Article type
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Abstract
Background: As defined by the COMET initiative, core outcome sets (COS) are an agreed minimum set of outcomes to be measured and reported in trials in a specific area, making it easier for results to be combined and compared. In Australia, the WOMBAT Collaboration, which supports high-quality perinatal trials, recognises the need for standard outcomes in research, including for gestational diabetes (GDM), a common pregnancy complication associated with significant adverse outcomes for women and babies.
Objectives: To assess progress made towards COS in GDM Cochrane Reviews and clinical trials.
Methods: We identified all Cochrane Reviews/Protocols of interventions for the prevention, detection, management or follow-up of GDM. We reviewed choices of review outcomes, reporting of outcome data by included trials, and compared review outcomes pre and post development of standard outcomes by the WOMBAT Collaboration (developed in 2009 through extraction and group harmonisation of outcomes from selected clinical trials and reviews).
Results: Following the WOMBAT Collaboration’s release of a GDM COS, there has been increased consistency in pre-specified primary and secondary review outcomes (in 11 Cochrane Reviews/Protocols published 2010-2014 versus 6 published 2001-2009). The total number of pre-specified review outcomes has increased over time [mean: 52 (2010-14) vs 29 (2001-09)], signifying heightened recognition of important long-term maternal and child health outcomes. While on average over 80% of pre-specified review outcomes in recent reviews still have no reported outcome data, this in part reflects the age of included trials (published from 1985).
Conclusions: While some inconsistency in outcome choices between GDM trials and reviews persists, important progress towards core outcomes in this area has been made. This will increase value and reduce waste in future research, such as in a planned overview of Cochrane Reviews for GDM prevention. Selective reporting of outcomes in trial publications represents an ongoing challenge. Approaches to ensure that COS are further developed, adhered to and endorsed are required.
Objectives: To assess progress made towards COS in GDM Cochrane Reviews and clinical trials.
Methods: We identified all Cochrane Reviews/Protocols of interventions for the prevention, detection, management or follow-up of GDM. We reviewed choices of review outcomes, reporting of outcome data by included trials, and compared review outcomes pre and post development of standard outcomes by the WOMBAT Collaboration (developed in 2009 through extraction and group harmonisation of outcomes from selected clinical trials and reviews).
Results: Following the WOMBAT Collaboration’s release of a GDM COS, there has been increased consistency in pre-specified primary and secondary review outcomes (in 11 Cochrane Reviews/Protocols published 2010-2014 versus 6 published 2001-2009). The total number of pre-specified review outcomes has increased over time [mean: 52 (2010-14) vs 29 (2001-09)], signifying heightened recognition of important long-term maternal and child health outcomes. While on average over 80% of pre-specified review outcomes in recent reviews still have no reported outcome data, this in part reflects the age of included trials (published from 1985).
Conclusions: While some inconsistency in outcome choices between GDM trials and reviews persists, important progress towards core outcomes in this area has been made. This will increase value and reduce waste in future research, such as in a planned overview of Cochrane Reviews for GDM prevention. Selective reporting of outcomes in trial publications represents an ongoing challenge. Approaches to ensure that COS are further developed, adhered to and endorsed are required.