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Questions and Answers
What is the primary characteristic that distinguishes experimental studies from observational studies?
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?
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?
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?
What type of question do experimental studies typically aim to answer?
In the context of experimental studies, what is a control group used for?
In the context of experimental studies, what is a control group used for?
Which of the following statements about experimental studies is true?
Which of the following statements about experimental studies is true?
Which classification of epidemiological studies includes random controlled trials?
Which classification of epidemiological studies includes random controlled trials?
What is the primary objective of clinical trials?
What is the primary objective of clinical trials?
What is NOT a feature of experimental studies?
What is NOT a feature of experimental studies?
Which of the following is a key feature of randomized controlled trials (RCTs)?
Which of the following is a key feature of randomized controlled trials (RCTs)?
Which statistical measure assesses the incidence of disease in those exposed to an intervention compared to those not exposed?
Which statistical measure assesses the incidence of disease in those exposed to an intervention compared to those not exposed?
Which type of study is characterized by the random allocation of participants to different groups?
Which type of study is characterized by the random allocation of participants to different groups?
What ensures that confounding characteristics are equally distributed in groups in an RCT?
What ensures that confounding characteristics are equally distributed in groups in an RCT?
In which type of trial do participants receive both the intervention and a control condition in different periods?
In which type of trial do participants receive both the intervention and a control condition in different periods?
The measure known as the number needed to treat (NNT) is defined as what?
The measure known as the number needed to treat (NNT) is defined as what?
Which of the following types of studies can be classified as intervention studies?
Which of the following types of studies can be classified as intervention studies?
What is the primary purpose of randomization in a clinical trial?
What is the primary purpose of randomization in a clinical trial?
Which method is NOT typically used for randomization in clinical trials?
Which method is NOT typically used for randomization in clinical trials?
What characteristic is ideally attributed to groups in a randomized controlled trial (RCT)?
What characteristic is ideally attributed to groups in a randomized controlled trial (RCT)?
Which type of risk is calculated as the incidence of disease in exposed individuals divided by the incidence in non-exposed individuals?
Which type of risk is calculated as the incidence of disease in exposed individuals divided by the incidence in non-exposed individuals?
What element is crucial for the control group in an RCT?
What element is crucial for the control group in an RCT?
Which of the following is a form of randomization design used in clinical trials?
Which of the following is a form of randomization design used in clinical trials?
What does the term Number Needed to Treat (NNT) signify in clinical studies?
What does the term Number Needed to Treat (NNT) signify in clinical studies?
The Relative Risk Reduction (RRR) formula is expressed as which of the following?
The Relative Risk Reduction (RRR) formula is expressed as which of the following?
What is the primary purpose of conducting randomized controlled trials (RCTs)?
What is the primary purpose of conducting randomized controlled trials (RCTs)?
What is a key disadvantage of cross-over studies?
What is a key disadvantage of cross-over studies?
How does internal validity in RCTs compare to quasi-clinical trials?
How does internal validity in RCTs compare to quasi-clinical trials?
What defines a quasi-clinical trial?
What defines a quasi-clinical trial?
What type of exposure period follows the first treatment in a cross-over study?
What type of exposure period follows the first treatment in a cross-over study?
What is a limitation regarding the external validity of RCTs?
What is a limitation regarding the external validity of RCTs?
What happens during the washout period in a cross-over trial?
What happens during the washout period in a cross-over trial?
What aspect makes RCTs desirable despite their high costs?
What aspect makes RCTs desirable despite their high costs?
What is a key feature of a split mouth model in research?
What is a key feature of a split mouth model in research?
Which of the following best describes factorial designs?
Which of the following best describes factorial designs?
What distinguishes field trials from clinical trials?
What distinguishes field trials from clinical trials?
In community interventions, what is the unit of analysis?
In community interventions, what is the unit of analysis?
What is an advantage of using a split mouth design?
What is an advantage of using a split mouth design?
What type of study is meant to test interventions that influence group behavior?
What type of study is meant to test interventions that influence group behavior?
Which best describes the population targeted in field trials?
Which best describes the population targeted in field trials?
What is a notable characteristic of factorial designs?
What is a notable characteristic of factorial designs?
Flashcards
Experimental Studies
Experimental Studies
Studies where researchers actively control exposure and manipulate variables to observe effects.
Experimental Group
Experimental Group
A group of people who receive the intervention being studied.
Control Group
Control Group
A group of people who do not receive the intervention being studied. This serves as a comparison point.
Intervention
Intervention
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Randomized Controlled Trial (RCT)
Randomized Controlled Trial (RCT)
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Community Trial
Community Trial
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Experimentation
Experimentation
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Ethical Considerations in Experimental Studies
Ethical Considerations in Experimental Studies
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Analytical Study
Analytical Study
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Intervention Studies
Intervention Studies
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Relative Risk (RR)
Relative Risk (RR)
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Absolute Risk Reduction (ARR)
Absolute Risk Reduction (ARR)
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Number Needed to Treat (NNT)
Number Needed to Treat (NNT)
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Randomization
Randomization
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Clinical Trial
Clinical Trial
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Split-mouth design
Split-mouth design
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Community interventions
Community interventions
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Factorial designs
Factorial designs
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Field trial
Field trial
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Split mouth model
Split mouth model
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Intervention Group
Intervention Group
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Relative Risk Reduction (RRR)
Relative Risk Reduction (RRR)
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External Validity
External Validity
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Internal Validity
Internal Validity
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Cross-Over Study
Cross-Over Study
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Quasi-Clinical Trial
Quasi-Clinical Trial
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Carryover Effect
Carryover Effect
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Washout Period
Washout Period
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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
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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
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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).
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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
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Factorial designs
- Categorizes interventions by two or more independent factors
- Randomizes participants into resulting groups
- Commonly used when multiple factors/treatments are being evaluated
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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
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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).
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Measures of Risk in Intervention Studies
- Relative risk (RR)
- Absolute risk reduction (ARR)
- Number needed to treat (NNT)
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