Abstract
Aims/hypothesisThe 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.MethodsA 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.ResultsIn 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/interpretationThis 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.
Highlights
Women with pre-existing diabetes during pregnancy, referred to as pregestational diabetes, have an increased risk of adverse pregnancy outcomes including congenital anomalies, stillbirth and perinatal mortality [1, 2]
It is advocated that all trials and other non-randomised studies and audits in this area use this core outcome set (COS) with the aim of improving transparency and the ability to compare and combine future studies with greater ease
It is advocated that all trials and other non-randomised studies and audit in this area use this COS with the aim of improving transparency and the ability to compare and combine future studies with greater ease
Summary
Women with pre-existing diabetes during pregnancy, referred to as pregestational diabetes, have an increased risk of adverse pregnancy outcomes including congenital anomalies, stillbirth and perinatal mortality [1, 2]. Prepregnancy care describes the targeted support and additional care offered to women who are planning pregnancy [4] It typically involves regular review by a multidisciplinary diabetes team in a dedicated outpatient clinic. There is not an agreed proforma for delivery of this care and, while many groups have reported positive benefits associated with specific programmes, the outcomes reported are varied [3,4,5]. This inconsistency raises concern for outcome selection bias, makes meaningful comparison between studies difficult and limits the ability to combine the findings of individual studies into summary estimates [6]. In the field of women’s health, Methods
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