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

Aoife M Egan,Tomás P Griffin,Harold W De Valk,M Cervar-Zivkovic ,Mary R Loeken,Caroline A Crowther ,Delia Bogdanet,Declan Devane,Oratile Kgosidialwa,Mireille N M Van Poppel ,Ewa Wender-Ożegowska ,Shakila Thangaratinam,Angela Napoli,Cheril Clarson,John Allotey,Shamil D Cooray,Paula O’shea ,Fernanda Alvarado,Linda Biesty ,Sander Galjaard,Eugene M Dempsey ,Michael Maresh ,Fidelma Dunne

doi:10.1007/s00125-020-05123-6

Abstract

Aims/hypothesisThe 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).MethodsWe 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.ResultsOur 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/interpretationThis 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 registrationThis study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database: http://www.comet-initiative.org/studies/details/686/

Highlights

Gestational diabetes mellitus (GDM) is diabetes with onset or first recognition during pregnancy that was clearly not overtDiabetologia (2020) 63:1120–1127 diabetes prior to gestation [1]
74 GDM prevention outcomes and 116 GDM treatment outcomes were listed for inclusion in round 1 of the e-Delphi Study (ESM Table 2)
A global group of key stakeholders agreed on 14 outcomes to form a core outcome sets (COSs) essential for future trials of GDM prevention or treatment (Table 1)

Summary

Introduction

Gestational diabetes mellitus (GDM) is diabetes with onset or first recognition during pregnancy that was clearly not overtDiabetologia (2020) 63:1120–1127 diabetes prior to gestation [1]. GDM is associated with an increased risk of adverse pregnancy outcomes including pre-eclampsia and Caesarean delivery for the mother and neonatal hypoglycaemia, large for gestational age and birth trauma for the infant [3,4,5,6,7]. These offspring are at increased risk of diabetes and obesity [8, 9] during childhood and adulthood and the mothers have a significantly elevated risk of type 2 diabetes [10, 11]. In the field of women’s health, over 50 journals endorse the Core Outcomes in Women’s Health (CROWN) initiative, which promotes COS development and effective dissemination of related manuscripts [19]

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