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  1. Book ; Online ; E-Book: The affordable care act as a national experiment

    Selker, Harry P.

    health policy innovations and lessons

    2021  

    Author's details edited by Harry P. Selker
    Keywords Medical policy ; Health care reform ; United States
    Subject code 362.10973
    Language English
    Size 1 online resource (xvi, 155 pages) :, illustrations (some colour)
    Edition 2nd ed.
    Publisher Springer
    Publishing place Cham, Switzerland
    Document type Book ; Online ; E-Book
    Note Includes index.
    Remark Zugriff für angemeldete ZB MED-Nutzerinnen und -Nutzer
    ISBN 3-030-66726-X ; 3-030-66725-1 ; 978-3-030-66725-2 ; 978-3-030-66726-9
    Database ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

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  2. Book: The Affordable care act as a national experiment

    Selker, Harry P. / Wasser, June S.

    health policy innovations and lessons

    2014  

    Author's details Harry P. Selker ; June S. Wasser ed
    Language English
    Size XVI, 155 S. : Ill., graph. Darst., Kt.
    Publisher Springer
    Publishing place New York u.a.
    Publishing country United States
    Document type Book
    HBZ-ID HT017788461
    ISBN 978-1-4614-8350-2 ; 9781461483519 ; 1-4614-8350-6 ; 1461483514
    Database Catalogue ZB MED Medicine, Health

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  3. Article ; Online: Reporting of Clinical Trial Results: Aligning Incentives and Requirements to Do the Right Thing.

    Zarin, Deborah A / Selker, Harry P

    Clinical therapeutics

    2022  Volume 44, Issue 3, Page(s) 439–441

    MeSH term(s) Clinical Trials as Topic ; Humans ; Motivation ; Research Design
    Language English
    Publishing date 2022-02-25
    Publishing country United States
    Document type Journal Article ; Comment
    ZDB-ID 603113-4
    ISSN 1879-114X ; 0149-2918
    ISSN (online) 1879-114X
    ISSN 0149-2918
    DOI 10.1016/j.clinthera.2022.02.001
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: National common metrics for the NIH Clinical and Translational Science Award Institutions: A signal of the transformation of the American biomedical research enterprise.

    Selker, Harry P

    Journal of clinical and translational science

    2019  Volume 4, Issue 1, Page(s) 1–2

    Keywords covid19
    Language English
    Publishing date 2019-10-08
    Publishing country England
    Document type Editorial
    ISSN 2059-8661
    ISSN (online) 2059-8661
    DOI 10.1017/cts.2019.430
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: The continued evolution of team science.

    Selker, Harry P

    Journal of clinical and translational science

    2017  Volume 1, Issue 1, Page(s) 7

    Language English
    Publishing date 2017-04-12
    Publishing country England
    Document type Editorial
    ISSN 2059-8661
    ISSN (online) 2059-8661
    DOI 10.1017/cts.2017.4
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Glucose-Insulin-Potassium Therapy for Acute Myocardial Infarction: 50 Years On and Time for a Relook.

    Udelson, James E / Selker, Harry P / Braunwald, Eugene

    Circulation

    2022  Volume 146, Issue 7, Page(s) 503–505

    MeSH term(s) Glucose ; Humans ; Insulin/therapeutic use ; Myocardial Infarction/drug therapy ; Potassium
    Chemical Substances Insulin ; Glucose (IY9XDZ35W2) ; Potassium (RWP5GA015D)
    Language English
    Publishing date 2022-08-15
    Publishing country United States
    Document type Journal Article
    ZDB-ID 80099-5
    ISSN 1524-4539 ; 0009-7322 ; 0069-4193 ; 0065-8499
    ISSN (online) 1524-4539
    ISSN 0009-7322 ; 0069-4193 ; 0065-8499
    DOI 10.1161/CIRCULATIONAHA.121.058740
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: The use of N-of-1 trials to generate real-world evidence for optimal treatment of individuals and populations.

    Selker, Harry P / Dulko, Dorothy / Greenblatt, David J / Palm, Marisha / Trinquart, Ludovic

    Journal of clinical and translational science

    2023  Volume 7, Issue 1, Page(s) e203

    Abstract: Introduction: Ideally, real-world data (RWD) collected to generate real-world evidence (RWE) should lead to impact on the care and health of real-world patients. Deriving from care in which clinicians and patients try various treatments to inform ... ...

    Abstract Introduction: Ideally, real-world data (RWD) collected to generate real-world evidence (RWE) should lead to impact on the care and health of real-world patients. Deriving from care in which clinicians and patients try various treatments to inform therapeutic decisions, N-of-1 trials bring scientific methods to real-world practice.
    Methods: These single-patient crossover trials generate RWD and RWE by giving individual patients various treatments in a double-blinded way in sequential periods to determine the most effective treatment for a given patient.
    Results: This approach is most often used for patients with chronic, relatively stable conditions that provide the opportunity to make comparisons over multiple treatment periods, termed Type 1 N-of-1 trials. These are most helpful when there is heterogeneity of treatment effects among patients and no a
    Conclusions: To fulfill this potential, we believe N-of-1 trials should be built into our current healthcare ecosystem. To this end, we are building the needed infrastructure and engaging the stakeholders who should receive value from this approach.
    Language English
    Publishing date 2023-09-06
    Publishing country England
    Document type Journal Article
    ISSN 2059-8661
    ISSN (online) 2059-8661
    DOI 10.1017/cts.2023.604
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: From a decentralized clinical trial to a decentralized and clinical-trial-in-a-box platform: Towards patient-centric and equitable trials.

    Dulko, Dorothy / Kwong, Manlik / Palm, Marisha E / Trinquart, Ludovic / Selker, Harry P

    Journal of clinical and translational science

    2023  Volume 7, Issue 1, Page(s) e236

    Abstract: Background/objective: Despite the intuitive attractiveness of bringing research to participants rather than making them come to central study sites, widespread decentralized enrollment has not been common in clinical trials.: Methods: The need for ... ...

    Abstract Background/objective: Despite the intuitive attractiveness of bringing research to participants rather than making them come to central study sites, widespread decentralized enrollment has not been common in clinical trials.
    Methods: The need for clinical research in the context of the COVID-19 pandemic, along with innovations in technology, led us to use a decentralized trial approach in our Phase 2 COVID-19 trial. We used real-time acquisition and transmission of health-related data using home-based monitoring devices and mobile applications to assess outcomes. This approach not only avoids spreading COVID-19 but it also can support inclusion of participants in more diverse socioeconomic circumstances and in rural settings.
    Results: Our team developed and deployed a decentralized trial platform to support patient engagement and adverse event reporting. Clinicians, engineers, and informaticians on our research team developed a Clinical-Trial-in-a-Box tool to optimally collect and analyze data from multiple decentralized platforms.
    Conclusion: Applying the decentralized model in Long COVID, using digital health technology and personal devices integrated with our telehealth platform, we share the lessons learned from our work, along with challenges and future possibilities.
    Language English
    Publishing date 2023-10-09
    Publishing country England
    Document type Journal Article
    ISSN 2059-8661
    ISSN (online) 2059-8661
    DOI 10.1017/cts.2023.629
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Sharing data among clinical trials of therapeutics in COVID-19: Barriers and facilitators to collaborating in a crisis.

    Palm, Marisha E / Lindsell, Christopher J / Selker, Harry P

    Journal of clinical and translational science

    2021  Volume 6, Issue 1, Page(s) e52

    Abstract: Background: The Clinical and Translational Science Award Program (CTSA) Trial Innovation Network (TIN) was launched in 2016 to increase the efficiency and effectiveness of multisite trials by supporting the development of national infrastructure. With ... ...

    Abstract Background: The Clinical and Translational Science Award Program (CTSA) Trial Innovation Network (TIN) was launched in 2016 to increase the efficiency and effectiveness of multisite trials by supporting the development of national infrastructure. With the advent of the COVID-19 pandemic, it was therefore well-positioned to support clinical trial collaboration. The TIN was leveraged to support two initiatives: (1) to create and evaluate a mechanism for coordinating Data and Safety Monitoring Board (DSMB) activities among multiple ongoing trials of the same therapeutic agents, and (2) to share data across clinical trials so that smaller, likely underpowered studies, could be combined to produce meaningful and actionable data through pooled analyses. The success of these initiatives was understood to be dependent upon the willingness of investigators, study teams, and US National Institutes of Health research networks to collaborate and share information.
    Methods: To inform these two initiatives, we conducted semistructured interviews with members of CTSA hubs and clinical research stakeholders that probed barriers and facilitators to collaboration. Thematic analysis identified topics relevant across institutions, individuals, and DSMBs.
    Results: The DSMB coordination initiative was viewed as less controversial, while the data pooling initiative was seen as complex because of its potential impact on publication, authorship, and the rewards of discovery. Barriers related to resources, centralization, and technical work were significant, but interviewees suggested these could be handled by the provision of central funding and supportive frameworks. The more intractable findings were related to issues around credit and ownership of data.
    Conclusion: Based on our interviews, we conclude with nine recommended actions that can be implemented to support collaboration.
    Language English
    Publishing date 2021-10-07
    Publishing country England
    Document type Journal Article
    ISSN 2059-8661
    ISSN (online) 2059-8661
    DOI 10.1017/cts.2021.866
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Book: Emergency diagnostic tests for cardiac ischemia

    Selker, Harry P.

    a report from the National Heart Attack Alert Program (NHAAP)

    1997  

    Institution Working Group on Evaluation of Technologies for Identifying Acute Cardiac Ischemia in the Emergency Department
    Author's details Working Group on Evaluation of Technologies for Identifying Acute Cardiac Ischemia in the Emergency Department. Co-chairs Harry P. Selker
    Keywords Heart Function Tests ; Myocardial Infarction / diagnosis ; Myocardial Ischemia / diagnosis ; Emergency Medical Services / United States ; Evaluation Studies
    Language English
    Size XLI, 189 S. : Ill.
    Publisher Blackwell Science
    Publishing place Malden, Mass. u.a.
    Publishing country United States
    Document type Book
    HBZ-ID HT008357328
    ISBN 0-632-04304-0 ; 978-0-632-04304-0
    Database Catalogue ZB MED Medicine, Health

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