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

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.

PMID: 32193573
PMCID: PMC7228989
DOI: 10.1007/s00125-020-05123-6

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

Aoife M Egan et al. Diabetologia. 2020 Jun.

. 2020 Jun;63(6):1120-1127.

doi: 10.1007/s00125-020-05123-6. Epub 2020 Mar 20.

Authors

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.

PMID: 32193573
PMCID: PMC7228989
DOI: 10.1007/s00125-020-05123-6

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.

PubMed Disclaimer

Figures

**Fig. 1**
Summary of the study work packages

**Fig. 2**
Selection of studies for systematic review

See this image and copyright information in PMC

References

1. American Diabetes Association 2. Classification and diagnosis of diabetes. Diabetes Care. 2019;42(Suppl 1):S13–S28. doi: 10.2337/dc19-S002. - DOI - PubMed
1. Cho NH, Shaw JE, Karuranga S et al (2018) IDF diabetes atlas: global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract 138:271–28 - PubMed
1. Metzger BE, Lowe LP, Dyer AR, et al. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008;358(19):1991–2002. doi: 10.1056/NEJMoa0707943. - DOI - PubMed
1. The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study Cooperative Research Group (2010) Hyperglycemia and adverse pregnancy outcome (HAPO) study: preeclampsia. Am J Obstet Gynecol 202(3):255–e251–257 - PMC - PubMed
1. Sweeting AN, Ross GP, Hyett J, et al. Gestational diabetes mellitus in early pregnancy: evidence for poor pregnancy outcomes despite treatment. Diabetes Care. 2016;39(1):75–81. doi: 10.2337/dc15-0433. - DOI - PubMed

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Grants and funding

LinkOut - more resources

Full Text Sources

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Affiliations

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

Authors

Affiliations

Abstract

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources