Introduction: Mothers with gestational diabetes mellitus (GDM) are at high risk of future diabetes. An active area of research examines health behavior change strategies in women within 5 years of a GDM pregnancy to prevent diabetes after pregnancy. We aimed to develop a core outcome set (COS) to facilitate synthesis and comparison across trials.
Research design and methods: Candidate outcomes were identified through systematic review and scored for importance (1–9) by healthcare professionals, researchers, and women with prior GDM through an international two-round electronic-Delphi survey. Outcomes retained required round two scores above prespecified thresholds (=70% scoring 7–9) or expert panel endorsement when scores were indeterminate. The panel organized the COS by domain.
Results: 115 stakeholders participated in the survey and 56 completed both rounds. SD of scores decreased by 0.24 (95%CI 0.21 to 0.27) by round 2, signaling convergence. The final COS includes 19 domains (50 outcomes): diabetes (n=3 outcomes), other related diseases (n=3), complications in subsequent pregnancy (n=2), offspring outcomes (n=3), adiposity (n=4), cardiometabolic measures (n=5), glycemia (n=3), physical activity (n=2), diet (n=4), breast feeding (n=2), behavior change theory (n=5), diabetes-related knowledge (n=2), health literacy (n=1), social support (n=1), sleep (n=1), quality of life (n=1), program delivery (n=4), health economic evaluation (n=2), and diabetes risk screening (n=2). The seven outcomes endorsed by =90% were diabetes development and GDM recurrence, attending the postpartum diabetes screening and completing oral glucose tolerance testing and/or other glycemia measures, weight and total energy intake, and health behaviors in general. Among the 15 at the 80%–90% endorsement level, approximately half were specific elements related to the top 7, while the remainder related to diabetes knowledge, personal risk perception, motivation for change, program element completion, and health service use and cost.
Conclusion: Researchers should collect and report outcomes from the breadth of domains in the COS.
Nancy Wu, Sharleen O'Reilly, Karoline Kragelund Nielsen, Helle Terkildsen Maindal, Kaberi Dasgupta
Disease Category: Endocrine & metabolic
Disease Name: Gestational diabetes mellitus
Age Range: 16 - 75
Sex: Female
Nature of Intervention: Prevention
- Clinical experts
- Conference participants
- Consumers (patients)
- Epidemiologists
- Families
- Methodologists
- Researchers
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Semi structured discussion
- Systematic review
A systematic review will be carried out to determine the outcome measures and contextual factors in reported diabetes after pregnancy (DAP) prevention interventions. A semi-structured discussion meeting will inform the Delphi survey development and the survey will comprise of two rounds. A consensus meeting will be held with key stakeholders to discuss the identified outcomes and refine suitable measures to assess them.