Types of Studies
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Non-experimental
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Case report
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Case series
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Cross-sectional (survey)
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Case-control
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Prospective, observation (cohort)
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Experimental
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Randomized, clinical trial (RCT)
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Study Designs
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Observational studies:
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Observe both exposures and outcomes
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Experimental studies (clinical trials)
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Assign exposures
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Observe outcomes
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Advantages of Clinical Trials
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Often provides the strongest evidence in support of cause-effect relationships
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Basis for clinical and public health policy
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Minimize/eliminate bias and confounding
Core Elements of a Clinical Trial
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Research Question
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Hypothesis
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Core Design
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Study Participants
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Recruitment
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Allocation
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Masking (Blinding)
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Treatment Groups
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Data
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Analytical Issues
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Interpretation of Results
The Research Question
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Critical in design of a trial
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Types of Questions:
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Assessing efficacy of an intervention
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Assessing the effectiveness of an intervention
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