Aspectos éticos em estudos longitudinais: o caso do ELSA-Brasil

Historicamente a discussão acerca da eticidade dos atos em pesquisas com seres humanos privilegiou os estudos experimentais, pelo maior potencial de danos aos sujeitos envolvidos. Todavia, os estudos observacionais também envolvem riscos e suscitam questões relevantes. Neste artigo pretende-se apresentar e discutir aspectos éticos do desenvolvimento do ELSA-Brasil, um estudo longitudinal e multicêntrico, com financiamento público, no qual os sujeitos da pesquisa e pesquisadores pertencem às mesmas instituições. São descritos os procedimentos adotados para atender às exigências e compromissos éticos e a casuística que orientou as ações segundo seus princípios norteadores (beneficência, autonomia e justiça social). São apresentados alguns problemas morais que exigiram ponderação sobre riscos e benefícios na confluência com os objetivos do estudo e comentam-se peculiaridades de um estudo longitudinal e seus potenciais benefícios.

Questionário do ELSA-Brasil: desafios na elaboração de instrumento multidimensional

O artigo apresenta o processo de elaboração do questionário utilizado no Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil). Iniciamos pelo relato sobre a "Seleção de Temas" abordados no questionário, cujo conteúdo teria que abranger o conhecimento disponível acerca da complexa rede de causalidade dos desfechos de interesse, assim como possibilitar a comparabilidade com estudos semelhantes. Contextualizamos a "tradução e a adaptação de instrumentos de medida", necessárias no caso de escalas de avaliação de vizinhanças, do instrumento para diagnóstico de transtornos depressivos e de ansiedade, e do questionário de frequência alimentar. A seguir, comentamos os critérios que nortearam a "ordem dos blocos temáticos" e finalmente a importância prática dos "pré-testes e estudos-piloto". As relações entre o conjunto de informações reunidas no ELSA poderão constituir contribuição original sobre os fatores que causam ou agravam os desfechos de interesse no contexto brasileiro, assim como sobre seus fatores de proteção.

Adaptação transcultural e confiabilidade de medidas de características autorreferidas de vizinhança no ELSA-Brasil

OBJETIVO: Descrever o processo de adaptação de escalas de medida de características de vizinhança para o português brasileiro.MÉTODOS: As dimensões abordadas foram coesão social, ambiente propício para atividade física, disponibilidade de alimentos saudáveis, segurança em relação a crimes, violência percebida e vitimização. No processo de adaptação foram avaliados aspectos de equivalência entre as escalas originais e respectivas versões para o português. A confiabilidade teste-reteste foi avaliada em submostra de 261 participantes do Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil) que responderam ao mesmo questionário em dois momentos distintos em um intervalo de tempo de sete a 14 dias entre as duas aplicações.RESULTADOS: Os aspectos de equivalência avaliados mostraram-se adequados. O coeficiente de correlação intraclasse variou entre 0,83 (IC95% 0,78;0,87) para Coesão Social e 0,90 (IC95% 0,87;0,92) para Ambiente para Atividade Física. As escalas apresentaram consistência interna (alfa de Cronbach) que variaram entre 0,60 e 0,84.CONCLUSÕES: As medidas autorreferidas de características de vizinhança tiveram reprodutibilidade muito boa e boa consistência interna. Os resultados sugerem que essas escalas podem ser utilizadas em estudos com população brasileira que apresente características similares àquelas do ELSA-Brasil.

Capital social no ELSA-Brasil: confiabilidade teste-reteste do Resource Generator scale

OBJETIVO: Estimar a confiabilidade teste-reteste dos itens do Resource Generator scale para avaliação de capital social no Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil).MÉTODOS: A escala de capital social foi aplicada em subamostra de 281 participantes dos seis Centros de Investigação do ELSA, em duas oportunidades, com intervalo de sete a 14 dias. O instrumento é constituído por 31 itens que representam situações concretas para avaliar o acesso a diferentes tipos de recursos, além de avaliar a fonte dos recursos disponíveis (familiares, amigos ou conhecidos). A análise estatística foi realizada por meio de estatísticas kappa (k) e kappa ajustado pela prevalência (ka).RESULTADOS: Os recursos sociais investigados foram encontrados com grande frequência (acima de 50%). Em relação à presença ou ausência dos recursos, as estimativas de confiabilidade ajustadas pela prevalência (ka) variaram de 0,54 a 0,97. No que se refere à fonte de recurso, essas estimativas variaram de ka = 0,45 (alguém que tenha bons contatos com a mídia) a ka = 0,86 (alguém que se formou no Ensino Médio).CONCLUSÕES: A escala apresentou níveis adequados de confiabilidade, que variaram de acordo com o tipo de recurso.

Adolescência, comportamento sexual e fatores de risco à saúde

OBJETIVO : Analisar a relação entre comportamento sexual e fatores de risco à saúde física ou mental entre adolescentes. MÉTODOS : Estudo realizado com 3.195 escolares de 15 a 19 anos de idade, do segundo ano do ensino médio de escolas públicas e particulares das capitais de 10 estados do Brasil, em 2007-2008. Foi utilizada amostragem por conglomerados com multiestágio de seleção (escolas e alunos) em cada cidade e rede de ensino pública e particular. Foi aplicado questionário a todos os alunos selecionados, com os seguintes itens: dados socioeconômicos e demográficos; comportamento sexual; “transar” com pessoas do mesmo sexo, do sexo oposto ou de ambos os sexos; uso de bebida alcoólica e maconha; usar camisinha ao “transar”; presença de experiências sexuais traumáticas na infância ou adolescência; e ideação suicida. A análise incluiu descrição de frequências, teste de Qui-quadrado, análise de correspondência múltipla e de cluster. Foram analisadas qualitativamente, por análise dos conteúdos manifestos, as respostas a uma questão livre em que o adolescente expressou comentários gerais sobre si e sua vida. RESULTADOS : Cerca de 3,0% dos adolescentes referiu comportamento homossexual ou bissexual, sem diferenciação de sexo, idade, cor da pele, estrato social, estrutura familiar e rede de ensino. Adolescentes com comportamento homo/bissexual comparados aos heterossexuais relataram (p < 0,05): ficar de “porre” (18,7% e 10,5%, respectivamente), uso frequente de maconha (6,1% e 2,1%, respectivamente), ideação suicida (42,5% e 18,7%, respectivamente) e ter sido vítima de violência sexual (11,7% e 1,5%; respectivamente). Adolescentes com comportamento homo/bissexual relataram utilizar menos preservativo de forma frequente (74,2%) do que aqueles com comportamento heterossexual (48,6%, p < 0,001). Três grupos foram encontrados na análise de correspondência: composto por adolescentes com comportamento homo/bissexual e que vivenciava os fatores de risco: sofrer violência sexual, nunca utilizar camisinha ao “transar”, ideação suicida, uso frequente de maconha; composto por usuários ocasionais de maconha e camisinha e com frequentes “porres”; adolescentes com comportamento heterossexual e ausência dos fatores de risco investigados. Entre adolescentes com comportamento homo e bissexual, houve mais fatores de risco quando comparados àqueles com comportamento heterossexual. Os adolescentes com comportamento homo e bissexual expuseram mais suas vivências pessoais positivas e relacionamentos negativos do que seus pares heterossexuais, mas se expressaram menos sobre religiosidade. CONCLUSÕES : O tema não somente deve ser mais estudado como também devem ser ampliadas as ações preventivas voltadas aos adolescentes com relações afetivo-sexuais homo/bissexuais.

Non-adherence to telemedicine interventions for drug users: systematic review

OBJECTIVE To estimate rates of non-adherence to telemedicine strategies aimed at treating drug addiction. METHODS A systematic review was conducted of randomized controlled trials investigating different telemedicine treatment methods for drug addiction. The following databases were consulted between May 18, 2012 and June 21, 2012: PubMed, PsycINFO, SciELO, Wiley (The Cochrane Library), Embase, Clinical trials and Google Scholar. The Grading of Recommendations Assessment, Development and Evaluation was used to evaluate the quality of the studies. The criteria evaluated were: appropriate sequence of data generation, allocation concealment, blinding, description of losses and exclusions and analysis by intention to treat. There were 274 studies selected, of which 20 were analyzed. RESULTS Non-adherence rates varied between 15.0% and 70.0%. The interventions evaluated were of at least three months duration and, although they all used telemedicine as support, treatment methods differed. Regarding the quality of the studies, the values also varied from very poor to high quality. High quality studies showed better adherence rates, as did those using more than one technique of intervention and a limited treatment time. Mono-user studies showed better adherence rates than poly-user studies. CONCLUSIONS Rates of non-adherence to treatment involving telemedicine on the part of users of psycho-active substances differed considerably, depending on the country, the intervention method, follow-up time and substances used. Using more than one technique of intervention, short duration of treatment and the type of substance used by patients appear to facilitate adherence.

Institutional and matrix support and its relationship with primary healthcare

OBJECTIVE To analyze whether the level of institutional and matrix support is associated with better certification of primary healthcare teams.METHODS In this cross-sectional study, we evaluated two kinds of primary healthcare support – 14,489 teams received institutional support and 14,306 teams received matrix support. Logistic regression models were applied. In the institutional support model, the independent variable was “level of support” (as calculated by the sum of supporting activities for both modalities). In the matrix support model, in turn, the independent variables were the supporting activities. The multivariate analysis has considered variables with p < 0.20. The model was adjusted by the Hosmer-Lemeshow test.RESULTS The teams had institutional and matrix supporting activities (84.0% and 85.0%), respectively, with 55.0% of them performing between six and eight activities. For the institutional support, we have observed 1.96 and 3.77 chances for teams who had medium and high levels of support to have very good or good certification, respectively. For the matrix support, the chances of their having very good or good certification were 1.79 and 3.29, respectively. Regarding to the association between institutional support activities and the certification, the very good or good certification was positively associated with self-assessment (OR = 1.95), permanent education (OR = 1.43), shared evaluation (OR = 1.40), and supervision and evaluation of indicators (OR = 1.37). In regards to the matrix support, the very good or good certification was positively associated with permanent education (OR = 1.50), interventions in the territory (OR = 1.30), and discussion in the work processes (OR = 1.23).CONCLUSIONS In Brazil, supporting activities are being incorporated in primary healthcare, and there is an association between the level of support, both matrix and institutional, and the certification result.

Specialized care for people with AIDS in the state of Ceara, Brazil

OBJECTIVE To analyze if the distribution of specialized care services for HIV/AIDS is associated with AIDS rates. METHODS Ecological study, for which the distribution of 10 specialized care services in the Ceara state, Northeastern Brazil, was obtained, and the mean rates of the disease were estimated per mesoregion. We evaluated 7,896 individuals who had been diagnosed with AIDS, were aged 13 years or older, lived in Ceara, and had been informed of their condition between 2001 and 2011. Maps were constructed to verify the relationship between the distribution of AIDS cases and institutionalized support networks in the 2001-2006 and 2007-2011 periods. BoxMap and LisaMap were used for data analysis. The Voronoi diagram was applied for the distribution of the studied services. RESULTS Specialized care services concentrated in AIDS clusters in the metropolitan area. The Noroeste Cearense and west of the Sertoes Cearenses had high AIDS rates, but a low number of specialized care services over time. Two of these services were implemented where clusters of the disease exist in the second period. The application of the Voronoi diagram showed that the specialized care services located outside the metropolitan area covered a large territory. We identified one polygon that had no services. CONCLUSIONS The scenario of AIDS cases spread away from major urban areas demands the creation of social support services in areas other than the capital and the metropolitan area of the state; this can reduce access barriers to these institutions. It is necessary to create specialized care services for HIV/AIDS in the Noroeste Cearense and north of Jaguaribe.

Validation of an instrument to evaluate health promotion at schools

ABSTRACT OBJECTIVE To validate an instrument designed to assess health promotion in the school environment. METHODS A questionnaire, based on guidelines from the World Health Organization and in line with the Brazilian school health context, was developed to validate the research instrument. There were 60 items in the instrument that included 40 questions for the school manager and 20 items with direct observations made by the interviewer. The items’ content validation was performed using the Delphi technique, with the instrument being applied in 53 schools from two medium-sized cities in the South region of Brazil. Reliability (Cronbach’s alpha and split-half) and validity (principal component analysis) analyses were performed. RESULTS The final instrument remained composed of 28 items, distributed into three dimensions: pedagogical, structural and relational. The resulting components showed good factorial loads (> 0.4) and acceptable reliability (> 0.6) for most items. The pedagogical dimension identifies educational activities regarding drugs and sexuality, violence and prejudice, auto care and peace and quality of life. The structural dimension is comprised of access, sanitary structure, and conservation and equipment. The relational dimension includes relationships within the school and with the community. CONCLUSIONS The proposed instrument presents satisfactory validity and reliability values, which include aspects relevant to promote health in schools. Its use allows the description of the health promotion conditions to which students from each educational institution are exposed. Because this instrument includes items directly observed by the investigator, it should only be used during periods when there are full and regular activities at the school in question.

Hospitalization due to drug use did not change after a decade of the Psychiatric Reform

ABSTRACT OBJECTIVE To investigate whether the psychiatric hospitalization rates due to use of psychoactive substances and average time of hospitalization suffered any changes after the first decade of effective implementation of the psychiatric reform in Brazil. METHODS This article examines the evolution of hospitalizations due to disorders arising from the use of alcohol or other substances in the state of Santa Catarina, Southern Brazil, from 2000 to 2012. This is an ecological, time-series study, which uses data from admissions obtained by the Informatics Service of the Brazilian Unified Health System. Hospitalization rates by 100,000 inhabitants and average time of occupancy of beds were estimated. Coefficients of variation of these rates were estimated by Poisson Regression. RESULTS The total and male hospitalization rates did not vary (p = 0.056 and p = 0.244, respectively). We observed an increase of 3.0% for the female sex (p = 0.049). We did not observe any significant variation for occupancy time of beds. CONCLUSIONS The deployment of services triggered by the Brazilian psychiatric reform was not accompanied by a reduction of hospitalization rates or mean occupancy time of hospitalized patients during this first decade of implementation of the reform.

Difficulties in access and estimates of public beds in intensive care units in the state of Rio de Janeiro

ABSTRACT OBJECTIVE To estimate the required number of public beds for adults in intensive care units in the state of Rio de Janeiro to meet the existing demand and compare results with recommendations by the Brazilian Ministry of Health. METHODS The study uses a hybrid model combining time series and queuing theory to predict the demand and estimate the number of required beds. Four patient flow scenarios were considered according to bed requests, percentage of abandonments and average length of stay in intensive care unit beds. The results were plotted against Ministry of Health parameters. Data were obtained from the State Regulation Center from 2010 to 2011. RESULTS There were 33,101 medical requests for 268 regulated intensive care unit beds in Rio de Janeiro. With an average length of stay in regulated ICUs of 11.3 days, there would be a need for 595 active beds to ensure system stability and 628 beds to ensure a maximum waiting time of six hours. Deducting current abandonment rates due to clinical improvement (25.8%), these figures fall to 441 and 417. With an average length of stay of 6.5 days, the number of required beds would be 342 and 366, respectively; deducting abandonment rates, 254 and 275. The Brazilian Ministry of Health establishes a parameter of 118 to 353 beds. Although the number of regulated beds is within the recommended range, an increase in beds of 122.0% is required to guarantee system stability and of 134.0% for a maximum waiting time of six hours. CONCLUSIONS Adequate bed estimation must consider reasons for limited timely access and patient flow management in a scenario that associates prioritization of requests with the lowest average length of stay.

Depressão humoral específica em pacientes crônicos infectados pelo Trypanosoma cruzi

Realizamos um estudo comparativo entre o xenodiagnóstico e os testes sorológicos para a doença de Chagas. Cento e cincoenta pacientes de algumas áreas endêmicas foram estudados. Quatro deles pareceram revelar um estado particular com um xenodiagnóstico positivo e uma sorologia negativa, esta realizada com quatro diferentes técnicas clássicas (teste de immunofluorescência, ELISA: Enzyme Linked Immunosorbent Assay, teste de fixação do complemento e teste de immuno-eletroforese). O soro de um dos pacientes que apresentou depressão humoral específica mostra elevada quantidade de antígenos circulantes comprovada pela técnica da immuno-eletroforese. Os Autores sugerem o uso de um teste sorológico para detectar a presença de antígenos circulantes de T. cruzi, além da utilização de testes sorológicos clássicos. Isto permitiria o diagnóstico da doença de Chagas em pacientes com uma baixa (ou mesmo inexistente) produção de anticorpos específicos.

Trypanosoma cruzi: expression of antigenic component 5 among 35 laboratory clones obtained from 18 different isozymic variants

Two monoclonal antibodies anti-component 5 of Trypanosoma cruzi (I-35/115 and II-190/30) were tested in IFA and ELISA respectively against 35 T. cruzi laboratory clones. Among the 35 clones tested, 18 different isozyme patterns were detected. All clones were recognized by both monoclonal antibodies except one clone which did not react with II-190/30. These results support the universal expression of specific component 5 within the taxon T. cruzi.

Prevalence of HTLV-I and HTLV-II infections among HIV-1-infected asymptomatic individuals in São Paulo, Brazil

Human immunodeficiency virus (HIV-1)-infected subjects with acquired immunodeficiency syndrome (AIDS) are often infected with multiple pathogens. In particular, HTLV-I and HTLV-II infections have been found more frequently in AIDS patients than in asymptomatic individuals in Europe and Japan. We carried out a serosurvey among asymptomatic HIV-1-infected subjects in São Paulo, Brazil and compared our results with those of other investigators. In this study, we found HTLV infection in 1.5% of 266 asymptomatic and 14% of 28 AIDS patients. Epidemiological data obtained from patients pointed out the use of intravenous drugs as the principal risk factor for acquiring retroviruses. In conclusion, our results are in accordance with other studies done in Brazil and elsewhere where the principal risk group for HIV/HTLV-I/II coinfection was IDU

Histoplasmin reaction. Comparison of a polysaccharide antigen to the filtrate antigen

This work was planned by taking into account all the knowledge accumulated from the immunological study of paracoccidioidomycosis. It aimed at comparing a polysaccharide antigen from Histoplasma capsulatum to a classic histoplasmin with the help of intradermal tests of delayed type of hypersensitivity. Tests were applied to 115 individuals in Santo Amaro, a town in the state of São Paulo. Positive results using classic histoplasmin were obtained in 46.0% cases whereas positive results using the polysaccharide antigen at its hightest concentration were obtained in 51.30% cases. The major conclusion in this investigation is that it is possible to use the polysaccharide antigen as histoplasmin instead of the filtrate antigen