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Observational and interventional studies
• Observational studies Descriptive
(e.g., What is the incidence of measles?) Analytic
(e.g., What are the risk factors for leishmaniasis?)
• Interventional studies Descriptive
(e.g., “demonstration” studies / projects) Analytic
(e.g., What is the effect of this intervention?)
Basic relation between exposure, time and outcome
Exposure
Outcomes(e.g., Disease)
Time
Referent exposure
period
General considerations about analytical studies
• All risk factors studies should be conducted with incident cases
• Prevalent cases expose to difficulties: Selective survival Impossibility to determine when the disease
occurred Impossibility to determine when the
exposure occurred Lack of information about the exposure -
disease sequence prevents causal inference
Cohort study
• Recruitment of study participants at risk Population Population sample
• Follow-up over time• Observation for the occurrence of one
or more outcomes
Cohorts
Potential objectives of a cohort study
• Descriptive Estimate incidence
• Analytic Compare the incidence of a disease in
various subgroups• Exposed • Unexposed
Cohorts
Elements defining an analytical cohort study
• Study participants At risk for the outcome Selected on the basis of their exposure
status
• Logic Prospective follow-up to measure incidence
• Logistic Prospective Retrospective
Cohorts
Ill Non-ill Total
Exposed a b a+b
Non-exposed c d c+d
Total a+c b+d a+b+c+d
Presentation of the data of an analytical cohort study in a 2 x 2
table
Cohorts
Known at the beginning of the study
Examples of cohort studies
• Retrospective cohort study to investigate an outbreak Wedding dinner
• Long-term cohort to estimate the incidence of cardio-vascular diseases Framingham
• Clinical trials An example of interventional studies
Cohorts
Case control study
• Recruitment of: Case-patients affected with a disease Unaffected control-subjects who are at risk
• Comparison of exposure status• Observation for the presence in the past
of one or more potential risk factors
Case control studies
Objective of a case control study
• Analytic Compare, in terms of exposure status:
• Case-patients affected by a disease • Unaffected control-subjects
Case control studies
Elements defining a case control study
• Study participants Selected on the basis of their disease status
• Logic Retrospective examination of potential
exposures
• Logistic Prospective Retrospective
Case control studies
Cases Controls Total
Exposed a b -
Non-exposed c d -
Total a+c b+d -
Presentation of the data of a case control study in a 2 x 2 table
Case control studies
Fixed at the beginning of the study
Examples of case control studies
• Case control study to investigate an outbreak Risk factor for hepatitis E during an
outbreak in a metropolitan area
• Case control study to investigate the risk factors for a rare disease Creutzfeld-Jacob
Case control studies
Cross-sectional study
• Recruitment of study participants Population Population sample
• Observation for the presence of: One or more outcomes One or more exposures
Cross sectional studies
Potential objectives of a cross-sectional study
• Descriptive Estimate prevalence
• Analytic Compare the prevalence of a disease in
various subgroups, exposed and unexposed Compare the prevalence of an exposure in
various subgroups, affected and unaffected
Cross sectional studies
Elements defining an analytical cross-sectional study
• Study participants Selected independently from their disease
or exposure status
• Logic Simultaneous measurement of outcomes
and potential exposures
• Logistic Cross-sectional
Cross sectional studies
Ill Non-ill Total
Exposed a b a+b
Non-exposed c d c+d
Total a+c b+d a+b+c+d
Presentation of the data of an analytical cross-sectional study in a
2 x 2 table
Cross sectional studies
Known simultaneously when the study is completed
Limitations of causal inference in analytical cross-sectional studies
• Prevalent cases• Exposure and outcome examined at the
same time
Cross-sectional studies
Compared logic and logistics of cohorts, case control and cross-
sectional studies Cohorts Case-control
studiesCross-sectional studies
Logic •Prospective •Retrospective •Cross-sectional
Logistic •Prospective•Retrospective
•Prospective•Retrospective
•Cross-sectional
Comparing cohorts and case control studies (1)
Case control
Cohort
Rare outcomes Adapted Less adapted
Rare exposures Less adapted
Adapted
Multiple exposures Yes Difficult
Multiple outcomes No Yes
Estimation of incidence No Yes
Comparing cohorts and case control studies (2)
Case control
Cohort
Outcome status Easier Difficult if retrospective
Exposure status Recall bias Easier
Natural history - Can be studied
Use of existing data Yes Yes(Retrospective)
Sample size Smaller Larger
Comparing cohorts and case control studies (3)
Case control
Cohort
Cost Lower Higher
Time needed Short Longer
Follow-up (F/U) N/A Lost to F/U
Logistics Easier More difficult
Concept Difficult Easier
Ethics Easier More difficult