Audit versus
clinical research
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.