Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome set

Abstract

BackgroundMany 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.ObjectivesTo 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.ResultsThe 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.ConclusionsThis 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.

Ten-Year Trends of Persistent Mortality With Gallstone Disease: A Retrospective Cohort Study in New Jersey

“… 20 , 34 Better understanding and consensus on patient-centered outcomes of importance across the stages and complications of gallstone disease may guide such concerted and complementary approaches to preventing and modifying the persistent metabolic, biologic, behavioral, structural, social, and economic etiologies upstream from the preventable clinical etiologies of morbidity, mortality, and disability with dGD. 35 – 37 …”

Patient-reported outcome measures (PROMs) after laparoscopic cholecystectomy: systematic review

“…This study utilized articles published only in the English language, which may have prevented the identification of some PROM tools used in LC. Four gallstone-disease-specific PROMs have been developed 54 . The present search did not identify any gallstone-specific PROMs; however, these do not seem to have gained traction in LC as they have not been utilized in the recent literature.…”

Core outcome set for symptomatic uncomplicated gallstone disease

“…This phase of outcome mapping has been published elsewhere 3 . In brief, a systematic literature review was conducted to identify outcomes reported in trials of interventions for symptomatic uncomplicated gallstone disease, and outcomes from exploratory studies reported by patients with a lived experience of symptomatic uncomplicated gallstone disease.…”

“…A recent in-depth analysis 3 of outcomes that had been reported or were considered relevant to symptomatic gallstone disease highlighted the significant variability between studies. In addition, outcome mapping also included empirical research that identified new, unreported in this context, outcomes of importance 3 .…”

“…A recent in-depth analysis 3 of outcomes that had been reported or were considered relevant to symptomatic gallstone disease highlighted the significant variability between studies. In addition, outcome mapping also included empirical research that identified new, unreported in this context, outcomes of importance 3 . This heterogeneity, and absence of outcomes deemed important to patients (and other stakeholders), brings into question the adequacy of existing evidence.…”