The Experts below are selected from a list of 360 Experts worldwide ranked by ideXlab platform

Tracy A Lieu - One of the best experts on this subject based on the ideXlab platform.

  • the food and drug administration s post licensure rapid immunization safety monitoring program strengthening the federal vaccine safety enterprise
    Pharmacoepidemiology and Drug Safety, 2012
    Co-Authors: Michael Nguyen, Robert Ball, Karen Midthun, Tracy A Lieu
    Abstract:

    In 2009, the Department of Health and Human Services created the new Post-Licensure Rapid Immunization Safety Monitoring (Prism) program, which used data from national health insurance plans and immunization registries to monitor the safety of the H1N1 influenza vaccine. Prism has now been integrated into the FDA's Mini-Sentinel pilot program. It strengthens the federal vaccine safety enterprise in two important ways. First, Prism monitors the largest US general population cohort designated for active surveillance of vaccine safety. Second, Prism links data from health plans with data from state and city immunization registries, which were a crucial source of exposure data in the H1N1 vaccine evaluation. The Mini-Sentinel data that support Prism are updated quarterly, and Prism can conduct medical record review for validation of computerized data. The FDA has structured Prism as a program that includes specific vaccine evaluations, development of an operational framework to guide the design of vaccine safety evaluations, and development of new statistical methods. A human papillomavirus vaccine, Gardasil, and two rotavirus vaccines, RotaTeq and Rotarix, have been chosen for surveillance in the current cycle because their evaluations would benefit most from Prism's large cohort size. The Prism program creates important opportunities by offering a robust, responsive new surveillance program with features complementary to existing systems. Methodological and logistical lessons can be shared among Prism and other surveillance systems, offering potential synergies. FDA and Prism will work to maximize the program's unique strengths and contributions to a unified federal vaccine safety enterprise. Copyright © 2012 John Wiley & Sons, Ltd.

  • the food and drug administration s post licensure rapid immunization safety monitoring program strengthening the federal vaccine safety enterprise
    Pharmacoepidemiology and Drug Safety, 2012
    Co-Authors: Michael Nguyen, Robert Ball, Karen Midthun, Tracy A Lieu
    Abstract:

    In 2009, the Department of Health and Human Services created the new Post-Licensure Rapid Immunization Safety Monitoring (Prism) program, which used data from national health insurance plans and immunization registries to monitor the safety of the H1N1 influenza vaccine. Prism has now been integrated into the FDA's Mini-Sentinel pilot program. It strengthens the federal vaccine safety enterprise in two important ways. First, Prism monitors the largest US general population cohort designated for active surveillance of vaccine safety. Second, Prism links data from health plans with data from state and city immunization registries, which were a crucial source of exposure data in the H1N1 vaccine evaluation. The Mini-Sentinel data that support Prism are updated quarterly, and Prism can conduct medical record review for validation of computerized data. The FDA has structured Prism as a program that includes specific vaccine evaluations, development of an operational framework to guide the design of vaccine safety evaluations, and development of new statistical methods. A human papillomavirus vaccine, Gardasil, and two rotavirus vaccines, RotaTeq and Rotarix, have been chosen for surveillance in the current cycle because their evaluations would benefit most from Prism's large cohort size. The Prism program creates important opportunities by offering a robust, responsive new surveillance program with features complementary to existing systems. Methodological and logistical lessons can be shared among Prism and other surveillance systems, offering potential synergies. FDA and Prism will work to maximize the program's unique strengths and contributions to a unified federal vaccine safety enterprise.

Michael Nguyen - One of the best experts on this subject based on the ideXlab platform.

  • the food and drug administration s post licensure rapid immunization safety monitoring program strengthening the federal vaccine safety enterprise
    Pharmacoepidemiology and Drug Safety, 2012
    Co-Authors: Michael Nguyen, Robert Ball, Karen Midthun, Tracy A Lieu
    Abstract:

    In 2009, the Department of Health and Human Services created the new Post-Licensure Rapid Immunization Safety Monitoring (Prism) program, which used data from national health insurance plans and immunization registries to monitor the safety of the H1N1 influenza vaccine. Prism has now been integrated into the FDA's Mini-Sentinel pilot program. It strengthens the federal vaccine safety enterprise in two important ways. First, Prism monitors the largest US general population cohort designated for active surveillance of vaccine safety. Second, Prism links data from health plans with data from state and city immunization registries, which were a crucial source of exposure data in the H1N1 vaccine evaluation. The Mini-Sentinel data that support Prism are updated quarterly, and Prism can conduct medical record review for validation of computerized data. The FDA has structured Prism as a program that includes specific vaccine evaluations, development of an operational framework to guide the design of vaccine safety evaluations, and development of new statistical methods. A human papillomavirus vaccine, Gardasil, and two rotavirus vaccines, RotaTeq and Rotarix, have been chosen for surveillance in the current cycle because their evaluations would benefit most from Prism's large cohort size. The Prism program creates important opportunities by offering a robust, responsive new surveillance program with features complementary to existing systems. Methodological and logistical lessons can be shared among Prism and other surveillance systems, offering potential synergies. FDA and Prism will work to maximize the program's unique strengths and contributions to a unified federal vaccine safety enterprise. Copyright © 2012 John Wiley & Sons, Ltd.

  • the food and drug administration s post licensure rapid immunization safety monitoring program strengthening the federal vaccine safety enterprise
    Pharmacoepidemiology and Drug Safety, 2012
    Co-Authors: Michael Nguyen, Robert Ball, Karen Midthun, Tracy A Lieu
    Abstract:

    In 2009, the Department of Health and Human Services created the new Post-Licensure Rapid Immunization Safety Monitoring (Prism) program, which used data from national health insurance plans and immunization registries to monitor the safety of the H1N1 influenza vaccine. Prism has now been integrated into the FDA's Mini-Sentinel pilot program. It strengthens the federal vaccine safety enterprise in two important ways. First, Prism monitors the largest US general population cohort designated for active surveillance of vaccine safety. Second, Prism links data from health plans with data from state and city immunization registries, which were a crucial source of exposure data in the H1N1 vaccine evaluation. The Mini-Sentinel data that support Prism are updated quarterly, and Prism can conduct medical record review for validation of computerized data. The FDA has structured Prism as a program that includes specific vaccine evaluations, development of an operational framework to guide the design of vaccine safety evaluations, and development of new statistical methods. A human papillomavirus vaccine, Gardasil, and two rotavirus vaccines, RotaTeq and Rotarix, have been chosen for surveillance in the current cycle because their evaluations would benefit most from Prism's large cohort size. The Prism program creates important opportunities by offering a robust, responsive new surveillance program with features complementary to existing systems. Methodological and logistical lessons can be shared among Prism and other surveillance systems, offering potential synergies. FDA and Prism will work to maximize the program's unique strengths and contributions to a unified federal vaccine safety enterprise.

Karen Midthun - One of the best experts on this subject based on the ideXlab platform.

  • the food and drug administration s post licensure rapid immunization safety monitoring program strengthening the federal vaccine safety enterprise
    Pharmacoepidemiology and Drug Safety, 2012
    Co-Authors: Michael Nguyen, Robert Ball, Karen Midthun, Tracy A Lieu
    Abstract:

    In 2009, the Department of Health and Human Services created the new Post-Licensure Rapid Immunization Safety Monitoring (Prism) program, which used data from national health insurance plans and immunization registries to monitor the safety of the H1N1 influenza vaccine. Prism has now been integrated into the FDA's Mini-Sentinel pilot program. It strengthens the federal vaccine safety enterprise in two important ways. First, Prism monitors the largest US general population cohort designated for active surveillance of vaccine safety. Second, Prism links data from health plans with data from state and city immunization registries, which were a crucial source of exposure data in the H1N1 vaccine evaluation. The Mini-Sentinel data that support Prism are updated quarterly, and Prism can conduct medical record review for validation of computerized data. The FDA has structured Prism as a program that includes specific vaccine evaluations, development of an operational framework to guide the design of vaccine safety evaluations, and development of new statistical methods. A human papillomavirus vaccine, Gardasil, and two rotavirus vaccines, RotaTeq and Rotarix, have been chosen for surveillance in the current cycle because their evaluations would benefit most from Prism's large cohort size. The Prism program creates important opportunities by offering a robust, responsive new surveillance program with features complementary to existing systems. Methodological and logistical lessons can be shared among Prism and other surveillance systems, offering potential synergies. FDA and Prism will work to maximize the program's unique strengths and contributions to a unified federal vaccine safety enterprise. Copyright © 2012 John Wiley & Sons, Ltd.

  • the food and drug administration s post licensure rapid immunization safety monitoring program strengthening the federal vaccine safety enterprise
    Pharmacoepidemiology and Drug Safety, 2012
    Co-Authors: Michael Nguyen, Robert Ball, Karen Midthun, Tracy A Lieu
    Abstract:

    In 2009, the Department of Health and Human Services created the new Post-Licensure Rapid Immunization Safety Monitoring (Prism) program, which used data from national health insurance plans and immunization registries to monitor the safety of the H1N1 influenza vaccine. Prism has now been integrated into the FDA's Mini-Sentinel pilot program. It strengthens the federal vaccine safety enterprise in two important ways. First, Prism monitors the largest US general population cohort designated for active surveillance of vaccine safety. Second, Prism links data from health plans with data from state and city immunization registries, which were a crucial source of exposure data in the H1N1 vaccine evaluation. The Mini-Sentinel data that support Prism are updated quarterly, and Prism can conduct medical record review for validation of computerized data. The FDA has structured Prism as a program that includes specific vaccine evaluations, development of an operational framework to guide the design of vaccine safety evaluations, and development of new statistical methods. A human papillomavirus vaccine, Gardasil, and two rotavirus vaccines, RotaTeq and Rotarix, have been chosen for surveillance in the current cycle because their evaluations would benefit most from Prism's large cohort size. The Prism program creates important opportunities by offering a robust, responsive new surveillance program with features complementary to existing systems. Methodological and logistical lessons can be shared among Prism and other surveillance systems, offering potential synergies. FDA and Prism will work to maximize the program's unique strengths and contributions to a unified federal vaccine safety enterprise.

Robert Ball - One of the best experts on this subject based on the ideXlab platform.

  • the food and drug administration s post licensure rapid immunization safety monitoring program strengthening the federal vaccine safety enterprise
    Pharmacoepidemiology and Drug Safety, 2012
    Co-Authors: Michael Nguyen, Robert Ball, Karen Midthun, Tracy A Lieu
    Abstract:

    In 2009, the Department of Health and Human Services created the new Post-Licensure Rapid Immunization Safety Monitoring (Prism) program, which used data from national health insurance plans and immunization registries to monitor the safety of the H1N1 influenza vaccine. Prism has now been integrated into the FDA's Mini-Sentinel pilot program. It strengthens the federal vaccine safety enterprise in two important ways. First, Prism monitors the largest US general population cohort designated for active surveillance of vaccine safety. Second, Prism links data from health plans with data from state and city immunization registries, which were a crucial source of exposure data in the H1N1 vaccine evaluation. The Mini-Sentinel data that support Prism are updated quarterly, and Prism can conduct medical record review for validation of computerized data. The FDA has structured Prism as a program that includes specific vaccine evaluations, development of an operational framework to guide the design of vaccine safety evaluations, and development of new statistical methods. A human papillomavirus vaccine, Gardasil, and two rotavirus vaccines, RotaTeq and Rotarix, have been chosen for surveillance in the current cycle because their evaluations would benefit most from Prism's large cohort size. The Prism program creates important opportunities by offering a robust, responsive new surveillance program with features complementary to existing systems. Methodological and logistical lessons can be shared among Prism and other surveillance systems, offering potential synergies. FDA and Prism will work to maximize the program's unique strengths and contributions to a unified federal vaccine safety enterprise. Copyright © 2012 John Wiley & Sons, Ltd.

  • the food and drug administration s post licensure rapid immunization safety monitoring program strengthening the federal vaccine safety enterprise
    Pharmacoepidemiology and Drug Safety, 2012
    Co-Authors: Michael Nguyen, Robert Ball, Karen Midthun, Tracy A Lieu
    Abstract:

    In 2009, the Department of Health and Human Services created the new Post-Licensure Rapid Immunization Safety Monitoring (Prism) program, which used data from national health insurance plans and immunization registries to monitor the safety of the H1N1 influenza vaccine. Prism has now been integrated into the FDA's Mini-Sentinel pilot program. It strengthens the federal vaccine safety enterprise in two important ways. First, Prism monitors the largest US general population cohort designated for active surveillance of vaccine safety. Second, Prism links data from health plans with data from state and city immunization registries, which were a crucial source of exposure data in the H1N1 vaccine evaluation. The Mini-Sentinel data that support Prism are updated quarterly, and Prism can conduct medical record review for validation of computerized data. The FDA has structured Prism as a program that includes specific vaccine evaluations, development of an operational framework to guide the design of vaccine safety evaluations, and development of new statistical methods. A human papillomavirus vaccine, Gardasil, and two rotavirus vaccines, RotaTeq and Rotarix, have been chosen for surveillance in the current cycle because their evaluations would benefit most from Prism's large cohort size. The Prism program creates important opportunities by offering a robust, responsive new surveillance program with features complementary to existing systems. Methodological and logistical lessons can be shared among Prism and other surveillance systems, offering potential synergies. FDA and Prism will work to maximize the program's unique strengths and contributions to a unified federal vaccine safety enterprise.

Sara R A Wijnant - One of the best experts on this subject based on the ideXlab platform.

  • trajectory and mortality of preserved ratio impaired spirometry the rotterdam study
    European Respiratory Journal, 2020
    Co-Authors: Sara R A Wijnant, Emmely De Roos, Maryam Kavousi, Bruno H Stricker, Natalie Terzikhan, Lies Lahousse
    Abstract:

    Preserved ratio impaired spirometry (Prism) is a heterogeneous condition but its course and disease progression remain to be elucidated. We aimed to examine its prevalence, trajectories and prognosis in the general population.In the Rotterdam Study (population-based prospective cohort) we examined prevalence, trajectories and prognosis of subjects with normal spirometry (controls; forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ≥0.7, FEV1  ≥80%), Prism (FEV1/FVC ≥0.7, FEV1 <80%) and chronic obstructive pulmonary disease (COPD) (FEV1/FVC <0.7) at two study visits. Hazard ratios with 95% confidence intervals for mortality (until December 30, 2018) were adjusted for age, sex, body mass index, current smoking and pack-years.Of 5487 subjects (age 69.1±8.9 years; 7.1% Prism), 1603 were re-examined after 4.5 years. Of the re-examined Prism subjects, 15.7% transitioned to normal spirometry and 49.4% to COPD. Median lung function decline was highest in subjects with incident Prism (FEV1 -92.8 mL·year-1, interquartile range (IQR) -131.9- -65.8 mL·year-1; FVC -93.3 mL·year-1, IQR -159.8- -49.1 mL·year-1), but similar in persistent Prism (FEV1 -30.2 mL·year-1, IQR -67.9- -7.5 mL·year-1; FVC -20.1 mL·year-1, IQR -47.7-21.7 mL·year-1) and persistent controls (FEV1 -39.6 mL·year-1, IQR -64.3--12.7 mL·year-1; FVC -20.0 mL·year-1, IQR -55.4-18.8 mL·year-1). Of 5459 subjects with informed consent for follow-up, 692 (12.7%) died during 9.3 years (maximum) follow-up: 10.3% of controls, 18.7% of Prism subjects and 20.8% of COPD subjects. Relative to controls, subjects with Prism and COPD Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2-4 had increased all-cause mortality (Prism: HR 1.6, 95% CI 1.2-2.0; COPD GOLD 2-4: HR 1.7, 95% CI 1.4-2.1) and cardiovascular mortality (Prism: HR 2.8, 95% CI 1.5-5.1; COPD 2-4: HR 2.1, 95% CI 1.2-3.6). Mortality within <1 year was highest in Prism, with patients often having cardiovascular comorbidities (heart failure or coronary heart disease; 70.0%).Prism is associated with increased mortality and this population encompasses at least three distinct subsets: one that develops COPD during follow-up, a second with high cardiovascular burden and early mortality, and a third with persistent Prism and normal age-related lung function decline.