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.
There is currently no agreed published core outcome set for symptomatic uncomplicated gallstone disease. Recommendations from the recent NICE guideline on Gallstone Disease1 has clearly demonstrated insufficient information for patients on the effect of cholecystectomy on patient outcomes. The Guideline recommends “research is needed to establish the long term patient benefits and harms, so that appropriate information can be provided to patients to aid decision making and long term management of their condition.”
ContributorsDr Katie Gillies
Mrs Rumana Newlands
Dr Moira Cruickshank
Dr Miriam Brazelli
Miss Karen Innes
Mr Irfan Ahmed
Professor Craig Ramsay (PI)
Disease Category: Gastroenterology
Disease Name: Gallstone disease
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- COS for clinical trials or clinical research
- Interview
- Nominal group technique (NGT)
- Survey
- Systematic review
The general methodology describing the development of a core outcome set (a review of the literature to identify outcomes reported to date; interviews with stakeholders to explore additional outcomes of importance; and a consensus based approach to determine which outcomes should be considered core). This methodology will be adopted to develop a core outcome set for symptomatic uncomplicated gallstone disease. The methodology used to develop the COS for symptomatic uncomplicated gallstone disease will be as follows:
1. A review of the literature to identify outcomes reported to date.
A recent systematic review led by our team2 identified two trials of cholecystectomy versus conservative management. This review will be supplemented with additional randomised studies that report outcomes in symptomatic uncomplicated gallstone disease (e.g. trials of early versus delayed laparoscopic cholecystectomy for uncomplicated biliary colic). A scoping search of the qualitative literature exploring patients’ experiences of uncomplicated gallstones and associated interventions and outcomes will be conducted and supplement the findings from the quantitative studies. Full text papers will be obtained for those studies that on initial screening are considered potentially relevant and will be further assessed for inclusion. This review phase will produce a list of all outcomes variables reported in intervention studies and those exploring patients experience of living with the disease.
2. Interviews with stakeholders to explore additional outcomes of importance.
Qualitative interviews will be used as a way to identify additional potential outcomes of importance (to both patients and clinicians) that are not identified from the literature search. Up to thirty interviews (numbers which are in line with guidance on sampling for Delphi interview studies will be conducted with stakeholders, who will be invited to participate in semi-structured interviews in which their views on the outcomes identified thus far will be explored. This should allow identification of outcomes that, as yet, have not been considered, or used, in empirical studies of uncomplicated gallstone disease. The interviews will be audio-recorded, transcribed, and thematically analysed using a modified framework approach, facilitated by NVivo.
3. Consensus based approach to determine which outcomes should be considered core.
The outcomes (identified in the review and qualitative interviews) will be generated into a list and distributed by questionnaire to upper GI surgeons and a gallstone PPI group. Responders will be asked to rate the importance of each outcome for inclusion in a core outcome set. Initial analysis of the questionnaire will aim to identify a shortlist of outcomes for further discussion at consensus meeting. Following initial analysis of this questionnaire a Nominal Group Technique (NGT) will be conducted. The NGT will involve key stakeholders (patients and clinicians) and will summarise and discuss the questionnaire results with an additional round of anonymised rating to determine the final core set. It is anticipated that this set will consist of no more than 10 individual outcomes.