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  1. Book ; Conference proceedings: Development and clinical progress of DNA vaccines : Paul-Ehrlich -Institut, Langen, Germany, October 6-8, 1999 ; proceedings of a symposium organized and sponsored by the International Association for Biologicals (IABS) ... [et al.] / volume editors, Fred Brown, Klaus Cichutek, and James S. Robertson

    Brown, Fred / Cichutek, Klaus / Robertson, James S

    (Developments in biologicals ; v. 104)

    2000  

    Institution International Association for Biologicals
    Series title Developments in biologicals ; v. 104
    MeSH term(s) Vaccines, DNA/immunology ; Vaccines, DNA/therapeutic use
    Language English
    Size ix, 208 p. :, ill.
    Publisher Karger
    Publishing place Basel ; New York
    Document type Book ; Conference proceedings
    ISBN 9783805571029 ; 380557102X
    Database Catalogue of the US National Library of Medicine (NLM)

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  2. Article: Online multiple hypothesis testing.

    Robertson, David S / Wason, James M S / Ramdas, Aaditya

    Statistical science : a review journal of the Institute of Mathematical Statistics

    2023  Volume 38, Issue 4, Page(s) 557–575

    Abstract: Modern data analysis frequently involves large-scale hypothesis testing, which naturally gives rise to the problem of maintaining control of a suitable type I error rate, such as the false discovery rate (FDR). In many biomedical and technological ... ...

    Abstract Modern data analysis frequently involves large-scale hypothesis testing, which naturally gives rise to the problem of maintaining control of a suitable type I error rate, such as the false discovery rate (FDR). In many biomedical and technological applications, an additional complexity is that hypotheses are tested in an online manner, one-by-one over time. However, traditional procedures that control the FDR, such as the Benjamini-Hochberg procedure, assume that all
    Language English
    Publishing date 2023-09-20
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2009740-2
    ISSN 2168-8745 ; 0883-4237
    ISSN (online) 2168-8745
    ISSN 0883-4237
    DOI 10.1214/23-STS901
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Book ; Conference proceedings: PDA/EMEA European virus safety forum

    Robertson, James S.

    Langen, September 29 - October 1, 2003 ; proceedings of a conference ; 33 tables

    (Developments in biologicals ; 118)

    2004  

    Institution Paul-Ehrlich-Institut
    Author's details Paul-Ehrlich-Institut, Langen. Vol. ed. James S. Robertson
    Series title Developments in biologicals ; 118
    Collection
    Keywords Pharmazeutische Technologie ; Biotechnologie ; Mikrobielle Kontamination ; Arzneimittelsicherheit
    Subject Drug safety ; Technische Biochemie ; Technische Biologie ; Biotechnik ; Biotech ; Arzneimittelherstellung ; Galenische Pharmazie ; Arzneiformenlehre ; Galenik
    Language English
    Size XII, 177 S. : Ill., graph. Darst., 30 schw.-w. Abb., 33 schw.-w. Tab., 240 mm x 170 mm
    Publisher Karger
    Publishing place Basel u.a.
    Publishing country Switzerland
    Document type Book ; Conference proceedings
    HBZ-ID HT014257994
    ISBN 3-8055-7873-3 ; 978-3-8055-7873-8
    Database Catalogue ZB MED Medicine, Health

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  4. Article ; Online: Online error rate control for platform trials.

    Robertson, David S / Wason, James M S / König, Franz / Posch, Martin / Jaki, Thomas

    Statistics in medicine

    2023  Volume 42, Issue 14, Page(s) 2475–2495

    Abstract: Platform trials evaluate multiple experimental treatments under a single master protocol, where new treatment arms are added to the trial over time. Given the multiple treatment comparisons, there is the potential for inflation of the overall type I ... ...

    Abstract Platform trials evaluate multiple experimental treatments under a single master protocol, where new treatment arms are added to the trial over time. Given the multiple treatment comparisons, there is the potential for inflation of the overall type I error rate, which is complicated by the fact that the hypotheses are tested at different times and are not necessarily pre-specified. Online error rate control methodology provides a possible solution to the problem of multiplicity for platform trials where a relatively large number of hypotheses are expected to be tested over time. In the online multiple hypothesis testing framework, hypotheses are tested one-by-one over time, where at each time-step an analyst decides whether to reject the current null hypothesis without knowledge of future tests but based solely on past decisions. Methodology has recently been developed for online control of the false discovery rate as well as the familywise error rate (FWER). In this article, we describe how to apply online error rate control to the platform trial setting, present extensive simulation results, and give some recommendations for the use of this new methodology in practice. We show that the algorithms for online error rate control can have a substantially lower FWER than uncorrected testing, while still achieving noticeable gains in power when compared with the use of a Bonferroni correction. We also illustrate how online error rate control would have impacted a currently ongoing platform trial.
    MeSH term(s) Humans ; Data Interpretation, Statistical ; Research Design ; Computer Simulation
    Language English
    Publishing date 2023-04-02
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 843037-8
    ISSN 1097-0258 ; 0277-6715
    ISSN (online) 1097-0258
    ISSN 0277-6715
    DOI 10.1002/sim.9733
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Patients with Classic Hodgkin Lymphoma and Follicular Lymphoma Compared to Single Malignancy Controls.

    Cotta, Claudiu V / Bhavsar, Shweta / Robertson, Scott / Cook, James R

    The American journal of surgical pathology

    2024  

    Abstract: Classic Hodgkin lymphoma (CHL) can arise in patients with low-grade B-cell lymphoma. The features of CHL arising in follicular lymphoma (FL) and its outcome are still unclear, mainly due to the very few cases reported. This study compares 17 patients ... ...

    Abstract Classic Hodgkin lymphoma (CHL) can arise in patients with low-grade B-cell lymphoma. The features of CHL arising in follicular lymphoma (FL) and its outcome are still unclear, mainly due to the very few cases reported. This study compares 17 patients with CHL and FL to 2 control groups: 1 of 26 patients with FL and a second of 60 patients older than 40 when diagnosed with CHL. Of the FL and CHL patients, 8 had simultaneous FL and CHL, while 9 had FL first, followed by CHL 4.7 years later on average. The age at the diagnosis of FL was 61 years for patients with synchronous FL and CHL and of 60 years for FL, followed by CHL at 65 years. Patients with FL only were, on average, 59 years old at presentation, while CHL patients were 61. FL was grade 1-2 in 75% of FL and CHL patients and 67% of FL first and CHL second patients, lower proportions than in the FL control group-92%. Epstein-Barr virus (EBV) was detected in a lower fraction (29%) of the FL and CHL group than in CHL-only controls (46%). BCL2 translocations were detected in 4 of the 7 cases with FL, but in positive cases, the rearrangement was also present in the CHL component, indicating a clonal relationship between FL and CHL. Patients with FL and CHL treated for CHL had an initial outcome more similar to FL than to CHL controls.
    Language English
    Publishing date 2024-04-11
    Publishing country United States
    Document type Journal Article
    ZDB-ID 752964-8
    ISSN 1532-0979 ; 0147-5185
    ISSN (online) 1532-0979
    ISSN 0147-5185
    DOI 10.1097/PAS.0000000000002225
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Infantile hemangioma affecting the iris.

    Robertson, Susan J / Elder, James E / Bekhor, Philip S

    Pediatric dermatology

    2021  Volume 38, Issue 6, Page(s) 1579–1580

    Abstract: An infant girl developed a hemangioma affecting her left iris concurrently with diffuse cutaneous infantile hemangiomas from day 2 of life. Intraocular hemangiomas are rarely reported and are usually associated with neonatal hemangiomatosis, the presence ...

    Abstract An infant girl developed a hemangioma affecting her left iris concurrently with diffuse cutaneous infantile hemangiomas from day 2 of life. Intraocular hemangiomas are rarely reported and are usually associated with neonatal hemangiomatosis, the presence of which indicates a high risk for visceral lesions. This striking case highlights the unusual clinical presentation of iris hemangioma and demonstrates the importance of conducting visceral screening when faced with these lesions. Oral propranolol was commenced and resulted in rapid improvement of all lesions without complication.
    MeSH term(s) Female ; Hemangioma/diagnosis ; Hemangioma/drug therapy ; Hemangioma, Capillary/diagnosis ; Hemangioma, Capillary/drug therapy ; Humans ; Infant, Newborn ; Iris ; Skin Neoplasms/diagnosis ; Skin Neoplasms/drug therapy
    Language English
    Publishing date 2021-10-11
    Publishing country United States
    Document type Journal Article
    ZDB-ID 605539-4
    ISSN 1525-1470 ; 0736-8046
    ISSN (online) 1525-1470
    ISSN 0736-8046
    DOI 10.1111/pde.14833
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Language about the future on social media as a novel marker of anxiety and depression: A big-data and experimental analysis.

    Robertson, Cole / Carney, James / Trudell, Shane

    Current research in behavioral sciences

    2023  Volume 4, Page(s) None

    Abstract: Anxiety and depression negatively impact many. Studies suggest depression is associated with future time horizons, or how "far" into the future people tend to think, and anxiety is associated with temporal discounting, or how much people devalue future ... ...

    Abstract Anxiety and depression negatively impact many. Studies suggest depression is associated with future time horizons, or how "far" into the future people tend to think, and anxiety is associated with temporal discounting, or how much people devalue future rewards. Separate studies from linguistics and economics have shown that how people refer to future time predicts temporal discounting. Yet no one-that we know of-has investigated whether future time reference habits are a marker of anxiety and/or depression. We introduce the FTR classifier, a novel classification system researchers can use to analyse linguistic temporal reference. In Study 1, we used the FTR classifier to analyse data from the social-media website Reddit. Users who had previously posted popular contributions to forums about anxiety and depression referenced the future and past more often than controls, had more proximal future and past time horizons, and significantly differed in their linguistic future time reference patterns: They used fewer future tense constructions (e.g.
    Language English
    Publishing date 2023-03-29
    Publishing country Netherlands
    Document type Journal Article
    ISSN 2666-5182
    ISSN (online) 2666-5182
    DOI 10.1016/j.crbeha.2023.100104
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Graphical approaches for the control of generalized error rates.

    Robertson, David S / Wason, James M S / Bretz, Frank

    Statistics in medicine

    2020  Volume 39, Issue 23, Page(s) 3135–3155

    Abstract: When simultaneously testing multiple hypotheses, the usual approach in the context of confirmatory clinical trials is to control the familywise error rate (FWER), which bounds the probability of making at least one false rejection. In many trial settings, ...

    Abstract When simultaneously testing multiple hypotheses, the usual approach in the context of confirmatory clinical trials is to control the familywise error rate (FWER), which bounds the probability of making at least one false rejection. In many trial settings, these hypotheses will additionally have a hierarchical structure that reflects the relative importance and links between different clinical objectives. The graphical approach of Bretz et al (2009) is a flexible and easily communicable way of controlling the FWER while respecting complex trial objectives and multiple structured hypotheses. However, the FWER can be a very stringent criterion that leads to procedures with low power, and may not be appropriate in exploratory trial settings. This motivates controlling generalized error rates, particularly when the number of hypotheses tested is no longer small. We consider the generalized familywise error rate (k-FWER), which is the probability of making k or more false rejections, as well as the tail probability of the false discovery proportion (FDP), which is the probability that the proportion of false rejections is greater than some threshold. We also consider asymptotic control of the false discovery rate, which is the expectation of the FDP. In this article, we show how to control these generalized error rates when using the graphical approach and its extensions. We demonstrate the utility of the resulting graphical procedures on three clinical trial case studies.
    MeSH term(s) Humans ; Probability ; Research Design
    Language English
    Publishing date 2020-06-17
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 843037-8
    ISSN 1097-0258 ; 0277-6715
    ISSN (online) 1097-0258
    ISSN 0277-6715
    DOI 10.1002/sim.8595
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Controlling type I error rates in multi-arm clinical trials: A case for the false discovery rate.

    Wason, James M S / Robertson, David S

    Pharmaceutical statistics

    2020  Volume 20, Issue 1, Page(s) 109–116

    Abstract: Multi-arm trials are an efficient way of simultaneously testing several experimental treatments against a shared control group. As well as reducing the sample size required compared to running each trial separately, they have important administrative and ...

    Abstract Multi-arm trials are an efficient way of simultaneously testing several experimental treatments against a shared control group. As well as reducing the sample size required compared to running each trial separately, they have important administrative and logistical advantages. There has been debate over whether multi-arm trials should correct for the fact that multiple null hypotheses are tested within the same experiment. Previous opinions have ranged from no correction is required, to a stringent correction (controlling the probability of making at least one type I error) being needed, with regulators arguing the latter for confirmatory settings. In this article, we propose that controlling the false-discovery rate (FDR) is a suitable compromise, with an appealing interpretation in multi-arm clinical trials. We investigate the properties of the different correction methods in terms of the positive and negative predictive value (respectively how confident we are that a recommended treatment is effective and that a non-recommended treatment is ineffective). The number of arms and proportion of treatments that are truly effective is varied. Controlling the FDR provides good properties. It retains the high positive predictive value of FWER correction in situations where a low proportion of treatments is effective. It also has a good negative predictive value in situations where a high proportion of treatments is effective. In a multi-arm trial testing distinct treatment arms, we recommend that sponsors and trialists consider use of the FDR.
    MeSH term(s) Control Groups ; Data Interpretation, Statistical ; Humans ; Probability ; Research Design ; Sample Size
    Language English
    Publishing date 2020-08-12
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2083706-9
    ISSN 1539-1612 ; 1539-1604
    ISSN (online) 1539-1612
    ISSN 1539-1604
    DOI 10.1002/pst.2059
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: COVID-19 in Patients with a Primary Refugee-Associated Language in a Kentucky Emergency Department During 2020.

    Hamm, Joel / Duncan, Meredith S / Robertson, Nicole M / Keck, James W / Crabtree, Katherine

    Journal of immigrant and minority health

    2022  Volume 25, Issue 3, Page(s) 728–732

    Abstract: COVID-19 has heavily impacted the refugee population in the United States due to exposure risks, living and working conditions, and healthcare access, but little is known about outcomes. We reviewed emergency department visits to a Kentucky hospital ... ...

    Abstract COVID-19 has heavily impacted the refugee population in the United States due to exposure risks, living and working conditions, and healthcare access, but little is known about outcomes. We reviewed emergency department visits to a Kentucky hospital among 2163 patients from March-December 2020, studying incidence of COVID-19 diagnosis for patients with a primary refugee-associated language compared to English speakers, and outcomes after diagnosis including hospitalization, length of stay, and in-hospital mortality. Patients in the population of interest had higher odds of COVID-19 diagnosis in the hospital (OR = 12.31, 95% CI 7.80-19.40), but, among those with COVID-19, lower odds of hospital admission (OR = 0.58, 95% CI 0.37-0.90) and shorter median length of stay (4.1 vs. 10.5 days) compared to English speakers. The study corroborates reports of comparatively higher COVID-19 incidence in patients speaking a primary refugee-associated language, but implies milder illness severity, possibly reflecting this population's baseline health.
    MeSH term(s) Humans ; COVID-19 ; COVID-19 Testing ; Emergency Service, Hospital ; Kentucky/epidemiology ; Language ; Refugees ; Retrospective Studies ; United States
    Language English
    Publishing date 2022-12-06
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2220162-2
    ISSN 1557-1920 ; 1557-1912
    ISSN (online) 1557-1920
    ISSN 1557-1912
    DOI 10.1007/s10903-022-01435-4
    Database MEDical Literature Analysis and Retrieval System OnLINE

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