Core Outcome Measures in Effectiveness Trials

Metabolic follow up at one year and beyond of women with gestational diabetes treated with insulin and/or oral hypoglycaemic agents: identification of a core outcomes set using a Delphi survey

General Information

Summary:
Gestational diabetes (GDM) is associated with an increased lifetime risk for development of glucose abnormalities, metabolic syndrome, cardiovascular disease, depression and tumours. Despite this high risk of additional comorbidities, there is no standardised approach to the long-term follow-up of women with a previous diagnosis of GDM. Also, there is no standardisation of outcome selection and reporting in studies involving this population. This increases the risk of reporting bias and reduces the possibility of meaningful comparisons between studies.
The aim of this study is to develop a protocol for a core outcome set (COS) for the metabolic follow-up at one year and beyond of women with previous GDM treated with insulin and/or oral hypoglycaemic agents.


Contributors:
Prof. Fidelma Dunne - NUIG, Galway
Prof. Declan Devane - NUIG, Galway

other contributors
Dr. Aoife Egan - NUIG, Galway
Prof Caroline Crowther - University of Auckland, New Zeeland
Prof Eugene Dempsey - UCC, Infant Centre Cork
Dr. Narjes Fhlelelboom - NUIG, Galway
Linda Biesty - NUIG, Galwaya

Further Study Information

Current Stage:
Ongoing
Date:
October 2017 - November 2018
Funding source(s):
Research Funding

Health Area

Disease Category
Endocrine & metabolic

Disease Name
Gestational diabetes mellitus

Target Population

Age Range
18 - 50

Sex
Female


Nature / type of Intervention
Insulin and/or hypoglycemic agents

Method(s)

Consensus conference
Consensus meeting
Delphi process
Focus group(s)
Literature review
Semi structured discussion
Survey
Systematic review

The study will consist of 3 parts: 1. A systematic review of the literature of the outcomes reported in previous randomized controlled trials of the follow up at one year and beyond of women with GDM treated with insulin and/or oral hypoglycaemic agents; 2. A three-round, online Delphi survey with key stakeholders in order to prioritise these outcomes; 3. A consensus meeting where the final COS will be decided.


Stakeholders Involved

Clinical experts
Conference participants
Consumers (patients)
Policy makers
Researchers
Service providers
Service users

Study Type

COS for clinical trials or clinical research
COS for practice

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