Audit versus clinical research (Fig 71.1)

Clinical research requires that a prospective controlled trial is performed. Such a trial requires a hypothesis, a control and an experimental group and will be the subject of rigorous statistical analysis.

Audit data should be acquired prospectively but there will be no comparison between defined groups. Care will be needed in interpreting the data because there will be many factors that are not controlled. In order to make use of these data they will need to be compared with a standard, i.e. what is acceptable practice prior to the audit? The standard should be established by examining the published data and using prospective clinical trials as the primary source. It is important to examine the clinical trials on which the standard is based. This is to ensure that the patient groups are similar to those which will be the subject of the audit, and that the surgical procedure and other treatment roughly match what is being audited, etc.