Statistics / study design / ebm / audit

“Candidates will be expected to understand the statistical fundamentals upon which most clinical research is based. They may be asked to suggest suitable approaches to test problems, or to comment on experimental results. They will not be asked to perform detailed calculations or individual statistical tests. Candidates will be expected to understand the statistical background to measurement error and statistical uncertainty”.


  1. Types of data and their representation
  2. The normal distribution as an example of parametric distribution
  3. Indices of central tendency and variability
  4. The null hypothesis
  5. Simple probability theory and the relation to confidence intervals
  6. Choice of simple statistical tests for different data types
  7. Type I and type II errors

Study Design

  1. Simple aspects of study design
    1. Defining a clinical research question
    2. Defining the outcome measures and the uncertainty of measuring them
    3. Understanding bias
    4. Controls, placebos, randomisation, blinding exclusion criteria
    5. Statistical issues, especially sample size ethical issues

Evidence Based Medicine

  1. Able to locate published research in a systematic manner. Skill
  2. Critically interpret and evaluate the value of published clinical research. Skill
  3. The methodology and processes of clinical and laboratory research including the ethical considerations raised by research, the importance of study design in clinical research and the importance of statistical analyses
  4. Distinguishing statistical from clinical significance
  5. Understanding the limits of clinical trials
  6. The basics of systematic review and its pitfalls
  7. The basic concept of meta-analysis and evidence based medicine.


  • The audit cycle

The major national audit processes, including National Confidential Enquiry into Perioperative Death, CEMACH

Fang Gao Smith, Jeffrey L Tong, and John E Smith
Evidence-based medicine