Maternal and neonatal data collection systems in low- and middle-income countries for maternal vaccines active safety surveillance systems: A scoping review

Abstract

Background 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. Methods 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authors of key studies and experts in the field to validate the information and identify additional sources of relevant unpublished information. Results 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. Conclusion 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.

Assessment of data collection systems for active safety surveillance of vaccines during pregnancy in low- and middle-income countries through key informant’s interviews

“…During previous steps of this landscape analysis, we performed a scoping review and an expert consultation to select perinatal collection systems in LMICs. The systems selection criteria during those steps are summarized in Figure 1, and the ndings are described elsewhere (5). Only three systems that could perform MNCH data collection at the individual level were prioritized during those steps.…”

“…Through this review, eight potential systems were identi ed. (5) Out of the total eight data collection systems identi ed, three were prioritized by a consensus of experts in the eld, based on seven different dimensions: governance, system design, system management, data management, data sources, outcome measurement, and data quality. Speci cally, these three systems selected were: District Health Information Systems (DHIS2),…”

“…The International Network for the Demographic Evaluation of Populations and Their Health (INDEPTH), and The Global Network Maternal Newborn Health Registry (GNMNHR). (5) Brie y, DHIS2 is a free, open-source custom software platform that collects, analyzes, visualizes, and shares data and that has been used mainly as a health management information system. It supports aggregate and individual-level data in more than 75 LMICs, including national-level health programs.…”

“…Nearly 370,000 mothers and their infants have been enrolled in this registry from 2008 until June 2021. (8) (9) Although general information on these systems has been described (5), there are likely differences in the operational use characteristics at different geographical sites using them. ( 5) For instance, although many sites currently use DHIS2 to track individual data, not all use the system to track individual MNCH information, which is essential to support active safety surveillance.…”

Cohort profile: the Western Cape Pregnancy Exposure Registry (WCPER)

“… 17 Background rates of adverse maternal and obstetric outcomes are necessary to determine deviations from expected proportions (signals). Such data may be limited or lacking in low/middle income countries 18 19 or differ sufficiently from the source population so as to introduce bias (eg, use of the Metropolitan Atlanta Congenital Defects Program as external comparator for USA-based studies. 17 )…”