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Lecture 7. Objective 18. Describe the elements of design of observational studies: case‑control studies (retrospective studies). Discuss the advantages and disadvantages of this design. Retrospective Case Control Studies.
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Lecture 7 Objective 18. Describe the elements of design of observational studies: case‑control studies (retrospective studies). Discuss the advantages and disadvantages of this design.
Retrospective Case Control Studies • Case-control studies select cases (with disease) and controls (without disease of interest) • sometimes matched on potentially confounding variables
Retrospective Case Control Studies • presence or absence of the risk factor is determined for each individual. • This is the most commonly used design to study etiologic risk factors
Selection of Subjects • based on outcome (disease) status
Assignment of Exposure • exposure determined by genetics, environment or behavior of subject
Temporal Relationship of Exposure • Exposure and onset of disease precedes investigator followup __________________________ t | | | E O I
Measurement of Risk and Association • Risk: Cannot be estimated • Association: Odds Ratio (OR) as an estimate of the relative risk (RR)
Validity • Confounding Bias: may be difficult to get information on potential confounders because of retrospective nature of exposure; matching on potential confounders will not eliminate confounding
Validity • Information Bias: may reduce possibility by "blinding" investigator to outcome when determining exposure status; objective criteria for identifying exposure may also reduce possibility of bias
Validity • Selection Bias: as exposure and outcome have occurred prior to selection, the potential exists to use knowledge of exposure status in selecting subjects
Advantages • best method for studying rare outcomes • normally less expensive than prospective study • can be used to study outcomes with long latent periods; • quickly done
Limitations • must use retrospective information on exposure and confounders • cannot estimate incidence • problems of validity shared with those of retrospective studies
GUIDE FOR EVALUATING A CASE-CONTROL STUDY • Are cases and controls clearly defined? Were these criteria fulfilled in this study? • Were cases and controls comparable? • Do cases and controls come from the same population? Did cases and controls enter the study similarly? Did authors adjust for any differences?
GUIDE FOR EVALUATING A CASE-CONTROL STUDY • Was exposure status clearly defined and consistently obtained? • What was the response rate for cases? controls? • Were cases and controls blinded as to the study hypothesis? • Was the study size sufficiently large to justify the author's conclusions?
Lecture 7 Objective 19. Describe the elements of design of observational studies: cross‑sectional studies. Discuss the advantages and disadvantages of this design.
Crosssectional (Prevalence) Studies • Relate the disease outcome and exposure status at the same time. • These studies are important in establishing the current health status of the population in diseases of short duration.
Selection of Subjects • from total population
Assignment of Exposure • exposure determined by genetics, environment or behavior of subject
Temporal Relationship • Investigator (I), Exposure (E) and Outcome (O) are coincident E |O _____________________ t | I
Measurement of Association • Risk: Prevalence (P) • Association: Prevalence Ratio (PR) or Prevalence Difference (PD)
Validity • Confounding Bias: may be difficult to get information on potential confounder because of retrospective nature of exposure
Validity • Information Bias: eliminate through "blinding", although it may be difficult as exposure and outcome are determined simultaneously; reduce possibility with objective diagnostic criteria
Validity • Selection Bias: because outcome has occurred prior to selection, potential exists for knowledge of outcome status to influence selection of subjects
Advantages • done quickly; no need for follow‑up • can be used to study diseases with long latent periods • good for hypothesis generation
Limitations • uses prevalence to measure risk • not useful for studying rare diseases • not useful for studying rare exposures • must use retrospective information on exposure and confounders • problems of validity shared with those of retrospective studies