Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 Diabetes (SCORE-IT): study protocol for the development of a core outcome set
Abstract Background Type 2 diabetes is characterised by abnormal glucose metabolism, and treatment is aimed at normalising glycaemia. Outcomes measured in clinical trials should be meaningful to patients, health care professionals and researchers, yet there is heterogeneity in the outcomes used acro...
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doaj-2b7355a5ad5f40d493afd4406ffca9b32020-11-24T21:56:05ZengBMCTrials1745-62152018-08-011911610.1186/s13063-018-2805-2Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 Diabetes (SCORE-IT): study protocol for the development of a core outcome setNicola L. Harman0John Wilding1Dave Curry2James Harris3Jennifer Logue4R. John Pemberton5Leigh Perreault6Gareth Thompson7Sean Tunis8Paula R. Williamson9on behalf of the SCORE-IT study teamDepartment of Biostatistics, Institute of Translational Medicine, University of LiverpoolObesity and Endocrinology Clinical Research Group, Institute of Ageing and Chronic Disease, University Hospital AintreeDepartment of Biostatistics, Institute of Translational Medicine, University of LiverpoolDepartment of Biostatistics, Institute of Translational Medicine, University of LiverpoolInstitute of Cardiovascular and Medical Sciences, University of GlasgowDepartment of Biostatistics, Institute of Translational Medicine, University of LiverpoolInstitute of Cardiovascular and Medical Sciences, University of GlasgowDepartment of Biostatistics, Institute of Translational Medicine, University of LiverpoolCenter for Medical Technology Policy (CMTP), World Trade Center BaltimoreDepartment of Biostatistics, Institute of Translational Medicine, University of LiverpoolAbstract Background Type 2 diabetes is characterised by abnormal glucose metabolism, and treatment is aimed at normalising glycaemia. Outcomes measured in clinical trials should be meaningful to patients, health care professionals and researchers, yet there is heterogeneity in the outcomes used across trials of glucose-lowering interventions. This inconsistency affects the ability to compare findings and may mean that the results have little importance to health care professionals and the patients for whom they care. The SCORE-IT study aims to develop a core outcome set (COS) for use in all trials of glucose-lowering interventions for people with type 2 diabetes. Methods/design This study will involve three key stages in the development of a COS: (1) A list of outcomes will be identified from multiple sources, specifically registered clinical trials, online patient resources, the qualitative literature and landmark studies identified by a Study Steering Committee. (2) The list of outcomes will be scored by multiple stakeholder groups in a two-round online international Delphi survey. (3) The results of the online Delphi will be summarised and discussed at a face-to-face consensus meeting with representation from all stakeholder groups. Discussion The SCORE-IT study aims to develop an internationally relevant set of core outcomes for use in future trials of glucose-lowering interventions for type 2 diabetes. The use of a COS will improve the consistency of outcomes, allowing results of studies to be compared and combined and for new effective treatments to made available more quickly. Trial registration The COS study, of which this is a part, is registered in the Core Outcome Measures in Effectiveness Trials (COMET) database, http://www.comet-initiative.org/studies/details/956. Registered January 2017.http://link.springer.com/article/10.1186/s13063-018-2805-2Core outcome setSystematic reviewType 2 diabetes |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Nicola L. Harman John Wilding Dave Curry James Harris Jennifer Logue R. John Pemberton Leigh Perreault Gareth Thompson Sean Tunis Paula R. Williamson on behalf of the SCORE-IT study team |
spellingShingle |
Nicola L. Harman John Wilding Dave Curry James Harris Jennifer Logue R. John Pemberton Leigh Perreault Gareth Thompson Sean Tunis Paula R. Williamson on behalf of the SCORE-IT study team Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 Diabetes (SCORE-IT): study protocol for the development of a core outcome set Trials Core outcome set Systematic review Type 2 diabetes |
author_facet |
Nicola L. Harman John Wilding Dave Curry James Harris Jennifer Logue R. John Pemberton Leigh Perreault Gareth Thompson Sean Tunis Paula R. Williamson on behalf of the SCORE-IT study team |
author_sort |
Nicola L. Harman |
title |
Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 Diabetes (SCORE-IT): study protocol for the development of a core outcome set |
title_short |
Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 Diabetes (SCORE-IT): study protocol for the development of a core outcome set |
title_full |
Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 Diabetes (SCORE-IT): study protocol for the development of a core outcome set |
title_fullStr |
Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 Diabetes (SCORE-IT): study protocol for the development of a core outcome set |
title_full_unstemmed |
Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 Diabetes (SCORE-IT): study protocol for the development of a core outcome set |
title_sort |
selecting core outcomes for randomised effectiveness trials in type 2 diabetes (score-it): study protocol for the development of a core outcome set |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2018-08-01 |
description |
Abstract Background Type 2 diabetes is characterised by abnormal glucose metabolism, and treatment is aimed at normalising glycaemia. Outcomes measured in clinical trials should be meaningful to patients, health care professionals and researchers, yet there is heterogeneity in the outcomes used across trials of glucose-lowering interventions. This inconsistency affects the ability to compare findings and may mean that the results have little importance to health care professionals and the patients for whom they care. The SCORE-IT study aims to develop a core outcome set (COS) for use in all trials of glucose-lowering interventions for people with type 2 diabetes. Methods/design This study will involve three key stages in the development of a COS: (1) A list of outcomes will be identified from multiple sources, specifically registered clinical trials, online patient resources, the qualitative literature and landmark studies identified by a Study Steering Committee. (2) The list of outcomes will be scored by multiple stakeholder groups in a two-round online international Delphi survey. (3) The results of the online Delphi will be summarised and discussed at a face-to-face consensus meeting with representation from all stakeholder groups. Discussion The SCORE-IT study aims to develop an internationally relevant set of core outcomes for use in future trials of glucose-lowering interventions for type 2 diabetes. The use of a COS will improve the consistency of outcomes, allowing results of studies to be compared and combined and for new effective treatments to made available more quickly. Trial registration The COS study, of which this is a part, is registered in the Core Outcome Measures in Effectiveness Trials (COMET) database, http://www.comet-initiative.org/studies/details/956. Registered January 2017. |
topic |
Core outcome set Systematic review Type 2 diabetes |
url |
http://link.springer.com/article/10.1186/s13063-018-2805-2 |
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