Abstract
BackgroundMost 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.MethodsA 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authors of key studies and experts in the field to validate the information and identify additional sources of relevant unpublished information.ResultsA total of 11,817 records were identified.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.ConclusionThis 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.
Highlights
Most post-licensure vaccine pharmacovigilance in low- and middle-income countries (LMICs) are passive reporting systems
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
Spontaneous or passive reporting systems are a cornerstone of vaccine safety surveillance in low- and middleincome countries (LMICs) [1]
Summary
Most post-licensure vaccine pharmacovigilance in low- and middle-income countries (LMICs) are passive reporting systems. Perinatal outcomes information is generally unavailable in LMICs, due to many reasons, including the scarcity of resources and trained staff to support robust data collection systems, occurrence of vital and clinical events outside medical facilities, the lack of standardized, comprehensive, national registers and registration systems, inconsistencies among maternal newborn health outcome definitions, and the fact that medical records are often incomplete, poorly maintained and only paper based [1, 2, 6] Lack of these records makes linking individual data from mother and their babies across systems cumbersome or sometimes impossible
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