1. Define, compare, and contrast the concepts of internal and external validity, bias, and confound¬ing in clinical study design.
2. Identify potential sources of bias in clinical trials; select strategies to eliminate or control for bias.
3. Outline the hierarchy of evidence generated by various study designs.
4. Compare and contrast the advantages and disad¬vantages of various study designs (e.g., prospective; retrospective; case-control; cohort; cross-sectional; randomized controlled clinical trials; systematic review; meta-analysis). Delineate the difference between parallel and crossover study designs.
5. Select from various biostatistical measures to appropriately compare groups or their assessments from various study designs and use their findings/ output to interpret results.
6. Define and evaluate odds, odds ratio, risk/incidence rate, risk ratio/relative risks (RRs), and other risk estimates. Compute and evaluate number needed to treat and number needed to harm. Define and calculate terms such as point and period preva¬lence, incidence rate, prevalence rate, absolute risk difference, and RR difference.
7. Define and calculate terms such as true positive, false positive, true negative, false negative, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio.
8. Define research and differentiate it from quality improvement activities.
9. Define the composition, functions, and roles of the institutional review board (IRB).
10. Describe the various steps of the professional writ¬ing and peer-review processes.