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Open Access 01-12-2022 | Gestational Diabetes | Commentary

Pragmatic trials can address diagnostic controversies: recent lessons from gestational diabetes

Authors: Jean Raymond, Hélène Long, Tim Darsaut

Published in: Trials | Issue 1/2022

Abstract

Objective

The aim of the paper is to discuss how a pragmatic definition could change our conception of diagnosis, using gestational diabetes mellitus (GDM) as an example.

Study design

We review the diagnostic controversy that followed an observational study showing a linear relationship between maternal glycaemia and adverse pregnancy outcomes and the resolution proposed 15 years later by a recent pragmatic trial comparing two screening approaches (one- vs two-step) with different diagnostic thresholds.

Results

The pragmatic trial involved approximately 24,000 women. The one-step screening strategy using lower GDM thresholds diagnosed twice as many women with GDM, but pregnancy outcomes were not different. We examine how the pragmatic approach integrates research into practice and defines the meaning of a diagnosis according to patient outcomes. The approach is ethically and scientifically sound as compared to the previous methodology, where observational research separated from care gave a theoretical definition of GDM that may have misled medical practice for two decades.

Conclusion

Pragmatic research integrated into practice can revolutionize our conception of medical diagnosis in the best medical interest of patients.

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Title: Pragmatic trials can address diagnostic controversies: recent lessons from gestational diabetes
Authors: Jean Raymond
Hélène Long
Tim Darsaut
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Gestational Diabetes
Gestational Diabetes
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06169-0

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Pragmatic trials can address diagnostic controversies: recent lessons from gestational diabetes

Abstract

Objective

Study design

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Objective

Study design

Results

Conclusion

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