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Stages in epidemiologic study
Observe possible association
Develop a hypothesis about a cause and effect relationship
Test the hypothesis through a formal epidemiologic study
And next…………?
Issues around data interpretation
Is the reported study scientifically valid? This relates to study design and methodology
Selective nature of presentation of results? Are you getting a balanced report (lay press) Positive results more likely to be published
Study validity
The degree to which inferences drawn from a study are warranted
Takes into account:
Study methods
Representativeness of study sample
Internal validity
The extent to which differences in outcome between groups in a study can be attributed to the hypothesized effects of an exposure, an intervention, or other causal factor being investigated.
Proper selection of study group (sample)
Lack of error in measurement: random error, systematic bias, confounding have been ruled out
Appropriate measurement of:
1. Exposure
2. Outcome
3. Association between exposure & outcome
External validity
Ability to extrapolate results from a sample population to a target
population
Random error
Leads to a false association between exposure and disease that arises from “chance”, that seems to have no assignable cause”. Unlike bias and confounding, random errors are unsystematic, because they arise from an unpredictable, non-discernable process
Sampling error
The possibility that the sample collected is not representative of the
target population. Is relevant to all types of epi studies
A non-representative sample may occur even in random sampling – bad luck
How might one reduce sampling error?
To Avoid: increase sample size
Poor precision
Study factor is not measured sharply
Example: Bogalusa Heart Study – prospective cohort study on CVD. Measure blood pressure (BP) in children. Six BP measurements by two observers,
Average BP
By taking the average of 6 readings, improved precision and reduced random measurement error
To Avoid: Increase number of measurements
Systematic error
This type of error is introduced by the investigative study process.
3 Types:
1. Selection Bias: more likely to include some over others
2. Information/Observation Bias
3. Confounding
A more serious problem to study validity
Selection and information bias
result from an error committed by the investigator in the design or conduct of the study that leads to a false association between exposure and disease
Confounding bias
stems from the natural mixing of effects between exposure and disease and a third variable called a confounder. Distorts the relationship between exposure and disease
Selection bias
Relation between exposure and disease is different for those who participate in the study and those, who theoretically would be eligible for the study but, who do not participate.
Relevant to both:
Selection & retention (how many people stay) of study subjects in the study
Bias in epidemiology
Not prejudice or inclination by investigator
Rather → ignorance or poor decision
Important because: It results in an incorrect or invalid estimate of
the measure of association derived in the study results
Where is selection bias most likely?
Case control and retrospective cohort studies
because both exposure & outcome have
occurred by the time of study subject selection