Review

The challenges faced in the design, conduct and analysis of surgical randomised controlled trials

Jonathan A Cook^1,2

¹  Health Services Research Unit, University Of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, Scotland, AB25 2ZD, UK

²  Clinical Epidemiology Program, Ottawa Health Research Institute, 1053 Carling Avenue, Ottawa, Ontario, K1Y 4E9, Canada

author email corresponding author email

Trials 2009, 10:9doi:10.1186/1745-6215-10-9

Published:	6 February 2009

Abstract

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.