Evaluation of the report quality of Chinese and English randomized controlled trials of acupuncture based on CONSORT statement and STRICTA checklist / 中国针灸

OBJECTIVE@#To evaluate the report quality of Chinese and English randomized controlled trials (RCTs) of acupuncture based on the CONSORT statement and STRICTA checklist.@*METHODS@#The Chinese and English RCTs of acupuncture published from January 1, 2015 to December 31, 2019 were searched in 7 databases including PubMed. The report quality of the included RCTs was evaluated with the CONSORT 2010 statement and STRICTA checklist.@*RESULTS@#A total of 506 Chinese RCTs and 76 English RCTs were included. According to the CONSORT statement, in Chinese RCTs, the items with report rate less than 50% accounted for 78.38% of all items, and the report rate of 25 items, such as background and reason, study design, outcome index, and sample size, was less than 10%. In English RCTs, the items with report rate less than 50% accounted for 35.14% of all items, and 5 items had a report rate of less than 10%. The difference of the report rate of 15 items, such as background, reason and study design, was more than 50% between Chinese and English RCTs. The report rate of all items of STRICTA checklist was relatively high in both Chinese and English RCTs. In Chinese RCTs, the items with report rate less than 50% accounted for 29.41% of all items, which included acupuncture rationale and depth of insertion. In English RCTs, only two items had a report rate less than 50%, which were acupuncture rationale, setting and context of treatment. The report rate of five items, including needle retention time, frequency and duration of treatment sessions, details of other interventions administered to the acupuncture group, setting and context of treatment, and precise description of the control or comparator in Chinese RCTs, were higher than in English RCTs.@*CONCLUSION@#The report quality of Chinese acupuncture RCT needs to be improved urgently, and corresponding measures should be taken to further standardize the writing and reporting of acupuncture clinical research.

Evaluating the methodology of studies conducted during the global COVID-19 pandemic: A systematic review of randomized controlled trials / 中西医结合学报

BACKGROUND@#The therapeutic evidence collected from well-designed studies is needed to help manage the global pandemic of the coronavirus disease 2019 (COVID-19). Evaluating the quality of therapeutic data collected during this most recent pandemic is important for improving future clinical research under similar circumstances.@*OBJECTIVE@#To assess the methodological quality and variability in implementation of randomized controlled trials (RCTs) for treating COVID-19, and to analyze the support that should be provided to improve data collected during an urgent pandemic situation.@*SEARCH STRATEGY@#PubMed, Excerpta Medica Database, China National Knowledge Infrastructure, Wanfang, and Chongqing VIP, and the preprint repositories including Social Science Research Network and MedRxiv were systematically searched, up to September 30, 2020, using the keywords "coronavirus disease 2019 (COVID-19)," "2019 novel coronavirus (2019-nCoV)," "severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2)," "novel coronavirus pneumonia (NCP)," "randomized controlled trial (RCT)" and "random."@*INCLUSION CRITERIA@#RCTs studying the treatment of COVID-19 were eligible for inclusion.@*DATA EXTRACTION AND ANALYSIS@#Screening of published RCTs for inclusion and data extraction were each conducted by two researchers. Analysis of general information on COVID-19 RCTs was done using descriptive statistics. Methodological quality was assessed using the risk-of-bias tools in the Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1.0). Variability in implementation was assessed by comparing consistency between RCT reports and registration information.@*RESULTS@#A total of 5886 COVID-19 RCTs were identified. Eighty-one RCTs were finally included, of which, 45 had registration information. Methodological quality of the RTCs was not optimal due to deficiencies in five main domains: allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, and selective reporting. Comparisons of consistency between published protocols and registration information showed that the 45 RCTs with registration information had common deviations in seven items: inclusion and exclusion criteria, sample size, outcomes, research sites of recruitment, interventions, and blinding.@*CONCLUSION@#The methodological quality of COVID-19 RCTs conducted in early to mid 2020 was consistently low and variability in implementation was common. More support for implementing high-quality methodology is needed to obtain the quality of therapeutic evidence needed to provide positive guidance for clinical care. We make an urgent appeal for accelerating the construction of a collaborative sharing platform and preparing multidisciplinary talent and professional teams to conduct excellent clinical research when faced with epidemic diseases of the future. Further, variability in RCT implementation should be clearly reported and interpreted to improve the utility of data resulting from those trials.

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.

Methodological quality of randomized clinical trials of respiratory physiotherapy in coronary artery bypass grafting patients in the intensive care unit: a systematic review

Abstract Objective: To assess methodological quality of the randomized controlled trials of physiotherapy in patients undergoing coronary artery bypass grafting in the intensive care unit. Methods: The studies published until May 2015, in MEDLINE, Cochrane and PEDro were included. The primary outcome extracted was proper filling of the Cochrane Collaboration's tool's items and the secondary was suitability to the requirements of the CONSORT Statement and its extension. Results: From 807 studies identified, 39 were included. Most at CONSORT items showed a better adequacy after the statement's publication. Studies with positive outcomes presented better methodological quality. Conclusion: The methodological quality of the studies has been improving over the years. However, many aspects can still be better designed.

Overview of systematic reviews - a new type of study. Part II / Overview de revisões sistemáticas - um novo tipo de estudo. Parte II

CONTEXT AND OBJECTIVE: Overviews of Systematic Reviews (OoRs) are a new type of study in which multiple evidence from systematic reviews (SRs) is compiled into an accessible and useful document. The aim here was to describe the state of the art and critically assess Cochrane OoRs that have been published. DESIGN AND SETTING: Descriptive study conducted at a research center. METHODS: The OoRs identified through the filter developed in Part I of this study were evaluated in five domains: methodological quality; quality of evidence; implications for practice; general profile of OoRs; and length of work. RESULTS: All 13 OoRs included had high methodological quality. Some OoRs did not present sufficient data to judge the quality of evidence; using sensitivity analysis, the quality of evidence of the OoRs increased. Regarding implications for practice, 64% of the interventions were judged as beneficial or harmful, while 36% of them showed insufficient evidence for judgment. It is expected (with 95% confidence interval) that one OoR will include 9,462 to 64,469 patients, 9 to 29 systematic reviews and 80 to 344 primary studies, and assess 6 to 21 interventions; and that 50 to 92% of OoRs will produce meta-analysis. The OoRs generated 2 to 26 meta-analyses over a period of 18 to 31 months. CONCLUSION: The OoRs presented high methodological quality; the quality of evidence tended to be moderate/high; most interventions were judged to be beneficial/harmful; the mean length of work was 24 months. The OoR profile adds power to decision-making. .

CONTEXTO E OBJETIVO: Overviews de revisões sistemáticas (OoRs) representam um novo tipo de estudo que compila múltiplas evidências de revisões sistemáticas (SRs) em um documento acessível e útil. O objetivo foi de descrever o estado da arte e avaliar criticamente as OoRs Cochrane publicadas. DESENHO E LOCAL: Estudo descritivo realizado em centro de pesquisa. MÉTODOS: As OoRs identificadas através do filtro desenvolvido na parte I deste estudo foram avaliadas por cinco domínios: qualidade metodológica, qualidade da evidência, implicações para a prática, perfil geral das OoRs e tempo de execução. RESULTADOS: As 13 OoRs incluídas apresentaram alta qualidade metodológica. Algumas OoRs não apresentavam dados suficientes para julgar a qualidade da evidência; com a análise de sensibilidade, a qualidade evidência nas OoRs aumentou. Implicações para prática foram julgadas como benéficas ou danosas em 64% das intervenções; em 36% das intervenções há evidências insuficientes para o julgamento. É esperado (com intervalo de confiança de 95%) que uma OoR inclua 9.462 a 64.469 pacientes, 9 a 29 revisões sistemáticas e 80 a 344 estudos primários, e avaliem entre 6 e 21 intervenções; que 50 a 92% das OoRs realizem metanálise. As OoRs geraram entre 2 e 26 metanálises em um período de 18 a 31 meses. CONCLUSÃO: As OoRs apresentam alta qualidade metodológica; a qualidade da evidência tende a ser alta/moderada; as intervenções, em sua maioria, foram julgadas como benéficas/danosas; o tempo de execução foi de 24 meses em média. O perfil das OoRs potencializa a tomada de decisão. .

Fatty Acid and Cholesterol Concentrations in Usually Consumed Fish in Brazil / Concentração de Ácidos Graxos e Colesterol de Peixes Habitualmente Consumidos no Brasil

Background: Several studies have demonstrated clinical benefits of fish consumption for the cardiovascular system. These effects are attributed to the increased amounts of polyunsaturated fatty acids in these foods. However, the concentrations of fatty acids may vary according to region. Objective: The goal of this study was to determine the amount of,cholesterol and fatty acids in 10 Brazilian fishes and in a non-native farmed salmon usually consumed in Brazil. Methods: The concentrations of cholesterol and fatty acids, especially omega-3, were determined in grilled fishes. Each fish sample was divided in 3 sub-samples (chops) and each one was extracted from the fish to minimize possible differences in muscle and fat contents. Results: The largest cholesterol amount was found in white grouper (107.6 mg/100 g of fish) and the smallest in badejo (70 mg/100 g). Omega-3 amount varied from 0.01 g/100 g in badejo to 0.900 g/100 g in weakfish. Saturated fat varied from 0.687 g/100 g in seabass to 4.530 g/100 g in filhote. The salmon had the greatest concentration of polyunsaturated fats (3.29 g/100 g) and the highest content of monounsaturated was found in pescadinha (5.98 g/100 g). Whiting and boyfriend had the best omega-6/omega 3 ratios respectively 2.22 and 1.19, however these species showed very little amounts of omega-3. Conclusion: All studied Brazilian fishes and imported salmon have low amounts of saturated fat and most of them also have low amounts of omega-3. .

Fundamento: Inúmeros estudos demonstram os efeitos benéficos do consumo de peixe para o aparelho cardiovascular. Isso seria decorrente da presença de ácidos graxos poli-insaturados nesses alimentos. Contudo, as concentrações desses nutrientes podem variar conforme a região. Objetivo: Analisar a composição e a quantidade de colesterol e ácidos graxos de peixes brasileiros e do salmão de cativeiro, habitualmente consumidos em nosso meio. Métodos: Foi analisada a concentração de colesterol e ácidos graxos, particularmente o ômega-3, de 10 tipos diferentes de peixes grelhados, sendo um deles o salmão. Cada amostra foi composta por três subamostras (“postas”), e cada uma retirada de uma porção, do início, do meio e do final do peixe, com o objetivo de minimizar problemas com relação a possíveis diferenças entre as porções musculares e de gorduras. Resultados: O maior teor de colesterol encontrado foi no cherne (107,6 mg/100 g), e o menor foi no badejo (70 mg/100 g). A concentração de ômega-3 variou de 0,01 g/100 g no badejo a 0,900 g/100 g na pescadinha. Já a gordura saturada variou de 0,687 g/100 g no pirarucu a 4,530 g/100 g no filhote. O salmão apresentou a maior quantidade de gordura poli-insaturada (3,29 g/100 g), e a pescadinha, o maior teor de gordura monoinsaturada (5,98 g/100 g). Quando avaliada as relações ômega 6/3, as melhores foram as do badejo (2,22) e do namorado (1,19), no entanto essas espécies apresentam muito pouca quantidade de ômega-3. Conclusão: Todos os peixes brasileiros estudados e o salmão importado têm baixos teores de gordura saturada, contudo a maioria desses peixes também tem baixos teores de ômega-3. .

Medicina Basada en Evidencia: ¿podemos confiar en los resultados de los estudios clínicos aleatorizados bien diseñados? / Evidence-based medicine: Can we trust the results of well-designed randomized trials?

Evidence based medicine assists in clinical decision-making by integrating critically appraised information with patient's values and preferences within an existing clinical context. A fundamental concept in this paradigm is the hierarchy of information. The randomized clinical trial is recognized as one of the designs that is less prone to bias and therefore of higher methodological quality. Clinical guidelines are one of the principal tools that evidence based medicine uses to transfer scientific information to clinical practice and many of their recommendations are based on these type of studies. In this review we present some of the limitations that the results can have, in even well designed and executed randomized clinical trials. We also discuss why valid results in these types of studies could not necessarily be extrapolated to the general population. Although the randomized clinical trial continues to be one of the best methodological designs, we suggest that the reader be careful when interpreting its results.

La Medicina Basada en Evidencia es una propuesta que asiste en la toma de decisiones clínicas integrando la información críticamente analizada con los valores y preferencias del paciente en el contexto clínico existente. Un concepto fundamental en este paradigma es la jerarquización de la información. El estudio clínico aleatorizado es reconocido como uno de los diseños metodológicos con menor probabilidad de sesgo y por ende de la más alta calidad metodológica. En este tipo de estudios se basan muchas de las recomendaciones de las guías clínicas, que son uno de los principales instrumentos que utiliza la medicina basada en evidencia para transferir la información a la práctica clínica. En esta revisión se exponen algunas de las limitaciones que pueden tener los resultados de estudios clínicos aleatorizados incluso cuando han sido bien diseñados y ejecutados. Se discute también el porqué resultados validos pueden no necesariamente ser extrapolables a la población general en este tipo de estudios. Si bien el estudio clínico aleatorizado sigue siendo uno de los mejores diseños metodológicos, se sugiere que el usuario de la información sea cuidadoso al interpretar sus resultados.

Neuraxial anesthesia versus general anesthesia for urological surgery: systematic review / Anestesia neuroaxial versus anestesia geral para cirurgias urológicas: revisão sistemática

CONTEXT AND OBJECTIVE Choosing the best anesthetic technique for urological surgery with the aim of mortality reduction remains controversial. The objective here was to compare the effectiveness and safety of neuraxial anesthesia versus general anesthesia for urological surgery. DESIGN AND SETTING Systematic review, Universidade Federal de Alagoas. METHODS We searched the Cochrane Central Register of Controlled Trials in the Cochrane Library (Issue 10, 2012), Medline via PubMed (1966 to October 2012), Lilacs (1982 to October 2012), SciELO and EMBASE (1974 to October 2012). The reference lists of the studies included and of one systematic review in the same field were also analyzed. The studies included were randomized controlled trials (RCT) that analyzed neuraxial anesthesia and general anesthesia for urological surgery. RESULTS The titles and abstracts of 2720 articles were analyzed. Among these, 16 studies were identified and 11 fulfilled the inclusion criteria. One RCT was published twice. The study validity was: Jadad score > 3 in one RCT; seven RCTs with unclear risk of bias as the most common response; and five RCTs not fulfilling half of the Delphi list items. The frequency of mortality was not significant between study groups in three RCTs. Meta-analysis was not performed. CONCLUSION At the moment, the evidence available cannot prove that neuraxial anesthesia is more effective and safer than general anesthesia for urological surgery. There were insufficient data to pool the results relating to mortality, stroke, myocardial infarction, length of hospitalization, quality of life, degree of satisfaction, postoperative cognitive dysfunction and blood transfusion requirements. .

CONTEXTO E OBJETIVO A escolha da melhor técnica anestésica para cirurgias urológicas para reduzir mortalidade permanece controversa. O objetivo foi comparar a efetividade e segurança da anestesia neuroaxial versus anestesia geral para cirurgias urológicas. TIPO DE ESTUDO E LOCAL Revisão sistemática, Universidade Federal de Alagoas. MÉTODO Fizemos a busca em Cochrane Central Register of Controlled Trials na Cochrane Library (2012, volume 10), Medline via PubMed (1966 até outubro de 2012), Lilacs (1982 até outubro de 2012), SciELO e EMBASE (1974 até outubro de 2012). As listas de referências dos estudos incluídos e de uma revisão sistemática em urologia também foram analisadas. Os estudos incluídos foram ensaios clínicos randomizados (ECR) que analisaram as anestesias neuroaxial e geral para cirurgias urológicas. RESULTADOS Os títulos e resumos de 2.720 artigos foram analisados. Entre eles, 16 estudos foram identificados e 11 preencheram os critérios de inclusão. Um ECR foi publicado duas vezes. A validade dos estudos foi: escore de Jadad > 3 em um ECR; sete ECRs com indeterminado risco de viés como a resposta mais comum; cinco ECR sem preenchimento da metade dos itens da lista de Delphi. A frequência de mortalidade não foi significante entre os grupos de estudo em três ECR. A metanálise não foi realizada. CONCLUSÃO Até o momento, as evidências disponíveis não puderam provar que a anestesia neuroaxial seja mais efetiva e segura do que a anestesia geral para cirurgias urológicas. Não houve dados suficientes para reunir os resultados de mortalidade, infarto cerebral, infarto do miocárdio, duração de internação hospitalar, qualidade de vida, grau ...

Quality of reports on randomized controlled trials published in Iranian journals: application of the new version of consolidated standards of reporting trials [CONSORT]

The Consolidated Standards for Reporting of Trials [CONSORT] statement is a device to standardize reporting and improve the quality of controlled trials. The aim of this study is to determine the quality of controlled clinical trial reports by national peer-reviewed journals in Iran. In a cross-sectional study, we evaluated clinical trial reports by national peer-reviewed Iranian journals between 2008 and 2010 by CONSORT2010. The sample was selected from Iran Medex. The proportion of adherence to each item of the CONSORT checklist was assessed for each clinical trial. The reliability of evaluation by reviewers was calculated by Pearson correlation coefficient, and was determined to be 0.73 - 0.89, with a significance level of P < 0.01 between reviewers. A total of 509 articles published in 80 peer-reviewed national journals were evaluated. The average adherence of evaluated randomized controlled trials [RCTs] to the 37 items of the CONSORT statement was 43.8%. The mean CONSORT score significantly differed across each year of publication. None of the articles mentioned the location where the full trial protocol could be accessed. The quality of reporting RCTs published in national peer-reviewed journals needs significant improvement as the majority did not adhere to CONSORT guidelines. It is necessary for the editors of Iranian journals to consider CONSORT criteria for evaluation of all future RCTs

Assessing the Quality of Randomized Controlled Trials Published in the Journal of Korean Medical Science from 1986 to 2011

Low quality clinical trials have a possibility to have errors in the process of deriving the results and therefore distort the study. Quality assessment of clinical trial is necessary in order to prevent any clinical application erroneous results is important. Randomized controlled trial (RCT) is a design for evaluate the effectiveness of medical procedure. This study was conducted by extracting the RCTs from the original articles published in the Journal of Korean Medical Science (JKMS) from 1986 to 2011 and conducting a qualitative analysis using three types of analysis tools: Jadad scale, van Tulder scale and Cochrane Collaboration risk of bias Tool. To compare the quality of articles of JKMS, quality analysis of the RCTs published in Yonsei Medical Journal (YMJ) and Korean Journal of Internal Medicine was also conducted. In the JKMS, YMJ and Korean Journal of Internal Medicine, the quantitative increase of RCT presented over time was observed but no qualitative improvement of RCT was observed over time. From the results of this study, it is required for the researchers to plan for and perform higher quality studies.

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.

Evidence-based approach to glaucoma management.

Evidence-based medicine is an evolving new paradigm. With the advent of numerous new diagnostic techniques and therapeutic interventions, one needs to critically evaluate and validate them by appropriate methods before adopting them into day-to-day patient care. The concepts involved in the evaluation of diagnostic tests and therapy are discussed. For delivering the highest level of clinical care, evidence alone is not sufficient. Integrating individual clinical experience and patients’ perspectives with the best available external evidence is essential.

Limits to clinical trials in surgical areas

Randomized clinical trials are considered to be the gold standard of evidence-based medicine nowadays. However, it is important that we point out some limitations of randomized clinical trials relating to surgical interventions. There are limitations that affect the external and internal validity of many surgical study designs. Some limitations can be bypassed, but can make it more difficult for the study to be carried out. Other limitations cannot be bypassed. When it is intended to extrapolate the result of a randomized clinical trial, the premise is that the performed or to be performed intervention will be similar wherever applied and/or for every doctor using it. However, no matter how standardized the technique may be, the results are not similar for all surgeons, which implies a significant limitation to surgical randomized clinical trials concerning external validity. When considering the various limitations presented for performing surgical trials capable of generating scientific evidence within the patterns currently proposed in the evidence level classifications of medical publications, it is necessary to rethink whether those scientific evidence levels are similarly applicable to surgical works and to nonsurgical trials. We currently live in a time of supposed ''inferiority'' of surgical scientific works under the optics of the current quality criteria for a ''suitable'' clinical trial.

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.