Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 20 de 124
Filter
1.
Revista Digital de Postgrado ; 9(2): 204, ago. 2020.
Article in Spanish | LILACS (Americas), LIVECS | ID: biblio-1103539

ABSTRACT

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)


Subject(s)
Humans , Male , Female , Bioethics , Practice Guidelines as Topic , Biomedical Research/standards , Informed Consent , Patient Advocacy , Schools, Medical , Human Rights
2.
Int. j. morphol ; 38(3): 774-786, June 2020. tab, graf
Article in English | LILACS (Americas) | ID: biblio-1098319

ABSTRACT

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.


Subject(s)
Research Design , Evidence-Based Medicine , Biomedical Research/standards , Research Report/standards , Quality Control , Biomedical Research/methods , Checklist
4.
Evid. actual. práct. ambul ; 21(1): 14-19, 2018. tab.
Article in Spanish | LILACS (Americas) | ID: biblio-1017175

ABSTRACT

En este ensayo, el autor reflexiona sobre la relevancia de las investigaciones clínicas que se desarrollan con frecuencia en la actualidad. Destaca que a diferencia de la "investigación creativa, especulativa o basada en la curiosidad" (blue-sky research), que no puede ser juzgada directamente en base al impacto práctico, la investigación clínica debería ser útil: es decir, hacer una diferencia para la salud de los pacientes, o ser realizada con una perspectiva realista. Para ello realiza algunas propuestas de mejora, como ser; una correcta justificación y puesta en contexto del problema en estudio, procurar una adecuada ganancia de información, pragmatismo, estar centrada en los pacientes, ser viable, con una adecuada relación precio-calidad y transparente. Muchos estudios, aún en la mayoría de las revistas médicas generales, no satisfacen ninguna de estas características, y muy pocos satisfacen la mayoría o todas ellas. Gran parte de la investigación falla en su utilidad no por sus hallazgos, sino por su diseño. Por otro lado, el autor sostiene que las fuerzas que guían la producción y diseminación de investigación clínica inútil son claramente identificables y modificables. Se necesita una reforma. Alterar nuestro abordaje podría producir fácilmente más investigación clínica útil y, al mismo tiempo, de menor costo. (AU)


In this essay, the author reflects on the relevance of today's clinical research. Stresses that unlike blue-sky research, which can not be judged directly based on practical impact, clinical research should be useful: that is, make a difference to the health of patients, or be carried out with a realistic perspective. Proposed key features of clinical investigation to achieve that are: problem based, context placement, information gain, pragmatism, patient centered, value for money, feasibility and transparency. Many studies, even those published in core clinical journals, do not satisfy any of these characteristics, and very few satisfy most or all of them. Most research fails in its utility not because of its findings, but because of its design. On the other hand, the author argues that the forces that guide the production and dissemination of useless clinical research are clearly identifiable and modifiable. A reform is needed. Altering our approach could easily produce more useful clinical research and, at the same time, with lower cost. (AU)


Subject(s)
Humans , Biomedical Research/standards , Biomedical Research/classification , Biomedical Research/organization & administration
5.
Cad. Saúde Pública (Online) ; 34(11): e00158017, 2018. tab, graf
Article in Portuguese | LILACS (Americas) | ID: biblio-974595

ABSTRACT

A Saúde Mental Global é um campo de ensino, pesquisa e prática, cuja prioridade é melhorar o acesso e assegurar a equidade no cuidado em saúde mental para todas as pessoas do mundo, propondo ações especialmente em países de média e baixa renda, como o Brasil. Diante desse panorama mundial e considerando o avanço local dos processos das reformas sanitária e psiquiátrica, torna-se importante investigar o estado atual da literatura brasileira e sua relação com a Saúde Mental Global, descrevendo como a produção nacional aborda assuntos enfatizados nesse campo. Assim, adotando abordagem qualitativa e perspectiva descritiva, foi realizada revisão integrativa da literatura do período de 2014-2015, por meio de pesquisa bibliográfica em português e inglês, utilizando os termos saúde mental e Brasil combinados a palavras-chave correspondentes aos principais tópicos discutidos por autores da Saúde Mental Global. Foram encontrados 88 artigos apreciados segundo sua autoria, periódicos e regiões de publicação, metodologia e de acordo com as categorias de análise e acesso; atenção primária; atenção psicossocial; determinantes sociais da saúde; direitos humanos; e equidade. Constatou-se haver na produção científica nacional um conjunto de estudos muito rico e diversificado com paralelos com a literatura da Saúde Mental Global, mas apresenta um baixo índice de sistematização. Esses achados revelam, portanto, que, apesar dos esforços para a geração de conhecimento local, existem barreiras que, possivelmente, comprometem a participação brasileira no debate internacional.


La Salud Mental Global es un campo de enseñanza, investigación y práctica, cuya prioridad es mejorar el acceso y asegurar la equidad en el cuidado en salud mental para todas las personas del mundo, proponiendo acciones especialmente en países de renta media y baja, como Brasil. Ante el actual panorama mundial, y considerando el avance local de los procesos de reforma sanitaria y psiquiátrica, es importante investigar el estado actual de la literatura brasileña y su relación con la Salud Mental Global, describiendo de qué forma la producción nacional aborda asuntos centrados en este campo. De este modo, adoptando un enfoque cualitativo y una perspectiva descriptiva, se realizó una revisión integradora de la literatura existente durante el período de 2014-2015, mediante una investigación bibliográfica en portugués e inglés, utilizando los términos salud mental y Brasil, combinados con palabras-clave correspondientes a los principales temas discutidos por parte de autores sobre Salud Mental Global. Se encontraron 88 artículos evaluados según su autoría, periódicos, regiones de publicación y metodología, de acuerdo con las categorías de análisis y acceso: atención primaria, atención psicosocial, determinantes sociales de la salud, derechos humanos y equidad. Se constató que existe en la producción científica nacional un conjunto de estudios muy rico y diversificado, con paralelismos con la literatura de la Salud Mental Global, pero que presenta un bajo índice de sistematización. Estos hallazgos revelan, por tanto, que, a pesar de los esfuerzos para la generación de conocimiento local, existen barreras que, posiblemente, comprometen la participación brasileña en el debate internacional sobre esta cuestión.


Global Mental Health is a field of teaching, research, and practice whose goal is to improve access to mental health and reduce inequalities in mental health outcomes for all people worldwide, especially proposing action in low- and middle-income countries like Brazil. Given this global scenario and Brazil's progress in health and psychiatric reforms, it is important to investigate the current status of the Brazilian mental health literature and its relationship to Global Mental Health, describing how Brazilian research deals with key topics in the Global Mental Health field. The authors performed an integrative literature review using a qualitative and descriptive approach. The article search was performed for the years 2014 and 2015 in Portuguese and English, using the terms "mental health" and "Brazil", combined with key words corresponding to the principal themes addressed by authors in Global Mental Health. The search yielded 88 articles, which were analyzed according to authorship, periodicals and regions, and the analytical categories of access, primary care, community mental health services, social determinants of health, human rights, and equity. Brazil's mental health research revealed a rich and diverse body of studies, showing parallels with the literature on global mental health, but with limited systematization. Although the review revealed efforts to generate knowledge in this field within Brazil, some barriers may be limiting Brazil's participation in the international debate on Global Mental Health.


Subject(s)
Humans , Biomedical Research/standards , Research Design , Brazil , Bibliometrics , Mental Health/standards
6.
Cad. Saúde Pública (Online) ; 34(7): e00174017, 2018. tab, graf
Article in English | LILACS (Americas) | ID: biblio-952421

ABSTRACT

Multidisciplinary research in public health is approached using methods from many scientific disciplines. One of the main characteristics of this type of research is dealing with large data sets. Classic statistical variable selection methods, known as "screen and clean", and used in a single-step, select the variables with greater explanatory weight in the model. These methods, commonly used in public health research, may induce masking and multicollinearity, excluding relevant variables for the experts in each discipline and skewing the result. Some specific techniques are used to solve this problem, such as penalized regressions and Bayesian statistics, they offer more balanced results among subsets of variables, but with less restrictive selection thresholds. Using a combination of classical methods, a three-step procedure is proposed in this manuscript, capturing the relevant variables of each scientific discipline, minimizing the selection of variables in each of them and obtaining a balanced distribution that explains most of the variability. This procedure was applied on a dataset from a public health research. Comparing the results with the single-step methods, the proposed method shows a greater reduction in the number of variables, as well as a balanced distribution among the scientific disciplines associated with the response variable. We propose an innovative procedure for variable selection and apply it to our dataset. Furthermore, we compare the new method with the classic single-step procedures.


La investigación multidisciplinaria en salud pública se enfoca usando métodos de muchas disciplinas científicas. Una de las principales características de este tipo de investigación es lidiar con conjuntos voluminosos de datos. Los métodos clásicos estadísticos de selección de variables, conocidos como "screen and clean", y utilizados en un solo paso, seleccionan las variables con mayor peso explicativo en su modelo. Estos métodos, comúnmente usados en investigación pública en salud, pueden inducir a enmascarar la multicolinealidad, excluyendo variables relevantes para los expertos en cada disciplina y sesgando el resultado. Se usan algunas técnicas específicas para resolver este problema, como las regresiones penalizadas y estadísticas bayesianas, que ofrecen resultados más equilibrados entre subconjuntos de variables, pero con umbrales menos restrictivos de selección. Usando la combinación de métodos clásicos, se propone en este trabajo un tercer paso en el procedimiento, recogiendo variables relevantes de cada disciplina científica, minimizando la selección de variables en cada una de ellas y obteniendo una distribución equilibrada que explica la mayor parte de la variabilidad. Este procedimiento fue aplicado en un conjunto de datos de una investigación en salud pública. Comparando los resultados con los métodos de un solo paso, el método propuesto expone una gran reducción en el número de variables, así como la distribución equilibrada entre las disciplinas científicas asociadas con la variable de respuesta. Proponemos un procedimiento innovador para la selección de variables y aplicarlo a nuestro conjunto de datos. Asimismo, comparamos el nuevo método con los procedimientos clásicos de un solo paso.


A pesquisa multidisciplinar em saúde pública emprega métodos provenientes de diversas disciplinas científicas. Uma das principais características desse tipo de pesquisa é o fato de lidar com conjuntos de dados grandes. Os métodos clássicos de seleção de variáveis estatísticas, conhecidos como "screen and clean" (filtrar e limpar), e aplicados a partir de um passo único, selecionam as variáveis com o maior peso explanatório no modelo. Esses métodos, amplamente disseminados na pesquisa em saúde pública, podem induzir ao mascaramento e à multi-colinearidade, excluindo variáveis que seriam relevantes para os especialistas em cada disciplina e enviesando os resultados. Algumas técnicas específicas usadas para resolver esse problema, como regressões penalizadas e estatísticas Bayesianas, oferecem resultados mais equilibrados entre subconjuntos de variáveis, porém com limiares de seleção menos restritivos. O artigo propõe um procedimento com três passos, usando uma combinação de métodos clássicos, captando as variáveis relevantes de cada disciplina científica, minimizando a seleção de variáveis em cada disciplina e obtendo uma distribuição equilibrada que explica a maior parte da variabilidade. O procedimento foi aplicado a um conjunto de dados de uma pesquisa em saúde pública. Ao comparar os resultados com os métodos que utilizam um único passo, o método proposto demonstra maior redução no número de variáveis, assim como, uma distribuição equilibrada entre as disciplinas científicas relacionadas à variável dependente. Propomos um procedimento inovador para a seleção de variáveis, que aplicamos depois ao nosso conjunto de dados. Além disso, comparamos o método novo com os procedimentos clássicos de apenas um estágio.


Subject(s)
Humans , Research Design/standards , Public Health , Models, Statistical , Biomedical Research/standards , Reference Standards , Regression Analysis , Reproducibility of Results
7.
Int. j. morphol ; 35(3): 1031-1036, Sept. 2017. ilus
Article in Spanish | LILACS (Americas) | ID: biblio-893089

ABSTRACT

La metodología de la investigación científica constituye un conjunto de métodos, leyes y procedimientos que orientan los esfuerzos de la investigación hacia la solución de los problemas científicos con un máximo de eficiencia. El método se basa en el desarrollo de distintas etapas que conducen al establecimiento de una conclusión válida sustentada en la verificación de una hipótesis y supuestos de la investigación realizada. Así, la investigación científica no está exenta a la ocurrencia de errores, los cuales pueden ser originados durante el planteamiento del problema de estudio, el diseño de investigación, el establecimiento de los criterios de elegibilidad, la estimación del tamaño de la muestra, el proceso de medición, durante el seguimiento de los sujetos o debido a la falta de discusión de las limitaciones del estudio. En este contexto, una de las estrategias que permite reducir los potenciales errores en la conducción de un estudio radica en el adecuado desarrollo de un proyecto o protocolo de investigación, el cual, debe ser elaborado en base a un problema de investigación, diseño y método de medición, otorgándole al investigador una serie de ventajas asociadas con la planificación documentada del proceso, reproducibilidad de los protocolos experimentales y facilitación del proceso de divulgación de los resultados. En la presente revisión se discuten los aspectos esenciales referentes al método científico en investigación clínica y se analizan los principales problemas, beneficios y elementos asociados con la factibilidad de desarrollar un protocolo de investigación.


Research methodology is a set of methods, laws and procedures that guide research efforts towards solving scientific problems with maximum efficiency. The method is based on the development of different stages that lead to the establishment of a valid conclusion supported on the verification of a hypothesis and assumptions of the performed research. Thus, scientific research is not exempt from the errors, which can originate during the study issue, research design, establishment of eligibility criteria, sample size estimation, measurement process, during follow-up or due to lack of discussion of study limitations. In this context, one of the strategies to reduce potential errors in conducting a study lies in the proper development of a research project or protocol, which must be elaborated based on a research, design and method problem. This provides the researcher with a number of advantages associated with documented process planning, reproducibility of experimental protocols and facilitation of the results publication. This review aims to discuss the essential aspects regarding the scientific method in clinical research and to analyze the main problems, benefits and elements associated with the feasibility of developing a research protocol.


Subject(s)
Biomedical Research/methods , Biomedical Research/standards , Epidemiologic Research Design , Research Design
9.
Ciênc. saúde coletiva ; 22(1): 43-52, jan. 2017.
Article in Portuguese | LILACS (Americas) | ID: biblio-839903

ABSTRACT

Resumo Norplant® é a marca do primeiro implante hormonal subdérmico contraceptivo registrado no mundo, desenvolvido nos laboratórios do Population Council, organização internacional direcionada ao tema da fertilidade e crescimento populacional. O artigo revisita a trajetória deste contraceptivo no Brasil desde sua chegada, através de pesquisas clínicas, até sua proibição em 1986 pelo órgão brasileiro responsável por medicamentos na ocasião. Sua circulação gerou controvérsias relacionadas a práticas de pesquisa, efeitos colaterais e usos políticos do método. Este artigo concentra sua análise nas divergências relacionadas com as práticas de pesquisa. Utilizou-se a técnica de análise de controvérsia, revisitando as versões dos envolvidos, investigando suas compreensões e os efeitos que este objeto produziu em suas redes. O Norplant® provocou deslocamentos e associações entre grupos da sociedade, autoridades do Estado, cientistas e médicos, indústria, produtos farmacêuticos, procedimentos de pesquisas, instrumentos burocráticos, usuárias de contraceptivos. Estilos de pensamento médico científicos foram sacudidos e novas formas de pensar autonomia científica começaram a ser discutidas no país.


Abstract Norplant® is the brand name of the world's first registered subdermal hormonal contraceptive implant, developed by the laboratories of the Population Council, an international organisation working in the area of fertility and population growth. The article revisits the trajectory of this contraceptive in Brazil from its arrival through clinical trials to its eventual ban in 1986 by the Brazilian regulatory agency responsible for approving medications at the time. Its circulation generated controversies related to research practices, side effects and political uses of the drug as a birth control method. This article focuses its analysis on the divergences related to research practices. It uses a controversy analysis technique, reviewing the versions of those involved, investigating their understandings and the effects that this object generated in their networks. Norplant® provoked displacements and associations between civil society groups, State authorities, scientists and physicians, industry, pharmaceutical products, research procedures, bureaucratic instruments, and the female users of the contraceptives. Scientific styles of medical thought were shaken up and new forms of thinking about scientific autonomy began to be discussed in the country.


Subject(s)
Humans , Female , Biomedical Research/standards , Contraceptive Agents, Female/administration & dosage , Drug Approval , Levonorgestrel/administration & dosage , Biomedical Research/ethics , Brazil , Contraceptive Agents, Female/adverse effects , Drug Implants , Ethics, Research , Levonorgestrel/adverse effects , Politics
10.
Cad. Saúde Pública (Online) ; 33(7): e00051816, 2017. tab, graf
Article in Portuguese | LILACS (Americas) | ID: biblio-889718

ABSTRACT

Peso ao nascer é uma informação essencial nos estudos de programação fetal e, em geral, obtida retrospectivamente. No Sistema de Informações sobre Nascidos Vivos (SINASC), peso ao nascer é uma informação válida, mas nem sempre acessível. Objetivou-se estabelecer um algoritmo para seleção da fonte de dados de maior confiabilidade do peso ao nascer na ausência da informação do SINASC. No estudo seccional de estudantes de 6-14 anos, Niterói, Rio de Janeiro, Brasil, 2010, peso ao nascer foi coletado por meio de questionário de autopreenchimento, entrevista, prontuários do Programa Médico de Família (PMF), além do SINASC. Foram calculados coeficientes de correlação intraclasse (CCI) e diferenças das médias de peso ao nascer. CCIs variaram de 0,90 a 0,99. Todas as fontes apresentaram médias de peso ao nascer maiores do que SINASC, considerando-se aceitáveis diferenças até 100g. O peso ao nascer é registrado no nascimento (SINASC) ou próximo deste (PMF) e, na ausência dessas fontes, a lembrança do peso ao nascer de 6-14 anos após o nascimento é uma opção confiável. Para complementar a informação sobre peso ao nascer na ausência do SINASC, recomenda-se a seguinte ordenação: PMF, entrevista e questionário.


Birth weight is essential information in fetal programming studies and is generally obtained retrospectively. In Brazil's Information System on Live Births (SINASC), birth weight is valid information but is not always accessible. The study aimed to establish an algorithm for the selection of the most reliable data source for birth weight in the absence of information in the SINASC database. In a cross-sectional study of 6-14-year-old schoolchildren in Niterói, Rio de Janeiro State, Brazil, in 2010, birth weight was collected through a self-completed questionnaire, interview, medical records from the Family Physician Program, and the SINASC database. We calculated intra-class correlation coefficients (ICCs) and differences in mean birth weight. ICCs varied from 0.90 to 0.99. All the other sources showed higher mean birth weight than SINASC, allowing differences up to 100g. Birth weight is recorded at birth (SINASC) or close to it (Family Physician Program), and in the absence of these sources, birth weight as retrieved at 6-14 years of age is a reliable option. To complement information on birth weight in the absence of SINASC, we recommend the following order: Family Physician Program, interview, and questionnaire.


El peso al nacer es una información esencial en los estudios de programación fetal y, en general, obtenida retrospectivamente. En el Sistema de Información sobre Nacidos Vivos (SINASC), peso al nacer es una información válida, pero no siempre accesible. Tuvo como objetivo establecer un algoritmo para la selección de la fuente de datos de mayor confiabilidad del peso al nacer, en ausencia de información del SINASC. En el estudio por secciones de estudiantes de 6-14 años, Niterói, Río de Janeiro, Brasil, 2010, el peso al nacer se recogió mediante un cuestionario para autocompletar, entrevista, historias clínicas del Programa Médico de Familia (PMF), además del SINASC. Se calcularon coeficientes de correlación intraclase (CCI) y diferencias de las medias de peso al nacer. Los CCIs variaron de 0,90 a 0,99. Todas las fuentes presentaron medias de peso al nacer mayores que el SINASC, considerándose aceptables diferencias hasta 100g. El peso al nacer es registrado en el nacimiento (SINASC) o cercano a este (PMF) y, en la ausencia de estas fuentes, el recuerdo del peso al nacer de 6-14 años tras el nacimiento es una opción fiable. Para complementar la información sobre peso al nacer, en ausencia del SINASC, se recomienda la siguiente ordenación: PMF, entrevista y cuestionario.


Subject(s)
Humans , Male , Female , Child , Adolescent , Birth Weight , Algorithms , Fetal Development , Health Information Systems/standards , Data Accuracy , Reference Standards , Reference Values , Research Design , Brazil , Registries/standards , Cross-Sectional Studies , Surveys and Questionnaires/standards , Reproducibility of Results , Retrospective Studies , Biomedical Research/standards
12.
Braz. j. med. biol. res ; 49(12): e5646, 2016. tab, graf
Article in English | LILACS (Americas) | ID: biblio-828175

ABSTRACT

The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.


Subject(s)
Humans , Animals , Biomedical Research/standards , Drug Evaluation, Preclinical/standards , Laboratories/standards , Clinical Trials, Phase I as Topic , Drugs, Investigational/chemistry , Drugs, Investigational/pharmacokinetics , Mutagenicity Tests , Pharmacology, Clinical/standards
14.
Int. j. morphol ; 33(4): 1463-1467, Dec. 2015. ilus
Article in English | LILACS (Americas) | ID: lil-772339

ABSTRACT

The assessment of methodological quality (MQ) in biomedical research is an area of dynamic development over recent years globally. Understood as a complex and multidimensional construct, various groups have proposed tools for its assessment. Our team has designed and validated scales to assess MQ of therapy, diagnosis, and prognosis studies. However, as with other instruments, it is necessary to specify in detail how it is applied, in order to standardize the measurements made with this instrument. The aim of this article is to provide a guideline for the standardized application of the MInCir MQ scale for therapy or therapeutic procedure studies. A detailed description of the 3 domains and 6 items comprising the scale, specifying for each of them how to assess the characteristics and score articles on therapy or therapeutic procedures is presented. This article provides an application guideline that may help to improve interobserver and intraobserver reliability of the MInCir MQ scale for therapy or therapeutic procedures.


La evaluación de la calidad metodológica (CM) en la investigación biomédica es un área de desarrollo dinámico en los últimos años a nivel global. Entendida ésta, como un constructo multidimensional y complejo; diversos grupos han propuesto herramientas para su valoración. Nuestro equipo de trabajo ha diseñado y validado escalas para valorar CM de estudios de terapia, diagnóstico y pronóstico. Sin embargo, como ocurre con otros instrumentos, es necesario especificar detalladamente la forma en que se aplica, de forma tal de poder estandarizar las mediciones efectuadas con dicho instrumento. El objetivo de este artículo es detallar la aplicación de la escala MInCir de CM de estudios de terapia o procedimientos terapéuticos. De este modo, se presenta una descripción pormenorizada de los 3 dominios y 6 ítems que componen la escala, precisando para cada uno de ellos las características a evaluar y puntuar en los artículos primarios de terapia o procedimientos terapéuticos. Este artículo aporta una guía de aplicación que permite otorgar una adecuada confiabilidad intra e inter observador a las mediciones que se realicen aplicando la escala MInCir de terapia o procedimientos terapéuticos.


Subject(s)
Biomedical Research/standards , Evaluation Studies as Topic , Quality Control , Research Design/standards , Therapeutics , Epidemiologic Studies , Evidence-Based Medicine , Observer Variation , Periodicals as Topic/standards , Reproducibility of Results , Sample Size
15.
Int. j. morphol ; 33(4): 1553-1558, Dec. 2015. ilus
Article in English | LILACS (Americas) | ID: lil-772353

ABSTRACT

The assessment of methodological quality (MQ) in biomedical research is an area of dynamic development over recent years globally. Understood as a complex and multidimensional construct, several groups have been proposed tools for its evaluation, between them our group has designed and validated scales to assess MQ in therapy, diagnosis and prognosis studies. However, as with other instruments, it is necessary to specify in detail how the measurement is performed. The aim of this article is to provide a guideline for the standardized application of MInCir MQ scale for prognosis studies. A detailed description of the 11 items and 4 domains of the scale, indicating for each of them how to assess and rate the characteristics in primary prognosis articles is presented. This article provides an application guideline that may help to improve interobserver and intraobserver reliability of MInCir MQ scale for prognosis studies.


La evaluación de la calidad metodológica (CM) en la investigación biomédica es un área de desarrollo dinámico en los últimos años a nivel global. Entendida como un constructo multidimensional y complejo, diversos grupos han propuesto herramientas para su valoración, entre ellos nuestro equipo de trabajo ha diseñado y validado escalas para valorar CM de estudios de terapia, diagnóstico y pronóstico. Sin embargo, como ocurre con otros instrumentos, es necesario especificar detalladamente la forma en que se aplica, de forma tal de poder estandarizar las mediciones. El objetivo de este artículo es explicar la aplicación de la escala MInCir de CM para estudios de pronóstico. Se presenta una descripción pormenorizada de los 11 ítems y 4 dominios que componen la escala, precisando para cada uno de ellos las características a evaluar y puntuar en los artículos primarios de pronóstico. El presente artículo aporta una guía de aplicación que permite otorgar una adecuada confiabilidad intra e inter observador en las mediciones con la escala MInCir Pronóstico.


Subject(s)
Biomedical Research/standards , Evaluation Studies as Topic , Prognosis , Quality Control , Research Design/standards , Epidemiologic Studies , Periodicals as Topic , Reproducibility of Results , Sample Size
17.
Biomédica (Bogotá) ; 35(2): 274-284, abr.-jun. 2015. ilus, tab
Article in Spanish | LILACS (Americas) | ID: lil-754837

ABSTRACT

Cada vez son más los países que adoptan las guías de buenas prácticas clínicas como parte de la reglamentación de los estudios clínicos para el registro de productos farmacéuticos y de otros relacionados con la salud. Por ello, todos los involucrados en la investigación y el desarrollo de dichos productos tienen la obligación de conocerlas, implementarlas y velar por su cumplimiento. Sin embargo, las buenas prácticas clínicas son solo una de las iniciativas que buscan alcanzar los más altos estándares éticos y científicos en la investigación en salud y en otras áreas en las que los seres humanos son sujetos de investigación. En esta revisión se definen las buenas prácticas clínicas y su objetivo, se presenta en forma práctica su marco legal en Colombia, se aclara su aplicación en estudios con intervenciones sin medicamentos, o en aquellos que no son ensayos clínicos, y se discuten los retos para lograr que contribuyan a la protección de los participantes en investigaciones, a la formación de profesionales íntegros y a una cultura de respeto por el ser humano.


An increasing number of countries are adopting good clinical practices guidelines as part of the regulation of clinical studies to register pharmaceutical products and other health-related products. Consequently, all parties involved in the research and development of these products should know them, implement them and ensure their compliance. However, good clinical practices guidelines are just one of the initiatives seeking to achieve the highest ethical and scientific standards in health research and in other areas where humans are research subjects. This review defines such practices and their objectives presenting in a practical manner their legal framework in Colombia, and clarifying their application in studies where interventions use no medications or those that are not clinical trials. Finally, the work discusses the challenges to ensure that good clinical practices contribute to the protection of research participants, the education of trustworthy health professionals, and a culture of respect for human beings.


Subject(s)
Humans , Biomedical Research/standards , Clinical Trials as Topic/standards , Biomedical Research
18.
Rev. pediatr. electrón ; 12(1): 40-42, abr. 2015. tab
Article in Spanish | LILACS (Americas) | ID: lil-774925
19.
Säo Paulo med. j ; 133(2): 109-114, Mar-Apr/2015. tab, graf
Article in English | LILACS (Americas) | ID: lil-746651

ABSTRACT

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


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


Subject(s)
Humans , Exercise , Information Storage and Retrieval , Review Literature as Topic , Randomized Controlled Trials as Topic/statistics & numerical data , Biomedical Research/standards , Periodicals as Topic/classification , PubMed/statistics & numerical data
20.
An. bras. dermatol ; 89(4): 609-615, Jul-Aug/2014. tab, graf
Article in English | LILACS (Americas) | ID: lil-715543

ABSTRACT

The importance of estimating sample sizes is rarely understood by researchers, when planning a study. This paper aims to highlight the centrality of sample size estimations in health research. Examples that help in understanding the basic concepts involved in their calculation are presented. The scenarios covered are based more on the epidemiological reasoning and less on mathematical formulae. Proper calculation of the number of participants in a study diminishes the likelihood of errors, which are often associated with adverse consequences in terms of economic, ethical and health aspects.


Subject(s)
Humans , Biomedical Research/standards , Sample Size , Dermatology , Reference Values , Risk Factors
SELECTION OF CITATIONS
SEARCH DETAIL