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

Moira Cruickshank, Rumana Newlands, Jane Blazeby, Irfan Ahmed, Mohamed Bekheit, Miriam Brazzelli, Bernard Croal, Karen Innes, Craig Ramsay, Katie Gillies

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Abstract

Background: Many completed trials of interventions for uncomplicated gallstone disease are not as helpful as they could be due to lack of standardization 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 RCTs, four gallstone disease specific PROMs, and eight qualitative studies were included. This was supplemented with data from six individual interviews, one 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.
Original languageEnglish
Article numbere045568
Number of pages23
JournalBMJ Open
Volume11
Issue number6
DOIs
Publication statusPublished - 24 Jun 2021

Bibliographical note

Funding Information:
Funding This work was supported by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme grant (14/192/71). The work was also supported by an NHS Grampian Endowment grant (16/11/006). KG held a Medical Research Council UK Methodology Fellowship during the delivery of this project (MR/L01193X/1). The Health Services Research Unit, 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. Disclaimer The funders had no involvement in study design, collection, analysis and interpretation of data, reporting or the decision to publish.

Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

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