A core outcome set for studies evaluating the effectiveness of prepregnancy care for women with pregestational diabetes
Egan, Aoife M.
Maresh, Michael J. A.
Loeken, Mary R.
de Valk, Harold W.
van Poppel, Mireille
Dunne, Fidelma P.
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Egan, Aoife M. Galjaard, Sander; Maresh, Michael J. A.; Loeken, Mary R.; Napoli, Angela; Anastasiou, Eleni; Noctor, Eoin; de Valk, Harold W.; van Poppel, Mireille; Todd, Marie; Smith, Valerie; Devane, Declan; Dunne, Fidelma P. (2017). A core outcome set for studies evaluating the effectiveness of prepregnancy care for women with pregestational diabetes. Diabetologia 60 (7), 1190-1196
Aims/hypothesis 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. Methods 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. Results 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). Conclusions/interpretation 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.