Learning Outcomes

On successful completion of this unit, you will be able to:

• ULO1: Statistical Process Control: Understand the concepts of Continuous Quality Improvement and their usage; Distinguish between Special Causes and Common Causes of variation; Detect Special Causes of variation using a Shewhart control chart; Detect Common Causes of variation using a CUSUM control chart; Detect Common Causes of variation using a EWMA chart
• ULO2: Clinical Agreement: Explain the concepts of validity and reliability of measurements; Explain the concepts of agreement and consistency between 2 or more measures and how, for continuous measurements, these relate to simple correlation or regression; Use appropriate graphical and analytical methods to assess agreement between 2 raters using continuous, nominal or ordinal category measurement using Bland-Altman methods and kappa statistics; Use appropriate intra-class correlations for agreement and consistency involving more than 2 raters using continuous scale measurements
• ULO3: Diagnostic Tests, Systematic Reviews and Meta-Analysis: Calculate measures of performance of a diagnostic test: sensitivity, specificity, and likelihood ratios; Translate the pre-test probability of disease for a particular patient into post-test, predictive values; Plot and interpret a ROC curve; Calculate the diagnostic odds ratio and explain its relationship to the ROC curve; Explain the rationale for doing systematic reviews, rather than narrative reviews; Describe the steps involved in undertaking a systematic review; Conduct a meta-analysis for various study types (including RCTs, observational studies and diagnostic tests) and various outcome variables; Estimate and interpret heterogeneity across studies.
• ULO4: Clinical Trials: Understand the advantages and disadvantages of using cross-over trials; Prepare appropriate graphical displays of cross-over trial data; Analyse 2x2 cross-over trials with a continuous response using both t-tests and analysis of variance; Produce point estimates and confidence intervals for the parameters of interest in a 2x2 cross-over trial with a continuous response; Understand the underlying assumptions of these analyses and be able to perform appropriate model checks; Analyse 2x2 cross-over trials with binary outcomes; Estimate the sample size required for a 2x2 cross-over trial.; Understand the difference between equivalence and efficacy designs; Appreciate the impact of such designs on analysis principles, e.g. intention-to-treat, especially in the presence of non-compliance.; Calculate the sample size needed in equivalence designs and understand the difference with a similar calculation in a standard efficacy trial; Get some exposure to non-inferiority studies, their role and link with equivalence trials; Calculate the sample size needed in non-inferiority studies; Have an idea on internal validity of equivalence/non-inferiority studies.