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Questions and Answers
What are the levels of the dependent variable for the study involving the anti-nausea drug?
What are the levels of the dependent variable for the study involving the anti-nausea drug?
- Mothers who gave birth to infants with a birth defect vs. mothers who gave birth to infants without a birth defect
- Babies who took the anti-nausea drug vs. babies who did not take the anti-nausea drug
- Both A and B (correct)
- Neither A nor B
What measure of comparison is most appropriate for the study design concerning mothers' recall of anti-nausea medication use?
What measure of comparison is most appropriate for the study design concerning mothers' recall of anti-nausea medication use?
- The exposure odds ratio (OR) (correct)
- The relative risk (RR)
- The rate ratio (RR)
- The population attributable risk percent (PAR%)
What is the formula for the odds ratio?
What is the formula for the odds ratio?
OR = a × d / (b × c)
Which statements regarding bias and odds ratio are true? (Select two)
Which statements regarding bias and odds ratio are true? (Select two)
Which type of bias are the investigators likely investigating?
Which type of bias are the investigators likely investigating?
Selection bias is most likely to occur in which types of studies?
Selection bias is most likely to occur in which types of studies?
Identify three ways confounding can be controlled in the design phase of an epidemiologic study.
Identify three ways confounding can be controlled in the design phase of an epidemiologic study.
Identify three ways confounding can be controlled in the analysis phase of an epidemiologic study.
Identify three ways confounding can be controlled in the analysis phase of an epidemiologic study.
Is it better to control for confounding at the design phase or the analytic phase of a study?
Is it better to control for confounding at the design phase or the analytic phase of a study?
What are the limitations of controlling for confounding in the design phase of an epidemiologic study?
What are the limitations of controlling for confounding in the design phase of an epidemiologic study?
What are the limitations of controlling for confounding in the analysis phase of an epidemiologic study?
What are the limitations of controlling for confounding in the analysis phase of an epidemiologic study?
What is residual confounding?
What is residual confounding?
Do you suspect socioeconomic status (SES) is a confounder based on examining the crude and the stratified data?
Do you suspect socioeconomic status (SES) is a confounder based on examining the crude and the stratified data?
Is SES a confounder in this analysis?
Is SES a confounder in this analysis?
What is the magnitude of the confounding?
What is the magnitude of the confounding?
Identify the independent variable, dependent variable, and potential confounding factor in the study about exercise habits and heart attacks.
Identify the independent variable, dependent variable, and potential confounding factor in the study about exercise habits and heart attacks.
What is happening with the observed measure of association when positive confounding is present?
What is happening with the observed measure of association when positive confounding is present?
What is happening with the observed measure of association when negative confounding is present?
What is happening with the observed measure of association when negative confounding is present?
Which statement about smoking in relation to heart disease is false?
Which statement about smoking in relation to heart disease is false?
What is the difference between a mediator and a confounder?
What is the difference between a mediator and a confounder?
Mediators cannot be in the causal pathway between exposure and disease.
Mediators cannot be in the causal pathway between exposure and disease.
Confounding is the same as random error.
Confounding is the same as random error.
It may be possible to control for confounding in both the design phase and the analytic phase of research studies.
It may be possible to control for confounding in both the design phase and the analytic phase of research studies.
Define random error.
Define random error.
In which types of studies can random error occur?
In which types of studies can random error occur?
What effect(s) does having random error have in epidemiologic studies?
What effect(s) does having random error have in epidemiologic studies?
What are the top two causes of random error in epidemiologic studies?
What are the top two causes of random error in epidemiologic studies?
Interpret the RR measure from the researcher studying sedentary computer programmers' risk of cardiovascular disease.
Interpret the RR measure from the researcher studying sedentary computer programmers' risk of cardiovascular disease.
What does the term 'validity' mean?
What does the term 'validity' mean?
What are the three alternative explanations to consider when assessing the validity of a study? Define each.
What are the three alternative explanations to consider when assessing the validity of a study? Define each.
Define generalizability.
Define generalizability.
Is it possible to have both random error and systematic error in the same study?
Is it possible to have both random error and systematic error in the same study?
Explain what happens when there is bias in a study that biases results towards the null.
Explain what happens when there is bias in a study that biases results towards the null.
Explain what happens when there is bias in a study that biases results away from the null.
Explain what happens when there is bias in a study that biases results away from the null.
If bias occurs in a study, it is possible for us to fix or remove it when we do the analysis.
If bias occurs in a study, it is possible for us to fix or remove it when we do the analysis.
Briefly describe when/how selection bias occurs in an epidemiologic study.
Briefly describe when/how selection bias occurs in an epidemiologic study.
What types of studies is selection bias more likely to occur?
What types of studies is selection bias more likely to occur?
List specific types of selection bias.
List specific types of selection bias.
What can be done to fix selection bias?
What can be done to fix selection bias?
How does selection bias impact measures of association?
How does selection bias impact measures of association?
Name methods to avoid selection bias.
Name methods to avoid selection bias.
Define information bias.
Define information bias.
What are three types of information bias?
What are three types of information bias?
What is recall bias?
What is recall bias?
What is interviewer bias?
What is interviewer bias?
What is measurement/misclassification error?
What is measurement/misclassification error?
List some ways to prevent/avoid interviewer bias.
List some ways to prevent/avoid interviewer bias.
What is differential misclassification?
What is differential misclassification?
What is non-differential misclassification?
What is non-differential misclassification?
What can non-differential misclassification do to the true value for a measure of association?
What can non-differential misclassification do to the true value for a measure of association?
What can differential misclassification do to a measure of association?
What can differential misclassification do to a measure of association?
When does information bias occur?
When does information bias occur?
List the three alternative explanations to consider for internal validity.
List the three alternative explanations to consider for internal validity.
Methods to avoid information bias?
Methods to avoid information bias?
What does selection bias have to do with?
What does selection bias have to do with?
When does selection bias occur?
When does selection bias occur?
What can selection bias lead to?
What can selection bias lead to?
Bias can occur if controls are more (or less) likely to be selected based on their exposure status.
Bias can occur if controls are more (or less) likely to be selected based on their exposure status.
Differential participation is a type of selection bias.
Differential participation is a type of selection bias.
Bias occurs when an investigator chooses to analyze only a subset of participants in a study.
Bias occurs when an investigator chooses to analyze only a subset of participants in a study.
Only once a study is deemed as having internal validity is it appropriate to consider generalizability.
Only once a study is deemed as having internal validity is it appropriate to consider generalizability.
Having participants refuse to participate in a study can lead to self-selection bias.
Having participants refuse to participate in a study can lead to self-selection bias.
Bias can be introduced at any stage of a study.
Bias can be introduced at any stage of a study.
Loss to follow up results in selection bias in a cohort study when the loss is associated with both the exposure and outcome.
Loss to follow up results in selection bias in a cohort study when the loss is associated with both the exposure and outcome.
If bias occurs in a study, it is possible to fix/correct with special analytic methods.
If bias occurs in a study, it is possible to fix/correct with special analytic methods.
Define confounding.
Define confounding.
What are the three criteria for a variable to be considered a confounder?
What are the three criteria for a variable to be considered a confounder?
What might be considered a confounder in epidemiological research?
What might be considered a confounder in epidemiological research?
What is positive confounding doing regarding the true value for a measure of association?
What is positive confounding doing regarding the true value for a measure of association?
What is negative confounding doing regarding the true value for a measure of association?
What is negative confounding doing regarding the true value for a measure of association?
What could be the relationship between modest alcohol consumption and coronary heart disease according to a directed acyclic graph?
What could be the relationship between modest alcohol consumption and coronary heart disease according to a directed acyclic graph?
According to the directed acyclic graph, what is the exposure of interest, health outcome, and potential confounder?
According to the directed acyclic graph, what is the exposure of interest, health outcome, and potential confounder?
What is a mediator variable?
What is a mediator variable?
Confounding is one source of systematic error in epidemiological research.
Confounding is one source of systematic error in epidemiological research.
Confounding can be thought of as a failure of the comparison group to reflect the counterfactual experience of the control group.
Confounding can be thought of as a failure of the comparison group to reflect the counterfactual experience of the control group.
Confounding always biases the resulting measures of association away from the null.
Confounding always biases the resulting measures of association away from the null.
Mediator variables are confounding variables.
Mediator variables are confounding variables.
Confounding variables are considered independent variables.
Confounding variables are considered independent variables.
Confounding variables result from random error.
Confounding variables result from random error.
Is it possible to control for confounding in the design phase of research studies?
Is it possible to control for confounding in the design phase of research studies?
Is it possible to control for confounding in the analysis phase of research studies?
Is it possible to control for confounding in the analysis phase of research studies?
The crude measure of association is the measure obtained from study data.
The crude measure of association is the measure obtained from study data.
The true RR=2.5, but the confounded RR=3.8. This is an example of negative confounding.
The true RR=2.5, but the confounded RR=3.8. This is an example of negative confounding.
In a case-control study, what are the levels of the independent variable?
In a case-control study, what are the levels of the independent variable?
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Study Notes
Validity and Bias
- Validity denotes the accuracy of a study, characterized by the absence of random error, bias, and confounding.
- Three critical alternative explanations to assess study validity:
- Bias: Systematic error that skews the perceived relationship between exposure and disease.
- Confounding: Influence of a third variable that distorts the true association between exposure and disease.
- Random Error: Variability in study results that occurs by chance, lacking a specific cause.
Generalizability and Association
- Generalizability refers to extending study conclusions beyond the specific study population and setting.
- Bias can lead to both random and systematic errors simultaneously.
- When bias drives results toward the null hypothesis, the true association is underestimated; when it moves away, the true association is overestimated relative to the null.
Selection Bias
- Selection bias arises from differences in how study groups are chosen.
- More common in case-control and retrospective cohort studies; also a concern in prospective cohort studies due to differential follow-up.
- Strategies to mitigate selection bias: consistent case/control selection criteria, high participation rates, and effective tracking methods.
- The impact of selection bias can distort association metrics, shifting them either towards or away from the null.
Information Bias
- Information bias occurs from systematic discrepancies in how data on exposure and disease is gathered from participants.
- Types of information bias include:
- Recall Bias: Differences in accuracy of reported information between groups.
- Interviewer Bias: Systematic differences in data collection by interviewers.
- Measurement Error: Nonsystematic errors that affect both exposure and outcome assessment.
- Preventive methods for information bias involve careful study design and data collection methods.
Confounding Variables
- Confounding is the interplay of an exposure, outcome, and a third variable that alters the perceived relationship.
- A valid confounder meets three criteria:
- Associated with the exposure in the population being studied.
- Acts independently as a predictor of the disease.
- Is not part of the causal pathway between exposure and disease.
Misclassification
- Differential Misclassification: Errors are related to a specific axis (exposure or disease) and can bias outcomes in either direction.
- Non-Differential Misclassification: Errors on one axis unrelated to the other, generally biasing results towards the null hypothesis.
- Preventing misclassification focuses on enhancing data collection accuracy through various measurement techniques.
Case-Control Study Framework
- In case-control studies, determining how participants recall past exposure can affect odds ratio calculations.
- Bias introduced through inaccurate reporting can shift odds ratios toward the null value due to non-differential misclassification.
- Understanding how exposure and outcome relate in these studies is critical for evaluating true associations.
Statistical Concepts and Directions
- Adjusting for confounding can be achieved during both study design and analysis phases.
- The "crude measure of association" represents initial estimates without adjustment for confounding factors.
- Direction of bias can vary significantly depending on whether confounding leads to overestimation or underestimation of the true association.
Key Takeaways
- Recognizing and addressing different biases is essential to maintain the integrity of epidemiological research.
- Effective study design, critical evaluation of variables, and comprehensive data collection methodologies are key to minimizing errors.
- Continuous vigilance for biases at all study stages can enhance the reliability and applicability of research findings.### Bias in Epidemiological Studies
- The magnitude of the Odds Ratio (OR) is often less than the true value due to bias.
- Investigators commonly investigate types of bias such as recall bias and interviewer bias, both of which are forms of information bias.
- Selection bias is prevalent in case-control studies and retrospective cohort studies, leading to incorrect associations.
Confounding Control
- Confounding can be managed during the design phase using:
- Randomization
- Restriction
- Matching
- In the analysis phase, confounding can be controlled through:
- Standardization
- Stratified analysis
- Multivariate analysis
- Controlling confounding during the design phase is generally more effective than during the analysis phase.
Limitations in Confounding Control
- Matching is challenging due to its dependence on known confounders; may incur high costs and time.
- Restriction limits generalizability and sample size and may not fully control for confounders.
- Randomization is primarily applicable to experimental studies and is less effective with smaller samples.
- In the analysis phase, stratified analysis is complex with multiple confounders, and multivariate analysis requires stringent model assumptions.
Residual Confounding
- Residual confounding refers to unaddressed confounding variables that remain even after some confounding has been controlled.
Confounding Example
- If socioeconomic status (SES) shows different Relative Risks (RR) across stratifications, and an SES-adjusted RR differs significantly, SES is identified as a confounder.
Observed vs True Association
- Positive confounding results in the observed association exaggerating the true association, moving farther from the null value.
- Negative confounding causes the observed association to mask the true association, pulling it toward the null value.
Mediators vs Confounders
- A mediator is part of the causal pathway between an exposure and disease, while a confounder is not.
- It is possible to control for confounding in both design and analytic phases of research.
Random Error
- Random error encompasses unsystematic errors due to chance and can occur in all study types.
- It can create false associations or obscure true associations.
- Causes include measurement error and sampling variability, both contributing to random error in epidemiological studies.
Hypothesis Testing Outcomes
- Null hypothesis (H0) may be true and either not rejected (correct conclusion) or mistakenly rejected (Type I error).
- Alternative hypothesis (HA) may be true and either not confirmed (Type II error) or correctly supported (correct conclusion).
Statistical Practice
- The p-value indicates the probability of observing results due to chance if the null hypothesis is true.
- A confidence interval quantifies random error, indicating variability around a measure and providing a range in which the true effect lies.
- Wider confidence intervals signify greater random error and reduced precision, while narrower intervals indicate less random error and more precision.
Risk Interpretation
- A calculated Relative Risk (RR) of 4.3 indicates that sedentary computer programmers have 4.3 times higher risk of cardiovascular disease compared to non-computer programmers, based on a p-value of 0.02.
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