Effectiveness of prepregnancy care for women with pregestational diabetes mellitus: protocol for a systematic review of the literature and identification of a core outcomes set using a Delphi survey.
BACKGROUND
Women with pregnancy complicated by pregestational diabetes experience increased rates of adverse pregnancy outcomes. Prepregnancy care is the targeted support and additional care offered to those women who are planning pregnancy and is associated with improved outcomes. However, there is significant heterogeneity in the outcomes measured and reported in studies evaluating the effects of prepregnancy care, which makes meaningful comparison difficult. The aim of this article is to present a protocol for a study to develop a Core Outcome Set (COS) for trials and other studies evaluating the effectiveness of prepregnancy care for women with pregestational diabetes mellitus.


METHODS
This study will include a systematic review of the literature to identify outcomes that have previously been reported in studies evaluating prepregnancy care for women with pregestational diabetes. We will then prioritise these outcomes from the perspective of key stakeholders, including women with pregestational diabetes as well as clinicians, using a Delphi survey. A final consensus meeting will be held with stakeholders to review and finalise the outcomes.


CONCLUSIONS
The expectation is that the COS will always be collected and reported in all clinical trials, audits of practice and other forms of research that involve prepregnancy care programs for women with pregestational diabetes. This will facilitate comparing and contrasting of studies and allow for combining of appropriate studies with the ultimate goal of improved patient care.
Galway Diabetes Research Centre, School of Medicine, National University of Ireland, Galway, Ireland. aoife.egan@gmail.com.
Aoife M
AM
Egan
School of Nursing & Midwifery, Trinity College Dublin, Dublin, Ireland. Smithv1@tcd.ie.|School of Nursing & Midwifery, National University of Ireland, Galway, Ireland. Smithv1@tcd.ie.
Valerie
V
Smith
School of Nursing & Midwifery, National University of Ireland, Galway, Ireland. Declan.devane@nuigalway.ie.|Saolta University Health Care Group, Galway, Ireland. Declan.devane@nuigalway.ie.|Health Research Board - Trials Methodology Research Network (HRB-TMRN), Galway, Ireland. Declan.devane@nuigalway.ie.
Declan
D
Devane
Galway Diabetes Research Centre, School of Medicine, National University of Ireland, Galway, Ireland. Fidelma.dunne@nuigalway.ie.|Saolta University Health Care Group, Galway, Ireland. Fidelma.dunne@nuigalway.ie.
Fidelma P
FP
Dunne
D032921:Consensus; D003245:Consensus Statements as Topic; D003697:Delphi Technique; D003922:Diabetes Mellitus, Type 1 / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D005260:Female; D006302:Health Services Research; D006801:Humans; D008427:Maternal Health Services; D011247:Pregnancy; D011254:Pregnancy in Diabetics / Q000175:diagnosis / Q000628:therapy*; D015397:Program Evaluation; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D000078202:Systematic Reviews as Topic; D016896:Treatment Outcome