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. 2017 Jul;60(7):1190-1196.
doi: 10.1007/s00125-017-4277-4. Epub 2017 Apr 13.

A core outcome set for studies evaluating the effectiveness of prepregnancy care for women with pregestational diabetes

Aoife M Egan  1 , Sander Galjaard  2 , Michael J A Maresh  3 , Mary R Loeken  4   5 , Angela Napoli  6 , Eleni Anastasiou  7 , Eoin Noctor  8 , Harold W de Valk  9 , Mireille van Poppel  10   11 , Marie Todd  12 , Valerie Smith  13   14 , Declan Devane  14   15 , Fidelma P Dunne  16
Affiliations

A core outcome set for studies evaluating the effectiveness of prepregnancy care for women with pregestational diabetes

Aoife M Egan et al. Diabetologia. 2017 Jul.

Abstract

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.

Keywords: Clinical diabetes; Healthcare delivery; Other techniques; Pregnancy.

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Conflict of interest statement

Data availability

Data are available on request from the authors.

Funding

We acknowledge the Health Research Board of Ireland for supporting prepregnancy care research through grant HRA_POR/2010/16.

Duality of interest

The authors declare that there is no conflict of interest associated with this manuscript.

Contribution statement

AME designed the study and analysed the data. AME drafted the manuscript. All authors made substantial contributions to the acquisition and interpretation of data, revised the manuscript critically for important intellectual content and approved the final version to be published. AME is responsible for the integrity of the work as a whole.

Figures

Fig. 1
Fig. 1
Selection of studies for systematic review
See this image and copyright information in PMC

References

    1. Macintosh MC, Fleming KM, Bailey JA, et al. Perinatal mortality and congenital anomalies in babies of women with type 1 or type 2 diabetes in England, Wales, and Northern Ireland: population-based study. BMJ. 2006;333:177. doi: 10.1136/bmj.38856.692986.AE. - DOI - PMC - PubMed
    1. Dunne FP, Avalos G, Durkan M, et al. ATLANTIC DIP: pregnancy outcome for women with pregestational diabetes along the Irish Atlantic seaboard. Diabetes Care. 2009;32:1205–1206. doi: 10.2337/dc09-1118. - DOI - PMC - PubMed
    1. Egan AM, Danyliv A, Carmody L, Kirwan B, Dunne FP. A prepregnancy care program for women with diabetes: effective and cost saving. J Clin Endocrinol Metab. 2016;101:1807–1815. doi: 10.1210/jc.2015-4046. - DOI - PubMed
    1. Murphy HR, Roland JM, Skinner TC, et al. Effectiveness of a regional prepregnancy care program in women with type 1 and type 2 diabetes benefits beyond glycemic control. Diabetes Care. 2010;33:2514–2520. doi: 10.2337/dc10-1113. - DOI - PMC - PubMed
    1. Steel JM, Johnstone FD, Smith AF, Duncan LJ. Five years experience of a “prepregnancy” clinic for insulin-dependent diabetics. Br Med J (Clin Res Ed) 1982;285:353–356. doi: 10.1136/bmj.285.6338.353. - DOI - PMC - PubMed

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