Epidemiologic Study Design Quiz

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Questions and Answers

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?

  • 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?

  • Intervening variables
  • Exposures (correct)
  • Dependent variables
  • Confounders

What role do Institutional Review Boards (IRBs) play in epidemiologic studies?

<p>They review the study protocol for ethical compliance (C)</p> Signup and view all the answers

In the illustrative example, what is the expected change in incidence of VTE from the study?

<p>From 8/10,000 to 4/10,000 person-years (B)</p> Signup and view all the answers

What type of data sources can be used in epidemiologic studies?

<p>A variety of sources including environmental and health care records (A)</p> Signup and view all the answers

Which of the following describes a characteristic of cofactors in epidemiologic studies?

<p>Potential confounders that can affect the relationship between exposure and disease (C)</p> Signup and view all the answers

What is meant by the induction period in an epidemiologic hypothesis?

<p>The period during which exposure occurs before a disease is diagnosed (C)</p> Signup and view all the answers

What is the main difference between cohort studies and case-control studies?

<p>Cohort studies select subjects based on exposure status while case-control studies select based on disease status. (A)</p> Signup and view all the answers

Which of the following statements is true regarding stable characteristics like genetic factors?

<p>Knowing their status now also indicates their status in the past. (C)</p> Signup and view all the answers

What is a characteristic of cohort studies?

<p>They identify and monitor disease-free individuals over time. (B)</p> Signup and view all the answers

In the context of epidemiologic studies, what does a case-control study primarily focus on?

<p>Retrospective ascertainment of exposure among cases and controls. (B)</p> Signup and view all the answers

Why are both cohort and case-control studies considered longitudinal?

<p>They monitor changes in disease status over time. (A)</p> Signup and view all the answers

In a cohort study aimed at linking cigarette smoking to lung cancer, how are participants classified?

<p>Based on their smoking history. (D)</p> Signup and view all the answers

What is the primary role of a referent or control group in an epidemiologic study?

<p>To provide a baseline for comparison (D)</p> Signup and view all the answers

Which of the following best describes the sampling method of case-control studies?

<p>Non-cases are selected from the same population as the cases. (B)</p> Signup and view all the answers

What key factor do cohort studies and case-control studies have in common?

<p>They both reconstruct events in individuals over a period of time. (D)</p> Signup and view all the answers

Which of the following accurately differentiates between randomized and nonrandomized trials?

<p>Randomized trials assign exposures randomly to participants (D)</p> Signup and view all the answers

What is meant by the unit of observation in an epidemiologic study?

<p>The level of aggregation upon which measurements are available (D)</p> Signup and view all the answers

What distinguishes observational studies from experimental studies in epidemiology?

<p>Experimental studies introduce or withhold an exposure (D)</p> Signup and view all the answers

Why are longitudinal observations preferred in conducting etiologic research?

<p>They allow for accurate time-sequencing of events (D)</p> Signup and view all the answers

What is a key characteristic of observational cohort studies?

<p>They classify subjects based on exposure status (A)</p> Signup and view all the answers

What is the primary difference between longitudinal and cross-sectional studies?

<p>Longitudinal studies track changes over time in individuals (D)</p> Signup and view all the answers

What is the benefit of randomization in experimental studies?

<p>It ensures the study's outcome is more reliable (C)</p> Signup and view all the answers

In comparing cardiovascular disease rates, what would observational studies typically focus on?

<p>Classifying participants based on hormone usage (B)</p> Signup and view all the answers

In order to establish causation in epidemiologic studies, which condition must be met?

<p>The exposure must precede the outcome by a reasonable amount of time (D)</p> Signup and view all the answers

What type of data is used when assessing lung cancer rates based on individual smoking status?

<p>Person-level data (B)</p> Signup and view all the answers

Which of the following best describes a cohort study design?

<p>Subjects are classified based on exposure and followed over time (A)</p> Signup and view all the answers

Why is the referent group important for determining exposure effects in epidemiological studies?

<p>It provides a comparison for the index group's outcomes (C)</p> Signup and view all the answers

Which statement best describes the limitations of cross-sectional studies?

<p>They lack temporal sequence in data collection (B)</p> Signup and view all the answers

What is an example of longitudinal data for studying HIV status?

<p>Repeated serological measurements from initially seronegative individuals (C)</p> Signup and view all the answers

What does the term 'aggregate-level data' refer to in an epidemiologic study?

<p>Data that summarizes characteristics of a population or region (B)</p> Signup and view all the answers

Flashcards

Epidemiologic Hypothesis

A testable statement predicting a relationship between exposure and disease in a specific population.

Elements of Epidemiologic Hypothesis

Key components that must be defined: population, exposure, disease, induction period, expected change, cofactors, mechanism, and sample size.

Exposure

A factor potentially associated with a health outcome (disease).

Cofactor (Confounder)

A variable that can influence both exposure and disease, potentially masking the true relationship.

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Data Sources

Various ways to collect information for a study: interviews, questionnaires, records, exams, and biological samples.

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Institutional Review Boards (IRBs)

Ethics committees that review research protocols involving human subjects to ensure ethical conduct.

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Hypothesis Statement

A proposed explanation for an observation that predicts a relationship between factors.

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Causal Mechanism

The biological pathway through which an exposure leads to a disease.

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Unit of Observation

The level of aggregation at which data is collected in an epidemiologic study. It can range from the individual to entire populations.

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Person-level Data

Data collected on individual people, allowing for detailed analysis of their characteristics and experiences.

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Aggregate-level Data

Data collected on groups of individuals, such as communities or regions. Useful for assessing trends and patterns.

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Longitudinal Observation

Data collected over time on the same individuals, allowing for tracking changes and establishing cause-and-effect relationships.

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Cross-sectional Observation

Data collected at a single point in time, providing a snapshot of factors and health outcomes.

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Time Sequencing

The ability to determine the order in which events occur, crucial for establishing causality in epidemiologic research.

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Etiologic Research

Research focused on identifying causes of disease or health conditions.

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Seroconversion

The point in time when a person's blood tests positive for an antibody, indicating infection.

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Longitudinal vs. Cross-sectional Studies

Longitudinal studies track individuals over time, while cross-sectional studies examine a snapshot of data at a single point in time.

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Stable Characteristics

Factors that don't change significantly over time, like genetics or deeply ingrained habits.

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Cohort Study

A research design that follows a group of people with similar characteristics over time to observe disease development.

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Case-Control Study

A research design that compares people with a disease (cases) to those without the disease (controls) to identify risk factors.

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Retrospective vs. Prospective

Retrospective studies look back at past events, while prospective studies follow individuals forward in time.

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Key Difference: Cohort vs. Case-Control

Cohort studies start with a disease-free group, while case-control studies start with people who have the disease.

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Sampling in Epidemiologic Studies

The process of selecting a representative group of individuals from a larger population for a study.

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Hypothesis in Epidemiology

A testable prediction that proposes a relationship between an exposure and a disease outcome.

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Referent Group

A group in a study that is not exposed to the factor being investigated. They act as a comparison point to see if the exposure has an effect.

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Observational Study

A type of study where researchers observe and record data about existing groups without manipulating any factors.

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Experimental Study

A study where researchers actively control and manipulate the exposure to see its effects.

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Longitudinal Study

A study that follows individuals over time to track changes in exposure and outcome.

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Cross-Sectional Study

A study that captures data at a single point in time, providing a snapshot of a population.

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Randomized Controlled Trial (RCT)

A type of experimental study where participants are randomly assigned to receive an exposure or control.

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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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