Resumo Objetivo Avaliar o conhecimento, atitude e prática de médicos brasileiros sobre a inserção de dispositivos intrauterinos no pós-parto e pós-aborto imediatos. Métodos Estudo transversal com inquérito online envolvendo médicos plantonistas de hospitais públicos brasileiros. Os participantes responderam a um questionário anônimo com perguntas fechadas para avaliar seu conhecimento, atitude e experiência sobre a inserção de dispositivos intrauterinos de cobre no pós-parto e pós-aborto imediatos. Resultados Cento e vinte sete médicos de 23 hospitais localizados nas 5 regiões do Brasil preencheram o questionário. A maioria era do sexo feminino (68,5%) e trabalhava em hospitais de ensino (95,3%). O escore médio (desvio padrão) de conhecimento (escala 0–10) foi 5,3 (1,3); apenas 27,6% tiveram escore ≥7,0. A maioria (73,2%) faria inserção de dispositivo intrauterino no pós-parto imediato em si mesma/familiares. Cerca de 42% dos participantes declararam não ter recebido nenhum treinamento sobre inserção de dispositivos intrauterinos no pós-parto ou pós-aborto imediatos. Nos últimos 12 meses, 19,7%, 22,8% e 53,5% declararam não ter inserido nenhum dispositivo intrauterino durante uma cesárea, após um parto vaginal ou um aborto, respectivamente. Conclusão A maioria dos participantes tem uma atitude positiva em relação à inserção de dispositivos intrauterinos no pós-parto imediato, porém tem um conhecimento limitado sobre esse método. Uma grande porcentagem dos respondentes não teve treinamento sobre inserção de dispositivos intrauterinos no pós-parto ou pós-aborto imediatos e não fez nenhuma inserção desse tipo nos últimos 12 meses. São necessárias estratégias para melhorar o conhecimento, o treinamento e a experiência dos médicos brasileiros sobre a inserção de dispositivos intrauterinos no pós-parto e pós-aborto imediatos. pósparto pós pósaborto aborto 2 68,5% 685 68 (68,5% 95,3%. 953 95,3% . 95 3 (95,3%) desvio padrão escala 0–10 010 0 10 53 5, 1,3 13 1 (1,3) 276 27 6 27,6 70 7 ≥7,0 73,2% 732 73 (73,2% mesmafamiliares mesma familiares mesma/familiares 42 meses 197 19 19,7% 228 22 8 22,8 535 53,5 cesárea respectivamente método 68,5 (68,5 95,3 9 (95,3% 0–1 01 1, (1,3 27, ≥7, 73,2 (73,2 4 19,7 22, 53, 68, (68, 95, (95,3 0– (1, ≥7 73, (73, 19, (68 (95, (1 ≥ (73 (6 (95 ( (7 (9

Abstract Objective To assess the knowledge, attitude, and practice of Brazilian physicians about immediate postpartum and postabortion intrauterine device insertion. Methods Cross-sectional online survey involving physicians on duty in public Brazilian hospitals. Participants answered an anonymous questionnaire with close-ended questions to assess their knowledge, attitude, and experience on the immediate postpartum and postabortion insertion of copper intrauterine devices. Results One hundred twenty-seven physicians working in 23 hospitals in the 5 geographic regions of Brazil completed the questionnaire. Most were female (68.5%) and worked in teaching hospitals (95.3%). The mean (standard deviation) knowledge score (0–10 scale) was 5.3 (1.3); only 27.6% of the participants had overall scores ≥7.0. Most physicians (73.2%) would insert a postpartum intrauterine device in themselves/family members. About 42% of respondents stated that they had not received any training on postpartum or postabortion intrauterine device insertion. In the past 12 months, 19.7%, 22.8%, and 53.5% of respondents stated they had not inserted any intrauterine device during a cesarean section, immediately after a vaginal delivery, or after an abortion, respectively. Conclusion Most study participants have a positive attitude toward the insertion of intrauterine devices in the immediate postpartum period, but they have limited knowledge about the use of this contraceptive method. A large percentage of respondents did not have previous training on postpartum and postabortion intrauterine device insertion and had not performed any such insertions in the last 12 months. Strategies are needed to improve the knowledge, training, and experience of Brazilian physicians on immediate postpartum and postabortion intrauterine device insertion. Crosssectional Cross sectional closeended close ended twentyseven twenty seven 2 68.5% 685 68 (68.5% 95.3%. 953 95.3% . 95 3 (95.3%) standard deviation 0–10 010 0 10 (0–1 scale 53 5. 1.3 13 1 (1.3) 276 27 6 27.6 70 7 ≥7.0 73.2% 732 73 (73.2% themselvesfamily themselves family members 42 months 197 19 19.7% 228 22 8 22.8% 535 53.5 section delivery abortion respectively period method 68.5 (68.5 95.3 9 (95.3% 0–1 01 (0– 1. (1.3 27. ≥7. 73.2 (73.2 4 19.7 22.8 53. 68. (68. 95. (95.3 0– (0 (1. ≥7 73. (73. 19. 22. (68 (95. ( (1 ≥ (73 (6 (95 (7 (9

SUMMARY OBJECTIVE: The aim of this study was to investigate and compare the sexual function of Brazilian adolescents and young women who were using popular contraceptive methods. METHODS: This cross-sectional study took place in 2012–2014 in a free family planning clinic of a tertiary teaching hospital in Brazil. Participants were female adolescents (10–19 years) and young adults (20–24 years) who were using barrier (condom) or hormonal contraceptive methods. The Female Sexual Function Index questionnaire was used to assess the sexual function in the last 4 weeks. RESULTS: A total of 199 women (128 adolescents and 71 young adults) were included. There were no significant differences in the mean total Female Sexual Function Index scores of adolescents and young adults (26.6±5.7 versus 27.6±6.2, respectively, p=0.264). Compared to young adults, adolescents had significantly lower mean scores for orgasm (3.9±1.5 versus 4.4±1.4, p=0.020) and dyspareunia (4.4±1.6 versus 5.2±1.5, p=0.001; lower scores indicate more dyspareunia). There were no significant differences in the proportion of adolescents versus adults classified as being at risk for sexual dysfunction (38.3 versus 42.3%, p=0.651) or at risk of low desire (18.0 versus 21.1%, p=0.579). CONCLUSION: Nearly 40% of Brazilian female adolescents and young adults are at risk for sexual dysfunctional symptoms and 19% have low desire, without significant differences between the two age groups.

Resumo Objetivo Nós realizamos uma revisão sistemática para avaliar a efetividade e a segurança do Tribulus terrestris no tratamento da disfunção sexual feminina (DSF). Fontes de dados Nós realizados uma busca eletrônica irrestrita nas seguintes bases de dados: MEDLINE, CENTRAL, EMBASE, LILACS, CINAHL, PsycINFO, WHO-ICTR, Clinicaltrials.gov, e OpenGrey. Seleção dos estudos Nós incluímos todos os ensaios clínico randomizados (ECR) que comparou T. terrestris com controles ativos/inativos. Após o processo de seleção, conduzido por 2 revisores, 5 ECRs (n = 279 participantes) foram incluídos. Extração de dados O processo de extração de dados foi realizado por dois revisores, utilizando-se um formulário de extração de dados pré-estabelecido. Síntese de dados Devido à falta de dados disponíveis e à heterogeneidade clínica entre os estudos incluídos, nós não realizamos meta-análises. O risco de viés foi avaliado pela tabela de risco de viés da Cochrane e, a certeza do corpo da evidência foi avaliada pelo Grading of Recommendations, Assessment, Development and Evaluations (GRADE). Resultados Após 1 a três 3 meses de tratamento, mulheres na pré e pós-menopausa randomizadas ao T. terrestris tiveram um aumento significante nos escores de função sexual. O grupo com 3 meses de tratamento com T. terrestris exibiu um aumento significante dos níveis séricos de testosterona emmulheres pré-menopausa. Não houve relato de eventos adversos graves, e nenhum estudo avaliou qualidade de vida das participantes. A certeza da evidência foi considerada muito baixa, o que significa que existe pouca certeza na estimativa dos efeitos e que é provável que futuros estudos mudem estas estimativas. Conclusão Mais ECRs são importantes para apoiar ou refutar o uso do T. terrestris. A decisão de usar essa intervenção deve ser compartilhada com pacientes, e as incertezas sobre seus efeitos devem ser discutidas durante o processo de decisão clínica.

Abstract Objective We performed a systematic review to assess the effectiveness and safety of Tribulus terrestris to treat female sexual dysfunction (FSD). Data sources We performed unrestricted electronic searches in the MEDLINE, CENTRAL, EMBASE, LILACS, CINAHL, PsycINFO,WHO-ICTR, Clinicaltrials.gov and OpenGrey databases. Selection of studies We included any randomized controlled trials (RCTs) that compared T. terrestris versus inactive/active interventions. After the selection process, conducted by two reviewers, 5 RCTs (n = 279 participants) were included. Data collection Data extraction was performed by two reviewers with a preestablished data collection formulary. Data synthesis Due to lack of data and clinical heterogeneity, we could not perform meta-analyses. The risk of bias was assessed by the Cochrane Risk of Bias (RoB) tool, and the certainty of evidence was assessed with Grading of Recommendations, Assessment, Development and Evaluations (GRADE). Results After 1 to 3 months of treatment, premenopausal and postmenopausal women randomized to T. terrestris had a significant increase in sexual function scores. Three months of treatment with T. terrestris showed a significant increase in the serum testosterone levels of premenopausal women. There was no report of serious adverse events, and none of the studies assessed health-related quality of life. The certainty of the evidence was very low, whichmeans that we have very little confidence in the effect estimates, and future studies are likely to change these estimates. Conclusion MoreRCTs are needed to supportor refute the use of T. terrestris. The decision to use this intervention should be shared with the patients, and the uncertainties around its effects should be discussed in the clinical decision-making process. Number of Protocol registration in PROSPERO database: CRD42019121130

ABSTRACT BACKGROUND: This study identified and summarized all Cochrane systematic reviews (SRs) on the effects of ten integrative practices that were recently added to the Brazilian public healthcare system (SUS). DESIGN AND SETTING: Review of systematic reviews, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (Unifesp). METHODS: Review of Cochrane SRs on the following interventions were identified, summarized and critically assessed: apitherapy, aromatherapy, bioenergetics, family constellation, flower therapy, chromotherapy, geotherapy, hypnotherapy, hand imposition or ozone therapy. RESULTS: We included a total of 16 SRs: 4 on apitherapy, 4 on aromatherapy, 6 on hypnotherapy and 2 on ozone therapy. No Cochrane SR was found regarding bioenergetics, family constellation, chromotherapy, clay therapy, flower therapy or hand imposition. The only high-quality evidence was in relation to the potential benefit of apitherapy, specifically regarding some benefits from honey dressings for partial healing of burn wounds, for reduction of coughing among children with acute coughs and for preventing allergic reactions to insect stings. CONCLUSION: Except for some specific uses of apitherapy (honey for burn wounds and for acute coughs and bee venom for allergic reactions to insect stings), the use of ten integrative practices that have recently been incorporated into SUS does not seem to be supported by evidence from Cochrane SRs.

Resumo Objetivo: avaliar a cobertura, completude e confiabilidade das informações sobre nascidos vivos em maternidades da rede pública de São Paulo-SP, Brasil. Métodos: comparou-se o Sistema de Informações sobre Nascidos Vivos (Sinasc), ao estudo de avaliação, considerado padrão ouro, realizado por três meses em 2011, cujos dados foram coletados em quatro maternidades/SUS; calculou-se o coeficiente kappa para avaliar concordância. Resultados: analisaram-se 5.785 registros de nascimentos; a cobertura do Sinasc foi de 99,8% sobre o total de nascimentos e a completude, 96,2%; os valores kappa mostraram concordâncias excelente e boa para idade materna (0,99), tipo de gravidez, sexo e peso (0,98), tipo de parto (0,97), Apgar no 1º (0,96) e 5º minutos (0,95), filhos tidos vivos (0,87) e escolaridade (0,62), concordância moderada para consultas de pré-natal (0,60) e duração de gestação (0,56), e concordância fraca para filhos tidos mortos (0,09). Conclusão: nos hospitais avaliados, o Sinasc apresentou elevadas cobertura, completude e confiabilidade.

Abstract Objective: to assess the coverage, completeness and reliability of data on live births in public maternity wards in São Paulo, Brazil. Methods: data recorded in the Information System on Live Births (Sinasc) were compared with data collected in a field study (gold standard) during three months in 2011 in four maternity wards in hospital from the SUS network; kappa coefficient was calculated to assess agreement. Results: 5,785 birth records were analyzed; Sinasc coverage was 99.8% and completeness was 96.2%; kappa values showed excellent and good agreement for maternal age (0.99), type of pregnancy, sex and newborn sex and birth weight (0.98), type of delivery (0.97), 1 minute (0.96) and 5th (0.95) minutes, previous live births (0.87) and education level (0.62); regular agreement for prenatal care visits (0.60) and gestational age (0.56); and weak agreement for previous stillbirths (0.09). Conclusion: in the assessed hospitals, Sinasc presented high coverage, completeness and reliability.

Resumen Objetivo: evaluar la cobertura, conformidad documental y confiabilidad de informaciones sobre nacidos vivos en maternidades de la red pública de la ciudad de São Paulo-SP, Brasil. Métodos: se comparó el sistema de informaciones de nacidos vivos al estudio de evaluación, considerado padrón oro, realizado por tres meses en 2011, cuyos datos fueron colectados en cuatro maternidades/SUS; se calculó el coeficiente kappa para evaluar la concordancia. Resultados: se analizaron 5.785 registros de nacimientos; la cobertura Sinasc fue 99,8% del total de nacimientos, y la conformidad documental, 96,2%; las estadísticas de kappa mostraron concordancia excelente y buena para edad materna (0,99), tipo de embarazo, sexo y peso (0,98), tipo de parto (0,97), Apgar en el 1º (0,96) y 5º minutos (0,95), hijos vivos (0,87) y escolaridad (0,62), concordancia moderada para consultas de prenatal (0,60) y duración de gestación (0,56), y concordancia débil para hijos muertos (0,09). Conclusión: en los hospitales analizados, el Sinasc presentó alto grado de cobertura, conformidad documental y confiabilidad.

Resumo Objetivo: avaliar a cobertura, completude e confiabilidade das informações sobre nascidos vivos em maternidades da rede pública de São Paulo-SP, Brasil. Métodos: comparou-se o Sistema de Informações sobre Nascidos Vivos (Sinasc), ao estudo de avaliação, considerado padrão ouro, realizado por três meses em 2011, cujos dados foram coletados em quatro maternidades/SUS; calculou-se o coeficiente kappa para avaliar concordância. Resultados: analisaram-se 5.785 registros de nascimentos; a cobertura do Sinasc foi de 99,8% sobre o total de nascimentos e a completude, 96,2%; os valores kappa mostraram concordâncias excelente e boa para idade materna (0,99), tipo de gravidez, sexo e peso (0,98), tipo de parto (0,97), Apgar no 1º (0,96) e 5º minutos (0,95), filhos tidos vivos (0,87) e escolaridade (0,62), concordância moderada para consultas de pré-natal (0,60) e duração de gestação (0,56), e concordância fraca para filhos tidos mortos (0,09). Conclusão: nos hospitais avaliados, o Sinasc apresentou elevadas cobertura, completude e confiabilidade.

Abstract Objective: to assess the coverage, completeness and reliability of data on live births in public maternity wards in São Paulo, Brazil. Methods: data recorded in the Information System on Live Births (Sinasc) were compared with data collected in a field study (gold standard) during three months in 2011 in four maternity wards in hospital from the SUS network; kappa coefficient was calculated to assess agreement. Results: 5,785 birth records were analyzed; Sinasc coverage was 99.8% and completeness was 96.2%; kappa values showed excellent and good agreement for maternal age (0.99), type of pregnancy, sex and newborn sex and birth weight (0.98), type of delivery (0.97), 1 minute (0.96) and 5th (0.95) minutes, previous live births (0.87) and education level (0.62); regular agreement for prenatal care visits (0.60) and gestational age (0.56); and weak agreement for previous stillbirths (0.09). Conclusion: in the assessed hospitals, Sinasc presented high coverage, completeness and reliability.

Resumen Objetivo: evaluar la cobertura, conformidad documental y confiabilidad de informaciones sobre nacidos vivos en maternidades de la red pública de la ciudad de São Paulo-SP, Brasil. Métodos: se comparó el sistema de informaciones de nacidos vivos al estudio de evaluación, considerado padrón oro, realizado por tres meses en 2011, cuyos datos fueron colectados en cuatro maternidades/SUS; se calculó el coeficiente kappa para evaluar la concordancia. Resultados: se analizaron 5.785 registros de nacimientos; la cobertura Sinasc fue 99,8% del total de nacimientos, y la conformidad documental, 96,2%; las estadísticas de kappa mostraron concordancia excelente y buena para edad materna (0,99), tipo de embarazo, sexo y peso (0,98), tipo de parto (0,97), Apgar en el 1º (0,96) y 5º minutos (0,95), hijos vivos (0,87) y escolaridad (0,62), concordancia moderada para consultas de prenatal (0,60) y duración de gestación (0,56), y concordancia débil para hijos muertos (0,09). Conclusión: en los hospitales analizados, el Sinasc presentó alto grado de cobertura, conformidad documental y confiabilidad.

Resumo As revisões sistemáticas são consideradas o mais alto nível de evidência para a tomada de decisão em questões de cuidados de saúde. Um dos primeiros passos de uma RS envolve a identificação de todos ensaios clínicos relevantes sobre o tema de interesse. Porém, a recuperação de ensaios clínicos em uma base de dados, depende em parte da qualidade da indexação. O objetivo deste artigo é avaliar a adequação da indexação dos ensaios clínicos como tipo de publicação na base de dados LILACS, em uma amostra de artigos publicados em periódicos de cardiologia. Estudo transversal de análise da indexação dos ensaios clínicos publicados entre 2008-2009 em periódicos de cardiologia na LILACS. Duas revisoras identificaram e reclassificaram, de forma independente, todos os estudos publicados nesses periódicos e compararam sua classificação tipo de publicação com a indexação LILACS. Foram incluídos 721 artigos publicados em 11 periódicos. Os revisores classificaram 63 artigos como ensaios clínicos; 44 desses haviam sido corretamente indexados na LILACS, enquanto 19 tinham sido indexados como outros tipos de estudos (falsos negativos). As revisoras classificaram 658 estudos como não ensaios clínicos; 651 haviam sido corretamente indexados como não ensaios clínicos na LILACS e 7 haviam sido indexados como ensaios clínicos na LILACS (falsos positivos). A sensibilidade, especificidade e a acurácia da indexação LILACS foram de 69,8%, 98,9% e 96,4% (695/721), respectivamente. Quase um terço dos ensaios clínicos em periódicos de cardiologia da LILACS não está corretamente indexado. É necessário melhorar a qualidade da indexação dos estudos publicados nesses periódicos.

Abstract Systematic reviews are considered the highest level of evidence for decision making in health care issues. One of the first steps of a SR involves identifying all relevant clinical trials on the topic of interest. However, the retrieval of clinical trials in a database partially depends on the article indexing quality. The aim of this article is to evaluate the adequacy of indexing of clinical trials as a publication type in the LILACS database in a sample of articles published in cardiology journals. This cross-sectional study analyzed the indexing quality of clinical trials published between 2008 and 2009 in cardiology journals indexed in LILACS. Two independent reviewers identified and reclassified all original studies published in these journals as being clinical trials or other types of studies. The result of their classification was compared with the indexing publication type produced by LILACS. A total of 721 articles published in 11 cardiology journals were included. The reviewers classified 63 articles as clinical trials; 44 of these were correctly indexed in LILACS, while 19 were indexed as other types of studies (false negatives). The reviewers classified 658 articles as non-clinical trials; 651 were correctly indexed and 7 were incorrectly indexed in LILACS as being clinical trials (false positives). The sensitivity, specificity and global accuracy of LILACS indexing were 69.8%, 98.9% and 96.4% (695/721), respectively. Almost one third of the clinical trials published in LILACS-indexed Cardiology journals are not adequately indexed. The indexing quality of the studies published in these journals must be improved.

Resumo Objetivos Relatar a experiência de um curso de educação a distância sobre questões sexuais na gestação e puerpério para médicos residentes. Métodos Estudo prospectivo de intervenção educacional, realizado entre abril e setembro de 2014, por investigadores da Universidade Federal de São Paulo. Os participantes foram 219 médicos (R1 a R6). O curso teve carga horária de 24 horas (10 videoaulas e discussões online). No início do curso, os participantes responderam perguntas sobre treinamento, atitude e prática relativas a questões sexuais na gestação; antes e após o curso, responderam perguntas de conhecimento sobre o tema; ao final, preencheram questionário sobre a qualidade do curso. O teste t de Student foi utilizado para comparar os testes de conhecimento, antes e após o curso; valores de p < 0,05 foram considerados estatisticamente significantes. Resultados Um total de 143 residentes concluiu o curso; a maioria estava no 1° (27,2%) ou 3° (29,4%) anos de residência. Houve aumento significativo nas notas médias dos questionários que avaliavam o conhecimento sobre o tema: 4,4 (1,6) versus 6,0 (1,3; nota máxima: 10), no início e final do curso, respectivamente (p < 0,0001). A maioria dos participantes (74,1%) declarou que a qualidade geral do curso atingiu suas expectativas, e 81,1% recomendariam o curso a um amigo. Conclusões O curso de Sexologia online para residentes de Ginecologia e Obstetrícia promoveu o aumento do conhecimento sobre questões sexuais no ciclo gravídico puerperal, e atendeu às expectativas dos participantes. Essa experiência pode servir de modelo para outros cursos de sexualidade voltados para esse público.

Abstract Purpose To describe the experience of a distance education course on sexual issues during pregnancy and after birth for residents. Methods This prospective educational intervention study was conducted by investigators from the Universidade Federal de São Paulo, Brazil, between April and September 2014. The participants were 219 physicians (residents from the 1st to the 6th years). The duration of the course was of 24 hours (10 video lectures and online chats). At baseline, the participants answered questions about their training, attitude and experience regarding sexual issues during pregnancy and after birth; before and after the course, they answered questions to assess their knowledge about the topic; at the end of the course, they answered questions on the quality of the course. The Student t-test was used to compare the before and after scores of the knowledge tests; values of p < 0.05 were considered statistically significant. Results A total of 143 residents concluded the course; most were in their 1st (27.2%) or 3rd (29.4%) years of residency. There was a significant increase in themean scores of the questionnaires that assessed the knowledge of the topic: 4.4 (1.6) versus 6.0 (1.3; maximum score: 10), before and after the course respectively (p < 0.0001). Most of the participants (74.1%) declared that the quality of the course as a whole reached their expectations, and 81.1% would recommend the course to a friend. Conclusions The online Sexology course for Obstetrics and Gynecology residents increased their knowledge about the sexual issues during pregnancy and after birth, and fulfilled the participants’ expectations. The experience described heremay serve as a model for other sexuality courses targeting similar audiences.

CONTEXTO E OBJETIVO: O registro dos ensaios clínicos é pré-requisito para publicação em revistas científicas de prestígio. Recentes mecanismos regulatórios brasileiros também exigem o registro de determinados ensaios clínicos na plataforma nacional (Registro Brasileiro de Ensaios Clínicos, ReBEC). Porém há pouca informação disponível sobre questões práticas envolvidas no processo de registro. Este trabalho discute a importância do registro de ensaios clínicos e aspectos práticos envolvidos nesse processo. DESENHO DE ESTUDO E LOCAL: Estudo descritivo realizado por pesquisadores de um programa de pós-graduação em uma universidade pública em São Paulo, Brasil. MÉTODOS: Informações foram obtidas em plataformas de registro de ensaios clínicos, referências dos artigos encontrados e websites (última busca: setembro, 2014) sobre os seguintes temas: definição de ensaio clínico, história, objetivo e importância das plataformas de registro, quais informações devem ser registradas e o processo de registro. RESULTADOS: O registro de ensaios clínicos visa evitar viés de publicação e é exigido por revistas brasileiras disponíveis no LILACS, SciELO e revistas afiliadas ao Comitê Internacional de Editores de Revistas Médicas (ICMJE). Recentes normas brasileiras exigem que todos os ensaios clínicos (fases I a IV) envolvendo novos medicamentos no país sejam registrados no ReBEC. São discutidos os prós e contras da utilização de diferentes bases de registro de ensaios clínicos. CONCLUSÃO: O registro de ensaios clínicos é importante e atualmente existem vários mecanismos que obrigam seu uso. Quando forem escolher em qual plataforma registrar seu ensaio clínico, os pesquisadores devem levar em consideração quais são as normas nacionais e as exigências para publicação.

CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

<sec><title>OBJETIVO:</title><p> Comparar a qualidade do sono de gestantes com e sem sobrepeso no segundo e terceiro trimestres.</p></sec><sec><title>MÉTODOS:</title><p> Estudo transversal incluindo 223 gestantes com ≥14 semanas: 105 com sobrepeso (índice de massa corporal - IMC - pré-gestacional ≥25,0 km²) e 118 eutróficas (IMC 18,5-24,9 kg/m²) em acompanhamento pré-natal. A versão brasileira do questionário <italic>Pittsburgh Sleep Quality Index</italic> (PSQI-BR) foi utilizada para avaliação do sono. Testes do χ² e <italic>t</italic> de Student foram utilizados para comparar diferenças entre os grupos; p<0,05 foi considerado significante.</p></sec><sec><title>RESULTADOS:</title><p> A maioria (65,9%) apresentou baixa qualidade de sono (escore total >5) e essa proporção foi significativamente mais alta entre as mulheres com sobrepeso (80/105), em comparação às eutróficas (67/118) (76,2 <italic>versus</italic> 56,8%, p=0,004). No 2º trimestre, essa proporção não alcançou significância estatística (72,5 <italic>versus</italic> 53,7%, p=0,06), mas o escore médio total do PSQI-BR foi mais alto entre aquelas com sobrepeso (7,0±3,8 <italic>versus</italic> 5,5±3,2, p=0,02). Nesse período, os escores médios de latência e qualidade subjetiva do sono foram significativamente mais altos entre as mulheres com sobrepeso (1,4±1,0 <italic>versus</italic> 1,0±0,9, p=0,02, e 1,3±0,8 <italic>versus</italic> 0,8±0,8, p=0,02, respectivamente). No 3º trimestre, a proporção de gestantes com baixa qualidade do sono foi mais alta entre as mulheres com sobrepeso, mas sem diferença significante (79,6 <italic>versus</italic> 60,8%, p=0,06). Nessa fase, o escore total do instrumento foi semelhante entre as mulheres com e sem sobrepeso (9,4±4,2 <italic>versus</italic> 8,3±4,6, p=0,2). No entanto, gestantes com sobrepeso apresentaram escores médios mais altos para distúrbios do sono (2,3±0,7 <italic>versus</italic> 2,0±0,8, p=0,04).</p></sec><sec><title>CONCLUSÃO:</title><p> Mulheres com sobrepeso pré-gestacional apresentaram sono mais comprometido do que as eutróficas, no segundo e terceiro trimestres da gravidez.</p></sec>

<sec><title>PURPOSE:</title><p> To compare sleep quality of overweight <italic>versus</italic> normal weight women in the second and third trimesters of pregnancy.</p></sec><sec><title>METHODS:</title><p> A cross-sectional study involving 223 women with 14 or more weeks of pregnancy, 105 of them overweight (pre-pregnancy body mass index - BMI - ≥25.0 kg/m²) and 118 of normal weight (BMI 18.5-24.9 kg/m²), attending the prenatal care clinic. The Brazilian version of the Pittsburgh Sleep Quality Index (PSQI-BR) questionnaire was used to evaluate sleep quality. The Student t-test and the chi-square test were used to compare differences between groups and a p value <0.05 was considered statistically significant.</p></sec><sec><title>RESULTS:</title><p> Most of the participants (67.7%) were poor sleepers (total score >5); this proportion was significantly higher among overweight (80/105) <italic>versus</italic> normal weight (67/118) women (76.2 <italic>versus</italic> 56.8%, p=0,004). During the second trimester, this difference did not reach statistical significance (72.5 <italic>versus</italic> 53.7%, respectively, p=0.06) but mean total PSQI-BR scores were significantly higher among overweight participants (7.0±3.8 <italic>versus</italic> 5.5±3.2, p=0.02). In the 2^nd trimester, overweight women also had higher scores for sleep latency (1.4±1.0 <italic>versus</italic> 1.0±0.9, p=0.02) and subjective sleep quality (1.3±0.8 <italic>versus</italic> 0.8±0.8, p=0.02). In the third trimester, the proportion of women with poor sleep quality was significantly higher in the overweight group, but did not reach statistical significance (79.6 <italic>versus</italic> 60.8%, p=0.06). During this period, total mean scores were similar for women with and without excess weight (9.4±4.2 <italic>versus</italic> 8.3±4.6, p=0.2). However, overweight women had higher mean scores for sleep disturbance (2.3±0.7 <italic>versus</italic> 2.0±0.8, p=0.04).</p></sec><sec><title>CONCLUSION:</title><p> Overweight women had a poorer sleep quality than normal weight women in the second and third trimesters of pregnancy.</p></sec>

BACKGROUND:Herpes zoster or, as it is commonly called, 'shingles' is a neurocutaneous disease characterised by the reactivation of varicella zoster virus (VZV), the virus that causes chickenpox, which is latent in the dorsal spinal ganglia when immunity to VZV declines. It is an extremely painful condition which can often last for many weeks or months, impairing the patient's quality of life. The natural aging process is associated with a reduction of cellular immunity which predisposes to herpes zoster. Vaccination with an attenuated form of VZV activates specific T cell production, therefore avoiding viral reactivation. A herpes zoster vaccine with an active virus has been approved for clinical use among older adults by the Food and Drug Administration and has been tested in large populations.OBJECTIVE:To evaluate the effectiveness and safety of vaccination for preventing herpes zoster in older adults.METHODSSearch methods: We searched the following sources for relevant studies: CENTRAL 2012, Issue 7, MEDLINE (1948 to July week 1, 2012), EMBASE (2010 to July 2012), LILACS (1982 to July 2012) and CINAHL (1981 to July 2012). We also reviewed reference lists of identified trials and reviews for additional studies.Selection criteria: Randomised controlled trials (RCTs) or quasi-RCTs comparing zoster vaccine with placebo or no vaccine, to prevent herpes zoster in older adults (mean age > 60 years).Data collection and analysis: Two review authors independently collected and analysed data using a data extraction form. They also carried out an assessment of risk of bias.MAIN RESULTS:We identified eight RCTs with a total of 52,269 participants. Three studies were classified at low risk of bias. The main outcomes on effectiveness and safety were extracted from one clinical trial with a low risk of bias. Four studies compared zoster vaccine versus placebo; one study compared high-potency zoster vaccine versus low-potency zoster vaccine; one study compared refrigerated zoster vaccine versus frozen zoster vaccine; one study compared live zoster vaccine versus inactivated zoster vaccine and one study compared zoster vaccine versus pneumococcal polysaccharide vaccine (pneumo 23).Confirmed cases of herpes zoster were less frequent in patients who received the vaccine than in those who received a placebo: risk ratio (RR) 0.49 (95% confidence interval (CI) 0.43 to 0.56), with a risk difference (RD) of 2%, and number needed to treat to benefit (NNTB) of 50. Analyses according to age groups indicated a greater benefit in participants aged 60 to 69 years, RR 0.36 (95% CI 0.30 to 0.45) and in participants aged 70 years and over, RR 0.63 (95% CI 0.53 to 0.75). Vaccine-related systemic adverse effects were more frequent in the vaccinated group (RR 1.29, 95% CI 1.05 to 1.57, number needed to treat to harm (NNTH) = 100). The pooled data risk ratio for adverse effects for participants with one or more inoculation site adverse effect was RR 4.51 (95% CI 2.35 to 8.68), and the NNTH was 2.8 (95% CI 2.3 to 3.4). Side effects were more frequent in younger (60 to 69 years) than in older (70 years and over) participants.AUTHORS' CONCLUSIONS:Herpes zoster vaccine is effective in preventing herpes zoster disease. Although vaccine benefits are larger in the younger age group (60 to 69 years), this is also the age group with more adverse events. In general, zoster vaccine is well tolerated; it produces few systemic adverse events and injection site adverse effects of mild to moderate intensity.

Objetivo Comparar o desenvolvimento neuromotor de pacientes submetidos à cirurgia fetal intrauterina da mielomeningocele ao de pacientes não submetidos ao procedimento. Métodos Foram avaliados: o desenvolvimento neuromotor (descrevendo o nível anatômico e motor funcional), o tipo de marcha, a necessidade de órteses e o nível cognitivo de crianças com mielomeningocele entre 3,5 e 6 anos de idade, submetidas (Grupo A; n=6) ou não submetidas (Grupo B; n=7) à cirurgia fetal intra-uterina. Resultados A função motora apre-sentou melhora significante, com nível funcional mais elevado em dois ou mais segmentos em relação ao nível anatômico em todas as crianças do Grupo A e em duas crianças do Grupo B, com diferença estatística entre os grupos (p<0.05). Cinco crianças do Grupo A e uma do grupo B eram deambuladoras comunitárias. Conclusão Apesar da pequena amostragem, nos 6 casos de cirurgia prenatal observouse melhora da função motora e menor necessidade de shunts pós-natais.

Objective To compare neuromotor development between patients who did and those who did not undergo intrauterine myelomeningocele repair. Methods Children with myelomeningocele aged between 3.5 and 6 years who did undergo intrauterine repair (Group A, n=6) or not (Group B; n=7) were assessed for neuromotor development at both anatomical and functional levels, need for orthoses, and cognitive function. Results Intrauterine myelomeningocele repair significantly improved motor function. The functional level was higher than the anatomical level by 2 or more spinal segments in all children in Group A and 2 children in Group B, with a significant statistical difference between groups (p<0.05). Five children in Group A and one in Group B were community ambulators. Conclusion Despite the small sample, it was observed that an improvement of motor function and decreased need for postnatal shunting in the 6 children who had undergone intrauterine myelomeningocele repair.

OBJECTIVES: To assess the quality of systematic reviews and clinical trials on women's health recently published in a Brazilian evidence-based health journal. METHOD: All systematic reviews and clinical trials on women's health published in the last five years in the Brazilian Journal of Evidence-based Health were retrieved. Two independent reviewers critically assessed the methodological quality of reviews and trials using AMSTAR and the Cochrane Risk of Bias Table, respectively. RESULTS: Systematic reviews and clinical trials accounted for less than 10% of the 61 original studies on women's health published in the São Paulo Medical Journal over the last five years. All five reviews were considered to be of moderate quality; the worst domains were publication bias and the appropriate use of study quality in formulating conclusions. All three clinical trials were judged to have a high risk of bias. The participant blinding, personnel and outcome assessors and allocation concealment domains had the worst scores. CONCLUSIONS: Most of the systematic reviews and clinical trials on women's health recently published in a Brazilian evidence-based journal are of low to moderate quality. The quality of these types of studies needs improvement.