Aims/hypothesis
Gestational diabetes mellitus (GDM) is linked with a higher lifetime risk for the development of impaired fasting glucose, impaired glucose tolerance, type 2 diabetes, the metabolic syndrome, cardiovascular disease, postpartum depression and tumours. Despite this, there is no consistency in the long-term follow-up of women with a previous diagnosis of GDM. Further, the outcomes selected and reported in the research involving this population are heterogeneous and lack standardisation. This amplifies the risk of reporting bias and diminishes the likelihood of significant comparisons between studies. The aim of this study is to develop a core outcome set (COS) for RCTs and other studies evaluating the long-term follow-up at 1 year and beyond of women with previous GDM treated with insulin and/oral glucose-lowering agents.
Methods
The study consisted of three work packages: (1) a systematic review of the outcomes reported in previous RCTs of the follow-up at 1 year and beyond of women with GDM treated with insulin and/or oral glucose-lowering agents; (2) a three-round online Delphi survey with key stakeholders to prioritise these outcomes; and (3) a consensus meeting where the final COS was decided.
Results
Of 3344 abstracts identified and evaluated, 62 papers were retrieved and 25/62 papers were included in this review. A total of 121 outcomes were identified and included in the Delphi survey. Delphi round 1 was emailed to 835 participants and 288 (34.5%) responded. In round 2, 190 of 288 (65.9%) participants responded and in round 3, 165 of 190 (86.8%) participants responded. In total, nine outcomes were selected and agreed for inclusion in the final COS: assessment of glycaemic status; diagnosis of type 2 diabetes since the index pregnancy; number of pregnancies since the index pregnancy; number of pregnancies with a diagnosis of GDM since the index pregnancy; diagnosis of prediabetes since the index pregnancy; BMI; post-pregnancy weight retention; resting blood pressure; and breastfeeding.
Conclusions/interpretation
This study identified a COS that will help bring consistency and uniformity to outcome selection and reporting in clinical trials and other studies involving the follow-up at 1 year and beyond of women diagnosed with GDM treated with insulin and/or oral glucose-lowering agents during pregnancy.
Protocol: https://www.ncbi.nlm.nih.gov/pubmed/30611300
Delia Bogdanet
Catriona Reddin
Esther Macken
Tomas P. Griffin
Narjes Fhelelboom
Linda Biesty
Shakila Thangaratinam
Eugene Dempsey
Caroline Crowther
Sander Galjaard
Michael Maresh
Mary R. Loeken
Angela Napoli
Eleni Anastasiou
Eoin Noctor
Harold W. de Valk
Mireille N. M. van Poppel
Andrea Agostini
Cheril Clarson
Aoife M. Egan
Paula M. O’Shea
Declan Devane
Fidelma P. Dunne
Disease Category: Endocrine & metabolic, Pregnancy & childbirth
Disease Name: Gestational diabetes mellitus
Age Range: 18 - 50
Sex: Female
Nature of Intervention: Device, Drug
- Clinical experts
- Consumers (patients)
- Policy makers
- Researchers
- Epidemiologists
- COS for clinical trials or clinical research
- Systematic review of outcomes measured in trials
- Consensus meeting
- Delphi process
- Systematic review
The study consisted of three work packages: (1) a systematic review of the outcomes reported in previous RCTs of the follow-up at 1 year and beyond of women with GDMtreated with insulin and/or oral glucose-lowering agents; (2) a three-round online Delphi survey with key stakeholders to prioritise these outcomes; and (3) a consensus meeting where the final COS was decided.