Dataset Information

COVID-19 Vaccine Safety Monitoring Studies in Low- and Middle-Income Countries (LMICs)-A Systematic Review of Study Designs and Methods.

ABSTRACT:

Background

Post-marketing vaccine safety surveillance aims to monitor and quantify adverse events following immunization in a population, but little is known about their implementation in low- and middle-income countries (LMICs). We aimed to synthesize methodological approaches used to assess adverse events following COVID-19 vaccination in LMICs.

Methods

For this systematic review, we searched articles published from 1 December 2019 to 18 February 2022 in main databases, including MEDLINE and Embase. We included all peer-reviewed observational COVID-19 vaccine safety monitoring studies. We excluded randomized controlled trials and case reports. We extracted data using a standardized extraction form. Two authors assessed study quality using the modified Newcastle-Ottawa Quality Assessment Scale. All findings were summarized narratively using frequency tables and figures.

Results

Our search found 4254 studies, of which 58 were eligible for analysis. Many of the studies included in this review were conducted in middle-income countries, with 26 studies (45%) in lower-middle-income and 28 (48%) in upper-middle-income countries. More specifically, 14 studies were conducted in the Middle East region, 16 in South Asia, 8 in Latin America, 8 in Europe and Central Asia, and 4 in Africa. Only 3% scored 7-8 points (good quality) on the Newcastle-Ottawa Scale methodological quality assessment, while 10% got 5-6 points (medium). About 15 studies (25.9%) used a cohort study design and the rest were cross-sectional. In half of them (50%), vaccination data were gathered from the participants' self-reporting methods. Seventeen studies (29.3%) used multivariable binary logistic regression and three (5.2%) used survival analyses. Only 12 studies (20.7%) performed model diagnostics and validity checks (e.g., the goodness of fit, identification of outliers, and co-linearity).

Conclusions

Published studies on COVID-19 vaccine safety surveillance in LMICs are limited in number and the methods used do not often address potential confounders. Active surveillance of vaccines in LMICs are needed to advocate vaccination programs. Implementing training programs in pharmacoepidemiology in LMICs is essential.

SUBMITTER: Sisay MM

PROVIDER: S-EPMC10305514 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

COVID-19 Vaccine Safety Monitoring Studies in Low- and Middle-Income Countries (LMICs)-A Systematic Review of Study Designs and Methods.

Sisay Malede Mequanent MM Montesinos-Guevara Camila C Osman Alhadi Khogali AK Saraswati Putri Widi PW Tilahun Binyam B Ayele Tadesse Awoke TA Ahmadizar Fariba F Durán Carlos E CE Sturkenboom Miriam C J M MCJM van de Ven Peter P Weibel Daniel D

Vaccines 20230529 6

<h4>Background</h4>Post-marketing vaccine safety surveillance aims to monitor and quantify adverse events following immunization in a population, but little is known about their implementation in low- and middle-income countries (LMICs). We aimed to synthesize methodological approaches used to assess adverse events following COVID-19 vaccination in LMICs.<h4>Methods</h4>For this systematic review, we searched articles published from 1 December 2019 to 18 February 2022 in main databases, includin ...[more]

PMID: 37376424

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Project description:BackgroundLow-to-middle income countries (LMICs) experience a high burden of disease from both non-communicable and communicable diseases. Addressing these public health concerns requires effective implementation strategies and localization of translation of knowledge into practice.AimTo identify and categorize barriers and strategies to evidence implementation in LMICs from published evidence implementation studies.MethodsA descriptive analysis of key characteristics of evidence implementation projects completed as part of a 6-month, multi-phase, intensive evidence-based clinical fellowship program, conducted in LMICs and published in the JBI Database of Systematic Reviews and Implementation Reports was undertaken. Barriers were identified and categorized to the Donabedian dimensions of care (structure, process, and outcome), and strategies were mapped to the Cochrane effective practice and organization of care taxonomy.ResultsA total of 60 implementation projects reporting 58 evidence-based clinical audit topics from LMICs were published between 2010 and 2018. The projects included diverse populations and were predominantly conducted in tertiary care settings. A total of 279 barriers to implementation were identified. The most frequently identified groupings of barriers were process-related and associated predominantly with staff knowledge. A total of 565 strategies were used across all projects, with every project incorporating more than one strategy to address barriers to implementation of evidence-based practice; most strategies were categorized as educational meetings for healthcare workers.Linking evidence to actionContext-specific strategies are required for successful evidence implementation in LMICs, and a number of common barriers can be addressed using locally available, low-cost resources. Education for healthcare workers in LMICs is an effective awareness-raising, workplace culture, and practice-transforming strategy for evidence implementation.

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Dataset Information

COVID-19 Vaccine Safety Monitoring Studies in Low- and Middle-Income Countries (LMICs)-A Systematic Review of Study Designs and Methods.

Background

Methods

Results

Conclusions

Publications

COVID-19 Vaccine Safety Monitoring Studies in Low- and Middle-Income Countries (LMICs)-A Systematic Review of Study Designs and Methods.

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