Risk factors for adverse events of colorectal endoscopic submucosal dissection: a systematic review and meta-analysis.

Colorectal endoscopic submucosal dissection (ESD) is already an established treatment for superficial colorectal tumors. However, its technical difficulty and high adverse events rates, compared to endoscopic piecemeal mucosal resection, are a concern to some specialists and have probably contributed to discouragement in its widespread adoption. The debate mentioned above stimulated us to perform a systematic review aiming to identify risk factors for colorectal ESD-related adverse events. We conducted this study following the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement and registered in the PROSPERO (University of York) international database (CRD42016042625). We searched MEDLINE, EMBASE, Cochrane Library and LILACS for the publications focused on risk factors for colorectal ESD-related adverse events from inception until April 2020. We included a total of 22 qualified studies in this analysis. We found that fibrosis had an odds ratio (OR) for perforation of 2.90 [95% confidence interval, (1.83-4.59)], right colon location of 2.35 (1.58-3.50), colonic location of 2.20 (1.44-3.35) and larger size of 2.17 (1.47-3.21), as well as one protective factor, the endoscopist experience OR = 0.62 (0.45-0.86). For bleeding, we considered rectal location a risk factor [OR = 3.55 (2.06-6.12)]. Through the several meta-analyses that we performed in this article, we could summarize the main risk factors for perforation and bleeding on colorectal ESD. Therefore, we provide insightful information for clinical judgment on regions where colorectal ESD is already widespread and help in the learning process of this challenging technique.

Avaliação crítica de estudos de custo-efetividade de medicamentos oncológicos recomendados para incorporação pela Conitec no Brasil / Critical appraisal of cost-effectiveness studies of oncologic drugs recommended for incorporation by the Conitec in Brazil

Objetivo: Realizar uma análise descritiva e avaliar a qualidade metodológica das análises de custo-efetividade dos medicamentos recomendados para incorporação pela Comissão Nacional de Incorporação de Tecnologias no SUS (Conitec) para o tratamento de câncer. Métodos: Um levantamento no site da Conitec foi realizado para identificar os relatórios de recomendação para medicamentos utilizados no tratamento de câncer, datados de janeiro/2012 a junho/2019. Os relatórios dos medicamentos com recomendação para incorporação e que apresentavam estudos de avaliação econômica em saúde foram incluídos. Uma análise descritiva e da qualidade metodológica (ferramenta Consensus on Health Economic Criteria [CHEC]) foi realizada. Resultados: Dez indicações diferentes, de oito medicamentos, para tratamento de câncer foram recomendadas pela Conitec de janeiro/2012 a junho/2019, porém somente cinco (50%) dispunham de estudos de avaliação econômica. Um estudo foi excluído da avaliação da qualidade devido a limitações de acesso às informações. A qualidade metodológica foi variável nos estudos apresentados, e os domínios com pior avaliação se relacionavam a medida apropriada do desfecho e custos, discussões sobre ética, conflito de interesse e generalização dos dados. Observa-se uma falta de padronização na forma como foram realizadas as avaliações econômicas dos estudos submetidos à Conitec. Conclusão: Há grande heterogeneidade em relação à qualidade dos estudos de custo-efetividade de medicamentos oncológicos recomendados para incorporação pela Conitec e limitações metodológicas relevantes foram identificadas na maioria dos estudos

Objective: To perform a descriptive analysis and evaluate the methodological quality of the costeffectiveness studies that based the "Comissão Nacional de Incorporação de Tecnologias no SUS" (Conitec) recommendations for cancer treatment. Methods: A survey on the Conitec website was performed in order to identify the recommendation reports for anticancer drugs, from January/2012 to June/2019. Reports for new drug incorporation that presented cost-effectiveness were included and analyzed. The methodological quality of these reports was assessed with the tool Consensus on Health Economic Criteria (CHEC). Results: Ten different indications of eight anticancer drugs were recommended by Conitec from 2012 to June/2019, but only five (50%) had health economic analysis. One study was excluded from quality assessment due to limited information access. Methodological quality varies among the studies. The worst domains assessed were related to appropriate measurement of outcome and costs, ethics-related discussions, conflict of interest, and generalizability of the results. A lack of standardization was observed in Conitec's assessment on health economic studies submitted. Conclusion: There is a great heterogeneity in cost-effectiveness study quality of cancer drugs recommended by Conitec and relevant methodological limitations was noticed

Decrease in mortality rate and hospital admissions for acute myocardial infarction after the enactment of the smoking ban law in São Paulo city, Brazil.

BACKGROUND: Smoking restriction laws have spread worldwide during the last decade. Previous studies have shown a decline in the community rates of myocardial infarction after enactment of these laws. However, data are scarce about the Latin American population. In the first phase of this study, we reported the successful implementation of the law in São Paulo city, with a decrease in carbon monoxide rates in hospitality venues. OBJECTIVE: To evaluate whether the 2009 implementation of a comprehensive smoking ban law in São Paulo city was associated with a reduction in rates of mortality and hospital admissions for myocardial infarction. METHODS: We performed a time-series study of monthly rates of mortality and hospital admissions for acute myocardial infarction from January 2005 to December 2010. The data were derived from DATASUS, the primary public health information system available in Brazil and from Mortality Information System (SIM). Adjustments and analyses were performed using the Autoregressive Integrated Moving Average with exogenous variables (ARIMAX) method modelled by environmental variables and atmospheric pollutants to evaluate the effect of smoking ban law in mortality and hospital admission rate. We also used Interrupted Time Series Analysis (ITSA) to make a comparison between the period pre and post smoking ban law. RESULTS: We observed a reduction in mortality rate (-11.9% in the first 17 months after the law) and in hospital admission rate (-5.4% in the first 3 months after the law) for myocardial infarction after the implementation of the smoking ban law. CONCLUSIONS: Hospital admissions and mortality rate for myocardial infarction were reduced in the first months after the comprehensive smoking ban law was implemented.

Quality of life in adult intradural primary spinal tumors: 36-Item Short Form Health Survey correlation with McCormick and Aminoff-Logue scales.

OBJECT: The most appropriate method to determine the quality of life of patients with intradural primary spinal tumors (IPSTs) is not still well established. METHODS: Clinical data in 234 patients who underwent surgery for intradural spinal disease were collected prospectively. The 36-Item Short Form Health Survey (SF-36), a generic score scale, was administered to 148 patients with IPSTs to demonstrate if the survey can be used to effectively evaluate these patients. Forty-eight patients were excluded because they did not complete the protocol. The study was finally conducted with 100 patients (45 male and 55 female) with IPSTs, and the results were compared with those of 2 other scales: the McCormick scale and the Aminoff-Logue scale. RESULTS: Construct validity was demonstrated by confirming the hypothesized relationship between the scores of the SF-36 and the McCormick scale (p = 0.003), the Aminoff-Logue gait subscale (p = 0.025), the Aminoff-Logue micturition subscale (p = 0.013), and the Aminoff-Logue defecation subscale (p = 0.004). Reliability was demonstrated for all 8 SF-36 domain scales and the Physical Component Summary and the Mental Component Summary of the SF-36, where in each the Cronbach alpha satisfied the Nunnally criterion of > 0.85. CONCLUSIONS: The authors' results demonstrated that SF-36 provides valid and reliable data for patients with IPSTs and that the survey can be used appropriately to evaluate these patients.

Low-level laser therapy for pain relief after episiotomy: a double-blind randomised clinical trial.

AIMS AND OBJECTIVES: To evaluate the effectiveness of a low-level laser therapy for pain relief in the perineum following episiotomy during childbirth. BACKGROUND: Laser irradiation is a painless and non-invasive therapy for perineal pain treatment and its effects have been investigated in several studies, with no clear conclusion on its effectiveness. DESIGN: A double-blind randomised controlled clinical trial. METHOD: One hundred and fourteen women who underwent right mediolateral episiotomies during vaginal birth in an in-hospital birthing centre in São Paulo, Brazil and reported pain ≥ 3 on a numeric scale (0-10) were randomised into three groups of 38 women each: two experimental groups (treated with red and infrared laser) and a control group. The experimental groups were treated with laser applied at three points directly on the episiotomy after suturing in a single session between 6-56 hours postpartum. We used a diode laser with wavelengths of 660 nm (red laser) and 780 nm (infrared laser). The control group participants underwent all laser procedures, excluding the emission of irradiation. The participants and the pain scores evaluator were blinded to the type of intervention. The perineal pain scores were assessed at three time points: before, immediately after and 30 minutes after low-level laser therapy. RESULTS: The comparison of perineal pain between the three groups showed no significant differences in the three evaluations (p = 0.445), indicating that the results obtained in the groups treated with low-level laser therapy were equivalent to the control group. CONCLUSIONS: Low-level laser therapy did not decrease the intensity of perineal pain reported by women who underwent right mediolateral episiotomy. RELEVANCE TO CLINICAL PRACTICE: The effect of laser in perineal pain relief was not demonstrated in this study. The dosage may not have been sufficient to provide relief from perineal pain after episiotomy during a vaginal birth.

Effectiveness of school-based nutrition education interventions to prevent and reduce excessive weight gain in children and adolescents: a systematic review.

OBJECTIVE: To evaluate the effectiveness of school-based nutrition education in reducing or preventing overweight and obesity in children and adolescents. SOURCES: Systematic search in 14 databases and five systematic reviews for randomized controlled trials conducted in schools to reduce or prevent overweight in children and adolescents. Body mass index and fruit and vegetable intake were used as primary and secondary measures of outcome, respectively. There was no restriction by date of publication or language, except for languages with structured logograms. We excluded studies on specific populations presenting eating disorders, dyslipidemia, diabetes, and physical or mental disabilities, as well as studies that used drugs or food supplements as components of the intervention. The assessment by title and abstract and the quality assessment were performed independently by two researchers. We used the Centre for Reviews and Dissemination's guidance for undertaking reviews in health care and the software EPPI-Reviewer 3. SUMMARY OF THE FINDINGS: From the initially retrieved 4,809 references, 24 articles met the inclusion criteria. The extracted data show that there is evidence of positive effects on anthropometry and of increase in fruit and vegetable consumption. Characteristics of the interventions that demonstrated effectiveness are: duration > 1 year, introduction into the regular activities of the school, parental involvement, introduction of nutrition education into the regular curriculum, and provision of fruits and vegetables by school food services. CONCLUSION: Interventions in schools to reduce overweight and obesity, as well as to increase fruits and vegetable consumption, have demonstrated effectiveness in the best-conducted studies.

A efetividade de intervenções de educação nutricional nas escolas para prevenção e redução do ganho excessivo de peso em crianças e adolescentes: uma revisão sistemática / Effectiveness of school-based nutrition education interventions to prevent and reduce excessive weight gain in children and adolescents: a systematic review

OBJETIVO: Avaliar a efetividade da educação nutricional em escolas na redução ou prevenção de sobrepeso e obesidade em crianças e adolescentes. FONTES DOS DADOS: Busca sistemática em 14 bases de dados e cinco revisões sistemáticas por ensaios controlados randomizados realizados em escolas com o objetivo de reduzir ou prevenir o sobrepeso em crianças e adolescentes. O índice de massa corporal e o consumo de frutas e verduras foram utilizados como desfechos primário e secundário, respectivamente. Não houve restrição de data de publicação ou idioma, exceto para idiomas com logogramas. Excluímos estudos em populações com distúrbios alimentares, dislipidemia, diabetes e deficiência física ou mental, e que utilizassem medicamentos ou suplementos alimentares. A avaliação por título e resumo e a avaliação de qualidade foram realizadas de forma independente por dois pesquisadores. Utilizamos as orientações do Centre for Reviews and Dissemination para a elaboração de artigos de revisão em saúde e o programa EPPI-Reviewer 3. SÍNTESE DOS DADOS: Das 4.809 referências inicialmente encontradas, 24 artigos preencheram os critérios de inclusão. Os dados extraídos apresentam evidências de efeitos antropométricos positivos e de aumento no consumo de frutas e verduras. As intervenções com as seguintes características demonstraram ser efetivas: duração > 1 ano, introdução como atividade regular da escola, envolvimento dos pais, introdução da educação nutricional no currículo regular e fornecimento de frutas e verduras pelos serviços de alimentação da escola. CONCLUSÃO: As intervenções para reduzir o sobrepeso e a obesidade e aumentar o consumo de frutas e verduras foram efetivas nos estudos bem conduzidos.

OBJECTIVE: To evaluate the effectiveness of school-based nutrition education in reducing or preventing overweight and obesity in children and adolescents. SOURCES: Systematic search in 14 databases and five systematic reviews for randomized controlled trials conducted in schools to reduce or prevent overweight in children and adolescents. Body mass index and fruit and vegetable intake were used as primary and secondary measures of outcome, respectively. There was no restriction by date of publication or language, except for languages with structured logograms. We excluded studies on specific populations presenting eating disorders, dyslipidemia, diabetes, and physical or mental disabilities, as well as studies that used drugs or food supplements as components of the intervention. The assessment by title and abstract and the quality assessment were performed independently by two researchers. We used the Centre for Reviews and Dissemination's guidance for undertaking reviews in health care and the software EPPI-Reviewer 3. SUMMARY OF THE FINDINGS: From the initially retrieved 4,809 references, 24 articles met the inclusion criteria. The extracted data show that there is evidence of positive effects on anthropometry and of increase in fruit and vegetable consumption. Characteristics of the interventions that demonstrated effectiveness are: duration > 1 year, introduction into the regular activities of the school, parental involvement, introduction of nutrition education into the regular curriculum, and provision of fruits and vegetables by school food services. CONCLUSION: Interventions in schools to reduce overweight and obesity, as well as to increase fruits and vegetable consumption, have demonstrated effectiveness in the best-conducted studies.

The effect of Sao Paulo's smoke-free legislation on carbon monoxide concentration in hospitality venues and their workers.

BACKGROUND: Studies have shown that there is no safe level of secondhand smoke (SHS) exposure and there is a close link between SHS and the risk of coronary heart disease and stroke. Carbon monoxide (CO) is one of the most important components present in SHS. OBJECTIVE: To evaluate the impact of the smoking ban law in the city of Sao Paulo, Brazil, on the CO concentration in restaurants, bars, night clubs and similar venues and in their workers. METHODS: In the present study we measured CO concentration in 585 hospitality venues. CO concentration was measured in different environments (indoor, semi-open and open areas) from visited venues, as well as, in the exhaled air from approximately 627 workers of such venues. Measurements were performed twice, before and 12 weeks after the law implementation. In addition, the quality of the air in the city during the same period of our study was verified. RESULTS The CO concentration pre-ban and pot-ban in hospitality venues was indoor area 4.57 (3.70) ppm vs 1.35 (1.66) ppm (p<0.0001); semi-open 3.79 (2.49) ppm vs 1.16 (1.14) ppm (p<0.0001); open area 3.31(2.2) ppm vs 1.31 (1.39) ppm (p<0.0001); smoking employees 15.78 (9.76) ppm vs 11.50 (7.53) ppm (p<0.0001) and non-smoking employees 6.88 (5.32) ppm vs 3.50 (2.21) ppm (p<0.0001). The average CO concentration measured in the city was lower than 1 ppm during both pre-ban and post-ban periods. CONCLUSION: São Paulo's smoking-free legislation reduced significantly the CO concentration in hospitality venues and in their workers, whether they smoke or not.

Entendimento do termo de consentimento por pacientes partícipes em pesquisas com fármaco na cardiologia / Informed consent as viewed by patients participating in cardiology drug trial / La comprensión del formulario de consentimiento por los pacientes que forman parte de investigaciones con fármaco en la cardiología

Fundamento: Em ensaios clínicos, o Termo de Consentimento Livre e Esclarecido (TCLE) é fundamental para preservar a ética, mas pela sua complexidade ele pode não ser entendido completamente. Neste estudo, avaliamos o entendimento do TCLE pelo paciente. Objetivo: Abordamos a questão sobre o nível de compreensão dos pacientes em relação aos estudos baseados no Consentimento Informado. Métodos: Convidamos participantes de pesquisa ambulatorial fases II, III e IV, com fármacos, para responder um questionário estruturado com 29 questões, tais como: por que aceitou participar? Leu o TCLE antes de assinar? Ao assiná-lo, estava certo de tê-lo entendido? Oitenta indivíduos (20 mulheres e 60 homens) compareceram, num universo de 106 pacientes. As variáveis de cada questão foram consideradas por frequência de ocorrência. A comparação entre as médias entre os grupos foi realizada pelos testes t de Student ou Wilcoxon; e para associações, o Qui-quadrado ou Razão de Verossimilhança, ou teste exato de Fisher. Resultados: A média das idades foi de 58,7 ± 9,3 anos. Das motivações para participar da pesquisa, 66,2 por cento apontaram seu próprio benefício; 42,5 por cento, o bem da ciência; 25,0 por cento alegaram atender a um pedido de seu médico; 50 por cento não entenderam corretamente o TCLE; e 32,9 por cento sequer o leram, mas o assinaram. Dentre os que receberam placebo após a randomização (n = 47), 66,7 por cento não entenderam o significado deste termo. Houve forte correlação entre o não entender o significado de placebo com a escolaridade (p = 0,02), evidenciando que quanto menor o nível de instrução, menor este entendimento. Conclusão: O TCLE é pouco compreendido pelos pacientes e para alguns deles a confiança no médico teve impacto na decisão de participar do ensaio clínico com fármaco, havendo também influência do nível de instrução dos sujeitos no entendimento do termo "placebo".

Background: In clinical tests, the Informed Consent is critical to preserve the ethics, but due to its high complexity level, it cannot be fully understood. This study assesses the Informed Consent as viewed by patients. Objective: We addressed the issue of what do patients understand about the studies based on the IC. Methods: We invited participants of outpatient clinical drug trials phase II, III and IV to answer a questionnaire with 29 questions, such as: why have you accepted to participate? Did you read the Informed Consent before signing it? By signing it, were you sure you have fully understood it? Eighty individuals (20 women and 60 men) showed up, from 106 patients. The variables of each question were considered as often as they appeared. The comparison of the averages among the groups was made by t tests of Student or Wilcoxon; and for associations, Chi-square or Likelihood Ratio, or Fisher's exact test. Results: Ages averaged 58.7 ± 9.3 years. Concerning their reasons to taking part in the survey, 66.2 percent pointed out their own benefit; 42.5 percent, for science's sake; 25.0 percent claimed they were doing so at their doctor's request; 50 percent did not understand the Informed Consent properly; and 32.9 percent did not read it, but signed it. Among those who were administered placebo after randomization (n = 47), 66.7 percent did not understand the meaning of the informed consent. A strong correlation between failure to understand the meaning of placebo with literacy level (p = 0,02) was verified, which is an evidence that the smaller is the literacy level, the smaller is the understanding level. Conclusion: The Informed Consent is poorly understood by patients and for some of them, trusting a doctor affected their decision in taking part in the clinical trial with drugs. Their literacy level also influenced their understanding of the term "placebo".

Fundamento: En ensayos clínicos, el Formulario de Consentimiento Informado (FCI) es fundamental para que se preserve la ética, sin embargo por su complexidad él puede no comprenderse completamente. En este estudio, evaluamos la comprensión del FCI por parte del paciente. Objetivo: Abordamos la cuestión sobre el nivel de comprensión de los pacientes respecto a los estudios basados en el Consentimiento Informado. Métodos: Invitamos a los participantes de investigación clínica fase II, III y IV con fármacos para responder un cuestionario estructurado con 29 cuestiones, tales como: ¿Por qué aceptó participar?¿Leyó el FCI antes de firmarlo?¿Al firmarlo estaba seguro de haberlo entendido? Ochenta individuos (20 mujeres y 60 varones) comparecieron, en un total de 106 pacientes. Las variables de cada cuestión se llevaron a cabo por frecuencia de ocurrencia. La comparación entre los promedios entre los grupos se realizó mediante las pruebas t de Student o Wilcoxon; y para asociaciones, el Chi-cuadrado o Razón de Verosimilitud, o prueba exacta de Fisher. Resultados: El promedio de las edades fue de 58,7 ± 9,3 años. De las motivaciones para participar en la investigación, el 66,2 por ciento señaló su propio beneficio; un 42,5 por ciento, el bien de la ciencia; un 25,0 por ciento alegó atender a una petición de su médico; el 50 por ciento no comprendió correctamente el FCI; y un 32,9 por ciento tampoco leyó el formulario, pero lo firmó. Entre los que recibieron placebo tras la randomización (n = 47), un 66,7 por ciento no entendió el significado de este término. Hubo una fuerte correlación entre las personas que no entendían el significado de placebo con la escolaridad (p = 0,02), evidenciando que cuanto menor era el nivel de instrucción, menor era la comprensión. Conclusión: EL FCI es poco comprendido por los pacientes y para algunos de ellos la confianza en el médico tuvo impacto en la decisión de participar en el ensayo clínico con fármaco, habiendo...

Controle de diabetes mellitus e hipertensão arterial com grupos de intervenção educacional e terapêutica em seguimento ambulatorial de uma unidade básica de saúde / Diabetes mellitus and arterial hypertension control with educational and therapeutic groups in outpatient follow-up in a unidade basica de saúde (Basic health unit)

A educação em saúde, associada ao autocontrole dos níveis de pressão e/ou glicemia, à atividade física e à dieta alimentar, é importante instrumento para aumentar a procura por tratamento e controlar os índices de pacientes hipertensos e/ou diabéticos. O conhecimento das doenças está relacionado à melhora da qualidade de vida, à redução do número de descompensações, ao menor número de internações hospitalares e à maior aceitação da doença. Na Unidade Básica de Saúde Vila Romana, São Paulo, foi proposta intervenção em uma população de pacientes diabéticos e hipertensos por meio de formação de grupos para ação educativa, seguimento regular, fornecimento de medicação, controles periódicos e atendimento de intercorrências. Nos primeiros 3 meses, ocorreram encontros mensais, seguidos de consultas periódicas, controle das doenças e dispensação da medicação por mais 27 meses. Com os 191 pacientes, foram formados grupos de hipertensos e grupos de diabéticos hipertensos. Comparando-se os resultados iniciais com os pós-intervenção, observou-se redução relativa de 42 porcento e absoluta de 26 porcento no número de pacientes com pressão moderada e grave. Para os diabéticos, a redução absoluta foi de 22 porcento, para aqueles com glicemia superior a 200mg/dl, e aumento de 33 porcento, para aqueles com níveis inferiores a 125 mg/dl. Para pacientes dependentes do sistema oficial de saúde e do fornecimento da medicação, em grande parte idosos e pessoas com baixa escolaridade, embora não se tenha obtido no estudo o controle de todos os determinantes de adesão e o controle das doenças, a intervenção se mostrou eficiente. Sugere-se que seja institucionalizada.