Article Text
Abstract
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.
- diabetes
- gestational
- preventive medicine
- diabetes mellitus
- type 2
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Footnotes
Contributors SO'R, KKN, HTM, and KD conceived the original project. Project design was further developed with NW. NW and KD executed the project with assistance and input at various stages from SOR, KKN, and HTM. NW collected, cleaned, analyzed, and interpreted the data with oversight from KD. NW and KD drafted the manuscript. All authors critically reviewed the manuscript and approved the final version as submitted.
Funding It is supported by the Canadian Institutes of Health Research Planning and Dissemination Grant (Funding Reference #: PCS-155268).
Disclaimer The funder had no input into the conduct of the research or article preparation.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The study design and protocol were approved by the research ethics board of the McGill University Health Centre on July 31, 2018 (reference number MP-37-2019-4765). Informed consent was obtained from all survey participants using a procedure that was approved by the ethics board.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplemental information.
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