Sesgos en investigación quirúrgica / Biases in surgical research

Resumen Los resultados de diversos hallazgos de investigación han sido objeto de crítica, en especial en los últimos años, debido a presencia de errores sistemáticos (sesgos), los que ponen en duda la validez interna de los resultados obtenidos. Estos sesgos pueden ocurrir en cualquier etapa del curso de una investigación, es decir, desde la planificación del estudio hasta la presentación y publicación de sus resultados. Los sesgos se han clasificado de diferentes formas, intentado agruparlos bajo dimensiones conceptuales, objeto de organizar de mejor forma la información existente, que además es considerable. Los sesgos pueden ocurrir por diversos motivos, pero en general, los más frecuentes son aquellos originados por el observador (él o los que miden), por lo que es observado (sujeto en estudio); y aquello con lo que se observa (instrumento de medición). Por otra parte, varios de los múltiples sesgos existentes, se pueden agrupar en: sesgos de selección, de medición o información, y de confusión. El objetivo de este manuscrito fue comentar la importancia de los sesgos más comunes en la investigación quirúrgica, y su relación con algunos diseños de investigación; así como, conocer las estrategias existentes para minimizar su ocurrencia.

The results of many research findings have come under scrutiny in recent years due to the introduction of systematic errors (biases), which can occur at any stage during an investigation, from planning to presentation of results and their presentation and further publication. Biases have been classified in different ways, trying to group them under conceptual dimensions to better organize the existing information, which is considerable. Biases can occur for various reasons, but in general, the most frequent are those originated by the observer, what is observed; and what is observed with. I.e., the subject that is measured, who measures it and with what it measures it. On the other hand, several of the multiple biases can be grouped into selection, measurement or information, and confounding biases. The aim of this manuscript was to comment on the importance of the most common biases in surgical research, and their relationship with some research designs; as well as know the existing strategies to reduce its occurrence.

Análisis comparativo de las pautas del consejo de organizaciones internacionales de ciencias médicas (CIOMS) 2016: (Parte 2 de 3) / Comparative analysis of the standards of the council of international organizations of medical sciences (CIOMS) 2016. (Part 2 of 3)

Como parte de la evaluación de la asignatura Bioética e Investigación de la Maestría en Bioética, se solicitó a los estudiantes de la VI Cohorte que realizarán un análisis comparativo de las Pautas CIOMS 2016 con documentos anteriores. En esta segunda parte, se presentan las pautas relacionadas con el consentimiento informado, la recolección, almacenamiento y uso de materiales biológicos y datos relacionados, así como la rendición pública de cuentas y la publicación de las investigaciones. Estas pautas son fundamentales para la realización de investigaciones científicas en seres humanos por eso el objetivo de estos trabajos es proporcionar a los investigadores un aporte en su formación y una rápida adaptación a la nueva propuesta CIOMS(AU)

As part of the evaluation of the Bioethics and Research subject of the Master in Bioethics, students of the VI Cohort were asked to make a comparative analysis of the CIOMS 2016 Guidelines with previous documents. In this second part, the guidelines related to informed consent, collection, storage and use of biological materials and related data, as well as public accountability and publication of research are presented. These guidelines are fundamental for carrying out scientific research on human beings, and for this reason the objective of this work is to provide researchers with a contribution in their training and a rapid adaptation to the new CIOMS proposal(AU)

Statements, recommendations, proposals, guidelines, checklists and scales available for reporting results in biomedical research and quality of conduct: a systematic review / Declaraciones, recomendaciones, propuestas, directrices, listas de verificación y escalas disponibles para informar resultados y calidad metodológica en investigación biomédica: revisión sistemática

SUMMARY: Research reporting statements, recommendations, proposals, guidelines, checklists and scales can improve quality of reporting results in biomedical research. The aim of this study was to describe statements, recommendations, proposals, guidelines, checklists and scales available for reporting results and quality of conduct in biomedical research. Systematic review. All types statements, recommendations, proposals, guidelines, checklists and scales generated to improve the quality of the biomedical research results report were included. Data sources: EMBASE, HINARI, MEDLINE and Redalyc; in the libraries BIREME-BVS, SciELO and The Cochrane Library; in the meta-searchers Clinical Evidence and TRIP Database; and on the Websites of EQUATOR Network, BMC Medical Education and EUROPE PMC were used. The recovered documents were grouped as study design related to systematic reviews (SR) meta-analysis and meta-reviews, CT and RCTs and quasi-experimental studies, observational studies, diagnostic accuracy studies, clinical practice guidelines; biological material, animal and preclinical studies; qualitative studies; economic evaluation and decision analysis studies; and methodological quality (MQ) scales). The 93 documents were obtained. 19 for SR (QUOROM, MOOSE, AMSTAR, AMSTAR 2, PRISMA, PRISMA-Equity, PRISMA-C, PRISMA-IPD, PRISMA-NMA, PRISMA-RR, PRESS, PRISMA-Search, PRISMA-TCM, PRISMA-ScR, PRISMA-DTA, PRISMA-P, MARQ, GRAPH, ROBIS), 32 for CT and RCTs (CONSORT and it update, STRICTA, RedHot, NPT, CONSORT-PRO, CONSORT-SPI, IMPRINT, TIDieR, CT in orthodontics, "n-de-1", PAFS, KCONSORT, STORK, Protocol health data, SW-CRT, ADs, MAPGRT, PRT, TREND, GNOSIS, ISPOR RCT Report, Newcastle-Ottawa, REFLECT, Ottawa, SPIRIT, SPIRIT-C, SPAC, StaRI, TRIALS, ROBINS-I, ROB 2), 11 for observational studies (STROBE, STREGA, STROBE-nut, INSPIRE, STROME-ID, STROBE-Vet, RECORD, ORION, STNS, MInCir-ODS, GATHER), 10 for diagnostic accuracy studies (STARD and it update, ARDENT, QUADAS, QUADAS-2, QAREL and it update, GRRAS, TRIPOD, APOSTEL), 3 for clinical practice guidelines (AGREE, AGREE II, RIGHT), 10 for biological material, animal and preclinical studies (MIAME, REMARK, SQUIRE, SQUIRE 2.0, REHBaR, ARRIVE, GRIPS, CARE, AQUA, PREPARE), 5 for qualitative studies (COREQ, ENTREQ, GREET and it update, SRQR), and 3 for economic evaluations (NHS-HTA, NICE-STA, CHEERS). There are a great variety of statements, recommendations, proposals, guidelines, checklists with its extensions and scales available. These can be used to improve the quality of the report and the quality of conduct of scientific articles, by authors, reviewers and editors.

RESUMEN: El uso de recomendaciones, propuestas, listas de verificación y escalas pueden mejorar la calidad del informe de resultados en investigación biomédica. El objetivo de este estudio fue describir las declaraciones, recomendaciones, propuestas, directrices, listas de verificación y escalas disponibles para informar resultados y calidad metodológica en investigación biomédica. Revisión sistemática. Se incluyeron todas las tipos de declaraciones, recomendaciones, propuestas, pautas, listas de verificación y escalas disponibles para informar resultados y calidad metodológica en investigación biomédica. Fuentes de datos: EMBASE, HINARI, MEDLINE y Redalyc; bibliotecas BIREME-BVS, SciELO y The Cochrane Library; metabuscadores Clinical Evidence y TRIP Database; sitios Web EQUATOR Network, BMC Medical Education y EUROPE PMC. Los documentos recuperados se agruparon por tipo de diseño de estudio: revisiones sistemáticas (RS), ensayos clínicos (EC), estudios cuasi experimentales, observacionales, de precisión diagnóstica, guías de práctica clínica (GPC); de material biológico, estudios animales y preclínicos; estudios cualitativos; estudios de evaluación económica y estudios de análisis de decisiones; y escalas de calidad metodológica (CM). se obtuvieron 93 documentos. 19 para RS (QUOROM, MOOSE, AMSTAR, AMSTAR 2, PRISMA, PRISMA-Equity, PRISMA-C, PRISMA-IPD, PRISMA-NMA, PRISMA-RR, PRESS, PRISMA-Search, PRISMA-TCM, PRISMAScR, PRISMA-DTA, PRISMA-P, MARQ, GRAPH, ROBIS), 32 para EC (CONSORT y su actualización, STRICTA, RedHot, NPT, CONSORT-PRO, CONSORT-SPI, IMPRINT, TIDieR, CT en ortodoncia, "n-de-1 ", PAFS, KCONSORT, STORK, datos de salud del protocolo, SW-CRT, ADs, MAPGRT, PRT, TREND, GNOSIS, ISPOR RCT Report, Newcastle-Ottawa, REFLECT, Ottawa, SPIRIT, SPIRIT-C, SPAC, StaRI , PRUEBAS, ROBINS-I, ROB 2), 11 para estudios observacionales (STROBE, STREGA, STROBE-nut, INSPIRE, STROME-ID, STROBE-Vet, RECORD, ORION, STNS, MInCir-ODS, GATHER), 10 para estudios de precisión diagnóstica (STARD y su update, ARDENT, QUADAS, QUADAS-2, QAREL y su update, GRRAS, TRIPOD, APOSTEL), 3 para GPC (AGREE, AGREE II, RIGHT), 10 para material biológico, animal y estudios preclínicos (MIAME, REMARK, SQUIRE, SQUIRE 2.0, REHBaR, ARRIVE, GRIPS, CARE, AQUA, PREPARE), 5 para estudios cualitativos (COREQ, ENTREQ, GREET y su update, SRQR), y 3 para evaluaciones económicas (NHS-HTA, NICE-STA, CHEERS). Existe una gran variedad de instrumentos disponibles. Estos pueden ser utilizados por autores, revisores y editores; para mejorar la calidad del informe y de la CM de artículos científicos.

Estudios de cohortes especiales / Special cohort studies

Resumen Como se comentó en el artículo anterior (Estudios de cohortes. 1ª parte. Descripción, metodología y aplicaciones), los estudios de cohortes se caracterizan por ser observacionales, longitudinales y analíticos; y en todos ellos se debe considerar una exposición o "factor de exposición", un período de seguimiento, eventuales pérdidas de seguimiento y el desenlace de un resultado. Se han propuesto modificaciones y variantes al diseño del estudio de cohortes tradicional. Se describen de forma resumida, las características principales de los estudios de cohortes con base poblacional, de cohortes bidireccional o ambispectivo; y de otras variantes: según número de cohortes (única y múltiple), de acuerdo al tipo de reclutamiento de la población a estudio (cerrada y abierta), según el tipo de exposición (fija y dinámica); estudio de casos y controles anidado, cohorte-caso; y cohortes ocupacionales (simple con población de referencia externa, simple con grupo de referencia interna y de cohortes múltiples). Finalmente, se desarrollan algunos ejemplos de la literatura de las variantes de cohortes más frecuentes. El objetivo de este manuscrito fue generar un documento de estudio referente a las modificaciones y variantes del diseño del estudio de cohortes.

As we mentioned in a previous article (Cohort studies. 1st part. Description, methodology and applications), cohort studies are characterized by being observational, longitudinal and analytical studies; and in all of them an exposure, a follow-up period, eventual loss of follow-up; and an outcome should be considered. A number of modifications and variants to the traditional cohort study design have been proposed. A summary with the main characteristics of population-based cohort studies, bidirectional cohorts, and of other variants according: to the number of cohorts (single and multiple), to the recruitment of the study population (closed and open), to the exposure (fixed and dynamic); nested case-control study, cohort-case, and occupational cohorts (simple with external reference population, simple with internal reference group and multiple cohorts), are described. Finally, examples of the literature of the most frequent cohort variants are developed. The aim of this manuscript was to generate a study document referring to some of the modifications and variants of cohort studies.

Analysis of the technical-scientific production of the National Council for Scientific and Technological Development (CNPq) productivity fellows in Pediatrics / Análise da produção técnico-científica de bolsistas de produtividade do Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) na área da Pediatria

ABSTRACT Objective: To analyze the technical-scientific production of research productivity fellows of the National Council for Scientific and Technological Development, in Pediatrics, from 2013 to 2016. Methods: First, data were obtained identifying fellowship researchers using the Lattes Platform, and subsequently calculating the indicators present in their Lattes curricula using scriptLattes software v8.10. Results: In the period studied, 17 fellowship researchers were identified. They published a total of 524 articles in journals, most of them ranked as high and intermediate Qualis. In addition, fellowship researchers conducted 158 supervisions during the period, published 119 books or chapters and 465 papers in conference proceedings. Conclusion: The Brazilian scientific production in Pediatrics has shown to be significant and of good impact, both nationally and internationally. However, the distribution of research groups is concentrated in specific regions of Brazil.

RESUMO Objetivo: Analisar a produção técnico-científica de bolsistas de produtividade em pesquisa do Conselho Nacional de Desenvolvimento Científico e Tecnológico, na área de Pediatria, no período de 2013 a 2016. Métodos: Os dados foram obtidos identificando-se os bolsistas, por meio da Plataforma Lattes, e, posteriormente, contabilizando-se os indicadores presentes em seus currículos Lattes, pelo software scriptLattes v8.10. Resultados: No período, foram identificados 17 pesquisadores bolsistas, os quais publicaram 524 artigos em periódicos, em sua maioria classificados com Qualis elevado/intermediário. Ainda, os pesquisadores realizaram, no período, 158 orientações, publicaram 119 livros/capítulos e 465 trabalhos em anais de congressos. Conclusão: A produção científica brasileira na área de Pediatria mostrou-se expressiva e de impacto, em âmbito nacional e internacional. Entretanto, a distribuição dos grupos é concentrada em regiões específicas do Brasil.

Integridad y conductas inapropiadas en investigación biomédica / Integrity and misconduct in biomedical research

Resumen: Los Comités Editoriales de revistas de corriente principal se ven enfrentados ocasionalmente a con ductas éticas inapropiadas en los manuscritos recibidos. El Comité de Ética en las publicaciones (COPE) ofrece recomendaciones para los editores respecto a cómo actuar frente a la sospecha de falta de ética en los manuscritos, ya sea recibidos o publicados. Cuando se pesquisa una mala práctica durante el proceso de revisión por pares, el manuscrito es rechazado, no obstante, si la conducta ina propiada es detectada después de la publicación de manuscrito, se procede a retractar la publicación. Revista Chilena de Pediatría no ha sido exenta a este tipo de conflictos. En este artículo analizamos los distintos aspectos relacionados con la falta de integridad de las publicaciones, como son las autorías, el plagio y el conflicto de intereses. Podemos concluir que las malas prácticas ocurren principalmente por desconocimiento de los autores, más que por intención de fraude. Se espera que el presente ma nuscrito logre instruir y sensibilizar a nuestros investigadores, respecto a las buenas prácticas en la investigación y publicación, y, contribuir, en lo posible, a prevenir que estas acciones ocurran en los manuscritos enviados a nuestra Revista.

Abstract: Editorial Boards of mainstream journals occasionally face ethical misconducts in received manus cripts. The Committee on Publication Ethics (COPE) provides recommendations for editors on how to deal with suspected ethical misconduct in either received or published manuscripts. The manus cript is rejected when malpractice is observed during the peer review process, however, if the mis conduct is detected after the publication, the publication will be retracted. The Revista Chilena de Pediatría (Chilean Journal of Pediatrics) has not been exempt from these type of conflicts. In this article, we analyze different aspects regarding the lack of integrity in publications, such as authorship, plagiarism, and conflict of interest. We can conclude that malpractices take place mainly due to the lack of knowledge of the authors rather than intent to defraud. It is expected that this article will suc ceed in instructing and sensitizing our researchers on good practices in research and publication, and contribute, as far as possible, to prevent this actions in the manuscripts sent to our Journal.

Mapping the scientific research on the negative aspects of the medical school learning environment

SUMMARY Objective: We sought to understand the landscape of published articles regarding medical schools' learning environments (LE) worldwide, with an explicit focus on potentially negative aspects of the LE as an effort to identify areas specifically in need of remediation or intervention that could prevent future unprofessional behaviours, burnout, violence and mistreatment among students and physicians. Methods: A bibliometric analysis was conducted in six electronic databases (PubMed/Medline, Web of Science, Cochrane Library, SCOPUS, ERIC-ProQuest and PsycINFO) through December 31, 2016, including 12 themes: learning environment - general, hidden curriculum (negative), unethical behaviours, bullying/hazing, violence, sexual discrimination, homophobia, racism, social discrimination, minorities' discrimination, professional misconduct, and "other" negative aspects. Results: Of 9,338 articles found, 710 met the inclusion criteria. The most common themes were general LE (233 articles), unprofessional behaviours (91 articles), and sexual discrimination (80 articles). Approximately 80% of articles were published in the 21st century. Conclusion: There is a clear increase in scientific articles on negative aspects of the medical school LE in high-quality journals, especially in the 21st century. However, more studies are needed to investigate negative LE aspects with greater attention paid to experimental, longitudinal, and cross-cultural study designs.

RESUMO OBJETIVO: Buscou-se entender o panorama dos artigos publicados sobre os ambientes de aprendizagem (AA) das escolas médicas em todo o mundo, com um foco explícito nos aspectos potencialmente negativos do AA como um esforço para identificar áreas específicamente necessitadas de remediação ou intervenção que poderiam evitar futuros comportamentos não profissionais, violência e maus-tratos entre estudantes e médicos. Métodos: Foi realizada uma análise bibliométrica em seis bases de dados eletrônicas (PubMed/Medline, Web of Science, Biblioteca Cochrane, Scopus, Eric-ProQuest e PsycInfo) até 31 de dezembro de 2016, incluindo 12 temas: ambiente de aprendizagem - geral, currículo oculto (negativo), comportamentos antiéticos, bullying/trote, violência, discriminação sexual, homofobia, racismo, discriminação social, discriminação de minorias, má conduta profissional e "outros" aspectos negativos. Resultados: Dos 9.338 artigos encontrados, 710 preencheram os critérios de inclusão. Os temas mais comuns foram LE geral (233 artigos), comportamentos não profissionais (91 artigos) e discriminação sexual (80 artigos). Aproximadamente 80% dos artigos foram publicados no século XXI. Conclusão: Há um claro aumento em artigos científicos sobre aspectos negativos da escola de medicina LE em periódicos de alta qualidade, especialmente no século XXI. No entanto, mais estudos são necessários para investigar aspectos negativos do LE com maior atenção aos desenhos de estudos experimentais, longitudinais e transculturais.