1. Follow-up at 1 year and beyond of women with gestational diabetes treated with insulin and/or oral glucose-lowering agents: a core outcome set using a Delphi survey
- Author
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Catriona Reddin, Declan Devane, Esther Macken, Michael Maresh, Tomás P. Griffin, Linda Biesty, Caroline A Crowther, Mireille N M van Poppel, Mary R. Loeken, Aoife M. Egan, Eugene M. Dempsey, Sander Galjaard, Eoin Noctor, Eleni Anastasiou, Angela Napoli, Paula M O'Shea, Harold W. de Valk, Delia Bogdanet, Andrea Agostini, Shakila Thangaratinam, Narjes Fhelelboom, Fidelma Dunne, Cheril Clarson, and Obstetrics & Gynecology
- Subjects
0301 basic medicine ,Blood Glucose ,Pediatrics ,medicine.medical_specialty ,Delphi Technique ,Endocrinology, Diabetes and Metabolism ,Population ,030209 endocrinology & metabolism ,Type 2 diabetes ,Gestational diabetes mellitus ,Article ,Body Mass Index ,Impaired glucose tolerance ,03 medical and health sciences ,0302 clinical medicine ,SDG 3 - Good Health and Well-being ,Pregnancy ,Glucose Intolerance ,Internal Medicine ,medicine ,Insulin ,Humans ,Hypoglycemic Agents ,Prediabetes ,education ,core outcome set ,gestational diabetes mellitus ,insulin ,oral hypoglycaemic agents ,Randomized Controlled Trials as Topic ,education.field_of_study ,Oral hypoglycaemic agents ,business.industry ,Core outcome set ,medicine.disease ,Impaired fasting glucose ,Gestational diabetes ,Obstetrics ,Diabetes, Gestational ,030104 developmental biology ,Treatment Outcome ,Female ,Metabolic syndrome ,business ,Delivery of Health Care ,Algorithms ,Follow-Up Studies - Abstract
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. Electronic supplementary material The online version of this article (10.1007/s00125-019-4935-9) contains peer-reviewed but unedited supplementary material, which is available to authorised users.
- Published
- 2019