The aim of this study was to develop a core outcome set (COS) for trials and other studies evaluating the effectiveness of prepregnancy care for women with pregestational (pre-existing) diabetes mellitus.
A systematic literature review was completed to identify all outcomes reported in prior studies in this area. Key stakeholders then prioritised these outcomes using a Delphi study. The list of outcomes included in the final COS were finalised at a face-to-face consensus meeting.
In total, 17 outcomes were selected and agreed on for inclusion in the final COS. These outcomes were grouped under three domains: measures of pregnancy preparation (n = 9), neonatal outcomes (n = 6) and maternal outcomes (n = 2).
This study identified a COS essential for studies evaluating prepregnancy care for women with pregestational diabetes. It is advocated that all trials and other non-randomised studies and audits in this area use this COS with the aim of improving transparency and the ability to compare and combine future studies with greater ease.
The aim of this study was to develop a core outcome set (COS) for trials and other studies evaluating the effectiveness of prepregnancy care for women with pregestational (pre-existing) diabetes mellitus.Contributors
Aoife M. Egan
Michael J. A. Maresh
Mary R. Loeken
Harold W. de Valk
Mireille van Poppel
Fidelma P. Dunne
- COS for clinical trials or clinical research
- Systematic review of outcomes measured in trials
- Consensus meeting
- Delphi process
- Systematic review
• Systematic review to identify reported outcome measures in clinical studies on prepregnancy care; ?
• Development of a preliminary COS for use in prepregnancy care studies. ?This will be facilitated through an international, electronic Dephi survey
• Consensus meeting to discuss and agree on the final prepregnancy care COS.