Evidence-based surgical procedures to optimize caesarean outcomes: an overview of systematic reviews.

Background: Caesarean section (CS) is the most performed major surgery worldwide. Surgical techniques used for CS vary widely and there is no internationally accepted standardization. We conducted an overview of systematic reviews (SR) of randomized controlled trials (RCT) to summarize the evidence on surgical techniques or procedures related to CS. Methods: Searches were conducted from database inception to 31 January 2024 in Cochrane Database of Systematic Reviews, PubMed, EMBASE, Lilacs and CINAHL without date or language restrictions. AMSTAR 2 and GRADE were used to assess the methodological quality of the SRs and the certainty of evidence at outcome level, respectively. We classified each procedure-outcome pair into one of eight categories according to effect estimates and certainty of evidence. The overview was registered at PROSPERO (CRD 42023208306). Findings: The analysis included 38 SRs (16 Cochrane and 22 non-Cochrane) published between 2004-2024 involving 628 RCT with a total of 190,349 participants. Most reviews were of low or critically low quality (AMSTAR 2). The SRs presented 345 procedure-outcome comparisons (237 procedure versus procedure, 108 procedure versus no treatment/placebo). There was insufficient or inconclusive evidence for 256 comparisons, clear evidence of benefit for 40, possible benefit for 17, no difference of effect for 13, clear evidence of harm for 14, and possible harm for 5. We found no SRs for 7 pre-defined procedures. Skin cleansing with chlorhexidine, Joel-Cohen-based abdominal incision, uterine incision with blunt dissection and cephalad-caudal expansion, cord traction for placental extraction, manual cervical dilatation in pre-labour CS, changing gloves, chromic catgut suture for uterine closure, non-closure of the peritoneum, closure of subcutaneous tissue, and negative pressure wound therapy are procedures associated with benefits for relevant outcomes. Interpretation: Current evidence suggests that several CS surgical procedures improve outcomes but also reveals a lack of or inconclusive evidence for many commonly used procedures. There is an urgent need for evidence-based guidelines standardizing techniques for CS, and trials to fill existing knowledge gaps. Funding: UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a cosponsored programme executed by the World Health Organization (WHO).

Conhecimento, atitude e prática de médicos brasileiros sobre a inserção do DIU imediatamente após o parto e o abortamento / Knowledge, Attitudes, and Practices of Brazilian Physicians Regarding Intrauterine Device Insertion Immediately After Childbirth and Abortion

RESUMO Objetivo: Avaliar o conhecimento, a atitude e a prática dos mé- dicos brasileiros sobre a inserção do dispositivo intrauterino no pós-parto e pós-abortamento imediatos. Métodos: Estudo trans- versal envolvendo enquete de plantonistas de hospitais públicos brasileiros. Os participantes responderam a um questionário on- line anônimo com perguntas fechadas para avaliar seu conhe- cimento, atitude e experiência quanto à inserção de dispositivo intrauterino de cobre no pós-parto e pós-abortamento imedia- tos. Resultados: Cento e vinte e sete médicos que trabalham em 23 hospitais nas cinco regiões geográficas do Brasil responde- ram ao questionário. A maioria era do sexo feminino (68,5%) e trabalhava em hospitais universitários (95,3%). O escore médio (desvio-padrão) de conhecimento (escala de 0-10) foi de 5,3 (1,3); apenas 27,6% dos participantes tiveram escores ≥ 7,0. A maioria dos médicos (73,2%) colocaria o DIU pós-parto em si/familia- res. Cerca de 42% afirmaram não ter recebido nenhum treina- mento sobre inserção de dispositivo intrauterino pós-parto ou pós-abortamento. Nos últimos 12 meses, 19,7%, 22,8% e 53,5% dos respondentes afirmaram não ter inserido nenhum dispositi- vo intrauterino durante uma cesariana, imediatamente após um parto vaginal e um abortamento, respectivamente. Conclusão: A maioria das participantes do estudo tem atitude positiva em relação à inserção de dispositivos intrauterinos no pós-parto imediato, mas tem conhecimento limitado sobre o uso desse método contraceptivo. Grande porcentagem dos participantes não teve treinamento anterior sobre inserção de dispositivo in- trauterino pós-parto e pós-abortamento e não realizou nenhuma inserção nos últimos doze meses. São necessárias estratégias para melhorar o conhecimento, o treinamento e a experiência dos médicos brasileiros sobre a inserção de dispositivo intraute- rino no pós-parto e pós-abortamento imediatos.

Alemtuzumab for multiple sclerosis.

BACKGROUND: Multiple sclerosis (MS) is an autoimmune, T-cell-dependent, inflammatory, demyelinating disease of the central nervous system, with an unpredictable course. Current MS therapies focus on treating and preventing exacerbations, and avoiding the progression of disability. At present, there is no treatment that is capable of safely and effectively reaching these objectives. Clinical trials suggest that alemtuzumab, a humanized monoclonal antibody, could be a promising option for MS. OBJECTIVES: To evaluate the benefits and harms of alemtuzumab alone or associated with other treatments in people with any form of MS. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 21 June 2022. SELECTION CRITERIA: We included randomized controlled trials (RCTs) in adults with any subtype of MS comparing alemtuzumab alone or associated with other medications versus placebo; another active drug; or alemtuzumab in another dose, regimen, or duration. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our co-primary outcomes were 1. relapse-free survival, 2. sustained disease progression, and 3. number of participants experiencing at least one adverse event. Our secondary outcomes were 4. participants free of clinical disability, 5. quality of life, 6. change in disability, 7. fatigue, 8. new or enlarging lesions on resonance imaging, and 9. dropouts. We used GRADE to assess certainty of evidence for each outcome. MAIN RESULTS: We included three RCTs (1713 participants) comparing intravenous alemtuzumab versus subcutaneous interferon beta-1a for relapsing-remitting MS. Participants were treatment-naive (two studies) or had experienced at least one relapse after interferon or glatiramer (one study). Alemtuzumab was given at doses of 12 mg/day or 24 mg/day for five days at months 0 and 12, or 24 mg/day for three days at months 12 and 24. Participants in the interferon beta-1a group received 44 µg three times weekly. Alemtuzumab 12 mg: 1. may improve relapse-free survival at 36 months (hazard ratio [HR] 0.31, 95% confidence interval [CI] 0.18 to 0.53; 1 study, 221 participants; low-certainty evidence); 2. may improve sustained disease progression-free survival at 36 months (HR 0.25, 95% CI 0.11 to 0.56; 1 study, 223 participants; low-certainty evidence); 3. may make little to no difference on the proportion of participants with at least one adverse event at 36 months (risk ratio [RR] 1.00, 95% CI 0.98 to 1.02; 1 study, 224 participants; low-certainty evidence), although the proportion of participants with at least one adverse event was high with both drugs; 4. may slightly reduce disability at 36 months (mean difference [MD] -0.70, 95% CI -1.04 to -0.36; 1 study, 223 participants; low-certainty evidence). The evidence is very uncertain regarding the risk of dropouts at 36 months (RR 0.81, 95% CI 0.57 to 1.14; 1 study, 224 participants; very low-certainty evidence). Alemtuzumab 24 mg: 1. may improve relapse-free survival at 36 months (HR 0.21, 95% CI 0.11 to 0.40; 1 study, 221 participants; low-certainty evidence); 2. may improve sustained disease progression-free survival at 36 months (HR 0.33, 95% CI 0.16 to 0.69; 1 study, 221 participants; low-certainty evidence); 3. may make little to no difference on the proportion of participants with at least one adverse event at 36 months (RR 0.99, 95% CI 0.97 to 1.02; 1 study, 215 participants; low-certainty evidence), although the proportion of participants with at least one adverse event was high with both drugs; 4. may slightly reduce disability at 36 months (MD -0.83, 95% CI -1.16 to -0.50; 1 study, 221 participants; low-certainty evidence); 5. may reduce the risk of dropouts at 36 months (RR 0.08, 95% CI 0.01 to 0.57; 1 study, 215 participants; low-certainty evidence). For quality of life, fatigue, and participants free of clinical disease activity, the studies either did not consider these outcomes or they used different measuring tools to those planned in this review. AUTHORS' CONCLUSIONS: Compared with interferon beta-1a, alemtuzumab may improve relapse-free survival and sustained disease progression-free survival, and make little to no difference on the proportion of participants with at least one adverse event for people with relapsing-remitting MS at 36 months. The certainty of the evidence for these results was very low to low.

Knowledge, Attitude, and Practice of Brazilian Physicians about Immediate Postpartum and Postabortion Intrauterine Device Insertion / Conhecimento, atitude e prática de médicos brasileiros sobre inserção de dispositivo intrauterino no pós-parto e pós-aborto imediatos

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.

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.

Sexual function in Brazilian female adolescents and young adults: a cross-sectional study

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.

Route of oxytocin administration for preventing blood loss at caesarean section: a systematic review with meta-analysis.

OBJECTIVES: Assess the effects of different routes of prophylactic oxytocin administration for preventing blood loss at caesarean section (CS). DESIGN: Systematic review and meta-analysis. METHODS: Medline, EMBASE, CINAHL, Cochrane Library, BVS, SciELO and Global Index Medicus were searched through 24 May 2020 for randomised controlled trials (RCTs) comparing different routes of prophylactic oxytocin administration during CS. Study selection, data extraction and quality assessment were conducted by two investigators independently. We pooled results in fixed effects meta-analyses and calculated average risk ratio (RR), mean difference (MD) and 95% CI. We used GRADE to assess the overall quality of evidence for each outcome. RESULTS: Three trials (180 women) were included in the review. All studies compared intramyometrial (IMY) versus intravenous oxytocin in women having prelabour CS. IMY compared with intravenous oxytocin administration may result in little or no difference in the incidence of postpartum haemorrhage (RR 0.14, 95% CI 0.01 to 2.70; N=100 participants; 1 RCT), hypotension (RR 1.00, 95% CI 0.29 to 3.45; N=40; 1 RCT), headache (RR 3.00, 95% CI 0.13 to 69.52; N=40; 1 RCT) or facial flushing (RR 0.50, 95% CI 0.05 to 5.08; N=40; 1 RCT); IMY oxytocin may reduce nausea/vomiting (RR 0.13, 95% CI 0.02 to 0.69; N=140; 2 RCTs). We are very uncertain about the effect IMY versus intravenous oxytocin on the need for additional uterotonics (RR 0.82; 95% CI 0.25 to 2.69; N=140; 2 RCTs). IMY oxytocin may reduce blood loss slightly (MD -57.40 mL, 95% CI -101.71 to -13.09; N=40; 1 RCT). CONCLUSIONS: There is limited, low to very low certainty evidence on the effects of IMY versus intravenous oxytocin at CS for preventing blood loss. The evidence is insufficient to support choosing one route over another. More trials, including studies that assess intramuscular oxytocin administration, are needed on this relevant question. PROSPERO REGISTRATION NUMBER: CRD42020186797.

Tribulus terrestris for female sexual dysfunction: a systematic review / Tribulus terrestris para disfunção sexual feminina: uma revisão sistemática

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

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.

The Brazilian Portuguese Version of the DISCERN Instrument: Translation Procedures and Psychometric Properties.

OBJECTIVES: To report on the translation procedures and psychometric properties of the DISCERN tool in Brazilian Portuguese. METHODS: Three people translated the DISCERN from English into Brazilian Portuguese. A committee of experts and community representatives evaluated the quality of the 3 versions in 2 online voting rounds. Two native speakers back-translated the questionnaire into English. We compared these versions to the original DISCERN and made small adjustments. The final Brazilian Portuguese version of DISCERN was tested twice by journalism students to evaluate the quality of a text about smoking cessation treatments. We evaluated participants' health literacy with the Short Assessment of Health Literacy for Portuguese-Speaking Adults (SAHL-PA) tool, assessed the internal consistency of the translated questionnaire with the Cronbach test, and measured its reproducibility with the intraclass correlation coefficient (ICC). We then investigated the relationship between DISCERN and SAHL-PA scores and demographic variables. RESULTS: The participants (n = 126) had no difficulty in using the questionnaire. Cronbach's alpha was 0.865 (95% confidence interval [CI], 0.826-0.898), and the ICC between the 2 evaluations was 0.845 (CI 0.717-0.912). The mean health literacy of the participants was adequate. There was no correlation between the DISCERN score and the SAHL-PA score, age, or sex (P > .05). CONCLUSIONS: The Brazilian Portuguese version of the DISCERN questionnaire has excellent internal consistency and good reproducibility. The evaluators' ages, sex, and health literacy did not interfere with the score resulting from the evaluation of the quality of the text.

Interventions to reduce unnecessary caesarean sections in healthy women and babies.

Optimising the use of caesarean section (CS) is of global concern. Underuse leads to maternal and perinatal mortality and morbidity. Conversely, overuse of CS has not shown benefits and can create harm. Worldwide, the frequency of CS continues to increase, and interventions to reduce unnecessary CSs have shown little success. Identifying the underlying factors for the continuing increase in CS use could improve the efficacy of interventions. In this Series paper, we describe the factors for CS use that are associated with women, families, health professionals, and health-care organisations and systems, and we examine behavioural, psychosocial, health system, and financial factors. We also outline the type and effects of interventions to reduce CS use that have been investigated. Clinical interventions, such as external cephalic version for breech delivery at term, vaginal breech delivery in appropriately selected women, and vaginal birth after CS, could reduce the frequency of CS use. Approaches such as labour companionship and midwife-led care have been associated with higher proportions of physiological births, safer outcomes, and lower health-care costs relative to control groups without these interventions, and with positive maternal experiences, in high-income countries. Such approaches need to be assessed in middle-income and low-income countries. Educational interventions for women should be complemented with meaningful dialogue with health professionals and effective emotional support for women and families. Investing in the training of health professionals, eliminating financial incentives for CS use, and reducing fear of litigation is fundamental. Safe, private, welcoming, and adequately resourced facilities are needed. At the country level, effective medical leadership is essential to ensure CS is used only when indicated. We conclude that interventions to reduce overuse must be multicomponent and locally tailored, addressing women's and health professionals' concerns, as well as health system and financial factors.

What do Cochrane systematic reviews say about new practices on integrative medicine?

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.

Breast surgery for metastatic breast cancer.

BACKGROUND: Metastatic breast cancer is not a curable disease, but women with metastatic disease are living longer. Surgery to remove the primary tumour is associated with an increased survival in other types of metastatic cancer. Breast surgery is not standard treatment for metastatic disease, however several recent retrospective studies have suggested that breast surgery could increase the women's survival. These studies have methodological limitations including selection bias. A systematic review mapping all randomised controlled trials addressing the benefits and potential harms of breast surgery is ideal to answer this question. OBJECTIVES: To assess the effects of breast surgery in women with metastatic breast cancer. SEARCH METHODS: We conducted searches using the MeSH terms 'breast neoplasms', 'mastectomy', and 'analysis, survival' in the following databases: the Cochrane Breast Cancer Specialised Register, CENTRAL, MEDLINE (by PubMed) and Embase (by OvidSP) on 22 February 2016. We also searched ClinicalTrials.gov (22 February 2016) and the WHO International Clinical Trials Registry Platform (24 February 2016). We conducted an additional search in the American Society of Clinical Oncology (ASCO) conference proceedings in July 2016 that included reference checking, citation searching, and contacting study authors to identify additional studies. SELECTION CRITERIA: The inclusion criteria were randomised controlled trials of women with metastatic breast cancer at initial diagnosis comparing breast surgery plus systemic therapy versus systemic therapy alone. The primary outcomes were overall survival and quality of life. Secondary outcomes were progression-free survival (local and distant control), breast cancer-specific survival, and toxicity from local therapy. DATA COLLECTION AND ANALYSIS: Two review authors independently conducted trial selection, data extraction, and 'Risk of bias' assessment (using Cochrane's 'Risk of bias' tool), which a third review author checked. We used the GRADE tool to assess the quality of the body of evidence. We used the risk ratio (RR) to measure the effect of treatment for dichotomous outcomes and the hazard ratio (HR) for time-to-event outcomes. We calculated 95% confidence intervals (CI) for these measures. We used the random-effects model, as we expected clinical or methodological heterogeneity, or both, among the included studies. MAIN RESULTS: We included two trials enrolling 624 women in the review. It is uncertain whether breast surgery improves overall survival as the quality of the evidence has been assessed as very low (HR 0.83, 95% CI 0.53 to 1.31; 2 studies; 624 women). The two studies did not report quality of life. Breast surgery may improve local progression-free survival (HR 0.22, 95% CI 0.08 to 0.57; 2 studies; 607 women; low-quality evidence), while it probably worsened distant progression-free survival (HR 1.42, 95% CI 1.08 to 1.86; 1 study; 350 women; moderate-quality evidence). The two included studies did not measure breast cancer-specific survival. Toxicity from local therapy was reported by 30-day mortality and did not appear to differ between the two groups (RR 0.99, 95% CI 0.14 to 6.90; 1 study; 274 women; low-quality evidence). AUTHORS' CONCLUSIONS: Based on existing evidence from two randomised clinical trials, it is not possible to make definitive conclusions on the benefits and risks of breast surgery associated with systemic treatment for women diagnosed with metastatic breast cancer. Until the ongoing clinical trials are finalised, the decision to perform breast surgery in these women should be individualised and shared between the physician and the patient considering the potential risks, benefits, and costs of each intervention.

Cobertura, completude e confiabilidade das informações do Sistema de Informações sobre Nascidos Vivos de maternidades da rede pública no município de São Paulo, 2011 / Cobertura, conformidad documental y confiabilidad de las informaciones del Sistema de Informaciones sobre Nacidos Vivos de maternidades de la red pública en la ciudad de São Paulo, Brasil, 2011 / Coverage, completeness and reliability of the data in the Information System on Live Births in public maternity wards in the municipality in São Paulo, Brazil, 2011

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.

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.

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.

Distance education course about sexuality for obstetrics and gynecology residents / Curso de educação a distância sobre sexualidade para residentes em obstetrícia e ginecologia

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.

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.

Maternal obesity and inflammatory mediators: A controversial association.

The link between maternal obesity and inflammatory mediators is still unclear. Our aim was to summarize the main findings of recently published studies on this topic. We performed a search in Medline for studies published in the last years on obesity, human pregnancy, and inflammatory mediators. We report the findings of 30 studies. The characteristics and number of participants, study design, gestational age at sample collection, and type of sample varied widely. Approximately two-thirds of them investigated more than one mediator, and 50% included participants in only one trimester of pregnancy. The most frequently investigated mediators were leptin, tumour necrosis factor-alpha (TNF-α), and interleukin (IL)-6. Almost all studies reported an association between maternal obesity, leptin, and C-reactive protein (CRP) serum levels but not with IL-1ß and IL-10. The association of IL-6, TNF-α, monocyte chemo-attractant protein-1 (MCP-1), adiponectin, and resistin with maternal obesity is still controversial. To clarify the physiopathological link between maternal obesity and inflammation, more high-quality studies are needed.

Practical and conceptual issues of clinical trial registration for Brazilian researchers / Aspectos práticos e conceituais do registro de ensaios clínicos para pesquisadores brasileiros

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.

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.

Qualidade do sono em gestantes com sobrepeso / Sleep quality in overweight pregnant women

Comparar a qualidade do sono de gestantes com e sem sobrepeso no segundo e terceiro trimestres.

Use of the Robson classification to assess caesarean section trends in 21 countries: a secondary analysis of two WHO multicountry surveys.

BACKGROUND: Rates of caesarean section surgery are rising worldwide, but the determinants of this increase, especially in low-income and middle-income countries, are controversial. In this study, we aimed to analyse the contribution of specific obstetric populations to changes in caesarean section rates, by using the Robson classification in two WHO multicountry surveys of deliveries in health-care facilities. The Robson system classifies all deliveries into one of ten groups on the basis of five parameters: obstetric history, onset of labour, fetal lie, number of neonates, and gestational age. METHODS: We studied deliveries in 287 facilities in 21 countries that were included in both the WHO Global Survey of Maternal and Perinatal Health (WHOGS; 2004-08) and the WHO Multi-Country Survey of Maternal and Newborn Health (WHOMCS; 2010-11). We used the data from these surveys to establish the average annual percentage change (AAPC) in caesarean section rates per country. Countries were stratified according to Human Development Index (HDI) group (very high/high, medium, or low) and the Robson criteria were applied to both datasets. We report the relative size of each Robson group, the caesarean section rate in each Robson group, and the absolute and relative contributions made by each to the overall caesarean section rate. FINDINGS: The caesarean section rate increased overall between the two surveys (from 26.4% in the WHOGS to 31.2% in the WHOMCS, p=0.003) and in all countries except Japan. Use of obstetric interventions (induction, prelabour caesarean section, and overall caesarean section) increased over time. Caesarean section rates increased across most Robson groups in all HDI categories. Use of induction and prelabour caesarean section increased in very high/high and low HDI countries, and the caesarean section rate after induction in multiparous women increased significantly across all HDI groups. The proportion of women who had previously had a caesarean section increased in moderate and low HDI countries, as did the caesarean section rate in these women. INTERPRETATION: Use of the Robson criteria allows standardised comparisons of data across countries and timepoints and identifies the subpopulations driving changes in caesarean section rates. Women who have previously had a caesarean section are an increasingly important determinant of overall caesarean section rates in countries with a moderate or low HDI. Strategies to reduce the frequency of the procedure should include avoidance of medically unnecessary primary caesarean section. Improved case selection for induction and prelabour caesarean section could also reduce caesarean section rates. FUNDING: None.

[Congenital Anomalies Detected at Birth in Newborns of Adolescent Women]. / Anomalias Congénitas Identificadas ao Nascimento em Recém-Nascidos de Mulheres Adolescentes.

INTRODUCTION: To analyze the prevalence of congenital anomalies detected at birth among children of pregnant adolescents, emphasizing the most common types and the time of diagnosis. MATERIAL AND METHODS: Retrospective study of type census, in which were analyzed in all newborns, living or dead, weighing more than 500 g of women who gave birth at Hospital São Paulo in a period of six years. The fetuses bearing anomalies were identified prenatally or through postnatal physical examination period, according to the criteria of the Latin American Collaborative Study of Congenital Malformations. The results were expressed descriptively using absolute and relative values, the prevalence of anomalies was calculated, as well as the comparison between groups using nonparametric tests. RESULTS: We analyzed 6 257 pregnancies, of which 577 newborns had some congenital anomaly identified at birth (prevalence 9.2%). Among these 6 257, 907 were adolescents, which showed a 9.9% prevalence of anomalies among their newborns. There was no significant difference between the presence of abnormalities in newborns of adolescents and women with age greater than or equal to 20 years. About 56% of congenital anomalies were diagnosed in the prenatal period. We observed a higher prevalence of defects of neural tube between newborns of adolescents (p = 0.027). DISCUSSION: We observed high rate of deliveries in adolescents, higher than developed countries. We observed also high frequency of congenital anomalies in newborns, probably because our tertiary reference center. The high prevalence of neural tube defect among young pregnant women could be explained by the absent of acid folic supplementation in non-planned gestations which is typical of adolescents. CONCLUSION: The prevalence and time of diagnosis of congenital anomalies showed similar behavior among newborns of teenagers and women with age greater than or equal to 20 years, except for the defects of the neural tube, which were more prevalent among newborns of teenagers.

Introdução: Analisar a prevalência das anomalias congénitas, detetadas no nascimento, entre filhos de gestantes adolescentes, enfatizando os tipos mais comuns e a época do diagnóstico. Material e Métodos: Estudo retrospetivo do tipo censo, no qual foram analisados todos recém-nascidos, vivos ou mortos, com peso superior a 500 g, de mulheres que tiveram o parto no Hospital São Paulo num período de seis anos. Os produtos da conceção portadores de anomalias foram identificados no período pré-natal ou através do exame físico pós-natal, segundo os critérios do Estudo Colaborativo Latino-Americano das Malformações Congênitas. Os resultados são apresentados de forma descritiva através de valores absolutos e relativos, calcula-se a prevalência das anomalias e comparam-se os diferentes grupos recorrendo a testes não paramétricos. Resultados: Foram analisadas 6 257 gestações, das quais 577 resultaram em recém-nascidos com alguma anomalia congénita identificada no nascimento (prevalência de 9,2%). Do total de gestações, 907 eram de adolescentes (idade inferior a 20 anos), para as quais se verificou uma prevalência de anomalias nos recém-nascidos de 9,9%. Comparando os recém-nascidos de adolescentes com os das mulheres com idade superior a 20 anos, apenas se encontrou diferença estatisticamente significativa para a prevalência dos defeitos do tubo neural (p = 0,027). Discussão: Observamos uma alta taxa de partos em adolescentes, acima das taxas dos países desenvolvidos. Observamos também alta frequência de anomalias congénitas em recém-nascidos, provavelmente por sermos um serviço terciário de referência. A elevada prevalência dos defeitos do tubo neural entre grávidas jovens pode ser explicada pela não suplementação pré-concecional de ácido fólico em gravidezes não planeadas, como é característico nas adolescentes.Conclusão: A prevalência e momento do diagnóstico das anomalias congénitas em recém-nascidos apresentam comportamentos semelhantes entre grávidas com idade inferior ou superior a 20 anos, exceto para os defeitos do tubo neural, de maior prevalência nos recém-nascidos das grávidas adolescentes.

Vaccines for preventing herpes zoster in older adults

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. METHODS Search 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 ...