COMET Initiative | Core outcome set for symptomatic uncomplicated gallstone disease

Core outcome set for symptomatic uncomplicated gallstone disease

Background: Heterogeneity 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.

Methods: An 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.

Results: A 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.

Conclusion: A 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.

Aim

To develop a COS for uncomplicated symptomatic gallstone disease effectiveness trials, which recommends what outcomes should be measured and reported as a minimum, reflecting the interests of relevant stakeholders to facilitate decision-making.

Contributors

Karen Innes, Jemma Hudson, Katie Banister, Bernard Croal, Craig Ramsay, Irfan Ahmed, Jane Blazeby and Katie Gillies,on behalf of the CGALL Trial Group

Publication

Journal: BJS
Volume: 109
Issue: 6
Pages: 539 - 544
Year: 2022
DOI: 10.1093/bjs/znac095

Further Study Information

Current Stage: Completed
Date:
Funding source(s): This work was supported by a National Institute for Health Research Health Technology Assessment Programme Grant (14/192/71). The work was also supported by an NHS Grampian Endowment grant (16/11/006). K.G. held a Medical Research Council UK Methodology Fellowship during the delivery of this project (MR/L01193X/1). The HSRU, Institute of Applied Health Sciences (University of Aberdeen) is core funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates.

Health Area

Disease Category: Gastroenterology

Disease Name: Gallstone disease

Target Population

Age Range: 18

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Delphi process
- Semi structured discussion
- Systematic review

The first phase involved the generation of a longlist of outcomes informed by a systematic review of quantitative and qualitative evidence, and qualitative
interviews with patients. Second, a face-to-face meeting with patients was conducted to determine which outcomes they considered to be core. Then, a three-round Delphi survey with healthcare professionals was used to determine the final COS.