Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome set
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 stu...
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BMJ Publishing Group
2021-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/6/e045568.full |
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| author | Jane Blazeby Irfan Ahmed Rumana Newlands Miriam Brazzelli Craig Ramsay Karen Innes Bernard Croal Moira Cruickshank Mohamed Bekheit |
| author_facet | Jane Blazeby Irfan Ahmed Rumana Newlands Miriam Brazzelli Craig Ramsay Karen Innes Bernard Croal Moira Cruickshank Mohamed Bekheit |
| author_sort | Jane Blazeby |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-e0bc9c8b24824a9e9a81532c5aefa006 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-e0bc9c8b24824a9e9a81532c5aefa0062024-11-20T06:00:07ZengBMJ Publishing GroupBMJ Open2044-60552021-06-0111610.1136/bmjopen-2020-045568Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome setJane Blazeby0Irfan Ahmed1Rumana Newlands2Miriam Brazzelli3Craig Ramsay4Karen Innes5Bernard Croal6Moira Cruickshank7Mohamed Bekheit8Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UKPublic health department, Barts and The London NHS Trust, London, UKHealth Services Research Unit, University of Aberdeen Institute of Applied Health Sciences, Aberdeen, UKHealth Services Research Unit, University of Aberdeen Health Services Research Unit, Aberdeen, UKHealth Services Research Unit, University of Aberdeen Health Services Research Unit, Aberdeen, UKHealth Services Research Unit, University of Aberdeen Health Services Research Unit, Aberdeen, UKClinical Biochemistry, NHS Grampian, Aberdeen, UKHealth Services Research Unit, University of Aberdeen, Aberdeen, UKDepartment of Surgery, NHS Grampian, Aberdeen, UKBackground 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.https://bmjopen.bmj.com/content/11/6/e045568.full |
| spellingShingle | Jane Blazeby Irfan Ahmed Rumana Newlands Miriam Brazzelli Craig Ramsay Karen Innes Bernard Croal Moira Cruickshank Mohamed Bekheit Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome set BMJ Open |
| title | Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome set |
| title_full | Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome set |
| title_fullStr | Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome set |
| title_full_unstemmed | Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome set |
| title_short | Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome set |
| title_sort | identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease in depth analysis to inform the development of a core outcome set |
| url | https://bmjopen.bmj.com/content/11/6/e045568.full |
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