State-of-the-art workshop: Methods for placebo comparator group selection and use in surgical trials

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A workshop will develop guidance to inform the future design of surgical trials, specifically the optimal use of placebos.Using a placebo control or comparator is often thought as the “best” trial design to investigate healthcare interventions. A placebo reduces several biases which otherwise undermine a comparative study’s validity. Placebo controlled trials in surgery are highly controversial for ethical and design reasons. The construction of a placebo surgical intervention, the achievement of satisfactory participation/acceptance by surgeons and other key personnel (e.g. anaesthetists) and interpretation of the trial can all be challenging.It is crucial that trialists, patients and surgeons understand the circumstances in which a surgical placebo control a) could or should be used and b) if so, what type of placebo control would be appropriate. There is a need for clear guidance to aid trialists, funders, patients, journal editors and regulators. We will address this knowledge gap.We propose to bring together leading national and international experts to produce state of the art thinking and knowledge on placebo control in surgical evaluation.