{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,11]],"date-time":"2026-03-11T09:10:56Z","timestamp":1773220256906,"version":"3.50.1"},"reference-count":15,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2020,2,5]],"date-time":"2020-02-05T00:00:00Z","timestamp":1580860800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["OPP1210509"],"award-info":[{"award-number":["OPP1210509"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["gatesopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Gates Open Res"],"abstract":"<ns5:p>\n                    <ns5:bold>Background:<\/ns5:bold>\n                    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.\n                  <\/ns5:p>\n                  <ns5:p>\n                    <ns5:bold>Methods:<\/ns5:bold>\n                    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 Also, experts will be contacted to identify unpublished information on relevant data collection systems.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.\n                  <\/ns5:p>","DOI":"10.12688\/gatesopenres.13106.1","type":"journal-article","created":{"date-parts":[[2020,2,5]],"date-time":"2020-02-05T11:25:07Z","timestamp":1580901907000},"page":"18","update-policy":"https:\/\/doi.org\/10.12688\/gatesopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":8,"title":["Maternal and neonatal data collection systems in low- and middle-income countries: scoping review protocol"],"prefix":"10.12688","volume":"4","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7915-5643","authenticated-orcid":false,"given":"Mabel","family":"Berrueta","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4437-0073","authenticated-orcid":false,"given":"Ariel","family":"Bardach","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Agustin","family":"Ciaponni","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9292-5059","authenticated-orcid":false,"given":"Xu","family":"Xiong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andy","family":"Stergachis","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sabra","family":"Zaraa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pierre","family":"Buekens","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"Scoping Review Collaboration Group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2560","published-online":{"date-parts":[[2020,2,5]]},"reference":[{"key":"ref-1","doi-asserted-by":"publisher","first-page":"2643-50","DOI":"10.1016\/j.vaccine.2019.03.060","article-title":"Maternal interventions vigilance harmonization in low- and middle-income countries: Stakeholder meeting report; Amsterdam, May 1-2, 2018.","volume":"37","author":"A Sobanjo-Ter Meulen","year":"2019","journal-title":"Vaccine."},{"key":"ref-2","doi-asserted-by":"publisher","first-page":"1191-1210","DOI":"10.1016\/S1473-3099(18)30310-4","article-title":"Estimates of the global, regional, and national morbidity, mortality, and aetiologies of lower respiratory infections in 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016.","volume":"18","year":"2018","journal-title":"Lancet Infect Dis."},{"key":"ref-3","first-page":"1-30","article-title":"Postapproval Pregnancy Safety Studies Guidance for Industry Postapproval Pregnancy Safety Studies Guidance for Industry","year":"2019"},{"key":"ref-4","article-title":"Maternal Immunization Safety Monitoring in Low- and Middle-Income Countries: A Roadmap for Program Development.","author":"E Lackritz","year":"2017"},{"key":"ref-5","article-title":"Stakeholders Meeting on Maternal Interventions Vigilance: Safety Monitoring and Surveillance in Vaccine and other Research Settings.","year":"2018"},{"key":"ref-6","doi-asserted-by":"publisher","first-page":"e001053","DOI":"10.1136\/bmjgh-2018-001053","article-title":"Mapping the landscape of global programmes to evaluate health interventions in pregnancy: the need for harmonised approaches, standards and tools.","volume":"3","author":"P Zuber","year":"2018","journal-title":"BMJ Glob Health."},{"key":"ref-7","doi-asserted-by":"publisher","first-page":"2967-2974","DOI":"10.1016\/j.vaccine.2019.03.074","article-title":"Immunization in pregnancy safety surveillance in low and middle-income countries- field performance and validation of novel case definitions.","volume":"37","author":"S Kochhar","year":"2019","journal-title":"Vaccine."},{"key":"ref-8","doi-asserted-by":"publisher","first-page":"5993-7","DOI":"10.1016\/j.vaccine.2016.07.006","article-title":"Global alignment of immunization safety assessment in pregnancy - The GAIA project.","volume":"34","author":"J Bonhoeffer","year":"2016","journal-title":"Vaccine."},{"key":"ref-9","doi-asserted-by":"publisher","first-page":"6736-43","DOI":"10.1016\/j.vaccine.2018.09.033","article-title":"Vaccine safety surveillance in pregnancy in low- and middle-income countries using GAIA case definitions: A feasibility assessment.","volume":"36","author":"A Stuurman","year":"2018","journal-title":"Vaccine."},{"key":"ref-10","doi-asserted-by":"publisher","first-page":"19-32","DOI":"10.1080\/1364557032000119616","article-title":"Scoping studies: towards a methodological framework.","volume":"8","author":"H Arksey","year":"2005","journal-title":"Int J Soc Res Methodol."},{"key":"ref-11","doi-asserted-by":"publisher","first-page":"147-50","DOI":"10.1093\/pubmed\/fdr015","article-title":"Cochrane Update. 'Scoping the scope' of a cochrane review.","volume":"33","author":"R Armstrong","year":"2011","journal-title":"J Public Health (Oxf)."},{"key":"ref-12","doi-asserted-by":"publisher","first-page":"g7647","DOI":"10.1136\/bmj.g7647","article-title":"Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation.","volume":"350","author":"L Shamseer","year":"2015","journal-title":"BMJ."},{"key":"ref-13","doi-asserted-by":"publisher","first-page":"69","DOI":"10.1186\/1748-5908-5-69","article-title":"Scoping studies: advancing the methodology.","volume":"5","author":"D Levac","year":"2010","journal-title":"Implement Sci."},{"key":"ref-14","article-title":"The Joanna Briggs Institute Reviewers\u2019 Manual 2015.","year":"2015"},{"key":"ref-15","doi-asserted-by":"crossref","DOI":"10.12688\/gatesopenres.13106.1","article-title":"Maternal and neonatal data collection systems in low- and middle-income countries: scoping review protocol.","author":"M Berrueta","year":"2020"}],"container-title":["Gates Open Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/gatesopenresearch.org\/articles\/4-18\/v1\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/gatesopenresearch.org\/articles\/4-18\/v1\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/gatesopenresearch.org\/articles\/4-18\/v1\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,7,28]],"date-time":"2020-07-28T09:06:36Z","timestamp":1595927196000},"score":1,"resource":{"primary":{"URL":"https:\/\/gatesopenresearch.org\/articles\/4-18\/v1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,2,5]]},"references-count":15,"URL":"https:\/\/doi.org\/10.12688\/gatesopenres.13106.1","relation":{"has-review":[{"id-type":"doi","id":"10.21956\/gatesopenres.14271.r28775","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/gatesopenres.14271.r28726","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/gatesopenres.14271.r28774","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/gatesopenres.14271.r28726","asserted-by":"object"},{"id-type":"doi","id":"10.21956\/gatesopenres.14271.r28775","asserted-by":"object"},{"id-type":"doi","id":"10.21956\/gatesopenres.14271.r28774","asserted-by":"object"}]},"ISSN":["2572-4754"],"issn-type":[{"value":"2572-4754","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,2,5]]},"assertion":[{"value":"Indexed","URL":"https:\/\/gatesopenresearch.org\/articles\/4-18\/v1#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/gatesopenres.14271.r28726, Russell S. Kirby, College of Public Health, University of South Florida, Tampa, FL, USA, 14 Apr 2020, version 1, indexed","URL":"https:\/\/gatesopenresearch.org\/articles\/4-18\/v1#referee-response-28726","order":0,"name":"referee-response-28726","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/gatesopenres.14271.r28774, Alba Vilajeliu, Pan American Health Organization (PAHO)\/WHO Regional Office for the Americas, Washington, DC, USA, 04 May 2020, version 1, indexed","URL":"https:\/\/gatesopenresearch.org\/articles\/4-18\/v1#referee-response-28774","order":1,"name":"referee-response-28774","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/gatesopenres.14271.r28775, Barbara Jauregui Wurst, M\u00e9rieux Foundation USA, Washington, DC, USA, 04 May 2020, version 1, indexed","URL":"https:\/\/gatesopenresearch.org\/articles\/4-18\/v1#referee-response-28775","order":2,"name":"referee-response-28775","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"Bill and Melinda Gates Foundation [OPP1210509]. This grant was awarded to the Administrators of the Tulane Educational Fund (Tulane University). The PI is Dr. Pierre Buekens. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":3,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}