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  1. Article: Simultaneous Quantitative SARS-CoV-2 Antigen and Host Antibody Detection and Pre-Screening Strategy at the Point of Care.

    Srinivasan Rajsri, Kritika / McRae, Michael P / Christodoulides, Nicolaos J / Dapkins, Isaac / Simmons, Glennon W / Matz, Hanover / Dooley, Helen / Fenyö, David / McDevitt, John T

    Bioengineering (Basel, Switzerland)

    2023  Volume 10, Issue 6

    Abstract: As COVID-19 pandemic public health measures are easing globally, the emergence of new SARS-CoV-2 strains continue to present high risk for vulnerable populations. The antibody-mediated protection acquired from vaccination and/or infection is seen to wane ...

    Abstract As COVID-19 pandemic public health measures are easing globally, the emergence of new SARS-CoV-2 strains continue to present high risk for vulnerable populations. The antibody-mediated protection acquired from vaccination and/or infection is seen to wane over time and the immunocompromised populations can no longer expect benefit from monoclonal antibody prophylaxis. Hence, there is a need to monitor new variants and its effect on vaccine performance. In this context, surveillance of new SARS-CoV-2 infections and serology testing are gaining consensus for use as screening methods, especially for at-risk groups. Here, we described an improved COVID-19 screening strategy, comprising predictive algorithms and concurrent, rapid, accurate, and quantitative SARS-CoV-2 antigen and host antibody testing strategy, at point of care (POC). We conducted a retrospective analysis of 2553 pre- and asymptomatic patients who were tested for SARS-CoV-2 by RT-PCR. The pre-screening model had an AUC (CI) of 0.76 (0.73-0.78). Despite being the default method for screening, body temperature had lower AUC (0.52 [0.49-0.55]) compared to case incidence rate (0.65 [0.62-0.68]). POC assays for SARS-CoV-2 nucleocapsid protein (NP) and spike (S) receptor binding domain (RBD) IgG antibody showed promising preliminary results, demonstrating a convenient, rapid (<20 min), quantitative, and sensitive (ng/mL) antigen/antibody assay. This integrated pre-screening model and simultaneous antigen/antibody approach may significantly improve accuracy of COVID-19 infection and host immunity screening, helping address unmet needs for monitoring vaccine effectiveness and severe disease surveillance.
    Language English
    Publishing date 2023-06-01
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2746191-9
    ISSN 2306-5354
    ISSN 2306-5354
    DOI 10.3390/bioengineering10060670
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: A Rapid and Sensitive Microfluidics-Based Tool for Seroprevalence Immunity Assessment of COVID-19 and Vaccination-Induced Humoral Antibody Response at the Point of Care.

    Rajsri, Kritika Srinivasan / McRae, Michael P / Simmons, Glennon W / Christodoulides, Nicolaos J / Matz, Hanover / Dooley, Helen / Koide, Akiko / Koide, Shohei / McDevitt, John T

    Biosensors

    2022  Volume 12, Issue 8

    Abstract: As of 8 August 2022, SARS-CoV-2, the causative agent of COVID-19, has infected over 585 million people and resulted in more than 6.42 million deaths worldwide. While approved SARS-CoV-2 spike (S) protein-based vaccines induce robust seroconversion in ... ...

    Abstract As of 8 August 2022, SARS-CoV-2, the causative agent of COVID-19, has infected over 585 million people and resulted in more than 6.42 million deaths worldwide. While approved SARS-CoV-2 spike (S) protein-based vaccines induce robust seroconversion in most individuals, dramatically reducing disease severity and the risk of hospitalization, poorer responses are observed in aged, immunocompromised individuals and patients with certain pre-existing health conditions. Further, it is difficult to predict the protection conferred through vaccination or previous infection against new viral variants of concern (VoC) as they emerge. In this context, a rapid quantitative point-of-care (POC) serological assay able to quantify circulating anti-SARS-CoV-2 antibodies would allow clinicians to make informed decisions on the timing of booster shots, permit researchers to measure the level of cross-reactive antibody against new VoC in a previously immunized and/or infected individual, and help assess appropriate convalescent plasma donors, among other applications. Utilizing a lab-on-a-chip ecosystem, we present proof of concept, optimization, and validation of a POC strategy to quantitate COVID-19 humoral protection. This platform covers the entire diagnostic timeline of the disease, seroconversion, and vaccination response spanning multiple doses of immunization in a single POC test. Our results demonstrate that this platform is rapid (~15 min) and quantitative for SARS-CoV-2-specific IgG detection.
    MeSH term(s) Aged ; Antibodies, Viral ; Antibody Formation ; COVID-19/diagnosis ; COVID-19/therapy ; Ecosystem ; Humans ; Immunization, Passive ; Immunoglobulin G ; Microfluidics ; Point-of-Care Systems ; SARS-CoV-2 ; Seroepidemiologic Studies ; Vaccination ; COVID-19 Serotherapy
    Chemical Substances Antibodies, Viral ; Immunoglobulin G
    Language English
    Publishing date 2022-08-10
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2662125-3
    ISSN 2079-6374 ; 2079-6374
    ISSN (online) 2079-6374
    ISSN 2079-6374
    DOI 10.3390/bios12080621
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Innovative Programmable Bio-Nano-Chip Digitizes Biology Using Sensors That Learn Bridging Biomarker Discovery and Clinical Implementation.

    Christodoulides, Nicolaos J / McRae, Michael P / Abram, Timothy J / Simmons, Glennon W / McDevitt, John T

    Frontiers in public health

    2017  Volume 5, Page(s) 110

    Abstract: The lack of standard tools and methodologies and the absence of a streamlined multimarker approval process have hindered the translation rate of new biomarkers into clinical practice for a variety of diseases afflicting humankind. Advanced novel ... ...

    Abstract The lack of standard tools and methodologies and the absence of a streamlined multimarker approval process have hindered the translation rate of new biomarkers into clinical practice for a variety of diseases afflicting humankind. Advanced novel technologies with superior analytical performance and reduced reagent costs, like the programmable bio-nano-chip system featured in this article, have potential to change the delivery of healthcare. This universal platform system has the capacity to digitize biology, resulting in a sensor modality with a capacity to learn. With well-planned device design, development, and distribution plans, there is an opportunity to translate benchtop discoveries in the genomics, proteomics, metabolomics, and glycomics fields by transforming the information content of key biomarkers into actionable signatures that can empower physicians and patients for a better management of healthcare. While the process is complicated and will take some time, showcased here are three application areas for this flexible platform that combines biomarker content with minimally invasive or non-invasive sampling, such as brush biopsy for oral cancer risk assessment; serum, plasma, and small volumes of blood for the assessment of cardiac risk and wellness; and oral fluid sampling for drugs of abuse testing at the point of need.
    Language English
    Publishing date 2017-05-22
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2711781-9
    ISSN 2296-2565
    ISSN 2296-2565
    DOI 10.3389/fpubh.2017.00110
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Clinical decision support tool and rapid point-of-care platform for determining disease severity in patients with COVID-19.

    McRae, Michael P / Simmons, Glennon W / Christodoulides, Nicolaos J / Lu, Zhibing / Kang, Stella K / Fenyo, David / Alcorn, Timothy / Dapkins, Isaac P / Sharif, Iman / Vurmaz, Deniz / Modak, Sayli S / Srinivasan, Kritika / Warhadpande, Shruti / Shrivastav, Ravi / McDevitt, John T

    Lab on a chip

    2020  Volume 20, Issue 12, Page(s) 2075–2085

    Abstract: SARS-CoV-2 is the virus that causes coronavirus disease (COVID-19) which has reached pandemic levels resulting in significant morbidity and mortality affecting every inhabited continent. The large number of patients requiring intensive care threatens to ... ...

    Abstract SARS-CoV-2 is the virus that causes coronavirus disease (COVID-19) which has reached pandemic levels resulting in significant morbidity and mortality affecting every inhabited continent. The large number of patients requiring intensive care threatens to overwhelm healthcare systems globally. Likewise, there is a compelling need for a COVID-19 disease severity test to prioritize care and resources for patients at elevated risk of mortality. Here, an integrated point-of-care COVID-19 Severity Score and clinical decision support system is presented using biomarker measurements of C-reactive protein (CRP), N-terminus pro B type natriuretic peptide (NT-proBNP), myoglobin (MYO), D-dimer, procalcitonin (PCT), creatine kinase-myocardial band (CK-MB), and cardiac troponin I (cTnI). The COVID-19 Severity Score combines multiplex biomarker measurements and risk factors in a statistical learning algorithm to predict mortality. The COVID-19 Severity Score was trained and evaluated using data from 160 hospitalized COVID-19 patients from Wuhan, China. Our analysis finds that COVID-19 Severity Scores were significantly higher for the group that died versus the group that was discharged with median (interquartile range) scores of 59 (40-83) and 9 (6-17), respectively, and area under the curve of 0.94 (95% CI 0.89-0.99). Although this analysis represents patients with cardiac comorbidities (hypertension), the inclusion of biomarkers from other pathophysiologies implicated in COVID-19 (e.g., D-dimer for thrombotic events, CRP for infection or inflammation, and PCT for bacterial co-infection and sepsis) may improve future predictions for a more general population. These promising initial models pave the way for a point-of-care COVID-19 Severity Score system to impact patient care after further validation with externally collected clinical data. Clinical decision support tools for COVID-19 have strong potential to empower healthcare providers to save lives by prioritizing critical care in patients at high risk for adverse outcomes.
    MeSH term(s) Algorithms ; Biomarkers ; COVID-19 ; Comorbidity ; Coronavirus Infections/diagnosis ; Coronavirus Infections/physiopathology ; Critical Care ; Decision Support Systems, Clinical/organization & administration ; Humans ; Image Processing, Computer-Assisted ; Immunoassay/methods ; Machine Learning ; Pandemics ; Pneumonia, Viral/diagnosis ; Pneumonia, Viral/physiopathology ; Point-of-Care Systems ; Predictive Value of Tests ; Risk Factors ; Severity of Illness Index ; Software ; Treatment Outcome
    Chemical Substances Biomarkers
    Keywords covid19
    Language English
    Publishing date 2020-06-03
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2056646-3
    ISSN 1473-0189 ; 1473-0197
    ISSN (online) 1473-0189
    ISSN 1473-0197
    DOI 10.1039/d0lc00373e
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Managing COVID-19 With a Clinical Decision Support Tool in a Community Health Network: Algorithm Development and Validation.

    McRae, Michael P / Dapkins, Isaac P / Sharif, Iman / Anderman, Judd / Fenyo, David / Sinokrot, Odai / Kang, Stella K / Christodoulides, Nicolaos J / Vurmaz, Deniz / Simmons, Glennon W / Alcorn, Timothy M / Daoura, Marco J / Gisburne, Stu / Zar, David / McDevitt, John T

    Journal of medical Internet research

    2020  Volume 22, Issue 8, Page(s) e22033

    Abstract: Background: The coronavirus disease (COVID-19) pandemic has resulted in significant morbidity and mortality; large numbers of patients require intensive care, which is placing strain on health care systems worldwide. There is an urgent need for a COVID- ... ...

    Abstract Background: The coronavirus disease (COVID-19) pandemic has resulted in significant morbidity and mortality; large numbers of patients require intensive care, which is placing strain on health care systems worldwide. There is an urgent need for a COVID-19 disease severity assessment that can assist in patient triage and resource allocation for patients at risk for severe disease.
    Objective: The goal of this study was to develop, validate, and scale a clinical decision support system and mobile app to assist in COVID-19 severity assessment, management, and care.
    Methods: Model training data from 701 patients with COVID-19 were collected across practices within the Family Health Centers network at New York University Langone Health. A two-tiered model was developed. Tier 1 uses easily available, nonlaboratory data to help determine whether biomarker-based testing and/or hospitalization is necessary. Tier 2 predicts the probability of mortality using biomarker measurements (C-reactive protein, procalcitonin, D-dimer) and age. Both the Tier 1 and Tier 2 models were validated using two external datasets from hospitals in Wuhan, China, comprising 160 and 375 patients, respectively.
    Results: All biomarkers were measured at significantly higher levels in patients who died vs those who were not hospitalized or discharged (P<.001). The Tier 1 and Tier 2 internal validations had areas under the curve (AUCs) of 0.79 (95% CI 0.74-0.84) and 0.95 (95% CI 0.92-0.98), respectively. The Tier 1 and Tier 2 external validations had AUCs of 0.79 (95% CI 0.74-0.84) and 0.97 (95% CI 0.95-0.99), respectively.
    Conclusions: Our results demonstrate the validity of the clinical decision support system and mobile app, which are now ready to assist health care providers in making evidence-based decisions when managing COVID-19 patient care. The deployment of these new capabilities has potential for immediate impact in community clinics and sites, where application of these tools could lead to improvements in patient outcomes and cost containment.
    MeSH term(s) Betacoronavirus/pathogenicity ; COVID-19 ; Community Networks/standards ; Coronavirus/pathogenicity ; Coronavirus Infections/epidemiology ; Decision Support Systems, Clinical/standards ; Female ; Humans ; Male ; Pandemics ; Pneumonia, Viral/epidemiology ; SARS-CoV-2
    Keywords covid19
    Language English
    Publishing date 2020-08-24
    Publishing country Canada
    Document type Journal Article
    ZDB-ID 2028830-X
    ISSN 1438-8871 ; 1438-8871
    ISSN (online) 1438-8871
    ISSN 1438-8871
    DOI 10.2196/22033
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: Clinical Decision Support Tool and Rapid Point-of-Care Platform for Determining Disease Severity in Patients with COVID-19.

    McRae, Michael P / Simmons, Glennon W / Christodoulides, Nicolaos J / Lu, Zhibing / Kang, Stella K / Fenyo, David / Alcorn, Timothy / Dapkins, Isaac P / Sharif, Iman / Vurmaz, Deniz / Modak, Sayli S / Srinivasan, Kritika / Warhadpande, Shruti / Shrivastav, Ravi / McDevitt, John T

    medRxiv : the preprint server for health sciences

    2020  

    Abstract: SARS-CoV-2 is the virus that causes coronavirus disease (COVID-19) which has reached pandemic levels resulting in significant morbidity and mortality affecting every inhabited continent. The large number of patients requiring intensive care threatens to ... ...

    Abstract SARS-CoV-2 is the virus that causes coronavirus disease (COVID-19) which has reached pandemic levels resulting in significant morbidity and mortality affecting every inhabited continent. The large number of patients requiring intensive care threatens to overwhelm healthcare systems globally. Likewise, there is a compelling need for a COVID-19 disease severity test to prioritize care and resources for patients at elevated risk of mortality. Here, an integrated point-of-care COVID-19 Severity Score and clinical decision support system is presented using biomarker measurements of C-reactive protein (CRP), N-terminus pro B type natriuretic peptide (NT-proBNP), myoglobin (MYO), D-dimer, procalcitonin (PCT), creatine kinase-myocardial band (CK-MB), and cardiac troponin I (cTnI). The COVID-19 Severity Score combines multiplex biomarker measurements and risk factors in a statistical learning algorithm to predict mortality. The COVID-19 Severity Score was trained and evaluated using data from 160 hospitalized COVID-19 patients from Wuhan, China. Our analysis finds that COVID-19 Severity Scores were significantly higher for the group that died versus the group that was discharged with median (interquartile range) scores of 59 (40-83) and 9 (6-17), respectively, and area under the curve of 0.94 (95% CI 0.89-0.99). These promising initial models pave the way for a point-of-care COVID-19 Severity Score system to impact patient care after further validation with externally collected clinical data. Clinical decision support tools for COVID-19 have strong potential to empower healthcare providers to save lives by prioritizing critical care in patients at high risk for adverse outcomes.
    Keywords covid19
    Language English
    Publishing date 2020-04-22
    Publishing country United States
    Document type Preprint
    DOI 10.1101/2020.04.16.20068411
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Point-of-care oral cytology tool for the screening and assessment of potentially malignant oral lesions.

    McRae, Michael P / Modak, Sayli S / Simmons, Glennon W / Trochesset, Denise A / Kerr, A Ross / Thornhill, Martin H / Redding, Spencer W / Vigneswaran, Nadarajah / Kang, Stella K / Christodoulides, Nicolaos J / Murdoch, Craig / Dietl, Steven J / Markham, Roger / McDevitt, John T

    Cancer cytopathology

    2020  Volume 128, Issue 3, Page(s) 207–220

    Abstract: Background: The effective detection and monitoring of potentially malignant oral lesions (PMOL) are critical to identifying early-stage cancer and improving outcomes. In the current study, the authors described cytopathology tools, including machine ... ...

    Abstract Background: The effective detection and monitoring of potentially malignant oral lesions (PMOL) are critical to identifying early-stage cancer and improving outcomes. In the current study, the authors described cytopathology tools, including machine learning algorithms, clinical algorithms, and test reports developed to assist pathologists and clinicians with PMOL evaluation.
    Methods: Data were acquired from a multisite clinical validation study of 999 subjects with PMOLs and oral squamous cell carcinoma (OSCC) using a cytology-on-a-chip approach. A machine learning model was trained to recognize and quantify the distributions of 4 cell phenotypes. A least absolute shrinkage and selection operator (lasso) logistic regression model was trained to distinguish PMOLs and cancer across a spectrum of histopathologic diagnoses ranging from benign, to increasing grades of oral epithelial dysplasia (OED), to OSCC using demographics, lesion characteristics, and cell phenotypes. Cytopathology software was developed to assist pathologists in reviewing brush cytology test results, including high-content cell analyses, data visualization tools, and results reporting.
    Results: Cell phenotypes were determined accurately through an automated cytological assay and machine learning approach (99.3% accuracy). Significant differences in cell phenotype distributions across diagnostic categories were found in 3 phenotypes (type 1 ["mature squamous"], type 2 ["small round"], and type 3 ["leukocytes"]). The clinical algorithms resulted in acceptable performance characteristics (area under the curve of 0.81 for benign vs mild dysplasia and 0.95 for benign vs malignancy).
    Conclusions: These new cytopathology tools represent a practical solution for rapid PMOL assessment, with the potential to facilitate screening and longitudinal monitoring in primary, secondary, and tertiary clinical care settings.
    MeSH term(s) Adult ; Algorithms ; Biomarkers, Tumor/metabolism ; Carcinoma, Squamous Cell/diagnosis ; Carcinoma, Squamous Cell/metabolism ; Cytodiagnosis/instrumentation ; Cytodiagnosis/methods ; Early Detection of Cancer/methods ; Female ; Humans ; Machine Learning ; Male ; Mass Screening/methods ; Middle Aged ; Models, Theoretical ; Mouth Neoplasms/diagnosis ; Mouth Neoplasms/metabolism ; Point-of-Care Systems ; Prospective Studies ; ROC Curve ; Software
    Chemical Substances Biomarkers, Tumor
    Language English
    Publishing date 2020-02-07
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2594979-2
    ISSN 1934-6638 ; 1934-662X
    ISSN (online) 1934-6638
    ISSN 1934-662X
    DOI 10.1002/cncy.22236
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article: Clinical decision support tool and rapid point-of-care platform for determining disease severity in patients with COVID-19

    McRae, Michael P / Simmons, Glennon W / Christodoulides, Nicolaos J / Lu, Zhibing / Kang, Stella K / Fenyo, David / Alcorn, Timothy / Dapkins, Isaac P / Sharif, Iman / Vurmaz, Deniz / Modak, Sayli S / Srinivasan, Kritika / Warhadpande, Shruti / Shrivastav, Ravi / McDevitt, John T

    Lab Chip

    Abstract: SARS-CoV-2 is the virus that causes coronavirus disease (COVID-19) which has reached pandemic levels resulting in significant morbidity and mortality affecting every inhabited continent. The large number of patients requiring intensive care threatens to ... ...

    Abstract SARS-CoV-2 is the virus that causes coronavirus disease (COVID-19) which has reached pandemic levels resulting in significant morbidity and mortality affecting every inhabited continent. The large number of patients requiring intensive care threatens to overwhelm healthcare systems globally. Likewise, there is a compelling need for a COVID-19 disease severity test to prioritize care and resources for patients at elevated risk of mortality. Here, an integrated point-of-care COVID-19 Severity Score and clinical decision support system is presented using biomarker measurements of C-reactive protein (CRP), N-terminus pro B type natriuretic peptide (NT-proBNP), myoglobin (MYO), D-dimer, procalcitonin (PCT), creatine kinase-myocardial band (CK-MB), and cardiac troponin I (cTnI). The COVID-19 Severity Score combines multiplex biomarker measurements and risk factors in a statistical learning algorithm to predict mortality. The COVID-19 Severity Score was trained and evaluated using data from 160 hospitalized COVID-19 patients from Wuhan, China. Our analysis finds that COVID-19 Severity Scores were significantly higher for the group that died versus the group that was discharged with median (interquartile range) scores of 59 (40-83) and 9 (6-17), respectively, and area under the curve of 0.94 (95% CI 0.89-0.99). Although this analysis represents patients with cardiac comorbidities (hypertension), the inclusion of biomarkers from other pathophysiologies implicated in COVID-19 (e.g., D-dimer for thrombotic events, CRP for infection or inflammation, and PCT for bacterial co-infection and sepsis) may improve future predictions for a more general population. These promising initial models pave the way for a point-of-care COVID-19 Severity Score system to impact patient care after further validation with externally collected clinical data. Clinical decision support tools for COVID-19 have strong potential to empower healthcare providers to save lives by prioritizing critical care in patients at high risk for adverse outcomes.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #506003
    Database COVID19

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  9. Article: Managing COVID-19 With a Clinical Decision Support Tool in a Community Health Network: Algorithm Development and Validation

    McRae, Michael P / Dapkins, Isaac P / Sharif, Iman / Anderman, Judd / Fenyo, David / Sinokrot, Odai / Kang, Stella K / Christodoulides, Nicolaos J / Vurmaz, Deniz / Simmons, Glennon W / Alcorn, Timothy M / Daoura, Marco J / Gisburne, Stu / Zar, David / McDevitt, John T

    J Med Internet Res

    Abstract: BACKGROUND: The coronavirus disease (COVID-19) pandemic has resulted in significant morbidity and mortality; large numbers of patients require intensive care, which is placing strain on health care systems worldwide. There is an urgent need for a COVID- ... ...

    Abstract BACKGROUND: The coronavirus disease (COVID-19) pandemic has resulted in significant morbidity and mortality; large numbers of patients require intensive care, which is placing strain on health care systems worldwide. There is an urgent need for a COVID-19 disease severity assessment that can assist in patient triage and resource allocation for patients at risk for severe disease. OBJECTIVE: The goal of this study was to develop, validate, and scale a clinical decision support system and mobile app to assist in COVID-19 severity assessment, management, and care. METHODS: Model training data from 701 patients with COVID-19 were collected across practices within the Family Health Centers network at New York University Langone Health. A two-tiered model was developed. Tier 1 uses easily available, nonlaboratory data to help determine whether biomarker-based testing and/or hospitalization is necessary. Tier 2 predicts the probability of mortality using biomarker measurements (C-reactive protein, procalcitonin, D-dimer) and age. Both the Tier 1 and Tier 2 models were validated using two external datasets from hospitals in Wuhan, China, comprising 160 and 375 patients, respectively. RESULTS: All biomarkers were measured at significantly higher levels in patients who died vs those who were not hospitalized or discharged (P<.001). The Tier 1 and Tier 2 internal validations had areas under the curve (AUCs) of 0.79 (95% CI 0.74-0.84) and 0.95 (95% CI 0.92-0.98), respectively. The Tier 1 and Tier 2 external validations had AUCs of 0.79 (95% CI 0.74-0.84) and 0.97 (95% CI 0.95-0.99), respectively. CONCLUSIONS: Our results demonstrate the validity of the clinical decision support system and mobile app, which are now ready to assist health care providers in making evidence-based decisions when managing COVID-19 patient care. The deployment of these new capabilities has potential for immediate impact in community clinics and sites, where application of these tools could lead to improvements in patient outcomes and cost containment.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #694384
    Database COVID19

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  10. Article ; Online: Managing COVID-19 With a Clinical Decision Support Tool in a Community Health Network

    McRae, Michael P / Dapkins, Isaac P / Sharif, Iman / Anderman, Judd / Fenyo, David / Sinokrot, Odai / Kang, Stella K / Christodoulides, Nicolaos J / Vurmaz, Deniz / Simmons, Glennon W / Alcorn, Timothy M / Daoura, Marco J / Gisburne, Stu / Zar, David / McDevitt, John T

    Journal of Medical Internet Research, Vol 22, Iss 8, p e

    Algorithm Development and Validation

    2020  Volume 22033

    Abstract: BackgroundThe coronavirus disease (COVID-19) pandemic has resulted in significant morbidity and mortality; large numbers of patients require intensive care, which is placing strain on health care systems worldwide. There is an urgent need for a COVID-19 ... ...

    Abstract BackgroundThe coronavirus disease (COVID-19) pandemic has resulted in significant morbidity and mortality; large numbers of patients require intensive care, which is placing strain on health care systems worldwide. There is an urgent need for a COVID-19 disease severity assessment that can assist in patient triage and resource allocation for patients at risk for severe disease. ObjectiveThe goal of this study was to develop, validate, and scale a clinical decision support system and mobile app to assist in COVID-19 severity assessment, management, and care. MethodsModel training data from 701 patients with COVID-19 were collected across practices within the Family Health Centers network at New York University Langone Health. A two-tiered model was developed. Tier 1 uses easily available, nonlaboratory data to help determine whether biomarker-based testing and/or hospitalization is necessary. Tier 2 predicts the probability of mortality using biomarker measurements (C-reactive protein, procalcitonin, D-dimer) and age. Both the Tier 1 and Tier 2 models were validated using two external datasets from hospitals in Wuhan, China, comprising 160 and 375 patients, respectively. ResultsAll biomarkers were measured at significantly higher levels in patients who died vs those who were not hospitalized or discharged (P<.001). The Tier 1 and Tier 2 internal validations had areas under the curve (AUCs) of 0.79 (95% CI 0.74-0.84) and 0.95 (95% CI 0.92-0.98), respectively. The Tier 1 and Tier 2 external validations had AUCs of 0.79 (95% CI 0.74-0.84) and 0.97 (95% CI 0.95-0.99), respectively. ConclusionsOur results demonstrate the validity of the clinical decision support system and mobile app, which are now ready to assist health care providers in making evidence-based decisions when managing COVID-19 patient care. The deployment of these new capabilities has potential for immediate impact in community clinics and sites, where application of these tools could lead to improvements in patient outcomes and cost containment.
    Keywords Computer applications to medicine. Medical informatics ; R858-859.7 ; Public aspects of medicine ; RA1-1270
    Subject code 610
    Language English
    Publishing date 2020-08-01T00:00:00Z
    Publisher JMIR Publications
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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