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  1. Article ; Online: Precision Medicine Landscape of Genomic Testing for Patients With Cancer in the National Institutes of Health All of Us Database Using Informatics Approaches.

    Ronquillo, Jay G / Lester, William T

    JCO clinical cancer informatics

    2022  Volume 6, Page(s) e2100152

    Abstract: Purpose: The rapid growth of biomedical data ecosystems has catalyzed research for oncology and precision medicine. We leverage federal cloud-based precision medicine databases and tools to better understand the current landscape of precision medicine ... ...

    Abstract Purpose: The rapid growth of biomedical data ecosystems has catalyzed research for oncology and precision medicine. We leverage federal cloud-based precision medicine databases and tools to better understand the current landscape of precision medicine and genomic testing for patients with cancer.
    Methods: Retrospective observational study of genomic testing for patients with cancer in the National Institutes of Health
    Results: There were 5,678 (1.8%)
    Conclusion: Although not yet ubiquitous, diverse clinical genomic analyses in oncology can set the stage to grow the practice of precision medicine by integrating research patient data repositories, cancer data ecosystems, and biomedical informatics.
    MeSH term(s) Databases, Factual ; Ecosystem ; Genetic Testing ; Humans ; National Institutes of Health (U.S.) ; Neoplasms/diagnosis ; Neoplasms/genetics ; Population Health ; Precision Medicine ; United States/epidemiology
    Language English
    Publishing date 2022-01-24
    Publishing country United States
    Document type Journal Article ; Observational Study ; Research Support, N.I.H., Extramural
    ISSN 2473-4276
    ISSN (online) 2473-4276
    DOI 10.1200/CCI.21.00152
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Pharmacogenomic testing and prescribing patterns for patients with cancer in a large national precision medicine cohort.

    Ronquillo, Jay G / Lester, William T

    Journal of medical genetics

    2021  Volume 60, Issue 1, Page(s) 81–83

    Abstract: Population databases could help patients with cancer and providers better understand current pharmacogenomic prescribing and testing practices. This retrospective observational study analysed patients with cancer, drugs with pharmacogenomic evidence and ... ...

    Abstract Population databases could help patients with cancer and providers better understand current pharmacogenomic prescribing and testing practices. This retrospective observational study analysed patients with cancer, drugs with pharmacogenomic evidence and related genetic testing in the National Institutes of Health
    MeSH term(s) Humans ; Precision Medicine ; Pharmacogenomic Testing ; Population Health ; Pharmacogenetics ; Neoplasms/drug therapy ; Neoplasms/genetics
    Language English
    Publishing date 2021-12-06
    Publishing country England
    Document type Observational Study ; Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 220881-7
    ISSN 1468-6244 ; 0022-2593
    ISSN (online) 1468-6244
    ISSN 0022-2593
    DOI 10.1136/jmedgenet-2021-108112
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 177: Show issues Location:
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    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  3. Article ; Online: Practical Aspects of Implementing and Applying Health Care Cloud Computing Services and Informatics to Cancer Clinical Trial Data.

    Ronquillo, Jay G / Lester, William T

    JCO clinical cancer informatics

    2021  Volume 5, Page(s) 826–832

    Abstract: Purpose: Cloud computing has led to dramatic growth in the volume, variety, and velocity of cancer data. However, cloud platforms and services present new challenges for cancer research, particularly in understanding the practical tradeoffs between ... ...

    Abstract Purpose: Cloud computing has led to dramatic growth in the volume, variety, and velocity of cancer data. However, cloud platforms and services present new challenges for cancer research, particularly in understanding the practical tradeoffs between cloud performance, cost, and complexity. The goal of this study was to describe the practical challenges when using a cloud-based service to improve the cancer clinical trial matching process.
    Methods: We collected information for all interventional cancer clinical trials from ClinicalTrials.gov and used the Google Cloud Healthcare Natural Language Application Programming Interface (API) to analyze clinical trial Title and Eligibility Criteria text. An informatics pipeline leveraging interoperability standards summarized the distribution of cancer clinical trials, genes, laboratory tests, and medications extracted from cloud-based entity analysis.
    Results: There were a total of 38,851 cancer-related clinical trials found in this study, with the distribution of cancer categories extracted from Title text significantly different than in ClinicalTrials.gov (
    Conclusion: Current general-purpose cloud health care tools-like the Google service in this study-should not be used for automated clinical trial matching unless they can perform effective extraction and classification of the clinical, genetic, and medication concepts central to precision oncology research. A strong understanding of the practical aspects of cloud computing will help researchers effectively navigate the vast data ecosystems in cancer research.
    MeSH term(s) Cloud Computing ; Delivery of Health Care ; Ecosystem ; Humans ; Informatics ; Neoplasms/diagnosis ; Neoplasms/epidemiology ; Neoplasms/therapy ; Precision Medicine
    Language English
    Publishing date 2021-08-12
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 2473-4276
    ISSN (online) 2473-4276
    DOI 10.1200/CCI.21.00018
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  4. Article ; Online: Electronic Health Records.

    Ronquillo, Jay G / Zuckerman, Diana M

    Annals of internal medicine

    2017  Volume 166, Issue 7, Page(s) 536

    Language English
    Publishing date 2017-04-04
    Publishing country United States
    Document type Journal Article
    ZDB-ID 336-0
    ISSN 1539-3704 ; 0003-4819
    ISSN (online) 1539-3704
    ISSN 0003-4819
    DOI 10.7326/L17-0050
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    In stock of ZB MED Cologne/Königswinter

    Ua VI Zs.178/2: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

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  5. Article ; Online: Using informatics to guide public health policy during the COVID-19 pandemic in the USA.

    Ronquillo, Jay G / Lester, William T / Zuckerman, Diana M

    Journal of public health (Oxford, England)

    2020  Volume 42, Issue 4, Page(s) 660–664

    Abstract: Background: Current and future pandemics will require informatics solutions to assess the risks, resources and policies to guide better public health decision-making.: Methods: Cross-sectional study of all COVID-19 cases and deaths in the USA on a ... ...

    Abstract Background: Current and future pandemics will require informatics solutions to assess the risks, resources and policies to guide better public health decision-making.
    Methods: Cross-sectional study of all COVID-19 cases and deaths in the USA on a population- and resource-adjusted basis (as of 24 April 2020) by applying biomedical informatics and data visualization tools to several public and federal government datasets, including analysis of the impact of statewide stay-at-home orders.
    Results: There were 2753.2 cases and 158.0 deaths per million residents, respectively, in the USA with variable distributions throughout divisions, regions and states. Forty-two states and Washington, DC, (84.3%) had statewide stay-at-home orders, with the remaining states having population-adjusted characteristics in the highest risk quartile.
    Conclusions: Effective national preparedness requires clearly understanding states' ability to predict, manage and balance public health needs through all stages of a pandemic. This will require leveraging data quickly, correctly and responsibly into sound public health policies.
    MeSH term(s) COVID-19/epidemiology ; COVID-19/mortality ; Cross-Sectional Studies ; Datasets as Topic ; Government Regulation ; Humans ; Medical Informatics ; Pandemics ; Physical Distancing ; Public Health Administration ; Public Policy ; Quarantine ; SARS-CoV-2 ; United States/epidemiology
    Keywords covid19
    Language English
    Publishing date 2020-07-09
    Publishing country England
    Document type Journal Article
    ZDB-ID 2142082-8
    ISSN 1741-3850 ; 1741-3842
    ISSN (online) 1741-3850
    ISSN 1741-3842
    DOI 10.1093/pubmed/fdaa081
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.B 2186: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

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  6. Article ; Online: Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health.

    Ronquillo, Jay G / Zuckerman, Diana M

    The Milbank quarterly

    2017  Volume 95, Issue 3, Page(s) 535–553

    Abstract: Policy Points: Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial. No studies of medical devices and software assess the impact on patient safety of the FDA' ...

    Abstract Policy Points: Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial. No studies of medical devices and software assess the impact on patient safety of the FDA's current regulatory safeguards and new legislative changes to those standards. Our analysis quantifies the impact of software problems in regulated medical devices and indicates that current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market. New legislative changes will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients.
    Context: Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. To understand which policies might best protect patients, we examined the impact of the US Food and Drug Administration's (FDA's) regulatory safeguards on software-related technologies in recent years and the implications for newly passed legislative changes in regulatory policy.
    Methods: Using FDA databases, we identified all medical devices that were recalled from 2011 through 2015 primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall of electronic medical records to determine the manufacturer, device classification, submission type, number of units, and product details.
    Findings: A total of 627 software devices (1.4 million units) were subject to recalls, with 12 of these devices (190,596 units) subject to the highest-risk recalls. Eleven of the devices recalled as high risk had entered the market through the FDA review process that does not require evidence of safety or effectiveness, and one device was completely exempt from regulatory review. The largest high-risk recall categories were anesthesiology and general hospital, with one each in cardiovascular and neurology. Five electronic medical record systems (9,347 units) were recalled for software defects classified as posing a moderate risk to patient safety.
    Conclusions: Software problems in medical devices are not rare and have the potential to negatively influence medical care. Premarket regulation has not captured all the software issues that could harm patients, evidenced by the potentially large number of patients exposed to software products later subject to high-risk and moderate-risk recalls. Provisions of the 21st Century Cures Act that became law in late 2016 will reduce safeguards further. Absent stronger regulations and implementation to create robust risk assessment and adverse event reporting, physicians and their patients are likely to be at risk from medical errors caused by software-related problems in medical devices.
    MeSH term(s) Device Approval/standards ; Electronic Health Records/standards ; Humans ; Medical Device Recalls/standards ; Medical Informatics/standards ; Patient Safety/standards ; Product Surveillance, Postmarketing/standards ; Software/standards ; United States ; United States Food and Drug Administration
    Keywords covid19
    Language English
    Publishing date 2017-09-01
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 632829-5
    ISSN 1468-0009 ; 0887-378X
    ISSN (online) 1468-0009
    ISSN 0887-378X
    DOI 10.1111/1468-0009.12278
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    In stock of ZB MED Cologne/Königswinter

    Zs.A 285: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  7. Article: Using informatics to guide public health policy during the COVID-19 pandemic in the USA

    Ronquillo, Jay G / Lester, William T / Zuckerman, Diana M

    J. public health (Oxf)

    Abstract: BACKGROUND: Current and future pandemics will require informatics solutions to assess the risks, resources and policies to guide better public health decision-making. METHODS: Cross-sectional study of all COVID-19 cases and deaths in the USA on a ... ...

    Abstract BACKGROUND: Current and future pandemics will require informatics solutions to assess the risks, resources and policies to guide better public health decision-making. METHODS: Cross-sectional study of all COVID-19 cases and deaths in the USA on a population- and resource-adjusted basis (as of 24 April 2020) by applying biomedical informatics and data visualization tools to several public and federal government datasets, including analysis of the impact of statewide stay-at-home orders. RESULTS: There were 2753.2 cases and 158.0 deaths per million residents, respectively, in the USA with variable distributions throughout divisions, regions and states. Forty-two states and Washington, DC, (84.3%) had statewide stay-at-home orders, with the remaining states having population-adjusted characteristics in the highest risk quartile. CONCLUSIONS: Effective national preparedness requires clearly understanding states' ability to predict, manage and balance public health needs through all stages of a pandemic. This will require leveraging data quickly, correctly and responsibly into sound public health policies.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #641306
    Database COVID19

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  8. Article ; Online: Using informatics to guide public health policy during the COVID-19 pandemic in the USA

    Ronquillo, Jay G / Lester, William T / Zuckerman, Diana M

    Journal of Public Health ; ISSN 1741-3842 1741-3850

    2020  

    Abstract: Abstract Background Current and future pandemics will require informatics solutions to assess the risks, resources and policies to guide better public health decision-making. Methods Cross-sectional study of all COVID-19 cases and deaths in the USA on a ... ...

    Abstract Abstract Background Current and future pandemics will require informatics solutions to assess the risks, resources and policies to guide better public health decision-making. Methods Cross-sectional study of all COVID-19 cases and deaths in the USA on a population- and resource-adjusted basis (as of 24 April 2020) by applying biomedical informatics and data visualization tools to several public and federal government datasets, including analysis of the impact of statewide stay-at-home orders. Results There were 2753.2 cases and 158.0 deaths per million residents, respectively, in the USA with variable distributions throughout divisions, regions and states. Forty-two states and Washington, DC, (84.3%) had statewide stay-at-home orders, with the remaining states having population-adjusted characteristics in the highest risk quartile. Conclusions Effective national preparedness requires clearly understanding states’ ability to predict, manage and balance public health needs through all stages of a pandemic. This will require leveraging data quickly, correctly and responsibly into sound public health policies.
    Keywords Public Health, Environmental and Occupational Health ; General Medicine ; covid19
    Language English
    Publisher Oxford University Press (OUP)
    Publishing country uk
    Document type Article ; Online
    DOI 10.1093/pubmed/fdaa081
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  9. Article ; Online: Assessing the readiness of precision medicine interoperabilty: An exploratory study of the National Institutes of Health genetic testing registry.

    Ronquillo, Jay G / Weng, Chunhua / Lester, William T

    Journal of innovation in health informatics

    2017  Volume 24, Issue 4, Page(s) 918

    Abstract: Background:   Precision medicine involves three major innovations currently taking place in healthcare:  electronic health records, genomics, and big data.  A major challenge for healthcare providers, however, is understanding the readiness for ... ...

    Abstract Background:   Precision medicine involves three major innovations currently taking place in healthcare:  electronic health records, genomics, and big data.  A major challenge for healthcare providers, however, is understanding the readiness for practical application of initiatives like precision medicine.
    Objective:   To better understand the current state and challenges of precision medicine interoperability using a national genetic testing registry as a starting point, placed in the context of established interoperability formats.
    Methods:   We performed an exploratory analysis of the National Institutes of Health Genetic Testing Registry.  Relevant standards included Health Level Seven International Version 3 Implementation Guide for Family History, the Human Genome Organization Gene Nomenclature Committee (HGNC) database, and Systematized Nomenclature of Medicine - Clinical Terms (SNOMED CT).  We analyzed the distribution of genetic testing laboratories, genetic test characteristics, and standardized genome/clinical code mappings, stratified by laboratory setting.
    Results: There were a total of 25472 genetic tests from 240 laboratories testing for approximately 3632 distinct genes.  Most tests focused on diagnosis, mutation confirmation, and/or risk assessment of germline mutations that could be passed to offspring.  Genes were successfully mapped to all HGNC identifiers, but less than half of tests mapped to SNOMED CT codes, highlighting significant gaps when linking genetic tests to standardized clinical codes that explain the medical motivations behind test ordering.  Conclusion:  While precision medicine could potentially transform healthcare, successful practical and clinical application will first require the comprehensive and responsible adoption of interoperable standards, terminologies, and formats across all aspects of the precision medicine pipeline.
    MeSH term(s) Genetic Testing ; Health Information Interoperability/standards ; Humans ; Precision Medicine ; Registries ; Systematized Nomenclature of Medicine
    Language English
    Publishing date 2017-11-17
    Publishing country England
    Document type Journal Article
    ZDB-ID 2105081-8
    ISSN 2058-4563 ; 2058-4555
    ISSN (online) 2058-4563
    ISSN 2058-4555
    DOI 10.14236/jhi.v24i4.918
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Assessing the readiness of precision medicine interoperabilty

    Jay G Ronquillo / Chunhua Weng / William T Lester

    Journal of Innovation in Health Informatics, Vol 24, Iss

    An exploratory study of the National Institutes of Health genetic testing registry

    2017  Volume 4

    Abstract: Background: Precision medicine involves three major innovations currently taking place in healthcare: electronic health records, genomics, and big data. A major challenge for healthcare providers, however, is understanding the readiness for practical ... ...

    Abstract Background: Precision medicine involves three major innovations currently taking place in healthcare: electronic health records, genomics, and big data. A major challenge for healthcare providers, however, is understanding the readiness for practical application of initiatives like precision medicine. Objective: To better understand the current state and challenges of precision medicine interoperability using a national genetic testing registry as a starting point, placed in the context of established interoperability formats. Methods: We performed an exploratory analysis of the National Institutes of Health Genetic Testing Registry. Relevant standards included Health Level Seven International Version 3 Implementation Guide for Family History, the Human Genome Organization Gene Nomenclature Committee (HGNC) database, and Systematized Nomenclature of Medicine – Clinical Terms (SNOMED CT). We analyzed the distribution of genetic testing laboratories, genetic test characteristics, and standardized genome/clinical code mappings, stratified by laboratory setting. Results: There were a total of 25472 genetic tests from 240 laboratories testing for approximately 3632 distinct genes. Most tests focused on diagnosis, mutation confirmation, and/or risk assessment of germline mutations that could be passed to offspring. Genes were successfully mapped to all HGNC identifiers, but less than half of tests mapped to SNOMED CT codes, highlighting significant gaps when linking genetic tests to standardized clinical codes that explain the medical motivations behind test ordering. Conclusion: While precision medicine could potentially transform healthcare, successful practical and clinical application will first require the comprehensive and responsible adoption of interoperable standards, terminologies, and formats across all aspects of the precision medicine pipeline.
    Keywords informatics ; electronic health records ; genomics ; interoperability ; precision medicine ; Computer applications to medicine. Medical informatics ; R858-859.7
    Subject code 170
    Language English
    Publishing date 2017-11-01T00:00:00Z
    Publisher BCS, The Chartered Institute for IT
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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