Core outcome set for studies on pregnant women with vasa previa (COVasP): a study protocol
Core outcome set for studies on pregnant women with vasa previa (COVasP): a study protocol
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DOI：
10.1136/bmjopen-2019-034018
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发表时间：
2020-07-01
期刊：
影响因子：
2.9
通讯作者：
Javid, Nasrin
中科院分区：
文献类型：
--
作者：
D'Souza, Rohan;Villani, Linda;Javid, Nasrin
前置血管是一种胎儿血管在脐带外的膜中无保护地流过并穿过子宫颈内部开口的情况。在胎膜破裂时，这些血管会破裂，使婴儿面临严重失血和死亡的危险。正在进行大量的研究，以改进诊断方式和建立明确的管理计划，以改善妊娠结局。然而，由于对前置血管的研究缺乏一套标准化的结果，因此很难比较研究结果并得出有意义的结论。通过该项目，我们将开发一套用于先兆血管（COVasP）孕妇研究的核心结局集。COVasP的开发将分为五个步骤。首先是系统回顾，我们将根据已发表的妊娠合并前置血管的研究得出一长串结果。第二部分将涉及对现在和以前的病人、他们的家庭成员和照顾这些病人的医疗保健提供者的深入访谈。随后将进行两轮德尔菲调查，其目的是将长长的结果列表缩小到四组“利益相关者”认为重要的结果：(1)患者、家属和患者倡导者/代表，(2)医疗保健提供者，(3)研究人员、流行病学家和方法学家，以及(4)直接或间接参与这些妊娠管理的其他利益相关者，如管理者、指南制定者和决策者。第四步将涉及面对面的协商一致会议，使用名义上的小组方法来确定最终的核心成果集。最后一步将包括使用系统评价和德尔菲调查相结合的方法来衡量和定义已确定的结果。本研究以及利益相关者参与的同意书已于2018年9月5日获得西奈山医院研究伦理委员会（REB号18-0173-E）的批准，并于2019年7月30日获得澳大利亚悉尼科技大学人类研究伦理委员会（UTS HREC参考号ETH19-3718）的批准。所有进展将被记录在国际前瞻性系统评价登记册和有效性试验数据库中的核心结果测量。注册详情。
Introduction Vasa previa is a condition where fetal blood vessels run unprotected in the membranes, outside the umbilical cord, and cross the internal opening of the cervix. During rupture of membranes, these vessels can rupture and put the baby at serious risk of severe blood loss and death. Numerous studies are being conducted to improve diagnostic modalities and establish clear management plans to improve pregnancy outcomes. However, the lack of a standardised set of outcomes for studies on vasa previa makes it difficult to compare study findings and draw meaningful conclusions. Through this project, we will be developing a core outcome set for studies on pregnant women with vasa previa (COVasP).Methods and analysis The development of COVasP will involve five steps. The first will be a systematic review, in which we will generate a long list of outcomes based on published studies in pregnancies complicated with vasa previa. The second will involve in-depth interviews with current and former patients, their family members and healthcare providers who care for these patients. This will be followed by a two-round Delphi survey, which will aim to narrow down the long list of outcomes into those considered important by four groups of 'stakeholders': (1) patients, family members and patient advocates/representatives, (2) healthcare providers, (3) researchers, epidemiologists and methodologists and (4) other stakeholders directly or indirectly involved in the management of these pregnancies such as administrators, guideline developers and policymakers. The fourth step will involve a face-to-face consensus meeting using a nominal group approach to establish a finalised core outcome set. The final step will involve measuring and defining the identified outcomes using a combination of systematic reviews and Delphi surveys.Ethics and dissemination This study as well as consent forms for stakeholder participation have received approval from the Mount Sinai Hospital Research Ethics Board (REB number 18-0173-E) on 05 September 2018 and the Human Research Ethics Committee at The University of Technology Sydney, Australia on 30 July 2019 (UTS HREC reference number ETH19-3718). All progress will be documented on the international prospective register of systematic reviews and Core Outcome Measures in Effectiveness Trials databases. Registration details .