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Abstract：
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).
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.
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: http://www.comet-initiative.org/studies/details/1117.
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.
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: http://www.comet-initiative.org/studies/details/1117.
摘要：
前置血管是一种胎儿血管在膜中无保护的情况，脐带外,穿过子宫颈的内部开口。在胎膜破裂期间,这些血管会破裂，使婴儿面临严重失血和死亡的严重风险。正在进行许多研究以改善诊断方式并建立明确的管理计划以改善妊娠结局。然而,由于缺乏一套标准化的前置血管研究结果,因此很难比较研究结果并得出有意义的结论.通过这个项目,我们将为患有血管前置的孕妇(COVasP)的研究制定一套核心结果集.
COVasP的开发将涉及五个步骤。首先是系统的审查,其中我们将根据已发表的妊娠合并血管前置的研究得出一长串结局.第二个将涉及对现任和前任患者的深入访谈，他们的家庭成员和照顾这些患者的医疗保健提供者。接下来将进行两轮Delphi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，家庭成员和患者倡导者/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和（4）直接或间接参与这些怀孕管理的其他利益相关者，如管理人员，指导方针开发人员和政策制定者。第四步将涉及使用名义小组方法进行面对面的共识会议，以建立最终的核心成果集。最后一步将涉及使用系统评价和德尔菲调查的组合来衡量和定义已确定的结果。
这项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编号18-0173-E）和悉尼科技大学人类研究伦理委员会的批准。2019年7月30日，澳大利亚（UTSHREC参考号ETH19-3718）。所有进展将记录在国际前瞻性系统审查登记册和有效性试验中的核心成果措施数据库中。REGISTRATIONDETAILS:http://www.comet-initiative.org/studies/details/1117.
COVasP的开发将涉及五个步骤。首先是系统的审查,其中我们将根据已发表的妊娠合并血管前置的研究得出一长串结局.第二个将涉及对现任和前任患者的深入访谈，他们的家庭成员和照顾这些患者的医疗保健提供者。接下来将进行两轮Delphi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，家庭成员和患者倡导者/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和（4）直接或间接参与这些怀孕管理的其他利益相关者，如管理人员，指导方针开发人员和政策制定者。第四步将涉及使用名义小组方法进行面对面的共识会议，以建立最终的核心成果集。最后一步将涉及使用系统评价和德尔菲调查的组合来衡量和定义已确定的结果。
这项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编号18-0173-E）和悉尼科技大学人类研究伦理委员会的批准。2019年7月30日，澳大利亚（UTSHREC参考号ETH19-3718）。所有进展将记录在国际前瞻性系统审查登记册和有效性试验中的核心成果措施数据库中。REGISTRATIONDETAILS:http://www.comet-initiative.org/studies/details/1117.
