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Este artículo es la actualización de un EOP publicado en 2021 sobre la eficacia y la seguridad de las vacunas contra el dengue. En la práctica, la inmunización con la única vacuna aprobada por la Agencia Nacional de Medicamentos, Alimentos y Tecnologia de Argentina en ese momento, Dengvaxia® (CYD-TDV), estuvo limitada por la necesidad de corroborar el estado serológico de las personas antes de su aplicación, debido al aumento del riesgo de desarrollar dengue grave en las personas que no habían tenido infección previa por el virus salvaje. A partir de la autorización de una nueva vacuna a fines de 2023, indicada en personas de 4 a 60 años de edad, desarrollada por el laboratorio Takeda y conocida como Qdenga®, y en un contexto epidemiológico de gran aumento de los casos en grandes centros urbanos de Argentina, esta actualización se propone revisar la evidencia más actualizada sobre las nuevas vacunas contra el dengue, en especial la que sustentaría su uso en la población general.

Abstract Introduction Neisseria gonorrhoeae causes gonorrhoea, a globally neglected but increasing disease. This systematic review and meta-analysis reviewed the epidemiology and economic burden of gonorrhoea in Latin America and the Caribbean (LAC). Methods We searched PubMed, EMBase, Cochrane Library, EconLIT, CINAHL, CRD, LILACS, Global Health, Global Dissertations and Theses, SciELO, Web of Science databases, countries’ ministries of health, and the IHME’s Global Burden of Disease databases. Studies published in the last 10 years (20 years for economic studies) were included if conducted in any LAC country, without language restrictions. The main outcome measures were incidence/prevalence, proportion of co-infections, case fatality rates, specific mortality/hospitalisation rates, direct/indirect costs, and impact of gonorrhoea on quality of life. To assess evidence quality, we used a checklist developed by the US National Heart, Lung, and Blood Institute for observational studies and trial control arms, the Cochrane Effective Practice Organization of Care Group tool for randomised controlled trials, and the CICERO checklist for economic studies. Results We identified 1290 articles; 115 included epidemiological studies and one included an economic study. Ministry of health data from Argentina, Brazil, Chile, Colombia, Mexico, and Uruguay were identified. Gonorrhoea prevalence was 1.46% (95% confidence interval [CI] 1.00–2.00%) from 48 studies and 5.68% (95% CI 4.23–7.32%) from 58 studies for non-high-risk and high-risk populations, respectively. Cumulative incidence for the high-risk population was 2.05 cases per 100 persons/year. Few published studies were rated as “good” in the risk of bias assessments. Variations in the methodology of the sources and limited information found in the countries’ surveillance systems hinder the comparison of data. Conclusion The burden of gonorrhoea in LAC is not negligible. Our results provide public health and clinical decision support to assess potential interventions to prevent gonorrhoea. Trial Registration The protocol is registered on PROSPERO (CRD42021253342). The study was funded by GlaxoSmithKline Biologicals SA (GSK study identifier VEO-000025).

This systematic review describes herpes zoster (HZ) economic burden in terms of healthcare resource use and cost outcomes in the Latin America and Caribbean (LAC) region. We searched online databases from 1 January 2000 to 20 February 2020 to identify eligible publications. We identified 23 publications that reported direct costs, indirect costs, and resources associated with HZ and its complications. The primary direct medical resources reported in the different studies were visits to doctors, transportation, days in the hospital, nursing, medication schedules, and physical therapy. Direct total costs per patient ranged from $99.99 to $4177.91. The highest cost was found in Brazil. Direct costs are, in average, 81.39% higher than indirect costs. The cost per patient that includes postherpetic neuralgia treatment is 115% higher on average for the directs and 73% for the indirect costs. Brazil reported a higher total cost per patient than Argentina and Mexico, while for indirect costs per patient, Brazil and Argentina had higher costs than Mexico, respectively. A meta-analysis on the number of days due to HZ hospitalization, performed on non-immunosuppressed patients over 65 years of age from three studies, resulted in a cumulative measure of 4.5 days of hospitalization. In the LAC region, the economic burden of HZ and associated complications is high, particularly among high-risk populations and older age groups. Preventative strategies such as vaccination could help avoid or reduce the HZ-associated disease economic burden in the LAC region.

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.

En Argentina, tres de las vacunas contra el COVID-19 autorizadas por la entidad regulatoria local se aplican en menores de edad: la vacuna desarrollada por Sinopharm (BBIBP-CorV) para niños de 3 años o más, y las desarrolladas por Moderna (ARNm 1273) y Pfizer (BNT162b2) a partir de los 12 años. Dado que estas recomendaciones no coinciden exactamente con las emitidas por diferentes organismos internacionales y debido al corto plazo de seguimiento de los ensayos publicados, surgieron dudas fundamentalmente en relación a su seguridad. En este artículo, los autores sintetizan la evidencia disponible hasta el momento sobre las vacunas aplicadas en niños, niñas y adolescentes en nuestro país, basada en informes preliminares de ensayos clínicos y reportes de vigilancia epidemiológica.

La declaración de ítems preferidos de reporte para revisiones sistemáticas y metaanálisis (PRISMA, por sus iniciales en inglés), publicada en 2009, fue diseñada para ayudar a los autores de revisiones sistemáticas a reportar de manera transparente las razones para realizar la revisión, y qué hicieron y encontraron los autores. Durante la última década, los avances en la metodología y la terminología de las revisiones sistemáticas requirieron una actualización de la guía. La declaración PRISMA 2020 reemplaza la declaración de 2009 e incluye una nueva guía de reporte que refleja los avances metodológicos para identificar, seleccionar, evaluar y sintetizar estudios. La estructura y presentación de los ítems se han modificado para facilitar su implementación. En este artículo, el autor resume los aspectos relevantes de la actualización del instrumento y presenta la lista de verificación PRISMA 2020 (de 27 elementos), la lista de verificación ampliada que detalla las recomendaciones para aplicar cada ítem, la lista de verificación de resúmenes de revisiones sistemáticas, y los diagramas de flujo para revisiones nuevas y actualizadas (traducidas al español en archivos MS Word para que puedan ser fácilmente editables y utilizables en la práctica).

Tomando como excusa el análisis crítico del reciente informe suscripto por profesionales del Instituto de Cálculo de la Facultad de Ciencias Exactas y Naturales (UBA–CONICET) respecto del impacto de la suspensión de la presencialidad escolar como medida de control de la pandemia de COVID-19, que generó gran debate en Argentina, el autor de este artículo resume la evidencia a nivel internacional proveniente de revisiones sistemáticas sobre la eficacia y seguridad de este tipo de intervenciones, deteniéndose en cuándo, cómo y durante cuánto tiempo es razonable aplicarla. Por último, reflexiona y esboza propuestas que ayuden a fortalecer la racionalidad en la toma de decisiones.

Background Testing used in screening, diagnosis and follow-up of COVID-19 has been a subject of debate. Several organisations have developed formal advice about testing for COVID-19 to assist in the control of the disease. We collated, delineated and appraised current worldwide recommendations about the role and applications of tests to control SARS-CoV-2/COVID-19.Methods We searched for documents providing recommendations for COVID-19 testing in PubMed, EMBASE, LILACS, the Coronavirus Open Access Project living evidence database and relevant websites such as TRIP database, ECRI Guidelines Trust, the GIN database, from inception to 21 September 2020. Two reviewers applied the eligibility criteria to potentially relevant citations without language or geographical restrictions. We extracted data in duplicate, including assessment of methodological quality using the Appraisal of Guidelines for Research and Evaluation-II tool.Results We included 47 relevant documents and 327 recommendations about testing. Regarding the quality of the documents, we found that the domains with the lowest scores were ‘Editorial independence’ (Median=4%) and ‘Applicability’ (Median=6%). Only six documents obtained at least 50% score for the ‘Rigour of development’ domain. An important number of recommendations focused on the diagnosis of suspected cases (48%) and deisolation measures (11%). The most frequently recommended test was the reverse transcription-PCR (RT-PCR) assay (87 recommendations) and the chest CT (38 recommendations). There were 22 areas of agreement among guidance developers, including the use of RT-PCR for SARS-Cov-2 confirmation, the limited role of bronchoscopy, the use chest CT and chest X-rays for grading severity and the co-assessment for other respiratory pathogens.Conclusion This first scoping review of recommendations for COVID-19 testing showed many limitations in the methodological quality of included guidance documents that could affect the confidence of clinicians in their implementation. Future guidance documents should incorporate a minimum set of key methodological characteristics to enhance their applicability for decision making.

The epidemiology and burden of Herpes Zoster (HZ) are largely unknown, and there are no recent reviews summarizing the available evidence from the Latin America and Caribbean (LAC) region. We conducted a systematic review and meta-analysis to characterize the epidemiology and burden of HZ in LAC. Bibliographic databases and grey literature sources were consulted to find studies published (January 2000 -February 2020) with epidemiological endpoints: cumulative incidence and incidence density (HZ cases per 100,000 person-years), prevalence, case-fatality rates, HZ mortality, hospitalization rates, and rates of each HZ complication. Twenty-six studies were included with most studies coming from Brazil. No studies reported the incidence of HZ in the general population. In population at higher risk, the cumulative incidence ranged from 318-3,423 cases of HZ per 100,000 persons per year of follow-up. The incidence density was 6.4-36.5 cases per 1,000 person-years. Age was identified as a major risk factor towards HZ incidence which increase significantly in people >50 years of age. Hospitalization rates ranged from 3%-35.7%. The in-hospital HZ mortality rate ranged from 0%-36%. Overall, HZ mortality rates were found to be higher in females across all age groups and countries. The incidence of HZ complications (such as post-herpetic neuralgia, ophthalmic herpes zoster, and Ramsay Hunt syndrome) was higher in the immunosuppressed compared to the immunocompetent population. Acyclovir was the most frequently used therapy. Epidemiological data from Ministry of Health databases (Argentina, Brazil, Colombia, Chile y Mexico) and Institute for Health Metrics and Evaluation's Global Burden of Disease project reported stable rates of hospitalizations and deaths over the last 10 years. High-risk groups for HZ impose a considerable burden in LAC. They could benefit from directed healthcare initiatives, including adult immunization, to prevent HZ occurrence and its complications.

Background: Air pollution is a leading cause of mortality and morbidity worldwide. Short-term exposure (from one hour to days) to selected air pollutants has been associated with human mortality. This systematic review was conducted to analyse the evidence on the effects of short-term exposure to particulate matter with aerodynamic diameters less or equal than 10 and 2.5 µm (PM10, PM2.5), nitrogen dioxide (NO2), and ozone (O3), on all-cause mortality, and PM10 and PM2.5 on cardiovascular, respiratory, and cerebrovascular mortality. Methods: We included studies on human populations exposed to outdoor air pollution from any source, excluding occupational exposures. Relative risks (RRs) per 10 µg/m3 increase in air pollutants concentrations were used as the effect estimates. Heterogeneity between studies was assessed using 80% prediction intervals. Risk of bias (RoB) in individual studies was analysed using a new domain-based assessment tool, developed by a working group convened by the World Health Organization and designed specifically to evaluate RoB within eligible air pollution studies included in systematic reviews. We conducted subgroup and sensitivity analyses by age, sex, continent, study design, single or multicity studies, time lag, and RoB. The certainty of evidence was assessed for each exposure-outcome combination. The protocol for this review was registered with PROSPERO (CRD42018087749). Results: We included 196 articles in quantitative analysis. All combinations of pollutants and all-cause and cause-specific mortality were positively associated in the main analysis, and in a wide range of sensitivity analyses. The only exception was NO2, but when considering a 1-hour maximum exposure. We found positive associations between pollutants and all-cause mortality for PM10 (RR: 1.0041; 95% CI: 1.0034–1.0049), PM2.5 (RR: 1.0065; 95% CI: 1.0044–1.0086), NO2 (24-hour average) (RR: 1.0072; 95% CI: 1.0059–1.0085), and O3 (RR: 1.0043; 95% CI: 1.0034–1.0052). PM10 and PM2.5 were also positively associated with cardiovascular, respiratory, and cerebrovascular mortality. We found some degree of heterogeneity between studies in three exposure-outcome combinations, and this heterogeneity could not be explained after subgroup analysis. RoB was low or moderate in the majority of articles. The certainty of evidence was judged as high in 10 out of 11 combinations, and moderate in one combination. Conclusions: This study found evidence of a positive association between short-term exposure to PM10, PM2.5, NO2, and O3 and all-cause mortality, and between PM10 and PM2.5 and cardiovascular, respiratory and cerebrovascular mortality. These results were robust through several sensitivity analyses. In general, the level of evidence was high, meaning that we can be confident in the associations found in this study.

El autor aborda el caso de la cloroquina y la hidroxicloroquina en el contexto de la actual pandemia de COVID-19, a través de dos ejes centrales. Por un lado, el escándalo a nivel editorial y de comunicación de la evidencia, y por otro, el de la toma de decisiones en salud pública. Describe flagrantes debilidades en la cadena de generación, difusión y aplicación del nuevo conocimiento. Adicionalmente, explora iniciativas y propuestas que podrían contribuir a solucionar estos problemas.

BackgroundA false-negative case of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is defined as a person with suspected infection and an initial negative result by reverse transcription-polymerase chain reaction (RT-PCR) test, with a positive result on a subsequent test. False-negative cases have important implications for isolation and risk of transmission of infected people and for the management of coronavirus disease 2019 (COVID-19). We aimed to review and critically appraise evidence about the rate of RT-PCR false-negatives at initial testing for COVID-19.MethodsWe searched MEDLINE, EMBASE, LILACS, as well as COVID-19 repositories, including the EPPI-Centre living systematic map of evidence about COVID-19 and the Coronavirus Open Access Project living evidence database. Two authors independently screened and selected studies according to the eligibility criteria and collected data from the included studies. The risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. We calculated the proportion of false-negative test results using a multilevel mixed-effect logistic regression model. The certainty of the evidence about false-negative cases was rated using the GRADE approach for tests and strategies. All information in this article is current up to July 17, 2020.ResultsWe included 34 studies enrolling 12,057 COVID-19 confirmed cases. All studies were affected by several risks of bias and applicability concerns. The pooled estimate of false-negative proportion was highly affected by unexplained heterogeneity (tau-squared = 1.39; 90% prediction interval from 0.02 to 0.54). The certainty of the evidence was judged as very low due to the risk of bias, indirectness, and inconsistency issues.ConclusionsThere is substantial and largely unexplained heterogeneity in the proportion of false-negative RT-PCR results. The collected evidence has several limitations, including risk of bias issues, high heterogeneity, and concerns about its applicability. Nonetheless, our findings reinforce the need for repeated testing in patients with suspicion of SARS-Cov-2 infection given that up to 54% of COVID-19 patients may have an initial false-negative RT-PCR (very low certainty of evidence).Systematic review registrationProtocol available on the OSF website: https://tinyurl.com/vvbgqya.

En este artículo, el editor de la revista EVIDENCIA, Actualización en la práctica ambulatoria le da la bienvenida a investigadores de Argentina y otros países que deseen comunicar los hallazgos de sus estudios primarios sobre temas relevantes para la atención primaria de la salud.

This article presents the results of a dialogue between decision-makers and experts in Latin America and the Caribbean on priority-setting for interventions and studies on Aedes aegypti control. The article is part of a project that included a systematic review of mosquito control strategies and a qualitative study with key informants from the region. Using a collective deliberative process assisted by the results of the above-mentioned projects, a list of priorities was developed by consensus for the implementation of vector control strategies and the development of key regional research lines. It was agreed that the best strategy is integrated vector management, divided into: (a) chemical control; (b) biological control; (c) environmental management; (d) community participation; and (e) integrated surveillance. The workshop highlighted the crucial role of government leadership and inter-sector coordination between government agencies and civil society stakeholders. The proposed priorities for research lines were: Ae. aegypti vector competence and associated factors; community components of interventions; incorporation of technology into vector control and monitoring; most efficient modalities of integrated surveillance; entomological indicators with the best predictive capacity; and resistance to insecticides. The policy dialogue methodology allowed validating and enriching the results of other levels of research, besides establishing priorities for regional research and control strategies.

Cuando no disponemos de estudios que cotejen directamente las ventajas y desventajas de dos intervenciones, o cuando se necesita un ranking de las mejores intervenciones, este nuevo tipo de estudio ofrece una respuesta. En este artículo, el autor explica en qué consiste el meta-análisis en red y los requisitos que deben cumplir los estudios primarios para que sus resultados puedan ser combinados con esta metodología.

El número de revisiones sistemáticas (RS) de estudios de intervenciones sanitarias publicadas ha aumentado rápidamente. Estos documentos de síntesis son ampliamente utilizados para la toma de decisiones clínicas y de políticas de salud, pero están sujetos a una serie de sesgos y es importante que los usuarios pueden identificar las RS de mejor calidad. Considerando la relevancia de la actualización de la herramienta Ameasurement Tool to Assess Systematic Reviews (AMSTAR) para la valoración crítica de RS de estudios de intervenciones en salud, el autor resume los aspectos más relevantes de la publicación de Shea y col, traduce el instrumento y su guía de aplicación, y comenta los aspectos salientes del instrumento AMSTAR-2 junto con sus potenciales implicancias en el desarrollo y reporte de RS.