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OBJECTIVE:To explore an effective method to formulate management-related strategies for off-lable use of drugs by the evidence-based medicine. METHODS:The process of guideline formulation included seven procedures,i.g. establishment ofguideliesformulation workgroup;investigation and selection of the status quo on off-label drug use;identification of the clinical problems;retrieval and evaluation and comprehensing of evidence;applification of GRADE in evidence quality grading;formation of the recommendations consensus;peer review and result publication. And eventually guidelines were formed based on the steps. This study took off-label use of rheumatoid immunoprotective subjects as a case to explore. RESULTS & CONCLUSIONS:Based on the evidence evaluation system and above 7 steps,the methods and process of guideline formulation on off-label use of rheuma-toid immunoprotective subjects that integrated administration,law,clinical medicine,pharmacy subjects were made .The process of guideline formulation fully reflects multidisciplinary characteristics of the workgroup,the advanced nature of the process,the comprehensiveness of evidence ,the rigor of evidence quality grading,and the normalization of consensus. It provides reference in methodology for establishing a comprehensive evidence-based evaluation and management system of off-label use of drugs for all clinical specialist disease. Therefore,this scientific research results may promote the standardization and legalization of the off-label use of drugs management in China.
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Las guías en práctica clínica buscan brindar recomendaciones basadas en evidencia para abordar los procesos de atención para así alcanzar los más altos estándares de calidad. Son procesos participativos e interdisciplinarios. El objetivo de este documento es describir los procesos metodológicos que facilitan desarrollar las recomendaciones de las guías y ofrecer un análisis del contexto que puede modificar el proceso en su conjunto, deteniéndose en los tipos de relacionamiento que lo hacen posible. Se presenta un análisis del desarrollo de la estrategia de elaboración de guías en práctica clínica en Colombia como herramienta del subsistema de calidad y se revisan los antecedentes y avances a la fecha. Se discuten los aspectos teóricos y prácticos de los mecanismos de participación y su alcance en la formulación de recomendaciones. Se ilustra a manera de ejemplo el caso de la Guía de atención en enfermedad cerebro vascular. Se dispone de un Manual de Elaboración de Guías y de un Manual de Implementación, así como de un número de productos para patologías específicas y se esperan nuevas guías en el próximo año. Los mecanismos de participación se enmarcan en las dinámicas de empoderamiento de actores dentro del ámbito social. Las guías son herramientas útiles para resolver problemas específicos en la atención de problemas de salud desde una perspectiva amplia de construcción social de políticas públicas en salud que enfrentan retos y dificultades que deben superarse.
Clinical practice guidelines (CPG) seek to provide evidence-based recommendations for clinicians and decision-makers aiming at the highest quality standards of care. CPG are developed by multidisciplinary teams and through social participation. To describe the methodological process and contextual analysis of the development of CPG. To analyze the social participation process in the formulation of health policy. This paper presents an analysis of a new strategy for the development of CPG in Colombia as a tool for the sub-system of quality in health. The starting point and the current advances of the CPG movement in Colombia are described. We discuss the theoretical and practical mechanisms of social participation and their influence in the formulation of CPG recommendations. We report the case-study of the development of Stroke Clinical Practice Guideline for Colombia. We used, as framework, a CPG Development Manual and an Implementation Manual, as well, as several technical reports of specific pathologies. The mechanisms of social participation are based on the dynamics of stakeholders' empowerment into the Colombian social context. Clinical practice guidelines are useful tools for solving specific issues with health care providers. From the point of view of the social construction of health policies, CPG implementation has still several barriers to overcome.
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In Japan, acupuncturists generally use Oshide (Japanese style handling of the needle) to insert needles. It means that Japanese acupuncturists frequently handle the needle shaft during insertion and treatment (albeit with sterilized fingers). This everyday practice of Oshide used by almost all Japanese Practitioners differs significantly from the global Safety Standards for medical and acupuncture sterilization procedures. Furthers, practitioners in other countries may report such practices of needle handling as malpractice.<BR>The author introduces the history and status of Oshide in Japan and other countries and hopes that Japanese practitioners will discuss it.