Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods.

Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods.
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在怀孕和产后期间描述2019年冠状病毒疾病(COVID-19)的顺序,前瞻性荟萃分析的方案。

DOI:
10.1371/journal.pone.0270150
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发表时间:
2022
期刊:
影响因子:
3.7
通讯作者:
--
中科院分区:
综合性期刊3区
文献类型:
--
作者:

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我们迫切需要关于孕妇和产后感染SARS-CoV-2及其对新生儿影响的基本流行病学问题的答案。虽然许多国家登记机构、卫生机构和研究小组正在收集相关数据,但我们需要一种协作和方法严格的方法,以更好地结合这些数据并解决知识差距,特别是与罕见结果有关的知识差距。我们认为,使用顺序的、前瞻性的荟萃分析(PMA)是为政策和实践导向的指南生成数据的最佳方法。随着大流行的发展,指导委员会或通过活的系统评价确定的更多研究将被邀请参加这次PMA。调查人员可以通过提交个别患者数据或运行标准化代码来生成总体数据估计,从而为PMA做出贡献。对于初步分析,我们将使用两阶段荟萃分析方法汇集数据。荟萃分析将随着每项贡献研究中积累的额外数据以及其他研究达到分享特定研究的时间或数据应计阈值而更新。在发表时,41个国家的25项研究的研究人员,包括76,000多名孕妇,已经同意分享这项分析的数据。在纳入的研究中,12项是未使用新冠肺炎的同期妊娠对照组,4项研究包括未怀孕的育龄妇女使用新冠肺炎的对照组。协议和更新将公开维护。结果将与主要利益攸关方分享,包括世界卫生组织(WHO)孕产妇、新生儿、儿童和青少年健康(MNCAH)研究工作组。数据贡献者将与当地利益攸关方共享结果。科学出版物将持续在开放获取的期刊上发表。
We urgently need answers to basic epidemiological questions regarding SARS-CoV-2 infection in pregnant and postpartum women and its effect on their newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologically rigorous approach to better combine these data and address knowledge gaps, especially those related to rare outcomes. We propose that using a sequential, prospective meta-analysis (PMA) is the best approach to generate data for policy- and practice-oriented guidelines. As the pandemic evolves, additional studies identified retrospectively by the steering committee or through living systematic reviews will be invited to participate in this PMA. Investigators can contribute to the PMA by either submitting individual patient data or running standardized code to generate aggregate data estimates. For the primary analysis, we will pool data using two-stage meta-analysis methods. The meta-analyses will be updated as additional data accrue in each contributing study and as additional studies meet study-specific time or data accrual thresholds for sharing. At the time of publication, investigators of 25 studies, including more than 76,000 pregnancies, in 41 countries had agreed to share data for this analysis. Among the included studies, 12 have a contemporaneous comparison group of pregnancies without COVID-19, and four studies include a comparison group of non-pregnant women of reproductive age with COVID-19. Protocols and updates will be maintained publicly. Results will be shared with key stakeholders, including the World Health Organization (WHO) Maternal, Newborn, Child, and Adolescent Health (MNCAH) Research Working Group. Data contributors will share results with local stakeholders. Scientific publications will be published in open-access journals on an ongoing basis.
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