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

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Bashir, M
Syed, A
Furuya-Kanamori, L
Musa, OAH
Mohamed, AM
Skarulis, M
Thalib, L
Konje, JC
Abou-Samra, AB
Doi, SAR
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Aims: With 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 & Methods: A 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. Results: The 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. Conclusions: Based on the results of this study, it is recommended that future clinical trials on GDM report outcomes uniformly keeping to the recommended COS outcomes.

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Obesity Science and Practice

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© 2020 The Authors. Obesity Science & Practice published by World Obesity and The Obesity Society and John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

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Bashir, M; Syed, A; Furuya-Kanamori, L; Musa, OAH; Mohamed, AM; Skarulis, M; Thalib, L; Konje, JC; Abou-Samra, AB; Doi, SAR, Core outcomes in gestational diabetes for treatment trials: The Gestational Metabolic Group treatment set, Obesity Science and Practice, 2020