Key result
Surgical randomized controlled trials face distinct practical and methodological challenges regarding timing, research question definition, and trial design, necessitating greater use of pragmatic approaches.
Highlights the methodological and practical challenges of conducting surgical RCTs and emphasizes the need for collaboration to improve trial design.
Urges caution interpreting surgical RCT results; leaves open optimal pragmatic designs for future trials.
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.
No takes yet. Share an insight, caveat, or question.
Jonathan Cook (2009) conducted a review in Surgical interventions. Surgical randomized controlled trials face distinct practical and methodological challenges regarding timing, research question definition, and trial design, necessitating greater use of pragmatic approaches.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: