Background: over the last few years, systematic reviews (SR) have contributed to decision-making and, as a consequence, generate confidence in decision-makers and policy makers. Ensuring the validity and methodological rigor of SRs is essential given that the degree of quality and the presence of risk of bias could have a direct impact on the analysis of findings and estimates of vaccines´ effects. Currently, there are tools such as AMSTAR II (Assessing the Methodological Quality of Systematic Reviews II) and ROBIS (Risk of Bias in Systematic Reviews) for evaluating methodological rigor and risk of bias in SR, omission of their use in the critical assessment can represent a potential risk in the analysis and therefore in evidence-based decision making. Their application contributes to improvements in the National Immunization Programs' performance, trust and benefit.
Objectives: to assess the quality and risk of bias in SR about vaccines included in the national immunization programs of Latin American countries using AMSTAR II and ROBIS.
First phase (initial recognition): we will identify basic and complementary vaccines for the infant population in 20 Latin American countries, registered in the World Health Organization (WHO) immunization surveillance system up to October 2018. We will not consider vaccines used in outbreak situations or for comorbidities.
Second phase (systematic search): we will develop search strategies in MEDLINE (PubMed), Embase (Ovid), the Cochrane Library and LILACS databases. We will select all SR on efficacy, effectiveness and safety of vaccines.
Third phase (methodological rigor): quality and risk of bias will be evaluated by two paired and blinded reviewers with different levels of experience (high level and low level) using AMSTAR II and ROBIS.
Fourth phase (association analysis): we will evaluate the statistical association between quality and the risk of bias, as well as the inter-rater reliability assessment for each tool.
Conclusions: the study will provide a methodological approach for evaluation of SR, allowing a strengthening confidence in the use of evidence for decision making in the national immunization programs of Latin America.
Patient or healthcare consumer involvement: patients did not participate in the development of the study, but will be the main beneficiaries.