Peritonitis diverticular: ¿Qué nos enseñó Ladies Trial? Análisis metodológico de su diseño, aplicación y resultados / Diverticular peritonitis: What did LADIES Trial teach us? Analysis of design, application and results

Contexto y Antecedentes: LADIES TRIAL es uno de los ensayos más importantes referidos a peritonitis diverticular. A pesar de este y otros ensayos publicados, aún se debate cuáles son los procedimientos adecuados para cada escenario de peritonitis diverticular, haciendo necesaria una revisión profunda de la metodología empleada en los ensayos para validar u objetar sus conclusiones. Objetivos: Analizar la metodología empleada en el diseño, aplicación, análisis de resultados y conclusiones de sus publicaciones. Secundariamente, colaborar en el mejoramiento de la investigación de la peritonitis diverticular y facilitar el análisis del tema por parte de los lectores. Métodos: Se analizaron las partes centrales de toda investigación, desde la pregunta de investigación, elaboración de hipótesis, operacionalización de variables y diseño del ensayo, análisis estadístico de resultados y conclusiones. Se buscaron errores, sesgos y debilidades que pudiesen objetar los hallazgos del estudio. Resultados: LADIES se trató de un estudio randomizado, abierto con análisis de superioridad según intención de tratar modificada en aquellos casos de incumplimiento de los criterios de inclusión y exclusión. Su diseño fue en general correcto, aunque en su aplicación se detectaron errores, debilidades y sesgos. En cuanto a resultados LOLA mostró que en Hinchey III el lavado laparoscópico tiene mayor morbimortalidad temprana que la sigmoidectomía, con un tiempo operatorio menor. Por su parte, DIVA mostró que en Hinchey III y IV la anastomosis primaria tiene mayor sobrevida libre de ostomía con menor morbilidad, combinando la cirugía inicial y cierre ostomía, respecto de la operación de Hartmann. Conclusiones: El no haber llegado al tamaño de muestra calculado hizo que solo grandes diferencias consiguieran significancia estadística. Las bajas frecuencias de eventos adversos acentuaron este problema metodológico. La especialización de los centros y cirujanos intervinientes, como la exclusión de pacientes hemodinámicamente inestables o bajo corticoterapia comprometieron su validación externa.

Background: LADIES TRIAL is considered one of the most important trials related to diverticular peritonitis. Its protocol and results were published in 2010, 2015, 2017, and 2019. Despite this one and other published trials, the proper procedures for each diverticular peritonitis scenario are still being debated, a thorough review of the methodology used in this trial is necessary to validate or reject their conclusions. Aim: To analyze the methodology used in the design, application, analysis of results, and conclusions of all LADIES TRIAL publications. Secondly, to collaborate in the improvement of the research about diverticular peritonitis and to facilitate its analysis by the readers. Methods: The central parts of a research trial were analyzed, from the research question, hypothesis development, operationalization of variables and trial design, statistical analysis of results, to conclusions. Errors, biases and weaknesses were searched for to try and challenge the trial's findings. Results: LADIES was a randomized, open-label, superiority trial analyzed according to intention to treat modified in cases of non-compliance with the inclusion-exclusion criteria. Its design was generally correct, although errors, weaknesses, and biases were detected in its application. Regarding results, LOLA showed that, in Hinchey 3, laparoscopic lavage has a higher rate in early morbidity and mortality than sigmoidectomy, but with a shorter operative time. For its part, DIVA showed that, in Hinchey 3 and 4, the primary anastomosis has higher ostomy-free survival with less morbidity, combining the initial surgery and ostomy closure, compared to the Hartmann procedure. Conclusions: Not having reached the sample size calculated in its design implies that only large effect differences achieved statistical significance. The low frequencies of adverse events accentuated this methodological problem. The specialization of the intervening centers and surgeons, the exclusion of hemodynamically unstable patients or patients undergoing steroid therapy, compromised the external validation of their findings.

Changes in diet quality 6 and 12 months post-intervention: the Healthy Habits, Healthy Girls: a Brazilian study / Mudanças na qualidade da dieta em 6 e em 12 meses pós-intervenção: Hábitos Saudáveis, Meninas Saudáveis: estudo brasileiro

ABSTRACT Objective To determine the sustainability of food quality in an obesity-prevention strategy for adolescent girls. Methods The study is a randomized controlled trial with 253 girls (Mean=15.61, 95% Confidence Interval 15.51-15.72) enrolled in 10 vocational schools in São Paulo. The diet intake was determined using a "Food Frequency Questionnaire" and analyzed according to the Brazilian Healthy Eating Index-Revised adequacy, moderation, and overall scores. The adolescents' dietary intake was compared to the baseline 6 months and 12 months post-intervention. Descriptive statistics and analyses of covariance were used, considering a 5% significance level. Results Significant increases were found on the components total fruits (F=6.98, p<0.01), total vegetables (F=5.76, p=0.02), beans (F=5.96, p=0.02), and whole cereals (F=12.35, p<0.001). However, there was also a significant decrease on the scores for milk and dairy (F=6.48, p=0.02), and oils (F=5.98, p=0.02). At 12-month post intervention, improvement on the overall score was found (F=3.89, p=0.05), but there was a decrease on the component whole cereals (F=11.85, p<0.001), as well as in milk and dairies (F=6.38, p=0.02). Despite no significant effect for the SoFAAS component, a moderate effect size was revealed (d=0.56). Conclusion There were significant effects on some diet quality components and for the overall scores at 6-month and 12-month post intervention. Therefore, sustainable dietary changes should be the focus of obesity prevention programs for adolescents. Socio-economic influences on diet behaviors would also need to be acknowledged.

RESUMO Objetivo Determinar a sustentabilidade da qualidade da alimentação presente em uma estratégia de prevenção à obesidade para adolescentes do sexo feminino. Métodos Ensaio randomizado controlado com 253 meninas (Média=15.61, 95% Intervalo de confiança 15.51-15.72) matriculadas em 10 escolas técnicas de São Paulo. Por meio do "Questionário de Frequência Alimentar" a ingestão dietética foi determinada e analisada de acordo com os componentes de adequação, de moderação e de pontuação total do Índice da Qualidade da Dieta-Revisado. A ingestão dietética das adolescentes foi comparada na linha base, em 6 e em 12 meses após a intervenção. Estatística descritiva e análise de covariância foram utilizadas, considerando 5% do nível de significância. Resultados Houve um aumento significativo nos componentes das frutas totais (F=6.98, p<0.01), vegetais totais (F=5.76, p=0.02), feijões (F=5.96, p=0.02) e cereais integrais (F=12.35, p<0.001). Entretanto, houve expressiva redução para a pontuação dos componentes leite e derivados (F=6.48, p=0.02) e óleos (F=5.98, p=0.02). Aos 12 meses de pós-intervenção, foi encontrada melhora na pontuação total do Índice da Qualidade da Dieta-Revisado (F=3.89, p=0.05), porém redução para os componentes cereais integrais (F=11.85, p<0.001) e leites e derivados (F=6.38, p=0.02). Apesar de não haver significância para os componentes gorduras sólidas, açúcar de adição e álcool, o tamanho de efeito moderado foi revelado (d=0.56). Conclusão Foram identificadas mudanças significativas para alguns componentes da qualidade da alimentação e da pontuação total aos 6 e aos 12 meses pós-intervenção. Mudanças dietéticas sustentáveis devem ser o foco de programas de prevenção para adolescentes. Além disso, influências socioeconômicas nos comportamentos dietéticos também devem ser consideradas.

Qualidade dos ensaios clínicos aleatórios publicados por cirurgiões plásticos: seguimento de longo prazo / Quality of randomized clinical trials published by plastic surgeons: a long-term follow-up study

Introdução: Em dois estudos prévios, avaliou-se a qualidade dos ensaios clínicos aleatórios (ECAs) com a participação de pelo menos um cirurgião plástico, em dois períodos: 1966 a 2003 e 2004 a 2008. O objetivo é avaliar a evolução da qualidade das publicações de ECAs por cirurgiões plásticos no período subsequente de cinco anos, de 2009 a 2013. Métodos: ECAs publicados de 2009 a 2013, em língua inglesa, com a participação de pelo menos um cirurgião plástico, foram identificados por busca eletrônica e classificados quanto ao sigilo de alocação, por dois avaliadores independentes. Os estudos com sigilo de alocação adequado tiveram a qualidade avaliada por dois avaliadores, utilizando-se a Lista de Delphi e a Escala de Qualidade de Jadad. Resultados: Dos 6.997 estudos identificados, 261 foram classificados quanto ao sigilo de alocação. Destes, 43 (16,47%) tinham sigilo de alocação adequado. Segundo a avaliação pela Lista de Delphi, houve melhora, em relação a 1966-2003, nos itens "características mais importantes do prognóstico" (p < 0,001), "uso de avaliador independente" (p = 0,0029) e "medidas de variabilidade e estimativa de pontos para a variável primária" (p = 0,0057); não houve diferença em relação a 2004-2008. Quanto à Escala de Qualidade de Jadad, houve um aumento dos escores em relação a 1996-2003 (p < 0,0004), mas também sem diferença significante em relação ao período 2004-2008. Conclusão: Não houve diferença na qualidade das publicações de ECAs por cirurgiões plásticos no período de 2009 a 2013, em relação aos cinco anos anteriores (2004 a 2008). Entretanto, ambos os períodos apresentaram maior qualidade quando comparados ao período de 1966 a 2003.

Introduction: In two previous studies, the quality of randomized clinical trials (RCTs) with the participation of at least one plastic surgeon was assessed in two periods: from 1966 to 2003 and from 2004 to 2008. The objective is to evaluate the evolution of the quality of RCTs published by plastic surgeons in the subsequent five-year period, from 2009 to 2013. Methods: RCTs published from 2009 to 2013, in English, with the participation of at least one plastic surgeon, were identified by an electronic search and classified according to allocation concealment by two independent evaluators. The quality of the studies with adequate allocation concealment was evaluated by two evaluators using the Delphi List and the Jadad Scale. Results: Of the 6,997 identified studies, 261 were classified according to allocation concealment. Of these, 43 (16.47%) had adequate allocation concealment. According to an assessment conducted using the Delphi List, there was an improvement in the items "most important characteristics of the prognosis" (p < 0.001), "use of an independent evaluator" (p = 0.0029), and "measures of variability and estimation of points for the primary variable" (p = 0.0057) compared to the 1966-2003 assessment ; there was no difference in the assessment of the same items from 2004-2008. Regarding the Jadad Scale, there was an increase in the scores from 2009 to 2013 compared to the 1996-2003 period (p < 0.0004); however, there was no significant difference in the 2004-2008 period. Conclusion: There was no difference in the quality of the RCTs published by plastic surgeons in the 2009-2013 period compared to the previous five-year period (2004 to 2008). However, both periods indicated higher quality compared to the 1966-2003 period.

Ensayos clínicos publicados en el Boletín Médico del Hospital Infantil de México: un análisis crítico / Clinical trials published in the Boletín Médico del Hospital Infantil de México: a critical analysis

Resumen Introducción: El ensayo clínico es la manera más rigurosa de conducir los experimentos en seres humanos. Desde su introducción en investigación biomédica se han implementado cambios en el modo de establecer las bases para el diagnóstico, pronóstico y la terapéutica en la práctica clínica. Se han realizado estudios para identificar los ensayos clínicos publicados en diferentes áreas médicas, pero hasta el momento ninguno había identificado los ensayos clínicos publicados en el Boletín Médico del Hospital Infantil de México (BMHIM). El objetivo de este trabajo fue identificar y describir los ensayos clínicos controlados (ECC) publicados en el BMHIM. Métodos: Se realizó búsqueda manual y sistemática en cada uno de los números y volúmenes del BMHIM de 1968 a 2016. Se registraron los ECC para obtener sus principales características. Adicionalmente, se evaluó su calidad metodológica mediante la herramienta de riesgo de sesgo. Los resultados se presentan de forma descriptiva, gráfica y temporal. Resultados: Se revisaron 73 números con 363 volúmenes, analizando 4925 artículos. La proporción de ECC identificados en el BMHIM fue del 1% (67/4925). En general, los ensayos clínicos se realizaron en el contexto nacional, en el tercer nivel de atención, con un tamaño de muestra reducido, y las intervenciones farmacológicas fueron las más utilizadas. La calidad metodológica de los estudios fue baja, con alto riesgo de sesgo. Conclusiones: Los ensayos clínicos representan el 1% de todos los artículos de investigación originales publicados en el BMHIM. Aún existen áreas de investigación pediátrica, las cuales requieren del desarrollo de ECC para mejorar la práctica clínica, así como para elevar la calidad de la investigación.

Abstract Background: Controlled clinical trials (CCT) are the study design with the highest accuracy and evidence level. From its introduction in biomedical research, changes have been implemented in the way of establishing the basis for diagnosis, prognosis and treatment in clinical practice. Studies to identify published CCTs regarding different medical fields have been carried out. To date, none of them has identified the clinical trials that have been published in the Boletín Médico del Hospital Infantil de México (BMHIM). The aim of this study was to identify and describe the controlled clinical trials published in the BMHIM. Methods: A manual and systematic search was performed in each of the volumes of the BMHIM from 1968 to 2016. CCTs were recorded to obtain their main characteristics. Additionally, their methodological quality was assessed through the "risk of bias" tool. Results are presented in a descriptive, graphic and time-based manner. Results: In total, 73 issues with 363 volumes were reviewed, and 4925 articles were analyzed. The proportion of CCTs identified in the BMHIM was 1% (67/4925). In general, clinical trials were performed in the national context and in the third-level of medical care. CCTs also presented reduced sample sizes; pharmacological interventions were the most frequent. The methodological quality of the studies was low with a high risk of bias. Conclusions: Clinical trials represented 1% of all the original research articles published in the BMHIM. There are still pediatric research fields that require CCTs to be developed in order to improve clinical practice, as well as to increase the quality of the research.

Randomized clinical trials of dental bleaching - Compliance with the CONSORT Statement: a systematic review

Abstract We reviewed the literature to evaluate: a) The compliance of randomized clinical trials (RCTs) on bleaching with the CONSORT; and b) the risk of bias of these studies using the Cochrane Collaboration risk of bias tool (CCRT). We searched the Cochrane Library, PubMed and other electronic databases, to find RCTs focused on bleaching (or whitening). The articles were evaluated in compliance with CONSORT in a scale: 0 = no description, 1 = poor description and 2 = adequate description. Descriptive analyses of the number of studies by journal, follow-up period, country and quality assessments were performed with CCRT for assessing risk of bias in RCTs. 185 RCTs were included for assessment. More than 30% of the studies received score 0 or 1. Protocol, flow chart, allocation concealment and sample size were more critical items, as 80% of the studies scored 0. The overall CONSORT score for the included studies was 16.7 ± 5.4 points, which represents 52.2% of the maximum CONSORT score. A significant difference among journal, country and period of time was observed (p < 0.02). Only 7.6% of the studies were judged at "low" risk; 62.1% were classified as "unclear"; and 30.3% as "high" risk of bias. The adherence of RCTs evaluating bleaching materials and techniques to the CONSORT is still low with unclear/high risk of bias.

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.

Differences between the real and the desired worlds in the results of clinical trials

OBJECTIVE:We refer to the effectiveness (known as pragmatic or real world) and efficacy (known as explanatory or desired or ideal world) of interventions. However, these terms seem to be randomly chosen by investigators who design clinical trials and do not always reflect the true purpose of the study. A pragmatic-explanatory continuum indicator summary tool was thus developed with the aim of identifying the characteristics of clinical trials that distinguish between effectiveness and efficacy issues. We verified whether clinical trials used the criteria proposed by the indicator summary tool, and we categorized these clinical trials according to a new classification.METHOD:A systematic survey of randomized clinical trials was performed. We added a score ranging from 0 (more efficacious) to 10 (more effective) to each domain of the indicator summary tool and proposed the following classifications: high efficacy (<25), moderate efficacy (25-50), moderate effectiveness (51-75), and high effectiveness (<75).RESULTS:A total of 844 randomized trials were analyzed. No analyzed trials used the criteria proposed by the indicator summary tool. Approximately 44% of the trials were classified as having moderate effectiveness, and 43.82% were classified as having moderate efficacy.CONCLUSIONS:Most clinical trials used the term “efficacy” to illustrate the application of results in clinical practice, but the majority of those were classified as having moderate effectiveness according to our proposed score. The classification based on the 0-100 score is still highly subjective and can be easily misunderstood in all domains based on each investigator’s own experiences and knowledge.

Searching for randomized controlled trials and systematic reviews on exercise. A descriptive study / Busca de ensaios clínicos randomizados e revisões sistemáticas sobre exercício físico. Um estudo descritivo

CONTEXT AND OBJECTIVE: The current paradigm of science is to accumulate as much research data as possible, with less thought given to navigation or synthesis of the resulting mass, which hampers locating and using the research. The aim here was to describe the number of randomized controlled trials (RCTs) and systematic reviews (SRs) focusing on exercise, and their journal sources, that have been indexed in PubMed over time. DESIGN AND SETTING: Descriptive study conducted at Bond University, Australia. METHOD: To find RCTs, a search was conducted in PubMed Clinical Queries, using the category "Therapy" and the Medical Subject Headings (MeSH) term "Exercise". To find SRs, a search was conducted in PubMed Clinical Queries, using the category "Therapy", the MeSH term "Exercise" and various methodological filters. RESULTS: Up until 2011, 9,354 RCTs about exercise were published in 1,250 journals and 1,262 SRs in 513 journals. Journals in the area of Sports Science published the greatest number of RCTs and journals categorized as belonging to "Other health professions" area (for example nursing or psychology) published the greatest number of SRs. The Cochrane Database of Systematic Reviews was the principal source for SRs, with 9.8% of the total, while the Journal of Strength and Conditioning Research and Medicine & Science in Sports & Exercise published 4.4% and 5.0% of the RCTs, respectively. CONCLUSIONS: The rapid growth and resulting scatter of RCTs and SRs on exercise presents challenges for locating and using this research. Solutions for this issue need to be considered. .

CONTEXTO E OBJETIVO: O paradigma atual da ciência é acumular o máximo de dados de pesquisa possível, com menos atenção dada a navegação ou a síntese do volume resultante, o que dificulta a localização e utilização das pesquisas. O objetivo foi descrever o número de ensaios clínicos randomizados (ECRs) e revisões sistemáticas (RSs) focados em exercício físico publicados em periódicos, que foram indexados no PubMed ao longo do tempo. TIPO DE ESTUDO E LOCAL: Estudo descritivo conduzido na Bond University, Austrália. MÉTODO: Para encontrar ECRs, foi realizada uma busca no PubMed Clinical Queries, usando a categoria "Terapia" e o termo de Medical Subject Headings (MeSH) "Exercício". Para encontrar RSs, foi realizada uma busca no PubMed Clinical Queries, usando a categoria "Therapy" e o termo MeSH "Exercício" e vários filtros. RESULTADOS: Até 2011, 9.354 ECRs sobre exercício foram publicados em 1.250 periódicos e 1.262 RSs em 513 periódicos. Periódicos na área de Ciências do Esporte publicaram o maior número de ECRs e revistas classificadas como pertencentes à area "Outras profissões de saúde" (por exemplo, enfermagem ou psicologia) publicaram o maior número de RSs. A Cochrane Database of Systematic Reviews foi a principal fonte para RSs, com 9,8% do total, enquanto o Journal of Strength and Conditioning Research e o Medicine & Science Sports & Exercise publicaram 4,4% e 5,0% dos ECRs, respectivamente. CONCLUSÃO: O rápido crescimento e consequente dispersão dos ECRs e RSs sobre exercício físico apresentam desafios para localizar e usar pesquisas. Precisa-se de reflexões sobre a resolução do assunto. .

Introducción al meta-análisis indirecto / Introduction to the indirect meta-analyses

Los meta-análisis son estudios que tienen la finalidad de compilar toda la información disponible, agrupándola según un tema específico y evaluándola a través de herramientas de calidad metodológica. Cuando existen comparaciones de dos tratamientos específicos basados en ensayos clínicos aleatorizados los meta-análisis tradicionales son la mejor opción, pero existen escenarios en donde no se dispone de suficientes estudios comparativos directos. En estos casos una opción a tomar en consideración son las comparaciones indirectas o meta-análisis indirectos. El objetivo de la presente revisión es comprender el fundamento conceptual, la necesidad, las aplicaciones y limitaciones de las comparaciones indirectas para el posterior entendimiento de los meta-análisis en red o network meta-análisis.

Meta-analyses are studies that aim to compile all available information, grouping them according to an specific theme and evaluating it through methodological quality tools. When there are two specific comparisons of treatments based on randomized clinical trials, standard meta-analyses are the best option, but there are scenarios in which there is no available literature for those direct comparisons. In these cases, an alternative method to consider is indirect comparison or indirect meta-analyses. The aim of this review is to understand the conceptual foundations, the need, applications and limitations of indirect comparisons for further understanding of network meta-analyses.

Collaborative multicenter trials in Latin America: challenges and opportunities in orthopedic and trauma surgery / Estudos colaborativos na America Latina: desafios e oportunidades em cirurgia ortopedica e traumatologica

CONTEXT AND OBJECTIVE Orthopedic research agendas should be considered from a worldwide perspective. Efforts should be planned as the means for obtaining evidence that is valid for health promotion with global outreach. DESIGN AND SETTING Exploratory study conducted at Universidade Federal de São Paulo (Unifesp), São Paulo, Brazil, and McMaster University, Hamilton, Canada. METHODS We identified and analyzed collaborative and multicenter research in Latin America, taking into account American and Canadian efforts as the reference points. We explored aspects of the data available from official sources and used data from traffic accidents as a model for discussing collaborative research in these countries. RESULTS The evaluation showed that the proportion of collaborative and multicenter studies in our setting is small. A brief analysis showed that the death rate due to traffic accidents is very high. Thus, it seems clear to us that initiatives involving collaborative studies are important for defining and better understanding the patterns of injuries resulting from orthopedic trauma and the forms of treatment. Orthopedic research may be an important tool for bringing together orthopedic surgeons, researchers and medical societies for joint action. CONCLUSIONS We have indicated some practical guidelines for initiatives in collaborative research and have proposed some solutions with a summarized plan of action for conducting evidence-based research involving orthopedic trauma. .

CONTEXTO E OBJETIVOS A programação de pesquisa em ortopedia deve ser considerada do ponto de vista global. Esforços devem ser planejados como forma de se obter evidência que seja válida para promoção da saúde de alcance mundial. TIPO DE ESTUDO E LOCAL Estudo exploratório conduzido na Universidade Federal de São Paulo (Unifesp), São Paulo, Brasil e na McMaster University, Hamilton, Canadá. MÉTODOS Identificamos e analisamos pesquisas multicênticas/colaborativas realizadas na América Latina, considerando os esforços nos Estados Unidos e Canadá como referência. Para tal, exploramos os aspectos dos dados disponíveis em fontes oficiais e utilizamos os dados provenientes de acidentes de trânsito como modelo de discussão de pesquisas colaborativas nestes países. RESULTADOS A avaliação demonstra uma pequena proporção de estudos colaborativos/multicêntricos em nosso meio. Análise breve demonstrou que existe enorme proporção de mortes devidas a traumas provenientes dos acidentes de trânsito. Dessa forma, parece-nos claro que iniciativas envolvendo estudos colaborativos são importantes para a definição e melhor entendimento do padrão das lesões provenientes de trauma ortopédico e as formas de tratamento. A pesquisa ortopédica pode ser importante ferramenta para aglutinar cirurgiões ortopédicos, pesquisadores e sociedades médicas para uma ação em conjunto. CONCLUSÕES Apontamos algumas diretrizes práticas para iniciativas em pequisas colaborativas e propusemos algumas soluções com um plano de ação resumido para a realização de pesquisa baseada em evidências envolvendo trauma ortopédico. .

Compliance to micronutrient supplementation in children 3 to 24 months of age from a semi-rural community in Mexico

OBJECTIVE: To identify associated factors to compliance for multiple micronutrient (MM) or iron and vitamin A (IVITA) supplementation, in children (3 to 24 months old). MATERIALS AND METHODS: A database (n=465 children) from a randomized, controlled, clinical trial, carried out in a semi-rural setting in Mexico, was analyzed. The compliance rate of MM and IVITA supplements was calculated. Adequate compliance rate (AC>80%), and its association with children and households characteristics, was determined. RESULTS: The compliance mean was high (MM:78.2%, IVITA:80.1%; p<0.05). The odds of AC were 59% greater in the children of IVITA than with MM group, although the estimate was only marginally significant (p=0.052). Maternal education (p<0.001), child birth weight (p=0.003), and children with cough (p<0.001) or fever (p=0.024) were significantly associated with AC and significantly marginal was maternal indigenous (p=0.071). CONCLUSION: The high AC was consistent with others efficacy studies. More research is needed to document physiological, cultural, social and operative factors affecting compliance with supplementation.

OBJETIVO: Identificar factores asociados con el cumplimiento del consumo de suplementos con micronutrimentos múltiples (MM) o con hierro y vitamina A (FEVITA) en niños (<24 meses de edad). MATERIAL Y MÉTODOS: Información de un ensayo clínico aleatorizado, doble ciego en una localidad semirrural en México. Se calculó el porcentaje de cumplimiento (n=465 niños), cumplimiento adecuado (CA: >80%) y su asociación con varias características. RESULTADOS: El cumplimiento fue alto (MM: 78.2%, FEVITA: 80.1%; p<0.05). Los momios de CA fueron 59% mayores en niños del grupo FEVITA que en MM (p=0.052). Escolaridad materna (p<0.001), peso al nacer del niño (p=0.003), porcentaje de tiempo con tos (p<0.001) y con fiebre (p=0.024) y marginalmente, la condición indígena materna (p=0.071) se asociaron con el CA. CONCLUSIONES: La alta tasa de cumplimiento fue consistente con otros estudios. Es necesaria mayor investigación sobre factores fisiológicos, culturales, sociales y operativos relacionados con el cumplimiento del consumo de suplementos.

Type of delivery and gestational age is not affected by pregnant Latin-American women engaging in vigorous exercise. A secondary analysis of data from a controlled randomized trial / El tipo de parto y la edad gestacional no se afectan por el ejercicio aeróbico vigoroso en mujeres gestantes latinas. Análisis secundario de un ensayo clínico

ABSTRACT Objective There is controversy concerning whether exercise during pregnancy may increase preterm delivery risk and type of delivery. The effect of pregnant Latin-American women engaging in vigorous exercise during the second and third trimester was examined regarding type of delivery and gestational age. Materials and Methods This was a secondary analysis of data from a controlled randomized trial for determining the influence of physical exercise on pregnant women's endothelial function. The study included 35 nulliparous women, gestational week 16-20 attending prenatal care at three tertiary hospitals in Colombia, who were randomly assigned to one of two groups. The experimental group engaged in aerobic exercise involving 55 % - 75 % maximum heart rate for 60 min, three times a week for 12 weeks. The control group engaged in their usual physical activity. Maternal weight, height, weight gain, blood pressure and type of delivery were recorded; gender, abdominal and head circumference (cm), weight (g), height (cm), vitality (Apgar score at 1 and 5 min) and gestational age at the time of delivery (in weeks, days) were recorded for the newborn. Results There was no difference in type of delivery by the end of the 12-week program (p>0.05), nor regarding newborn anthropometric variables, Apgar score, or maternal variables concerning weight, height, relative weight gain, blood pressure or weeks of gestation (p>0.05). Conclusion The potential public health benefits of vigorous exercise were enormous. This study support ed existing guidelines indicating that Latin-American women may begin or maintain an on-going exercise program during pregnancy. Trial registration: NCT00741312.

Objetivo Existe controversia acerca del efecto del ejercicio físico vigoroso (EFV) durante el embarazo por sus posibles consecuencias en el tipo de parto y la edad gestacional. El objetivo de este estudio fue evaluar el efecto del EFV durante el segundo y tercer trimestre, en mujeres gestantes latinas sobre el tipo de parto y la edad gestacional. Materiales y Métodos Se trata de un análisis secundario de un ensayo clínico controlado en 35 gestantes, asignadas al azar en dos grupos. Grupo experimental (n=18): EFV entre el 55 % y 75 % de la FC max, por 60 min, 3 veces por sem. Por 12 sem. Grupo Control (n=17): actividad física cotidiana y control prenatal habitual. Se registraron en las maternas: peso, talla, ganancia de peso, presión arterial y tipo de parto. En el recién nacido se registró: género, perímetro cefálico y abdominal (cm), peso (g), talla (cm), semanas de gestación, vitalidad (score Apgar al 1 y 5 min), y semanas de gestación. Resultados No se encontraron diferencias estadísticamente significativas respecto al tipo de parto (p>0,05). Tampoco en las variables antropométricas del recién nacido, ni en las variables maternas: peso, talla, ganancia de peso, presión arterial o semanas de gestación (p>0,05). Conclusión Los beneficios potenciales en salud pública del efecto EFV durante la gestación son importantes y este estudio favorece que mujeres latinas puedan comenzar o mantener un programa de ejercicios durante el embarazo. Trial registration: NCT00741312.

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.

Challenges in recruitment, attendance and adherence of acute stroke survivors to a randomized trial in Brazil: a feasibility study / Desafios no recrutamento, presença e adesão ao protocolo de intervenção em um ensaio controlado aleatorizado com sobreviventes de AVE agudo no Brasil: um estudo de viabilidade

BACKGROUND: There is a high demand for stroke rehabilitation in the Brazilian public health system which should make undertaking clinical trials straightforward. OBJECTIVES: The aims of this study were to 1) determine the rate of recruitment of community-dwelling stroke survivors into a randomized trial of the effects of strength training in addition to task-specific gait training, 2) compare the effectiveness of various recruitment strategies on accrual rates, and 3) determine the attendance at training sessions and adherence to the intervention protocol. METHODS: Participants within six months of a stroke were screened for eligibility and invited to participate. Recruitment strategies were classified as advertisement or referral. The number of people who were screened, eligible and recruited for each strategy was recorded. Attendance at training sessions and adherence to the intervention protocol were recorded. RESULTS: Over the first 14 months, 150 stroke survivors were screened, 10 were recruited, and 35 (23%) were eligible. Twenty-five of these patients (71%) were unable to participate with lack of transport given as the most common reason. The most successful strategy was referral via hospital-based physical therapists (50%). Overall attendance was 72% with lack of transport being the most common reason for non-attendance. Overall adherence to the protocol was 97% with feeling unwell being the most common reason for non-adherence. CONCLUSIONS: Recruitment of stroke survivors was inefficient. Lack of transport was the most common barrier to participate in and attend training sessions. Funding for transport is essential to make carrying out trials in Brazil feasible. Trial Registration ACTRN12609000803291.

CONTEXTUALIZAÇÃO: O sistema de saúde pública no Brasil apresenta uma alta demanda para a reabilitação de indivíduos após acidente vascular encefálico (AVE). Consequentemente, a condução de ensaios clínicos com essa população deveria ser simples. OBJETIVOS: Determinar a taxa de recrutamento de sobreviventes de AVE para ensaio controlado aleatorizado sobre os efeitos do fortalecimento muscular em adição ao treino específico de marcha; comparar a eficácia de várias estratégias de recrutamento e determinar a presença nas sessões de treinamento assim como a adesão ao protocolo de intervenção. MÉTODOS: Sobreviventes de AVE há menos de seis meses foram triados para elegibilidade e convidados a participar do estudo. Estratégias de recrutamento foram classificadas como propagandas ou encaminhamento. O número de pessoas triadas, elegíveis e recrutadas por cada estratégia assim como presença nas sessões e adesão ao protocolo de intervenção foram registrados. RESULTADOS: Durante 14 meses, 150 indivíduos foram triados e dez, recrutados. Trinta e cinco (23%) eram elegíveis; 25 deles (71%) eram incapazes de participar do estudo, sendo a falta de recursos para transporte a principal razão. Encaminhamento por meio de fisioterapeutas de hospitais representou a estratégia de recrutamento de maior sucesso (50%). A taxa de presença foi de 72%, e a taxa de adesão foi de 97%. A falta de transporte representou a principal razão para falta nas sessões de intervenção. CONCLUSÕES: A falta de recursos para o transporte representou a principal barreira à participação e presença. Portanto, o financiamento de transporte torna-se essencial para a condução de ensaios clínicos viáveis no Brasil. Registro de Ensaios Clínicos ACTRN12609000803291.

Overview of systematic reviews - a new type of study: part I: why and for whom? / Overview de revisões sistemáticas - um novo tipo de estudo: parte I: por que e para quem?

CONTEXT AND OBJECTIVE: Healthcare decision-making is complex and should involve healthcare professionals, patients and the best level of evidence. The speed of information production creates barriers against keeping up to date. In this light, methodologists have proposed a new type of study: overviews of systematic reviews (OoRs). The aim here was to introduce and demonstrate the role of OoRs in information synthesis for healthcare professionals, managers, researchers and patients. DESIGN AND SETTING: Time-series study conducted at the Brazilian Cochrane Center, jointly with the Postgraduate Program on Internal Medicine and Therapeutics, Discipline of Emergency Medicine and Evidence-Based Medicine, Department of Medicine, Federal University of São Paulo. METHODS: To show the growth in the numbers of published papers that provide high-level evidence and thus demonstrate the importance of OoRs for synthesis and integration of information, three filters for study designs were applied to two databases. An equation for predicting the expected number of published papers was developed and applied. RESULTS: Over the present decade, the number of randomized controlled trials in Medline might reach 2,863,203 and the number of systematic reviews might reach 174,262. Nine OoRs and 15 OoRs protocols have been published in the Cochrane Library. CONCLUSIONS: With the exponential growth of published papers, as shown in this study, a new type of study directed especially towards healthcare decision-makers was proposed, named "overview of systematic reviews". This could reduce the uncertainties in decision-making and generate a new hierarchy in the pyramid of evidence.

CONTEXTO E OBJETIVO: A tomada de decisão em saúde é complexa e deve envolver o profissional de saúde, o paciente e a evidência de melhor nível. A velocidade de geração da informação cria barreiras para manter-se atualizado. Diante disso, metodologistas propuseram um novo tipo de estudo, as overviews de revisões sistemáticas (OoRs). O objetivo é introduzir e demonstrar o papel das OoRs na síntese de informações para profissionais da área da saúde, gestores, pesquisadores e pacientes. TIPO DE ESTUDO E LOCAL: Estudo de série temporal realizado no Centro Cochrane do Brasil, em conjunto com o Programa de Pós-Graduação em Medicina Interna e Terapêutica da Disciplina de Medicina de Urgência e Medicina Baseada em Evidências do Departamento de Medicina da Universidade Federal de São Paulo. MÉTODOS: Para mostrar o crescimento das publicações que fornecem evidência com alto nível e assim justificar a importância das OoRs na síntese e integração das informações, três filtros para desenhos de estudos foram aplicados em duas bases de dados. Uma equação de predição do número esperado de publicações foi desenvolvida e aplicada. RESULTADOS: Na presente década, o número de ensaios clínicos randomizados no Medline poderá chegar a 2.863.203 e o número de revisões sistemáticas poderá chegar a 174.262. Nove OoRs e 15 protocolos de OoRs foram publicados na Biblioteca Cochrane. CONCLUSÕES: Com o crescimento exponencial das publicações, demonstrado neste estudo, um novo tipo de estudo, direcionado especialmente aos decisores em saúde, foi proposto, a OoRs, o qual poderá reduzir incertezas para a tomada de decisão e gerar uma nova hierarquia na pirâmide de evidências.

Assessing the risk of bias in randomized controlled trials in the field of dentistry indexed in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database / Avaliação do risco de viés de ensaios controlados randomizados de odontologia indexados na base de dados Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde)

CONTEXT AND OBJECTIVE: Well-conducted randomized controlled trials (RCTs) represent the highest level of evidence when the research question relates to the effect of therapeutic or preventive interventions. However, the degree of control over bias between RCTs presents great variability between studies. For this reason, with the increasing interest in and production of systematic reviews and meta-analyses, it has been necessary to develop methodology supported by empirical evidence, so as to encourage and enhance the production of valid RCTs with low risk of bias. The aim here was to conduct a methodological analysis within the field of dentistry, regarding the risk of bias in open-access RCTs available in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database. DESIGN AND SETTING: This was a methodology study conducted at Universidade Federal de São Paulo (Unifesp) that assessed the risk of bias in RCTs, using the following dimensions: allocation sequence generation, allocation concealment, blinding, and data on incomplete outcomes. RESULTS: Out of the 4,503 articles classified, only 10 studies (0.22 percent) were considered to be true RCTs and, of these, only a single study was classified as presenting low risk of bias. The items that the authors of these RCTs most frequently controlled for were blinding and data on incomplete outcomes. CONCLUSION: The effective presence of bias seriously weakened the reliability of the results from the dental studies evaluated, such that they would be of little use for clinicians and administrators as support for decision-making processes.

CONTEXTO E OBJETIVO: Ensaios controlados randomizados (ECRs) bem conduzidos representam o mais alto nível de evidência quando a pergunta de pesquisa é sobre o efeito de intervenções terapêuticas ou preventivas. No entanto, o grau de controle de viés entre os ECRs apresenta grande variabilidade entre estudos. Por esta razão, com o aumento do interesse e produção das revisões sistemáticas e metanálises, foi necessário desenvolver metodologia suportada por evidência empírica, para incentivar e valorizar a produção de ECRs válidos e com baixo risco de viés. O objetivo deste trabalho foi realizar uma análise metodológica da área de odontologia quanto ao risco de viés de ECRs de acesso aberto, disponibilizados no banco de dados do Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde). TIPO DE ESTUDO E LOCAL: Trata-se de um estudo sobre metodologia conduzido na Universidade Federal de São Paulo (Unifesp) que avaliou o risco de viés dos ECRs, utilizando as seguintes dimensões: geração da sequência de alocação, sigilo da alocação, cegamento e dados sobre desfechos incompletos. RESULTADOS: Dos 4.503 artigos classificados somente 10 (0,22 por cento) estudos foram considerados verdadeiros ECR e, destes, somente um estudo foi classificado como sendo de baixo risco de viés. Os itens mais frequentemente controlados pelos autores dos ECR foram cegamento e dados sobre desfechos incompletos. CONCLUSÃO: A presença efetiva de viés enfraqueceu seriamente a confiança nos resultados dos estudos de odontologia avaliados, sendo pouco úteis para clínicos e gestores como suporte a processos de decisão.

Validity of Qualis database as a predictor of evidence hierarchy and risk of bias in randomized controlled trials: a case study in dentistry

OBJECTIVE: To evaluate the validity of the Qualis database in identifying the levels of scientific evidence and the quality of randomized controlled trials indexed in the Lilacs database. METHODS: We selected 40 open-access journals and performed a page-by-page hand search, to identify published articles according to the type of study during a period of six years. Classification of studies was performed by independent reviewers assessed for their reliability. Randomized controlled trials were identified for separate evaluation of risk of bias using four dimensions: generation of allocation sequence, allocation concealment, blinding, and incomplete outcome data. The Qualis classification was considered to be the outcome variable. The statistical tests used included Kappa, Spearman's correlation, Kendall-tau and ordinal regressions. RESULTS: Studies with low levels of scientific evidence received similar Qualis classifications when compared to studies with high levels of evidence. In addition, randomized controlled trials with a high risk of bias for the generation of allocation sequences and allocation concealment were more likely to be published in journals with higher Qualis levels. DISCUSSION: The hierarchy level of the scientific evidence as classified by type of research design, as well as by the validity of studies according to the bias control level, was not correlated or associated with Qualis stratification. CONCLUSION: Qualis classifications for journals are not an approximate or indirect predictor of the validity of randomized controlled trials published in these journals and are therefore not a legitimate or appropriate indicator of the validity of randomized controlled trials.

Designs of studies published in two Brazilian journals of orthopedics and sports medicine, recently indexed in the ISI Web of Science / Desenhos dos estudos publicados em dois periódicos Brasileiros na área de ortopedia e medicina do esporte e recentemente indexados na ISI Web of Science

CONTEXT AND OBJECTIVE: The methodology and relevance of articles are among the keystones for promoting their citation and increasing journals' impact factors. Study designs appropriate for answering the questions and adequate sample sizes have the aim of reducing the risk of bias. This study evaluated the articles published in two Brazilian journals of orthopedics and sports medicine that were recently indexed in the ISI Web of Science, regarding study design, sample size calculation, randomization and blinding. DESIGN AND SETTING: Descriptive study at Brazilian Cochrane Center. METHODS: Through a manual search, all original manuscripts published in 2007 in Acta Ortopédica Brasileira and Revista Brasileira de Medicina do Esporte were selected and evaluated. RESULTS: All the 60 articles published in Acta Ortopédica Brasileira and the 87 articles in Revista Brasileira de Medicina do Esporte were included and evaluated. The commonest design in Acta Ortopédica Brasileira was experimental studies (n = 19) and in Revista Brasileira de Medicina do Esporte, update or review articles (n =14). Sample calculations were seen in a minority of the articles. None of the eight clinical trials published presented sample calculations or adequate randomization processes. Three were described as blinded, but none described the measures taken to prevent disclosure of the allocation concealment. CONCLUSIONS: Publication of studies of good methodological quality other than review and experimental studies should be strongly encouraged among Brazilian journals, with the aim of increasing their citation and therefore their impact factor.

CONTEXTO E OBJETIVO: A qualidade metodológica e a pertinência dos artigos estão entre algumas das peças fundamentais para promover sua citação e aumentar o fator de impacto da revista. Um desenho de estudo apropriado para responder às perguntas e uma amostra de tamanho adequado visam reduzir o risco de viés. Este estudo avaliou os artigos publicados em duas revistas brasileiras das áreas de ortopedia e medicina esportiva recentemente indexadas no ISI Web of Science, com relação a desenho do estudo, cálculo do tamanho amostral, aleatorização e mascaramento. TIPO DE ESTUDO E LOCAL: Estudo descritivo no Centro Cochrane do Brasil. MÉTODOS: Por meio de pesquisa manual, foram selecionados e avaliados todos os manuscritos originais publicados em 2007 na Acta Ortopédica Brasileira e Revista Brasileira de Medicina do Esporte. RESULTADOS: Todos os 60 artigos publicados na Acta Ortopédica Brasileira e os 87 artigos da Revista Brasileira de Medicina do Esporte foram incluídos e avaliados. O desenho mais comum na Acta Ortopédica Brasileira foi de estudo experimental (n = 19) e na Revista Brasileira de Medicina do Esporte, de atualização ou revisão (n = 14). O cálculo da amostra foi observado em uma minoria dos artigos. Nenhum dos oito ensaios clínicos publicados apresentou o cálculo do tamanho da amostra, nem o processo de aleatorização adequado. Três foram descritos como cegos, no entanto, nenhum descreveu as medidas tomadas para impedir a quebra do sigilo da alocação. CONCLUSÕES: A publicação de estudos de boa qualidade metodológica, que não estudos experimentais e de revisão, deve ser fortemente incentivada entre os periódicos brasileiros com o objetivo de aumentar a sua citação e, portanto, seu fator de impacto.