Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States.
Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States.
Diabetes Res Clin Pract. 2024 Jan;207:111085. doi: 10.1016/j.diabres.2023.111085. Epub 2024 Jan 7.
This study analyzed uptake of the core outcome set (COS) for type 1 diabetes (T1D) and trends in its use before and after its development in December 2017.
On June 26, 2023, ClinicalTrials.gov was systematically searched for T1D randomized controlled trials. The Core Outcome Measures in Effectiveness Trials (COMET) database provided a COS of eight key outcomes for analysis. Included trials were analyzed for COS uptake before and after its release in December 2017 in a masked, duplicate fashion by independent reviewers. We also calculated the proportion of trials that measured the complete COS and assessed the most frequently reported COS outcomes.
Of 3,792 originally screened articles, 144 RCTs were included in the final sample. Following COS publication, its use steadily decreased. Within the COS, HbA1c and severe hypoglycemia were most frequently implemented as endpoints; other recommended outcomes were rarely used in the published trials.
Despite the 2017 T1D COS publication, use has decreased over time. This inconsistency negatively influences evidence-based practices and care. Educating researchers on COS and promoting uptake is crucial. Wider COS adoption in T1D trials could enhance clinical research overall. Further study of barriers and facilitators influencing uptake is essential to support consistent use and reporting.
本研究分析了 1 型糖尿病（T1D）核心结局集（COS）的采用情况，并分析了在 2017 年 12 月开发该集之前和之后的使用趋势。
2023 年 6 月 26 日，系统地在 ClinicalTrials.gov 上搜索了 T1D 随机对照试验。核心结局测量指标在有效性试验（COMET）数据库提供了一个分析用的 8 个关键结局的 COS。采用独立评审员以掩蔽、重复的方式分析了在 2017 年 12 月发布之前和之后纳入试验的 COS 采用情况。我们还计算了测量完整 COS 的试验比例，并评估了最常报告的 COS 结局。
在最初筛选的 3792 篇文章中，有 144 项 RCT 被纳入最终样本。COS 发布后，其使用量稳步下降。在 COS 内，HbA1c 和严重低血糖最常被用作终点；其他推荐的结局在已发表的试验中很少使用。
尽管 2017 年 T1D COS 发布了，但随着时间的推移，其使用量有所下降。这种不一致性对基于证据的实践和护理产生了负面影响。教育研究人员了解 COS 并促进其采用至关重要。在 T1D 试验中更广泛地采用 COS 可以整体提高临床研究水平。进一步研究影响采用的障碍和促进因素对于支持一致的使用和报告至关重要。
