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  1. Article: Conformity between protocol eligibility criteria for electronic patient identification: a comparison of clinical trials.

    Kamauu, Allise / Agbor, Stephen / Kamauu, Aaron

    Studies in health technology and informatics

    2013  Volume 192, Page(s) 1167

    Abstract: Clinical trial eligibility criteria define the target patient population for research studies. We assessed the eligibility criteria from 40 different protocols for Type II Diabetes Mellitus and depression (20 protocols each), to determine the extent to ... ...

    Abstract Clinical trial eligibility criteria define the target patient population for research studies. We assessed the eligibility criteria from 40 different protocols for Type II Diabetes Mellitus and depression (20 protocols each), to determine the extent to which protocol eligibility criteria were similar at three levels (test, test-value, and test-value-time clause). This was done to determine criteria that could be standardized to aid in identification of eligible patients from electronic health records. It was found that Type II Diabetes Mellitus had 36.9% similar and depression protocols had 53.1% similar at the test-value-clause level. This study demonstrates the need for more standardization of study protocol criteria as well as the associated query definitions to be run against the electronic healthcare data. Standardizing criteria based on the similar eligibility criteria between protocols will aid in patient recruitment by being able to reuse criteria and minimizing the time and money it takes to recruit patients.
    MeSH term(s) Clinical Trials as Topic/methods ; Data Mining ; Depression/therapy ; Diabetes Mellitus, Type 2/therapy ; Electronic Health Records/classification ; Eligibility Determination/methods ; Humans ; Patient Identification Systems/methods ; Patient Selection ; United States
    Language English
    Publishing date 2013
    Publishing country Netherlands
    Document type Comparative Study ; Journal Article
    ISSN 0926-9630
    ISSN 0926-9630
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Cost-utility analysis of antiviral use under pandemic influenza using a novel approach - linking pharmacology, epidemiology and heath economics.

    Wu, D B C / Chaiyakunapruk, N / Pratoomsoot, C / Lee, K K C / Chong, H Y / Nelson, R E / Smith, P F / Kirkpatrick, C M / Kamal, M A / Nieforth, K / Dall, G / Toovey, S / Kong, D C M / Kamauu, A / Rayner, C R

    Epidemiology and infection

    2018  Volume 146, Issue 4, Page(s) 496–507

    Abstract: Simulation models are used widely in pharmacology, epidemiology and health economics (HEs). However, there have been no attempts to incorporate models from these disciplines into a single integrated model. Accordingly, we explored this linkage to ... ...

    Abstract Simulation models are used widely in pharmacology, epidemiology and health economics (HEs). However, there have been no attempts to incorporate models from these disciplines into a single integrated model. Accordingly, we explored this linkage to evaluate the epidemiological and economic impact of oseltamivir dose optimisation in supporting pandemic influenza planning in the USA. An HE decision analytic model was linked to a pharmacokinetic/pharmacodynamics (PK/PD) - dynamic transmission model simulating the impact of pandemic influenza with low virulence and low transmissibility and, high virulence and high transmissibility. The cost-utility analysis was from the payer and societal perspectives, comparing oseltamivir 75 and 150 mg twice daily (BID) to no treatment over a 1-year time horizon. Model parameters were derived from published studies. Outcomes were measured as cost per quality-adjusted life year (QALY) gained. Sensitivity analyses were performed to examine the integrated model's robustness. Under both pandemic scenarios, compared to no treatment, the use of oseltamivir 75 or 150 mg BID led to a significant reduction of influenza episodes and influenza-related deaths, translating to substantial savings of QALYs. Overall drug costs were offset by the reduction of both direct and indirect costs, making these two interventions cost-saving from both perspectives. The results were sensitive to the proportion of inpatient presentation at the emergency visit and patients' quality of life. Integrating PK/PD-EPI/HE models is achievable. Whilst further refinement of this novel linkage model to more closely mimic the reality is needed, the current study has generated useful insights to support influenza pandemic planning.
    MeSH term(s) Adolescent ; Adult ; Aged ; Antiviral Agents/economics ; Antiviral Agents/therapeutic use ; Child ; Child, Preschool ; Cost-Benefit Analysis ; Drug Costs ; Female ; Humans ; Infant ; Influenza, Human/drug therapy ; Influenza, Human/epidemiology ; Male ; Middle Aged ; Models, Economic ; Models, Theoretical ; Oseltamivir/economics ; Oseltamivir/therapeutic use ; Pandemics ; Quality-Adjusted Life Years
    Chemical Substances Antiviral Agents ; Oseltamivir (20O93L6F9H)
    Language English
    Publishing date 2018-02-15
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 632982-2
    ISSN 1469-4409 ; 0950-2688
    ISSN (online) 1469-4409
    ISSN 0950-2688
    DOI 10.1017/S0950268818000158
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Cost-Utility Analysis of Optimal Dosing of Oseltamivir Under Pandemic Influenza Using a Novel Approach: Linking Health Economics and Transmission Dynamic Models.

    Wu, D B C / Chaiyakunapruk, N / Pratoomsoot, C / Lee, K K C / Chong, H Y / Nelson, R E / Smith, P F / Kirkpatrick, C / Kamal, M A / Nieforth, K / Dall, G / Toovey, S / Kong, D C / Kamauu, A / Rayner, C

    Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

    2014  Volume 17, Issue 7, Page(s) A807

    Language English
    Publishing date 2014-11
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1471745-1
    ISSN 1524-4733 ; 1098-3015
    ISSN (online) 1524-4733
    ISSN 1098-3015
    DOI 10.1016/j.jval.2014.08.527
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    Zs.A 5904: Show issues Location:
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    Jg. 1995 - 2021: Lesesall (2.OG)
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  4. Article ; Online: Risk of hospitalized bacterial infections associated with biologic treatment among US veterans with rheumatoid arthritis.

    Curtis, J R / Yang, S / Patkar, N M / Chen, L / Singh, J A / Cannon, G W / Mikuls, T R / Delzell, E / Saag, K G / Safford, M M / DuVall, S / Alexander, K / Napalkov, P / Winthrop, Kevin L / Burton, M J / Kamauu, A / Baddley, J W

    Arthritis care & research

    2014  Volume 66, Issue 7, Page(s) 990–997

    Abstract: Objective: The comparative risk of infection associated with non-anti-tumor necrosis factor (anti-TNF) biologic agents is not well established. Our objective was to compare risk for hospitalized infections between anti-TNF and non-anti-TNF biologic ... ...

    Abstract Objective: The comparative risk of infection associated with non-anti-tumor necrosis factor (anti-TNF) biologic agents is not well established. Our objective was to compare risk for hospitalized infections between anti-TNF and non-anti-TNF biologic agents in US veterans with rheumatoid arthritis (RA).
    Methods: Using 1998-2011 data from the US Veterans Health Administration, we studied RA patients initiating rituximab, abatacept, or anti-TNF therapy. Exposure was based upon days supplied (injections) or usual dosing intervals (infusions). Treatment episodes were defined as new biologic agent use. Hazard ratios (HRs) and 95% confidence intervals (95% CIs) for hospitalization for a bacterial infection were estimated from Cox proportional hazards models, adjusting for potential confounders.
    Results: Among 3,152 unique RA patients contributing 4,158 biologic treatment episodes to rituximab (n = 596), abatacept (n = 451), and anti-TNF agents (n = 3,111), the patient mean age was 60 years and 87% were male. The most common infections were pneumonia (37%), skin/soft tissue (22%), urinary tract (9%), and bacteremia/sepsis (7%). Hospitalized infection rates per 100 person-years were 4.4 (95% CI 3.1-6.4) for rituximab, 2.8 (95% CI 1.7-4.7) for abatacept, and 3.0 (95% CI 2.5-3.5) for anti-TNF. Compared to etanercept, the adjusted rate of hospitalized infection was not different for adalimumab (HR 1.4, 95% CI 0.9-2.2), abatacept (HR 1.1, 95% CI 0.6-2.1), or rituximab (HR 1.4, 0.8-2.6), although it was increased for infliximab (HR 2.3, 95% CI 1.3-4.0). Infection risk was greater for those taking prednisone >7.5 mg/day (HR 1.8, 95% CI 1.3-2.7) and in the highest quartile of C-reactive protein (HR 2.3, 95% CI 1.4-3.8) and erythrocyte sedimentation rate (HR 4.1, 95% CI 2.3-7.2) compared to the lowest quartile.
    Conclusion: In older, predominantly male US veterans with RA, the risk of hospitalized bacterial infections associated with rituximab or abatacept was similar to etanercept.
    MeSH term(s) Abatacept ; Aged ; Antibodies, Monoclonal, Murine-Derived/adverse effects ; Antirheumatic Agents/adverse effects ; Arthritis, Rheumatoid/complications ; Arthritis, Rheumatoid/drug therapy ; Arthritis, Rheumatoid/epidemiology ; Bacterial Infections/epidemiology ; Bacterial Infections/etiology ; Comorbidity ; Female ; Glucocorticoids/adverse effects ; Hospitalization ; Humans ; Immunoconjugates/adverse effects ; Incidence ; Male ; Middle Aged ; Retrospective Studies ; Risk Assessment ; Rituximab ; Tumor Necrosis Factor-alpha/antagonists & inhibitors ; United States/epidemiology ; Veterans/statistics & numerical data
    Chemical Substances Antibodies, Monoclonal, Murine-Derived ; Antirheumatic Agents ; Glucocorticoids ; Immunoconjugates ; Tumor Necrosis Factor-alpha ; Rituximab (4F4X42SYQ6) ; Abatacept (7D0YB67S97)
    Language English
    Publishing date 2014-02-18
    Publishing country United States
    Document type Comparative Study ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 645059-3
    ISSN 2151-4658 ; 0893-7524 ; 2151-464X
    ISSN (online) 2151-4658
    ISSN 0893-7524 ; 2151-464X
    DOI 10.1002/acr.22281
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    Zs.A 2446: Show issues Location:
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  5. Article ; Online: Interdisciplinary pharmacometrics linking oseltamivir pharmacology, influenza epidemiology and health economics to inform antiviral use in pandemics.

    Kamal, Mohamed A / Smith, Patrick F / Chaiyakunapruk, Nathorn / Wu, David B C / Pratoomsoot, Chayanin / Lee, Kenneth K C / Chong, Huey Yi / Nelson, Richard E / Nieforth, Keith / Dall, Georgina / Toovey, Stephen / Kong, David C M / Kamauu, Aaron / Kirkpatrick, Carl M / Rayner, Craig R

    British journal of clinical pharmacology

    2017  Volume 83, Issue 7, Page(s) 1580–1594

    Abstract: Aims: A modular interdisciplinary platform was developed to investigate the economic impact of oseltamivir treatment by dosage regimen under simulated influenza pandemic scenarios.: Methods: The pharmacology module consisted of a pharmacokinetic ... ...

    Abstract Aims: A modular interdisciplinary platform was developed to investigate the economic impact of oseltamivir treatment by dosage regimen under simulated influenza pandemic scenarios.
    Methods: The pharmacology module consisted of a pharmacokinetic distribution of oseltamivir carboxylate daily area under the concentration-time curve at steady state (simulated for 75 mg and 150 mg twice daily regimens for 5 days) and a pharmacodynamic distribution of viral shedding duration obtained from phase II influenza inoculation data. The epidemiological module comprised a susceptible, exposed, infected, recovered (SEIR) model to which drug effect on the basic reproductive number (R
    Results: Oseltamivir 75 mg relative to no treatment reduced the median number of infected patients, increased change in quality-adjusted life years by deaths averted, and was cost-saving under all scenarios; 150 mg relative to 75 mg was not cost effective in low transmissibility scenarios but was cost saving in high transmissibility scenarios.
    Conclusion: This methodological study demonstrates proof of concept that the disciplines of pharmacology, disease epidemiology and health economics can be linked in a single quantitative framework.
    MeSH term(s) Antiviral Agents/economics ; Antiviral Agents/pharmacology ; Antiviral Agents/therapeutic use ; Cost-Benefit Analysis/methods ; Humans ; Influenza, Human/drug therapy ; Influenza, Human/economics ; Influenza, Human/epidemiology ; Influenza, Human/mortality ; Interdisciplinary Communication ; Methods ; Models, Theoretical ; Oseltamivir/economics ; Oseltamivir/pharmacology ; Oseltamivir/therapeutic use ; Pandemics/economics
    Chemical Substances Antiviral Agents ; Oseltamivir (20O93L6F9H)
    Language English
    Publishing date 2017-02-20
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 188974-6
    ISSN 1365-2125 ; 0306-5251 ; 0264-3774
    ISSN (online) 1365-2125
    ISSN 0306-5251 ; 0264-3774
    DOI 10.1111/bcp.13229
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