Abstract
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.
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.
| Original language | English |
|---|---|
| Pages (from-to) | 539–544 |
| Number of pages | 6 |
| Journal | British Journal of Surgery |
| Volume | 109 |
| Issue number | 6 |
| Early online date | 5 Apr 2022 |
| DOIs | |
| Publication status | Published - 1 Jun 2022 |
Bibliographical note
Open Access via the OUP AgreementFunding
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.
Acknowledgements
The study team thank the DelphiManager team for support and guidance on use of the Delphi platform; and all participants in the study and organizations that disseminated the survey.
Keywords
- endoscopic retrograde cholangiopancreatography
- pain
- patient readmission
- repeat surgery
- consensus
- cholelithiasis
- general surgery
- Hepato-Pancreato-Biliary Surgery