Background Many completed trials of interventions for uncomplicated gallstone disease are not as helpful as they could be due to lack of standardisation across studies, outcome definition, collection and reporting. This heterogeneity of outcomes across studies hampers useful synthesis of primary studies and ultimately negatively impacts on decision making by all stakeholders. Core outcome sets offer a potential solution to this problem of heterogeneity and concerns over whether the ‘right’ outcomes are being measured. One of the first steps in core outcome set generation is to identify the range of outcomes reported (in the literature or by patients directly) that are considered important.
Objectives To develop a systematic map that examines the variation in outcome reporting of interventions for uncomplicated symptomatic gallstone disease, and to identify other outcomes of importance to patients with gallstones not previously measured or reported in interventional studies.
Results The literature search identified 794 potentially relevant titles and abstracts of which 137 were deemed eligible for inclusion. A total of 129 randomised controlled trials, 4 gallstone disease specific patient-reported outcome measures (PROMs) and 8 qualitative studies were included. This was supplemented with data from 6 individual interviews, 1 focus group (n=5 participants) and analysis of 20 consultations. A total of 386 individual recorded outcomes were identified across the combined evidence: 330 outcomes (which were reported 1147 times) from trials evaluating interventions, 22 outcomes from PROMs, 17 outcomes from existing qualitative studies and 17 outcomes from primary qualitative research. Areas of overlap between the evidence sources existed but also the primary research contributed new, unreported in this context, outcomes.
Conclusions This study took a rigorous approach to catalogue and map the outcomes of importance in gallstone disease to enhance the development of the COS ‘long’ list. A COS for uncomplicated gallstone disease that considers the views of all relevant stakeholders is needed.
Moira Cruickshank, Rumana Newlands, Jane Blazeby, Irfan Ahmed, Mohamed Bekheit, Miriam Brazzelli, Bernard Croal, Karen Innes, Craig Ramsay, Katie Gillies
Disease Category: Gastroenterology
Disease Name: Gallstone disease
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Consumers (patients)
- Patient perspectives
- Systematic review of outcomes measured in trials
- Systematic review of qualitative research
- Consultations
- Focus group(s)
- Interview
- Systematic review
The identification of outcomes was informed by two sources: existing evidence and new primary research. The specifics of these are detailed below.
1. Identification of outcomes from existing literature:
a) Outcomes reported in trials of interventions for symptomatic uncomplicated gallstone disease.
b) Content analysis of individual items within disease-specific patient-reported outcome measures (PROMs).
c) Outcomes from exploratory studies reported by patients with a lived experience of symptomatic uncomplicated gallstone disease.
2. Identification of outcomes of relevance to patients from new primary research.
a) Interviews and focus groups with patients with a diagnosis of symptomatic uncomplicated gallstone disease and a range of treatments planned or received.
b) Audiorecordings of consultations for a clinical trial evaluating treatments for symptomatic uncomplicated gallstone disease.