Core Outcome Measures in Effectiveness Trials

SCORE-IT - Selecting a Core Outcome Set for Randomised Effectiveness trials In Type 2 Diabetes

General Information

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.


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

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:
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


Nature / type of Intervention


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

Stakeholders Involved

Clinical experts
Service users

Study Type

COS for clinical trials or clinical research

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