Financiamiento en investigación en salud: obteniendo financiamiento. Consejos útiles para aumentar las chances de éxito. Parte 2 / Health research funding: obtaining grants. Tips to improve the success rate. Part 2

Esta es la segunda parte de un artículo sobre la búsqueda de financiamiento para un proyecto de investigación. Todo proyecto de investigación requiere una fuente de financiamiento para poder ser llevado adelante. La búsqueda de fondos es una tarea que lleva tiempo y esfuerzo con una baja tasa de éxito. Compartimos algunos consejos que podrían ayudar a aumentar esa tasa de éxito en relación con: 1) cómo reconocer la necesidad de búsqueda de una fuente de financiamiento externo, 2) de dónde provienen los fondos, 3) qué gastos se pueden financiar habitualmente con los fondos y 4) cómo mejorar la escritura y la presentación a una convocatoria. (AU)

This is the second part of our series on searching funds for a research plan. Every research proposal requires a source of funding to be carried out. Looking for funds is a time and effort consuming task with a low success rate. We share some tips that may help to improve that success rate related to (1) how to recognize the need of an external funding source, (2) where the funds are coming from, (3) what costs can be funded and (4) how to improve a proposal writing and submission. (AU)

Sesgos en investigación quirúrgica / Biases in surgical research

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

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

Desenvolvimento de novos medicamentos para doenças negligenciadas: uma análise bibliométrica / New drug development for neglected diseases: a bibliometric analysis / Desarrollo de nuevos fármacos para enfermedades desatendidas: un análisis bibliométrico

Doenças negligenciadas impõem um fardo humano, social e econômico devastador a mais de um bilhão de pessoas em todo o mundo. Embora existam ferramentas para controlar e até mesmo eliminar muitas dessas doenças, novos produtos terapêuticos precisam urgentemente ser desenvolvidos. Este artigo se baseia em um estudo que buscou quantificar e caracterizar a produção científica global sobre desenvolvimento de novos medicamentos para doenças negligenciadas, por meio de uma análise bibliométrica. De modo a investigar a pesquisa relacionada ao desenvolvimento de novos medicamentos para as doenças negligenciadas em âmbito global na última década, foi utilizada a base de dados Scopus. Observou-se aumento da produção de conhecimento sobre o tema, com relevante participação de autores, instituições e financiamento brasileiros, sobretudo de instituições públicas. Contudo, os esforços realizados têm sido insuficientes, sendo necessária a implementação de estratégias futuras de pesquisa e de financiamento que propiciem maior produção científica e uma tradução da pesquisa básica para a prática clínica.

Neglected diseases impose a devastating human, social, and economic burden on more than one billion people worldwide. While tools exist to control and even eliminate many of these diseases, new therapeutic products urgently need to be developed. This article is based on a study that sought to quantify and characterize the global scientific production on new drug development for neglected diseases through a bibliometric analysis. The Scopus database was used to investigate the research related to the development of new drugs for neglected diseases globally in the last decade. An increase in the production of knowledge about the theme and the relevant participation of Brazilian authors, institutions and funding, especially from public institutions were observed. However, their efforts have been insufficient, and the implementation of future research and funding strategies that provide greater scientific production and a translation of basic research into clinical practice is necessary.

Las enfermedades desatendidas imponen una carga humana, social y económica devastadora a más de mil millones de personas en todo el mundo. A pesar de haber herramientas para controlar y incluso eliminar muchas de estas enfermedades, es necesario desarrollar con urgencia nuevos productos terapéuticos. Este artículo se basa en un estudio lo cual ha buscado cuantificar y caracterizar la producción científica global sobre el desarrollo de nuevos fármacos para enfermedades desatendidas, a través de un análisis bibliométrico. Para inspeccionar investigaciones relacionadas con el desarrollo de nuevos medicamentos para enfermedades desatendidas en ámbito mundial durante la última década se utilizó la base de datos Scopus. Hubo un aumento de la producción de conocimiento sobre el tema, con una participación relevante de autores, instituciones y financiamiento brasileños, especialmente de instituciones públicas. Sin embargo, los esfuerzos realizados siguen siendo insuficientes, requiriendo la implementación de futuras estrategias de investigación y financiamiento que propicien una mayor producción científica y una traducción de la investigación básica a la práctica clínica.

Financiamiento en investigación: ¿qué necesito antes de comenzar a buscar una fuente de financiamiento?: parte 1 / Research funding: what do I need before I start looking for a funding source?: part 1

Esta es la primera parte de un artículo sobre la búsqueda de financiamiento para un proyecto de investigación. Esta entrega resume los principales ítems para tener en consideración a la hora de postularse a una convocatoria. Requerimientos del proceso: 1. Tiempo protegido. 2. Propuesta de investigación sólida. 3. Equipo calificado y con experiencia. 4. Definición y organización de actividades. 5. Cronograma de actividades. 6. Estimación de costos. (AU)

This is the first part of an article about finding funding for a research project. This delivery summarizes the main ítems to take into consideration when applying for a call. Process requirements: 1. Protected time. 2. Strong research proposal. 3. Qualified and experienced team. 4. Definition and organization of activities. 5. Schedule of activities. 6. Cost estimate. (AU)

Trascendencia de los Comités de Ética de Investigación en Seres Humanos en el Ecuador / Research Ethics Committees of Human Beings in Ecuador

INTRODUCCIÓN. Los Comités de Ética de Investigación en Seres Humanos deben proteger la dignidad, los derechos, el bienestar y la seguridad de los sujetos investigados; evalúan aspectos éticos, metodológicos y jurídicos de los protocolos de investigación, competencia otorgada por el ente sanitario del país que ameritó observar si se cumplió. OBJETIVO. Evaluar la situación de los Comités de Ética de Investigación en Seres Humanos, basados en la percepción del cursillista, la normativa, las repercusiones y consecuencias para mantener su condición activa y su trascendencia. MATERIALES Y MÉTODOS. Estudio descriptivo, transversal y ambispectivo con un universo de 1 327 profesionales del área de la salud y una muestra de 385 encuestados que expresaron su percepción sobre trece Comités de Ética de Investigación en Seres Humanos a nivel nacional, con revisión bibliográfica nacional e internacional, se excluyeron los suspendidos. Se aplicó encuesta validada online, período abril a octubre de 2019. Data analizada en Excel y SPSS versión 23. RESULTADOS. El 76,92% Comités de Ética de Investigación en Seres Humanos fueron de la ciudad de Quito. Los cursillistas percibieron que el 64,16%, no trascendieron en su labor; desconocieron que: la Dirección Nacional de Inteligencia de la Salud, cuestionó el nombramiento de algún miembro un 97,14%; el cuestionamiento estuvo basado en la norma vigente un 79,48%; sobre la aprobación del plan anual de capacitación en investigación, 2019, un 95,06%; el plan anual de capacitación específico un 77,40%, y no recibieron directrices ni retroalimentación en temas de capacitación en calidad de investigador, un 90,39%. Además, percibieron que los Comités fueron responsables de capacitar otros Comités de ética de Investigación en Seres Humanos, un 81,82% y a los investigadores, un 85,71%; que deben elaborar el plan anual de educación específica para los miembros del comité, un 89,35%. CONCLUSIÓN. Se identificó entre los problemas que los investigadores casi no los conocen y hay necesidad de actualizar la norma que afectó el funcionamiento. Los justificativos para mantener la condición activa no se cumplieron, se evidenció la necesidad de asesoría para los comités por parte de las autoridades competentes, sin lograr conformación consolidada con actores y repercutió en su trascendencia.

INTRODUCTION. The Research Ethics Committees on Human Beings must protect the dignity, rights, well-being and safety of the research subjects; evaluate ethical, methodological and legal aspects of the research protocols, a competence granted by the health entity of the country that merited see if it is done. OBJECTIVE. Evaluate the situation of the Ethics Committees for Research in Human Beings, based on the perception of the trainee, the regulations, the repercussions and consequences to maintain their active condition and their transcendence. MATERIALS AND METHODS. Descriptive, cross-sectional and ambispective study with a universe of 1,327 professionals in the health area and a sample of 385 respondents who expressed their perception of thirteen Research Ethics Committees on Human Beings at the national level, with national and international bibliographic review. those suspended were excluded. An online validated survey was applied, from April to October 2019. Data analyzed in Excel and SPSS version 23. RESULTS. 76.92% Human Research Ethics Committees were from the city of Quito. The trainees perceived that 64,16%, did not transcend in their work; they did not know that: the National Directorate of Health Intelligence, questioned the appointment of a member 97,14%; the questioning was based on the current norm 79,48%; on the approval of the annual research training plan, 2019, 95,06%; the specific annual training plan 77,40%, and did not receive guidelines or feedback on training issues as a researcher, 90,39%. In addition, they perceived that the Committees were responsible for training other Human Beings Research Ethics Committees, 81,82% and the researchers, 85,71%; that they must prepare the annual specific education plan for the members of the committee, 89,35%. CONCLUSION. It was identified among the problems that the researchers hardly know them and there is a need to update the norm that affected the operation. The justifications to maintain the active condition were not fulfilled, the need for advice for the committees by the competent authorities was evidenced, without achieving a consolidated conformation with actors and had repercussions on its importance. hardly know them and there is a need to update the norm that affected the operation. The justifications to maintain the active condition were not fulfilled, the need for advice for the committees by the competent authorities was evidenced, without achieving a consolidated conformation with actors and had repercussions on its importance.

Inovações no cotidiano da saúde na Amazônia: encontros do trabalho com a educação permanente e a humanização / Innovations in the daily life of health in the Amazon: work encounters with permanent education and humanization

Este livro compõe a Série Saúde & Amazônia e foi composto com capítulos produzidos por pesquisadores da rede científica que se ocupa da pesquisa "Prevenção e controle da COVID-19: a transformação das práticas sociais da população em territórios de abrangência da Atenção Básica em Saúde no Estado do Amazonas". São contribuições teóricas, metodológicas e empíricas que permitem uma aproximação analítica do contexto do sistema de saúde e das respostas locais à pandemia. Com os levantamentos iniciais, percebemos que o exercício de aproximação sucessiva com a realidade dos municípios estudados se beneficiava muito da pesquisa empírica em materiais provenientes da "literatura cinza", principalmente nesses tempos em que as redes sociais compartilham os mais diferentes discursos, tornando-os visíveis e facilmente acessáveis. O exercício epistêmico de identificar e analisar informações disponíveis em documentos e bases de informação de acesso público foi um enorme aprendizado da pesquisa. Tão habituados aos imaginários hierárquicos da investigação tradicional, aprendemos que as respostas às perguntas da pesquisa, muitas vezes, estão ao alcance do olhar que quebra o saber disciplinar e mergulha na aventura epistêmica de produzir conhecimentos oportunos em cenários de complexidade, desafio enorme à ciência nesse período de crises. Os capítulos que compõem o livro destacam a produção de dados em diferentes fontes documentais e secundárias como estratégia de pesquisa em saúde coletiva e, ao mesmo tempo, de um movimento ascendente na construção de modelos de análise, onde a escuta ao contexto local ajusta e torna mais precisa a abordagem transversal da pesquisa. Dessa forma, compartilhar esta etapa da produção também é validar um percurso que foi feito, em grande medida, ao caminhar pelas etapas iniciais da pesquisa.

Resultados del grupo científico estudiantil Formación e investigación en apoyo vital en emergencias y desastres / Results of a student scientific group for Training and Research in Vital Support for Emergencies and Disasters

Introducción: El desarrollo de grupos científicos estudiantiles en las universidades es una necesidad en función de nuevos conocimientos y una formación más integral. Objetivo: Describir los principales resultados del grupo científico estudiantil Formación e investigación en apoyo vital en emergencias y desastres en sus primeros tres años de trabajo. Métodos: Investigación descriptiva, prospectiva, desarrollada en la Universidad de Ciencias Médicas de Cienfuegos entre 2017 y 2019. El universo estuvo conformado por todos los estudiantes (25) y profesores tutores (6) que integraban el grupo. Como técnicas se emplearon la revisión documental, la tormenta de ideas y el grupo focal. Resultados: El plan de formación investigativa anual fue diferenciado por año académico y necesidades. Se impartieron temas escalonadamente complejos sobre metodología de la investigación y otros afines a la carrera. En cada año se cumplieron las tareas propuestas. Los estudiantes desarrollaron 29 investigaciones (13,8 por ciento publicadas y 48,3 por ciento premiadas), que se presentaron en tres fórums estudiantiles y otros 12 eventos. La producción científica creció progresivamente tanto en cantidad como en calidad. Conclusiones: Los resultados del grupo científico estudiantil fueron positivos. El diseño de un programa de capacitación extracurricular, modular y de participación colectiva sobre metodología de la investigación y temas médicos afines al proyecto de los tutores facilitaron la adquisición de habilidades investigativas de los estudiantes, y la obtención de buenos indicadores de actividad científica, con excepción del número de publicaciones(AU)

Introduction: The development of student scientific groups in universities is a need in terms of new knowledge and a more comprehensive training. Objective: To describe the main results of a student scientific group for training and research in vital support for emergencies and disasters in its first three years of work. Methods: Descriptive and prospective research carried out at the University of Medical Sciences of Cienfuegos between 2017 and 2019. The universe consisted of all students (25) and tutor teachers (6) who were part of the group. Documental review, brainstorming and focus group were used as techniques. Results: The annual research training plan was differentiated by academic year and needs. Complex topics on research methodology and others related to the major were taught in stages. In each year, the proposed tasks were completed. The students developed 29 research projects (13.8 percent were published and 48.3 percent received awards), presented during three student scientific meetings and twelve other events. Scientific production grew progressively both in quantity and quality. Conclusions: The results of the student scientific group are positive. The design of an extracurricular, modular and collective participation training program on research methodology and medical topics related to the tutors' project facilitated the acquisition of students' research skills and the achievement of good indicators of scientific activity, with the exception of the number of publications(AU)

Common research strategy and outlook for the development of acupuncture translational medicine / 中国针灸

To explore the common questions of acupuncture translational medicine study and the development strategy of its translational application. It is believed that the research on the individual and common mechanisms of acupuncture effects, and the common molecule of acupoint and parameter research for the effect onset of acupuncture may promote clinical translation and instrument research and development. The study of meridian theory should be fully applied to clinical practice to build a meridian diagnostic system with clinical significance. Using evidence-based medicine, the clinical research of acupuncture can be transformed into clinical guidelines to provide the effective regimens for clinical practice. The communication and cooperation should be enhanced between the basic research and clinical application in the field of acupuncture. It is suggested that the promotion of acupuncture translational medicine research is contribute to the overall development of acupuncture discipline, and to better service for the human health engineering.

Establishment of multiple evidence-integrated evaluation and prediction method for "toxic" Chinese medicines / 中国中药杂志

Traditional Chinese medicine(TCM) carries the experience and theoretical knowledge of the ancients, and the use of "toxic" Chinese medicines is a major feature and advantage of TCM. "Toxic" Chinese medicines have unique clinical value and certain medication risk under the guidance of TCM theories such as compatibility for detoxification and treatment based on syndrome differentiation. In recent years, the safety events of Chinese medicines have occurred frequently, which has made the safety of Chinese medicine a public concern in China and abroad. However, limited by conventional cognitive laws and technical methods, basic research on toxicity of Chinese medicines fails to be combined with the clinical application. As a result, it is difficult to identify the clinical characteristics of, predict toxic and side effects of, or form a universal precise medication regimen for "toxic" Chinese medicines, which restricts the clinical application of them. In view of the problem that the toxicity of "toxic" Chinese medicines is difficult to be predicted and restricts the clinical application, the evidence-based research concept will provide new ideas for safe applcation of them in clinical practice. The integrated development of multiple disciplines and techniques in the field of big data and artificial intelligence will also promote the renewal and development of the research models for "toxic" Chinese medicines. Our team tried to propose the academic concept of evidence-based Chinese medicine toxicology and establish the data-intelligence research mode for "toxic" Chinese medicines and the intelligent risk prediction method for medicinal combination in the early stage, which provided methodological supports for solving the above problem. Thus, on the basis of summarizing the research status and problems of the clinical medication regimen of "toxic" Chinese medicines, our team took the evidence-based toxicology of TCM as the core concept, and tried to construct the multiple-evidence integrated evaluation and prediction method for "toxic" Chinese medicine, so as to guide the establishment of the non-toxic medication regimen of "toxic" Chinese medicines. Specifically, through the analysis of multivariate data obtained from the basic research, the evidence-based toxicology database of Chinese medicines and the individualized "toxicity-effect" intelligent prediction platform were built based on the disease-syndrome virtual patients, so as to identify the clinical characteristics and risks of "toxic" Chinese medicines and develop individualized medication regime. This study is expected to provide a methodological reference for the establishment of medication regimen and risk prevention strategy for "toxic" Chinese medicines. The method established in this study will bridge clinical research and basic research, enhance the transformation of the scientific connotation of attenuated compatibility, promote the development of evidence-based Chinese medicine toxicology, and ensure the clinical safety of "toxic" Chinese medicines.

Compatibility for toxicity attenuation of toxic traditional Chinese medicine: a review and strategies / 中国中药杂志

Toxicity-attenuating compatibility is an effective measure to ensure the safety of Chinese medicine. Involving the origin, processing method, compatibility mode, and dosage, it faces multiple challenges, such as the uncertainty of toxic substances, toxicity latency, indefinite safe dose, complex toxicity-efficacy relationship, and individual difference. As a result, research on clinical safety of Chinese medicine is limited by the consistency at "molecular-cellular-organ-overall" levels, unclear interaction of multiple medicinals and multiple substances, the "toxicity-efficacy-compatibility-syndrome" correlation, and the "dosage-time-toxicity-efficacy" conversion law. Therefore, following the principle of "starting from the clinical practice, verifying via the theoretical basis, and finally applying in clinical practice", we verified the toxicity at "molecular-cellular-organ-overall" levels, revealed the interaction of multiple medicinals and substances, collected evidence at multiple levels, clarified the "dosage-time-toxicity-efficacy" relationship, and tested the consistency between basic and clinical biomarkers. On this basis, we studied the toxicity-alleviating and efficacy-enhancing(preserving) compatibility characteristics, the fate of one medicinal and multiple medicinals in vivo, the molecular mechanism of toxicity, the "dosage-time-toxicity-efficacy" conversion law, and the clinical characteristics of toxic traditional Chinese medicine based on disease and syndrome. The three mechanisms of toxicity-attenuating compatibility reflect the seven-reaction theory in Chinese medicine compatibility. Finally, the strategies for safe use of Chinese medicine were proposed.

Exploration and reflection on evaluation methodology of human use experience for new Chinese drug development / 中国中药杂志

The "triple combination" review system provides an opportunity for the transformation of human use experience into new Chinese drugs. However, there are some methodological and technical limitations in the assessment of human experience. Hence, the efficacy and safety evaluation methods should be established in accordance with the characteristics of Chinese herbs. This study summarized some evidence-based methodology to promote the transformation of human use experience to new Chinese drugs, mainly including the individualized pragmatic randomized controlled trial(RCT), cluster RCT, single-case RCT, single arm RCT with objective performance criteria, and partially nested RCT. As the real world data can be used to support the transformation of human experience, attention should be paid to convenient and efficient collection of data, prudent selection of design types, and adoption of appropriate ana-lysis methods to deal with confounding bias, including multi-factor regression model and propensity score. The newly proposed mixed research method can also be utilized to assess the human use experience, which is suitable for mining the theory of traditional Chinese medicine(TCM) and expert experience from different aspects. Meanwhile, considering the study design requirements and TCM cha-racteristics, this study put forward the common problems and solutions in the development of new Chinese drugs based on human use experience, including how to select the feasible outcome indicators, how to collect prescription data in the case of herb and dosage adjustment, and how to evaluate the comprehensive effectiveness of TCM from the perspective of "combination of disease and syndrome".

Twenty years in the 21st century: research hotspots and frontier analysis on Chinese medicine processing mechanism / 中国中药杂志

The research on the processing mechanism of Chinese medicine is the key and core foundation to improve processing technologies of Chinese medicine, formulate the quality standards of Chinese medicinal pieces, enhance the clinical efficacy of Chinese medicine, enrich Chinese medicine processing theories, and promote the development of Chinese medicine processing. Many researc-hers have conducted in-depth exploration on the processing mechanism of Chinese medicine in the 20 years in the 21 st century. Significant progress has been made in the transformation of chemical components during the processing, the change of active components in the body, the law of toxicity attenuation in the processing of toxic Chinese medicine, the mechanism of efficacy enhancement and toxicity attenuation of processing with auxiliary materials, and the application of new biomedical technologies. At present, the processing mechanism of multiple Chinese medicines has been preliminarily clarified, which has greatly promoted the development of Chinese me-dicine processing. The development of the processing mechanism of Chinese medicine reveals that the in vitro transformation of chemical components is combined with the in vivo absorption, transport, and metabolism, and the macroscopic biological effects of the organism are combined with the cells, molecules, targets, and pathways in the study of the processing mechanism of Chinese medicine. More attention has been paid to exploring the processing mechanism from the overall level, and a modern systematic research system on the processing mechanism of Chinese medicine has been initially formed. To further promote the scientific development of Chinese me-dicine processing, the present study proposed that the research on the processing mechanism of Chinese medicine should take Chinese medicine properties into account, focus on the influence of disease condition on the mode of action and effect strength of the drugs, comply with the characteristics of clinical compound compatibility of Chinese medicine, use the holistic view research strategies of systems bio-logy, and deeply explore the processing mechanism of Chinese medicine from traditional Chinese medicine theories and the characteristics of clinical medication of Chinese medicine.

Randomized controlled trial outcome indicators of traditional Chinese medicine for gastrointestinal dysfunction in sepsis in recent two years / 中国中药杂志

The purpose of the study is to analyze the outcomes of randomized controlled trial(RCT) of Chinese herbal medicine formula(CHMF) in the treatment of gastrointestinal dysfunction in sepsis in recent two years. We systematically searched four Chinese databases, three English databases, and two clinical trial registries to analyze the reports of outcome indicators of clinical trials, and evaluated the risk of bias by using the ROB tool of Cochrane Collaboration. After screening, 55 clinical RCTs were included. The results showed that the current clinical studies of gastrointestinal dysfunction in sepsis reported the efficacy and safety indicators. The efficacy indicators included APACHE Ⅱ scores, gastrointestinal dysfunction scores, bowel sound scores, and inflammatory indicator such as C-reactive protein and procalcitonin. The safety indicators mainly include gastrointestinal reactions, skin reactions, and other adverse events and adverse reactions. However, there was no distinction between primary and secondary outcomes. The relevant indicators of health economics were not reported, and the quality of research methodology was poor. Therefore, we suggest that future researchers should be well prepared in the top-level design stage and actively construct the core outcome set, so as to improve the quality of clinical trials.

Application and significance of mixed methods research in traditional Chinese medicine and narrative medicine / 中国中药杂志

Since narrative medicine was introduced in China, it has been widely used in medical education and clinical practice. The research on narrative medicine in China is especially characterized by its combination with traditional Chinese medicine(TCM). At present, the research on narrative medicine in China is still in the stage of small-scale practicing and theory advocating. Besides, there is also a lack of guidance on experimental design methodology for clinical application, which leads to few high-quality studies in this field. The present study reviewed the current high-quality research on narrative medicine to discuss the value and prospects of mixed methods research in narrative medicine. In addition, the common design, application procedures, and notes of mixed methods research were explained to provide references for the extensive applications of narrative medicine in the medical field, especially TCM clinical practice, education, and scientific research.

Traditional Chinese medicine network pharmacology: development in new era under guidance of network pharmacology evaluation method guidance / 中国中药杂志

Traditional Chinese medicine(TCM) has unique advantages in the prevention and treatment of diseases owing to its holistic view and more than 2 000 years of experience in the clinical use of natural medicine. The "holistic" characteristic of TCM gives birth to a new generation of research paradigm featuring "network" and "system", which has been developing rapidly in the era of biomedical big data and artificial intelligence. Network pharmacology, a representative research field, provides new ideas and methods for the research of the interdiscipline of artificial intelligence and medicine, the analysis of massive biomedical data, and the transformation from data to knowledge. TCM plays an important role in proposing the core theory of "network target" and promoting the establishment and development of network pharmacology, and has taken the lead in formulating the first international standard of network pharmacology--Network Pharmacology Evaluation Method Guidance. In terms of theory, network target can systematically link drugs and diseases and quantitatively interpret the overall regulatory mechanism of drugs. In the aspect of method, network pharmacology is developing towards a research model that combines computational, experimental, and clinical approaches. This review introduces the resent important progress of TCM network pharmacology in predicting drug targets, understanding the biological basis of drugs and diseases, and searching for disease and syndrome biomarkers. Under the guidance of Network Pharmacology Evaluation Method Guidance, the development of network pharmacology is expected to become more and more standardized and healthy. Network target will help produce more high-quality research outcomes in TCM and effectively boost the modernization and internationalization of TCM.

Acupuncture randomized controlled trials: comparing China-based vs. Western-based studies / 中国针灸

With the worldwide spread of acupuncture as a therapeutic modality and the rapid development of acupuncture clinical research, the number of acupuncture randomized controlled trial (RCT) studies is steadily increasing in China and around the world. However, the results of these studies seem to come from two different worlds indeed. Chinese RCT studies overwhelmingly demonstrate positive outcomes from acupuncture, whereas Western-based studies generally conclude that there is no discernible difference between acupuncture and a placebo. Why should there be such different outcomes when the same scientific method is being used? This paper analyzes factors that may be contributing to the different outcomes between China-based and Western-based RCT studies by considering and comparing starting points, purpose, study design, investigators, acupuncture treatment regimen, methodological quality, results, conclusions, and deficiencies in acupuncture RCT. Based on these comparisons, this paper examines the value of acupuncture RCT in general, and the methodological confusion which seems to have propagated from study to study. We propose the following suggestions to remediate the acupuncture clinical research paradigm: First, acupuncture clinical researches should be carried out step-by-step according to universal, agreed-upon research protocols. Second, norms for reporting outcome metrics need to be standardized for each stage of a study.

Overview of research and development of polypeptide drugs and traditional Chinese medicine-peptides / 中国中药杂志

Peptide is a compound consisting of 2-50 amino acids, which is intermediate between small molecule and protein. It is characterized by a variety of biological activities, easy absorption, strong specific targeting, and few side effects and has become one of the hotspots in biomedical research in recent years. Chinese medicine contains a large number of peptides. The traditional processing methods such as decocting and boiling can effectively boost peptides to exert their due biological activities. At present, however, the research on Chinese medicinal components in laboratory generally employs high-concentration alcohol extraction method, which may cause the peptides to be ignored in many natural Chinese medicines. Substantial studies have revealed that the peptides in Chinese medicine are important material basis responsible for the traditional efficacy. Based on years of research and literature retrieval, this study put forward the concept of "traditional Chinese medicine(TCM)-peptides", referring to the components consisting of two or more amino acids with molecular weight between small molecules and proteins that can express the efficacy of Chinese medicine. Furthermore, this study also summarized the extraction and separation of TCM-peptides, and structure determination methods and routes, predicted the research prospect of modern research methods of TCM-peptides based on "holistic view" and big data. The artificial intelligence prediction was combined with high-throughput screening technology to improve the discovery efficiency and accuracy of TCM-peptides, and holographic images between TCM-peptides and biological targets were established to provide references for the innovative drug design and related health product development of TCM-peptides based on TCM theories.

Concept and method of evidence-based toxicology of traditional Chinese medicine from origin and development of evidence-based toxicology / 中国中药杂志

Advances in science and technology promote the rapid development of toxicological detection technologies. However, there is still a lack of decision-making tools for toxicological risk assessment, such as the lack of transparent schemes to evaluate current toxicological research and practice and the lag of toxicological testing tools to evaluate toxicity, resulting in difficulties in toxicity verification and hindering the transformation of toxicological research paradigm. Some scholars have proposed to integrate the concept of evidence-based medicine with the toxicological practice to improve the technical methods of toxicological research concept and risk assessment decision-making. With the promotion of relevant scholars and academic organizations, the concept and connotation of evidence-based toxicology have gradually become clear and a framework for research and practice has been initially formed. Although there are still many challenges, it also provides a new idea for the toxicity risk assessment and safe medication decision-making of traditional Chinese medicine(TCM). The era of digital intelligence has brought new opportunities and broad space for the development of TCM evidence-based toxicology. The exploration of TCM evidence-based toxicology from concept to method is an important embodiment of the development of TCM evidence-based toxicology, and will also promote the continuous enrichment and improvement of the research and practice system of TCM evidence-based toxicology.

Research strategies and methods for precious animal medicine substitutes / 中国中药杂志

Animal medicine is a large category of Chinese medicinecommonly used in clinical practice and has important scientific and therapeutic value. Animal medicine isscarcer than herbal medicine. In recent years, with the vigorous development of traditional Chinese medicine(TCM),the contradiction between the increasing industrial demand andsupply of scarce and even endangered medicinal animals has become increasingly prominent. The continuous lack of medicinal animal resources affects the clinical demandandalso causes serious damage to the ecological environment. Only relying on artificial breeding is not enough to alleviate the current condition of depletion. In the face of this dilemma, it is a major challenge for the current industrial development to protect animal resources and meet clinical and industrial needs with "available medicines". The application of substitutes for animal medicines isthe key focus to alleviate this problem, and it is also the key scientific issue to be solved urgently in the modernization of TCM. This paper summarizedand reviewedthe history, current situation, strategies, and methods of animal medicinesubstitution and put forward the point of view of "similar chemical characteristics, similar efficacy, and higher safety" to provide references for scientific substitution and resource protection of rare animals.

A comparative study of multiple parallel mediation analysis methods / 中华流行病学杂志

Objective: To introduce and compare four analysis methods of multiple parallel mediation model, including pure regression method, method based on inverse probability weighting, extended natural effect model method and weight-based imputation strategies. Methods: For the multiple parallel mediation model, the simulation experiments of three scenarios were carried out to compare the performance of different methods in estimating direct and indirect effects in different situations. Dataset from UK Biobank was then analyzed by using the four methods. Results: The estimation biases of the regression method and the inverse probability weighting method were relatively small, followed by the extended natural effect model method, and the estimation results of the weight-based imputation strategies were quite different from the other three methods. Conclusions: Different multiple parallel mediation analysis methods have different application situations and their own advantages and disadvantages. The regression method is more suitable for continuous mediator, and the inverse probability weighting method is more suitable for binary mediator. The extended natural effect model method has better performances when the residuals of two parallel mediators are positively correlated and the correlation degree is small. The weight-based imputation strategies might not be appropriate for parallel mediation analysis. Therefore, appropriate methods should be selected according to the specific situation in practice.