The importance of full text screening when judging eligibility criteria in a systematic review: a systematic survey / A importância da avaliação do texto completo ao julgar os critérios de elegibilidade em uma revisão sistemática: uma revisão de métodos

Aim: To evaluate if statistically significant results are more likely to be reported in title/abstracts compared to non-significant outcomes. Methods: In this methodological survey, we reanalyzed 59 observational studies from a previous systematic review. The PECO question was: Patient (P): children with primary teeth; Exposure (E): low birth weight and/or preterm; Comparison (C): normal birth weight and/or full-term; Outcome (O): dental caries. We analyzed the presence of key terms in the titles and abstracts, such as gestational age, preterm, full-term, birth weight, low/normal birth weight. Full texts were analyzed for "positive outcomes" (statistically significant association, p < 0.05 or 95% CI not crossing the null effect line) related to the association between the outcome and the exposure; and "negative outcomes" (when the outcome had statistically similar occurrence between the exposure and the comparison group). The odds ratio (OR) was calculated between the presence of key terms in titles/abstracts and the type of outcome (positive or negative). Results: Of 59 studies, 66% cited the key terms in titles/abstracts, and 75% reported negative outcomes. Studies with positive outcomes were more likely to report key terms in the titles/abstracts compared to studies with negative outcomes (OR: 4.5; 95% CI: 0.9-22.4; Chi-square test: p = 0.06). Studies with statistically significant outcomes, favoring the exposure or the comparison, were more likely to report these data in the titles/abstracts. Conclusion: When conducting a systematic review, the final decision related to the inclusion of a study must be based on a full-text level.

Objetivo: Avaliar se os resultados estatisticamente significativos são mais prováveis de serem relatados nos títulos/resumos dos artigos do que os resultados não significativos. Métodos: Neste levantamento metodológico, foram reanalisados 59 estudos observacionais de uma revisão sistemática anterior. A questão PECO foi: Paciente (P): crianças com dentes decíduos; Exposição (E): baixo peso ao nascer e/ou pré-termo; Comparação (C): peso normal ao nascer e/ou a termo; Resultado (O): cárie dentária. Foi analisada a presença de termos-chave nos títulos/resumos, como idade gestacional, pré-termo, a termo, peso ao nascer, baixo/peso normal ao nascer. Textos completos foram analisados para "desfechos positivos" (associação estatisticamente significativa, p < 0,05 ou IC 95% não cruzando a linha de efeito nulo) relacionados à associação entre o desfecho e a exposição; e "desfechos negativos" (quando o desfecho teve ocorrência estatisticamente semelhante entre a exposição e o grupo de comparação). Foi calculada a odds ratio (OR) entre a presença de termos-chave nos títulos/resumos e o tipo de resultado (positivo ou negativo). Resultados: Dos 59 estudos, 66% citaram os termos-chave nos títulos/resumos e 75% relataram resultados negativos. Estudos com resultados positivos foram mais propensos a relatar os termos-chave nos títulos/resumos em comparação com estudos com resultados negativos (OR: 4,5; IC 95%: 0,9-22,4; teste do qui-quadrado: p = 0,06). Estudos com significância estatística os desfechos, favorecendo a exposição ou a comparação, foram mais propensos a relatar esses dados nos títulos/resumos. Conclusão: Ao realizar uma revisão sistemática, a decisão final quanto à inclusão de um estudo deve ser baseada por meio da análise do texto completo.

The Jornal Brasileiro de Psiquiatria: a bibliometric survey of the one hundred most cited articles in the last 15 years / Jornal Brasileiro de Psiquiatria: uma pesquisa bibliométrica sobre os 100 artigos mais citados nos últimos 15 anos

OBJECTIVE: Bibliometrics is a group of statistical and mathematical methods employed to measure and analyze the quantity and the quality of scientific articles, books, and other forms of publications. The objective of the present study was to conduct a bibliometric analysis of the Jornal Brasileiro de Psiquiatria (JBP) by listing its 100 most highly cited articles in the scientific literature and identifying their main characteristics in terms of authorship and research topics and design. METHODS: The 100 topcited references in the JBP were identified through a search with Google Scholar. The main author, last author, corresponding author, the total number of authors, gender of the authors, year of publication, research institution, geographic origin, language, and the research design and subject of each reference were recorded and analyzed. RESULTS: A marked increase in the number of citations in the last 15 years, a relatively balanced distribution of publications among the Brazilian states and research centers, absence of gender bias among authors, and a varied range of published topics suggest a good current editorial performance by the JBP. Relative lack of systematic reviews and longitudinal studies, dearth of articles published in the English language, and modest participation of foreign authors were points requiring improvement. CONCLUSION: The present study suggests that a survey of the 100 most cited articles in the JBP can provide a historical overview of the progress of this journal, as well as highlight the main obstacles, constraints, and challenges faced by its editors and authors.

OBJETIVO: Bibliometria é um grupo de métodos estatísticos e matemáticos empregados para medir e analisar a quantidade e a qualidade de artigos científicos, livros e outras formas de publicações. O objetivo do presente estudo foi realizar uma análise bibliométrica do Jornal Brasileiro de Psiquiatria (JBP), relacionando seus 100 artigos mais citados na literatura científica e identificando suas principais características em termos de autoria e questões de pesquisa e delineamento experimental. MÉTODOS: As 100 referências mais citadas no JBP foram identificadas por meio de uma busca no Google Scholar. Foram registradas e analisadas as seguintes informações: autor principal, último autor, autor correspondente, número total de autores, gênero dos autores, ano de publicação, instituição de pesquisa, origem geográfica e idioma de cada referência e seu tema de investigação e delineamento metodológico. RESULTADOS: O aumento acentuado no número de citações nos últimos 15 anos, a boa distribuição das publicações entre os estados e centros de pesquisa brasileiros, a ausência de viés de gênero entre os autores e a variada gama de tópicos publicados sugerem um bom desempenho editorial atual do JBP. A relativa falta de revisões sistemáticas e estudos longitudinais, os poucos artigos publicados em inglês e a pequena participação de autores estrangeiros são pontos que requerem melhorias. CONCLUSÃO: O presente estudo sugere que o levantamento dos 100 artigos mais citados no JBP pode fornecer um panorama histórico da evolução dessa revista, bem como destacar os principais obstáculos, restrições e desafios enfrentados por seus editores e autores.

Truth in medical literature / La verdad en la literatura médica

Abstract Various characteristics influence the publication of scientific articles, including the quality of the content, its drafting, the journal's preferred topic, and the current needs, according to health advances or issues. However, other aspects such as the type of research results, the authors' recogni tion and editorial preferences mark the decision to reject or accept a manuscript; these are known as publication bias. Recognizing these biases allows teachers, researchers and students to maintain motivation and clinical judgement for presenting relevant academic proposals, and maintain a critical analysis of knowledge. (Acta Med Colomb 2021; 46. DOI: https://doi.org/10.36104/amc.2021.1859).

Resumen Diferentes características influyen en la publicación de artículos científicos, dentro de los cuales se destaca: la calidad del contenido, la redacción, el tema de preferencia de la revista y las necesidades del momento de acuerdo con los avances o problemáticas en salud. Sin embargo, otros aspectos como el tipo de resultados de la investigación, el reconocimiento de los autores y las preferencias editoriales marcan la decisión de rechazar o aceptar un manuscrito; conocidos como sesgos de pu blicación. Reconocerlos permite a docentes, investigadores y estudiantes mantener la motivación y el juicio clínico para plantear propuestas académicas relevantes y tener un análisis crítico del conocimiento. (Acta Med Colomb 2021; 46. DOI:https://doi.org/10.36104/amc.2021.1859).

El Registro Público Cubano de Ensayos Clínicos desde la perspectiva de los estudios de Ciencia Tecnología y Sociedad / The Cuban Public Registry of Clinical Trials from the perspective of Science, Technology and Society studies

RESUMEN El presente artículo es el resultado de un estudio dirigido a demostrar la contribución del Registro Público Cubano de Ensayos Clínicos (RPCEC) en la transparencia de las publicaciones de investigaciones en seres humanos. Se realizó una revisión bibliográfica de diferentes fuentes de información científica en la biblioteca electrónica SciELO y otros sitios web con el objetivo de caracterizar el RPCEC desde una perspectiva de los estudios sociales de la Ciencia y la Tecnología. Se precisaron consideraciones sobre las temáticas en el momento de realizar la investigación. Se constató que el RPCEC es una tecnología informática que favorece la limpieza de los datos y su generalización, lo cual contribuye a eliminar el sesgo de publicación. Además, desde el punto de vista de la bioética promueve el desarrollo científico y la búsqueda efectiva en la sociedad contemporánea.

ABSTRACT This article is the result of a study aimed at demonstrating the contribution of the Cuban Public Registry of Clinical Trials (RPCEC) in the transparency of research publications on human beings. A bibliographic review of different sources of scientific information was carried out in the SciELO electronic library and other websites in order to characterize the RPCEC from a perspective of the social studies of Science and Technology. Considerations on the issues were required at the time of conducting the research. It was found that RPCEC is a computer technology that favors data cleaning and generalization, which helps to eliminate publication bias. Furthermore, from the point of view of bioethics, it promotes scientific development and effective research in contemporary society.

Total arterial coronary bypass graft surgery is associated with better long-term survival in patients with multivessel coronary artery disease: a systematic review with meta-analysis

Abstract Introduction: The benefit of total arterial revascularization (TAR) in coronary artery bypass grafting (CABG) remains a controversial issue. This study sought to evaluate whether there is any difference on the long-term results of TAR and non-TAR CABG patients. Methods: The Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica dataBASE (EMBASE), Cochrane Central Register of Controlled Trials (CENTRAL/CCTR), Clinical Trials.gov, Scientific Electronic Library Online (SciELO), Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), and Google Scholar databases were searched for studies published by October 2020. Randomized clinical trials and observational studies with propensity score matching comparing TAR versus non-TAR CABG were included. Random-effects meta-analysis was performed. The current barriers to implementation of TAR in clinical practice and measures that can be used to optimize outcomes were reviewed. Results: Fourteen publications (from 2012 to 2020) involving a total of 22,746 patients (TAR: 8,941 patients; non-TAR: 13,805 patients) were included. The pooled hazard ratio (HR) for long-term mortality (over 10 years) was lower in the TAR group than in the non-TAR group (random effect model: HR 0.676, 95% confidence interval 0.586-0.779, P<0.001). There was evidence of low heterogeneity of treatment effect among the studies for mortality, and none of the studies had a particular impact on the summary result. The result was not influenced by age, sex, or comorbidities. We identified low risk of publication bias related to this outcome. Conclusion: This review found that TAR presents the best long-term results in patients who undergo CABG. Given that many patients are likely to benefit from TAR, its use should be encouraged.

Sobre las revisiones sistemáticas y narrativas de la literatura en Medicina / On systematic and narrative literature reviews in medicine

Las revisiones de la literatura son cada día más frecuentes en el ámbito biomédico, ya sea de tipo narrativo, revisiones sistemáticas o meta-análisis. En este artículo se revisan y describen las características de cada una de ellas, con sus ventajas y desventajas. Además, se presentan los principales elementos a tener en consideración en el análisis de los meta-análisis, incluyendo análisis de sensibilidad, búsqueda de heterogeneidad y sesgos de publicación.

Reviews are becoming more common in the biomedical field, whether it be a narrative type, systematic review, or meta-analysis. In this article, I review and describe the characteristics of each of them, with their advantages and disadvantages. In addition, I discuss main elements to considerer when you read meta-analyzes, including sensitivity analysis, search for heterogeneity and, publication biases.

Intervention meta-analysis: application and practice using R software / 한국역학회지

The objective of this study was to describe general approaches for intervention meta-analysis available for quantitative data synthesis using the R software. We conducted an intervention meta-analysis using two types of data, continuous and binary, characterized by mean difference and odds ratio, respectively. The package commands for the R software were “metacont”, “metabin”, and “metagen” for the overall effect size, “forest” for forest plot, “metareg” for meta-regression analysis, and “funnel” and “metabias” for the publication bias. The estimated overall effect sizes, test for heterogeneity and moderator effect, and the publication bias were reported using the R software. In particular, the authors indicated methods for calculating the effect sizes of the target studies in intervention meta-analysis. This study focused on the practical methods of intervention meta-analysis, rather than the theoretical concepts, for researchers with no major in statistics. Through this study, the authors hope that many researchers will use the R software to more readily perform the intervention meta-analysis and that this will in turn generate further related research.

Intervention meta-analysis: application and practice using R software / 한국역학회지

The objective of this study was to describe general approaches for intervention meta-analysis available for quantitative data synthesis using the R software. We conducted an intervention meta-analysis using two types of data, continuous and binary, characterized by mean difference and odds ratio, respectively. The package commands for the R software were “metacont”, “metabin”, and “metagen” for the overall effect size, “forest” for forest plot, “metareg” for meta-regression analysis, and “funnel” and “metabias” for the publication bias. The estimated overall effect sizes, test for heterogeneity and moderator effect, and the publication bias were reported using the R software. In particular, the authors indicated methods for calculating the effect sizes of the target studies in intervention meta-analysis. This study focused on the practical methods of intervention meta-analysis, rather than the theoretical concepts, for researchers with no major in statistics. Through this study, the authors hope that many researchers will use the R software to more readily perform the intervention meta-analysis and that this will in turn generate further related research.

Gestión de revisores en la revista Archivo Médico de Camagüey / Management of reviewers in the Archivo Médico de Camagüey journal

RESUMEN Fundamento: luego de la aceptación preliminar del artículo desde el punto de vista metodológico y de la redacción del texto, se procede a su revisión por expertos, proceso que es fundamental para refrendar su validez científica. Objetivo: describir la experiencia y resultados de la revista Archivo Médico de Camagüey en la gestión de incorporación de revisores. Métodos: se realizó una búsqueda en las bases de datos SciELO Cuba, SciELO Regional, se utilizaron los descriptores: árbitro, revisión por pares, criterios de selección, peer review, revisión de la investigación por pares. Resultados: cada vez es mayor el número de revisores incorporados, con representación de las provincias del país y de otros países, la mayor parte de las provincias están representadas y después de Cuba le siguen Chile y Perú. Conclusiones: la gestión de árbitros es un proceso complejo y minucioso que se planifica en tres momentos: identificación, verificación y negociación. La revista muestra un trabajo ascendente en la incorporación de árbitros, se incrementa la incorporación de árbitros de otros países de la región.

ABSTRACT Background: after the preliminary acceptance of the article from the methodological point of view, and the writing of the text, it is revised by experts, a process that is fundamental to validate its scientific validity. Objective: to describe the experience and results of the journal Archivo Médico de Camagüey in the management of reviewers´ incorporation. Methods: a search was made in the SciELO Cuba, SciELO Regional databases, the used descriptors were referee, peer review, selection criteria. Results: the number of incorporated reviewers is increasing, with representation of the provinces of the country and from other countries, most of the provinces are represented and after Cuba with (86,0 %) they are followed by Chile (2,7 %) and Peru (2,2 %). Conclusions: the management of reviewers is a complex and meticulous process, which is planned in three moments: identification, verification and negotiation. The magazine shows an ascending work in the incorporation of reviewers, the incorporation of referees from other countries of the region is increased.

The author and authorships in clinical trial: based on the interpretation and analysis of GPP3 / 中华医学科研管理杂志

Objective Clinical trial researches are sponsored by medical companies mostly,the research paper publishes in a potential publication bias inevitably.This paper discussed the author's and authorship's issues in clinical trials.Methods The Good Publication Practice for pharmaceutical companies (GPP) 3rd edition was interpreted,related literatures and domestic policies were analyzed.Results The issues including setting up publication steering committees,clarifying authorship,employing professional medical writers,personal fees,contributorship and acknowledgments,potential conflict of interest,and author's rights and obligations should be well panned and deal with in clinical trials.Conclusions Researchers who involved in clinical trials should treat the author's and authorship ’s issues with caution.

Exercise for depression in older adults: a meta-analysis of randomized controlled trials adjusting for publication bias

Objective: To evaluate the antidepressant effects of exercise in older adults, using randomized controlled trial (RCT) data. Methods: We conducted a meta-analysis of exercise in older adults, addressing limitations of previous works. RCTs of exercise interventions in older people with depression (≥ 60 years) comparing exercise vs. control were eligible. A random-effects meta-analysis calculating the standardized mean difference (SMD) (95% confidence interval [95%CI]), meta-regressions, and trim, fill, and fail-safe number analyses were conducted. Results: Eight RCTs were included, representing 138 participants in exercise arms and 129 controls. Exercise had a large and significant effect on depression (SMD = -0.90 [95%CI -0.29 to -1.51]), with a fail-safe number of 71 studies. Significant effects were found for 1) mixed aerobic and anaerobic interventions, 2) at moderate intensity, 3) that were group-based, 4) that utilized mixed supervised and unsupervised formats, and 5) in people without other clinical comorbidities. Conclusion: Adjusting for publication bias increased the beneficial effects of exercise in three subgroup analysis, suggesting that previous meta-analyses have underestimated the benefits of exercise due to publication bias. We advocate that exercise be considered as a routine component of the management of depression in older adults.

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

CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

CONTEXTO E OBJETIVO: O registro dos ensaios clínicos é pré-requisito para publicação em revistas científicas de prestígio. Recentes mecanismos regulatórios brasileiros também exigem o registro de determinados ensaios clínicos na plataforma nacional (Registro Brasileiro de Ensaios Clínicos, ReBEC). Porém há pouca informação disponível sobre questões práticas envolvidas no processo de registro. Este trabalho discute a importância do registro de ensaios clínicos e aspectos práticos envolvidos nesse processo. DESENHO DE ESTUDO E LOCAL: Estudo descritivo realizado por pesquisadores de um programa de pós-graduação em uma universidade pública em São Paulo, Brasil. MÉTODOS: Informações foram obtidas em plataformas de registro de ensaios clínicos, referências dos artigos encontrados e websites (última busca: setembro, 2014) sobre os seguintes temas: definição de ensaio clínico, história, objetivo e importância das plataformas de registro, quais informações devem ser registradas e o processo de registro. RESULTADOS: O registro de ensaios clínicos visa evitar viés de publicação e é exigido por revistas brasileiras disponíveis no LILACS, SciELO e revistas afiliadas ao Comitê Internacional de Editores de Revistas Médicas (ICMJE). Recentes normas brasileiras exigem que todos os ensaios clínicos (fases I a IV) envolvendo novos medicamentos no país sejam registrados no ReBEC. São discutidos os prós e contras da utilização de diferentes bases de registro de ensaios clínicos. CONCLUSÃO: O registro de ensaios clínicos é importante e atualmente existem vários mecanismos que obrigam seu uso. Quando forem escolher em qual plataforma registrar seu ensaio clínico, os pesquisadores devem levar em consideração quais são as normas nacionais e as exigências para publicação.

Tendencia de publicación de ensayos clínicos con resultados negativos financiados por industrias farmacéuticas durante el periodo 2007-2012 / Publication Trend of Clinical Trials with Negative Results Funded by Pharmaceutical industries for the 2007-2012 Period / Tendência de publicação de ensaios clínicos com resultados negativos financiados por indústrias farmacêuticas durante o período 2007-2012

Objetivo: Evaluar los resultados de ensayos clínicos financiados por la industria farmacéutica durante el periodo 2007-2012 en una revista médica general. Materiales y métodos: Se realizó un estudio observacional de corte transversal donde se revisaron ensayos clínicos originales financiados por la industria farmacéutica publicados entre el año 2007 y 2012 en la revista The New England Journal of Medicine (http://www.nejm.org). Se empleó la prueba de χ² de tendencia para evaluar los resultados de los estudios a través de los años. Se creó una base de datos con las diferentes variables, identificando el número de publicaciones y el periodo de mayor publicación de estudios negativos así como la especialidad médica e industria farmacéutica financiadora. Resultados: Se analizaron 321 ensayos clínicos. Se calculó el Odds Ratio para cada año evaluado, encontrando un χ² de tendencia lineal en estudios negativos de 2,91 con valor p 0,08 y en los estudios positivos de 1,16 con valor p 0,28. Se encontró que en el periodo 2007-2009 se publicaron 123 estudios, de los cuales el 40 % presentaron resultados negativos; a diferencia del periodo 2010-2012 en el cual se publicaron 198 ensayos clínicos, de los cuales 142 presentaron resultados negativos. OR 1,68 IC 95 % (1,02-2,78) valor p 0,03. El mayor año de publicación de estudios negativos fue el 2007 con 44,7%. Conclusiones: Se ha visto una disminución progresiva en el número de publicaciones con resultados negativos en general por año. No se encontró una diferencia estadísticamente significativa en la publicación de estudios negativos por año entre el período 2007-2012. La especialidad médica con mayor número de publicaciones totales y negativas en los dos periodos fue cardiología y las industrias farmacéuticas que más patrocinaron ensayos clínicos totales y con resultados negativos en los dos periodos fueron Merck, Glaxo SmithKline y Sanofi-Aventis. El 50 % de las publicaciones de neurología mostraron resultados negativos.

Objective: To evaluate the results of clinical trials financed by the pharmaceutical industries during the period 2007-2012 in a general medical journal. Materials and methods: We performed an observational cross sectional study where originals clinical trials financed by the pharmaceutical industry published between 2007 and 2012 in the journal The New England Journal of Medicine (http://www.nejm.org) were reviewed. Trend χ² test was used to evaluate the results of studies over the years. A database was created with different variables, identifying the number of publications and the period of greater publishing negatives studies, as well as the medical specialty and pharmaceutical industry funding. Results: 321 clinical trials were analyzed. The Odds Ratio was calculated for each year evaluated, finding a χ²of linear trend in negatives studies of 2.91 with value p 0.08 and positive studies of 1.16 with value p 0.28. It was found that in the period 2007-2009 123 studies were published, 40% of which presented negative results; unlike the 2010-2012 period in which 198 clinical trials where published, 142 of them, showed positive results, OR 1.68, 95 % CI (1.02-2.78) value p 0.03. The highest figures of negative results were published in 2007: 44.7 %. Conclusions: A progressive decrease in the number of publications with annual general negative results has been observed. A statistically significant difference in the publication of negative studies per year was not found between the periods 2007-2012. The medical specialty that showed the largest number of total and negative publications in both periods was cardiology. The pharmaceutical industry that sponsored most total clinical trials with negative results in both periods did so through Merck, Glaxo SmithKline, and Sanofi-Aventis. 50 % of neurology publications showed negative results.

Objetivo: avaliar os resultados de ensaios clínicos financiados pela indústria farmacêutica durante o período 2007-2012 em uma revista médica geral. Materiais e métodos: realizou-se um estudo observacional de corte transversal onde revisaram-se ensaios clínicos originais financiados pela indústria farmacêutica publicados entre o ano 2007 e o ano 2012 na revista The New England Journal of Medicine (http://www.nejm.org). Empregou-se o teste do χ²de tendência para avaliar os resultados dos estudos através dos anos. Criou-se uma base de dados com as diferentes variáveis, identificando o número de publicações e o período de maior publicação de estudos negativos assim como a especialidade médica e indústria financiadora. Resultados: analisaram-se 321 ensaios clínicos. Calculou-se o Odds Ratio para cada ano avaliado, encontrando um χ² de tendência lineal em estudos negativos de 2,91 com valor p 0,08 e nos estudos positivos de 1,16 com valor p 0,28. Encontrou-se que no período 2007-2009 se publicaram 123 estudos, dos quais o 40% apresentaram resultados negativos; ao contrário do período 2010-2012 no qual se publicaram 198 ensaios clínicos, dos quais 142 apresentaram resultados negativos 1,68 IC 95% (1,02-2,78) valor p 0,03. O ano com maior quantidade de publicações de estudos negativos foi 2007 com 44,7%. Conclusões: Tem-se identificado uma diminuição progressiva no número de publicações com resultados negativos em geral por ano. Não se encontrou uma diferença estatisticamente significativa na publicação de estudos negativos por ano entre o período 2007-2012. A especialidade médica com maior número de publicações totais e negativos nos dois períodos foi cardiologia e as indústrias farmacêuticas que mais patrocinaram ensaios clínicos totais e com resultados negativos nos dois períodos foram Merck, Glaxo SmithKline e Sanofi-Aventis. O 50% das publicações de neurologia mostraram resultados negativos.

Should a Trial with Lost Allocation Key be Incorporated in Meta-analysis.

Aims: On occasion randomized controlled studies may remain unpublished because the allocation key identifying which group received active treatment and which received placebo (or alternative treatment) has been lost. The purpose of this paper is to explore whether and under what circumstances an unpublished study like NCT00250237 whose allocation key has been irretrievably lost might be incorporated into a meta-analysis, allowing the information contained to contribute, however tentatively, to the evidence base around a clinical topic. Study Design: Review / meta-analysis Place and Duration of Study: Vancouver Coastal Health Research Institute and School of Population and Public Health, University of British Columbia and Department of Surgery, Rijnland Hospital, between 2009 and 2014. Methodology: For two published trials, we calculated separate effect measures for a simulated lost allocation key, under the alternative assumptions that Groups A or B received active treatment. These two effects were compared visually to the pooled effect from a meta-analysis of all other comparable studies. We present as well several quantitative methods for reconstituting a lost allocation code, involving frequentist meta-analysis, meta-regression, and Bayesian techniques. We apply these to an analysis of NCT00250237. Results: The simulated lost allocation keys of both trials were successfully identified through visual methods using meta-analysis. Reconstitution in this manner requires that the trial’s effect depart significantly from the null and that there exist a sufficient number of other high quality studies addressing the same clinical topic to allow unbiased calculation of a pooled summary effect. While direct reconstitution may sometimes be possible, our primary approaches are implicitly Bayesian and, as with NCT00250327, allow probabilities to be estimated for each allocation assignment. Conclusion: Under some circumstances studies with a lost allocation key may be incorporated cautiously into meta-analysis.

Adherencia a las guías de informe sobre investigaciones en revistas biomédicas en América Latina y el Caribe / Adherence to research reporting guidelines in biomedical journals in Latin America and the Caribbean

OBJETIVO: Evaluar el conocimiento que los editores de las revistas indizadas en la base de datos LILACS tienen acerca de las Guías para informar y publicar sobre investigaciones -promovidas por la Red EQUATOR (Enhancing Quality and Transparency of Health Research)-, los requisitos de las revistas para su uso y el conocimiento de los editores sobre los motivos de la baja tasa de uso. MÉTODOS: Se encuestó por correo electrónico a editores de LILACS sobre las Guías y su disponibilidad en el sitio web de EQUATOR y los requerimientos y dificultades para su uso. RESULTADOS: De los 802 editores, 16,4% respondieron la encuesta, más de la mitad dijeron no conocer las Guías (en especial STROBE y PRISMA) y 30% tenían conocimiento sobre la Red EQUATOR. CONCLUSIONES: El primer estudio en América Latina y el Caribe sobre el conocimiento que tienen los editores de LILACS sobre las Guías revela que más de la mitad no conoce las Guías ni la Red EQUATOR.

OBJECTIVE: To evaluate the familiarity of the editors of journals indexed in the LILACS database with the guidelines for reporting on and publishing research- promoted by the EQUATOR Network (Enhancing QUAlity and Transparency Of Health Research)-, the journals' requirements for use of the guidelines, and the editors' opinions regarding the reasons for the low rate of use. METHODS: LILACS editors were surveyed by e-mail about the guidelines and their availability at the EQUATOR website, and about the requirements and difficulties in using them. RESULTS: Of 802 editors, 16.4% answered the survey. More than half said they were not aware of the guidelines (especially STROBE and PRISMA) and 30% were familiar with the EQUATOR Network. CONCLUSIONS: The first Latin American and Caribbean study on LILACS editors' familiarity with the guidelines revealed that more than half of them were not familiar either with the guidelines or the EQUATOR Network.

An introduction to systematic review

Systematic review had become one of the important research area in medicine. Systematic review can be demonstrating benefit or harm of an intervention when results of individual studies are inconclusive. While narrative reviews can often include an element of selection bias, systematic reviews typically involve a comprehensive plan and search strategy with the goal of reducing bias by identifying, appraising, and synthesizing all relevant studies on a particular topic and investigation of heterogeneity among included studies. Systematic reviews typically include a meta-analysis component which involves using statistical techniques to synthesize the data from several studies into a single quantitative estimate or summary effect size. Systematic review overcomes the limitation of small sample sizes by pooling results from a number of individual studies to generate a single best estimate. Although systematic reviews are published in academic forums, the Cochrane Collaboration is a widely recognized international and not-for-profit organization that promotes, supports, and disseminates systematic reviews and meta-analyses on the efficacy of interventions in the health care field. Systematic review has become a popular and powerful tool. If rigorously conducted, it is essential for evidence-based decision making in clinical practice as well as on the health policy level.

Una historia de perjuicio, desperdicio y engaño: cómo la gran industria farmacéutica ha socavado la fe pública en los datos de sus ensayos clínicos y qué podemos hacer al respecto / A tale of harm, waste and deception: how big pharma has undermined public faith in trial data disclosure and what we can do about it

El artículo aborda el tema de los datos relacionados con los estudios de intervención en seres humanos conducidos por la industria farmacéutica y cómo la falta de datos, o bien la distorsión de éstos, puede determinar un impacto sobre la toma de decisiones en clínica y en las revisiones sistemáticas. Se comentan los casos de rosiglitazona (Avandia™, GlaxoSmithKline), rofecoxib (Vioxx™, Merck) y de oseltamivir (Tamiflu™, Roche), como ejemplos de perjuicio (morbilidad y mortalidad mayor en quienes han usado los fármacos), de desperdicio (mayor gasto de los gobiernos en programas de control de problemas de salud pública que no tenían base en evidencia) y de engaño (no reporte de eventos adversos por parte de los encargados de los estudios). Las consecuencias de esta conducta sobre la producción científica son múltiples. Principalmente se produce una reducción y distorsión de la base de evidencia para fundamentar las decisiones clínicas, lo que también incluye el sesgo de publicación. Se recogen varias soluciones planteadas en la literatura internacional como el registro de los ensayos clínicos antes de su realización, el uso de directrices para mejorar la calidad de los reportes, fomentar la publicación de todos los resultados de investigación y la autonomía de la academia e investigadores. El registro de los ensayos clínicos no ha sido eficaz en prevenir la opacidad que rodea la experimentación fase III de los ensayos de intervención financiados por la industria. Deben hacerse cargo de este problema los editores de las revistas biomédicas, las autoridades sanitarias encargadas de dar la aprobación a los fármacos antes de su comercialización, los comités de ética que autorizan la ejecución de ensayos en sus establecimientos, los investigadores y académicos y las organizaciones de pacientes. La industria farmacéutica está llamada a responder a estas propuestas que fomentan la transparencia...

The article addresses the issue of data stemming from interventional studies in humans conducted by the pharmaceutical industry and how lack of data, or data distortion, can impact on clinical decision making and systematic reviews. The cases of rosiglitazone (Avandia ™, GlaxoSmithKline), rofecoxib (Vioxx ™, Merck), and oseltamivir (Tamiflu ™, Roche), are discussed as examples of harm (morbidity and mortality were higher in the treatment groups), waste (government spending in public health programs was not based on evidence), and deception (non-reporting of adverse events in fase III trials). The consequences of this behavior on scientific production are manifold. Most importantly, evidence that is used to inform clinical decisions is reduced and distorted, which also includes publication bias. The article mentions several solutions that have appeared in international literature, such as registration of clinical trials prior to implementation, the use of guidelines to improve the quality of reports, encouraging the publication of all research results and safeguarding autonomy of academy and investigators. Registration of clinical trials has not been effective in preventing the opacity surrounding phase III intervention trials funded by industry. Editors of biomedical journals, health authorities in charge of approving drugs before marketing, ethics committees that authorize the conduct of trials in their facilities, researchers, academics and patient organizations, are all major stakeholders. The pharmaceutical industry is called upon to respond to these proposals that promote transparency. If they do so, public trust in research conducted by them may be recovered.

Existe viés de publicação para artigos brasileiros sobre câncer? / Is there publication bias towards Brazilian articles on cancer?

OBJETIVO: Investigar se artigos brasileiros sobre câncer são publicados em periódicos de fator impacto e/ou repercussão (medida pelo número de citações) inferiores aos oriundos de instituições estrangeiras MÉTODOS: Pesquisou-se, no PubMed, o MeSH Term "neoplasm" com os limitadores: clinical trial, afiliação de autor(es) brasileira e intervalo de 1º de julho de 2009 a 30 de junho de 2010. Foram selecionados para pareamento artigos relacionados, não brasileiros, publicados entre três meses antes e três meses depois da data de publicação do estudo brasileiro. Foram obtidos os números de citações, em duas bases de dados, assim como o fator de impacto para as revistas nas quais os artigos foram publicados. RESULTADOS: Identificaram-se 43 artigos nacionais e 876 internacionais relacionados. Os brasileiros apresentaram fator de impacto médio de 3.000 contra 3.430 dos internacionais (p=0,041). Não houve diferença estatisticamente significativa quanto ao número de citações entre os grupos. A afiliação do primeiro autor à instituição brasileira ou estrangeira também não influenciou significativamente no número de citações nem no fator de impacto. CONCLUSÃO: Artigos brasileiros são significativamente menos aceitos em revistas de maior impacto sem aparente comprometimento de sua repercussão na comunidade científica.

OBJECTIVE: To investigate whether Brazilian articles on cancer are published in journals with an impact factor and/or repercussion (measured by the number of citations) inferior to those that come from foreign organizations. METHODS: A search was carried out in PubMed for the MeSH term "neoplasm" with the limits clinical trial, affiliation of the Brazilian author(s), and interval from July 1st, 2009 to June 30, 2010. Selected for matching were non-Brazilian related articles published from three months prior to three months after the date of publication of the Brazilian study. The numbers of citations were obtained from two databases, as well as the impact factor for the journals in which the articles were published. RESULTS: Forty-three national and 876 related international articles were identified. The Brazilian publications had a mean impact factor of 3.000 versus 3.430 of the international ones (p=0.041). There was no statistically significant difference as to the number of citations between the two groups. The affiliation of the first author with a Brazilian or foreign organization did not significantly influence the number of citations or the impact factor. CONCLUSION: Brazilian articles are significantly less accepted in journals with higher impact factors, although it does not compromise its repercussion on the scientific community.

Registration and Reporting Guidelines for Clinical Trials / 대한내과학회지

Selective outcome reporting is a major problem because it has a negative impact on our scientific knowledge and is unethical as it involves research on human subjects. And inadequate quality of trials may distort the results from systematic reviews and meta-analyses. Thus, Clinical medicine tries to solve the problem of trials by making public registration before patient enrollment mandatory and encouraging to report the research outcomes by a specific guidelines. In the past few years, the registration of clinical trials and the reporting system has become routine, supported by the International Committee of Medical Journal Editors. In Korea, the clinical research registry named 'Clinical Research Information Service (CRiS)' was recently established and became a data provider as a primary registry to the World Health Organization (WHO) International Clinical Trial Registry Platform search portal. To expand the registration system and to operate them successfully and comprehensively, active participations of researchers as well as the government supports are required.

Avances y retos en el registro de ensayos clínicos en América Latina y el Caribe / Progress and challenges of clinical trials registration in Latin America and the Caribbean’s

Los registros de ensayos clínicos (EC) constituyen una de las mayores fuentes de información de investigaciones en intervenciones en salud que se han o se están llevando a cabo en el mundo. La Organización Mundial de la Salud estableció un conjunto mínimo de datos que se deben registrar (20 ítems), consensuado a nivel internacional con las partes interesadas, y estableció una red de registros primarios y de registros asociados. Existen actualmente dos registros primarios en las Américas (Brasil y Cuba) avalados por la OMS, además del registro ClinicalTrial.Gov (de los Estados Unidos de Norteamérica) que aportan datos a la plataforma internacional de registros de EC de la OMS (ICTRP). Adicionalmente, hay avances importantes en la región relacionados con las regulaciones, el desarrollo e implementación de registros nacionales y la adhesión de comités de ética y editores a la iniciativa.

Clinical trial registries are one of the main sources of information concerning health research interventions that have been or are being carried out throughout the world. The World Health Organization (WHO) established a minimum data set to be recorded (20 items), which was agreed upon internationally with the stakeholders, and established a network of primary and associated records. In addition to the register ClinicalTrial.Gov (of the United States of America), there are currently two primary registries in the Americas (from Brazil and Cuba) that meet WHO requirements and provide data to WHO’s International Clinical Trials Registry Platform (ICTRP). Furthermore, there are important advances in the region related to the regulations, development and implementation of national registries and to the support of the ethics committees and editors to this initiative.