Core Outcome Measures in Effectiveness Trials

COMPARE-Diabetes

General Information

Summary:
The COMPARE (Core Outcome Measures PAediatRic Endocrinology) Initiative is an international not-for-profit research collaboration working towards an international consensus on definitions and standardised outcome measures for therapeutic trials (and epidemiological studies) in Paediatric Endocrinology.

COMPARE-Diabetes will establish core outcome measures for trials of Type 1 Diabetes Mellitus in children.

The outcomes will be developed based on shared priorities between patients, families and caregivers, clinicians, researchers, policymakers and other relevant stakeholders.

Contributors:
Dr Richard G McGee
Prof Geoffrey Ambler
Dr Shubha Srinivasan
A/Prof Allison Tong
Ms Camilla Hanson

Further Study Information

Current Stage:
Planning
Date:
Not stated
Funding source(s):
To be confirmed

Health Area

Disease Category
Endocrine & metabolic

Disease Name
Diabetes mellitus
Paediatric Endocrinology

Target Population

Age Range
0 - 18

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Interview
Literature review
Survey
Systematic review

The process is based on the methods used in many other research areas, in particular the Outcome Measures in Rheumatology (OMERACT) initiative and the World Health Organisation (WHO)-endorsed OMERACT framework. This process is underpinned by the values of: partnership, transparency, equity, trust, respect, evidence, and diversity.
Each ‘domain’ will run individually under the guidance of the COMPARE steering group. For example, the COMPARE-Diabetes group will develop core outcomes for trials related to paediatric diabetes.
There is a five phase process to the creation of a core outcome set: study protocol, systematic review of published outcomes, online Delphi survey, consensus workshop, and publication of core outcome set.


Stakeholders Involved

Clinical experts
Conference participants
Consumers (caregivers)
Consumers (patients)
Device manufacturers
Economists
Epidemiologists
Ethicists
Families
Governmental agencies
Journal editors
Methodologists
Patient/ support group representatives
Pharmaceutical industry representatives
Policy makers
Regulatory agency representatives
Researchers
Statisticians

Study Type

COS for clinical trials or clinical research
COS for practice

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