ABSTRACT
La rehabilitación clínica nos enfrenta constantemente a situaciones de dudas que pueden ser resueltas a través de la practica basada en evidencia. En esta guía metodológica aprenderemos sobre cómo formular este primer importante elemento. De este modo, se podrá consultar a la literatura científica disponible a través de una pregunta clínica estructurada que permita buscar, con la mayor eficiencia posible, las publicaciones relacionadas para responder la pregunta clínica realizada, evaluar y aplicar los resultados encontrados y finalmente valorar su impacto. La pregunta clínica se organiza en el formato PICoR (paciente, intervención, comparación y resultados) para identificar sus componentes y estructurar la búsqueda sistemática de información científica. También tiene utilidad en la metodología de estudios clínicos, define el diseño de la investigación y forma parte importante de la construcción de guías de práctica clínica.
Clinical rehabilitation constantly confronts us with situations of doubt that can be resolved through evidence-based practice. In this methodological guide, we are going to learn about how formulate this first relevant issue. Thereby, it could be possible consulting the available scientific literature through a structured clinical question that allows search for, with the greatest possible efficiency, related publications to answer the clinical question asked, evaluate, and apply the results found, to finally assess their impact. The clinical question is organized in the PICO format (patient, intervention, comparison, and outcome) to identify its components and structure the systematic search for scientific information. It is also useful in the methodology of clinical studies, defines the research design and forms an important part of the construction of clinical practice guidelines.
ABSTRACT
Resumen Introducción: Los procesos reflexivos e interrogativos necesarios para desarrollar preguntas de investigación cualitativas efectivas, pueden dar forma y dirección a un estudio, sin embargo; a menudo se subestiman. Las buenas preguntas de investigación no necesariamente producen una buena investigación, pero las preguntas mal concebidas o elaboradas probablemente crearán problemas que afectarán todas las etapas posteriores de un estudio. Objetivo: Este artículo aborda el desarrollo de preguntas de investigación y cómo los procesos de generación y refinación de preguntas son fundamentales para la conformación de un estudio cualitativo. Desarrollo: Generar preguntas de investigación relevantes y adecuadas requiere que el investigador preste atención no solo a las preguntas en sí mismas, sino a sus conexiones con todos los componentes del diseño; es decir, los objetivos a los que pueden responder las preguntas; las implicaciones para las preguntas relacionadas con su marco conceptual; los métodos que podría usar para responder las preguntas y las amenazas de validez que deberá abordar. Al igual que con los otros componentes del diseño, reflexionar sobre estos temas es una herramienta extremadamente útil para desarrollar sus preguntas. Conclusiones: En los estudios cualitativos, el proceso continuo de preguntas es una parte integral en la comprensión de las vidas y perspectivas de otros. Es importante enfatizar que este tipo de investigación requiere que el investigador asuma una postura epistemológica, seleccione un método y también elija ciertas técnicas que le permitan recopilar información en el trabajo de campo.
Abstract Introduction: Although frequently underestimated, reflexive and interrogative processes needed to develop the research questions in qualitative research, can give shape and direction to a study. Good research questions do not necessarily produce a good research study, but badly conceived or elaborated research questions can create problems which will further have impacts on all stages of the study. Objective: This study addresses the development of research questions and how their generation and refinement processes are fundamental in the conformation of a qualitative study. Development: Generating relevant and adequate research questions requires the researchers to give attention to the questions and their relations to all the components of the design; in other words; to the objectives, the conceptual framework, the methods used, the possible implications involved, the validity, etcetera. Reflecting on these issues is a useful tool while developing research questions. Conclusions: In qualitative studies, the ongoing process of questioning is integral to the comprehension of the lives and perspectives of others. So, it is important to emphasize that qualitative research requires the researchers to adopt an epistemological posture by selecting methods and procedures which can support their field work information gathering.
Resumo Introdução: Os processos reflexivos e interrogativos necessários para desenvolver perguntas de pesquisa qualitativas efetivas podem dar forma e direção a um estudo, porém frequentemente são subestimados. As boas perguntas de pesquisa não necessariamente produzem uma boa pesquisa, mas as perguntas mal concebidas ou elaboradas provavelmente criarão problemas que afetarão todas as etapas posteriores de um estudo. Objetivo: Este artigo aborda o desenvolvimento de perguntas de pesquisa e como os processos de produção e refinamento de preguntas são fundamentais para a conformação de um estudo qualitativo. Desenvolvimento: Gerar perguntas de pesquisa relevantes e adequadas requer que o pesquisador preste atenção não só às preguntas em si mesmas, senão a suas conexões com todos os componentes do desenho: quer dizer, os objetivos aos que podem responder as preguntas; as implicações para as preguntas relacionadas com seu marco conceptual; os métodos que poderia usar para responder as perguntas e as ameaças de validade que deverá abordar. Ao igual que com os outros componentes do desenho, refletir sobre estes temas é uma ferramenta extremadamente útil para desenvolver suas perguntas. Conclusões: Nos estudos qualitativos, o processo contínuo de perguntas é uma parte integral na compreensão das vidas e perspectivas de outros. É importante enfatizar que este tipo de pesquisa, requer que o pesquisador assuma uma postura epistemológica, selecione um método e também eleja certas técnicas que lhe permitam recopilar informação no trabalho de campo.
ABSTRACT
The clinical research process requires framing a correct research question along with a concordant hypothesis. This would be the roadmap to achieve a successful scientific methodology. PICOT strategy help us to focalized and organize the question and FINER criterias precise on feasability and relevance of the project.
El proceso de investigación clínica exige plantear una pregunta de investigación e hipótesis concordante. Esta será la hoja de ruta del proyecto de investigación. La estrategia PICOT permite focalizar y precisar el problema y los criterios FINER precisan la factibilidad y relevancia del proyecto.
Subject(s)
Research Design/standards , Biomedical Research/methodsABSTRACT
Resumen La formulación de una pregunta de investigación clínica requiere la concurrencia de experiencia clínica y conocimiento en metodología y estadística. Inicialmente, la pregunta de investigación debe contar con una estructura que deje claro qué se busca (consecuencia o desenlace), en quién (estado basal) y por acción de qué (maniobra). Posteriormente, su argumentación debe explorar cuatro aspectos: factibilidad y sensatez del cuestionamiento, ausencia de respuesta previa, relevancia de la respuesta a obtener y aplicabilidad. Una vez que estos aspectos han sido cubiertos en forma satisfactoria puede considerarse que la pregunta es "clínicamente relevante", que es diferente a significancia estadística (la probabilidad de que el resultado se deba al azar y que no refleja la relevancia de la pregunta ni de los resultados). Nunca se debe olvidar que toda maniobra conlleva eventos adversos, que cuando son graves demeritan los buenos resultados. Es imperativo estimar la posible respuesta desde la estructura de la pregunta; la función de la investigación clínica es corroborar o rechazar una hipótesis, no probar empíricamente para ver qué resulta.
Abstract A clinical research question requires the concurrence of clinical experience and knowledge on methodology and statistics in that who formulates it. Initially, a research question should have a structure that clearly establishes what is that which is being sought (consequence or outcome), in whom (baseline status), and by action of what (maneuver). Subsequently, its reasoning must explore four aspects: feasibility and reasonableness of the questioning, lack of a prior answer, relevance of the answer to be obtained, and applicability. Once these aspects are satisfactorily covered, the question can be regarded as being "clinically relevant", which is different from being statistically significant, which refers to the probability of the result being driven by chance, which does not reflect the relevance of the question or the outcome. One should never forget that every maneuver entails adverse events that, when serious, discredit good results. It is imperative to have the possible answer estimated from within the structure of the question. The function of clinical research is to corroborate or reject a hypothesis, rather than to empirically test to find out what the outcome is.
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Humans , Research Design , Data Interpretation, Statistical , Biomedical Research/methodsABSTRACT
Medical Education Journal is the official journal of the Japanese Society for Medical Education. There are seven categories including original research papers and practice research articles. It is essential that original research is designed based on clear research questions and conducted using valid and reliable methodology. Literature review and discussions utilizing theoretical frameworks should not be omitted. This article illustrates the critical points in preparing full research papers and the lessons learned from unaccepted manuscripts. New category, Practice report: introduction of a new approach, is explained in this issue.
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Introducción: La formulación del problema científico en un artículo de investigación es un elemento fundamental para su comprensión y reproducibilidad. No definirlo o formularlo de manera incorrecta conduciría inevitablemente a un documento difícil de entender y de replicar. Objetivo: Identificar las líneas de investigación más comunes en revistas biomédicas cubanas indizadas en SciELO, la frecuencia de artículos de investigación con problema científico correctamente definido y los errores más comunes en su formulación. Material y métodos: Se realizó un estudio descriptivo en artículos de investigación publicados en el año 2016 en 32 revistas biomédicas cubanas indizadas en SciELO. A partir de 5 836 palabras clave se obtuvieron las líneas de investigación más frecuentes. Mediante una muestra aleatoria de 50 artículos, se estimó el porcentaje de publicaciones con problema científico correctamente definido. Se calcularon los porcentajes de errores según el tipo en cada artículo. Resultados: Las líneas de investigación más frecuentemente asociadas a las palabras clave fueron educación médica, factores de riesgo y atención secundaria de salud. Solo el 36 por ciento de los trabajos formularon correctamente el problema científico. Ningún artículo realizó una valoración crítica de este y el 58 por ciento incluyó métodos para abordarlo. Conclusiones: Las líneas de investigación identificadas en los artículos estudiados pueden ser de poco interés para la investigación biomédica. Los artículos de investigación con problemas científicos no definidos o formulados de forma incorrecta incrementan las dificultades para el análisis, la discusión y la crítica de los resultados científicos. Los errores más comunes en la formulación del problema científico sugieren que la motivación principal podría no ser la divulgación de un resultado científico, sino la publicación en sí misma(AU)
Introduction: The formulation of the scientific problem in a research article is a key element for its understanding and reproducibility. If it is not defined or if it is incorrectly formulated, it would inevitably lead to the creation of a document which would be very difficult to understand and replicate. Objective: To identify the most common lines of research in Cuban biomedical journals indexed in SciELO, the frequency of research articles with a correctly defined scientific problem, and the most common errors in its formulation. Material and Methods: A descriptive study was carried out in research articles that were published in 2016 in 32 Cuban biomedical journals indexed in SciELO. The most frequent lines of research were obtained from 5 836 keywords. The percentage of publication with a correctly defined scientific problem was estimated by a random selection of a sample of 50 articles, and the percentage of publications with a correctly defined scientific problem was also calculated. Percentages of errors according to type were measured in each article. Results: The most frequent lines of research associated with keywords were: medical education, risk factors, and secondary health care. Only 36 percent of the works formulated the scientific problem correctly. No article made a critical assessment of it, and the 58 percent included methods to address it. Conclusions: The lines of research identified in the articles under study may appear to be of minor interest for biomedical research. The research articles with not defined or incorrectly formulated scientific problems increase the difficulties for their analysis, discussion, and review of scientific results. The most common errors in the formulation of the scientific problem suggest that the main motivation could not be the dissemination of a scientific result, but the publication itself(AU)
Subject(s)
Research , Biomedical Research/education , Periodical , Methodology as a Subject , Epidemiology, Descriptive , Cross-Sectional Studies , CubaABSTRACT
This article describes findings about effective utilization of electronic medical databases from a viewpoint of a pharmaceutical company, with a progress of MIHARI Project in mind. Purposes of this article are (1) to understand merits to perform a database study and a drug use result survey as an additional pharmacovigilance activity for each risk in a risk management plan, and (2) to find points to be considered when their activities are to be selected. A database study has advantages as follows: a comparison group can be set easily; a power is high as a database has many cases; and no need to consider some points such as reporting bias and recall bias. On the other hand, some issues of a technical point (e.g. understanding characteristics of each database) and a regulatory system (e.g. clarifying association to the drug reexamination system) should be considered. A drug use result survey has advantages as follows: data can be collected, even the data that databases do not have; and a drug use result survey in a specific condition can be useful. As a usual design of drug use result surveys however is hard to answer a research question on each risk, more various designs should be considered. Each pharmacovigilance activity has different points to be considered. Therefore, we have to clearly understand the purpose to perform an additional activity and select the most appropriate activity to maximize the benefit of medication users.
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Following the notice of “Guidance of Drug Risk Management Plan (RMP)” by MHLW in 2012, Japanese Society for Pharmacoepidemiology (JSPE) started. “A Task Force to make an acceptable Pharmacovigilance Plan (PVP) in Japan” from May 2013. As an outcome, the force published a check list used to evaluate individual PVP for a specific medicinal product together with the guidance for the use of the check list in “Yakuzai-ekigaku”, Journal of JSPE. During over one year since RMP was implemented, RMPs with PVP (included as a component of RMP) were published for 40 compounds and we tried to evaluate those PVPs using the check list we developed. It turns out that an answer to the first question in the check list “Is the necessity of additional PVP described?” was “No” for all 40 PVPs. More serious problem was that one of a few stereotyped study designs was selected in all of the 40 PVPs. No rationale was given to explain why the selected study design could achieve the study aim associated with the important problems specified in the section of safety specification. We conclude that although RMP has been implemented over one year ago, the conventional study design remains to be used in the actual PVP and the main messages of ICH E2E guideline have not been fully realized.
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An overview is given of the process of developing a research question in medical education. Developing a question is the fundamental first step in research, regardless of whether the research is medical or educational. The medical researchers’ beliefs, emotions, and the changing trends in educational theory cannot be ignored when developing the educational research question. Therefore, educational researchers should reflect on their teaching and emotions to determine the subject of research. They must also consider whether the research question is appropriate through constructive brainstorming with peers, discussions with experts, and a broad literature review to acquire theoretical background information.
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A Task Force team consisting of members from pharmaceutical companies --a central player to develop and implement RMP (Risk Management Plan)-- as well as health care professionals and members from academia was established in JSPE. The Task Force developed guidance for scientific approach to practical and ICH-E2E-compliant Pharmacovigilance Plan (PVP) stated in Japanese Risk Management Plan issued in April 2012 by the Ministry of Health, Labour and Welfare. The guidance contains the following topics.<br>1．Introduction: JSPE's activities and this task force's objectives for pharmacovigilance activities<br>2．How to select Safety Specification (SS) and describe its characteristics<br>・Selection of SS<br>・Characterization of SS<br>・Association with Research Questions (RQ)<br>3．How to define and describe RQ<br>・What is RQ ?<br>・RQ interpretation in other relevant guidelines<br>・Methodology to develop RQ for PVP with examples<br>・Best approach to integrating PVP for whole aspects of safety concern<br>4．How to optimize PVP for specific RQ<br>・Routine PVP or additional PVP ?<br>・Additional PVP design (RQ and study design, RQ structured with PICO or GPP's research objectives, specific aims, and rationale)<br>・Checklist to help develop PVP<br>5．Epilogue:<br>・What can/should be “Drug use investigation” in the context of ICH-E2E-compliant PVP.<br>・Significance of background incidence rate and needs for comparator group<br>・Infrastructure for the future PVP activities<br>6．Appendix: Checklist to help develop PVP activities in RMP<br>The task force team is hoping that this guidance help develop and conduct SS and PVP in accordance with ICH E2E, as stated in Japanese Risk Management Plan Guideline.
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El proceso de la investigación en epidemiología requiere el reconocimiento de los elementos que lo constituyen, con el fin de alcanzar un desarrollo exitoso del mismo. Algunos de estos temas no son de fácil abordaje para el investigador clínico, que necesita guías claras para lograr reflejar sus preguntas en estudios clínicos. El siguiente artículo es el primero de una serie de documentos que presentarán los tópicos más importantes en investigación y epidemiología clínica iniciando con el tema de la pregunta de investigación.
Achievement of a succesful epidemiological research process requires knowledge on the elements comprised in it. Some of these matters are not easy to approach by the clinical researcher who needs clear guidelines to be able to reflect his questions in clinical trials. This article is the first of a series of documents that will present major topics in research and clinical epidemiology starting with the research question.