SCORE-IT - Selecting a Core Outcome Set for Randomised Effectiveness trials In Type 2 Diabetes
General Information
Summary:
Type 2 diabetes is a chronic condition affecting approximately 8.5% of the world’s population.
There is currently no published core outcome set for use in trials of treatment for type 2 diabetes. Consequently the outcomes measured may vary from trial to trial limiting the ability to combine and utilise data efficiently.
This core outcome set will focus on outcomes of importance when treating (not preventing) type 2 diabetes in an adult population.
Protocol: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2805-2
There is currently no published core outcome set for use in trials of treatment for type 2 diabetes. Consequently the outcomes measured may vary from trial to trial limiting the ability to combine and utilise data efficiently.
This core outcome set will focus on outcomes of importance when treating (not preventing) type 2 diabetes in an adult population.
Protocol: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2805-2
Contributors:
Dr Nicola Harman
Research Associate, University of Liverpool
Professor Paula Williamson
Professor of Biostatistics, University of Liverpool
Jacques Demotes-Mainard
European Clinical Research Infrastructure Network
Caroline Terwee
VU University Medical Center, Amsterdam
Michal Raess
INFRAFRONTIER GmbH
Silvio Garattini
Istituto Mario Negri
Serena Battaglia
European Clinical Research Infrastructure Network
Patricia da Silva-Buttkus
Helmholtz Zentrum München
Valerie Gailus-Durner
Helmholtz Zentrum München
Sanna Prinsen
VU University Medical Center, Amsterdam
Research Associate, University of Liverpool
Professor Paula Williamson
Professor of Biostatistics, University of Liverpool
Jacques Demotes-Mainard
European Clinical Research Infrastructure Network
Caroline Terwee
VU University Medical Center, Amsterdam
Michal Raess
INFRAFRONTIER GmbH
Silvio Garattini
Istituto Mario Negri
Serena Battaglia
European Clinical Research Infrastructure Network
Patricia da Silva-Buttkus
Helmholtz Zentrum München
Valerie Gailus-Durner
Helmholtz Zentrum München
Sanna Prinsen
VU University Medical Center, Amsterdam
Further Study Information
Current Stage:
Ongoing
Date:
January 2017 - July 2018
Funding source(s):
CORBEL EU Horizon 2020
Health Area
Disease Category
Endocrine & metabolic
Disease Name
Diabetes mellitus
Type 2 Diabetes
Target Population
Age Range
16 - 100
Sex
Either
Nature / type of Intervention
Any
Method(s)
Consensus meeting
Delphi process
Systematic review
Systematic review to identify reported outcome measures in clinical trials in type 2 diabetes
Systematic review of patient reported outcome measures
Delphi exercise with key stakeholders
Consensus meeting to discuss and agree final core outcome set
***Next steps will include seeking consensus on how these outcomes should be measured and to provide this guidance to researchers***
Stakeholders Involved
Clinical experts
Researchers
Service users
Study Type
COS for clinical trials or clinical research
Recommendations for outcome measures (measurement/how)
Related links
Related studies
- Incorporating patients’ perspectives into the initial stages of core outcome set development: a rapid review of qualitative studies of type 2 diabetes
- Selecting Core Outcomes for Randomised Effectiveness trials in Type 2 diabetes (SCORE-IT): A patient and healthcare professional consensus on a core outcome set for type 2 diabetes
- SCORE-IT (Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 diabetes): a systematic review of registered trials