New vaccines designed to prevent diseases endemic in low and middle-income countries (LMICs) are now being introduced without prior record of utilization in countries with robust pharmacovigilance systems. To address this deficit, our objective was to demonstrate feasibility of an international hospital-based network for the assessment of potential epidemiological associations between serious and rare adverse events and vaccines in any setting. This was done through a proof-of-concept evaluation of the risk of immune thrombocytopenic purpura (ITP) and aseptic meningitis (AM) following administration of the first dose of measles-mumps-containing vaccines using the self-controlled risk interval method in the primary analysis. The World Health Organization (WHO) selected 26 sentinel sites (49 hospitals) distributed in 16 countries of the six WHO regions. Incidence rate ratios (IRR) of 5.0 (95% CI: 2.5-9.7) for ITP following first dose of measles-containing vaccinations, and of 10.9 (95% CI: 4.2-27.8) for AM following mumps-containing vaccinations were found. The strain-specific analyses showed significantly elevated ITP risk for measles vaccines containing Schwarz (IRR: 20.7; 95% CI: 2.7-157.6), Edmonston-Zagreb (IRR: 11.1; 95% CI: 1.4-90.3), and Enders´Edmonston (IRR: 8.5; 95% CI: 1.9-38.1) strains. A significantly elevated AM risk for vaccines containing the Leningrad-Zagreb mumps strain (IRR: 10.8; 95% CI: 1.3-87.4) was also found. This proof-of-concept study has shown, for the first time, that an international hospital-based network for the investigation of rare vaccine adverse events, using common standardized procedures and with high participation of LMICs, is feasible, can produce reliable results, and has the potential to characterize differences in risk between vaccine strains. The completion of this network by adding large reference hospitals, particularly from tropical countries, and the systematic WHO-led implementation of this approach, should permit the rapid post-marketing evaluation of safety signals for serious and rare adverse events for new and existing vaccines in all settings, including LMICs.
Introducción. Las políticas de control de la malaria o paludismo no han logrado todos los resultados esperados, debido, entre otras razones, a la poca consideración prestada a los aspectos culturales. Objetivo. Explorar los dominios culturales en torno a esta enfermedad en una población colombiana asentada en zona endémica, con el propósito de diseñar e implementar planes de intervención efectivos. Materiales y métodos. Mediante muestreo por conveniencia se seleccionaron residentes de 12 veredas de Tierralta, Córdoba. Con el fin de generar listados libres, se les preguntó a los participantes sobre los problemas de salud en la comunidad, las causas de la malaria, las medidas de control y los responsables de aplicarlas. Para cada uno de estos ítems se calcularon índices de Smith. Resultados. Participaron entre 30 y 38 personas por vereda (n=401), con una edad promedio de 40,24 años (desviación estándar (DE)=14,22); las mujeres representaban 45,39 % del total de la población. El grupo de participantes reconoció la malaria y las infecciones respiratorias como los problemas de salud más importantes de la comunidad (mediana de los índices de Smith: 0,83 y 0,63, respectivamente). Se reconoció la falta de intervención en las condiciones ambientales como el factor más importante generador de la malaria (mediana del índice de Smith=0,65). Por último, los participantes identificaron al centro de salud (mediana del índice de Smith=0,71) y a los profesionales de la salud (mediana del índice de Smith=0,52) como los principales responsables del control de la malaria. Conclusiones. El diseño de programas para la reducción del impacto de la malaria exige la formulación de intervenciones o iniciativas que involucren la perspectiva de las comunidades y se adapten a las necesidades, demandas y recursos disponibles. La técnica de listados libres se propone como una alternativa eficiente de recolección de información sobre los dominios culturales relacionados con la salud.Palabras clave: malaria/prevención y control, cultura, promoción de la salud, salud pública, Colombia. doi: http://dx.doi.org/10.7705/biomedica.v34i2.1629Cultural domains pertaining to malaria: An approach to non-institutional knowledge Introduction: Malaria control policies have not fully achieved the expected results due to little consideration of cultural aspects, among other factors. Objective: To explore the cultural domains pertaining to this disease in an endemic Colombian population, in order to both design and implement effective action plans. Materials and methods: A convenience sampling was conducted to select inhabitants from 12 villages in Tierralta, Córdoba. In order to generate free-lists, participants were asked about their communities' health problems, causes of malaria, control measures and those responsible for malaria control. Smith's indexes were calculated for each item answered. Results: Between 30 and 38 individuals per village participated in the study (N=401). The mean age was 40.24 years (standard deviation (SD)=14.22) and women were 45.39...
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