• Br J Surg · May 2022

    Core outcome set for symptomatic uncomplicated gallstone disease.

    • Karen Innes, Jemma Hudson, Katie Banister, Bernard Croal, Craig Ramsay, Irfan Ahmed, Jane Blazeby, and Katie Gillies.
    • Health Services Research Unit, University of Aberdeen Institute of Applied Health Sciences, Aberdeen, UK.
    • Br J Surg. 2022 May 16; 109 (6): 539544539-544.

    BackgroundHeterogeneity of outcomes is a problem for assessing intervention effectiveness when considering treatments for uncomplicated symptomatic gallstone disease. The value to all stakeholders of outcomes that have been measured and reported to date is also unclear. The aim of this study was to develop a core outcome set for symptomatic uncomplicated gallstone disease.MethodsAn in person-meeting was held with patients to prioritize potentially important outcomes from a previously developed longlist of outcomes. This was followed by an online three-round Delphi survey that was conducted with healthcare professionals. The results of each consensus process were compared and combined to produce the final core outcome set.ResultsA total of 82 participants enrolled in round 1 of the Delphi survey, with a final sample of 40 participants contributing to round 3. Five patients contributed to the in-person group meeting. Following the consensus processes, 11 outcomes were considered to be core by patients and healthcare professionals, and included in the core outcome set. These were: quality of life; overall health state; overall satisfaction; overall pain; common bile duct injury; biliary leak; haemorrhage; need for endoscopic retrograde cholangiopancreatography; intra-abdominal collections; admission/readmission for problems; and reoperation.ConclusionA core outcome set for symptomatic uncomplicated gallstone disease has been developed with patients and healthcare professionals. Eleven outcomes across four key domains have been identified. These represent the minimum set of outcomes that should be reported in trials evaluating interventions for gallstone disease.© The Author(s) 2022. Published by Oxford University Press on behalf of BJS Society Ltd.

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