A Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints: the COSGROVE study
A Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints: the COSGROVE study
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DOI：
10.1016/j.ajog.2019.05.039
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发表时间：
2019-10-01
影响因子：
9.8
通讯作者：
Papageorghiou, Aris T.
中科院分区：
文献类型：
--
作者：
Healy, Patricia;Gordijn, Sanne J.;Papageorghiou, Aris T.
背景：胎儿生长受限是指胎儿没有达到其遗传预定的生长潜力。众所周知，生长受限的胎儿发生短期和长期不良结局的风险增加。系统评价胎儿生长受限临床试验的证据往往是困难的，因为测量和报告的结果的变化。胎儿生长受限研究的核心结果集的发展将使未来的试验，以衡量类似的有意义的outcome.Objective：本研究的目的是开发核心结果集的预防或治疗胎儿生长受限的试验。研究设计：这是一个德尔菲共识研究。进行了全面的文献综述，以确定预防或治疗胎儿生长受限研究中报告的结果。在3轮在线德尔菲调查中，向关键利益相关者（135名医疗保健提供者、68名研究人员/学者和35名公众）提供所有结果，以进行优先排序。先验共识标准被用来达成协议的最终结果inclusion在一个面对面的会议与5个医疗保健提供者，5名研究人员/学者，和6个产科服务users.RESULTS的核心outcome set. In总数，22个结果被列入最终的核心outcome set。这些结果分为4个领域：母亲（n=4），胎儿（n=1），新生儿（n=12），和儿童（n=5）。开发终点研究确定了大量潜在的相关结果，然后就这些因素达成共识，作为最低限度，应在未来所有预防或治疗胎儿生长受限的试验中进行测量和报告。这将使未来的试验能够衡量类似的有意义的结果，并确保不同研究的结果可以进行比较和组合。
BACKGROUND: Fetal growth restriction refers to a fetus that does not reach its genetically predetermined growth potential. It is well-recognized that growth-restricted fetuses are at increased risk of both short-and long-term adverse outcomes. Systematic evaluation of the evidence from clinical trials of fetal growth restriction is often difficult because of variation in the outcomes that are measured and reported. The development of core outcome sets for fetal growth restriction studies would enable future trials to measure similar meaningful outcomes.OBJECTIVE: The purpose of this study was to develop core outcome sets for trials of prevention or treatment of fetal growth restriction.STUDY DESIGN: This was a Delphi consensus study. A comprehensive literature review was conducted to identify outcomes that were reported in studies of prevention or treatment of fetal growth restriction. All outcomes were presented for prioritization to key stakeholders (135 healthcare providers, 68 researchers/academics, and 35 members of the public) in 3 rounds of online Delphi surveys. A priori consensus criteria were used to reach agreement on the final outcomes for in-clusion in the core outcome set at a face-to-face meeting with 5 healthcare providers, 5 researchers/academics, and 6 maternity service users.RESULTS: In total, 22 outcomes were included in the final core outcome set. These outcomes were grouped under 4 domains: maternal (n=4), fetal (n=1), neonatal (n=12), and childhood (n=5).CONCLUSION: The Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints study identified a large number of potentially relevant outcomes and then reached consensus on those factors that, as a minimum, should be measured and reported in all future trials of prevention or treatment of fetal growth restriction. This will enable future trials to measure similar meaningful outcomes and to ensure that findings from different studies can be compared and combined.