Women with pregestational diabetes and their babies are at an increased risk of poor outcomes. In the last number of years, there has been an increase in interventions for the treatment (including education, technology and treatment options) of pregestational diabetes in pregnant women. The aim of developing this core outcome set (COS) is to agree a core set of outcomes to be included in all trials of interventions for the treatment of pregestational diabetes in pregnant women.Contributors
On behalf of the INSPIRED (INternational collaboration for Studies in PREgnacy and Diabetes) research group
Oratile Kgosidialwa; Research fellow; University Hospital Galway and National University of Ireland Galway, Ireland
Delia Bogdanet; College of Medicine, Nursing and Health Sciences; National University Ireland, Galway, Ireland
Linda Biesty; Lecturer in Midwifery; School of Nursing and Midwifery; National University of Galway, Ireland
Declan Devane; Director of HRB Trials Methodology Research Network and Professor of Midwifery; School of Nursing and Midwifery, National University of Ireland Galway, Ireland
Paula O’Shea; Consultant Clinical Biochemist, University Hospital Galway, Ireland
Aoife M. Egan; Assistant Professor of Medicine, Division of Endocrinology and Metabolism; Mayo Clinic, Rochester, USA
Fidelma P. Dunne; Consultant Endocrinologist and Personal Professor; University Hospital Galway and National University of Ireland Galway, Ireland
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Systematic review
1. A systematic review to generate a list of outcomes reported previously.
2. A real time e-Delphi process to allow key stakeholders to rate these outcomes.
3. A face-to-face consensus meeting to finalise the final COS.