Development of a core outcome set for diabetes after pregnancy prevention interventions (COS-DAP): a study protocol

Abstract 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 p...

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Main Authors: Karoline Kragelund Nielsen, Sharleen O’Reilly, Nancy Wu, Kaberi Dasgupta, Helle Terkildsen Maindal
Format: Article
Language:English
Published: BMC 2018-12-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-018-3072-y
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author Karoline Kragelund Nielsen
Sharleen O’Reilly
Nancy Wu
Kaberi Dasgupta
Helle Terkildsen Maindal
author_facet Karoline Kragelund Nielsen
Sharleen O’Reilly
Nancy Wu
Kaberi Dasgupta
Helle Terkildsen Maindal
author_sort Karoline Kragelund Nielsen
collection DOAJ
description Abstract 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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spelling doaj.art-fc25d27ae4964022985fa5610adbbb222022-12-22T01:14:17ZengBMCTrials1745-62152018-12-011911710.1186/s13063-018-3072-yDevelopment of a core outcome set for diabetes after pregnancy prevention interventions (COS-DAP): a study protocolKaroline Kragelund Nielsen0Sharleen O’Reilly1Nancy Wu2Kaberi Dasgupta3Helle Terkildsen Maindal4Health Promotion Research, Steno Diabetes Center CopenhagenSchool of Agriculture and Food Science, University College DublinCentre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health CentreCentre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health CentreHealth Promotion Research, Steno Diabetes Center CopenhagenAbstract 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.http://link.springer.com/article/10.1186/s13063-018-3072-yGestational diabetesDiabetes preventionCore outcome setBehavior change interventions
spellingShingle Karoline Kragelund Nielsen
Sharleen O’Reilly
Nancy Wu
Kaberi Dasgupta
Helle Terkildsen Maindal
Development of a core outcome set for diabetes after pregnancy prevention interventions (COS-DAP): a study protocol
Trials
Gestational diabetes
Diabetes prevention
Core outcome set
Behavior change interventions
title Development of a core outcome set for diabetes after pregnancy prevention interventions (COS-DAP): a study protocol
title_full Development of a core outcome set for diabetes after pregnancy prevention interventions (COS-DAP): a study protocol
title_fullStr Development of a core outcome set for diabetes after pregnancy prevention interventions (COS-DAP): a study protocol
title_full_unstemmed Development of a core outcome set for diabetes after pregnancy prevention interventions (COS-DAP): a study protocol
title_short Development of a core outcome set for diabetes after pregnancy prevention interventions (COS-DAP): a study protocol
title_sort development of a core outcome set for diabetes after pregnancy prevention interventions cos dap a study protocol
topic Gestational diabetes
Diabetes prevention
Core outcome set
Behavior change interventions
url http://link.springer.com/article/10.1186/s13063-018-3072-y
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