients (780, 89%) had SARS-CoV-2 infection. Across the COVID-19 cohort, median age was 60 years (interquartile range, 48.0-71.0 yr) and 66% were male. Almost half (430, 49%) of the study population belonged to underserved communities. Most patients (76.5%) were admitted to the ICU, 52.5% received mechanical ventilation, and observed hospital mortality was 25.5%. As the pandemic progressed, we observed decreases in ICU utilization (94% to 58%), hospital length of stay (median, 26.0 to 8.5 d), and hospital mortality (32% to 12%), while the number of comorbid conditions increased. CONCLUSIONS AND RELEVANCE: We describe increasing comorbidities but improved outcomes across pandemic variant periods, in the setting of multiple factors, including evolving care delivery, countermeasures, and viral variants. An understanding of patient-level factors may inform treatment options for subsequent variants and future novel pathogens.


Subject(s)
COVID-19 , SARS-CoV-2 , Humans , COVID-19/epidemiology , Male , Female , Middle Aged , United States/epidemiology , Longitudinal Studies , Aged , Pandemics , Adult , Hospitalization/statistics & numerical data , Intensive Care Units , Cohort Studies
2.
Am J Forensic Med Pathol ; 45(2): 103-110, 2024 Jun 01.
Article in English | MEDLINE | ID: mdl-38411190

ABSTRACT

ABSTRACT: Multiple studies have documented various factors that influence or determine forensic pathologist classification of manner of death. There do not appear to be any published studies on manner of death classification specifically regarding arrest-related deaths (ARDs). The goal of this study was to consider a large body of cases of nonfirearm ARDs to analyze the homicide classification with regards to numerous decedent and practitioner (medical examiner/coroner [ME/C]) variables. We analyzed 1145 US autopsy reports from the years 2006-2020, inclusive, and considered decedent variables of age, ethnicity, height, weight, body mass index, toxicology, and mention of a conducted electrical weapon and ME/C influence variables of gender, country region, and year. We found that the homicide classification likelihood increased by a factor of 1.04-1.05 per year, 1.34-1.37 for a female medical examiner, and 1.4-1.5 going from Southern states to Western states. There is an increasing trend for ME/C to label nonfirearm ARDs as homicides in the United States. The homicide classification is more common in Western states and less common in Southern states, and it was more common with a female ME/C.


Subject(s)
Homicide , Humans , Homicide/statistics & numerical data , Female , Male , Adult , Middle Aged , Aged , Young Adult , Adolescent , United States , Child , Child, Preschool , Coroners and Medical Examiners , Infant , Aged, 80 and over , Sex Distribution , Conducted Energy Weapon Injuries , Age Distribution , Cause of Death , Infant, Newborn , Body Weight
3.
World J Surg ; 47(10): 2392-2400, 2023 10.
Article in English | MEDLINE | ID: mdl-37405445

ABSTRACT

BACKGROUND: The goal of this study was to investigate factors associated with 30-day readmission in a multivariate model, including the CDC wound classes "clean," "clean/contaminated," "contaminated," and "dirty/infected." METHODS: The 2017-2020 American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) database was queried for all patients undergoing total hip replacement, coronary artery bypass grafting, Ivor Lewis esophagectomy, pancreaticoduodenectomy, distal pancreatectomy, pneumonectomy, and colectomies. ACS-defined wound classes were concordant with CDC definitions. Multivariate linear mixed regression was used to determine risk factors for readmission while adjusting for type of surgery as a random intercept. RESULTS: 477,964 cases were identified, with 38,734 (8.1%) patients having experienced readmission within 30 days of surgery. There were 181,243 (37.9%) cases classified as wound class "clean", 215,729 (45.1%) cases classified as "clean/contaminated", 40,684 cases (8.5%) classified as "contaminated", and 40,308 (8.4%) cases classified as "dirty/infected". In the multivariate generalized mixed linear model adjusting for type of surgery, sex, body mass index, race, American Society of Anesthesiologists class, presence of comorbidity, length of stay, urgency of surgery, and discharge destination, "clean/contaminated" (p < .001), "contaminated" (p < .001), and "dirty/infected" (p < .001) wound classes (when compared to "clean") were significantly associated with 30-day readmission. Organ/space surgical site infection and sepsis were among the most common reasons for readmission in all wound classes. CONCLUSIONS: Wound classification was strongly prognostic for readmission in multivariable models, suggesting that it may serve as a marker of readmissions. Surgical procedures that are "non-clean" are at significantly greater risk for 30-day readmission. Readmissions may be due to infectious complications; optimizing antibiotic use or source control to prevent readmission are areas of future study.


Subject(s)
Esophagectomy , Patient Readmission , Humans , United States/epidemiology , Prognosis , Esophagectomy/adverse effects , Time Factors , Surgical Wound Infection/etiology , Surgical Wound Infection/complications , Risk Factors , Centers for Disease Control and Prevention, U.S. , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Postoperative Complications/surgery , Retrospective Studies
4.
Crit Care Med ; 51(4): 445-459, 2023 04 01.
Article in English | MEDLINE | ID: mdl-36790189

ABSTRACT

OBJECTIVES: The COVID-19 pandemic threatened standard hospital operations. We sought to understand how this stress was perceived and manifested within individual hospitals and in relation to local viral activity. DESIGN: Prospective weekly hospital stress survey, November 2020-June 2022. SETTING: Society of Critical Care Medicine's Discovery Severe Acute Respiratory Infection-Preparedness multicenter cohort study. SUBJECTS: Thirteen hospitals across seven U.S. health systems. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We analyzed 839 hospital-weeks of data over 85 pandemic weeks and five viral surges. Perceived overall hospital, ICU, and emergency department (ED) stress due to severe acute respiratory infection patients during the pandemic were reported by a mean of 43% ( sd , 36%), 32% (30%), and 14% (22%) of hospitals per week, respectively, and perceived care deviations in a mean of 36% (33%). Overall hospital stress was highly correlated with ICU stress (ρ = 0.82; p < 0.0001) but only moderately correlated with ED stress (ρ = 0.52; p < 0.0001). A county increase in 10 severe acute respiratory syndrome coronavirus 2 cases per 100,000 residents was associated with an increase in the odds of overall hospital, ICU, and ED stress by 9% (95% CI, 5-12%), 7% (3-10%), and 4% (2-6%), respectively. During the Delta variant surge, overall hospital stress persisted for a median of 11.5 weeks (interquartile range, 9-14 wk) after local case peak. ICU stress had a similar pattern of resolution (median 11 wk [6-14 wk] after local case peak; p = 0.59) while the resolution of ED stress (median 6 wk [5-6 wk] after local case peak; p = 0.003) was earlier. There was a similar but attenuated pattern during the Omicron BA.1 subvariant surge. CONCLUSIONS: During the COVID-19 pandemic, perceived care deviations were common and potentially avoidable patient harm was rare. Perceived hospital stress persisted for weeks after surges peaked.


Subject(s)
COVID-19 , Humans , COVID-19/epidemiology , SARS-CoV-2 , Pandemics , Cohort Studies , Prospective Studies , Hospitals
5.
J Psychiatr Res ; 160: 64-70, 2023 04.
Article in English | MEDLINE | ID: mdl-36774832

ABSTRACT

BACKGROUND: Delirium in the intensive care unit (ICU) is a common but serious condition that has been associated with in-hospital mortality and post-discharge psychological dysfunction. The aim of this before and after study is to determine the effect of a multidisciplinary care model entailing daily ICU rounds with a psychiatrist on the incidence of delirium and clinical outcomes. OBJECTIVE: To assess the impact of a proactive psychiatry consultation model in the surgical ICU on the incidence and duration of delirium. METHODS: This was a prospective, single institution, observational controlled cohort pilot study of adult patients admitted to a surgical ICU. A control group that received standard of care (SOC) with daily delirium prevention care bundles in the pre-intervention period was compared to an intervention group, which had a psychiatrist participate in daily ICU rounds (post-intervention period). The primary outcome was delirium incidence. The secondary outcomes were: delirium duration, ventilator days, hospital and ICU length of stay, and in-hospital mortality. RESULTS: A total of 104 patients were enrolled and equally split between SOC and intervention groups; 95 contributed to analysis. The overall incidence of ICU delirium was 19%. SOC and intervention groups had similar rates of delirium (21% vs 18%, p = 0.72). None of the secondary outcomes statistically significantly differed between the two groups. CONCLUSION: Delirium in ICU patients is a potentially preventable condition with serious sequelae. There was no difference in delirium incidence or duration between patients receiving SOC or patients who had multidisciplinary rounds with a psychiatrist.


Subject(s)
Delirium , Adult , Humans , Delirium/epidemiology , Delirium/prevention & control , Prospective Studies , Pilot Projects , Incidence , Aftercare , Patient Discharge , Intensive Care Units , Length of Stay
6.
Crit Care Explor ; 5(1): e0827, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36600780

ABSTRACT

Vascular dysfunction and capillary leak are common in critically ill COVID-19 patients, but identification of endothelial pathways involved in COVID-19 pathogenesis has been limited. Angiopoietin-like 4 (ANGPTL4) is a protein secreted in response to hypoxic and nutrient-poor conditions that has a variety of biological effects including vascular injury and capillary leak. OBJECTIVES: To assess the role of ANGPTL4 in COVID-19-related outcomes. DESIGN SETTING AND PARTICIPANTS: Two hundred twenty-five COVID-19 ICU patients were enrolled from April 2020 to May 2021 in a prospective, multicenter cohort study from three different medical centers, University of Washington, University of Southern California and New York University. MAIN OUTCOMES AND MEASURES: Plasma ANGPTL4 was measured on days 1, 7, and 14 after ICU admission. We used previously published tissue proteomic data and lung single nucleus RNA (snRNA) sequencing data from specimens collected from COVID-19 patients to determine the tissues and cells that produce ANGPTL4. RESULTS: Higher plasma ANGPTL4 concentrations were significantly associated with worse hospital mortality (adjusted odds ratio per log2 increase, 1.53; 95% CI, 1.17-2.00; p = 0.002). Higher ANGPTL4 concentrations were also associated with higher proportions of venous thromboembolism and acute respiratory distress syndrome. Longitudinal ANGPTL4 concentrations were significantly different during the first 2 weeks of hospitalization in patients who subsequently died compared with survivors (p for interaction = 8.1 × 10-5). Proteomics analysis demonstrated abundance of ANGPTL4 in lung tissue compared with other organs in COVID-19. ANGPTL4 single-nuclear RNA gene expression was significantly increased in pulmonary alveolar type 2 epithelial cells and fibroblasts in COVID-19 lung tissue compared with controls. CONCLUSIONS AND RELEVANCE: ANGPTL4 is expressed in pulmonary epithelial cells and fibroblasts and is associated with clinical prognosis in critically ill COVID-19 patients.

8.
JMIR Hum Factors ; 9(2): e35032, 2022 Jun 09.
Article in English | MEDLINE | ID: mdl-35679114

ABSTRACT

BACKGROUND: The Discovery Critical Care Research Network Program for Resilience and Emergency Preparedness (Discovery PREP) partnered with a third-party technology vendor to design and implement an electronic data capture tool that addressed multisite data collection challenges during public health emergencies (PHE) in the United States. The basis of the work was to design an electronic data capture tool and to prospectively gather data on usability from bedside clinicians during national health system stress queries and influenza observational studies. OBJECTIVE: The aim of this paper is to describe the lessons learned in the design and implementation of a novel electronic data capture tool with the goal of significantly increasing the nation's capability to manage real-time data collection and analysis during PHE. METHODS: A multiyear and multiphase design approach was taken to create an electronic data capture tool, which was used to pilot rapid data capture during a simulated PHE. Following the pilot, the study team retrospectively assessed the feasibility of automating the data captured by the electronic data capture tool directly from the electronic health record. In addition to user feedback during semistructured interviews, the System Usability Scale (SUS) questionnaire was used as a basis to evaluate the usability and performance of the electronic data capture tool. RESULTS: Participants included Discovery PREP physicians, their local administrators, and data collectors from tertiary-level academic medical centers at 5 different institutions. User feedback indicated that the designed system had an intuitive user interface and could be used to automate study communication tasks making for more efficient management of multisite studies. SUS questionnaire results classified the system as highly usable (SUS score 82.5/100). Automation of 17 (61%) of the 28 variables in the influenza observational study was deemed feasible during the exploration of automated versus manual data abstraction. The creation and use of the Project Meridian electronic data capture tool identified 6 key design requirements for multisite data collection, including the need for the following: (1) scalability irrespective of the type of participant; (2) a common data set across sites; (3) automated back end administrative capability (eg, reminders and a self-service status board); (4) multimedia communication pathways (eg, email and SMS text messaging); (5) interoperability and integration with local site information technology infrastructure; and (6) natural language processing to extract nondiscrete data elements. CONCLUSIONS: The use of the electronic data capture tool in multiple multisite Discovery PREP clinical studies proved the feasibility of using the novel, cloud-based platform in practice. The lessons learned from this effort can be used to inform the improvement of ongoing global multisite data collection efforts during the COVID-19 pandemic and transform current manual data abstraction approaches into reliable, real time, and automated information exchange. Future research is needed to expand the ability to perform automated multisite data extraction during a PHE and beyond.

9.
Crit Care Clin ; 38(3): 623-637, 2022 Jul.
Article in English | MEDLINE | ID: mdl-35667747

ABSTRACT

Hospitals and health care systems with active critical care organizations (CCOs) that unified ICU units before the onset of the COVID-19 Pandemic were better positioned to adapt to the demands of the pandemic, due to their established standardization of care and integration of critical care within the larger structure of the hospital or health care system. CCOs should continue to make changes, based on the real experience of COVID-19 that would lead to improved care during the ongoing pandemic, and beyond.


Subject(s)
COVID-19 , Critical Care , Humans , Intensive Care Units , Pandemics , SARS-CoV-2 , Surge Capacity
10.
Crit Care Explor ; 4(4): e0679, 2022 Apr.
Article in English | MEDLINE | ID: mdl-35474653

ABSTRACT

OBJECTIVES: Describe the effects of data literacy training and continuous performance reports on ICU staff compliance with the 6-element ICU quality bundle approach known as the ABCDEF (A-F) bundle and patient outcomes. DESIGN: Stepped-wedge cluster randomized trial conducted during an institutional A-F bundle implementation program. SETTING: Single-center study conducted in eight adult ICUs. PATIENTS: Adult patients admitted for at least 24 hours, not undergoing active withdrawal of life support or palliative care. INTERVENTIONS: Four ICUs in the intervention group received bundle-related staff education, data literacy training, and weekly bundle performance reports during the 12-month study period. The four ICUs in the nonintervention group received none of these interventions. Bundle compliance and patient outcomes were tracked, including ICU and hospital mortality, transfer and discharge, discharge disposition, mechanical ventilation, and ICU delirium. MEASUREMENT AND RESULTS: In the intervention group, staff education alone increased bundle compliance from 9% to 16% (p < 0.0001); data literacy training further increased compliance from 16% to 21% (p = 0.03). This improvement was sustained throughout the study period including the onset of the COVID-19 pandemic and was greater than improvement in the nonintervention group (p < 0.001). Full A-F bundle compliance was associated with a lower likelihood of next-day ICU and hospital mortality, discharge to a facility other than home, and was associated with a higher likelihood of next-day extubation in patients. Next-day ICU and hospital discharge likelihood decreased, and delirium frequency was not affected. CONCLUSIONS: This is the first study demonstrating that the combination of staff education, data literacy training, and access to performance data improves A-F bundle compliance, sustains performance, and improves ICU patient outcomes (ICU and hospital mortality, mechanical ventilation duration, and home discharge rates). In contrast to previous studies, increased bundle compliance did not hasten ICU or hospital discharges or reduce delirium frequency in patients.

11.
PLoS Med ; 19(4): e1003969, 2022 04.
Article in English | MEDLINE | ID: mdl-35442972

ABSTRACT

BACKGROUND: Acute kidney injury (AKI) is one of the most common and significant problems in patients with Coronavirus Disease 2019 (COVID-19). However, little is known about the incidence and impact of AKI occurring in the community or early in the hospital admission. The traditional Kidney Disease Improving Global Outcomes (KDIGO) definition can fail to identify patients for whom hospitalisation coincides with recovery of AKI as manifested by a decrease in serum creatinine (sCr). We hypothesised that an extended KDIGO (eKDIGO) definition, adapted from the International Society of Nephrology (ISN) 0by25 studies, would identify more cases of AKI in patients with COVID-19 and that these may correspond to community-acquired AKI (CA-AKI) with similarly poor outcomes as previously reported in this population. METHODS AND FINDINGS: All individuals recruited using the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC)-World Health Organization (WHO) Clinical Characterisation Protocol (CCP) and admitted to 1,609 hospitals in 54 countries with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection from February 15, 2020 to February 1, 2021 were included in the study. Data were collected and analysed for the duration of a patient's admission. Incidence, staging, and timing of AKI were evaluated using a traditional and eKDIGO definition, which incorporated a commensurate decrease in sCr. Patients within eKDIGO diagnosed with AKI by a decrease in sCr were labelled as deKDIGO. Clinical characteristics and outcomes-intensive care unit (ICU) admission, invasive mechanical ventilation, and in-hospital death-were compared for all 3 groups of patients. The relationship between eKDIGO AKI and in-hospital death was assessed using survival curves and logistic regression, adjusting for disease severity and AKI susceptibility. A total of 75,670 patients were included in the final analysis cohort. Median length of admission was 12 days (interquartile range [IQR] 7, 20). There were twice as many patients with AKI identified by eKDIGO than KDIGO (31.7% versus 16.8%). Those in the eKDIGO group had a greater proportion of stage 1 AKI (58% versus 36% in KDIGO patients). Peak AKI occurred early in the admission more frequently among eKDIGO than KDIGO patients. Compared to those without AKI, patients in the eKDIGO group had worse renal function on admission, more in-hospital complications, higher rates of ICU admission (54% versus 23%) invasive ventilation (45% versus 15%), and increased mortality (38% versus 19%). Patients in the eKDIGO group had a higher risk of in-hospital death than those without AKI (adjusted odds ratio: 1.78, 95% confidence interval: 1.71 to 1.80, p-value < 0.001). Mortality and rate of ICU admission were lower among deKDIGO than KDIGO patients (25% versus 50% death and 35% versus 70% ICU admission) but significantly higher when compared to patients with no AKI (25% versus 19% death and 35% versus 23% ICU admission) (all p-values <5 × 10-5). Limitations include ad hoc sCr sampling, exclusion of patients with less than two sCr measurements, and limited availability of sCr measurements prior to initiation of acute dialysis. CONCLUSIONS: An extended KDIGO definition of AKI resulted in a significantly higher detection rate in this population. These additional cases of AKI occurred early in the hospital admission and were associated with worse outcomes compared to patients without AKI.


Subject(s)
Acute Kidney Injury , COVID-19 , Acute Kidney Injury/diagnosis , Acute Kidney Injury/epidemiology , Acute Kidney Injury/etiology , COVID-19/complications , COVID-19/diagnosis , Female , Hospital Mortality , Humans , Intensive Care Units , Kidney/physiology , Male , Retrospective Studies , Risk Factors , SARS-CoV-2 , World Health Organization
12.
Crit Care Explor ; 4(1): e0606, 2022 Jan.
Article in English | MEDLINE | ID: mdl-35018345

ABSTRACT

OBJECTIVES: Demonstrate the feasibility of weekly data collection and analysis of public health emergency (PHE) data. Assess fluctuations in, and challenges of, resource matching and potential effect on patient care for influenza in ICUs. DESIGN: Multicenter prospective noninterventional study testing effectiveness of leveraging the Discovery Critical Care Research Network Program for Resilience and Emergency Preparedness (Discovery-PREP) in performing PHE research. A 20-question internet survey was developed to prospectively assess ICU influenza-related resource stress. An informatics tool was designed to track responses; data were analyzed within 24 hours of weekly survey completion by the team biostatistician for timely reporting. PARTICIPANTS: Critical care and Emergency Medicine Discovery-PREP network investigators self-selected to participate in the voluntary query. SETTING: ICUs of 13 hospitals throughout the United States, 12 academic, and one community. INTERVENTIONS: ICU physicians were electronically surveyed weekly over 17 weeks during the influenza season (January 2018-April 2018). Responses were collected for 48 hours after each email query. MEASUREMENTS AND MAIN RESULTS: The average weekly response among the sites was 79% (range, 65-100%). Significant stress, defined as alterations in ICU staffing and/or resource allocation, occurred in up to 41% of sites during the national peak of influenza activity. These alterations included changes in staffing, not accepting external patient transfers, and canceling elective surgery. During this same period, up to 17% of the sites indicated that these changes might not have been sufficient to prevent potentially avoidable patient harm. CONCLUSIONS: This novel approach to querying ICU operational stress indicated that almost half of participating sites experienced critical care resource limitations during peak influenza season and required process and/or staffing changes to better balance resources with patient care demands. This weekly national reporting infrastructure could be adapted and expanded to better inform providers, hospital emergency management teams, and government leaders during PHEs.

13.
Strateg Manag J ; 43(4): 697-723, 2022 Apr.
Article in English | MEDLINE | ID: mdl-34908629

ABSTRACT

Research Summary: The COVID-19 pandemic will rank among the greatest challenges many executives will have faced and not only due to the operational challenges it posed. Upon entering the U.S. context, the disease was immediately politically polarized, with clear partisan splits forming in risk perceptions of the disease unrelated to science. We exploit this context to examine whether firms' partisan positioning affects whether and how they communicate risk to their investors on a polarized public policy issue. To do so, we examine the covariation between firms' disclosure of COVID-19 risks and the partisanship of their political giving. Our analysis of earnings call and campaign contribution data for the S&P 500 reveals a positive association between a firm's contributions to Democrats and its disclosure of COVID-19 risks. Managerial Summary: From its onset in the United States, attitudes toward and discourse around the COVID-19 pandemic was heavily politicized and perceptions of the disease's risks were seen as more serious by Democratic-identifying individuals than Republican identifiers. In this study, we examine whether this pattern also holds for U.S. publicly traded firms, who can also stake out a political position through their corporate political action committee campaign contributions. In analyses of earnings call transcripts from the first quarter of 2020, we show that the more Republican-leaning (Democrat-leaning) a firm's campaign contributions are, the less (more) likely it was to voluntarily disclose risks related to COVID-19. We argue that these findings hold implications for parties interested in interpreting firm's risk disclosures on politically polarized issues.

14.
Biomed Instrum Technol ; 55(3): 103-111, 2021 Jul 01.
Article in English | MEDLINE | ID: mdl-34460906

ABSTRACT

OBJECTIVE: We sought to explore the technical and legal readiness of healthcare institutions for novel data-sharing methods that allow clinical information to be extracted from electronic health records (EHRs) and submitted securely to the Food and Drug Administration's (FDA's) blockchain through a secure data broker (SDB). MATERIALS AND METHODS: This assessment was divided into four sections: an institutional EHR readiness assessment, legal consultation, institutional review board application submission, and a test of healthcare data transmission over a blockchain infrastructure. RESULTS: All participating institutions reported the ability to electronically extract data from EHRs for research. Formal legal agreements were deemed unnecessary to the project but would be needed in future tests of real patient data exchange. Data transmission to the FDA blockchain met the success criteria of data connection from within the four institutions' firewalls, externally to the FDA blockchain via a SDB. DISCUSSION: The readiness survey indicated advanced analytic capability in hospital institutions and highlighted inconsistency in Fast Healthcare Interoperability Resources format utilitzation across institutions, despite requirements of the 21st Century Cures Act. Further testing across more institutions and annual exercises leveraging the application of data exchange over a blockchain infrastructure are recommended actions for determining the feasibility of this approach during a public health emergency and broaden the understanding of technical requirements for multisite data extraction. CONCLUSION: The FDA's RAPID (Real-Time Application for Portable Interactive Devices) program, in collaboration with Discovery, the Critical Care Research Network's PREP (Program for Resilience and Emergency Preparedness), identified the technical and legal challenges and requirements for rapid data exchange to a government entity using the FDA blockchain infrastructure.


Subject(s)
Blockchain , Electronic Health Records , Emergencies , Humans , Public Health , Technology Assessment, Biomedical , United States
16.
Osteoarthritis Cartilage ; 29(4): 445-455, 2021 04.
Article in English | MEDLINE | ID: mdl-33253887

ABSTRACT

OBJECTIVES: For a population with knee osteoarthritis (OA), determine: 1) the prevalence of single compartmental, bicompartmental and tricompartmental OA, 2) the prevalence of isolated medial tibiofemoral, lateral tibiofemoral, or patellofemoral OA, and combinations thereof. METHODS: PubMed and Web of Science databases, and reference lists of identified studies, were searched to find studies which reported on the compartmental distribution and prevalence of knee OA. Two independent reviewers assessed studies against pre-defined inclusion criteria and prevalence data were extracted along with subject characteristics. The methodological quality of each included study was assessed. A random-effects model meta-analysis was performed for each OA category to estimate the relative prevalence of OA in the knee compartments amongst people with knee OA. RESULTS: 16 studies (3,786 knees) met the inclusion criteria. High heterogeneity was measured. Normalised for knees with OA, estimated prevalence rates (95% CI) were: single compartmental 50% (31.5-58.3%), bicompartmental 33% (23.1-37.2%) and tricompartmental only 17% (8.8-24.8%). Isolated medial tibiofemoral OA, isolated patellofemoral OA, and combined medial tibiofemoral and patellofemoral OA were more common than tricompartmental disease, occurring in 27% (15.2-31.1%), 18% (9.9-22.7%) and 23% (14.1-27.3%) of people respectively. Single/bicompartmental patterns of disease involving the lateral tibiofemoral compartment were less common, summing to 15% (8.5-18.7%). CONCLUSION: Three-quarters of people with knee OA do not have tricompartmental disease. This is not reflected in the frequency with which partial and combined partial knee arthroplasties are currently used. TRIAL REGISTRATION NUMBER: PROSPERO systematic review protocol (CRD42019140345).


Subject(s)
Osteoarthritis, Knee/epidemiology , Patellofemoral Joint/diagnostic imaging , Humans , Knee Joint/diagnostic imaging , Knee Joint/pathology , Osteoarthritis, Knee/diagnostic imaging , Osteoarthritis, Knee/pathology , Patellofemoral Joint/pathology , Prevalence
17.
Anal Chim Acta ; 1141: 221-229, 2021 Jan 02.
Article in English | MEDLINE | ID: mdl-33248656

ABSTRACT

Accurate measurement of naturally occurring radionuclides in blast furnace slag, a by-product of the steel industry, is required for compliance with building regulations where it is often used as an ingredient in cement. A matrix reference blast furnace slag material has been developed to support traceability in these measurements. Raw material provided by a commercial producer underwent stability and homogeneity testing, as well as characterisation of matrix constituents, to provide a final candidate reference material. The radionuclide content was then determined during a comparison exercise that included 23 laboratories from 14 countries. Participants determined the activity per unit mass for 226Ra, 232Th and 40K using a range of techniques. The consensus values obtained from the power-moderated mean of the reported participant results were used as indicative activity per unit mass values for the three radionuclides: A0(226Ra) = 106.3 (34) Bq·kg-1, A0(232Th) = 130.0 (48) Bq·kg-1 and A0(40K) = 161 (11) Bq·kg-1 (where the number in parentheses is the numerical value of the combined standard uncertainty referred to the corresponding last digits of the quoted result). This exercise helps to address the current shortage of NORM industry reference materials, putting in place infrastructure for production of further reference materials.

18.
Am Surg ; 86(10): 1260-1263, 2020 Oct.
Article in English | MEDLINE | ID: mdl-33106000

ABSTRACT

Clinically, complication rates of brachial arterial catheterization appear to far exceed those of the radial or common femoral arteries. The study objective was to define the complication rate after brachial arterial line insertion. All patients undergoing arterial line placement to the brachial artery in the surgical intensive care units (SICUs) at our institution were retrospectively identified and included in the study (January 2016-December 2018). Demographics, complications (distal ischemia, thrombosis/dissection, brachial sheath hematoma, catheter-related sepsis, and inadvertent dislodgement), and outcomes were collected and analyzed. Over the study period, 53 patients underwent brachial arterial catheterization. Common admitting services were cardiothoracic surgery (n = 31, 58%), transplant surgery (n = 7, 13%), and neurosurgery (n = 4, 7%). The mean age was 55 ± 17 58 (24-84) years, and 58% (n = 31) were male. The hospital length of stay (LOS) was 37 ± 35 23 (1-132) days, and ICU LOS was 30 ± 27 20 (1-127) days. Mortality was 57% (n = 30). Complications of brachial arterial line placement occurred in 21 patients (40%). In summary, brachial arterial catheters were associated with high mortality and prolonged ICU length of stay. This likely reflects the critically ill nature of patients in whom conventional-site arterial line placement is not possible. Complications following brachial arterial catheterization were unacceptably high. On this basis, we recommend that the brachial artery be avoided whenever possible for arterial line placement in the SICU.


Subject(s)
Brachial Artery/surgery , Catheterization, Peripheral , Catheters, Indwelling , Intensive Care Units , Postoperative Complications/epidemiology , Adult , Aged , Aged, 80 and over , Female , Humans , Length of Stay/statistics & numerical data , Male , Middle Aged , Retrospective Studies
20.
Pulm Circ ; 10(2): 2045894020924325, 2020.
Article in English | MEDLINE | ID: mdl-32523685

ABSTRACT

Individuals with pulmonary arterial hypertension experience debilitating symptoms and psychological distress which may influence their cortisol regulation. We describe associations between diurnal salivary cortisol/cortisone levels and quality of life in adults with pulmonary arterial hypertension. Findings suggest potential clinical utility of cortisol/cortisone assessment as applied to a pulmonary arterial hypertension population.

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