Core Outcome Measures in Effectiveness Trials

Core Outcome Set and Core Contextual Factors in Diabetes After Pregnancy Prevention Trials (Core-DAP)

General Information

Summary:
Gestational Diabetes (GDM) is known to cause negative outcomes in pregnancy and around the time of birth. We also know that women with previous GDM are at high risk of developing chronic conditions like diabetes and heart disease and that their partners and children are also at risk. Research shows that a woman’s risk can be reduced by almost 60% if she changes her health behaviours to eat a healthy diet, be a healthy weight and exercise regularly. While the number of studies looking at changing the behaviours of women with previous GDM have steadily grown over recent years, it is not clear which outcome measures are the most effective to include in lifestyle change studies and which ones are more appropriate as the woman and her family get older and which contexts they are best suited to. A core outcome set (COS) will highlight which outcome measures have been collected in intervention studies and seek the input of healthcare professionals, research experts and women with previous GDM to identify which ones are most appropriate and when they should be measured. The aim of the COS is support better intervention design for both women with previous GDM, their families and the healthcare system that supports them.

Contributors:
Principal Investigators:
1. Assoc Professor Kaberi Dasgupta, Centre for Outcomes Research & Evaluation, Research Institute of the McGill University Health Centre, McGill University, Montreal, Canada.
2. Assoc Professor Helle Terkildsen Maindal, Department of Public Health, Aarhus University, Aarhus, Denmark.
3. Asst Professor Sharleen O'Reilly, School of Agriculture and Food Science, University College Dublin, Dublin, Ireland.

Further Study Information

Current Stage:
Ongoing
Date:
October 2017 - 2018
Funding source(s):
Canadian Institute of Health Research Planning and Dissemination Grant

Health Area

Disease Category
Endocrine & metabolic

Disease Name
Gestational diabetes mellitus

Target Population

Age Range
16 - 75

Sex
Female


Nature / type of Intervention
Prevention

Method(s)

Consensus meeting
Delphi process
Semi structured discussion
Systematic review

A systematic review will be carried out to determine the outcome measures and contextual factors in reported diabetes after pregnancy (DAP) prevention interventions. A semi-structured discussion meeting will inform the Delphi survey development and the survey will comprise of two rounds. A consensus meeting will be held with key stakeholders to discuss the identified outcomes and refine suitable measures to assess them.


Stakeholders Involved

Clinical experts
Conference participants
Consumers (patients)
Epidemiologists
Families
Methodologists
Researchers

Study Type

COS for clinical trials or clinical research

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