Core outcomes in gestational diabetes for treatment trials: The Gestational Metabolic Group treatment set
Author | Bashir, M. |
Author | Syed, A. |
Author | Furuya-Kanamori, L. |
Author | Musa, O.A.H. |
Author | Mohamed, A.M. |
Author | Skarulis, M. |
Author | Thalib, L. |
Author | Konje, J.C. |
Author | Abou-Samra, A.-B. |
Author | Doi, S.A.R. |
Available date | 2022-04-18T08:10:54Z |
Publication Date | 2021 |
Publication Name | Obesity Science and Practice |
Resource | Scopus |
Identifier | http://dx.doi.org/10.1002/osp4.480 |
Abstract | 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. |
Sponsor | Members of the GEM Group who did not qualify for authorship but who contributed to the QMI meetings include: Maha Abdulla H I Al?Asmakh, PhD, Department of Biomedical Sciences, Qatar University. Stephen Atkin, Professor of Medicine; Weill Cornell Medicine?Qatar; Senior Consultant in Endocrinology, Hamad Medical Corporation, Doha, Qatar. Ilham Bettahi, PhD, Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar. Odette Chagoury, PhD, Associate Director Clinical Research at Weill Cornell Medicine, Doha, Qatar. Tarik El Hadd, MD, Department of Endocrinology, Qatar Metabolic Institute, Hamad Medical Corporation (Hamad Teaching Hospital), Doha, Qatar. Ibrahim M. Ibrahim, MD, Endocrine Department, Sidra Medicine, Doha, Qatar. Gianfranco Pintus, PhD, College of Health Sciences, Qatar University, Doha, Qatar. Manjunath Ramanjaneya, BPharm, Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar. Hiba Mahmoud Hassan Satti, MD, Department of Obstetrics and Gynecology, Hamad Medical Corporation, Doha, Qatar. Hessa Ibrahim Shahbic, MD, Assistant Director of Women's Health Clinical Affairs Department, Primary Health Care Corporation, Doha, Qatar. Fatin Taha, MD, Department of Obstetrics and Gynecology, Hamad Medical Corporation, Doha, Qatar. Shahrad Taheri, BSc, MSc, MBBS, PhD, FRCP; Professor of Medicine; Weill Cornell Medicine?Qatar Senior Consultant in Endocrinology, Hamad Medical Corporation, Doha, Qatar. This study was made possible by program grant NPRP 10?0129?170274 from Qatar National Research Fund (a member of Qatar Foundation) to Suhail A. Doi. The findings herein reflect the work and are solely the responsibility of the authors. Open Access funding provided by the Qatar National Library. |
Language | en |
Publisher | John Wiley and Sons Inc |
Subject | hemoglobin A1c insulin triacylglycerol Apgar score Article chorioamnionitis Cochrane Library consultation controlled study Delphi study Embase female fetus gestational age gestational weight gain glycemic control group therapy hospitalization human hydramnios hyperbilirubinemia hypertension maternal hypertension maternal obesity Medline meta analysis metabolic regulation non insulin dependent diabetes mellitus outcome assessment preeclampsia pregnancy diabetes mellitus pregnancy outcome premature labor prevalence risk factor spontaneous abortion systematic review vaginal delivery venous thromboembolism |
Type | Article |
Pagination | 251-259 |
Issue Number | 3 |
Volume Number | 7 |
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