Gallstone disease (cholelithiasis) is one of the most common gastrointestinal disorders in industrialised countries. As yet there is no evidence on which treatment is the most clinical or cost-effective for the treatment of uncomplicated gallstone disease. Our team are currently running a randomised controlled trial comparing laparoscopic cholecystectomy (surgical management) with observation/conservative treatment (medical management) for preventing recurrent symptoms and complications in adults with uncomplicated symptomatic gallstones (The C-GALL Trial). The primary aim of this trial is to compare the clinical and cost effectiveness, as well as patients reported quality of life, of both interventions.
Many of the completed gallstone trials are not as helpful as they could be due to lack of standardization across studies, outcome definition, collection and reporting. This heterogeneity of outcomes across studies also hampers useful synthesis of primary studies in meta-analyses and ultimately negatively impacts on decision making by all stakeholders. In addition to the heterogeneity of outcomes currently reported and the problems this causes, measuring the wrong outcomes (i.e. those that are not valued by clinicians or, more importantly, patients) could also be a real risk for many studies if stakeholders are not consulted during the trial design process. One way that these problems with heterogeneity and relevance to stakeholders can be addressed is through the development and use of core outcome sets.
The aim of this study is to develop a core outcome set for uncomplicated symptomatic gallstone disease effectiveness trials, which recommends what outcomes should be measured and reported as a minimum, and that reflects the interests of relevant stakeholders in order to facilitate decision making.
Katie Gillies; firstname.lastname@example.org