Aplicação da microscopia confocal in vivo como método diagnóstico complementar ao exame de dermatoscopia digital: um estudo longitudinal retrospectivo / Application of in vivo confocal microscopy as a complementary diagnostic method to digital dermatoscopy examination: a longitudinal retrospective study

Introdução: O melanoma cutâneo é uma neoplasia que apresenta comportamento agressivo quando em estágio de evolução avançado, de forma que o sucesso no tratamento depende do diagnóstico precoce. A utilização da microscopia confocal in vivo (MC) como técnica complementar à dermatoscopia digital tem se mostrado útil para aumentar a acurácia diagnóstica dessa neoplasia. Semelhante à dermatoscopia, a MC revela detalhes morfológicos da arquitetura tecidual no plano paralelo à pele e, além disso, fornece imagens instantâneas com alta magnificação e resolução celular. Objetivo: Determinar como a utilização da microscopia confocal in vivo como técnica complementar à dermatoscopia digital pode melhorar a acurácia no diagnóstico do melanoma e reduzir o número de excisões cirúrgicas desnecessárias em um hospital referência de oncologia cutânea. Demonstrar por meio do cálculo do Número necessário para tratar (NNT), o impacto da associação dos métodos de imagem na rotina de um hospital referência em oncologia cutânea. Material e método: Trata-se de um estudo, retrospectivo observacional a ser realizado no Departamento de Oncologia Cutânea do A.C.Camargo Cancer Center. Foram incluídas 209 lesões melanocíticas duvidosas, divididas em dois grupos de análise: as lesões que sofreram modificações no seguimento dermatoscópico, sugestivas de melanoma, encaminhadas para excisão cirúrgica, após realização da MC (Grupo de lesões excisadas) e outro grupo em que os achados de benignidade da MC indicaram o seguimento da lesão (Grupo de lesões em seguimento). Todos os casos foram analisados em 3 etapas distintas: dermatoscopia isolada da lesão a ser analisada antes do exame de MC, utilizando-se o método de Análise de Padrão; dermatoscopia digital comparativa: análise das mudanças que levaram a indicação da MC; análise da Microscopia confocal, utilizando protocolo do Departamento. Para o cáculo do NNT da dermatoscopia de seguimento, foram analisadas mais 300 lesões melanocíticas de pacientes que estavam em acompanhamento digital. Resultados: Por meio da regressão logística simples e múltipla, foram criados dois nomogramas de análise para predizer a chance de uma dada lesão ser um melanoma. Posteriormente, de forma inédita, foi calculado valores de NNT em 3 cenários distintos. Os valores obtidos foram de 7,89 para dermatoscopia digital de seguimento, 5,8 para MC e um NNT hipotético de 3,09 quando aplicado aos nomogramas criados, aplicados na amostra. Conclusão: O presente estudo comprova a importância da MC como método de avaliação complementar no seguimento dos nevos melanocíticos em pacientes com alto risco para câncer de pele, aumentando a detecção do melanoma no seu estágio inicial, por meio da criação de dois nomogramas e a criação de uma aplicativo para a sua aplicabilidade.Comprovou-se a redução significativa do NNT quando associado o exame de microscopia confocal à dermatoscopia digital na rotina ambulatorial de seguimento dos pacientes de alto risco num hospital oncológico de referência (AU)

Introduction: Cutaneous melanoma is a neoplasm that presents aggressive behavior when in advanced stage of evolution, so success in treatment depends on early diagnosis. The use of in vivo confocal microscopy (CM) as a complementary technique to digital dermatoscopy has been shown to be useful to increase the diagnostic accuracy of this neoplasm. Similar to dermoscopy, CM reveals morphological details of tissue architecture in the plane parallel to the skin and, in addition, provides instant images with high magnification and cellular resolution. Objective: To determine how the use of in vivo confocal microscopy as a complementary technique to digital dermatoscopy can improve the accuracy of melanoma diagnosis and reduce the number of unnecessary surgical excisions in a cutaneous oncology referral hospital. Demonstrate by calculating the Number Needed to Treat (NNT) the impact of combining imaging methods on the routine of a referral cutaneous oncology hospital. Material and method: This is a retrospective observational study to be performed at the Department of Cutaneous Oncology, Hospital A.C.Camargo Cancer Center. We included 209 dubious melanocytic lesions divided into two groups of analysis: lesions that underwent changes in the dermoscopic follow-up, suggestive of melanoma, which were referred for surgical excision after MC (Excised lesions group) and another group in which the findings of benignity of the MC indicated follow-up of the lesion (Group of injuries in follow-up). All cases were analyzed in 3 distinct stages: isolated dermatoscopy of the lesion to be analyzed before the MC examination, using the Pattern Analysis method; Comparative digital dermatoscopy: analysis of changes that led to the indication of MC, analysis of confocal microscopy, using MC protocol of the Department. For the NNT calculation of the follow up dermatoscopy, it was analysed more than 300 melanocytic lesions from patients that were under digital follow up. Results: Through simple and multiple logistic regression, two analysis nomograms were created to predict the chance of a given lesion being a melanoma. Subsequently, unpublished, NNT values were calculated in 3 different scenarios. The values obtained were 7.89 for follow-up digital dermatoscopy, 5.8 for MC and a hypothetical NNT of 3.09 when applying the nomograms applied to the sample. Conclusion: The current study proves the importance of the MC as complementar evaluation method in the follow up of the melanocytic nevi in patients with high risk for skin cancer, increasing the melanoma detection in its early stage. Through the creation of two new nomograms and its applicability by the creation of an app, it was proven a significative reduction of the NNT when the confocal microscopy examination is associate to the digital dermoscopic in the ambulatory routine of high risk patients follow up in an oncologic reference hospital (AU)

Impact of Bariatric Surgery on Cardiovascular Risk Reduction in Korean Obese Patients

PURPOSE: Morbid obesity is a well-known risk factor for cardiovascular disease (CVD). This study aimed to quantitatively evaluate the effects of bariatric surgery on CVD risk reduction in Korean obese patients by using three CVD risk prediction models (Framingham General Cardiovascular Risk Score [FRS], Pooled Cohort Equation [PCE], and Korean Risk Prediction Model [KRPM]), and to investigate which procedure between laparoscopic Roux-en Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) is a better option for CVD risk reduction. MATERIALS AND METHODS: We retrospectively reviewed all obese patients who underwent bariatric surgery at a single institution from October 2009 to May 2016. Of the 1034 patients reviewed, 83 patients (6.5%) who met the criteria for calculating the FRS, PCE, and KRPM scores and had a follow-up of at least 1 year were included in this study. RESULTS: The FRS, PCE, and KRPM scores were significantly decreased at postoperative 1 year (10.47±7.30% to 6.33±4.59%, P=0.000; 5.45±6.25% to 2.75±2.75%, P=0.000; and 4.53±2.96% to 3.49±2.13%, P=0.000, respectively) in LRYGB. The PCE and KRPM scores were significantly decreased (4.13±3.63% to 2.42±2.45%, P=0.004 and 4.14±1.95% to 3.22±1.94%, P=0.000, respectively) in LSG, but not the FRS (9.43±3.58% to 5.63±3.24%, P=0.118). There was no difference in absolute risk reduction in FRS, PCE, and KRPM between LRYGB and LSG (4.13±5.08% and 3.80±3.50%, P=0.788; 2.70±0.52% and 1.72±0.49%, P=0.799; and 1.03±1.85% and 0.92±0.97%, P=0.776, respectively). CONCLUSION: LRYGB and LSG can equally significantly decrease the CVD risk in the Korean population, based on FRS, PCE, and KRPM.

There is no benefit in the use of postnatal intravenous immunoglobulin for the prevention of relapses of multiple sclerosis: findings from a systematic review and meta-analysis / Não há benefício do uso de imunoglobulina endovenosa para prevenção de surtos na esclerose múltipla: achados de revisão sistemática e meta-análise

ABSTRACT Multiple sclerosis (MS) is a complex autoimmune and neurodegenerative disease of the central nervous system. Since MS affects mostly fertile women, pregnancy issues often arise in daily practice. The present study assessed the use of postpartum intravenous immunoglobulin (IVIG) in MS. Methods The authors individually searched for records using PubMed, Medline, EMBASE, Cochrane, SciELO, LILACS, and Google Scholar, using the terms "multiple sclerosis" OR "MS" AND "pregnancy" OR "gestation" OR "partum" OR "post-partum" OR "puerperium" AND "immunoglobulin". Results The initial search returned 321 papers. There were 11 eligible articles selected for the review. In total, 380 patients had received post-natal IVIG to reduce the number of postpartum relapses. The unadjusted number needed to treat was 6.3 for the quantitative and 5.8 for the qualitative analyses. Conclusion The therapeutic effect of IVIG for prevention of postnatal relapses in MS could not clearly be established in this meta-analysis.

RESUMO Esclerose múltipla (EM) é uma complexa doença autoimune e neurodegenerativa do sistema nervoso central. Uma vez que EM afeta principalmente mulheres em idade fértil, assuntos relacionados à gravidez frequentemente surgem na prática diária. O presente estudo avaliou o uso pós-parto de imunoglobulina (IVIG) na EM. Métodos Os autores individualmente pesquisaram as bases de dados PubMed, Medline, EMBASE, Cochrane, SciELO, LILACS, e Google Scholar usando os termos "multiple sclerosis" OR "MS" AND "pregnancy" OR "gestation" OR "partum" OR "post-partum" OR "puerperium" AND "immunoglobulin". Resultados A pesquisa inicial retornou 321 artigos. Havia 11 artigos elegíveis para a revisão. No total, havia relato de 380 pacientes que receberam IVIG após a gravidez visando reduzir o número de surtos. O número necessário para tratar não ajustado foi 6,3 para análise quantitativa e 5,8 para análise qualitativa. Conclusão O efeito terapêutico da IVIG para prevenção dos surtos pós-parto na EM não pôde ser claramente estabelecida nesta meta-análise.

Comparação entre a associação de cobimetinibe e vemurafenibe e outras opções terapêuticas para o tratamento de melanoma metastático com mutação BRAFV600: número necessário para tratar (NNT) / Number needed to treat (NNT) comparison between the association of cobimetinib and vemurafenib among other treatment options for metastatic melanoma with brafv600 mutation

Objetivo: O objetivo do estudo foi estimar e comparar o número necessário para tratar (NNT) entre a associação de cobimetinibe + vemurafenibe e outras opções terapêuticas no tratamento de melanoma metastático BRAFV600 mutado em primeira linha. Métodos: O NNT foi calculado como o inverso do risco absoluto de um medicamento em um ponto específico de tempo (12 meses). Os comparadores considerados foram o vemurafenibe monoterapia, dabrafenibe monoterapia, dabrafenibe + trametinibe, nivolumabe e ipilimumabe. O desfecho considerado foi a sobrevida livre de progressão (SLP), cujas curvas foram obtidas dos estudos coBRIM, BRIM-3, Robert, 2015, BREAK-3 e Checkmate 67. Resultados: Em 12 meses, os resultados de NNT foram: cobimetinibe + vemurafenibe = 1,92, vemurafenibe = 3,33; dabrafenibe = 4,67; dabrafenibe + trametinibe = 2,04; nivolumabe = 4,39 e ipilimumabe = 7,84. Conclusão: A associação de cobimetinibe e vemurafenibe no tratamento de pacientes com melanoma irressecável ou metastático, positivo para mutação BRAFV600 sem tratamento sistêmico prévio para a doença, apresenta resultados favoráveis em termos de NNT quando comparada a todas as outras opções terapêuticas disponíveis no mercado brasileiro para essa mesma indicação.

Objective: The objective of the study was to estimate and compare the number needed to treat (NNT) between the association of cobimetinib + vemurafenib and other therapeutic options in the first line treatment of metastatic melanoma with BRAFV600 mutation. Methods: The NNT was calculated as the inverse of absolute risk of a drug in a specific time point (12 months). The considered comparators were vemurafenib (monotherapy), dabrafenib (monotherapy), dabrafenib + trametinib, nivolumab and ipilumumab. Progression free survival (PFS) was the defined outcome, and its curves were obtained from coBRIM, BRIM-3, BREAK-3, Robert, 2015 and Checkmate 67 studies. Results: In 12 months, the NNT results were: cobimetinib + vemurafenib = 1.92; vemurafenib = 3.33; dabrafenib = 4.67; dabrafenib + trametinib = 2.04; nivolumab = 4.39 and ipilimumab = 7.84. Conclusion: The association of cobimetinib and vemurafenib in the treatment of patients with unresectable or metastatic melanoma, BRAFV600 mutated without previous systemic treatment, showed favorable results in terms of NNT when compared to the other therapeutic options available in the Brazilian market for the same indication.

Medical education: Effectiveness of two simulation teaching methods in developing intubation skills of year level six medical students (clinical clerks)

OBJECTIVE: To describe outcomes of two simulation teaching methods in developing intubation skills of year level six medical students (clinical clerks).METHODS: Students were shown a 6-minute video on intubation. Students were exposed to video-assisted learning, video-assisted learning with instructor-guided simulation, and video-assisted learning with experiential learning. Each student was assessed by a non-graded 11 point objective structured clinical examination.RESULTS AND DISCUSSION: The three learning strategies: 1. Video-assisted learning, 2. Video-assisted learning with instructor-guided simulation, 3. Video-assisted learning with experiential learning (self-discovery learning) simulation showed OSCE mean scores (standard deviations) of 5.76 (2.16), 7.21 (2.35) and 7.60 (1.72), respectively. Failure of intubation was 21% (8/38), 2% (1/40) and 0% (0/36), respectively. There is an absolute risk reduction of 27-30% in failure of intubation when either VGL or VEL is used. Students recognized the contribution of the simulation-based activities to the development of their intubation skills. They appreciated the opportunity to actually perform intubation in a rehearsal setting before doing the procedure on real patients.CONCLUSION: Medical simulation enhanced student skills development. Experiential learning or self-discovery learning method may be as effective as instructor guided simulation.

Assessment of Coronary Artery Calcium Scoring for Statin Treatment Strategy according to ACC/AHA Guidelines in Asymptomatic Korean Adults

PURPOSE: The 2013 American College of Cardiology (ACC)/American Heart Association (AHA) cholesterol management guidelines advocate the use of statin treatment for prevention of cardiovascular disease. We aimed to assess the usefulness of coronary artery calcium (CAC) for stratifying potential candidates of statin use among asymptomatic Korean individuals. MATERIALS AND METHODS: A total of 31375 subjects who underwent CAC scoring as part of a general health examination were enrolled in the current study. Statin eligibility was categorized as statin recommended (SR), considered (SC), and not recommended (SN) according to ACC/AHA guidelines. Cox regression analysis was employed to estimate hazard ratios (HR) with 95% confidential intervals (CI) after stratifying the subjects according to CAC scores of 0, 1–100, and >100. Number needed to treat (NNT) to prevent one mortality event during study follow up was calculated for each group. RESULTS: Mean age was 54.4±7.5 years, and 76.3% were male. During a 5-year median follow-up (interquartile range; 3–7), there were 251 (0.8%) deaths from all-causes. A CAC >100 was independently associated with mortality across each statin group after adjusting for cardiac risk factors (e.g., SR: HR, 1.60; 95% CI, 1.07–2.38; SC: HR, 2.98; 95% CI, 1.09–8.13, and SN: HR, 3.14; 95% CI, 1.08–9.17). Notably, patients with CAC >100 displayed a lower NNT in comparison to the absence of CAC or CAC 1–100 in SC and SN groups. CONCLUSION: In Korean asymptomatic individuals, CAC scoring might prove useful for reclassifying patient eligibility for receiving statin therapy based on updated 2013 ACC/AHA guidelines.

Número necessário a tratar (NNT) e custo por evento evitado (COPE) de enzalutamida e acetato de abiraterona para o tratamento de câncer de próstata resistente à castração que falharam a terapia de privação de androgênio / Number needed to treat (NNT) and cost of preventing an event (COPE) of enzalutamide vs. abiraterone acetate plus prednisone for the treatment of metastatic castration-resistant prostate cancer (mCRPC) patients who failed androgen deprivation therapy (ADT)

Objetivo: O objetivo deste estudo foi estimar o número necessário a tratar (NNT) e custo por evento evitado (COPE) de enzalutamida (ENZ) em comparação com abiraterona+prednisona (AA+P) em 12 e 24 meses sob perspectiva do sistema de saúde suplementar em pacientes com câncer de próstata resistente à castração metastático (CPRCM) sem quimioterapia prévia. Métodos: O NNT é calculado pelo inverso da diferença do risco absoluto de uma intervenção versus placebo; adicionalmente, o COPE representa o NNT multiplicado pelo custo de tratamento total de um período determinado. O risco absoluto de ENZ e AA+P e seus respectivos controles foram obtidos das curvas de sobrevida livre de progressão radiográfica (SLPr) e sobrevida global (SG) dos estudos PREVAIL e COU-AA-302, respectivamente. A duração de tratamento média no horizonte de 24 meses foi estimada utilizando a área sob a curva das respectivas curvas de SLPr. Os resultados foram a comparação entre ENZ e AA+P versus seus respectivos placebos em 12 e 24 meses para NNT e COPE. O custo total de tratamento consistiu em custos de medicamento, monitoramento, e manejo de eventos adversos (≥1%, eventos de interesses especiais). Resultados: A análise de 12 meses resultou em NNTSG/ENZ= 12,79; NNTSLPr/ENZ= 2,59; NNTSG/AA+P= 116,28; NNTSLPr/AA+P= 4,72 e COPESG/ENZ= BRL 1.626.583; COPESLPr/ENZ= BRL 329.701; COPESG/AA+P= BRL 15.144.886; COPESLPr/AA+P= BRL 614.368. Para a análise de 24 meses, os resultados foram: NNTSG/ENZ= 11,00; NNTSLPr/ENZ= 3,58; NNTSG/AA+P= 16,56; NNTSLPr/AA+P= 5,00 e COPESG/ENZ= BRL 1.965.454; COPESLPr/ENZ= BRL 639.327; COPESG/AA+P= BRL 2.833.580; COPESLPr/AA+P= BRL 855.741. Conclusão: Para ambos horizontes de tempo, os resultados foram favoráveis para ENZ vs. AA+P em pacientes com CPRCM.

Objective: The aim of this study was to estimate the NNT and COPE of enzalutamide (ENZ) in comparison with abiraterone acetate+prednisone (AA+P) over a 12-month and 24-month period from the Supplementary Health System perspective in metastatic castration-resistant prostate cancer patients who are chemotherapy naïve (MCRPC). Methods: The NNT is calculated by the inverse of the absolute risk reduction of an intervention vs. control; additionally, COPE represents the NNT multiplied by total cost of treatment in a pre-defined period. The absolute risk of ENZ and AA+P, and their respective control treatments, were obtained from the Kaplan Meier curves for the co-primary end points of radiographic progression free survival (rPFS) and overall survival (OS) from the clinical studies PREVAIL and COU-AA-302, respectively. Mean treatment duration was estimated utilizing the area under curve (AUC) technique from the respective intervention rPFS curves. The results analyzed ENZ or AA+P versus its respective placebo at 12 and 24 months for NNT and COPE. Total treatment cost consisted of drug cost, monitoring cost and adverse event (>=1% incidence and special interest adverse events) related cost. Results: The 12 month analysis resulted in NNTOS/ENZ= 12.79; NNTrPFS/ENZ= 2.59; NNTOS/AA+P= 116.28; NNTrPFS/AA+P= 4.72 and COPEOS/ENZ= BRL 1,626,583; COPErPFS/ENZ= BRL 329,701; COPEOS/AA+P= BRL 15,144,886; COPErPFS/AA+P= BRL 614,368. For the 24-month analysis, the results were: NNTOS/ENZ= 11.00; NNTrPFS/ENZ= 3.58; NNTOS/AA+P=16.56; NNTrPFS/AA+P= 5.00 and COPEOS/ENZ= BRL 1,965,454; COPErPFS/ENZ= BRL 639,327; COPEOS/ AA+P= BRL 2,833,580; COPErPFS/AA+P= BRL 855,741. Conclusion: Across the 12- and 24-month time horizons, the NNT and COPE was favorable for ENZ vs. AA+P in patients with MCRPC.

CHEMOPROPHYLAXIS TO CONTROL LEPROSY AND THE PERSPECTIVE OF ITS IMPLEMENTATION IN BRAZIL: A PRIMER FOR NON-EPIDEMIOLOGISTS / Quimioprofilaxia para prevenção de hanseníase e sua implantação no Brasil: uma explicação introdutória para não epidemiologistas

The occurrence of leprosy has decreased in the world but the perspective of its elimination has been questioned. A proposed control measure is the use of post-exposure chemoprophylaxis (PEP) among contacts, but there are still questions about its operational aspects. In this text we discuss the evidence available in literature, explain some concepts in epidemiology commonly used in the research on this topic, analyze the appropriateness of implementing PEP in the context of Brazil, and answer a set of key questions. We argue some points: (1) the number of contacts that need to receive PEP in order to prevent one additional case of disease is not easy to be generalized from the studies; (2) areas covered by the family health program are the priority settings where PEP could be implemented; (3) there is no need for a second dose; (4) risk for drug resistance seems to be very small; (5) the usefulness of a serological test to identify a higher risk group of individuals among contacts is questionable. Given that, we recommend that, if it is decided to start PEP in Brazil, it should start on a small scale and, as new evidence can be generated in terms of feasibility, sustainability and impact, it could move up a scale, or not, for a wider intervention.

A ocorrência de hanseníase tem diminuído no mundo apesar de que a perspectiva de sua eliminação tem sido questionada. Uma proposta para o controle da endemia é a quimioprofilaxia pós-exposição entre contatos (post-exposure chemoprophylaxis, PEP), embora ainda existam dúvidas quanto aos seus aspectos operacionais e generalização de resultados. Nesse texto nós discutimos as evidências disponíveis na literatura, explicamos alguns conceitos epidemiológicos comumente encontrados em pesquisa sobre PEP e a implantação da PEP no contexto brasileiro. Nós argumentamos que: (1) a estimativa em diferentes estudos do numero de contatos necessário para receber PEP para prevenir um novo caso de hanseníase (number needed to treat, NNT) não é facilmente generalizável; (2) áreas cobertas pelo programa de saúde da família são as áreas prioritárias onde PEP poderia ser implantado; (3) não existe necessidade de segunda dose da quimioprofilaxia; (4) o risco de resistência à droga usada na PEP parece ser muito pequeno; (5) questionamos a necessidade de teste sorológico para identificar indivíduos entre os contatos que tenham maior risco de doença. Nós opinamos que, se houver uma decisão para se iniciar PEP no Brasil, essa intervenção deveria ser iniciada em pequena escala e, à proporção que novas evidências são geradas sobre a factibilidade, sustentabilidade e impacto da intervenção, a intervenção com PEP poderia ou não ser usada em larga escala.

Effects of presenting risk information in different formats to cardiologists. A Latin American survey / Encuesta sobre los efectos de la presentación de los riesgos y beneficios en distintos formatos a cardiólogos latinoamericanos

Objective: Previous publications demonstrated that the presentation of treatment benefits in terms of relative risk reduction (RRR) rather than in terms of absolute risk reduction (ARR) or number of patients to treat (NNT) might favor the perception of outcome effectiveness. The objective was to perform a cognitive evaluation to assess how the manner in which risks and benefits of screening methods and treatments are presented can affect medical care decision-taking in a sample of cardiologists. Methods: Four-hundred and six Latin American cardiologists answered a questionnaire reporting the results of clinical trials presented as RRR, ARR or NNT, associated or not to biased graphs. Results: Cardiologists' decision-taking was different when comparing treatment benefits presented as RRR (62.2%) vs. ARR (40.4%) (p = 0.000000), and as RRR vs. NNT (44.4%) (p = 0.000000). However, their decision-taking was similar when information was presented as NNT or ARR (p = 0.073). The inclusion of biased graphs was misinterpreted as an actual data difference (RRR: 61.6% vs. ARR: 14.0%, p = 0.000000). Conclusions: This study demonstrated that Latin American cardiologists could misinterpret statistical data when information of clinical trials is presented in terms of RRR. We emphasize the need to enhance cardiologists' training in quantitative techniques, to improve medical care decision-making.

Objetivo: Publicaciones previas demostraron que la presentación de los beneficios terapéuticos en términos de reducción del riesgo relativo (RRR) en lugar de en términos de reducción del riesgo absoluto (RRA) o número necesario a tratar (NNT) favorecería la percepción de que los resultados son más efectivos. El objetivo fue realizar una evaluación en una muestra de cardiólogos para determinar cómo afecta a la decisión médica la manera como se presentan los riesgos y beneficios de métodos diagnósticos y terapéuticos. Métodos: Cuatrocientos seis cardiólogos latinoamericanos respondieron a un cuestionario que contenía los resultados de ensayos clínicos como RRR, RRA y/o NNT, asociados o no a gráficos sesgados. Resultados: La toma de decisión de los cardiólogos fue diferente al comparar los beneficios terapéuticos presentados como RRR (62.2%) vs. RRA (40.4%) (p = 0.000000), y como RRR vs. NNT (44.4%) (p = 0.000000); sin embargo, fue similar cuando la información se presentó como NNT o RRA (p = 0.073). La inclusión de gráficos sesgados fue malinterpretada como una diferencia real (RRR: 61.6% vs. RRA: 14.0%, p = 0.000000). Conclusiones: Se demostró que los cardiólogos latinoamericanos podrían confundir resultados estadísticos cuando la información de los ensayos clínicos se presenta como RRR. Hacemos hincapié en la necesidad de entrenar a los cardiólogos en las técnicas cuantitativas para mejorar la toma de decisiones.

Quimioprofilaxia de contatos de doentes de hanseníase com rifampicina em dose única / Chemoprophylaxis of contacts of leprosy patients with rifampicin in a single dose

INTRODUÇÃO: Na década de 1940, a dapsona tornou-se a droga de escolha para o tratamento da hanseníase. No início de 1980 ela foi incluída no tratamento com poliquimioterapia (PQT), resultado da combinação da rifampicina, dapsona e clofazimina, instituído no Brasil na década de 1990. Desde então, mais de 15 milhões de pacientes de hanseníase foram curados em todo o mundo, como resultado da implementação global da PQT/OMS para eliminação da hanseníase como problema de saúde pública. Quanto a taxa de incidência da hanseníase, representada pela taxa de detecção, ocorreu redução na maioria dos países endêmicos. No Brasil as taxas de detecção sofrem redução contínua e linear com média de 5% ao ano desde 2003. Para regiões mais endêmicas como Norte, Nordeste e Centre-Oeste ocorre declínio anual mais expressivo da detecção, no entanto permanecem muitas áreas com alta endemicidade. Para a vigilância epidemiológica da hanseníase ressalta-se o exame de contatos como principal atividade em razão da insuficiência da detecção de casos por demanda espontânea. A quimioprofilaxia oferecida aos contatos de casos conhecidos tem sido testada em várias protocolos, como uma intervenção para a redução da incidência da hanseníase. Um termo mais amplamente utilizado para a quimioprofilaxia e/ou imunoprofilaxia é "profilaxia pós-exposição (PEP)". A PEP pode ser usada para expressar quimioprofilaxia ou imunoprofilaxia, ou ainda, para ambas. DELIBERAÇÃO FINAL: Os membros da CONITEC presentes na reunião do plenário do dia 11/06/2015 deliberaram, por unanimidade, recomendar a incorporação da quimioprofilaxia de contato de doentes de hanseníase com rifampicina em dose única de acordo com estratégia de implantação do Ministério da Saúde. Foi assinado o Registro de Deliberação nº 127/2015. DECISÃO: PORTARIA Nº 32, de 30 de junho de 2015 - Torna pública a decisão de incorporar a quimioprofilaxia de contatos de doentes de hanseníase com rifampicina em dose única no âmbito do Sistema Único de Saúde - SUS.

Writing Times in Three Digit Numerals: Relation between Times and Syntactic Structure of Verbal Expressions Dictated / Tiempos de escritura en numerales de tres dígitos: relación entre el tiempo y la estructura sintáctica de las expresiones verbales dictadas / Tempos de escritura em numerais de três dígitos: relação entre a tempo e a estrutura sintática das expressões verbais ditadas

Objective. This study evaluates in three-digit numerals how the writing times between digits (Inter Digit Jump - IDJ) adjust to the predictions deduced from the transcoding models proposed by Power and Dal Martello (1990) and Barrouillet, Camos, Perruchet and Seron (2004), who explain the writing of numerals in children. Method. The study had the participation of twenty five (25) first grade children who wrote down spoken verbal numerals in three-digit numerals correctly; the duration of the Inter-Digit Jump was analyzed for four types of numerals during the course of four sessions. Results. The results of the ANOVAs showed that in the four types of numerals, the duration in the first IDJ is greater than in the second IDJ, and that the shortest durations tended to take place prior to writing the zero digit. Conclusion. These findings best fit the predictions based on the model by Barrouliet et al., (2004), which assumes that the chain of digits is produced and stored in a buffer to be subsequently produced by the graphomotor procedures, showing that in three-digit numerals the IDJ duration reflects more the production program than the syntactic structure of the verbal numerals dictated.

Objetivo. El presente estudio evalúa el ajuste de los tiempos en las pausas entre dígitos, en la escritura de numerales arábigos, con las predicciones que se derivan de los modelos de transcodificación de Power y Dal Martello (1990) y Barrouillet, Camos, Perruchet y Seron (2004), quienes explican el proceso de transcodificación de numerales en niños. Método. En el estudio participaron 25 niños de primer grado que escribían correctamente numerales de tres dígitos a partir de un dictado, se analizó el tiempo de las pausas entre dígitos para cuatro tipos de numeral en cuatro sesiones de trabajo. Resultados. Los análisis de varianza ANOVA mostraron que en los cuatro tipos de numerales la duración en la primera pausa es mayor que en la segunda y que los menores tiempos tienen lugar antes de escribir el dígito cero. Conclusión. Estos resultados se ajustan mejor a las predicciones basadas en el modelo de Barrouliet et al. (2004), el cual supone que la cadena de dígitos se produce y almacena en una memoria intermedia para luego ser producida por los procedimientos de grafomotores, lo que sugiere que en los numerales de tres dígitos los tiempos en las pausas entre dígitos reflejan el programa motor de escritura más que la estructura sintáctica de los numerales verbales dictados.

Escopo. O presente estudo avalia o ajuste dos tempos nas pausas entre dígitos na escritura de numerais arábicos, com as predições que são derivadas dos modelos de trans-codificação de Power e Dal Martello (1990) e Barrouillet, Camos, Perruchet e Seron (2004), que explicam o processo de trans-codificação de numerais em crianças. Metodologia. No estudo participaram 25 crianças do primeiro ano que escreviam corretamente numerais de três dígitos a partir de um ditado, foi analisado o tempo das pausas entre dígitos para quatro tipos de numeral em quatro sessões de trabalho. Resultados. Os análises de variância ANOVA mostraram que nos quatro tipos de numerais a duração na primeira pausa é maior que na segunda e que os menores tempos têm lugar antes de escrever o dígito zero. Conclusão. Estos resultados ajustam-se melhor para as predições baseadas no modelo Barrouliet et al. (2004), no qual supõe que a cadeia de dígitos é produzida e armazenada numa memória intermédia para depois ser feita pelos procedimentos grafomotores, o que sugere que nos numerais de três dígitos os tempos nas pausas entre dígitos refletem o programa motor de escritura mais que a estrutura sintática dos numerais verbais ditados.

El número necesario a tratar como medida de efecto en el tratamiento de la trombocitopenia inmune primaria / The number needed to treat as a measure of effect in the treatment of primary immune thrombocytopenia

En estudios aleatorios placebo controlados o comparativos cuyos resultados son de tipo binario, el efecto de un determinado tratamiento puede ser reportado usando la reducción absoluta del riesgo (RAR) y el número necesario a tratar (NNT), el cual es el inverso de la RAR (1/RAR=NNT). El objetivo del presente estudio fue realizar una revisión de diferentes tipos de tratamiento en Trombocitopenia Inmune Primaria (PTI), calculando como medidas de efecto la RAR y el NNT con sus respectivos intervalos de confianza (IC 95%). El número necesario para dañar (NNH, del inglés Harm) se calcula de la misma forma que el NNT y señala el nivel de seguridad del medicamento, solo que en este caso se toma en cuenta los eventos adversos (escala CTCAE) del tratamiento en relación con el grupo control. Los resultados mostraron que el NNT en estudios aleatorios controlados fue mejor que en estudios de inferior diseño, Los resultados del NNH señalaron un nivel de seguridad aceptable para la mayoría de los tratamientos. Se pudo observar que la edad (menor a 40 años) y la condición no esplenectomizados influyen en algunas ocasiones en el reporte de NNT favorable. Se concluye que dadas las ventajas de la RAR y el NNT el cual engloba tanto la significación estadística como la clínica, deberían ser reportadas conjuntamente con otras medidas de efecto en cualquier trabajo observacional sobre tratamiento de PTI con resultados binarios o dicotómicos, porque orientan sustancialmente hacia la toma de decisiones clínicas apropiadas.

In randomized or comparative studies, when the outcomes are binary or dichotomous, the effect of a specific treatment can be reported using the absolute risk reduction (ARR) and the number needed to treat (NNT), which is the reciprocal of the ARR (1/ARR=NNT). The objective of the present study was to realize a review of the different modalities of treatment of primary immune thrombocytopenia (ITP), using as effect measurement the calculation of the ARR and NNT and their confidence intervals (CI95%). The number needed to harm (NNH) can be calculated with the same formula of NNT, taking in account only the adverse events (CTCAE scale) of the treatment in relation with those in the control group. The results showed the effect of different types of treatment of ITP. The NNT was better in randomized studies than those of inferior design. The NNH calculation showed the safe level of the intervention. It can be observed that age (youth) and no splenectomy condition exhibited some influence in the favorable NNT report. In conclusion, given the advantages of the ARR and the NNT for clinical decision making, it can be suggested that these measurements of effect should also be reported, in addition to other statistical measurements for ITP treatment or any observational study with dichotomous or binary outcomes.

Number needed to treat (NNT), an index for clinical therapeutic efficacy assessment--its significance and application / 中国中西医结合杂志

Number needed to treat (NNT) is a simple and effective index for clinical therapeutic effect assessment worldwide accepted in recent years. By calculation of absolute risk reduction (ARR) of classified variables, it made the effect estimate reflect objectively the therapeutic effect of an intervention. However, clinical application of this index was introduced rarely in Chinese literature. With the examples from some published clinical reports, the calculation of NNT and its 95% confidence interval were demonstrated in this paper, and its application was illustrated by some relevant terms explanation and Meta-analysis methods introduction.

Decompressive Craniectomy for Malignant Middle Cerebral Infarction / 대한뇌혈관외과학회지

Decompressive craniectomy is used to treat increased intracranial pressure due to brain swelling in middle cerebral artery infarction. Recently, 3 European multicenter, prospective, randomized trials and a pooled analysis were published. In the pooled analysis, decompressive craniectomy did not appear to increase the risk of complete dependency, misery, and hopelessness. Exactly 2 patients in the surgical and medical groups (5%) were bedbound and severely disabled (mRS 5) at 1 year. The proportion of patients alive with minimal-tomoderate disability (mRS 0-3), however, was significantly increased from 21% to 43%. Decompressive craniectomy resulted in a 49% absolute risk reduction in death, and an absolute increase in the proportion of patients rated as mRS 2 of 12%, mRS 3 of 10%, and mRS 4 of 29%. But, this can be applied in cases with relative young age and early surgical procedure. Therefore, the indication for decompressive craniectomy should be individualized and its potential implications on long-term outcomes should be comprehensively discussed with the caregivers.

Eficacia del bloqueo nervioso con Levobupivacaina en comparación a Bupivacaina / Effectiveness of nerve blocking with levobupivacaina in comparasion to bupivacaina

Pregunta de Investigación.- ¿Sera la eficacia clínica de levobupivacaina mejor que la producida por Bupivacaina ?. Objetivos.- Evaluar en el campo de la clínica anestesiológica la eficacia de la levobupivacaina en espacio peridural y raquídeo en comparación a Bupivacaina. Diseño.- Ensayo clínico a doble ciego. Lugar.- Hospital de Clínicas Universitario, Hospital del Niño, Hospital Militar COSSMIL y Hospital de la Mujer de la ciudad de La Paz, años 2002,2003,2004. Participantes.- Pacientes ASA 1 y 2 sometidos a cirugía. Métodos.- Pacientes divididos en 4 grupos y nueve subgrupos. Primer grupo (subgrupo ABC) con levobupivacaina 0,5 y 0,75 por ciento y Bupivacaina 0,5 por ciento. Segundo grupo (subgrupo D y E) con levobupivacaina y bupivacaina al 0,5 por ciento. Tercer grupo (subgrupos F y G) con levobupivacaina y Bupivacaina al 0,375 por ciento. Cuarto grupo (subgrupo H e I) con levobupivacaina pesada al 0,75 por ciento y Bupivacaina pesada al 0,5 por ciento . En cirugías de periné, cesárea, abdomen y extremidades inferiores.

Research questionWill the clinical effectiveness of Levobupivacaine be better than the produced one for Bupivacaine? Objectives Evaluate in the field of the clinical anestesiologist the effectiveness of Levobupivacaine in peridural and spinal space in comparison to Bupivacaine. DesignA clinical essay to blind double. Place University Hospital of Clinics, Hospital of the Boy, Military Hospital COSSMIL and Woman's Hospital from the city of La Paz, among 2002-2003. Participants Subjected patients ASA 1 and 2 to surgery Methods Patients divided in four groups. First group with Levobupivacaine 0,5-0,75% and Bupivacaine 0,5%. Second group with Levobupivacaine and Bupivacaine to 0,5%. Third group with Levobupivacaine and Bupivacaine to 0,375%. Fourth group with Levobupivacaine weighed 0,75% and Bupivacaine weighed to 0,5%. In perine surgeries, Caesarean operation, abdomen and inferior extremities. Results Total 258 patients. In Sub-group D and F smaller grade of blockade motor was obtained (grade 1 in 37% and null 65%) bigger analgesic duration (7 hours) and bigger quality of sensitive blockade. In the Sub-group H smaller time of latency (22 seconds +10.3). No group presented colateral goods of importance clínica. The hemodynamic changes were minimum in those that received Levobupivacaine. The Reduction of the Relative Risk, of the Attributable Risk and the Necessary Number to Try in favor of Levobupivacaína in peridural and spinal anesthesia. Conclusion The time average of latency and grade of blockade motor were smaller in patients who recived Levobupivacaine. The level and quality of sensitive blockade, the quality and duration of analgesia were bigger with Levobupivacaine in peridural and spinal anesthesia. They were not identified colateral effects of clinical importance in none of the study groups. Levobupivacaine offers bigger effectiveness in comparison to Bupivacaine.

Can Periodic Health Examinations Modify Risk Factors of Coronary Heart Disease?

BACKGROUND: The management of risk factors of coronary heart disease is highly needed because the prevalence of ischemic heart disease is increasing in Korea. This study was aimed to evaluate the effects of periodic health examination on risk factors of coronary heart disease using Framingham Point Scores. METHODS: The medical records of 343 clients who underwent periodic health examination five times from January 1996 to December 2001 at one medical center in Seoul were reviewed. The five risk factor scores (age, total cholesterol, smoking, HDL-cholesterol, systolic blood pressure), total risk scores, absolute risk and the proportion of the high risk group and the obesity group were analyzed for all the periodic health examinations. RESULTS: For the five periodic health examinations, age risk factor score increased in men and women. Scores of risk factors such as smoking, total cholesterol, HDL-cholesterol and systolic blood pressure decreased in men only (P<0.0001). The total risk score (P<0.0001) and the absolute risk (P=0.0002) increased in men. The total risk score (P<0.0001) and the absolute risk (P=0.3238) increased in women with no changes of other risk factors except increased age score and decreased HDL-cholesterol score. The proportion of the high risk group (P=0.5406) and the obesity group (P=0.0762) were very small and not changed. CONCLUSION: The risk of coronary heart disease as not reduced with the five periodic health examinations. Therefore, the total risk score and the absolute risk did not decrease. Continuous risk factors management must be emphasized after periodic health examination for absolute risk reduction.