Types of Epidemiologic Studies

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Questions and Answers

What is the primary characteristic that distinguishes experimental studies from observational studies?

  • The researcher controls the exposure effect within the study population. (correct)
  • Investigators gather data without intervention.
  • The subjects are randomly selected from a pre-defined population.
  • The research design relies on historical data.

Which of the following is an example of an experimental study design?

  • Cross-sectional survey
  • Cohort study
  • Case-control study
  • Randomized Controlled Trial (RCT) (correct)

What ethical consideration is crucial in the design of experimental studies?

  • No participant should become aware of the study's purpose.
  • The study must include only individuals with the same medical history.
  • All participants should receive the treatment being tested. (correct)
  • Participants must have equal knowledge about the treatment options.

What type of question do experimental studies typically aim to answer?

<p>What are the effects of a specific intervention? (B)</p> Signup and view all the answers

In the context of experimental studies, what is a control group used for?

<p>To measure the change resulting from an intervention (D)</p> Signup and view all the answers

Which of the following statements about experimental studies is true?

<p>They are used to test causal hypotheses through intervention. (B)</p> Signup and view all the answers

Which classification of epidemiological studies includes random controlled trials?

<p>Experimental studies (C)</p> Signup and view all the answers

What is the primary objective of clinical trials?

<p>To assess end point treatment results (D)</p> Signup and view all the answers

What is NOT a feature of experimental studies?

<p>Observation without intervention (D)</p> Signup and view all the answers

Which of the following is a key feature of randomized controlled trials (RCTs)?

<p>Random allocation of participants occurs (D)</p> Signup and view all the answers

Which statistical measure assesses the incidence of disease in those exposed to an intervention compared to those not exposed?

<p>Relative risk (RR) (D)</p> Signup and view all the answers

Which type of study is characterized by the random allocation of participants to different groups?

<p>Experimental study (A)</p> Signup and view all the answers

What ensures that confounding characteristics are equally distributed in groups in an RCT?

<p>Random allocation (D)</p> Signup and view all the answers

In which type of trial do participants receive both the intervention and a control condition in different periods?

<p>Cross-over trial (C)</p> Signup and view all the answers

The measure known as the number needed to treat (NNT) is defined as what?

<p>The number of patients needed to achieve one additional positive outcome (C)</p> Signup and view all the answers

Which of the following types of studies can be classified as intervention studies?

<p>Randomized controlled trials (C)</p> Signup and view all the answers

What is the primary purpose of randomization in a clinical trial?

<p>To ensure each participant has an equal chance of being placed in any group (A)</p> Signup and view all the answers

Which method is NOT typically used for randomization in clinical trials?

<p>Peer review (D)</p> Signup and view all the answers

What characteristic is ideally attributed to groups in a randomized controlled trial (RCT)?

<p>Balanced characteristics between the intervention and control groups (D)</p> Signup and view all the answers

Which type of risk is calculated as the incidence of disease in exposed individuals divided by the incidence in non-exposed individuals?

<p>Relative Risk (RR) (A)</p> Signup and view all the answers

What element is crucial for the control group in an RCT?

<p>They do not undergo any treatment or intervention (B)</p> Signup and view all the answers

Which of the following is a form of randomization design used in clinical trials?

<p>Cluster randomization (B)</p> Signup and view all the answers

What does the term Number Needed to Treat (NNT) signify in clinical studies?

<p>The number of individuals that need to be treated for one to benefit (B)</p> Signup and view all the answers

The Relative Risk Reduction (RRR) formula is expressed as which of the following?

<p>1 - RR (C)</p> Signup and view all the answers

What is the primary purpose of conducting randomized controlled trials (RCTs)?

<p>To demonstrate the effectiveness of a particular intervention (B)</p> Signup and view all the answers

What is a key disadvantage of cross-over studies?

<p>They may have carryover effects impacting the outcomes (B)</p> Signup and view all the answers

How does internal validity in RCTs compare to quasi-clinical trials?

<p>RCTs have stronger internal validity (B)</p> Signup and view all the answers

What defines a quasi-clinical trial?

<p>Allocation based on non-random factors like date or sequence (A)</p> Signup and view all the answers

What type of exposure period follows the first treatment in a cross-over study?

<p>Washout period (A)</p> Signup and view all the answers

What is a limitation regarding the external validity of RCTs?

<p>They often select participants based on specific criteria (A)</p> Signup and view all the answers

What happens during the washout period in a cross-over trial?

<p>The effects of the first exposure are minimized (A)</p> Signup and view all the answers

What aspect makes RCTs desirable despite their high costs?

<p>Their strong internal validity through robust methodology (B)</p> Signup and view all the answers

What is a key feature of a split mouth model in research?

<p>One side is treated while the other side serves as a control. (C)</p> Signup and view all the answers

Which of the following best describes factorial designs?

<p>They categorize interventions involving multiple independent factors. (A)</p> Signup and view all the answers

What distinguishes field trials from clinical trials?

<p>Field trials consist of disease-free individuals at risk for conditions. (D)</p> Signup and view all the answers

In community interventions, what is the unit of analysis?

<p>Communities, towns, or regions (C)</p> Signup and view all the answers

What is an advantage of using a split mouth design?

<p>It allows for the control of difficult factors like genotype. (B)</p> Signup and view all the answers

What type of study is meant to test interventions that influence group behavior?

<p>Community intervention (B)</p> Signup and view all the answers

Which best describes the population targeted in field trials?

<p>Disease-free individuals presumed at risk. (D)</p> Signup and view all the answers

What is a notable characteristic of factorial designs?

<p>They are identified by the number of factors and levels examined. (B)</p> Signup and view all the answers

Flashcards

Experimental Studies

Studies where researchers actively control exposure and manipulate variables to observe effects.

Experimental Group

A group of people who receive the intervention being studied.

Control Group

A group of people who do not receive the intervention being studied. This serves as a comparison point.

Intervention

The specific action or treatment being investigated in an experimental study.

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Randomized Controlled Trial (RCT)

A type of experimental study where participants are randomly assigned to either the experimental or control group.

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Community Trial

An experimental study where the intervention is applied to an entire community or population.

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Experimentation

A study that involves changing a variable (like a diet or treatment) in a group of people to see the effects.

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Ethical Considerations in Experimental Studies

Important ethical considerations must be made when conducting experiments. For example, participants should not be denied proper treatment.

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Analytical Study

A research study where specific hypotheses about causal associations between variables are tested.

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Intervention Studies

Studies that involve an intervention to observe the effect on a group of individuals.

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Relative Risk (RR)

A measure of the difference in the incidence of disease between those exposed to an intervention and those not exposed.

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Absolute Risk Reduction (ARR)

A measure of the difference in the absolute risk of disease between those exposed to an intervention and those not exposed.

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Number Needed to Treat (NNT)

The number of patients that need to be treated with an intervention to prevent one adverse event.

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Randomization

The process of assigning participants to either the experimental group or the control group purely by chance.

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Clinical Trial

A type of intervention study designed to evaluate the effectiveness of a treatment or intervention.

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Split-mouth design

An experimental design where one side of a person is used for the test and the other side acts as a control. This helps control for individual differences like genetics, saliva production, and immune response.

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Community interventions

A type of experimental study where the unit of allocation for intervention is the community, not individuals. This is often used to test interventions for diseases linked to social conditions.

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Factorial designs

An experimental design using two or more independent factors to categorize interventions. Participants are randomly assigned to the resulting groups. The number of factors and levels determines the design complexity.

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Field trial

A research study conducted in a natural setting with disease-free participants at risk of developing a condition. Data is collected in the field, usually among non-institutionalized people.

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Split mouth model

A study that compares a surgical treatment on one side of a person with a medical treatment on the other side. This is a specific example of a split-mouth design.

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Intervention Group

The group that receives the intervention being studied.

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Relative Risk Reduction (RRR)

The percentage reduction in risk achieved by the intervention compared to the control group.

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External Validity

The extent to which the results of a study can be generalized to other populations, settings, and times.

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Internal Validity

The extent to which the results of a study accurately reflect the true relationship between the intervention and the outcome.

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Cross-Over Study

A study design where participants receive two or more interventions in sequence, with a washout period between interventions. The same person serves as both the control and experimental group.

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Quasi-Clinical Trial

A type of study where participants are not randomly assigned to treatment groups. This can lead to bias as participants are not truly similar before the intervention.

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Carryover Effect

The lingering effect of a prior intervention on the outcome of a subsequent intervention in a cross-over study.

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Washout Period

A period between interventions in a cross-over study where the effects of the previous treatment are allowed to dissipate.

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Study Notes

Types of Epidemiologic Studies (Experimental Studies)

  • Experimental studies involve researchers controlling the exposure
  • Researchers ask questions like "What are the effects of this change of conditions?" or "What are the effects of this intervention?"
  • Intervention or experimentation involves changing a variable in one or more groups of people (e.g. eliminating a dietary factor, testing new treatment)
  • The effects of the intervention are measured by comparing outcomes of the experimental group with the control group
  • Ethical considerations are paramount in the design of experimental studies (e.g., no patient should be denied appropriate treatment).

Classification of Epidemiological Studies

  • According to objective:
    • Descriptive studies (case report/series, cross-sectional, ecological, time series)
    • Analytical studies (case-control and cohort)
  • According to methodology:
    • Observational studies (descriptive and analytical)
    • Experimental studies (RCTs, Field trials, community trials)

Types of Experimental Studies

  • Randomized Controlled Trials (RCTs)

    • Researcher allocates participants to one arm of the trial (intervention vs. control)
    • Intervention allocation is random, making the study randomized
    • Random allocation ensures characteristics of groups are balanced, enabling researchers to attribute any differences in outcome to the study intervention

    Methods for randomization include dice, computer-generated lists, and sealed envelopes/bottles Types of randomization designs include simple, cluster, stratified, and block

  • Quasi-clinical trials

    • Intervention allocation is not randomized (e.g., allocation based on date, weekday, or odd/even numbers).
    • Easier to conduct than RCTs but have poorer internal validity
  • Cross-over

    • Participants receive two or more different types of exposures in sequence
    • Exposure-free period (washout period) is allowed to eliminate effects of previous exposure before the next one
    • Key advantage: same person acts as his own control, thereby effectively matching for person-related factors
    • Disadvantage: possibility of carryover effect (first exposure influencing responses to the second exposure).
  • Split-plot design

    • Uses one side of the person for test and other side as control/comparison
    • Useful to control factors difficult to control (e.g. genotype, salivary flow rate, immunological response).
    • Control is exactly matched to the test for all measured and unmeasured sources of variation
  • Factorial designs

    • Categorizes interventions by two or more independent factors
    • Randomizes participants into resulting groups
    • Commonly used when multiple factors/treatments are being evaluated
  • Field trials

    • Involve disease-free but at-risk individuals
    • Data collection usually in the general population.
    • Often large-scale due to low disease frequency in the general population
  • Community interventions

    • Unit of analysis and allocation for intervention is the community (town, region)
    • Often used to test the effectiveness of an intervention that cannot be adequately tested in other study types (e.g., fluoridation of public water supply).
  • Measures of Risk in Intervention Studies

    • Relative risk (RR)
    • Absolute risk reduction (ARR)
    • Number needed to treat (NNT)

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