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.
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