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Resumen La prevención de la enfermedad tromboembólica venosa (ETV) es motivo de continua actualización en función de nueva evidencia que se genera permanentemente. Cada institución debe contar con una estrategia activa de prevención contra la ETV y debe generar normas de tromboprofilaxis (TP) de acuerdo con la realidad local. Durante este proceso de adaptación de una guía a la región debemos siempre tener en cuenta los recursos locales disponibles, el riesgo tromboembólico y hemorrágico propio del paciente, de la enfermedad por la que se encuentra internado (ya sea clínica o quirúrgica) y las consideraciones o preferencias del paciente. La tasa de adherencia a recomendaciones locales de TP es uno de los indicadores de excelencia más importantes evaluados en organismos que califican la calidad de una institución de salud. Las medidas de profilaxis que propongamos para los centros de salud, deben ser individualizadas para cada paciente, tienen que considerar antecedentes personales y familiares del enfermo y utilizar modelos de evaluación de riesgo validados de trombosis y de sangrado. También deben incluir a la población con riesgo de trombosis persistente luego del alta. Lo ideal es tener estadísticas propias de cada nosocomio para la toma de decisiones de cómo implementar una correcta TP. Extrapolar guías de los países desarrollados a nuestro ámbito podría tener un impacto negativo, si no se conoce la propia realidad. En este documento encontraremos herramientas prácticas para las instituciones de salud de la región, que les permita orientarse al momento de confeccionar recomendaciones para una adecuada TP.
Abstract Venous thromboembolism disease (VTE) prevention strategy has to be constantly updated based on new evidence that is generated every year. Each institution must have a formal and active prevention policy against VTE and must develop guidelines or standards for thromboprophylaxis (TP) according to the local reality. During this process of adapting a guideline to the region and the generation of hospital recommendations, we must always consider the available local resources, the thromboembolic and hemorrhagic risk of the patients, even after discharge, and also their considerations and preferences. Adherence to local TP recommendations is one of the most important items evaluated by organizations that measure institutional quality. Individualized prophylaxis should consider personal and family history of VTE, the use of validated risk assessment models or RAMs for thrombosis and bleeding events, as well as the special characteristics of each patient. Ideally, each center's own statistics should be available for decision-making. Extrapolating guidelines from developed countries could have a negative impact, if we ignore our hospital´s reality. In this document we will find practical tools for health institutions that will allow them to prepare recommendations or guidelines for adequate VTE prophylaxis.
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INTRODUCTION: Updating recommendations for guidelines requires a comprehensive and efficient literature search. Although new information platforms are available for developing groups, their relative contributions to this purpose remain uncertain. METHODS: As part of a review/update of eight selected evidence-based recommendationsfor type 2 diabetes, we evaluated the following five literature search approaches (targeting systematic reviews, using predetermined criteria): PubMed for MEDLINE, Epistemonikos database basic search, Epistemonikos database using a structured search strategy, Living overview of evidence (L.OVE) platform, and TRIP database. Three reviewers independently classified the retrieved references as definitely eligible, probably eligible, or not eligible. Those falling in the same "definitely" categories for all reviewers were labelled as "true" positives/negatives. The rest went to re-assessment and if found eligible/not eligible by consensus became "false" negatives/positives, respectively. We described the yield for each approach and computed "diagnostic accuracy" measures and agreement statistics. RESULTS: Altogether, the five approaches identified 318 to 505 references for the eight recommendations, from which reviewers considered 4.2 to 9.4% eligible after the two rounds. While Pubmed outperformed the other approaches (diagnostic odds ratio 12.5 versus 2.6 to 5.3), no single search approach returned eligible references for all recommendations. Individually, searches found up to 40% of all eligible references (n = 71), and no combination of any three approaches could find over 80% of them. Kappa statistics for retrieval between searches were very poor (9 out of 10 paired comparisons did not surpass the chance-expected agreement). CONCLUSION: Among the information platforms assessed, PubMed appeared to be more efficient in updating this set of recommendations. However, the very poor agreement among search approaches in the reference yield demands that developing groups add information from several (probably more than three) sources for this purpose. Further research is needed to replicate our findings and enhance our understanding of how to efficiently update recommendations.
INTRODUCCIÓN: La actualización de recomendaciones de las guías de práctica clínica requiere búsquedas bibliográficas exhaustivas y eficientes. Aunque están disponibles nuevas plataformas de información para grupos desarrolladores, su contribución a este propósito sigue siendo incierta. MÉTODOS: Como parte de una revisión/actualización de 8 recomendaciones basadas en evidencia seleccionadas sobre diabetes tipo 2, evaluamos las siguientes cinco aproximaciones de búsqueda bibliográfica (dirigidas a revisiones sistemáticas, utilizando criterios predeterminados): PubMed para MEDLINE; Epistemonikos utilizando una búsqueda básica; Epistemonikos utilizando una estrategia de búsqueda estructurada; plataforma (L.OVE) y TRIP . Tres revisores clasificaron de forma independiente las referencias recuperadas como definitivamente o probablemente elegibles/no elegibles. Aquellas clasificadas en las mismas categorías "definitivas" para todos los revisores, se etiquetaron como "verdaderas" positivas/negativas. El resto se sometieron a una nueva evaluación y, si se consideraban por consenso elegibles/no elegibles, se convirtieron en "falsos" negativos/positivos, respectivamente. Describimos el rendimiento de cada aproximación, junto a sus medidas de "precisión diagnóstica" y las estadísticas de acuerdo. RESULTADOS: En conjunto, las cinco aproximaciones identificaron 318-505 referencias para las 8 recomendaciones, de las cuales los revisores consideraron elegibles el 4,2 a 9,4% tras las dos rondas. Mientras que Pubmed superó a las otras aproximaciones (odds ratio de diagnóstico 12,5 versus 2,6 a 53), ninguna aproximación de búsqueda identificó por sí misma referencias elegibles para todas las recomendaciones. Individualmente, las búsquedas identificaron hasta el 40% de todas las referencias elegibles (n=71), y ninguna combinación de cualquiera de los tres enfoques pudo identificar más del 80% de ellas. Las estadísticas Kappa para la recuperación entre búsquedas fueron muy pobres (9 de cada 10 comparaciones pareadas no superaron el acuerdo esperado por azar). CONCLUSIONES: Entre las plataformas de información evaluadas, Pubmed parece ser la más eficiente para actualizar este conjunto de recomendaciones. Sin embargo, la escasa concordancia en el rendimiento de las referencias exige que los grupos desarrolladores incorporen información de varias fuentes (probablemente más de tres) para este fin. Es necesario seguir investigando para replicar nuestros hallazgos y mejorar nuestra comprensión de cómo actualizar recomendaciones de forma eficiente.
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Humanos , Guías de Práctica Clínica como Asunto , Medicina Basada en la Evidencia , Diabetes Mellitus Tipo 2 , Bases de Datos Bibliográficas , Almacenamiento y Recuperación de la Información/métodos , Almacenamiento y Recuperación de la Información/normas , ColombiaRESUMEN
Resumen Las guías de diagnóstico y tratamiento elaboradas por las sociedades científicas médicas, constituyen una herramienta muy útil para el ejercicio profesional de la especialidad. Sustentadas en bibliografía actualizada, representan un material de enorme valor con reco mendaciones de los expertos en los diversos temas de la especialidad. En el presente artículo se intenta determinar si las mismas podrían ser diseñadas acercándolas lo más estrechamente posible al formato de las Guías de Práctica Clínica Basadas en la Evidencia (GPC-BE), para lo cual se revisan las etapas en su elaboración y los requisitos que deberían cumplir para ser conside radas como tales. Las GPC-BE son un "conjunto de recomendaciones elaboradas de forma sistemática para ayudar a los profe sionales y a los pacientes en la toma de decisiones sobre la atención sanitaria más apropiada, seleccionando las opciones diagnósticas y/o terapéuticas más adecuadas en el abordaje de un problema de salud o una condición clínica específica". Su objetivo es mejorar la efectividad, la eficiencia y la seguridad de las decisiones clínicas, y pueden servir de base para la elaboración de políticas de salud. La elaboración de las GPC representa un proceso complejo, que requiere conocimientos, experiencia y re cursos tanto en tiempo como en dinero. Su robustez no depende de quienes la realizan, sino de cómo es realiza da. Ello implica la participación de técnicos que aporten la evaluación de la evidencia por el método GRADE, y la consideración de aspectos de costo-efectividad.
Abstract The guides for diagnosis and treatment prepared by scientific medical societies constitute a very useful tool for the professional practice of the specialty. Supported by an updated bibliography, they represent material of enormous value with recommendations from experts on the various topics of the specialty. This article attempts to determine if they could be designed as "Evidence - Based Clinical Practice Guide lines" (CPG BE), for which the stages in their develop ment and the requirements that they reviewed. The CPG BE are a "set of recommendations prepared systematically to help professionals and patients in making decisions about the most appropriate health care, selecting the most appropriate diagnostic and/or therapeutic options to address a problem of health or a specific clinical condition". Their objective is to improve the effectiveness, efficiency and safety of clinical deci sions, and they can serve a basis for the development of health policies. The preparation of CPGs represents a complex pro cess, which requires knowledge, experience and re sources, both in time and money. Its robustness does not depend on who does it, but on how it is done. This implies the participation of technicians who provide the evaluation of the evidence using the GRADE method and the consideration of cost-effectiveness aspects.
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INTRODUCCIÓN: Varias guías de práctica clínica para el tratamiento de la COVID-19 se han desarrollado durante los dos últimos años de pandemia, sin embargo, su calidad metodológica es poco clara. OBJETIVO: Realizar una evaluación sistemática de la calidad de las guías de práctica clínica publicadas entre 2021 y octubre de 2022 para el tratamiento de la COVID-19, utilizando la herramienta AGREE II, e identificar las recomendaciones formuladas en dichas guías. JUSTIFICACIÓN: Durante la pandemia, surgieron múltiples guías, pero la claridad so-bre su calidad metodológica fue limitada. MÉTODOS: Se realizó una búsqueda sistemática de guías de práctica clínica sobre el tratamiento para la COVID-19 leve o moderada utilizando metabuscadores como Epistemonikos y Trip Database, y sitios web de organizaciones de sa-lud. Las guías seleccionadas fueron evaluadas con el instrumento AGREE II. RESULTADOS: Se evaluaron 11 GPC, presentando altas puntuaciones en los dominios de alcance y propósito (98,74 %), participación de los implicados (97,22 %), rigor en la elaboración (92 %), claridad de presentación (100 %), aplicabilidad (85,61 %), e independencia editorial (100 %). Aunque la ca-lidad general de las guías fue alta, se identificó la necesidad de mejorar en los aspectos de rigor en la elaboración y aplicabilidad de las recomendaciones. CONCLUSIONES: Encontramos que la calidad de las guías de práctica clínica evaluadas, en su mayoría es alta y, por lo tanto, son recomendables, aunque reconocemos la necesidad de mejorar la descripción de los dominios de rigor en la elaboración y aplicabilidad de las recomendaciones.
INTRODUCTION: Several clinical practice guidelines for the management of COVID-19 have been developed during the last two years of the pandemic, but their methodological quality is unclear. OBJECTIVE: To systematically assess the quality of clinical practice guidelines for the treatment of COVID-19 published between 2021 and October 2022 using the AGREE II tool, and to identify the recommendations made in these guidelines. JUSTIFICATION: During the pandemic, many guidelines were published, but clarity about their methodological quality was limited. METHODS: A systematic search for clinical practice guidelines on the management of mild-to-moderate COVID-19 was performed using meta-search engines such as Epistemoni-kos and Trip Database, as well as health organization websites. The selected guidelines were appraised using the AGREE II instrument. RESULTS: Eleven clinical practice guidelines (CPGs) were evaluated, showing high scores in the domains of scope and purpose (98.74%), stakehol-der involvement (97.22%), rigor of development (92%), clarity of presentation (100%), applica-bility (85.61%), and editorial independence (100%). Although the overall quality of the guidelines was high, there was identified a need for improvement in the areas of rigor of development and applicability of the recommendations. CONCLUSIONS: We found that the quality of the evalua-ted clinical practice guidelines is predominantly high, and therefore, they are recommendable. However, we recognize the need to improve the descriptions of the domains of rigor of develop-ment and applicability of the recommendations,
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Humanos , Masculino , Femenino , Terapéutica , Guías de Práctica Clínica como Asunto , Medicina Basada en la Evidencia , Pandemias , SARS-CoV-2 , COVID-19 , Protocolos Clínicos , Bases de Datos Bibliográficas , Técnicas de Apoyo para la Decisión , Indicadores de Calidad de la Atención de Salud , Ecuador , Estudios de Evaluación como Asunto , Práctica Clínica Basada en la EvidenciaRESUMEN
Objetivo. Proporcionar un marco para profesionales de la salud que tratan a pacientes pediátricos bajo terapia con glucocorticoides (GC) y desarrollar recomendaciones para la prevención y el tratamiento de la osteoporosis inducida por GC en la población pediátrica. Métodos. Un panel de expertos en enfermedades óseas y pediátricas generó una serie de preguntas PICO que abordan aspectos relacionados con la prevención y el tratamiento de osteoporosis en pacientes bajo tratamiento con GC. Siguiendo la metodología GRADE, se realizó una revisión sistemática de la literatura, se resumieron las estimaciones del efecto y se calificó la calidad de la evidencia. Luego se procedió a la votación y a la formulación de las recomendaciones. Resultados. Se desarrollaron 7 recomendaciones y 6 principios generales para osteoporosis inducida por GC en población pediátrica. Conclusión. Estas recomendaciones proporcionan orientación para los médicos que deben tomar decisiones en pacientes pediátricos bajo tratamiento con GC.
Objective. To provide a framework for healthcare professionals managing pediatric patients who are on active glucocorticoid (GC) therapy and to develop recommendations for the prevention and treatment of GC-induced osteoporosis in the pediatric population. Methods. A panel of experts on bone and pediatric diseases developed a series of PICO questions that address issues related to the prevention and treatment of osteoporosis in patients on GC therapy. In accordance with the GRADE approach, we conducted a systematic review of the literature, summarized effect estimations, and classified the quality of the evidence. Then, voting and the formulation of recommendations followed. Results. Seven recommendations and six general principles were developed for GC-induced osteoporosis in the pediatric population. Conclusion. These recommendations provide guidance for clinicians who must make decisions concerning pediatric patients undergoing treatment with GC.
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Humanos , Niño , Osteoporosis/inducido químicamente , Osteoporosis/prevención & control , Osteoporosis/tratamiento farmacológico , Glucocorticoides/efectos adversosRESUMEN
RESUMEN Introducción: El suicidio es un complejo problema de salud pública global. La guía colombiana de práctica clínica es un insumo relevante para su prevención, diagnóstico y tratamiento. El objetivo es evaluar la calidad metodológica, la credibilidad y la aplicabilidad de la guía de práctica clínica colombiana sobre la conducta suicida. Métodos: Un grupo académico de 12 evaluadores se estandarizó para la valoración de la guía y sus recomendaciones mediante los instrumentos AGREE-II y AGREE-REX. Las valoraciones se dieron en el intervalo de 0,0-1,0, con 0,7 como punto de corte para apropiada calidad. Resultados: La valoración global del AGREE-II fue >0,7 en las dimensiones «alcance y objetivo¼ (0,86), «claridad de la presentación¼ (0,89), «aplicabilidad¼ (0,73) e «independencia editorial¼ (0,89). Los menores puntajes fueron para «participación de los implicados¼ (0,67) y «rigor en la elaboración¼ (0,69). Con el AGREE-REX los resultados en todas las dimensiones estuvieron por debajo de 0,70, lo cual indica menores calidad e idoneidad de uso. Conclusiones: El proceso de adopción de la guía colombiana sobre conducta suicida fue un proceso riguroso en lo metodológico, en tanto que las recomendaciones de práctica se valoraron como de baja aplicabilidad por el escaso sustento en evidencia local. Se requiere fortalecer la generación y la síntesis de evidencia en el país para dar más soporte y aplicabilidad a las recomendaciones de práctica.
ABSTRACT Introduction: Suicide is a complex, global public health problem. The Colombian clinical practice guideline provides relevant input for its prevention, diagnosis and treatment. The objective was to evaluate the methodological quality, credibility and applicability of the Colombian clinical practice guideline for suicidal behaviour. Methods: An academic group of 12 evaluators was established to assess the guide and its recommendations in a standardised way, using the AGREE-II and AGREE-REX instruments. The evaluations were given in the range of 0.0-1.0 with 0.7 as a cut-off point for appropriate quality. Results: The global assessment of the AGREE-II was greater than 0.7 in the dimensions: "scope and objective" (0.86), "clarity of presentation" (0.89), "applicability" (0.73) and "editorial independence" (0.89). The lowest scores were for "participation of those involved" (0.67) and "rigour in preparation" (0.69). With the AGREE-REX, the results in all dimensions were below 0.70, which indicates lower quality and suitability for use. Conclusions: The adoption process of the Colombian guideline for suicidal behaviour was a rigorous methodological process, while the practice recommendations were valued as of low applicability due to low support in local evidence. It is necessary to strengthen the genera-tion and synthesis of evidence at the national level to give greater support and applicability to the practice recommendations.
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RESUMEN Introducción: Dada la existencia de variadas guías para enfermedades respiratorias, se buscó conocer cuáles eligen los médicos para utilizar en su práctica clínica. Materiales y Métodos: se realizó un estudio descriptivo, transversal, mediante una encuesta a neumonólogos de la Asociación Argentina de Medicina Respiratoria. Resultados: La guía más utilizada para EPOC fue la Iniciativa Global para la Enferme dad Pulmonar Obstructiva Crónica (GOLD) (82 %), seguida por GesEPOC (51 %). Para asma las más usadas fueron la Iniciativa Global para el Asma (GINA) 2022 (89 %) y GEMA 5.2 (68 %). En asma de difícil control, se prefirieron GINA 2022 (82 %) y GEMA 2022 (53 %). En espirometría, un 54 % de los respondedores se inclinó por NHANES III y un 22 % utilizó valores teóricos de referencia de Knudson. En neumonía, el 62 % eligió SADI, el 37 %, IDSA y el 20 %, BTS. Para nódulos pulmonares, el 62 % prefirió las guías Fleischner, 35 % se inclinó por Lung-RADS 1.1. Para neumonitis por hip ersensibilidad, un 83 % seleccionó las guías de las sociedades conjuntas ATS/JRS/ ALAT. Para imágenes de fibrosis pulmonar, el 89 % utilizó ALAT/ERS/JRS/ALAT y el 18 % White Paper. Discusión: si bien hay estudios sobre adherencia a guías, no los hay acerca de pref erencias de utilización entre varias referidas a un mismo tema. En EPOC y asma (in cluyendo la de difícil control) se eligieron GOLD y GINA y las de la Sociedad Española de Patología Respiratoria (GesEPOC y GEMA). El uso preferencial de la guía nacional para neumonía es coherente con la necesidad de contemplar la epidemiología local.
ABSTRACT Introduction: Since there are various guidelines for respiratory diseases, we aimed to know which are chosen by physicians in their daily clinical practice. Materials and Methods: A descriptive, cross-sectional study was conducted through a questionnaire sent to pulmonologists of the Argentinian Association of Respiratory Medicine. Results: The most commonly used guideline for COPD (chronic obstructive pulmonary disease) was the Global Initiative for Chronic Obstructive Lung Disease (GOLD) (82 %), followed by GesEPOC (51 %). For asthma, the most commonly used guideline was the Global Initiative for Asthma (GINA) 2022 (89 %) and the Spanish Guideline on the Management of Asthma (known for its acronym in Spanish, GEMA), GEMA 5.2 (68 %). In difficult-to-control asthma, GINA 2022 (82 %) and GEMA 2022 (53 %) were used. With regard to spirometries, 54 % of respondents favored NHANES III (Third National Health and Nutrition Examination Survey) and 22 % used theoretical Knudson reference values. For pneumonia, 62 % chose the guidelines of the SADI (Argentinian Society of Infectious Diseases), 37 % preferred those of the IDSA (Infectious Diseases Society of America) and 20 %, chose the guidelines of the BTS (British Thoracic Society). For pulmonary nodules, 62 % used Fleischner guidelines, and 35 % favored Lung-RADS 1.1. For hypersensitivity pneumonitis, 83 % selected the ATS/JRS/ALAT Guidelines (American Thoracic Society/Japanese Respiratory Society/Latin American Thoracic Society). And with respect to pulmonary fibrosis imaging, 89 % used ALAT/ERS (Eu ropean Respiratory Society)/JRS recommendations, and 18 % preferred White Paper. Discussion: Although there are studies about adherence to guidelines, none of them shows which are the chosen recommendations within a group of guidelines of the same topic. In COPD and asthma (including difficult-to-control asthma) GOLD, GINA and the guidelines of the Spanish Society of Respiratory Disease (GesEPOC and GEMA) were chosen. The preference for the national guideline for pneumonia is consistent with the need to consider local epidemiology.
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The irrational use of Chinese patent medicines (CPM) is becoming more and more prominent, which makes the demand for clinical practice guidelines of CPM gradually increase. In order to make domestic scholars understand the latest developments and existing problems of the CPM guidelines, and promote its development, this paper introduced the concept of CPM guidelines, summarized the characteristics of the two development modes, namely “taking CPM as the key” and “taking disease/syndrome as the key”, and analyzed the current methodological status of developing and reporting CPM guidelines. Based on the existed problems, three suggestions have been put forward to optimize the quality of CPM guidelines, which were clarifying the target users and scope of CPM guidelines, establishing an open and transparent mechanism of the personnel involvement and process steps, and formulating implementable and operable recommendations for the use of CPM.
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The identification of clinical questions for clinical practice guidelines of Chinese patent medicine (CPM) is important for subsequent evidence retrieval, evaluation of evidence quality, formation of recommendations. This paper described a methodological proposal for the identification of clinical questions for CPM guidelines to highlight the characteristics of Chinese patent medicine and reflect its effect in specific stage of the disease. Considering four aspects, namely, the drug of Chinese patent medicine (D), the specific disease stage (S), comparison (C), and specific outcome (O), DSCO framework has been proposed to formulate the clinical questions. Multi-source information through scientific research, policy or standard documents, and clinical data are suggested for collecting clinical questions, and clear selection criteria should be set to finalize the clinical questions to be addressed by the guideline. In addition, the above process needs to be transparently and publicly reported in order to ensure the clarity and completeness of the guidelines.
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The retrieval and evaluation of evidence is the basis for the development of clinical practice guidelines for Chinese patent medicine. As traditional Chinese medicine has a different development trajectory and utilization characteristics from modern medicine, there is certain differences in terms of evidence composition, retrieval and integration.This paper discussed multi-source body of evidence on Chinese patent medicine based on modern evidence-based medicine and ancient medical literature, and summarized the retrieval strategy as well as the possible problems and solving methods. For different types of evidence on Chinese patent medicine, the corresponding evaluation tools have been recommended, and the order to integrate the evidence based on the quality of the evidence from high to low is suggested. Finally, a multi-source based evidence retrieval-evaluation-integration scheme for Chinese patent medicine has been formed, which will provide a methodological reference for practitioners in the development of clinical practice guidelines for Chinese patent medicine.
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Recommendations for Chinese patent medicine (CPM) based on key information on rational drug use are one of the important conditions for enhancing guideline enforceability as well as facilitating guideline implementation. In this study, we discussed in detail of the key information on the rational use of CPM in five aspects, which are dosage, drug discontinuation, drug-drug and drug-food interactions, safety and economy. Following the process of multi-source search, synthesis and prioritization, it is suggested to collect key information on the rational use of CPM from a multi-source search of drug instructions, policy documents, literature, and clinical experts' experiences. Then the searched information should be summarized and prioritized with the principle that taking drug instructions as the basis and other-sources information for check and supplementation. Finally, methodological recommendations for the retrieval and synthesis of key information on rational drug use in guideline recommendations has been formed.
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Recommendation formation is a key component of clinical practice guidelines for Chinese patent medicine (CPM), and should encompass the determination of the strength and direction of the recommendation, the rationale for the recommendation, and the methodology for implementing the recommendation. Recommendations can be formed through formal consensus and informal consensus. The strength and direction of recommendations for CPM guidelines should be determined by considering the quality of evidence for CPMs, the priority of the clinical questions, the pros and cons of efficacy and adverse effects, patient acceptance, the feasibility of the recommendation and the availability of resources, social fairness, economic benefits, and other influencing factors. In order to better guide guideline developers to consider these factors more rationally, this article provideed a detailed explanation of each factor in the context of the characteristics of TCM.
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The systematic and comprehensive introduction and interpretation of the Reporting Checklist of Clinical Practice Guidelines for Chinese Patent Medicines V1.0 is conducive to the presentation of high-quality clinical practice guidelines for Chinese patent medicines (CPMs), thus improving their dissemination and use. The Reporting Checklist of Clinical Practice Guidelines for Chinese Patent Medicines V1.0 specifies the requirements for clear, complete and transparent reporting of the whole process of developing CPMs guidelines, containing 4 domains, 17 topics and 43 items, and involving the basic information, recommendations and methods of guideline development. Especially, it details the items related to the rules and regulations of the use of CPMs in the recommendations, which is helpful for improving the completeness, scientificity and practicality of the reporting of CPMs guideline.
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ObjectiveTo evaluate the methodological and reporting quality of clinical practice guidelines for Chinese patent medicine (CPM) with internationally recognized tools the appraisal of guidelines for research and evaluation (AGEREE) Ⅱ and reporting items for practice guidelines in healthcare (RIGHT), thereby providing refe-rence for the clinical application and future development of CPM guidelines. MethodsDatabases including CNKI, VIP, Wanfang and Sinomed were searched for CPM guidelines, as well as medlive.cn, websites of China Association of Chinese Medicine and Chinese Medical Association, and reference lists of the included papers. The quality of the guidelines was evaluated using the AGREE Ⅱand RIGHT tools, and consistency tests were performed using Interclass Correlation Coefficient, and descriptive analysis and chi-square test were used to analyze the reporting rate for each domain and the average score for each item. ResultsFinally, 140 CPM guidelines were included, of which 51 were disease-oriented and 89 were drug-oriented, all of which were issued by China. For 51 disease-oriented CPM guidelines, the highest average score of all six AGREE Ⅱ domains was 73.32% for clarity, and the lowest was 26.80% for application; for 89 drug-oriented CPM guidelines, the highest average score was 55.62% for scope and purpose, and the lowest was 31.32% for rigour of development. In terms of the seven domains of the RIGHT checklist, the highest reporting rate was 68.26% for background, and lowest was 27.45% for other areas regarding the disease-oriented CPM guidelines; the highest reporting rate was 61.31% for background, and the lowest was 4.49% for other areas regarding drug-oriented CPM guidelines. The average reporting rate was higher for disease-oriented than drug-oriented CPM guidelines in three domains of AGREE Ⅱ (rigour of development, clarity of presentation, editorial independence), as well as four domains of RIGHT checklist (basic information, evidence, funding and declaration and management of interests, and other areas). ConclusionThe overall methodology and reporting quality of the current CPM guidelines still need to be improved. It is recommended that future guideline development teams should strictly refer to the AGREE Ⅱ and RIGHT checklist, and take into account of the characteristics of CPM guidelines and relevant methodo-logical suggestions in the development and reporting of CPM guidelines, thereby guiding the clinical use of CPM in a better way.
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ObjectiveTo explore the current status and issues regarding the application of ancient books in clinical practice guidelines and expert consensus of traditional Chinese medicine (TCM) published in China, and to provide methodological recommendations for the incorporation of ancient books in the development of TCM guidelines. MethodsWe searched China National Knowledge Infrastructure (CNKI), WanFang Data, VIP, SinoMed, PubMed, Embase, as well as six industry websites including China Association of Chinese Medicine, National Group Standards Information Platform, and Chinese Association of the Integration of Traditional and Western Medicine,etc. TCM clinical practice guidelines or expert consensus issued during January 1st, 2017, to November 26th, 2022 were searched. Clinical practice guidelines or expert consensus that explicitly referred to ancient books were included, and the content regarding the searching for ancient books, sources of access to ancient books, methods of evaluating the level of evidence, methods of evaluating the level of recommendation, and methods of evaluating the evidence for the ancient books were analysed. ResultsA total of 1,215 TCM clinical practice guidelines or expert consensus were retrieved, with 442 articles explicitly mentioning the application of ancient books, including 300 (67.87%) clinical practice guidelines and 142 (32.13%) expert consensus. Sixty of the 442 publications explicitly reported that ancient books searching had been conducted (13.57%); among these 60 publications 27 (45.00%) explicitly reported ancient books searching strategies, and the most frequent method was manual searching with a total of 24 articles (40.00%). The most popular search source was Chinese Medical Dictionary, a TCM classics database, with a total of 18 articles. 197 articles (44.57%) explicitly reported the evaluation criteria for the level of evidence, of which 141 articles (71.57%) involved the evaluation criteria for the ancient books; 413 articles (93.44%) mentioned ancient books in the recommendations, and only the source of formula name was mentioned in 409 (99.03%) of the publications. ConclusionThe current application of ancient books in TCM clinical practice guidelines and expert consensus is limited, with issues of non-standard searching and evaluation methods. Standar-dization and uniformity are needed in evidence grading and recommendation standards. Future research should clarify the scope and methods of applying ancient book, emphasize their integration with modern research evidence, and enhance their value and quality in the development of TCM clinical practice guidelines.
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ObjectiveTo analyze the development status and quality of clinical practice guidelines for the treatment of dominant diseases with Chinese patent medicines (CPMs). MethodsDatabases were searched from Jan. 2019 to Dec.2023 to collect the published clinical practice guidelines of CPMs for the treatment of dominant diseases. The information about the title, the participants, clinical problems, outcomes, evidence grade, recommendations, and recommendation strength in the included clinical practice guidelines were collected, for which the development status was analyzed, and the quality was evaluated with the Scientific, Transparent and Applicable Rankings (STAR) tool for clinical practice guidelines. ResultsTotally, 34 guidelines were included, involving 273 kinds of CPMs. One to ten (with the medium five) clinical problems were proposed from 29 clinical practice guidelines respectively. All the guidelines divided the evidence into four grades according to Grade of Recommendation Assessment, Deve-lopement an Evaluation. And 28 guidelines had five levels of recommendation strength. A total of 344 recommendations were extracted, including 86 strong-recommendations, 191 weak-recommendations (including 36 weak recommendations only based on expert consensus) and 67 recommendations with unclear recommendation strength. All guidelines had high scores in the three areas of “clinical questions (94.20%)”, “evidence (91.45%)” and “recommendations (89.06%)”, while the scores in the three areas of “registry (22.06%)”, “protocol (19.00%)” and “accessibility (31.51%)” were low. The STAR recommended stars of 8 guidelines were 5.0~4.0 stars, while that of 18 guidelines were 3.5~2.5 stars, and 8 guidelines were 2.0~1.0 stars. The three guidelines with the highest recommended stars were depressive disorder, community-acquired pneumonia, and influenza in adult. ConclusionThere is a certain gap in the quality of the published clinical practice guidelines of CPMs, and the quality of the guidelines could be further improved in registry, protocols, funds, and accessibility.
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Currently, there are many difficulties in formulating recommendations of traditional Chinese medicine (TCM) clinical practice guidelines. This paper analyzed and summarized the unique or prominent difficult issues in the formulation of recommendations faced by TCM guidelines, such as experts' professional background and experience bringing about the preferance from the academic emotion, inconsistency between different academic schools making it difficult to reach consensus, lack of guiding principles of the decision weight of different dimensions for recommendations. Therefore, methodological suggestions have been put forward, including organizing parallel TCM and western medicine consensus group, improving the method of combining TCM and western medicine paradigm, attaching great importance to the evidence-based governance of academic schools, and promoting the research on different dimensions for recommendation formulation, which may provide a methodological reference for the guideline development.
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It is necessary to develop rapid and living guidelines in order to improve the evidence translation and guidance for clinical practice in emergency situations, and to enhance the participation of traditional Chinese medicine (TCM) in management of emergencies. This paper introduced the process of developing rapid and living guidelines of TCM and divided it into three stages, that is preparation, rapid development and dynamic updating, which highlights the features of rapid development, high quality, and dynamic updating and the integration with the predominance of TCM. By comparing with general guidelines on composition, personnel number, timing to formulate and communication patterns of the guideline working groups, as well as the content and number of clinical questions, this paper mainly gave suggestions on how to formulate a concise but authoritative team during the preparation stage, how to efficiently manage the guideline team and promote the development process from conflict of interest management, working and communication mode adjustment, and how to formulate and update the important and prioritized clinical questions, all of which may provide reference for the development of TCM rapid and living guidelines.
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The lack of direct evidence is an important problem faced in the formation of recommendations in rapid living guidelines of traditional Chinese medicine under public health emergencies, and the supplementation of indirect evidence can be a key method to solve this problem. For the collection of evidence, the type of evidence required, including direct and indirect evidence, should be clarified, and ‘direct first’ principle for selecting evidence can be set to standardize and accelerate the guideline development. When integrating evidence, recommendations can be formed directly if there is sufficient direct evidence, while regarding insufficient direct evidence, recommendations need to be supplemented and improved by integrating indirect evidence. In addition, when the body of evidence contains evidence from multiple sources, it is suggested to rate the evidence according to “higher rather than lower” principle. Finally, when forming recommendations, the level of evidence, safety and economic efficiency should be taken into consideration to determine the strength of the recommendation.
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Objetivos: Describir los conocimientos, la idoneidad y las prácticas respecto a la "Guía de práctica clínica (GPC) basada en la evidencia para la atención integral de la sífilis gestacional (SG) y congénita (SC)". Materiales y métodos: Estudio descriptivo de corte transversal. Incluyó médicos generales, especialistas y enfermeras que laboraban en 52 instituciones de salud en el departamento de Bolívar (Colombia) y realizan el control prenatal o la atención al neonato en el 2020. Muestreo por conveniencia. Se aplicó cuestionario digital que recolectó información sociodemográfica; evaluó conocimientos, idoneidad y prácticas sobre la "Guía de práctica clínica (GPC)" mencionada en los objetivos. Se hace análisis descriptivo. Resultados: Se incluyeron 101 trabajadores. Hay deficiencias relacionadas con la aplicación correcta del algoritmo inverso de diagnóstico (48 %) y seguimiento de SG (77 %), manejo de la paciente con antecedentes de alergias de manifestaciones sistémicas (31 %) y tratamiento de la SG (61 %) y SC (10 %). La recomendación de no aplicar prueba de penicilina en pacientes sin antecedentes de alergias sistémicas se considera poco útil (60 %). El 23 % de los trabajadores no emplea las pruebas rápidas y el 44 % de los especialistas da tratamiento para sífilis al compañero sexual. Conclusiones: Es importante intensificar las estrategias de capacitación en el personal de salud con énfasis en el personal de enfermería y, de manera urgente, empoderar a este personal en las actividades relacionadas con el control de la sífilis. Se requiere hacer nuevas y continúas evaluaciones a nivel nacional y regional de la implementación de esta guía que permitan evaluar los indicadores que contiene la estrategia de eliminación de esta enfermedad.
Objectives: To describe the knowledge, appropriateness and practices regarding the evidence-based "Clinical Practice Guidelines (CPG) for the comprehensive management of gestational syphilis (GS) and congenital syphilis (CS)". Material and methods: A descriptive, cross-sectional study including general practitioners, specialists and nurses working at 52 healthcare institutions in the Bolivar Department (Colombia) who provided prenatal control or neonatal care in 2020. Convenience sampling was used. A digital questionnaire was administered to collect sociodemographic information, assessed knowledge, appropriateness and practices in terms of the evidenced-based "Clinical Practice Guidelines (CPG)" mentioned in the objectives. A descriptive analysis followed. Results: A total of 101 workers were included. There are deficiencies associated with the correct use of the inverse algorithm of diagnosis (48 %) and GS follow-up (77 %), management of the patient with a history of systemic manifestation allergies (31 %) and treatment of GS (61 %) and CS (10 %). The recommendation of not using the penicillin test in patients with no history of systemic allergies is considered of little benefit (60 %). 23 % of the workers do not use rapid tests and 44 % of the specialists administer syphilis treatment to the sexual partner. Conclusions: It is important to intensify the training strategies for health personnel with emphasis on nurses and, as a matter of urgency, empower them in syphilis control activities. New and continuous national and regional evaluations of the implementation of these guidelines are needed to assess the indicators associated with the strategy for the elimination of this disease.