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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用于描述妊娠期和产后期间的 2019 年冠状病毒病 (COVID-19) 的序贯前瞻性荟萃分析方案
DOI：
10.1101/2020.11.08.20228056
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发表时间：
2020
期刊：
影响因子：
--
通讯作者：
Smith E
中科院分区：
文献类型：
--
作者：
Smith E
我们迫切需要回答有关SARS-CoV-2在孕妇和产后感染及其对新生儿的影响的基本流行病学问题。虽然许多国家登记处、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严格的方法来更好地联合收割机这些数据并解决知识差距，特别是与罕见结果相关的知识差距。我们建议，使用一个连续的，前瞻性的荟萃分析（PMA）是最好的方法来生成数据的政策和实践为导向的指南。随着大流行的发展，将邀请指导委员会回顾性确定的其他研究或通过实时系统综述参与本PMA。研究者可以通过提交个体患者数据或运行标准化代码来生成汇总数据估计值，从而为PMA做出贡献。对于主要分析，我们将使用两阶段荟萃分析方法汇总数据。荟萃分析将随着每项贡献研究中的额外数据累积以及额外研究满足研究特定时间或数据累积阈值而更新。截至本报告发表时，来自41个国家的25项研究（包括76，000多名孕妇）的研究人员已同意分享数据。在纳入的研究中，有12项研究的同期对照组为未感染COVID-19的妊娠，有4项研究的对照组为未感染COVID-19的育龄妇女。协议和更新将公开维护。研究结果将与主要利益攸关方分享，包括世界卫生组织（世卫组织）孕产妇、新生儿、儿童和青少年健康研究工作组。数据贡献者将与当地利益相关者分享结果。科学出版物将持续在开放获取期刊上发表。
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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影响因子：
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