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Session Title: Ethics and Epidemiologic Decision-Making for Population Benefits
680
Abstracts / Annals of Epidemiology 22 (2012) 661e680
Session Title: Epidemiology and Evaluating Patient Outcomes Rising preterm births and prenatal care: are they connected? Diane S. Lauderdale PhD. Department of Health Studies, University of Chicago, Chicago, IL Overview: Health policy has supported increased access to and utilization of prenatal care with the object of decreasing preterm birth. While rates of prenatal care have increased in the past two decades, so too have rates of preterm birth. This session will present a series of studies exploring how prenatal care is related to increased preterm birth. Objectives: We will examine trends in the content and utilization of prenatal care in the United States over the past two decades using data from the National Ambulatory Medical Care Survey (NAMCS), National Hospital Ambulatory Medical Care Survey (NHAMCS) and birth certificate data. Then we will examine trends in preterm birth, separating spontaneous and medically induced births. We will test whether rising rates of preterm birth may be due to changing demographics of mothers, such as more high risk mothers who are older or having multiple births, and we will test whether medically induced preterm birth could mediate an association between increased prenatal care and lower rates of infant mortality. Moderator: Denise Oleske, PhD
Keynote Address: “How Epidemiology Shaped Healthy Chicago” Bechara Choucair MD. Commissioner, Chicago Department of Public Health Roderick Jones, MPH, Director of Epidemiology, Chicago Department of Public Health Overview: Released in August 2011, Healthy Chicago is the first-ever comprehensive plan for public health put forth by the City of Chicago. Mayor Emanuel originally called for the formation of an agenda during his transition report and Healthy Chicago now serves as a blueprint for a focused approach by CDPH to implement policies, systems, and environmental changes to prioritize and transform the health of the city over the next five years. Epidemiologic analysis and interpretation provided a foundation for three key aspects of the plan: 1) the development of 12 priority areas; 2) the establishment of meaningful indicators for use in defining baselines and targets; and 3) the identification of data gaps that required filling for adequate evaluation and monitoring of the plan. We report on our use of methodologies from Healthy People 2020 and other references, and how Healthy Chicago has spurred innovative approaches to epidemiologic analyses using data from public school physical exams, school-based oral health encounters, and outpatient health center networks.
health: assessment, policy development, and assurance. Population sciences– including epidemiology; behavioral, social, and communication sciences; and health economics, implementation science, and outcomes research–are needed to show value of genomic medicine. A “translational” epidemiologic foundation is strongly needed to subject genome-based discoveries to rigorous evaluation, evidence-based recommendations, and measurement of implementation and population health indicators.
Session Title: Ethics and Epidemiologic Decision-Making for Population Benefits James E. Enstrom PhD. UCLA, Los Angeles, CA, J. Morel Symons PhD. DuPont Epidemiology Program, Newark, DE Overview: Three professional ethical standards are paramount in determining the best approach to using epidemiology data to benefit population health: 1) inclusion of all well-designed and conducted studies; 2) consideration of effect size and population attributable risk; and 3) careful examination of causality. Epidemiology studies often show small effect size, statistical non-significance, and/or inconsistency with previous results. While weightof-evidence guidelines are widely available for the interpretation of epidemiologic research, these guidelines are useful mainly for qualitative hazard determinations for human health effects, e.g., the Hill criteria. We discuss the need for increased emphasis on variations in geographical exposure measurements, as well as the importance of effect size and population attributable risk, citing for example the relationship between fine particulate air pollution (PM2.5) and total mortality. Approaches that combine innovative statistical techniques with modern methods for causal inference may enhance the quantitative estimation of population benefits based on more inclusive use of epidemiologic study results Objectives: The objective of this Panel is to clarify ethical and epidemiologic principles that can promote better use of epidemiologic data for establishing policies and regulations concerning human exposure to potential health risk factors. Moderator: Robin C Leonard, Dept. of Health, West Chester University of PA, West Chester, PA
Session Title: Ethics and Epidemiologic Decision-Making for Population Benefits Establishing Causality for Small Effect Sizes with Large Population Lou M. Gallagher PhD. Center for Biologics Evaluation and Research, USFDA, Rockville, MD
Translational Genomic Epidemiology: From the Science of Discovery to the Science of Action M.J. Khoury. Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, Georgia Overview: Advances in genomics and related technologies are promising a new era of personalized or precision medicine in which treatments and other interventions are tailored to people's unique genetic and other characteristics. The term P4 medicine is often used to denote this evolving field of medicine. Its four components include predictive, preventive, personalized and participatory medicine. In order to fulfill the promise of P4 medicine we need to integrate a “fifth P”–the population perspective–into each of the other four components. A population perspective integrates predictive medicine into the ecological model of health; applies principles of population screening to preventive medicine; uses evidence-based practice to personalize medicine; and grounds participatory medicine on the three core functions of public
Overview: Careful examinations of causality, effect size and statistical significance are the first responsibility of scientists using epidemiological data for population benefit risk assessment. Objectives: This presentation will provide examples of environmental epidemiological data with small effect sizes that have supported sciencebased decision making for public health benefits in federal government, describe the complex environment of establishing causality from an existing evidence base including epidemiological, toxicological and other data and discuss significant public health outcomes associated with population-level exposures at small effect sizes. The use of epidemiological data in quantitative risk assessment, and standard models for dose-response evaluation at low doses will be discussed. Moderator: Robin Leonard, Westchester University of Pennsylvania Department of Health “The findings and conclusions in this [article, speech, or presentation] have not been formally disseminated by the Food and Drug Administration and should not be construed to represent any Agency determination or policy.”
Abstracts / Annals of Epidemiology 22 (2012) 661e680
Session Title: Epidemiology and Evaluating Patient Outcomes Rising preterm births and prenatal care: are they connected? Diane S. Lauderdale PhD. Department of Health Studies, University of Chicago, Chicago, IL Overview: Health policy has supported increased access to and utilization of prenatal care with the object of decreasing preterm birth. While rates of prenatal care have increased in the past two decades, so too have rates of preterm birth. This session will present a series of studies exploring how prenatal care is related to increased preterm birth. Objectives: We will examine trends in the content and utilization of prenatal care in the United States over the past two decades using data from the National Ambulatory Medical Care Survey (NAMCS), National Hospital Ambulatory Medical Care Survey (NHAMCS) and birth certificate data. Then we will examine trends in preterm birth, separating spontaneous and medically induced births. We will test whether rising rates of preterm birth may be due to changing demographics of mothers, such as more high risk mothers who are older or having multiple births, and we will test whether medically induced preterm birth could mediate an association between increased prenatal care and lower rates of infant mortality. Moderator: Denise Oleske, PhD
Keynote Address: “How Epidemiology Shaped Healthy Chicago” Bechara Choucair MD. Commissioner, Chicago Department of Public Health Roderick Jones, MPH, Director of Epidemiology, Chicago Department of Public Health Overview: Released in August 2011, Healthy Chicago is the first-ever comprehensive plan for public health put forth by the City of Chicago. Mayor Emanuel originally called for the formation of an agenda during his transition report and Healthy Chicago now serves as a blueprint for a focused approach by CDPH to implement policies, systems, and environmental changes to prioritize and transform the health of the city over the next five years. Epidemiologic analysis and interpretation provided a foundation for three key aspects of the plan: 1) the development of 12 priority areas; 2) the establishment of meaningful indicators for use in defining baselines and targets; and 3) the identification of data gaps that required filling for adequate evaluation and monitoring of the plan. We report on our use of methodologies from Healthy People 2020 and other references, and how Healthy Chicago has spurred innovative approaches to epidemiologic analyses using data from public school physical exams, school-based oral health encounters, and outpatient health center networks.
health: assessment, policy development, and assurance. Population sciences– including epidemiology; behavioral, social, and communication sciences; and health economics, implementation science, and outcomes research–are needed to show value of genomic medicine. A “translational” epidemiologic foundation is strongly needed to subject genome-based discoveries to rigorous evaluation, evidence-based recommendations, and measurement of implementation and population health indicators.
Session Title: Ethics and Epidemiologic Decision-Making for Population Benefits James E. Enstrom PhD. UCLA, Los Angeles, CA, J. Morel Symons PhD. DuPont Epidemiology Program, Newark, DE Overview: Three professional ethical standards are paramount in determining the best approach to using epidemiology data to benefit population health: 1) inclusion of all well-designed and conducted studies; 2) consideration of effect size and population attributable risk; and 3) careful examination of causality. Epidemiology studies often show small effect size, statistical non-significance, and/or inconsistency with previous results. While weightof-evidence guidelines are widely available for the interpretation of epidemiologic research, these guidelines are useful mainly for qualitative hazard determinations for human health effects, e.g., the Hill criteria. We discuss the need for increased emphasis on variations in geographical exposure measurements, as well as the importance of effect size and population attributable risk, citing for example the relationship between fine particulate air pollution (PM2.5) and total mortality. Approaches that combine innovative statistical techniques with modern methods for causal inference may enhance the quantitative estimation of population benefits based on more inclusive use of epidemiologic study results Objectives: The objective of this Panel is to clarify ethical and epidemiologic principles that can promote better use of epidemiologic data for establishing policies and regulations concerning human exposure to potential health risk factors. Moderator: Robin C Leonard, Dept. of Health, West Chester University of PA, West Chester, PA
Session Title: Ethics and Epidemiologic Decision-Making for Population Benefits Establishing Causality for Small Effect Sizes with Large Population Lou M. Gallagher PhD. Center for Biologics Evaluation and Research, USFDA, Rockville, MD
Translational Genomic Epidemiology: From the Science of Discovery to the Science of Action M.J. Khoury. Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, Georgia Overview: Advances in genomics and related technologies are promising a new era of personalized or precision medicine in which treatments and other interventions are tailored to people's unique genetic and other characteristics. The term P4 medicine is often used to denote this evolving field of medicine. Its four components include predictive, preventive, personalized and participatory medicine. In order to fulfill the promise of P4 medicine we need to integrate a “fifth P”–the population perspective–into each of the other four components. A population perspective integrates predictive medicine into the ecological model of health; applies principles of population screening to preventive medicine; uses evidence-based practice to personalize medicine; and grounds participatory medicine on the three core functions of public
Overview: Careful examinations of causality, effect size and statistical significance are the first responsibility of scientists using epidemiological data for population benefit risk assessment. Objectives: This presentation will provide examples of environmental epidemiological data with small effect sizes that have supported sciencebased decision making for public health benefits in federal government, describe the complex environment of establishing causality from an existing evidence base including epidemiological, toxicological and other data and discuss significant public health outcomes associated with population-level exposures at small effect sizes. The use of epidemiological data in quantitative risk assessment, and standard models for dose-response evaluation at low doses will be discussed. Moderator: Robin Leonard, Westchester University of Pennsylvania Department of Health “The findings and conclusions in this [article, speech, or presentation] have not been formally disseminated by the Food and Drug Administration and should not be construed to represent any Agency determination or policy.”