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

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mabel Berrueta ◽  
◽  
Agustin Ciapponi ◽  
Ariel Bardach ◽  
Federico Rodriguez Cairoli ◽  
...  

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of key studies and experts in the field to validate the information and identify additional sources of relevant unpublished information.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

2021 ◽  
Author(s):  
Mabel Berrueta ◽  
Agustin Ciapponi ◽  
Ariel Bardach ◽  
Federico Rodriguez Cairoli ◽  
Fabricio J. Castellano ◽  
...  

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 five-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.


2020 ◽  
Vol 4 ◽  
pp. 18 ◽  
Author(s):  
Mabel Berrueta ◽  
Ariel Bardach ◽  
Agustin Ciaponni ◽  
Xu Xiong ◽  
Andy Stergachis ◽  
...  

Background: Pregnant women and neonates represent one of the most vulnerable groups, especially in low- and middle-income countries (LMICs). A recent analysis reported that most vaccine pharmacovigilance systems in LMICs consist of spontaneous (passive) adverse event reporting. Thus, LMICs need effective active surveillance approaches, such as pregnancy registries. We intend to identify currently active maternal and neonatal data collection systems in LMICs, with the potential to inform active safety electronic surveillance for novel vaccines using standardized definitions. Methods: A scoping review will be conducted based on established methodology. Multiple databases of indexed and grey literature will be searched with a specific focus on existing electronic and paper-electronic systems in LMICs that collect continuous, prospective, and individual-level data from antenatal care, delivery, neonatal care (up to 28 days), and postpartum (up to 42 days) at the facility and community level, at the national and district level, and at large hospitals. Also, experts will be contacted to identify unpublished information on relevant data collection systems. General and specific descriptions of Health Information Systems (HIS) extracted from the different sources will be combined and duplicated HIS will be removed, producing a list of unique statements. We will present a final list of Maternal, Newborn, and Child Health systems considered flexible enough to be updated with necessary improvements to detect, assess and respond to safety concerns during the introduction of vaccines and other maternal health interventions. Selected experts will participate in an in-person consultation meeting to select up to three systems to be further explored in situ. Results and knowledge gaps will be synthesized after expert consultation.


PLoS ONE ◽  
2020 ◽  
Vol 15 (10) ◽  
pp. e0239683
Author(s):  
Seblewengel Lemma ◽  
Annika Janson ◽  
Lars-Åke Persson ◽  
Deepthi Wickremasinghe ◽  
Carina Källestål

2021 ◽  
Vol 5 ◽  
pp. 99
Author(s):  
Veronica Pingray ◽  
María Belizán ◽  
Sarah Matthews ◽  
Sabra Zaraa ◽  
Mabel Berrueta ◽  
...  

Background: Given that pregnant women are now included among those for receipt coronavirus disease 2019 (COVID-19) vaccines, it is important to ensure that information systems can be used (or available) for active safety surveillance, especially in low- and middle-income countries (LMICs). The aim of this study was to build consensus about the use of existing maternal and neonatal data collection systems in LMICs for COVID-19 vaccines active safety surveillance, a basic set of variables, and the suitability and feasibility of including pregnant women and LMIC research networks in COVID-19 vaccines pre-licensure activities.  Methods: A three-stage modified Delphi study was conducted over three months in 2020. An international multidisciplinary panel of 16 experts participated. Ratings distributions and consensus were assessed, and ratings’ rationale was analyzed.  Results: The panel recommended using maternal and neonatal data collection systems for active safety surveillance in LMICs (median 9; disagreement index [DI] -0.92), but there was no consensus (median 6; DI 1.79) on the feasibility of adapting these systems. A basic set of 14 maternal, neonatal, and vaccination-related variables. Out of 16 experts, 11 supported a basic set of 14 maternal, neonatal, and vaccination-related variables for active safety surveillance. Seven experts agreed on a broader set of 26 variables.The inclusion of pregnant women for COVID-19 vaccines research (median 8; DI -0.61) was found appropriate, although there was uncertainty on its feasibility in terms of decision-makers’ acceptability (median 7; DI 10.00) and regulatory requirements (median 6; DI 0.51). There was no consensus (median 6; DI 2.35) on the feasibility of including research networks in LMICs for conducting clinical trials amongst pregnant women. Conclusions: Although there was some uncertainty regarding feasibility, experts recommended using maternal and neonatal data collection systems and agreed on a common set of variables for COVID-19 vaccines active safety surveillance in LMICs.


2021 ◽  
Author(s):  
Jason Mulimba Were ◽  
SAVERIO STRANGES ◽  
Ishor Sharma ◽  
Juan-Camilo Vargas-Gonzalez ◽  
M. Karen Campbell

Introduction: The majority of the populations in Low-and Middle-Income Countries (LMICs) are encountering the double burden of malnutrition (DBM): the coexistence of both undernutrition and overnutrition sequalae. With DBM being a new phenomenon in research, little is known about its etiology, operational definitions and risk factors influencing its manifestation. The proposed scoping review is aimed at mapping literature with regards to the DBM phenomenon among preschool children and women of reproductive age in LMICs who are among the most high-risk groups to encounter DBM. Methods: A comprehensive literature search will be conducted in the following electronic databases: MEDLINE, EMBASE, Scopus, CINAHL, LILACS and ProQuest Dissertations & Thesis Global. Additionally, searches in other government and institutional sources (World Health Organization website and university repositories) and forward and backward citation tracking of seminal articles will also be done. Two reviewers will independently conduct title and abstract screening and full text screening. Similarly, data extraction and coding will independently be done by two reviewers. Information extracted from included literature will be analysed qualitatively using thematic analysis approach and reported as per the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. Ethics and Dissemination: Ethical approval is not required for this study because the review is based on literature from publicly available sources. The dissemination of our findings will be done through presentations in relevant conferences and publication in a peer-reviewed journal.


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Nessa Ryan ◽  
Vida Rebello ◽  
Desiree Gutierrez ◽  
Kameko Washburn ◽  
Alvaro Zevallos Barboza ◽  
...  

Background: Stroke is the second leading cause of death globally and an increasing concern in low- and middle-income countries (LMIC) where, due to limited capacity to treat stroke, preventative efforts are critically important. Although some research on evidence-based interventions for stroke prevention in LMIC exists, there remains a significant gap in understanding of their implementation across various contexts in LMIC. Objectives: In this scoping review, our objective was to identify and synthesize the implementation outcomes (using Proctor et al.’s taxonomy, 2011) for stroke prevention interventions, as well as to describe the diverse interventions employed. Methods: Eligible studies were empirical, focused on implementation of stroke prevention programs or policies, and occurred in at least one LMIC. Five databases were searched, including PubMed, PsycINFO, CINAHL, EMBASE, and Web of Science. Two reviewers independently assessed studies for selection and charted data; discrepancies were resolved through discussion with a third reviewer until consensus was reached. Narrative synthesis was used to analyze and interpret the findings. Results: Studies were predominantly focused in Asia, targeting primary or secondary prevention, and facility-based. Interventions were conducted at the level of individual (n=11), system (n=12), or both (n=4). Various implementation outcomes were reported, most commonly cost (n=10), acceptability (n=7), fidelity (n=7), and feasibility (n=6), but also adoption (n=4), penetration (n=3), appropriateness (n=1), and sustainability (n=1). Conclusions: Findings highlight the breadth of evidence-based interventions for stroke prevention available to implement in LMIC settings, including culturally acceptable education interventions, cost-effective medications, and community-based interventions implemented by community health workers. Implementation outcomes remain under-reported, and more rigorous research is needed to better plan and evaluate the implementation of these interventions to prevent stroke.


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