Picking the best study designs and methods

Study design

Learning outcomes:

  • 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.
Randomized Blinded Trials

Learning outcomes:

  • 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.
Studies of medical tests

Learning outcomes:

  • 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.
Enhancing causal inference

Learning outcomes:

  • 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.
The methods: matching study designs to research questions

Learning outcomes:

  • 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.
Subjects and variables

Learning outcomes:

  • 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.