Shi Jiyuan, Gao Ya, Wu Shuang, Niu MingMing, Chen Yamin, Yan Meili, Song Ziwei, Feng Hui, Zhang Junhua, Tian Jinhui
School of Nursing, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Evidence-Based Medicine Center, Lanzhou University, Lanzhou, Gansu, China.
Integr Med Res. 2022 Mar;11(1):100776. doi: 10.1016/j.imr.2021.100776. Epub 2021 Sep 28.
Core outcome sets (COSs) are the minimum outcomes which should be measured and reported by researchers investigating a specific condition. The definition of standards of COSs vary across different health-related areas. This investigated the characteristics of COSs regarding obstetrics and gynecology (OG) and examined the reports and designs of standards of OG COSs.
A comprehensive search was conduced on the COMET database on December 20, 2019 to identify systematic reviews on COSs. Two reviewers independently evaluated whether the reported OG COS met the reporting requirements as stipulated in the Core Outcome Set-STAndards for Reporting (COS-STAR) statement checklist and the minimum design recommendations as outlined in the Core Outcome Set-STAndards for Development (COS-STAD) checklist.
Forty-four OG COSs related to 26 topics were identified. None of them met all the 25 standards of COS-STAR statement which representing 18 items considered essential for transparent and complete reporting list for all COS studies (range: 6.0-24.0, median: 14.0). The compliance rates to 16 standards of methods and result sections ranged from 27.3%-68.2%. Total COS-STAR compliance items for OG COSs with the prior protocol was significantly higher than without prior protocol (MD = 3.846, 95% CI: 0.835-6.858, = 0.012). None of the OG COSs met all the 12 criteria in the COS-STAD minimum standards (range: 3.0-11.0, median: 5.0). The compliance rates for all three standards of stakeholders involved and all four standards of the consensus process were lower than 60%.
Methodological and reporting standards of OG COSs should be improved.
核心结局集（COSs）是研究特定疾病的研究人员应测量和报告的最小结局。COSs标准的定义在不同的健康相关领域有所不同。本研究调查了妇产科（OG）核心结局集的特征，并审视了OG COSs标准的报告和设计。
于2019年12月20日在COMET数据库进行全面检索，以识别关于COSs的系统评价。两名评审员独立评估报告的OG COS是否符合《核心结局集-报告标准》（COS-STAR）声明清单规定的报告要求，以及是否符合《核心结局集-制定标准》（COS-STAD）清单概述的最低设计建议。
共识别出44个与26个主题相关的OG COSs。它们均未完全符合COS-STAR声明的25项标准，这些标准代表了所有COS研究透明和完整报告清单中被认为必不可少的18项内容（范围：6.0-24.0，中位数：14.0）。方法和结果部分16项标准的符合率在27.3%-68.2%之间。有预先方案的OG COSs的COS-STAR总符合项显著高于无预先方案的情况（MD = 3.846，95%CI：0.835-6.858，P = 0.012）。没有一个OG COSs符合COS-STAD最低标准中的所有12项标准（范围：3.0-11.0，中位数：5.0）。所有三项利益相关者参与标准和共识过程的所有四项标准的符合率均低于60%。
OG COSs的方法学和报告标准应予以改进。
