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Core outcome set for symptomatic uncomplicated gallstone disease
Karen Innes1, Jemma Hudson1, Katie Banister1
1Health Services Research Unit, University of Aberdeen Institute of Applied Health Sciences, Aberdeen, UK.
The British Journal of Surgery
|May 16, 2022
Summary
A core outcome set was developed for symptomatic gallstone disease, identifying 11 essential outcomes for evaluating treatment effectiveness. This ensures consistent reporting in clinical trials for better patient care.
Area of Science:
- Gastroenterology and Hepatology
- Clinical Trial Methodology
- Health Outcomes Research
Background:
- Assessing intervention effectiveness for symptomatic gallstone disease is challenging due to outcome heterogeneity.
- The clinical utility of previously reported outcomes for gallstone disease is not well-defined.
- A standardized approach is needed to evaluate treatments for uncomplicated symptomatic gallstone disease.
Purpose of the Study:
- To develop a consensus-based core outcome set for symptomatic uncomplicated gallstone disease.
- To establish a minimum set of outcomes for consistent reporting in clinical trials.
- To improve the comparability and value of research findings in gallstone disease management.
Main Methods:
- Patient prioritization of outcomes through an in-person meeting.
- Online three-round Delphi survey with healthcare professionals.
- Consensus process combining patient and professional input to finalize the core outcome set.
Main Results:
- A total of 82 participants in round 1 of the Delphi survey, with 40 completing round 3.
- Five patients participated in the in-person outcome prioritization meeting.
- Eleven core outcomes were identified and agreed upon by patients and healthcare professionals.
Conclusions:
- A core outcome set for symptomatic uncomplicated gallstone disease has been successfully developed.
- The set includes 11 critical outcomes across four domains, reflecting patient and professional consensus.
- This core outcome set provides a standardized framework for reporting outcomes in future gallstone disease trials.
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