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  1. Article ; Online: A Ground's-Eye View on Racial and Ethnic Disparities in Cancer Clinical Trial Participation.

    Unger, Joseph M

    JAMA network open

    2023  Volume 6, Issue 7, Page(s) e2322436

    MeSH term(s) Humans ; Neoplasms/therapy ; Racial Groups ; Clinical Trials as Topic
    Language English
    Publishing date 2023-07-03
    Publishing country United States
    Document type Journal Article ; Comment
    ISSN 2574-3805
    ISSN (online) 2574-3805
    DOI 10.1001/jamanetworkopen.2023.22436
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Lost in Translation: Participation in Cancer Clinical Trials for Patients With Limited English Proficiency.

    Unger, Joseph M

    Journal of the National Comprehensive Cancer Network : JNCCN

    2023  Volume 21, Issue 1, Page(s) 99–100

    MeSH term(s) Humans ; Limited English Proficiency ; Neoplasms/therapy
    Language English
    Publishing date 2023-01-01
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2250759-0
    ISSN 1540-1413 ; 1540-1405
    ISSN (online) 1540-1413
    ISSN 1540-1405
    DOI 10.6004/jnccn.2022.7252
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Cancer Care During COVID-19-A Shock to the System.

    Unger, Joseph M

    JAMA network open

    2022  Volume 5, Issue 4, Page(s) e228864

    MeSH term(s) COVID-19 ; Humans ; Neoplasms/epidemiology ; Neoplasms/therapy ; Shock
    Language English
    Publishing date 2022-04-01
    Publishing country United States
    Document type Journal Article ; Comment
    ISSN 2574-3805
    ISSN (online) 2574-3805
    DOI 10.1001/jamanetworkopen.2022.8864
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Representativeness in Premarketing vs Postmarketing US Food and Drug Administration Trials.

    Unger, Joseph M

    JAMA network open

    2021  Volume 4, Issue 4, Page(s) e217159

    MeSH term(s) Humans ; Product Surveillance, Postmarketing ; United States ; United States Food and Drug Administration
    Language English
    Publishing date 2021-04-01
    Publishing country United States
    Document type Journal Article ; Comment
    ISSN 2574-3805
    ISSN (online) 2574-3805
    DOI 10.1001/jamanetworkopen.2021.7159
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Reproducible Findings in Systematic Reviews and Meta-analyses in Oncology: Verify, Then Trust.

    Unger, Joseph M

    JAMA oncology

    2019  Volume 5, Issue 11, Page(s) 1545–1546

    Language English
    Publishing date 2019-09-03
    Publishing country United States
    Document type Journal Article
    ISSN 2374-2445
    ISSN (online) 2374-2445
    DOI 10.1001/jamaoncol.2019.2664
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Impact of Broadening Trial Eligibility Criteria on the Inclusion of Patients With Brain Metastases in Cancer Clinical Trials: Time Series Analyses for 2012-2022.

    Xiao, Hong / Vaidya, Riha / Hershman, Dawn L / Unger, Joseph M

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology

    2024  , Page(s) JCO2301777

    Abstract: Purpose: In October 2017, an ASCO, Friends of Cancer Research (FoCR), and US Food and Drug Administration (ASCO/FoCR/FDA) task force recommended that common eligibility criteria be modified to make trials more inclusive. We examined whether patterns of ... ...

    Abstract Purpose: In October 2017, an ASCO, Friends of Cancer Research (FoCR), and US Food and Drug Administration (ASCO/FoCR/FDA) task force recommended that common eligibility criteria be modified to make trials more inclusive. We examined whether patterns of exclusions regarding patients with brain metastases changed over time in relation to these recommendations.
    Methods: Trial eligibility criteria were abstracted from ClinicalTrials.gov for phase I-III US-based interventional clinical trials for patients with advanced breast, colorectal, lung, or melanoma cancers from January 2012 to December 2022. Trials were examined to determine whether patients with brain metastases were not excluded, conditionally excluded (ie, excluded in some circumstances), or wholly excluded. An interrupted time series analysis with multinomial logistic regression was used to determine whether the ASCO/FoCR/FDA recommendations were associated with changes in brain metastases criteria.
    Results: We evaluated N = 3,077 trials. Patients with brain metastases were not excluded in 506 trials (16.4%), conditionally excluded in 2,263 trials (73.5%), and wholly excluded in 308 trials (10.0%). In the postrecommendation period, we estimated a 68% increase in the odds of brain metastases not excluded compared with conditionally excluded (odds ratio, 1.68 [95% CI, 1.06 to 2.66],
    Conclusion: The ASCO/FoCR/FDA task force recommendations were associated with a shift in patterns of brain metastases exclusion criteria from conditionally excluded to not excluded. These findings demonstrate that the cancer clinical trial community has begun to change the way trials are written to be more inclusive.
    Language English
    Publishing date 2024-03-27
    Publishing country United States
    Document type Journal Article
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.23.01777
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Patient Willingness to Enroll in Cancer Clinical Trials When Sites Return to Prepandemic Status-Reply.

    Fleury, Mark E / Unger, Joseph M

    JAMA oncology

    2021  Volume 7, Issue 6, Page(s) 940

    MeSH term(s) Humans ; Neoplasms/therapy ; Patient Participation
    Language English
    Publishing date 2021-04-01
    Publishing country United States
    Document type Letter ; Comment
    ISSN 2374-2445
    ISSN (online) 2374-2445
    DOI 10.1001/jamaoncol.2021.0387
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Dynamic zero-COVID policy and healthcare utilization patterns in China during the Shanghai COVID-19 Omicron outbreak.

    Xiao, Hong / Liu, Fang / Unger, Joseph M

    Communications medicine

    2023  Volume 3, Issue 1, Page(s) 143

    Abstract: Background: In April 2022, an outbreak of the SARS-CoV-2 virus Omicron variant in Shanghai precipitated an extensive lockdown. We assessed changes in healthcare utilization during this outbreak and investigated the relationship between the stringency of ...

    Abstract Background: In April 2022, an outbreak of the SARS-CoV-2 virus Omicron variant in Shanghai precipitated an extensive lockdown. We assessed changes in healthcare utilization during this outbreak and investigated the relationship between the stringency of mitigation strategies and disruptions in healthcare utilization.
    Methods: Using provincial-level data from routine health information systems covering all hospitals across Mainland China, we conducted an interrupted time series analysis to examine changes in healthcare utilization during the Shanghai outbreak. Linear regression was used to evaluate the direction and magnitude of the association between the relative changes in the move-out movement index, a proxy for the stringency in population-level mitigation strategies, and the estimated relative changes in healthcare utilization.
    Results: Overall, there were 22.9 billion outpatient visits and 1.2 billion discharged inpatients during the study period from January 2016 to May 2022, including 9.1 billion (39.7%) and 0.46 billion (38.2%) in the post-COVID-19 period (January 2020-May 2022), respectively. From March through May 2022, the outbreak resulted in an accumulative loss of 23.5 million (47%) outpatient visits and 0.6 million (55%) discharged inpatients in Shanghai, and a loss of 150.3 million (14%) outpatient visits and 3.6 million (7%) discharged inpatients in other regions. We find that for every 10-percentage point reduction in the relative change of move-out index, a 2.7 (95% CI: 2.0-3.4) percentage point decline in the relative change of outpatient visits, and a 4.3 (95% CI: 3.5-5.2) percentage points decline in the relative change of inpatient discharges.
    Conclusions: The Shanghai COVID-19 Omicron outbreak associates with a substantial reduction in outpatient visits and inpatient discharges within Shanghai and other regions in China. The stringency of the COVID-19 lockdown policies associates with more profound reductions in healthcare utilization.
    Language English
    Publishing date 2023-10-11
    Publishing country England
    Document type Journal Article
    ISSN 2730-664X
    ISSN (online) 2730-664X
    DOI 10.1038/s43856-023-00375-w
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Automatic electronic reporting improved the completeness of AMI and stroke incident surveillance in Tianjin, China: a modeling study.

    Xiao, Hong / Liu, Fang / Unger, Joseph M

    Population health metrics

    2023  Volume 21, Issue 1, Page(s) 2

    Abstract: Background: AMI and stroke are the leading causes of premature mortality and hospitalizations in China. Incidence data at the population level for the two diseases is limited and the reliability and completeness of the existing incidence registry have ... ...

    Abstract Background: AMI and stroke are the leading causes of premature mortality and hospitalizations in China. Incidence data at the population level for the two diseases is limited and the reliability and completeness of the existing incidence registry have not been investigated. We aim to assess if the completeness of case ascertainment of AMI and stroke incidence has improved since the implementation of electronic reporting and to estimate the incidence of AMI and stroke in Tianjin, China.
    Methods: We applied the DisMod II program to model the incidence of AMI and stroke from other epidemiological indicators. Inputs include mortality rates from Tianjin's mortality surveillance system, and the point prevalence, remission rates and relative risks taken from IHME's Global Burden of Disease studies. The completeness of AMI and stroke incidence reporting was assessed by comparing the sex and age-specific incidence rates derived from the incidence surveillance system with the modeled incidence rates.
    Results: The age and sex standardized modeled incidence per 100,000 person-year decreased (p < 0.0001) from 138 in 2007 to 119 in 2015 for AMI and increased (p < 0.0001) from 520 in 2007 to 534 in 2015 for stroke. The overall completeness of incidence report was 36% (95% CI 35-38%) for AMI and 54% (95% CI 53-55%) for stroke. The completeness was higher in men than in women for both AMI (42% vs 30%, p < 0.0001) and stroke (55% vs 53%, p < 0.0001) and was higher in residents aged 30-59 than those aged 60 or older for AMI (57% vs 38%, p < 0.0001). The completeness of reporting increased by 7.2 (95% CI 4.6-9.7) and 15.7 (95% CI 14.4-16.9) percentage points for AMI and stroke, respectively, from 2007 to 2015 among those aged 30 or above. The increases were observed in both men and women (p < 0.0001) and were more profound (p < 0.0001) among those aged between 30 and 59 and occurred primarily during the 2010 and 2015 period.
    Conclusions: Completeness of AMI and stroke incidence surveillance was low in Tianjin but has improved in recent years primarily owing to the incorporation of an automatic reporting component into the information systems of health facilities.
    MeSH term(s) Male ; Humans ; Female ; Adult ; Middle Aged ; Reproducibility of Results ; Myocardial Infarction/epidemiology ; Stroke/epidemiology ; Incidence ; China/epidemiology
    Language English
    Publishing date 2023-02-06
    Publishing country England
    Document type Journal Article
    ZDB-ID 2127230-X
    ISSN 1478-7954 ; 1478-7954
    ISSN (online) 1478-7954
    ISSN 1478-7954
    DOI 10.1186/s12963-023-00300-2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Patterns of Scientific and Clinical Impact in Cancer Randomized Clinical Trials.

    Nghiem, Van T / Vaidya, Riha / Unger, Joseph M

    JAMA network open

    2022  Volume 5, Issue 6, Page(s) e2219657

    MeSH term(s) Humans ; Neoplasms/drug therapy ; Randomized Controlled Trials as Topic ; Research Design
    Language English
    Publishing date 2022-06-01
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 2574-3805
    ISSN (online) 2574-3805
    DOI 10.1001/jamanetworkopen.2022.19657
    Database MEDical Literature Analysis and Retrieval System OnLINE

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