Committees for ethics in research involving human subjects

In Brazil since October 1996 there have been guidelines for research involving human subjects. Now human subjects know when their treatment is part of research. Deceit is no longer tolerated. But is not enough to say we offer an explanation to the potential subject and we offer a choice before he or she is confronted with an informed consent form. As in all professional activity, scientific investigation needs social controls. In Brazil, the ultimate responsibility of an investigation lies on the investigator, but in every institution where research is carried out there is a Committee for Ethics in Research. All Committees are subordinated to the National Commission of Ethics in Research, which is submitted to the Brazilian Institute of Health. During 2005 around 17,000 protocols involving 700,000 human subjects were revised by 475 Committees distributed all over the country. Approximately 7,000 people are now working in these Committees.

Preliminary Criteria for Global Flares in Childhood-Onset Systemic Lupus Erythematosus

Objective. To develop widely acceptable preliminary criteria of global flare for childhood-onset systemic lupus erythematosus (cSLE).Methods. Pediatric rheumatologists (n = 138) rated a total of 358 unique patient profiles with information about the cSLE flare descriptors from 2 consecutive visits: patient global assessment of well-being, physician global assessment of disease activity (MD-global), health-related quality of life, anti-double-stranded DNA antibodies, disease activity index scores, protein: creatinine (P:C) ratio, complement levels, and erythrocyte sedimentation rate (ESR). Based on 2,996 rater responses about the course of cSLE (baseline versus followup), the accuracy (sensitivity, specificity, and area under the receiver operating characteristic curve) of candidate flare criteria was assessed. An international consensus conference was held to rank these candidate flare criteria as per the American College of Rheumatology recommendations for the development and validation of criteria sets.Results. The highest-ranked candidate criteria considered absolute changes (Delta) of the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) or British Isles Lupus Assessment Group (BILAG), MD-global, P:C ratio, and ESR; flare scores can be calculated (0.5 x Delta SLEDAI + 0.45 x Delta P:C ratio + 0.5 x Delta MD-global + 0.02 x Delta ESR), where values of >= 1.04 are reflective of a flare. Similarly, BILAG-based flare scores (0.4 x Delta BILAG + Delta 0.65 x Delta P:C ratio + 0.5 + Delta MD-global + 0.02 x Delta ESR) of >= 1.15 were diagnostic of a flare. Flare scores increased with flare severity.Conclusion. Consensus has been reached on preliminary criteria for global flares in cSLE. Further validation studies are needed to confirm the usefulness of the cSLE flare criteria in research and for clinical care.

Orofacial functions and quality of life in oral health in subjects with dentofacial deformity

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Qualidade de vida em mulheres com câncer de mama submetidas à cirurgia conservadora e mastectomia

Pós-graduação em Enfermagem - FMB

Developing a research agenda for promoting physical activity in Brazil through environmental and policy change

Objective. To identify the highest priorities for research on environmental and policy changes for promoting physical activity (PA) in Brazil; to uncover any gaps between researchers' and practitioners' priorities; and to consider which tools, methods, collaborative strategies, and actions could be useful to moving a research agenda forward.Methods. This was a mixed-methods study (qualitative and quantitative) conducted by Project GUIA (Guide for Useful Interventions for Activity in Brazil and Latin America) in February 2010-January 2011. A total of 240 individuals in the PA field (186 practitioners and 54 researchers) were asked to generate research ideas; 82 participants provided 266 original statements from which 52 topics emerged. Participants rated topics by "importance" and "feasibility;" a separate convenience sample of 21 individuals categorized them. Cluster analysis and multidimensional scaling were used to create concept maps and pattern matches.Results. Five distinct clusters emerged from the concept mapping, of which " effectiveness and innovation in PA interventions" was rated most important by both practitioners and researchers. Pattern matching showed a divergence between the groups, especially regarding feasibility, where there was no consensus.Conclusions. The study results provided the basis for a research agenda to advance the understanding of environmental and policy influences on PA promotion in Brazil and Latin America. These results should stimulate future research and, ultimately, contribute to the evidence-base of successful PA strategies in Latin America.

A identidade do agente comunitário de saúde: Uma abordagem fenomenológica

The structure of Brazil's National Health System (SUS) is being firmed up through programs adding a new element to its multi-professional healthcare teams: Community Healthcare Agents. This study examines psycho-social factors that are significant for the construction of this identity, from the standpoint of these Community Healthcare Agents, using the hermeneutic phenomenology of Paul Ricoeur as its reference methodology. The subjects of this survey were seven Community Healthcare Agents who were asked during interviews (with informed consent and after approval by the Research Ethics Committee) to: 'Tell me about your experience as Community Healthcare Agent'. The analysis of their replies indicated the following topics: previous experience; capacity-building for the job; bonding; building up expertise; gratifying experience; feelings of power(lessness); communications; daily work routines, personal growth; criticisms of the institution; user-agent experiences; and insertion into the social reality. The overall analysis disclosed the phenomenon through the convergence and divergence of the grouping of these topics, viewed from the standpoint of these Community Healthcare Agents and the psycho-social aspects constructing their identity.

Perfil demográfico, sócio-econômico e morbidade referida na população do município de Pratânia, SP

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Violência doméstica: o que se espera do profissional de saúde?

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Revelando o processo de recriação do banho no leito no cenário da terapia intensiva: produto da sustentabilidade da enfermagem em incorporar o conhecimento êmico a sua práxis

Pós-graduação em Enfermagem (mestrado profissional) - FMB

Reflexões sobre a idéia de sociedade civil global e a ação política não-estatal além das fronteiras

Pós-graduação em Relações Internacionais (UNESP - UNICAMP - PUC-SP) - FFC

Violência contra a criança: formação, conhecimento, percepção e atitude de profissionais da saúde e da educação

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Qualidade dos estudos clínicos publicados na RBGO ao longo de uma década (1999-2009): aspectos metodológicos, éticos e procedimentos estatísticos

OBJETIVO: Avaliar a evolução metodológica e do delineamento estatístico nas publicações da Revista Brasileira de Ginecologia e Obstetrícia (RBGO) a partir da resolução 196/96. MÉTODOS: Uma revisão de 133 artigos publicados nos anos de 1999 (65) e 2009 (68) foi realizada por dois revisores independentes com formação em epidemiologia clínica e metodologia da pesquisa científica. Foram incluídos todos os artigos clínicos originais, séries e relatos de casos, sendo excluídos os editoriais, as cartas ao editor, os artigos de revisão sistemática, os trabalhos experimentais, artigos de opinião, além dos resumos de teses e dissertações. Características relacionadas com a qualidade metodológica dos estudos foram analisadas por artigo, por meio de check-list que avaliou dois critérios: aspectos metodológicos e procedimentos estatísticos. Utilizou-se a estatística descritiva e o teste do χ2 para comparação entre os anos. RESULTADOS: Observa-se que houve diferença entre os anos de 1999 e 2009 no tocante ao desenho dos estudos e ao delineamento estatístico, demonstrando maior rigor nos respectivos procedimentos com o uso de testes mais robustos, relativamente, entre os anos de 1999 e 2009. CONCLUSÕES: Na RBGO, observou-se evolução metodológica dos artigos publicados entre os anos de 1999 e 2009 e aprofundamento nas análises estatísticas com o uso de testes mais sofisticados, como o uso mais frequente das análises de regressão e da análise multinível, que são técnicas primordiais na produção do conhecimento e planejamento de intervenções em saúde. Isso pode resultar em menos erros de interpretações.

Condições bacteriológicas da superfície das poltronas hematológicas par hemodiálise

Pós-graduação em Enfermagem (mestrado profissional) - FMB

Violence against children and adolescents: awareness and attitudes of Brazilian dentists

Violence against children and adolescents, ranging from negligence to sexual abuse, is an imperative public health problem. The ill treatments are considered as nonaccidental traumas, actions or omissions against children, who suffer physical or emotional violence. The main perpetrators are fathers, mothers, guardians, family, friends or the children‘s primary caretaker. It is very important to identify abuse cases, because this allows proper medical and legal intervention. In Brazil, the law n. 8.069, of July 13, 1990, known as the ECA -Statute for Children and Adolescents (SCA), stipulates the obligation to report suspected or confirmed cases of ill treatment against a child or adolescent to the Guardianship Council of the respective locality. The health professionals play a crucial role with regard to identifying cases of violence, collecting information, making early diagnosis of suspect cases and reporting such cases to the authorities. The dentists can contribute significantly, as most injuries occur in the orofacial region. Bite marks, burns, bruising, among others, are easily identified during a dental consultation. The aim of this work was to verify the awareness and attitudes of Brazilian dentists concerning violence against children and adolescents. This research was approved by the Research Ethics Committee of the Faculty of Dentistry of Araraquara – São Paulo State University (FOAr – UNESP). Sixty-three dentists answered an open and closed questionnaire concerning their formation, knowledge, experience and attitudes towards ill-treated children and adolescents. Among other results, thirty-nine dentists (61.9%) affirmed to have the means to identify illtreatment cases, 13 (20.6%) reported having some experience on this matter, but only 8 reported the cases to the Council of Guardianship, as determined by Brazilian law. Twenty percent of the reasons presented for not notifying the Council were fear of reprisal, and 60.0% were uncertain concerning the ethical and legal implications. Physical violence was the most reported form of identified violence (76.9%), followed by negligence (38.5%). Among the 13 professionals that had experience with violence cases, in 10 cases the perpetrators were identified – in 70.0% of the cases, the parents were the originators of such violence. It was concluded that further formation and orientation are necessary, in order to prepare dentists to act correctly when, during their professional activities, they encounter cases of violence against children and adolescents.