A core outcome set for studies of gestational diabetes mellitus prevention and treatment

Aoife M Egan; Delia Bogdanet; Tomás P Griffin; Oratile Kgosidialwa; Mila Cervar-Zivkovic; Eugene Dempsey; John Allotey; Fernanda Alvarado; Cheril Clarson; Shamil D Cooray; Harold W de Valk; Sander Galjaard; Mary R Loeken; Michael J A Maresh; Angela Napoli; Paula M O'Shea; Ewa Wender-Ozegowska; Mireille N M van Poppel; Shakila Thangaratinam; Caroline Crowther; Linda M Biesty; Declan Devane; Fidelma P Dunne; INSPIRED research group

doi:10.1007/s00125-020-05123-6

A core outcome set for studies of gestational diabetes mellitus prevention and treatment

Diabetologia. 2020 Jun;63(6):1120-1127. doi: 10.1007/s00125-020-05123-6. Epub 2020 Mar 20.

Authors

Aoife M Egan¹, Delia Bogdanet², Tomás P Griffin^{2

3}, Oratile Kgosidialwa², Mila Cervar-Zivkovic⁴, Eugene Dempsey⁵, John Allotey⁶, Fernanda Alvarado⁷, Cheril Clarson^{8

9}, Shamil D Cooray^{6

10

11}, Harold W de Valk¹², Sander Galjaard¹³, Mary R Loeken^{14

15}, Michael J A Maresh¹⁶, Angela Napoli¹⁷, Paula M O'Shea², Ewa Wender-Ozegowska¹⁸, Mireille N M van Poppel¹⁹, Shakila Thangaratinam^{6

20}, Caroline Crowther²¹, Linda M Biesty^{22

23}, Declan Devane^{5

22

23}, Fidelma P Dunne²; INSPIRED research group

Affiliations

¹ Division of Endocrinology, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA. egan.aoife@mayo.edu.
² School of Medicine, National University of Ireland Galway, Galway, Ireland.
³ Department of Endocrinology, St Vincent's University Hospital, Dublin, Ireland.
⁴ Division of Obstetrics, Medizinische Universitat Graz, Graz, Austria.
⁵ INFANT Centre and Department of Paediatrics & Child Health, University College Cork, Cork, Ireland.
⁶ Barts Research Centre for Women's Health (BARC), Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
⁷ Mother Infant Research Institute, Tufts Medical Center, Boston, MA, USA.
⁸ Department of Pediatrics, University of Western Ontario, London, ON, Canada.
⁹ Lawson Health Research Institute, London, ON, Canada.
¹⁰ Diabetes and Vascular Medicine Unit, Monash Health, Melbourne, VIC, Australia.
¹¹ Monash Centre for Health Research and Implementation, Monash University, Melbourne, VIC, Australia.
¹² Department of Internal Medicine, University Medical Centre Utrecht, Utrecht, the Netherlands.
¹³ Department of Obstetrics and Gynaecology, Division of Obstetrics and Prenatal Medicine, Erasmus MC, University Medical Centre Rotterdam, 's-Gravendijkwal 230, 3015 CE, Rotterdam, the Netherlands. s.galjaard@erasmusmc.nl.
¹⁴ Section of Islet Cell and Regenerative Biology, Joslin Diabetes Center, Boston, MA, USA.
¹⁵ Department of Medicine, Harvard Medical School, Boston, MA, USA.
¹⁶ Department of Obstetrics, St Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
¹⁷ Department of Clinical and Molecular Medicine, Sant'Andrea University Hospital, Sapienza, University of Rome, Rome, Italy.
¹⁸ Department of Reproduction, Poznan University of Medical Sciences, Poznan, Poland.
¹⁹ Institute of Sport Science, University of Graz, Graz, Austria.
²⁰ Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.
²¹ Liggins Institute, The University of Auckland, Auckland, New Zealand.
²² School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.
²³ HRB-Trials Methodology Research Network, College of Medicine, Nursing and Health Sciences, National University of Ireland Galway, Galway, Ireland.

Abstract

Aims/hypothesis: The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM).

Methods: We identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised.

Results: Our review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth).

Conclusions/interpretation: This COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies.

Trial registration: This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database: http://www.comet-initiative.org/studies/details/686/.

Keywords: Clinical diabetes; Core outcome set; Insulin therapy; Pregnancy; Systematic review.

Publication types

Systematic Review

MeSH terms

Birth Weight / physiology
Diabetes, Gestational / epidemiology*
Female
Humans
Infant, Newborn
Pregnancy
Premature Birth / epidemiology
Treatment Outcome

Abstract

Publication types

MeSH terms

Grants and funding