Cookies on this website
We use cookies to ensure that we give you the best experience on our website. If you click 'Continue' we'll assume that you are happy to receive all cookies and you won't see this message again. Click 'Find out more' for information on how to change your cookie settings.

Randomised evaluations of surgical interventions are rare; some interventions have been widely adopted without rigorous evaluation. Unlike other medical areas, the randomised controlled trial (RCT) design has not become the default study design for the evaluation of surgical interventions. Surgical trials are difficult to successfully undertake and pose particular practical and methodological challenges. However, RCTs have played a role in the assessment of surgical innovations and there is scope and need for greater use. This article will consider the design, conduct and analysis of an RCT of a surgical intervention. The issues will be reviewed under three headings: the timing of the evaluation, defining the research question and trial design issues. Recommendations on the conduct of future surgical RCTs are made. Collaboration between research and surgical communities is needed to address the distinct issues raised by the assessment of surgical interventions and enable the conduct of appropriate and well-designed trials.

Original publication

DOI

10.1186/1745-6215-10-9

Type

Journal article

Journal

Trials

Publication Date

06/02/2009

Volume

10

Addresses

Health Services Research Unit, University Of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, Scotland, AB25 2ZD, UK. j.a.cook@abdn.ac.uk

Keywords

Humans, Treatment Outcome, Surgical Procedures, Operative, Data Interpretation, Statistical, Cooperative Behavior, Evidence-Based Medicine, Biomedical Research, Research Design, Time Factors, Clinical Competence, Diffusion of Innovation, Research Support as Topic, Randomized Controlled Trials as Topic, Practice Guidelines as Topic