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.

Trials
|December 31, 2018
PubMed

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.
Abstract

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