Public policy coverage and access to medicines in Brazil.

OBJECTIVE: Describe consumption patterns for monetary and non-monetary acquisition of medicines according to age and income groups, highlighting pharmaceuticals associated with health programs with specific access guarantees. METHODS: Descriptive observational study using microdata from the 2017-2018 Pesquisa de Orçamentos Familiares (Household Budget Survey, POF/IBGE). We initially reviewed programs/policies with specific guarantees of access to medicines in the SUS. Using the pharmaceutical product list of POF-4 (chart 29 of the questionnaire on individual expenditures), we selected the medicines related to these programs. We then described frequencies and percentages for not reporting medicine consumption and for reporting consumption (either through monetary or non-monetary acquisition) according to age and income groups. For medicines with distinctive access guarantees, we compared average monthly values of acquisitions and consumption patterns by age and income. RESULTS: 63% of those in the ≤ 2 minimum wage (MW) household income group did not report consuming medicines in the last month. Among those earning > 25 MW, 44.3% did not report consumption. Non-monetary acquisitions of medicines were mainly reported for the < 10 MW group and for the elderly and accounted for 20.5% of the total consumption of medicines (in value). For policies with specific access guarantees, non-monetary acquisitions reached 33.6% of total consumption. This percentage varied for the various selected medicines: vaccines, 83.3%; cancer drugs, 70.3%; diabetes, 47.9%; hypertension, 35.9%; asthma and bronchitis, 29.2%; eye problems, 14%; prostate and urinary tract, 10.7%; gynecological, 11.6%; and contraceptives, 9.7%. CONCLUSION: Shares for non-monetary acquisitions of medicines are still low but benefit mainly lower-income and older age groups. Policies and programs with specific access guarantees to medicines have increased access. Results suggest the need to strengthen and expand pharmaceutical care policies.

[Family expenditures on healthcare plans in Brazil and household budget commitment: an analysis of the Brazilian Household Budgets Survey (2017/2018)]. / Gastos das famílias com planos de saúde no Brasil e comprometimento da renda domiciliar: uma análise da Pesquisa de Orçamentos Familiares (2017/2018).

According to studies using previous editions of the Household Budgets Survey (POF) in Brazil, paying for a healthcare plan increases the percentage of income spent on health and fails to reduce the probability of incurring excessive health expenditures. The study's objective was to describe relations between expenditures on healthcare plans, income, and age groups, highlighting the effect of having a plan on the probability of committing more than 40% of income on health-related expenditures. An analysis of the POF 2017/2018 determined the commitment of per capita household income for payers of plans by age group and type of plan and logistic regression for factors associated with committing more than 40% of income to health-related expenditures. In 12 months, 22.1 million Brazilians spent BRL 78.1 billion on private medical insurance. The share of income spent on individual plans increases consistently with age, from 4.5% of per capita household income (at < 19 years) to 10.6% of this income (at 79 years or older). The probability of committing more than 40% of income to health expenditures decreases with income, increases with age, and is higher for those paying for health plans. Spending on healthcare plans alone exceeds 40% of per capita household income for 5.6% of Brazilians 60 years or older who pay for individual plans and for 4% of those who pay for company plans. Persons in the oldest age groups and in the lowest income brackets show the highest likelihood of spending more than 40% of their income on healthcare. A revision of the plans' adjustment by age is an alternative for attempting to mitigate this problem.

Estudos com edições anteriores da Pesquisa de Orçamentos Familiares (POF) indicam que, no Brasil, pagar um plano de saúde aumenta o percentual da renda gasto com saúde e não reduz a probabilidade de ter gastos excessivos com saúde. Descrevem-se relações entre gastos com planos de saúde, renda e faixas etárias, destacando o efeito de ter plano sobre a probabilidade de comprometer mais de 40% da renda com despesas relacionadas à saúde. Análise de microdados da POF 2017/2018 para determinar o comprometimento da renda domiciliar per capita dos pagantes de planos por faixa etária e por tipo de plano, e regressão logística para fatores associados a comprometer mais de 40% da renda com despesas de saúde. Em 12 meses, R$ 78,1 bilhões foram gastos com planos médicos por 22,1 milhões de pessoas. O comprometimento da renda com planos individuais aumenta consistentemente com a idade, passando de 4,5% da renda domiciliar per capita (< 19 anos) para 10,6% dessa renda (79 anos ou mais). A probabilidade de comprometer mais de 40% da renda com despesas de saúde diminui com a renda, cresce com a idade e é maior para quem paga plano de saúde. A despesa apenas com os planos supera 40% da renda domiciliar per capita para 5,6% das pessoas com 60 anos ou mais que pagam planos individuais e para 4% das que pagam planos empresariais. As pessoas nas faixas de idade mais altas e faixas de renda mais baixas são as com maior probabilidade de comprometer mais de 40% da renda com despesas de saúde. Rever as regras de reajuste por idade dos planos é uma alternativa para tentar mitigar esse problema.

Estudios con ediciones anteriores de la Encuesta de Presupuestos Familiares (POF) indican que, en Brasil, pagar un plan de salud aumenta el porcentaje de la renta gastado con salud y no reduce la probabilidad de tener gastos excesivos con la salud. El objetivo fue describir las relaciones entre gastos con planes de salud, renta y franjas de edad, destacando el efecto de tener un plan sobre la probabilidad de comprometer más de un 40% de la renta con gastos relacionados con la salud. Se realizó un análisis de microdatos de la POF 2017/2018 para determinar el comprometimiento de la renta domiciliaria per cápita de los pagadores de planes por franja etaria y por tipo de plan, así como una regresión logística para factores asociados con comprometer más de un 40% de la renta con gastos de salud. En 12 meses, BRL 78,1 mil millones se gastaron con planes médicos por 22,1 millones de personas. El comprometimiento de la renta con planes individuales aumenta consistentemente con la edad, pasando de 4,5% de la renta domiciliaria per cápita (< 19 años) al 10,6% de esa renta (79 años o más). La probabilidad de comprometer más de un 40% de la renta con gastos de salud disminuye con la renta, crece con la edad y es mayor para quien paga un plan de salud. El gasto solo con los planes supera un 40% de la renta domiciliaria per cápita para un 5,6% de las personas con 60 años o más que pagan planes individuales y para un 4% de los que pagan planes empresariales. Las personas en las franjas de edad más altas y franjas de renta más bajas son las que tienen mayor probabilidad de comprometer más de un 40% de la renta con gastos de salud. Revisar las reglas de reajuste por edad de los planes es una alternativa para intentar mitigar ese problema.

Public policy coverage and access to medicines in Brazil / Cobertura de políticas públicas e acesso a medicamentos no Brasil

ABSTRACT OBJECTIVE Describe consumption patterns for monetary and non-monetary acquisition of medicines according to age and income groups, highlighting pharmaceuticals associated with health programs with specific access guarantees. METHODS Descriptive observational study using microdata from the 2017-2018 Pesquisa de Orçamentos Familiares (Household Budget Survey, POF/IBGE). We initially reviewed programs/policies with specific guarantees of access to medicines in the SUS. Using the pharmaceutical product list of POF-4 (chart 29 of the questionnaire on individual expenditures), we selected the medicines related to these programs. We then described frequencies and percentages for not reporting medicine consumption and for reporting consumption (either through monetary or non-monetary acquisition) according to age and income groups. For medicines with distinctive access guarantees, we compared average monthly values of acquisitions and consumption patterns by age and income. RESULTS 63% of those in the ≤ 2 minimum wage (MW) household income group did not report consuming medicines in the last month. Among those earning > 25 MW, 44.3% did not report consumption. Non-monetary acquisitions of medicines were mainly reported for the < 10 MW group and for the elderly and accounted for 20.5% of the total consumption of medicines (in value). For policies with specific access guarantees, non-monetary acquisitions reached 33.6% of total consumption. This percentage varied for the various selected medicines: vaccines, 83.3%; cancer drugs, 70.3%; diabetes, 47.9%; hypertension, 35.9%; asthma and bronchitis, 29.2%; eye problems, 14%; prostate and urinary tract, 10.7%; gynecological, 11.6%; and contraceptives, 9.7%. CONCLUSION Shares for non-monetary acquisitions of medicines are still low but benefit mainly lower-income and older age groups. Policies and programs with specific access guarantees to medicines have increased access. Results suggest the need to strengthen and expand pharmaceutical care policies.

RESUMO OBJETIVO Descrever padrões de consumo de medicamentos com e sem desembolso direto de recursos, segundo faixas de idade e de renda, destacando os fármacos associados a programas de saúde com garantias específicas de acesso. MÉTODOS Estudo descritivo observacional usando microdados da Pesquisa de Orçamentos Familiares (POF/IBGE) 2017-2018. Inicialmente, foram definidas as garantias específicas de acesso a medicamentos do SUS pela sistematização de programas/políticas com essa previsão. A partir dos medicamentos do quadro 29 do questionário de despesas individuais (POF-4), foram selecionados tipos de medicamentos associados a essas garantias. Foram descritas as frequências e os percentuais de pessoas sem consumo e com consumo (aquisição com e sem desembolso direto de recursos), segundo faixas de idade e de renda. Para medicamentos vinculados a garantias específicas, comparou-se valores médios mensais de aquisições e padrões de consumo por faixa etária e renda. RESULTADOS Entre as pessoas com renda domiciliar até dois salários mínimos, 63% não declararam consumo de medicamentos no mês. Entre as acima de 25 salários mínimos, foram 44,3%. Aquisições sem desembolso direto foram feitas principalmente por pessoas na faixa com até 10 salários mínimos e entre os mais idosos. O consumo sem desembolso direto representou 20,5% do consumo total de medicamentos (em valor). Para políticas com garantias específicas de acesso, o consumo sem desembolso foi de 33,6% com variações desse percentual entre os medicamentos selecionados no estudo: vacinas, 83,3%; medicamentos para câncer, 70,3%; diabetes, 47,9%; hipertensão, 35,9%; asma e bronquite, 29,2%; problemas oftalmológicos, 14%; medicamentos para próstata e vias urinárias, 10,7%; para problemas ginecológicos, 11,6%; e anticoncepcionais, 9,7%. CONCLUSÃO O consumo sem desembolso ainda é baixo, mas beneficia principalmente pessoas de menor renda e idosos. Políticas e programas com garantias específicas de acesso a medicamentos têm aumentado esse acesso. Os resultados sugerem a necessidade de fortalecer e ampliar as políticas de assistência farmacêutica.

Gastos das famílias com planos de saúde no Brasil e comprometimento da renda domiciliar: uma análise da Pesquisa de Orçamentos Familiares (2017/2018) / Family expenditures on healthcare plans in Brazil and household budget commitment: an analysis of the Brazilian Household Budgets Survey (2017/2018) / Gastos de las familias con planes de salud en Brasil y comprometimiento de la renta domiciliaria: un análisis de la Encuesta de Presupuestos Familiares (2017/2018)

Estudos com edições anteriores da Pesquisa de Orçamentos Familiares (POF) indicam que, no Brasil, pagar um plano de saúde aumenta o percentual da renda gasto com saúde e não reduz a probabilidade de ter gastos excessivos com saúde. Descrevem-se relações entre gastos com planos de saúde, renda e faixas etárias, destacando o efeito de ter plano sobre a probabilidade de comprometer mais de 40% da renda com despesas relacionadas à saúde. Análise de microdados da POF 2017/2018 para determinar o comprometimento da renda domiciliar per capita dos pagantes de planos por faixa etária e por tipo de plano, e regressão logística para fatores associados a comprometer mais de 40% da renda com despesas de saúde. Em 12 meses, R$ 78,1 bilhões foram gastos com planos médicos por 22,1 milhões de pessoas. O comprometimento da renda com planos individuais aumenta consistentemente com a idade, passando de 4,5% da renda domiciliar per capita (< 19 anos) para 10,6% dessa renda (79 anos ou mais). A probabilidade de comprometer mais de 40% da renda com despesas de saúde diminui com a renda, cresce com a idade e é maior para quem paga plano de saúde. A despesa apenas com os planos supera 40% da renda domiciliar per capita para 5,6% das pessoas com 60 anos ou mais que pagam planos individuais e para 4% das que pagam planos empresariais. As pessoas nas faixas de idade mais altas e faixas de renda mais baixas são as com maior probabilidade de comprometer mais de 40% da renda com despesas de saúde. Rever as regras de reajuste por idade dos planos é uma alternativa para tentar mitigar esse problema.

According to studies using previous editions of the Household Budgets Survey (POF) in Brazil, paying for a healthcare plan increases the percentage of income spent on health and fails to reduce the probability of incurring excessive health expenditures. The study's objective was to describe relations between expenditures on healthcare plans, income, and age groups, highlighting the effect of having a plan on the probability of committing more than 40% of income on health-related expenditures. An analysis of the POF 2017/2018 determined the commitment of per capita household income for payers of plans by age group and type of plan and logistic regression for factors associated with committing more than 40% of income to health-related expenditures. In 12 months, 22.1 million Brazilians spent BRL 78.1 billion on private medical insurance. The share of income spent on individual plans increases consistently with age, from 4.5% of per capita household income (at < 19 years) to 10.6% of this income (at 79 years or older). The probability of committing more than 40% of income to health expenditures decreases with income, increases with age, and is higher for those paying for health plans. Spending on healthcare plans alone exceeds 40% of per capita household income for 5.6% of Brazilians 60 years or older who pay for individual plans and for 4% of those who pay for company plans. Persons in the oldest age groups and in the lowest income brackets show the highest likelihood of spending more than 40% of their income on healthcare. A revision of the plans' adjustment by age is an alternative for attempting to mitigate this problem.

Estudios con ediciones anteriores de la Encuesta de Presupuestos Familiares (POF) indican que, en Brasil, pagar un plan de salud aumenta el porcentaje de la renta gastado con salud y no reduce la probabilidad de tener gastos excesivos con la salud. El objetivo fue describir las relaciones entre gastos con planes de salud, renta y franjas de edad, destacando el efecto de tener un plan sobre la probabilidad de comprometer más de un 40% de la renta con gastos relacionados con la salud. Se realizó un análisis de microdatos de la POF 2017/2018 para determinar el comprometimiento de la renta domiciliaria per cápita de los pagadores de planes por franja etaria y por tipo de plan, así como una regresión logística para factores asociados con comprometer más de un 40% de la renta con gastos de salud. En 12 meses, BRL 78,1 mil millones se gastaron con planes médicos por 22,1 millones de personas. El comprometimiento de la renta con planes individuales aumenta consistentemente con la edad, pasando de 4,5% de la renta domiciliaria per cápita (< 19 años) al 10,6% de esa renta (79 años o más). La probabilidad de comprometer más de un 40% de la renta con gastos de salud disminuye con la renta, crece con la edad y es mayor para quien paga un plan de salud. El gasto solo con los planes supera un 40% de la renta domiciliaria per cápita para un 5,6% de las personas con 60 años o más que pagan planes individuales y para un 4% de los que pagan planes empresariales. Las personas en las franjas de edad más altas y franjas de renta más bajas son las que tienen mayor probabilidad de comprometer más de un 40% de la renta con gastos de salud. Revisar las reglas de reajuste por edad de los planes es una alternativa para intentar mitigar ese problema.

An index of Brazilian frailty and its association with social factors.

BACKGROUND: The Brazilian population is aging rapidly and it is necessary to establish tools to map the elderly population regarding its frailty, which is a common adverse condition during the aging process. The National Health Survey (PNS in Portuguese) data makes it possible. OBJECTIVE: This study aimed to construct a frailty index (FI) of the elderly Brazilian population using the PNS data, in order to compare it with the index of other population and to measure its association with social factors. METHOD: A set of the PNS variables was selected to carry out the index, taking into account criteria identified in the literature. The FI score was categorized as: non-frail (FI ≥ 0.10); vulnerable (0.10 < FI ≥ 0.21); frail (0.21 < FI ≥ 0.45); and most frail (FI > 0.45). A logistic regression model was adjusted to measure the association of the FI with some risk factors and social factors. RESULTS: The Brazilian FI, calculated with 26 variables, presented a mean score of 0.13 and the best was a gamma distribution. Of the individuals, 53.9% were non-frail, 30.1% vulnerable, 13.6% frail and 2.5% most frail. The variables that significantly distinguished each level of the frailty were: self-perceived health status; instrumental activities of daily living (IADL); and difficulty in hearing, seeing and concentrating. Additionally, socio-demographic and sedentary lifestyle were identified as risk factors. CONCLUSION: The proposed index showed a similar distribution to the ones observed in the literature and it is associated with social factors. These findings are useful to guide the planning of the Brazilian health policy for the elderly population.

The use of intervention analysis of the mortality rates from breast cancer in assessing the Brazilian screening programme

Abstract Introduction There is a need to develop methods to evaluate public health interventions. Therefore, this work proposed an intervention analysis on time series of breast cancer mortality rates to assess the effects of an action of the Brazilian Screening Programme. Methods The analysed series was the monthly female breast cancer mortality rates from January 1996 to March 2016. The intervention was the establishment of the National Information System on Breast Cancer in June 2009. The Box-Tiao approach was used to build a Global Intervention Model (GIM) composed of a component that fits the series without the intervention, and a component that fits the effect with the intervention. The intervention's response time was estimated and used to define the length of the residual series to assess the predictive accuracy of the GIM, which was compared to a one-step-ahead forecasting approach. Results The pre-intervention period was fitted to a SARIMA (0,1,2) (1,1,1)12 model and the intervention's effect to an ARIMA (1,1,0) model. The intervention led to an increase in the mortality rates, and its response time was 24 months. The forecast error (MAPE) for the GIM was 3.14%, and for the one-step-ahead forecast it was 2.15%. Conclusion This work goes one step further in relation to the studies carried out to evaluate the Breast Cancer Screening Programme in Brazil, considering that it was possible to quantify the effects and the response time of the intervention, demonstrating the potential of the proposed method to be used to evaluate health interventions.

AD-SISCOLO: a decision-support tool to aid the management of a cervical cancer screening program

AbstractIntroduction: This paper aims to develop a data warehouse (AD-SISCOLO) in order to support the management of the cervical cancer screening program in the municipality of Rio de Janeiro/Brazil. As a part of the management process, the program managers of the municipality perform tedious manual work in order to calculate a series of performance indicators and then take decisions based on them. Methods AD-SISCOLO was implemented using the Pentaho BI Suite Business Intelligence Platform and the MySQL database management system. The indicators to be calculated and visualized in the tool were based on the municipal data of the cytopathology and histopathology tests from January 2012 until December 2014, which was obtained from the Information System of Cervical Cancer (SISCOLO) after a record linkage process. The follow-up indicators were based on a simplified version of the Brazilian guidelines for the cervical cancer screening. Results AD-SISCOLO allows the visualization of a set of test-based and follow-up indicators from different views and dimensions, which enable managers to monitor all the phases of the screening process and to identify the process' failures. Conclusions Compared with the current available environments in Brazil, AD-SISCOLO is unique in its visualization of the follow-up indicators of groups of women, according to their test results and age. Thereby it provides presentation flexibility to suit the program manager's needs.

[Mapping stakeholders' preferences in prioritization criteria for horizon scanning in healthcare technologies]. / Mapeamento das preferências de atores estratégicos sobre os critérios de priorização para o monitoramento do horizonte tecnológico em saúde.

Filtration and prioritization are two basics steps in horizon scanning systems. This article aimed to map stakeholders' preferences in the Brazilian Unified National Health System (SUS) regarding filtration and prioritization criteria. Two filtration criteria (time horizon and innovation) and eight prioritization criteria (relevance to epidemiology, health policies, and clinical practice; potential impact on SUS budget, healthcare providers' costs, and mortality; safety; and legal, ethical, and social aspects) were selected. Multiple correspondence analysis was used to map stakeholders' preferences within and between groups. Two groups were more homogeneous and determinant for selection of prioritization criteria. Stakeholders' professional experience had more influence than institutional affiliations. The approach showed transparent criteria selection and analysis of stakeholders' individual preferences.

Mapeamento das preferências de atores estratégicos sobre os critérios de priorização para o monitoramento do horizonte tecnológico em saúde / Mapping stakeholders' preferences in prioritization criteria for horizon scanning in healthcare technologies / Mapeo de las preferencias de actores estratégicos sobre los criterios de priorización en la evaluación de tecnologías emergentes en salud

Resumo: Entre as etapas básicas de um sistema de monitoramento do horizonte de tecnologias emergentes, estão a filtragem e a priorização dessas tecnologias. Este trabalho tem por objetivo mapear as preferências dos atores estratégicos do Sistema Único de Saúde (SUS) quanto aos critérios de filtragem e priorização. Foram selecionados dois critérios de filtragem (horizonte de tempo e inovação) e oito critérios de priorização (relevância: epidemiológica, nas políticas de saúde e na prática clínica; impacto: orçamentário no SUS, no custo para o serviço em saúde e na mortalidade; segurança, e aspectos legais, éticos e sociais). A análise de correspondência múltipla foi aplicada para mapear as preferências dos atores nos grupos e entre grupos. Dois grupos foram mais homogêneos entre si e determinantes para a seleção dos critérios de priorização. A influência da formação profissional foi maior que a institucional. A metodologia permitiu a seleção de critérios de forma transparente e a análise das preferências individuais dos participantes.

Abstract: Filtration and prioritization are two basics steps in horizon scanning systems. This article aimed to map stakeholders' preferences in the Brazilian Unified National Health System (SUS) regarding filtration and prioritization criteria. Two filtration criteria (time horizon and innovation) and eight prioritization criteria (relevance to epidemiology, health policies, and clinical practice; potential impact on SUS budget, healthcare providers' costs, and mortality; safety; and legal, ethical, and social aspects) were selected. Multiple correspondence analysis was used to map stakeholders' preferences within and between groups. Two groups were more homogeneous and determinant for selection of prioritization criteria. Stakeholders' professional experience had more influence than institutional affiliations. The approach showed transparent criteria selection and analysis of stakeholders' individual preferences.

Resumen: Dentro de las etapas básicas de un sistema de evaluación precoz de tecnologías emergentes se encuentran las etapas de filtrado y priorización. Este trabajo tiene por objetivo mapear las preferencias de diferentes actores estratégicos del Sistema Único de Salud brasileño (SUS) para los criterios de filtrado y priorización. Se seleccionaron dos criterios de filtrado (horizonte de tiempo e innovación) y ocho criterios de priorización (relevancia: epidemiológica, en las políticas de salud y en la práctica clínica; impacto: en el presupuesto del SUS, en el costo para el servicio de salud y en la mortalidad; seguridad, aspectos legales, éticos y sociales). Se realizó un análisis de correspondencia múltiple para mapear las preferencias de los actores por grupo y entre grupos. Dos de los grupos fueron más homogéneos entre sí y determinantes para la selección de criterios de priorización. La influencia que tuvo la experiencia profesional fue más decisiva que la influencia institucional. Esta metodología permitió seleccionar criterios de forma transparente y analizar las preferencias individuales.

Integrating Brazilian health information systems in order to support the building of data warehouses

AbstractIntroductionThis paper's aim is to develop a data warehouse from the integration of the files of three Brazilian health information systems concerned with the production of ambulatory and hospital procedures for cancer care, and cancer mortality. These systems do not have a unique patient identification, which makes their integration difficult even within a single system.MethodsData from the Brazilian Public Hospital Information System (SIH-SUS), the Oncology Module for the Outpatient Information System (APAC-ONCO) and the Mortality Information System (SIM) for the State of Rio de Janeiro, in the period from January 2000 to December 2004 were used. Each of the systems has the monthly data production compiled in dbase files (dbf). All the files pertaining to the same system were then read into a corresponding table in a MySQL Server 5.1. The SIH-SUS and APAC-ONCO tables were linked internally and with one another through record linkage methods. The APAC-ONCO table was linked to the SIM table. Afterwards a data warehouse was built using Pentaho and the MySQL database management system.ResultsThe sensitivities and specificities of the linkage processes were above 95% and close to 100% respectively. The data warehouse provided several analytical views that are accessed through the Pentaho Schema Workbench.ConclusionThis study presented a proposal for the integration of Brazilian Health Systems to support the building of data warehouses and provide information beyond those currently available with the individual systems.

Systematization of information for identifying similar cardiovascular implantable devices

Introduction The lack of a terminology to compare medical devices together with the arbitrary and opaque nature of product registration systems are major obstacles to a more informed decision process regarding the use and acquisition of new medical devices. This paper describes the systematization of information to help in the identification of similar cardiovascular implantable devices. Methods The systematization was developed in four stages: definition of the technical attributes of each device group; classification of a sample of devices; implementation of the proposed systematization in Protégé; and evaluation of the application. The systematization dealt with a set of common attributes – indication of use, anatomic location, manufacturer, device model and lifetime; and a set of attributes specific for each type of device. Results The systematization was performed by means of a hierarchy of classes with the respective properties in Protégé, which support three basic functions: data entry, query, and maintenance. 38 queries were designed to allow the identification of similar devices according to their technical characteristics. The users’ evaluation showed that the application fulfilled the requirements to monitor the price of these devices on the market. Conclusions Protégé was a useful tool for the systematization of cardiovascular implantable devices that can be used for the post-market vigilance of medical device safety. To better fulfill this aim, other attributes may be incorporated to better characterize the safety aspects of these devices.

Determinantes da detecção de atipias celulares no programa de rastreamento do câncer do colo do útero no Rio de Janeiro, Brasil / Determinants of cellular atypia detection in the cervical screening program in Rio de Janeiro, Brazil

OBJETIVO: Identificar os principais determinantes da detecção de atipias celulares no programa de rastreamento do câncer do colo do útero no Estado do Rio de Janeiro, utilizando os dados do Sistema de Informação do Câncer do Colo do Útero (SISCOLO). MÉTODOS: Uma amostra aleatória de 65 535 exames citopatológicos realizados em 2007 foi obtida do SISCOLO. Essa amostra foi utilizada para construir um modelo de regressão logística que identificasse variáveis com impacto no processo de detecção de atipias celulares. Foi aplicada uma curva ROC para definir o ponto de corte mais adequado para classificar a presença ou a ausência de atipias. Uma análise de sensibilidade foi realizada para avaliar o impacto dos fatores relacionados à organização do serviço no modelo. RESULTADOS: As variáveis preditoras do modelo foram: "laboratório de referência", que reflete a escala de produção do laboratório; "presença de elementos celulares representativos da zona de transformação", que reflete a qualidade da coleta de amostras; "metaplasia escamosa imatura", "presença de outras alterações celulares benignas" e "ausência de microrganismos da microbiota vaginal". A cada acréscimo de 1 ano na idade da mulher, houve redução de 1,7% na chance de detecção de atipias. A curva ROC definiu o ponto de corte de 4,5%, que permitiu a maximização da sensibilidade (73,0%) e especificidade (66,8%) do modelo. A análise de sensibilidade indicou aumento da frequência de atipias de 46,4% quando simulou-se aumento na participação do laboratório de referência (42,9%) e na presença de elementos celulares representativos da zona de transformação (43,0%). CONCLUSÕES: O modelo revelou que a detecção de atipias celulares é fortemente influenciado por fatores organizacionais, como adequabilidade da lâmina e porte do laboratório de análise. Considerando que esses fatores são passíveis de alteração pelos gestores, o modelo pode ser uma importante ferramenta na melhoria dos programas de rastreamento.

OBJECTIVE: To identify the main determinants of cellular atypia detection in the cervical screening program in the state of Rio de Janeiro, Brazil, using data from the Cervical Cancer Information System SISCOLO. METHODS: A random sample of 65 535 Pap smears performed in 2007 was obtained from SISCOLO. This sample was used to produce a logistic regression model to identify variables that impact the process of detecting cellular atypia. A ROC curve was used to define the most suitable cutoff point to classify the presence or absence of atypia. A sensitivity analysis was performed to assess the impact on the model of factors related to the organization of the service model. RESULTS: The variables of impact were "reference laboratory," which reflects laboratory production scale; "presence of cellular elements representative of the transformation zone," which reflects the quality of the sampling; "immature squamous metaplasia," "presence of other benign cellular changes," and "absence of typical vaginal microorganisms." Each increase of 1 year in age was associated with a 1.7% reduction in the chance of detecting atypia. The ROC curve defined a cutoff of 4.5%, which allowed the maximization of the model's sensitivity (73.0%) and specificity (66.8%). Sensitivity analysis indicated an increase of 46.4% in the frequency of atypia following a simulated increase in the number of samples analyzed in the excellence (42.9%) and in the presence of cellular elements representative of the transformation zone (43.0%). CONCLUSIONS: The model revealed that the detection of atypical cells is strongly influenced by organizational factors such as adequate sample collection and laboratory size. Because these factors can be changed by adequate management practices, the proposed model may be an important tool to improve cervical screening programs.

O desenvolvimento do monitoramento do horizonte tecnológico no mundo e a proposta brasileira / Development of horizon scanning system for emerging health technology and Braszilian proposal

Monitoramento do Horizonte Tecnológico (MHT) é uma das etapas de um sistema de avaliação de tecnologias em saúde que tem por finalidade identificar e monitorar tecnologias novas e emergentes com possibilidades de repercussão econômica, na prática clínica e na organização de serviços. A partir da década de 1980 começaram a ser desenvolvidos os Sistemas de MHT. Em 1999, foi criada a European Information Network on New and Emerging Health Technologies (EuroSacan), uma rede de colaboração internacional formada por dezoito agências.

Associação entre a qualidade da amostra e a detecção de atipias celulares no exame citopatológico do colo do útero / Detection of atypical cells associated with sample quality in cervical pap smear tests

Introdução: Estudos mostraram que a presença de elementos celulares representativos da zona de transformação do colo do útero na lâmina coletada para o exame citopatológico favorece a detecção das atipias celulares. Objetivo: Analisara associação entre a presença dos elementos celulares representativos da zona de transformação e a detecção de atipias celulares utilizando dados do Sistema de Informação do Câncer do Colo do Útero do Estado do Rio de Janeiro no período de junho de 2006 a dezembro de 2009. Método: Neste estudo retrospectivo, foi utilizada a variável “epitélios representados na amostra” para gerar um indicador da presença de elementos celulares representativos da zona detransformação. Esse indicador foi analisado quanto à sua associação com a variável “atipias celulares” (maior e menor gravidade). Resultados: Verificou-se que a chance de se encontrar atipias na presença de elementos celulares da zona de transformação foi 5,19 (5,10 - 5,28) vezes maior que na ausência. Considerando-se as atipias de maior gravidade, a chance de detecção na presença de elementos celulares da zona de transformação foi maior do que a observada em toda a amostra, sendo de 5,85 (5,62-6,08). Nos municípios, observou-se heterogeneidade nos percentuais de lâminas com representatividade da zona de transformação e de atipias. Conclusão: Evidenciou-se o potencial da base de dados para avaliar a diferença na detecção de atipias entre os grupos analisados, apontando a necessidade de esforços na elhoria da capacidade de obtenção de amostras com qualidade

[An information system to integrate outpatient cancer care data in the Unified National Health System]. / Sistema de informação para integrar os dados da assistência oncológica ambulatorial do Sistema Unico de Saúde.

This study focuses on the development of a system to integrate monthly outpatient cancer care data in the Unified National Health System (SUS). The system was modeled to retrace the treatment evolution in each cancer case and services output, with the following advantage: the system focuses on the cancer case, does not require knowledge by the user in order to handle the database, and allows updating the base as new data emerge. The results of direct queries in the system were identical to those obtained from direct inspection of the original database and those from another integration approach. The use of a tool with these characteristics by public administrators can help improve the quality of outpatient cancer care provided by the National Health System.

Sistema de informação para integrar os dados da assistência oncológica ambulatorial do Sistema Único de Saúde / An information system to integrate outpatient cancer care data in the Unified National Health System

Este trabalho visa ao desenvolvimento de um sistema para integrar os dados da produção mensal da assistência oncológica ambulatorial no Sistema Único de Saúde (SUS). O sistema foi modelado para recuperar a evolução do tratamento de cada caso de câncer e a produção dos serviços, tendo como vantagens: ser orientado ao caso de câncer, não requerer do usuário conhecimentos para a manipulação de bancos de dados e permitir a atualização da base à medida que novos dados vão surgindo. Os resultados das consultas ao sistema, quando comparados com os obtidos na inspeção direta da base original e com os obtidos com outra rotina de integração, foram idênticos. A utilização de uma ferramenta com essas características pelos gestores públicos pode contribuir para a melhoria da gestão da assistência oncológica ambulatorial prestada pelo SUS.

This study focuses on the development of a system to integrate monthly outpatient cancer care data in the Unified National Health System (SUS). The system was modeled to retrace the treatment evolution in each cancer case and services output, with the following advantage: the system focuses on the cancer case, does not require knowledge by the user in order to handle the database, and allows updating the base as new data emerge. The results of direct queries in the system were identical to those obtained from direct inspection of the original database and those from another integration approach. The use of a tool with these characteristics by public administrators can help improve the quality of outpatient cancer care provided by the National Health System.

[Pap smear screening for the control of cervical cancer in Minas Gerais State, Brazil, 2002]. / Perfil de produção do exame citopatológico para controle do câncer do colo do útero em Minas Gerais, Brasil, em 2002.

This article analyzes the implementation of Pap smears by the Cervical Cancer Control Program in 2002 in women 25-59 years of age residing in 850 municipalities (counties) in Minas Gerais State, Brazil. Cluster analysis was performed to classify municipalities by: number of Pap smears performed; test findings; and adequacy of slides. The variable "satisfactory slide, but limited by" was the principal factor for classifying municipalities into 5 clusters. Spatial representation of clusters indicated a more critical situation in the North, Jequitinhonha, Vale do Mucuri, and Vale do Rio Doce "meso-regions" of Minas Gerais and identified operational problems resulting from inadequate collection of material, with more "desiccated" slides observed in the North of the State and more slides with "absent endocervical cells" in the Center and South. The methodology allowed identifying clusters of municipalities with problems in the screening process, related to quality of sampling and fixing and reading of slides.

Perfil de produção do exame citopatológico para controle do câncer do colo do útero em Minas Gerais, Brasil, em 2002 / Pap smear screening for the control of cervical cancer in Minas Gerais State, Brazil, 2002

Neste trabalho estudou-se o perfil de produção do exame citopatológico (Papanicolaou) realizado pelo Programa de Controle do Câncer do Colo do Utero, no ano de 2002, em mulheres na faixa etária de 25 a 59 anos, residentes em 850 municípios do Estado de Minas Gerais, Brasil. A análise de agrupamento foi utilizada para classificar os municípios quanto à quantidade de exames citopatológicos realizados na população, às alterações encontradas nos exames e à adequabilidade das lâminas. A variável "lâmina satisfatória, mas limitada por" foi o principal fator de discriminação dos municípios em cinco grupos. A representação espacial desses grupos apontou uma situação mais crítica nas mesorregiões Norte, Jequitinhonha, Vale do Mucuri e Vale do Rio Doce; e problemas operacionais decorrentes da coleta inadequada de material, sendo observadas mais lâminas "dessecadas" ao norte do Estado e mais lâminas com "ausência de células endocervicais" do centro para o sul. A metodologia adotada permitiu identificar grupos de municípios com problemas na execução do programa quanto à qualidade da coleta de material, à fixação e à leitura da lâmina para o exame citopatológico.

This article analyzes the implementation of Pap smears by the Cervical Cancer Control Program in 2002 in women 25-59 years of age residing in 850 municipalities (counties) in Minas Gerais State, Brazil. Cluster analysis was performed to classify municipalities by: number of Pap smears performed; test findings; and adequacy of slides. The variable "satisfactory slide, but limited by" was the principal factor for classifying municipalities into 5 clusters. Spatial representation of clusters indicated a more critical situation in the North, Jequitinhonha, Vale do Mucuri, and Vale do Rio Doce "meso-regions" of Minas Gerais and identified operational problems resulting from inadequate collection of material, with more "desiccated" slides observed in the North of the State and more slides with "absent endocervical cells" in the Center and South. The methodology allowed identifying clusters of municipalities with problems in the screening process, related to quality of sampling and fixing and reading of slides.