Core outcomes in gestational diabetes for treatment trials: The Gestational Metabolic Group treatment set.

Mohammed Bashir,Luis Furuya‐Kanamori,Justin C Konje,Lukman Thalib,Suhail A R Doi,Asma Syed,Omran A H Musa,Abdul‐Badi Abou‐Samra,Aisha M Mohamed,Monica Skarulis

doi:10.1002/osp4.480

Abstract

AimsWith the rising number of outcomes being reported following gestational diabetes (GDM), the outcomes in existing studies vary widely making it challenging to compare and contrast the effectiveness of different interventions for GDM. The purpose of this study was to develop a core outcome and measurement set (COS) for GDM treatment trials.Materials & MethodsA Delphi study with structured consultation with stakeholders and discussion within a specialist Gestational Metabolic Group (GEM) were combined with a comprehensive systematic search across different databases (PubMed, Cochrane Library, and Embase). Several Delphi rounds over 2 years were conducted culminating in this report.ResultsThe process resulted in a targeted set of outcomes constituting a “GEM treatment set” aligned with expert opinion. The final COS also included a measurement set for the 11 important clinical outcomes from three major domains: maternal metabolic, fetal, and pregnancy related.ConclusionsBased on the results of this study, it is recommended that future clinical trials on GDM report outcomes uniformly keeping to the recommended COS outcomes.

Highlights

Pre‐pregnancy obesity and gestational weight gain (GWG) during pregnancy are key risk factors for the development of gestational diabetes and mellitus (GDM).[1,2] This consequence of maternal obesity and GWG are defined as the occurrence of glucose intolerance duringMohammed Bashir and Asma Syed contributed .pregnancy which commonly resolves after birth.[3]
This paper presents the results of a core outcome and measurement set (COS) developed for treatment trials in GDM
After duplicates and robotic search removal of non‐RCTs, 1716 titles and abstracts were screened to exclude clearly nontreatment trials resulting in the Between May 2018 and April 2019, an initial set of 50 outcomes was developed based on the initial Delphi rounds among the group

Summary

| INTRODUCTION

Pre‐pregnancy obesity and gestational weight gain (GWG) during pregnancy are key risk factors for the development of gestational diabetes and mellitus (GDM).[1,2] This consequence of maternal obesity and GWG are defined as the occurrence of glucose intolerance during. The primary therapeutic strategy for women with GDM is usually lifestyle modification and dietary intervention.[16,17] if these strategies fail to improve glycemic control, pharmacotherapy interventions are provided such as insulin, sulfonylureas, and metformin.[18,19] There are several such therapeutic strategies available and these have been tested in a multitude of trials with inconsistent outcome reporting.[20,21,22] The selection of maternal and fetal outcomes reported in the existing intervention studies have varied widely making it difficult to compare the effectiveness of different interventions across studies.[23] This inconsistency in reporting makes it essential that a core outcome set (COS) be developed for researchers. The COS and COS measurement set can be used to plan outcome selection for future GDM treatment trials

| MATERIALS AND METHODS

| RESULTS

| DISCUSSION

Average plasma glucose

Adverse events related to treatment

Results