Instituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1014CPV), Buenos Aires, Argentina.
Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, 70112, USA.
BMC Pregnancy Childbirth. 2021 Mar 17;21(1):217. doi: 10.1186/s12884-021-03686-9.
Most post-licensure vaccine pharmacovigilance in low- and middle-income countries (LMICs) are passive reporting systems. These have limited utility for maternal immunization pharmacovigilance in LMIC settings and need to be supplemented with active surveillance. Our study's main objective was to identify existing perinatal data collection systems in LMICs that collect individual information on maternal and neonatal health outcomes and could be developed to inform active safety surveillance of novel vaccines for use during pregnancy.
A scoping review was performed following the Arksey and O'Malley six-stage approach. We included studies describing electronic or mixed paper-electronic data collection systems in LMICs, including research networks, electronic medical records, and custom software platforms for health information systems. Medline PubMed, EMBASE, Global Health, Cochrane Library, LILACS, Bibliography of Asian Studies (BAS), and CINAHL were searched through August 2019. We also searched grey literature including through Google and websites of existing relevant perinatal data collection systems, as well as contacted authors of key studies and experts in the field to validate the information and identify additional sources of relevant unpublished information.
A total of 11,817 records were identified. The full texts of 264 records describing 96 data collection systems were assessed for eligibility. Eight perinatal data collection systems met our inclusion criteria: Global Network's Maternal Newborn Health Registry, International Network for the Demographic Evaluation of Populations and their Health; Perinatal Informatic System; Pregnancy Exposure Registry & Birth Defects Surveillance; SmartCare; Open Medical Record System; Open Smart Register Platform and District Health Information Software 2. These selected systems were qualitatively characterized according to seven different domains: governance; system design; system management; data management; data sources, outcomes and data quality.
This review provides a list of active maternal and neonatal data collection systems in LMICs and their characteristics as well as their outreach, strengths, and limitations. Findings could potentially help further understand where to obtain population-based high-quality information on outcomes to inform the conduct of maternal immunization active vaccine safety surveillance activities and research in LMICs.
大多数中低收入国家（LMICs）的疫苗上市后药物警戒工作都是被动报告系统。这些系统对于中低收入国家的孕产妇免疫药物警戒的作用有限，需要通过主动监测来补充。我们的研究主要目的是确定中低收入国家中现有的围产期数据收集系统，这些系统收集有关孕产妇和新生儿健康结局的个体信息，并可以开发这些系统来为妊娠期间使用的新型疫苗的主动安全性监测提供信息。
我们采用 Arksey 和 O'Malley 的六阶段方法进行了范围综述。我们纳入了描述中低收入国家电子或混合纸质-电子数据收集系统的研究，包括研究网络、电子病历和用于卫生信息系统的定制软件平台。通过 2019 年 8 月的 Medline PubMed、EMBASE、全球卫生、Cochrane 图书馆、LILACS、亚洲研究文献目录（BAS）和 CINAHL 对文献进行了检索。我们还检索了灰色文献，包括通过 Google 和现有相关围产期数据收集系统的网站，以及联系关键研究的作者和该领域的专家，以验证信息并确定其他未发表的相关信息来源。
共确定了 11817 条记录。评估了 264 篇描述 96 个数据收集系统的全文记录，以确定其是否符合纳入标准。符合纳入标准的围产期数据收集系统共有 8 个：全球网络母婴健康登记处、人口及其健康的人口评估国际网络、围产期信息系统、妊娠暴露登记和出生缺陷监测、SmartCare、开放医疗记录系统、开放智能注册平台和地区卫生信息软件 2。根据七个不同的领域对这些选定的系统进行了定性描述：治理、系统设计、系统管理、数据管理、数据来源、结果和数据质量。
本综述提供了中低收入国家中积极开展的孕产妇和新生儿数据收集系统及其特征以及其覆盖范围、优势和局限性的清单。调查结果可能有助于进一步了解从何处获得关于结局的基于人群的高质量信息，以指导中低收入国家的孕产妇免疫主动疫苗安全性监测活动和研究。
