Background: Trials in surgery pose some special problems. This paper examines these with reference to 10 years of methodological research sponsored by the UK National Health Service Research and Development programme.
Methods: Solutions to common problems encountered in surgical studies were considered, such as issues of blinding, dependence of results on technical skill and continued evolution of technology.
Results: Numerous methodological developments are described, including the tracker trial concept in which trial design can be adapted to take account of technical developments and interim results. The governance of trials, solutions to ethical conundra and the rising importance of databases are also discussed.
Conclusion: Like surgery itself, the methodological toolkit for evaluation of surgical procedures continues to evolve. The rules of statistical and scientific probity provide plenty of scope for imaginative design solutions for surgical trials.
Copyright 2003 British Journal of Surgery Society Ltd.