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.
This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database: http://www.comet-initiative.org/studies/details/686/
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 & the INSPIRED research group
Egan.Aoife@mayo.edu
Disease Category: Pregnancy & childbirth
Disease Name: Diabetes mellitus , Gestational diabetes mellitus
Age Range: 16 - 50
Sex: Female
Nature of Intervention: Any, Prevention
- Clinical experts
- Researchers
- Service users
- Consumers (patients)
- COS for clinical trials or clinical research
- Systematic review of outcomes measured in trials
- Consensus meeting
- Systematic review
- Delphi process
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.