NDLI: Data collection systems for active safety surveillance of vaccines during pregnancy in low- and middle-income countries: developing and piloting an assessment tool (VPASS)

Content Provider	Springer Nature : BioMed Central
Author	Belizán, Maria Rodriguez Cairoli, Federico Mazzoni, Agustina Goucher, Erin Zaraa, Sabra Matthews, Sarah Pingray, Verónica Stergachis, Andy Xiong, Xu Berrueta, Mabel Buekens, Pierre
Abstract	Background There is an urgent need for active safety surveillance to monitor vaccine exposure during pregnancy in low- and middle-income countries (LMICs). Existing maternal, newborn, and child health (MNCH) data collection systems could serve as platforms for post-marketing active surveillance of maternal immunization safety. To identify sites using existing systems, a thorough assessment should be conducted. Therefore, this study had the objectives to first develop an assessment tool and then to pilot this tool in sites using MNCH data collection systems through virtual informant interviews. Methods We conducted a rapid review of the literature to identify frameworks on population health or post-marketing drug surveillance. Four frameworks that met the eligibility criteria were identified and served to develop an assessment tool capable of evaluating sites that could support active monitoring of vaccine safety during pregnancy. We conducted semi-structured interviews in six geographical sites using MNCH data collection systems (DHIS2, INDEPTH, and GNMNHR) to pilot domains included in the assessment tool. Results We developed and piloted the “VPASS (Vaccines during Pregnancy – sites supporting Active Safety Surveillance) assessment tool” through interviews with nine stakeholders, including central-level systems key informants and site-level managers from DHIS2 and GNMNHR; DHIS2 in Kampala (Uganda) and Kigali (Rwanda); GNMNHR from Belagavi (India) and Lusaka (Zambia); and INDEPTH from Nanoro (Burkina Faso) and Manhica (Mozambique). The tool includes different domains such as the system’s purpose, the scale of implementation, data capture and confidentiality, type of data collected, the capability of integration with other platforms, data management policies and data quality monitoring. Similarities among sites were found regarding some domains, such as data confidentiality, data management policies, and data quality monitoring. Four of the six sites met some domains to be eligible as potential sites for active surveillance of vaccinations during pregnancy, such as a routine collection of MNCH individual data and the capability of electronically integrating individual MNCH outcomes with information related to vaccine exposure during pregnancy. Those sites were: Rwanda (DHIS2), Manhica (IN-DEPTH), Lusaka (GNMNHR), and Belagavi (GNMNHR). Conclusion This study's findings should inform the successful implementation of active safety surveillance of vaccines during pregnancy by identifying and using active individual MNCH data collection systems in LMICs.
Related Links	https://bmcpregnancychildbirth.biomedcentral.com/counter/pdf/10.1186/s12884-023-05417-8.pdf
Ending Page	11
Page Count	11
Starting Page	1
File Format	HTM / HTML
ISSN	14712393
DOI	10.1186/s12884-023-05417-8
Journal	BMC Pregnancy and Childbirth
Issue Number	1
Volume Number	23
Language	English
Publisher	BioMed Central
Publisher Date	2023-03-13
Access Restriction	Open
Subject Keyword	Reproductive Medicine Maternal and Child Health Gynecology Safety surveillance Data collection system DHIS2 INDEPTH Global Network Pharmacovigilance Pregnancy Vaccines Maternal immunization COVID-19
Content Type	Text
Resource Type	Article
Subject	Obstetrics and Gynecology
Journal Impact Factor	2.8/2023
5-Year Journal Impact Factor	3.4/2023

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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

Perinatal outcomes and sinopharm BBIBP-CorV vaccination during pregnancy

Maternal multimorbidity during pregnancy and after childbirth in women in low- and middle-income countries: a systematic literature review

Is the Immunization of Pregnant Women against COVID-19 Justified?

Synthesis of evidence for managing hypertensive disorders of pregnancy in low middle-income countries: a scoping review

Improving pregnancy outcomes in low- and middle-income countries

Maternal and newborn outcomes in Pakistan compared to other low and middle income countries in the Global Network’s Maternal Newborn Health Registry: an active, community-based, pregnancy surveillance mechanism

Determining antenatal medicine exposures in South African women: a comparison of three methods of ascertainment

Medication exposure during pregnancy: a pilot pharmacovigilance system using health and demographic surveillance platform

Data collection systems for active safety surveillance of vaccines during pregnancy in low- and middle-income countries: developing and piloting an assessment tool (VPASS)

Similar Documents

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

Perinatal outcomes and sinopharm BBIBP-CorV vaccination during pregnancy

Maternal multimorbidity during pregnancy and after childbirth in women in low- and middle-income countries: a systematic literature review

Is the Immunization of Pregnant Women against COVID-19 Justified?

Synthesis of evidence for managing hypertensive disorders of pregnancy in low middle-income countries: a scoping review

Improving pregnancy outcomes in low- and middle-income countries

Maternal and newborn outcomes in Pakistan compared to other low and middle income countries in the Global Network’s Maternal Newborn Health Registry: an active, community-based, pregnancy surveillance mechanism

Determining antenatal medicine exposures in South African women: a comparison of three methods of ascertainment

Medication exposure during pregnancy: a pilot pharmacovigilance system using health and demographic surveillance platform

Data collection systems for active safety surveillance of vaccines during pregnancy in low- and middle-income countries: developing and piloting an assessment tool (VPASS)