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Development of a core outcome set for diabetes after pregnancy prevention interventions (COS-DAP): a study protocol
Karoline Kragelund Nielsen1,2, Sharleen O'Reilly3, Nancy Wu4
1Health Promotion Research, Steno Diabetes Center Copenhagen, Niels Steensens Vej 6, 2820, Gentofte, Denmark. karoline.kragelund.nielsen@regionh.dk.
Insights
This study aims to create a standardized Core Outcome Set for interventions preventing diabetes after pregnancy (DAP) in women with prior gestational diabetes mellitus (GDM). A robust methodology ensures the set is relevant and applicable for future research and improved health outcomes.
Area of Science:
- Reproductive Health
- Endocrinology
- Public Health Interventions
Background:
- Gestational diabetes mellitus (GDM) significantly increases long-term risks, including type 2 diabetes.
- Intensive lifestyle interventions can halve this risk, but studies often lack sufficient duration or sample size to assess incident diabetes.
- There is a growing need for standardized outcome measures in interventions aimed at preventing diabetes after pregnancy (DAP).
Purpose of the Study:
- To develop a Core Outcome Set for Diabetes After Pregnancy (COS-DAP) prevention interventions.
- To establish a standardized framework for evaluating interventions targeting women with prior GDM and their families.
- To enhance the comparability and synthesis of findings from future DAP prevention studies.
Main Methods:
- Systematic literature review of DAP prevention intervention studies post-GDM.
- Investigator meeting to catalog outcomes and implementation components.
- Two-round online Delphi survey for outcome prioritization.
- Consensus meeting with stakeholders using nominal group technique.
Main Results:
- The study is in the process of developing a Core Outcome Set (COS) for DAP prevention interventions.
- The methodology involves systematic review, expert consensus, and stakeholder input.
- Specific results regarding the finalized COS measures will be available upon study completion.
Conclusions:
- The COS-DAP project will yield a standardized COS for health behavior change interventions to prevent DAP.
- The developed COS will improve the ability to compare future studies and synthesize evidence.
- Involving diverse stakeholders ensures the COS's practical applicability and relevance in clinical and research settings.
Background:
Gestational diabetes mellitus (GDM) increases the risk of adverse short- and long-term outcomes, including development of type 2 diabetes. The US Diabetes Prevention Program demonstrates this risk can be halved with an intensive health behavior change intervention in women with pre-diabetes averaging 12 years since a GDM pregnancy. In recent years, the number of studies looking at changing the behaviors of women with previous GDM closer to the time of delivery has steadily grown, but reported outcomes vary and most studies are not long enough or large enough to examine incident diabetes. This initiative aims to develop a core outcome set (COS) for interventions seeking to prevent diabetes after pregnancy (DAP) in both women with prior GDM and their families.
Methods:
The COS-DAP project will use established COS methodology, in four stages: (1) a systematic literature review of DAP prevention intervention studies following GDM; (2) discussion and cataloguing of outcomes measured and implementation components at an investigator meeting; (3) a two-round online Delphi survey aimed at prioritizing the identified outcomes; and (4) a consensus meeting with key stakeholders to review, discuss, and refine suitable COS measures, using nominal group technique.
Discussion:
COS-DAP aims to develop a COS for health behavior change interventions to prevent DAP. The COS is expected to enhance opportunities for comparison of future studies and allow for better synthesis of the effects. The inclusion of multiple stakeholder perspectives will increase the final COSs applicability and relevance.
Trial Registration:
Comet Initiative, COMET 1083; PROSPERO, CRD42018084853 . Registered in prospero on 03/01/2018.
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