Centre for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
UCD Centre for Perinatal Research and Institute of Food and Health, School of Agriculture and Food Science, University College Dublin, Dublin, Ireland.
BMJ Open Diabetes Res Care. 2020 Nov;8(2). doi: 10.1136/bmjdrc-2020-001594.
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.
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.
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.
Researchers should collect and report outcomes from the breadth of domains in the COS.
患有妊娠糖尿病（GDM）的母亲未来患糖尿病的风险很高。目前研究的一个活跃领域是研究 GDM 妊娠后 5 年内女性的健康行为改变策略，以预防妊娠后糖尿病。我们旨在制定一个核心结局集（COS），以促进试验之间的综合和比较。
候选结局通过系统评价确定，并通过国际两轮电子德尔菲调查，由医疗保健专业人员、研究人员和有既往 GDM 的女性对其重要性（1-9 分）进行评分。第二轮保留的结局需要分数高于预设阈值（≥70%的评分 7-9 分）或专家小组在分数不确定时的认可。专家组按域组织 COS。
115 名利益相关者参与了调查，其中 56 名完成了两轮调查。第二轮的分数标准差下降了 0.24（95%CI 0.21-0.27），表明结果趋于一致。最终的 COS 包括 19 个领域（50 个结局）：糖尿病（n=3 个结局）、其他相关疾病（n=3 个）、后续妊娠并发症（n=2 个）、后代结局（n=3 个）、肥胖（n=4 个）、心脏代谢测量（n=5 个）、血糖（n=3 个）、体力活动（n=2 个）、饮食（n=4 个）、母乳喂养（n=2 个）、行为改变理论（n=5 个）、糖尿病相关知识（n=2 个）、健康素养（n=1 个）、社会支持（n=1 个）、睡眠（n=1 个）、生活质量（n=1 个）、方案实施（n=4 个）、卫生经济学评价（n=2 个）和糖尿病风险筛查（n=2 个）。≥90%的七个结局包括糖尿病发展和 GDM 复发、参加产后糖尿病筛查并完成口服葡萄糖耐量试验和/或其他血糖测量、体重和总能量摄入，以及一般健康行为。在 15 个处于 80%-90%认可水平的结局中，大约一半是与前 7 个结局相关的特定元素，其余的则与糖尿病知识、个人风险感知、改变动机、方案要素完成情况以及卫生服务的使用和成本有关。
研究人员应从 COS 的广泛领域中收集和报告结果。
