Sequential inactivated (IPV) and live oral (OPV) poliovirus vaccines for preventing poliomyelitis

BACKGROUND:Poliomyelitis mainly affects unvaccinated children under five years of age, causing irreversible paralysis or even death. The oral polio vaccine (OPV) contains live attenuated virus, which can, in rare cases, cause a paralysis known as vaccine-associated paralytic polio (VAPP), and also vaccine-derived polioviruses (VDPVs) due to acquired neurovirulence after prolonged duration of replication. The incidence of poliomyelitis caused by wild polio virus (WPV) has declined dramatically since the introduction of OPV and later the inactivated polio vaccine (IPV), however, the cases of paralysis linked to the OPV are currently more frequent than those related to the WPV. Therefore, in 2016, the World Health Organization (WHO) recommended at least one IPV dose preceding routine immunisation with OPV to reduce VAPPs and VDPVs until polio could be eradicated.OBJECTIVES:To assess the effectiveness, safety, and immunogenicity of sequential IPV-OPV immunisation schemes compared to either OPV or IPV alone.SEARCH METHODS:In May 2019 we searched CENTRAL, MEDLINE, Embase, 14 other databases, three trials registers and reports of adverse effects on four web sites. We also searched the references of identified studies, relevant reviews and contacted authors to identify additional references.SELECTION CRITERIA:Randomised controlled trials (RCTs), quasi-RCTs, controlled before-after studies, nationwide uncontrolled before-after studies (UBAs), interrupted time series (ITS) and controlled ITS comparing sequential IPV-OPV schedules (one or more IPV doses followed by one or more OPV doses) with IPV alone, OPV alone or non-sequential IPV-OPV combinations.DATA COLLECTION AND ANALYSIS:We used standard methodological procedures expected by Cochrane.MAIN RESULTS:We included 21 studies: 16 RCTs involving 6407 healthy infants (age range 96 to 975 days, mean 382 days), one ITS with 28,330 infants and four nationwide studies (two ITS, two UBA). Ten RCTs were conducted in high-income countries; five in the USA, two in the UK, and one each in Chile, Israel, and Oman. The remaining six RCTs were conducted in middle-income countries; China, Bangladesh, Guatemala, India, and Thailand. We rated all included RCTs at low or unclear risk of bias for randomisation domains, most at high or unclear risk of attrition bias, and half at high or unclear risk for conflict of interests. Almost all RCTs were at low risk for the remaining domains. ITSs and UBAs were mainly considered at low risk of bias for most domains. IPV-OPV versus OPV It is uncertain if an IPV followed by OPV schedule is better than OPV alone at reducing the number of WPV cases (very low-certainty evidence); however, it may reduce VAPP cases by 54% to 100% (three nationwide studies; low-certainty evidence). There is little or no difference in vaccination coverage between IPV-OPV and OPV-only schedules (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.96 to 1.06; 1 ITS study; low-certainty evidence). Similarly, there is little or no difference between the two schedule types for the number of serious adverse events (SAEs) (RR 0.88, 95% CI 0.46 to 1.70; 4 studies, 1948 participants; low-certainty evidence); or the number of people with protective humoral response P1 (moderate-certainty evidence), P2 (for the most studied schedule; two IPV doses followed by OPV; low-certainty evidence), and P3 (low-certainty evidence). Two IPV doses followed by bivalent OPV (IIbO) may reduce P2 neutralising antibodies compared to trivalent OPV (moderate-certainty evidence), but may make little or no difference to P1 or P2 neutralising antibodies following an IIO schedule or OPV alone (low-certainty evidence). Both IIO and IIbO schedules may increase P3 neutralising antibodies compared to OPV (moderate-certainty evidence). It may also lead to lower mucosal immunity given increased faecal excretion of P1 (low-certainty evidence), P2 and P3 (moderate-certainty evidence) after OPV challenge. IPV-OPV versus IPV It is uncertain if IPV-OPV is more effective than IPV alone at reducing the number of WPV cases (very low-certainty evidence). There were no data regarding VAPP cases. There is no clear evidence of a difference between IPV-OPV and OPV schedules for the number of people with protective humoral response (low- and moderate-certainty evidence). IPV-OPV schedules may increase mean titres of P1 neutralising antibodies compared to OPV alone (low- and moderate-certainty evidence), but the effect on P2 and P3 titres is not clear (very low- and moderate-certainty evidence). IPV-OPV probably reduces the number of people with P3 poliovirus faecal excretion after OPV challenge with IIO and IIOO sequences (moderate-certainty evidence), and may reduce the number with P2 (low-certainty evidence), but not with P1 (very low-certainty evidence). There may be little or no difference between the schedules in number of SAEs (RR 0.92, 95% CI 0.60 to 1.43; 2 studies, 1063 participants, low-certainty evidence). The number of persons with P2 protective humoral immunity and P2 neutralising antibodies are probably lower with most sequential schemes without P2 components (i.e. bOPV) than with trivalent OPV or IVP alone (moderate-certainty evidence). IPV (3)-OPV versus IPV (2)-OPV One study (137 participants) showed no clear evidence of a difference between three IPV doses followed by OPV and two IPV doses followed by OPV, on the number of people with P1 (RR 0.98, 95% CI 0.93 to 1.03), P2 (RR 1.00, 95% CI 0.97 to 1.03), or P3 (RR 1.01, 95% CI 0.97 to 1.05) protective humoral and intestinal immunity; all moderate-certainty evidence. This study did not report on any other outcomes.AUTHORS´ CONCLUSIONS:IPV-OPV compared to OPV may reduce VAPPs without affecting vaccination coverage, safety or humoral response, except P2 with sequential schemes without P2 components, but increase poliovirus faecal excretion after OPV challenge for some polio serotypes. Compared to IPV-only schedules, IPV-OPV may have little or no difference on SAEs, probably has little or no effect on persons with protective humoral response, may increase neutralising antibodies, and probably reduces faecal excretion after OPV challenge of certain polio serotypes. Using three IPV doses as part of a IPV-OPV schedule does not appear to be better than two IPV doses for protective humoral response. Sequential schedules during the transition from OPV to IPV-only immunisation schedules seems a reasonable option aligned with current WHO recommendations. Findings could help decision-makers to optimise polio vaccination policies, reducing inequities between countries.Fil: Ciapponi, Agustín. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Bardach, Ariel Esteban. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Rey Ares, Lucila. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Glujovsky, D.. No especifíca;Fil: Caferata, M.L.. No especifíca;Fil: Cesaroni, S.. No especifíca;Fil: Bhatti, A.. No especifíca

Implementing Health Technology Assessments in Latin America: Looking at the Past, Mirroring the Future. A Perspective from the ISPOR Health Technology Assessment Roundtable in Latin America

Objectives In the last two decades, several countries in Latin America (LA) have shown an interest in developing health technology assessments (HTAs), but the process has not been uniform and has often been challenged by the health systems characteristics and the political or economic idiosyncrasies of these countries. Methods This article summarizes the discussions held by the participants at the 40th ISPOR HTA Council Roundtable for LA. An additional literature review was carried out to support some of the concepts included. Results This article includes a brief description of the implementation of HTA over the last 30 years and then a conceptual analysis using examples of the broader use of HTA to support procurement decisions and risk-sharing agreements, which might play a future role in healthcare priority-setting in LA. Conclusions Formerly, HTA processes and methods played important although mostly isolated roles (with drug licensing or reimbursement being examples of this). Nowadays, with more and more innovative technologies and the establishment of value frameworks to support the priority setting in healthcare, HTA features a promising panorama for the health systems sustainability

Barreras del personal de salud para el tamizaje de sífilis en mujeres embarazadas de la Red Los Andes, Bolivia

RESUMEN Objetivo Identificar barreras del personal de salud por las cuales las embarazadas que asisten al control prenatal no se realizan el tamizaje de sífilis (Red de Salud Los Andes, Bolivia). Métodos Se realizaron 46 entrevistas semiestructuradas a proveedores de salud y se analizaron los registros de 249 expedientes clínicos de embarazadas de ocho establecimientos públicos de salud de la Red Los Andes. Resultados Entre las barreras del personal de salud para el tamizaje de sífilis en embarazadas se identificaron el tiempo insuficiente del personal para sensibilizar sobre el beneficio del tamizaje de sífilis, algunos mencionaron que las pruebas de sífilis se deberían hacer solo en centros donde atienden partos y tienen laboratorio, la poca comunicación entre el personal de la consulta médica y laboratorio, así como también problemas de abastecimiento de suministros y reactivos. En la revisión de expedientes clínicos se observó que 55,4% contaba con los resultados de laboratorio de sífilis en sus expedientes y solo 37,4% de historias clínicas perinatales contaba con registro de resultados de laboratorios. A través de las entrevistas, se pudo observar que los proveedores perciben que el tamizaje de sífilis se realiza al 100% de las embarazadas que asisten al control prenatal. Conclusión El tamizaje para sífilis no se está realizando según lo establecido en la estrategia de país para la eliminación de la sífilis congénita, y no llega a más de la mitad de embarazadas en control prenatal con registros en las historias clínicas perinatales. Esto no es percibido por los profesionales de la salud y puede transformarse en una barrera para el tamizaje de sífilis en mujeres embarazadas

Medical Devices – From Licensing To Coverage: Highlights From Argentina, Brazil, Colombia, And Mexico

Objectives: To assess, describe and compare the requirements and pathwaysof medical devices from licensing to coverage in four Latin American countries(LAC) health systems. Methods: We conducted a literature search (February 2015)on Pubmed, Lilacs and Value in Health Regional Issues journal. We also searchedspecific websites of Health Technology Assessment (HTA) and regulatory agencies,ministries of health and health agencies; and a performed generic Internet search.We included all publications describing aspects related to regulation, coverage,medical technology innovation, and HTA and Economic Evaluation (EE) guidelines.We additionally interviewed key informants from all countries to gather informationrelated to the aforementioned processes. We present here the literature searchresults. Results: We included 60 studies out of 2190. Five percent of the publicationsanalyzed the four countries jointly, 75% were from Brazil, 8.3% from Mexico, 5%from Colombia and 5.7% from LAC in general. Half of the studies described the roleof the HTA and EE in decision-making and aspects or policies related to innovation(25% and 23.3%). Regarding the description of the coverage process, it was addressedin 13.3% of the studies; 10% of the publications focused on technovigilance; and also10% on regulatory aspects. Remaining publications were methodological guidelinesand general descriptions of the health systems and the role of medical devices. Allcountries had HTA and EE guidelines, although there did not include device specificrecommendations. There is a spectrum of HTA formalization for technology incorporationafter licensing, higher in Brazil and lower in Argentina Conclusions:There is scarce information on the processes and requirements to achieve coveragefor medical devices in these countries. Processes differ, are in general not explicit,lack transparency, and usually replicate those of drugs not taking into account thespecificities of medical devices.Fil: Rey Ares, Lucila. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Garay, U. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: García Martí, S.. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Gilardino, R.. Johnson & Johnson Medical Argentina; ArgentinaFil: Cabra, H. A.. Johnson & Johnson Medical; MéxicoFil: Pichón-Riviere, Andrés. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Augustovski, Federico Ariel. Instituto de Efectividad Clínica y Sanitaria; Argentin

Interchangeability between Pneumococcal Conjugate Vaccines: A Systematic Review and Meta-Analysis

Objectives: To assess the efficacy, cost-effectiveness, immunogenicity, and safety related to the interchangeability between pneumococcal conjugate vaccines (PCVs) and vaccination schedules in pediatric population. Methods: Systematic searches were conducted in December 2010 and April 2015 for economic evaluations in MEDLINE, EMBASE, LILACS, and Cochrane Central Register of Controlled Trials. Web sites and databases from medical societies, experts, and associations related to the topic, proceedings or congressional annals, and doctoral theses were also searched. No language or temporal restriction was applied. We included randomized controlled trials, economic evaluations, and systematic reviews evaluating antibody response, cost-effectiveness, and effectiveness of PCVs' interchangeability. A Strengthening the Reporting of Observational Studies in Epidemiology-based checklist was used to assess the risk of bias in observational studies and a Cochrane approach for experimental/quasi-experimental studies. Pairs of reviewers independently selected (through the Web-based Early Reviewer Organizer Software), assessed the quality, and extracted the data of the studies. Discrepancies were resolved by consensus. We planned to perform meta-analysis whenever appropriate. Results: Forty-six of 202 studies were included. There was no direct information available on the interchangeability between PCVs. The immunogenicity and safety between the 10-valent PCV (PCV10) and the 7-valent PCV were similar when both vaccines were coadministered with other routine pediatric vaccines. PCV10 and 13-valent PCV (PCV13) were consistently more cost-effective than 7-valent PCV. Conclusions: There was no direct comparative information available on the interchangeability among PCVs, but they have pretty similar immunogenicity and safety. PCV10 versus PCV13 cost-effectiveness varied according to price, indirect effects, and indirect costs. PCV10 gains more quality-adjusted life-years because of the prevention of more frequent yet less severe events such as otitis media, and PCV13 prevents less frequent but more costly events such as invasive diseases.Fil: Ciapponi, Agustín. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Lee, Alison. Instituto de Efectividad Clínica y Sanitaria; Argentina. Centro de Excelencia en Salud Cardiovascular para América del Sur; ArgentinaFil: Bardach, Ariel Esteban. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Glujovsky, Demián. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Rey Ares, Lucila. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Luisa Cafferata, María. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Valanzasca, Pilar. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: García Martí, Sebastián. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentin

Lower tract respiratory infection in children younger than 5 years of age and adverse pregnancy outcomes related to household air pollution in Bariloche (Argentina) and Temuco (Chile)

The main objective of this study was to evaluate the association between household air pollution with lower tract respiratory infection (LRTI) in children younger than 5 years old and adverse pregnancy outcomes. This retrospective cohort study took place in two cities in Patagonia. Using systemic random sampling, we selected households in which at least one child  0.05). The use of biomass fuel to cook in traditional cookstoves in ventilated dwellings may increase the risk of perinatal morbidity and LRTI.Fil: Rey Ares, Lucila. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Irazola, Vilma. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Althabe, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Sobrino, E.. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Mazzoni, A.. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Serón, P.. Universidad de La Frontera; ChileFil: Lanas, F.. Universidad de La Frontera; ChileFil: Calandreli, M.. Sanatorio San Carlos; ArgentinaFil: Rubinstein, Adolfo Luis. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; Argentin

Cost-effectiveness of quadrivalent vaccine against human papilloma virus in Argentina based on a dynamic transmission model

Objective. To assess the cost-effectiveness of the qua- drivalent vaccine against human papillomavirus (HPV) in Argentina from the health system perspective. Materials and methods. A dynamic transmission model was used to estimate the impact of the vaccine on the incidence of cervical cancer, warts, and other HPV related diseases; in quality adjusted life years (QALYs); and in healthcare costs. Results. Vaccination could reduce the risk of cervical cancer by 60% and by 67% the risk of genital warts. Compared to a non-vaccine scenario, the immunization strategy showed an incremental benefit of 0.00234 QALY per person at an incremental cost of US$2.36, resulting in an incremental cost-effectiveness ratio of US$1007.55 per QALY gained. Sensitivity analysis proved the robustness of these results. Conclusions. Immunization with the quadrivalent vaccine was a cost-effective intervention in Argentina, and it was far below the threshold of one gross domestic product per capita (US$15 009) per QALY gained

Medical devices: from licensing to coverage. highlights from Argentina, Brazil, Colombia and Mexico

Objectives: To assess, describe and compare the requirements and pathwaysof medical devices from licensing to coverage in four Latin American countries(LAC) health systems. Methods: We conducted a literature search (February 2015)on Pubmed, Lilacs and Value in Health Regional Issues journal. We also searchedspecific websites of Health Technology Assessment (HTA) and regulatory agencies,ministries of health and health agencies; and a performed generic Internet search.We included all publications describing aspects related to regulation, coverage,medical technology innovation, and HTA and Economic Evaluation (EE) guidelines.We additionally interviewed key informants from all countries to gather informationrelated to the aforementioned processes. We present here the literature searchresults. Results: We included 60 studies out of 2190. Five percent of the publicationsanalyzed the four countries jointly, 75% were from Brazil, 8.3% from Mexico, 5%from Colombia and 5.7% from LAC in general. Half of the studies described the roleof the HTA and EE in decision-making and aspects or policies related to innovation(25% and 23.3%). Regarding the description of the coverage process, it was addressedin 13.3% of the studies; 10% of the publications focused on technovigilance; and also10% on regulatory aspects. Remaining publications were methodological guidelinesand general descriptions of the health systems and the role of medical devices. Allcountries had HTA and EE guidelines, although there did not include device specificrecommendations. There is a spectrum of HTA formalization for technology incorporationafter licensing, higher in Brazil and lower in Argentina Conclusions:There is scarce information on the processes and requirements to achieve coveragefor medical devices in these countries. Processes differ, are in general not explicit,lack transparency, and usually replicate those of drugs not taking into account thespecificities of medical devices.Fil: Rey Ares, Lucila. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Hernández Vásquez, Akram. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Garay, Osvaldo Ulises. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Pichón-Riviere, Andrés. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: García Martí, Sebastián. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Gilardino, Ramiro. Johnson & Johnson Medical Companies; ArgentinaFil: Cabra, Hermilio Arturo. Johnson & Johnson Medical Companies; ArgentinaFil: Augustovski, Federico Ariel. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; Argentin

Estrategia para mejorar el acceso al tratamiento etiológico para la enfermedad de Chagas en el primer nivel de atención en Argentina

RESUMEN Objetivo Mejorar la distribución del tratamiento etiológico para la enfermedad de Chagas mediante la identificación de barreras para su descentralización al primer nivel de atención en Argentina. Métodos Se llevó a cabo un estudio cualitativo, de carácter exploratorio y descriptivo, en base a entrevistas semiestructuradas a actores clave pertenecientes al Programa Nacional de Chagas y miembros de los equipos de salud del primer nivel de atención con el objetivo de identificar barreras para el diagnóstico y tratamiento de la enfermedad de Chagas en diferentes niveles (administrativo, efectores de salud y comunidad) que podrían afectar una estrategia descentralizada de distribución. Además, se implementó un piloto de descentralización en diez centros de atención primaria en una provincia argentina. Resultados Se realizaron 22 entrevistas semiestructuradas con responsables de programas y profesionales de la salud. Los principales obstáculos hallados fueron la falta de búsqueda sistemática de casos, la poca articulación entre los niveles de atención y los actores del sistema de salud, la falta de capacitación del equipo de salud respecto al tratamiento, el seguimiento de los pacientes y las barreras asociadas a los pacientes. Se llevó a cabo un programa piloto de descentralización y se evaluaron estrategias para optimizar la intervención a gran escala. Conclusiones Los resultados permitieron mejorar la implementación del plan de descentralización del tratamiento a través de una mejor articulación interprogramática, la capitalización de herramientas de monitoreo y de comunicación ya existentes, y la sensibilización de los equipos de salud. Además, se formularon recomendaciones tendientes a mejorar el diagnóstico y el tratamiento de la enfermedad de Chagas

An EQ-5D-5L value set based on Uruguayan population preferences

In the Original publication of the article, the mean valueindex has been published with an incorrect value in theabstracts part. The corrected line is ??The mean index value,using the selected Uruguayan EQ-5D-5L value set, for thegeneral population in Uruguay was 0.954??.Fil: Augustovski, Federico Ariel. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; Argentina. Universidad de Buenos Aires. Facultad de Medicina; ArgentinaFil: Rey Ares, Lucila. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Irazola, Vilma. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Garay, Osvaldo Ulises. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Gianneo, Oscar. Fondo Nacional de Recursos; UruguayFil: Fernández, Graciela. Fondo Nacional de Recursos; UruguayFil: Morales, Marcelo. Fondo Nacional de Recursos; UruguayFil: Gibbons, Luz. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Ramos Goñi, Juan Manuel. The EuroQol Research Foundation; Países Bajos. Red de Investigación en Servicios de Salud en Enfermedades Crónicas; Españ