ABSTRACT Seroprevalence studies are designed in population samples to assess the level and distribution of immunity induced by natural infection of certain infectious agents or by immunization against them. The purpose of the 2nd Seroprevalence Study in Spain is to assess the prevalence and distribution of immune status against vaccine-preventable diseases and generated by natural infection by other microorganisms. Pathologies specifically included in the study are: poliomyelitis, diphtheria, tetanus, pertussis, measles, rubella, mumps, varicella, invasive meningococcal disease by serogroup C, hepatitis A, hepatitis B, hepatitis E, hepatitis C and HIV. The study has a similar design of that conducted in 1996, as it is a descriptive cross-sectional study in resident population of 2 to 80 years of age in Spain. Two-stage conglomerate sampling was carried out on the population aged 2 to 80 years living in Spain, with an initial sample size of 10,000 people. The methodology of the study is described in this article.

RESUMEN Los estudios de seroprevalencia se realizan sobre una muestra de problación con el fin de investigar el nivel y distribución de la inmunidad inducida por infección natural de determinados agentes infecciosos o por vacunación frente a los mismos. El 2º Estudio de Seroprevalencia en España tiene el objetivo de estimar la prevalencia y distribución del estado inmune frente a las enfermedades inmunoprevenibles y de la generada por infección natural por otros microrganismos. En concreto, las patologías incluidas en el estudio son: poliomielitis, difteria, tétanos, tosferina, sarampión, rubéola, parotiditis, varicela, enfermedad meningocócica invasora por serogrupo C, hepatitis A, hepatitis B, hepatitis C, hepatitis E e infección por virus de la inmunodeficiencia humana (VIH). Para ello, se ha diseñado un estudio similar al realizado en 1996, observacional de tipo transversal en la población residente en España de 2 a 80 años de edad. Se ha realizado un muestreo por conglomerados bietápico de la población de 2 a 80 años residente en España, con un tamaño muestral inicial de 10.000 personas. En este artículo se describe la metodología utilizada en la realización del estudio.

ABSTRACT Seroprevalence studies are designed in population samples to assess the level and distribution of immunity induced by natural infection of certain infectious agents or by immunization against them. The purpose of the 2nd Seroprevalence Study in Spain is to assess the prevalence and distribution of immune status against vaccine-preventable diseases and generated by natural infection by other microorganisms. Pathologies specifically included in the study are: poliomyelitis, diphtheria, tetanus, pertussis, measles, rubella, mumps, varicella, invasive meningococcal disease by serogroup C, hepatitis A, hepatitis B, hepatitis E, hepatitis C and HIV. The study has a similar design of that conducted in 1996, as it is a descriptive cross-sectional study in resident population of 2 to 80 years of age in Spain. Two-stage conglomerate sampling was carried out on the population aged 2 to 80 years living in Spain, with an initial sample size of 10,000 people. The methodology of the study is described in this article.

RESUMEN Los estudios de seroprevalencia se realizan sobre una muestra de problación con el fin de investigar el nivel y distribución de la inmunidad inducida por infección natural de determinados agentes infecciosos o por vacunación frente a los mismos. El 2º Estudio de Seroprevalencia en España tiene el objetivo de estimar la prevalencia y distribución del estado inmune frente a las enfermedades inmunoprevenibles y de la generada por infección natural por otros microrganismos. En concreto, las patologías incluidas en el estudio son: poliomielitis, difteria, tétanos, tosferina, sarampión, rubéola, parotiditis, varicela, enfermedad meningocócica invasora por serogrupo C, hepatitis A, hepatitis B, hepatitis C, hepatitis E e infección por virus de la inmunodeficiencia humana (VIH). Para ello, se ha diseñado un estudio similar al realizado en 1996, observacional de tipo transversal en la población residente en España de 2 a 80 años de edad. Se ha realizado un muestreo por conglomerados bietápico de la población de 2 a 80 años residente en España, con un tamaño muestral inicial de 10.000 personas. En este artículo se describe la metodología utilizada en la realización del estudio.

Resumo Revisão integrativa da literatura, que teve como objetivo identificar evidências acerca da avaliação de desempenho de programas de controle de tuberculose no contexto brasileiro e espanhol. Foram selecionados materiais produzidos no Brasil e na Espanha indexados em bases de dados, diretórios de busca e bibliotecas virtuais, publicados entre 2002-2013. Para a análise foram incluídas 17 produções (9 brasileiras e 8 espanholas). Foi feita a identificação de conceitos relacionados à avaliação de programas, assim como métodos e indicadores utilizados para avaliação de programas de controle de tuberculose em ambos os países. No contexto espanhol identifica-se uma preocupação com a gestão orientada por resultados e o desenvolvimento de indicadores amplos para avaliação de uma série de programas em saúde, incluindo o de tuberculose. Já as produções brasileiras apresentaram maior proximidade com o método da pesquisa avaliativa clássica, e uma maior variedade de objetos de investigação dentro das atividades de controle da doença. Os resultados refletem a complexidade da avaliação de programas que envolvem múltiplas atividades e diversos atores, apontam para a necessidade da integração de indicadores epidemiológicos e operacionais em tuberculose.

Abstract This is an integrative review of the literature, which sought to locate evidence regarding the evaluation of the performance of tuberculosis control programs in the Brazilian and Spanish contexts. Articles indexed in databases, search directories and virtual libraries produced in Brazil and Spain from 2002 to 2013 were selected. A total of 17 articles (9 Brazilian and 8 Spanish) were included for analysis. The intention was to identify program evaluation concepts, methodologies and indicators for TB control program evaluation in both countries. In the Spanish context, a concern with results-oriented management and the attempt to develop broader indicators for the assessment of a series of health programs, including those related to tuberculosis control, was identified. The Brazilian references showed greater proximity to the classic methods of evaluation research, and a greater variety of objects of study regarding the activities expected in a control program. The findings highlight the complexity of program evaluation activities, which involve multiple and diverse stakeholders, and point to the need for integration of epidemiological and operational indicators in tuberculosis.

Resumo Revisão integrativa da literatura, que teve como objetivo identificar evidências acerca da avaliação de desempenho de programas de controle de tuberculose no contexto brasileiro e espanhol. Foram selecionados materiais produzidos no Brasil e na Espanha indexados em bases de dados, diretórios de busca e bibliotecas virtuais, publicados entre 2002-2013. Para a análise foram incluídas 17 produções (9 brasileiras e 8 espanholas). Foi feita a identificação de conceitos relacionados à avaliação de programas, assim como métodos e indicadores utilizados para avaliação de programas de controle de tuberculose em ambos os países. No contexto espanhol identifica-se uma preocupação com a gestão orientada por resultados e o desenvolvimento de indicadores amplos para avaliação de uma série de programas em saúde, incluindo o de tuberculose. Já as produções brasileiras apresentaram maior proximidade com o método da pesquisa avaliativa clássica, e uma maior variedade de objetos de investigação dentro das atividades de controle da doença. Os resultados refletem a complexidade da avaliação de programas que envolvem múltiplas atividades e diversos atores, apontam para a necessidade da integração de indicadores epidemiológicos e operacionais em tuberculose.

Abstract This is an integrative review of the literature, which sought to locate evidence regarding the evaluation of the performance of tuberculosis control programs in the Brazilian and Spanish contexts. Articles indexed in databases, search directories and virtual libraries produced in Brazil and Spain from 2002 to 2013 were selected. A total of 17 articles (9 Brazilian and 8 Spanish) were included for analysis. The intention was to identify program evaluation concepts, methodologies and indicators for TB control program evaluation in both countries. In the Spanish context, a concern with results-oriented management and the attempt to develop broader indicators for the assessment of a series of health programs, including those related to tuberculosis control, was identified. The Brazilian references showed greater proximity to the classic methods of evaluation research, and a greater variety of objects of study regarding the activities expected in a control program. The findings highlight the complexity of program evaluation activities, which involve multiple and diverse stakeholders, and point to the need for integration of epidemiological and operational indicators in tuberculosis.

Background: Employing molecular epidemiology techniques for the study of tuberculosis can afford the possibility of identifying tuberculosis transmission patterns. This study has been made for the purpose of estimating the incidence of tuberculosis related to recent transmission in Madrid and of identifying the risk factors making it possible to define transmission patterns. Methods: A three-year descriptive populational study was conducted on patients diagnosed with tuberculosis based on cultures in four districts in Madrid (550,442 inhabitants). The transmission patterns were described by means of conventional epidemiological research and molecular techniques (Restriction Fragment Length Polymorphism - RFLP- analysis with IS6110 and spoligotyping). Results: An RFLP analysis was conducted on 233 clinically isolated Mycobacterium tuberculosis strains, 99 (42.5%) of which were grouped into 29 clusters. The most numerous group was comprised of 134 patients infected with M. tuberculosis strains of a single RFLP pattern. These patients averaged 48.3 years of age (DE 19.4), and 17.2% were revealed to have an endogenous risk factor. Two transmission patterns were identified among the grouped cases. The first pattern included 57 patients pertaining to 23 small clusters (2-4 cases), 25 (43.9%) of which were epidemiologically linked to another case from the same cluster. The second pattern was comprised of 42 patients grouped into 6 large clusters (5 cases or more). The subjects averaged 31.4 years of age (DE 15.8), 28.6% being intravenous drug users, 31% infected with HIV, and 26.2% having a prison background. Conclusions: Identifying tuberculosis transmission patterns by using molecular biology techniques affords the possibility of detecting population groups for whom preferential measures can be taken in the prevention and control programs.

Fundamento: La aplicación de las técnicas de epidemiología molecular en el estudio de la tuberculosis puede permitir identificar los patrones de transmisión de la enfermedad. El objetivo de este estudio ha sido estimar la incidencia de tuberculosis asociada a transmisión reciente en Madrid e identificar los factores de riesgo que permitan definir patrones de transmisión. Métodos: Se realizó un estudio descriptivo poblacional de tres años de duración en pacientes diagnosticados de tuberculosis mediante cultivo en cuatro distritos de Madrid (550.442 habitantes). La descripción de los patrones de transmisión se realizó mediante la investigación epidemiológica convencional y las técnicas moleculares (análisis de fragmentos de restricción de longitud polimórfica -RFLP- con IS6110 y spoligotyping). Resultados: Se realizó RFLP en 233 aislados clínicos de Mycobacterium tuberculosis, de los que 99 (42,5%) estaban agrupados en 29 clusters. El grupo más numeroso lo formaban 134 enfermos infectados por cepas de M. tuberculosis con patrón RFLP único. Su media de edad era 48,3 años (DE 19,4) y el 17,2% presentaba un factor de riesgo de reactivación endógena. Entre los casos agrupados se identificaron dos patrones de transmisión. El primero de ellos incluía a 57 enfermos pertenecientes a 23 clusters pequeños (2-4 casos), de los que 25 (43,9%) estaban conectados epidemiológicamente con otro caso de su mismo cluster. El segundo lo formaban 42 pacientes agrupados en 6 clusters grandes (5 casos o más). La media de edad era de 31,4 años (DE 15,8), el 28,6% eran usuarios de drogas inyectadas, el 31% estaban infectados por el VIH, y el 26,2% tenían antecedentes de estancia en prisión. Conclusiones: La identificación de patrones de transmisión de la tuberculosis utilizando técnicas de biología molecular permite detectar grupos de población susceptibles de actuación preferente en los programas de prevención y control.

Background: Employing molecular epidemiology techniques for the study of tuberculosis can afford the possibility of identifying tuberculosis transmission patterns. This study has been made for the purpose of estimating the incidence of tuberculosis related to recent transmission in Madrid and of identifying the risk factors making it possible to define transmission patterns. Methods: A three-year descriptive populational study was conducted on patients diagnosed with tuberculosis based on cultures in four districts in Madrid (550,442 inhabitants). The transmission patterns were described by means of conventional epidemiological research and molecular techniques (Restriction Fragment Length Polymorphism - RFLP- analysis with IS6110 and spoligotyping). Results: An RFLP analysis was conducted on 233 clinically isolated Mycobacterium tuberculosis strains, 99 (42.5%) of which were grouped into 29 clusters. The most numerous group was comprised of 134 patients infected with M. tuberculosis strains of a single RFLP pattern. These patients averaged 48.3 years of age (DE 19.4), and 17.2% were revealed to have an endogenous risk factor. Two transmission patterns were identified among the grouped cases. The first pattern included 57 patients pertaining to 23 small clusters (2-4 cases), 25 (43.9%) of which were epidemiologically linked to another case from the same cluster. The second pattern was comprised of 42 patients grouped into 6 large clusters (5 cases or more). The subjects averaged 31.4 years of age (DE 15.8), 28.6% being intravenous drug users, 31% infected with HIV, and 26.2% having a prison background. Conclusions: Identifying tuberculosis transmission patterns by using molecular biology techniques affords the possibility of detecting population groups for whom preferential measures can be taken in the prevention and control programs.

Fundamento: La aplicación de las técnicas de epidemiología molecular en el estudio de la tuberculosis puede permitir identificar los patrones de transmisión de la enfermedad. El objetivo de este estudio ha sido estimar la incidencia de tuberculosis asociada a transmisión reciente en Madrid e identificar los factores de riesgo que permitan definir patrones de transmisión. Métodos: Se realizó un estudio descriptivo poblacional de tres años de duración en pacientes diagnosticados de tuberculosis mediante cultivo en cuatro distritos de Madrid (550.442 habitantes). La descripción de los patrones de transmisión se realizó mediante la investigación epidemiológica convencional y las técnicas moleculares (análisis de fragmentos de restricción de longitud polimórfica -RFLP- con IS6110 y spoligotyping). Resultados: Se realizó RFLP en 233 aislados clínicos de Mycobacterium tuberculosis, de los que 99 (42,5%) estaban agrupados en 29 clusters. El grupo más numeroso lo formaban 134 enfermos infectados por cepas de M. tuberculosis con patrón RFLP único. Su media de edad era 48,3 años (DE 19,4) y el 17,2% presentaba un factor de riesgo de reactivación endógena. Entre los casos agrupados se identificaron dos patrones de transmisión. El primero de ellos incluía a 57 enfermos pertenecientes a 23 clusters pequeños (2-4 casos), de los que 25 (43,9%) estaban conectados epidemiológicamente con otro caso de su mismo cluster. El segundo lo formaban 42 pacientes agrupados en 6 clusters grandes (5 casos o más). La media de edad era de 31,4 años (DE 15,8), el 28,6% eran usuarios de drogas inyectadas, el 31% estaban infectados por el VIH, y el 26,2% tenían antecedentes de estancia en prisión. Conclusiones: La identificación de patrones de transmisión de la tuberculosis utilizando técnicas de biología molecular permite detectar grupos de población susceptibles de actuación preferente en los programas de prevención y control.

BACGROUND: In 1997 (between 22 September and 14 November) an A+C meningococcal mass vaccination campaign was carried out in Madrid, targeting the age group of from 18 months to 19 years of age, in the face of an increase in the number of cases of meningococcal disease caused by serogroup C occurring in the 1996-97 season. This study forms a part of the impact assessment of that campaign. METHODS: The evolution of the meningococcal disease, by means of the comparison of rates of incidence; and the efficacy of the vaccination campaign was determined after one year (1997-98 season) and after two years (1997-98 and 1998-99 seasons) of monitoring. The vaccine efficacy has been calculated as [1-(Incidence rate in vaccinated /Incidence rate in unvaccinated)]*100. RESULTS: A significant drop was registered in the incidence of serogroup C meningococcal disease on comparing the 1997-98 and 1998-99 seasons with the epidemic season (1996-97). The vaccine efficacy after two years of monitoring subsequent to the vaccination campaign was 76.9% for the global population between 18 months and 19 years of age and 88.5% in the group of vaccinated individuals between 15 and 19 years of age. CONCLUSIONS: The vaccine efficacy obtained is compatible with that described in the relevant literature. The significant reduction in the incidence of meningococcal disease caused by serogroup C was due to the vaccine efficacy obtained.

FUNDAMENTO: En el año 1997 (entre el 22 de septiembre y el 14 de noviembre) se efectuó una campaña de vacunación antimeningocócica A+C en la Comunidad de Madrid, en el grupo de edad de 18 meses a 19 años, ante el aumento del número de casos de enfermedad meningocócica por serogrupo C presentado en la temporada 1996-97. Este estudio forma parte de la evaluación de dicha campaña. MÉTODOS: Se ha valorado la evolución de la incidencia de la enfermedad meningocócica, mediante la comparación de tasas; y se ha determinado la efectividad de la vacunación al año (temporada 1997-98) y a los dos años (temporadas 1997-98 y 1998-99) de seguimiento. La efectividad vacunal se ha calculado como (1-(Tasa en vacunados/Tasa en no vacunados))*100. RESULTADOS: Se ha producido un descenso significativo en la incidencia de enfermedad meningocócica por serogrupo C al comparar las temporadas 1997-98 y 1998-99 con la temporada epidémica (1996-97). La efectividad vacunal a los dos años de seguimiento tras la campaña de vacunación ha sido de un 76,9% para la población global de 18 meses a 19 años y de un 88,5% en el grupo de vacunados entre 15 y 19 años. CONCLUSIONES: La efectividad vacunal obtenida es compatible con lo descrito en la literatura. La disminución significativa de la incidencia de enfermedad meningocócica por serogrupo C ha sido debida a la efectividad vacunal obtenida.

BACGROUND: In 1997 (between 22 September and 14 November) an A+C meningococcal mass vaccination campaign was carried out in Madrid, targeting the age group of from 18 months to 19 years of age, in the face of an increase in the number of cases of meningococcal disease caused by serogroup C occurring in the 1996-97 season. This study forms a part of the impact assessment of that campaign. METHODS: The evolution of the meningococcal disease, by means of the comparison of rates of incidence; and the efficacy of the vaccination campaign was determined after one year (1997-98 season) and after two years (1997-98 and 1998-99 seasons) of monitoring. The vaccine efficacy has been calculated as [1-(Incidence rate in vaccinated /Incidence rate in unvaccinated)]*100. RESULTS: A significant drop was registered in the incidence of serogroup C meningococcal disease on comparing the 1997-98 and 1998-99 seasons with the epidemic season (1996-97). The vaccine efficacy after two years of monitoring subsequent to the vaccination campaign was 76.9% for the global population between 18 months and 19 years of age and 88.5% in the group of vaccinated individuals between 15 and 19 years of age. CONCLUSIONS: The vaccine efficacy obtained is compatible with that described in the relevant literature. The significant reduction in the incidence of meningococcal disease caused by serogroup C was due to the vaccine efficacy obtained.

FUNDAMENTO: En el año 1997 (entre el 22 de septiembre y el 14 de noviembre) se efectuó una campaña de vacunación antimeningocócica A+C en la Comunidad de Madrid, en el grupo de edad de 18 meses a 19 años, ante el aumento del número de casos de enfermedad meningocócica por serogrupo C presentado en la temporada 1996-97. Este estudio forma parte de la evaluación de dicha campaña. MÉTODOS: Se ha valorado la evolución de la incidencia de la enfermedad meningocócica, mediante la comparación de tasas; y se ha determinado la efectividad de la vacunación al año (temporada 1997-98) y a los dos años (temporadas 1997-98 y 1998-99) de seguimiento. La efectividad vacunal se ha calculado como (1-(Tasa en vacunados/Tasa en no vacunados))*100. RESULTADOS: Se ha producido un descenso significativo en la incidencia de enfermedad meningocócica por serogrupo C al comparar las temporadas 1997-98 y 1998-99 con la temporada epidémica (1996-97). La efectividad vacunal a los dos años de seguimiento tras la campaña de vacunación ha sido de un 76,9% para la población global de 18 meses a 19 años y de un 88,5% en el grupo de vacunados entre 15 y 19 años. CONCLUSIONES: La efectividad vacunal obtenida es compatible con lo descrito en la literatura. La disminución significativa de la incidencia de enfermedad meningocócica por serogrupo C ha sido debida a la efectividad vacunal obtenida.