Podcast
Questions and Answers
What is the main purpose of generating a hypothesis in epidemiologic studies?
What is the main purpose of generating a hypothesis in epidemiologic studies?
- To gather data from various health care records
- To clarify causal relations between exposures and health outcomes (correct)
- To identify the funding sources for the study
- To develop a study protocol for review by IRBs
Which element is NOT part of an epidemiologic hypothesis?
Which element is NOT part of an epidemiologic hypothesis?
- The budget of the study (correct)
- The causal mechanism
- Cofactors (potential confounders)
- The exposure
Which type of variables are considered independent in statistical analyses of epidemiologic studies?
Which type of variables are considered independent in statistical analyses of epidemiologic studies?
- Intervening variables
- Exposures (correct)
- Dependent variables
- Confounders
What role do Institutional Review Boards (IRBs) play in epidemiologic studies?
What role do Institutional Review Boards (IRBs) play in epidemiologic studies?
In the illustrative example, what is the expected change in incidence of VTE from the study?
In the illustrative example, what is the expected change in incidence of VTE from the study?
What type of data sources can be used in epidemiologic studies?
What type of data sources can be used in epidemiologic studies?
Which of the following describes a characteristic of cofactors in epidemiologic studies?
Which of the following describes a characteristic of cofactors in epidemiologic studies?
What is meant by the induction period in an epidemiologic hypothesis?
What is meant by the induction period in an epidemiologic hypothesis?
What is the main difference between cohort studies and case-control studies?
What is the main difference between cohort studies and case-control studies?
Which of the following statements is true regarding stable characteristics like genetic factors?
Which of the following statements is true regarding stable characteristics like genetic factors?
What is a characteristic of cohort studies?
What is a characteristic of cohort studies?
In the context of epidemiologic studies, what does a case-control study primarily focus on?
In the context of epidemiologic studies, what does a case-control study primarily focus on?
Why are both cohort and case-control studies considered longitudinal?
Why are both cohort and case-control studies considered longitudinal?
In a cohort study aimed at linking cigarette smoking to lung cancer, how are participants classified?
In a cohort study aimed at linking cigarette smoking to lung cancer, how are participants classified?
What is the primary role of a referent or control group in an epidemiologic study?
What is the primary role of a referent or control group in an epidemiologic study?
Which of the following best describes the sampling method of case-control studies?
Which of the following best describes the sampling method of case-control studies?
What key factor do cohort studies and case-control studies have in common?
What key factor do cohort studies and case-control studies have in common?
Which of the following accurately differentiates between randomized and nonrandomized trials?
Which of the following accurately differentiates between randomized and nonrandomized trials?
What is meant by the unit of observation in an epidemiologic study?
What is meant by the unit of observation in an epidemiologic study?
What distinguishes observational studies from experimental studies in epidemiology?
What distinguishes observational studies from experimental studies in epidemiology?
Why are longitudinal observations preferred in conducting etiologic research?
Why are longitudinal observations preferred in conducting etiologic research?
What is a key characteristic of observational cohort studies?
What is a key characteristic of observational cohort studies?
What is the primary difference between longitudinal and cross-sectional studies?
What is the primary difference between longitudinal and cross-sectional studies?
What is the benefit of randomization in experimental studies?
What is the benefit of randomization in experimental studies?
In comparing cardiovascular disease rates, what would observational studies typically focus on?
In comparing cardiovascular disease rates, what would observational studies typically focus on?
In order to establish causation in epidemiologic studies, which condition must be met?
In order to establish causation in epidemiologic studies, which condition must be met?
What type of data is used when assessing lung cancer rates based on individual smoking status?
What type of data is used when assessing lung cancer rates based on individual smoking status?
Which of the following best describes a cohort study design?
Which of the following best describes a cohort study design?
Why is the referent group important for determining exposure effects in epidemiological studies?
Why is the referent group important for determining exposure effects in epidemiological studies?
Which statement best describes the limitations of cross-sectional studies?
Which statement best describes the limitations of cross-sectional studies?
What is an example of longitudinal data for studying HIV status?
What is an example of longitudinal data for studying HIV status?
What does the term 'aggregate-level data' refer to in an epidemiologic study?
What does the term 'aggregate-level data' refer to in an epidemiologic study?
Flashcards
Epidemiologic Hypothesis
Epidemiologic Hypothesis
A testable statement predicting a relationship between exposure and disease in a specific population.
Elements of Epidemiologic Hypothesis
Elements of Epidemiologic Hypothesis
Key components that must be defined: population, exposure, disease, induction period, expected change, cofactors, mechanism, and sample size.
Exposure
Exposure
A factor potentially associated with a health outcome (disease).
Cofactor (Confounder)
Cofactor (Confounder)
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Data Sources
Data Sources
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Institutional Review Boards (IRBs)
Institutional Review Boards (IRBs)
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Hypothesis Statement
Hypothesis Statement
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Causal Mechanism
Causal Mechanism
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Unit of Observation
Unit of Observation
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Person-level Data
Person-level Data
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Aggregate-level Data
Aggregate-level Data
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Longitudinal Observation
Longitudinal Observation
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Cross-sectional Observation
Cross-sectional Observation
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Time Sequencing
Time Sequencing
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Etiologic Research
Etiologic Research
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Seroconversion
Seroconversion
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Longitudinal vs. Cross-sectional Studies
Longitudinal vs. Cross-sectional Studies
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Stable Characteristics
Stable Characteristics
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Cohort Study
Cohort Study
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Case-Control Study
Case-Control Study
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Retrospective vs. Prospective
Retrospective vs. Prospective
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Key Difference: Cohort vs. Case-Control
Key Difference: Cohort vs. Case-Control
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Sampling in Epidemiologic Studies
Sampling in Epidemiologic Studies
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Hypothesis in Epidemiology
Hypothesis in Epidemiology
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Referent Group
Referent Group
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Observational Study
Observational Study
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Experimental Study
Experimental Study
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Longitudinal Study
Longitudinal Study
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Cross-Sectional Study
Cross-Sectional Study
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Randomized Controlled Trial (RCT)
Randomized Controlled Trial (RCT)
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Study Notes
Introduction to Epidemiologic Study Design
- The lecture is about the design of epidemiological studies.
- Clarifying causal relationships between exposures and health outcomes is a key objective.
- Understanding ethical conduct in human subject studies is another key objective.
Etiologic Research
- Hypotheses are crucial for guiding research.
- Novalis famously stated, "Hypotheses are nets: only he who casts will catch."
Hypothesis Statement
- A hypothesis statement starts with a basic case report.
- Then follows with descriptive epidemiologic studies.
- Focused research questions and hypotheses are needed.
- The study design needs to support the research questions and hypotheses.
Elements of an Epidemiologic Hypothesis
- The hypothesis includes the population under study.
- The specific exposure being investigated.
- The disease or outcome of interest.
- The induction period—time from exposure to disease.
- The expected change in incidence (disease rate).
- Potential confounders (other factors that might influence the outcome).
- The causal mechanism linking exposure and outcome.
- The sample size for the study.
Illustrative Example (Estrogen and VTE Risk)
- Example of a hypothesis: Estrogen dose in oral contraceptives (COCs) is linked to venous thromboembolism (VTE) risk.
- Population: Women aged 15-44 using oral contraceptives.
- Exposure: COCs with estrogen doses ≥ 50µg or ≤35µg.
- Disease: Confirmed VTE diagnosis and treatment.
- Induction period: Current use of COCs.
- Expected change in incidence: A change from 8/10,000 to 4/10,000 person-years.
- Cofactors: Age, recent surgery, trauma, and postpartum period.
- Mechanism: Exogenous estrogen increases thrombogenesis and reduces fibrinolysis.
- Sample size: 60,000 women.
Variables
- Exposure → Disease?
- Independent variable: the factor being tested (e.g., coffee drinking).
- Dependent variable: the outcome being measured (e.g., heart disease).
- Potential confounders: other variables that could affect the relationship (e.g., cigarette smoking).
Data Sources
- Interviews with study subjects.
- Self-administered questionnaires.
- Employment records.
- Environmental records.
- Health care records.
- Social services records.
- Physical examinations.
- Biological specimen examination.
- Diagnostic tests.
Ethical Conduct of Studies Involving Human Subjects
- Ethical principles include respect for persons (informed consent).
- Beneficence (assessing risks and benefits).
- Justice (inclusive and equitable study group selection).
Institutional Review Boards (IRBs)
- IRBs are committees reviewing study protocols before initiation.
- Their goal is to ensure ethical treatment of subjects.
- Oversee informed consent procedures.
Equipoise
- Equipoise is a balanced doubt about the pros and cons of an intervention.
- Treatments with special hazards cannot be ethically assigned.
- Treatments believed to be beneficial cannot be ethically withheld.
Data and Safety Monitoring Board (DSMB)
- The DSMB is an independent group monitoring study safety and progress.
- It periodically evaluates the accumulated evidence.
- The job is to recommend continuation, modification, or termination of the study.
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