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

Research output: Contribution to journalArticle

Authors

  • INSPIRED research group

External organisations

  • Division of Endocrinology, Boston Children's Hospital, Boston, MA, USA.
  • School of Physics, National University of Ireland Galway, University Road, Galway, Ireland.
  • Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Mayo Clinic, Rochester, MN, USA.
  • Department of Obstetrics and Gynaecology, University College Cork, Cork University Maternity Hospital, Cork, Ireland
  • Queen Mary, University of London
  • Mother Infant Research Institute
  • University of Western Ontario
  • Department of Medical Microbiology, University Medical Centre Utrecht, Utrecht, Netherlands.
  • Department of Medical Informatics, Erasmus University Medical Centre Rotterdam, Rotterdam, Netherlands.
  • Joslin Diabetes Center
  • Department of Endocrinology, Central Manchester University Hospitals NHS Foundation Trust and University of Manchester, Manchester
  • Rome Transplant Network, Stem Cell Transplant Unit, Tor Vergata University of Rome, Rome, Italy.
  • Poznan University of Medical Sciences
  • Medical University of Graz, Graz, Austria.
  • Barts Research Centre for Women's Health (BARC)
  • Women's Health Research Unit
  • Blizard Institute, Queen Mary University London, London, UK
  • Centre for Immunobiology and Regenerative Medicine, Institute of Dentistry, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 4NS, UK.
  • Institute of Metabolism and Systems Research (IMSR)
  • Auckland Bioengineering Institute, The University of Auckland, Auckland, New Zealand.

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/.

Details

Original languageEnglish
Pages (from-to)1120-1127
Number of pages8
JournalDiabetologia
Volume63
Issue number6
Publication statusPublished - Jun 2020