Picking the best study designs and methods
Randomized Blinded Trials
- Observational Studies
- Define cohort studies
- Distinguish between prospective and retrospective cohorts
- Explain the nested case-control design and strategy
- Describe the multiple-cohort design
- Define cross-sectional studies
- Explain why cross-sectional studies yield weaker evidence for causality than cohort studies
- Define case-control studies and their benefits and problems
- Describe case-crossover studies.
Studies of medical tests
- Define randomized blinded trials
- Explain how to design RBTs
- Describe how to choose the intervention and control conditions
- Describe how to define outcomes and adverse effects
- Describe how to select participants
- Describe how to measure baseline and outcome variables
- Evaluate approaches to randomizing and blinding.
Enhancing causal inference
- Understand the definition of studies of medical tests and how these studies differ from therapeutic intervention trials or studies to assess causality
- Explain how to select subjects for a study of a medical test
- Understand how to measure reproducibility of a test including use of kappa and the coefficient of variation
- Define key metrics to use in studies that assess the accuracy of a diagnostic test including sensitivity, specificity, predictive value, ROC curves, and likelihood ratios
- Understand how to design studies of clinical prediction rules and the associated limitations and challenges with this design.
The methods: matching study designs to research questions
- Describe cause-effect relationships and enumerate the four rival explanations
- Identify ways to minimize chance
- Discuss bias and identify ways to avoid bias
- Identify ways to make confounding less likely
- Offer several suggestions or strategies for incorporating opportunistic observational designs
- Explain how causal inference can be enhanced by positive evidence.
Subjects and variables
- Why the methods section is the most important part
- How to report study methods accurately and fully
- How to report methods to minimise bias and confounding
- How to use reporting guidelines for different study types.
- Define sample and population, and describe how sample and population inform all clinical research
- Identify criteria for a target population
- Compare and contrast approaches to sampling
- Describe several strategies for recruiting a sample of subjects.