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

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.

Developing a core outcome set for the treatment of pregnant women with pregestational diabetes—a study protocol

“…Preparation of this protocol is in line with the COS-STAP Statement recommendations which gives guidance on items considered essential in a COS protocol [27]. Our methodology is similar to previous work our group has carried out in development of COS in other areas of maternal diabetes [28][29][30].…”

Core outcome sets in women’s and newborn health: A review, methodological and reporting quality assessment informing recommendations for core outcome set developers and wider stakeholders

“…Of seven previously identified protocols, four had published a COS development study. (17)(18)(19)(20) Overall publications had increased in all areas of women's, newborn and neonatal health (figure 2).…”

“…The variation in outcome reporting was considerable: for example, a review of intrauterine growth restriction trials identified 238 outcomes and a review of bladder pain syndrome trials identified only five. (46,58) Published core outcome sets Twenty completed COS development studies were identified (table S6) (17)(18)(19)(20)(84)(85)(86)(87)(88)(89)(90)(91)(92)(93)(94)(95)(96)(97)(98)(99) including: 13 (65%) in pregnancy and childbirth, 3 (15%) in newborn and neonatal health, 2 (10%) in benign gynaecology and subfertility and 2 (10%) in oncology. Sixteen studies (80%) were developed in an international context.…”

Protocol for development and validation of a clinical prediction model for adverse pregnancy outcomes in women with gestational diabetes

“…The committee also considered outcomes in the final core outcome set (COS) for GDM treatment research. 29 Reference to the COS for future GDM treatment research provided objective prioritisation of outcomes from a large international multidisciplinary group of relevant stakeholders. Finally, the committee considered all outcomes studied in the HAPO study, 5 the landmark international multicentre observational study that demonstrated associations between increasing levels of glucose levels on oral glucose tolerance testing and adverse pregnancy outcomes.…”