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Under the narrative medicine theory to establish the evidence-based medical record written by doctors and patients through integrated therapy of traditional Chinese and western on digestive system diseases 被引量:2
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作者 Bo Li Gui-Hua Tian +4 位作者 Rui Gao Ying-Pan Zhao Qing-Na Li Yang Zhao Hong-Cai Shang 《Traditional Medicine Research》 2017年第2期80-87,共8页
Objective:The aim of this article was to discuss the theory of doctor-patient co-operated evidence-based medical record and set up the preliminary frame of the doctor-patient co-operated evidence-based medical record ... Objective:The aim of this article was to discuss the theory of doctor-patient co-operated evidence-based medical record and set up the preliminary frame of the doctor-patient co-operated evidence-based medical record following the concept of narrative evidence-based medicine.Methods:The information was searched from Pubmed,Embase,CBMdisc,CNKI.A preliminary agreement was reached by referring to the principles of narrative medicine and advises given by experts of digestive system and evidence-based medicine in both Traditional Chinese Medicine and Western Medicine.Result:This research is a useful attempt to discuss the establishment of doctor-patient co-operated evidence-based medical record guided by the direction of narrative evidence-based medicine.Reflection and outlook:Doctor-patient co-operated medical record can be a key factor of the curative effect evaluation methodology system of integrated therapy of Tradition Chinese Medicine and Western Medicine on spleen and stomach diseases. 展开更多
关键词 evidence-based medicine Narrative medicine Therapeutic evaluation evidence-based medical record by doctor and patient
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Medical futility in the era of evidence-based medicine
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作者 Zhengyu Jiang Lu Yang +1 位作者 Pinhao Guo Shanshan Gong 《The Journal of Biomedical Research》 CAS 2014年第4期249-250,共2页
One definition of futility is any treatment that merely preserves permanent unconsciousness or fails to end total dependence of a patient on intensive medical care However, no agreement has ever been reached on what ... One definition of futility is any treatment that merely preserves permanent unconsciousness or fails to end total dependence of a patient on intensive medical care However, no agreement has ever been reached on what the exact defmition of futility is, as it is not only based on temporary values but also evolves into different subtypes, making it harder to define. The difficulty in dealing with futility problem is how doctors evaluate the futile situation, which is further complicated by lack of standards for specific diseases and experience-based prognosis, leading to subjectivity in evaluation for futility. 展开更多
关键词 EBM medical futility in the era of evidence-based medicine
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New evidence-based practice:Artificial intelligence as a barrier breaker
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作者 Ricardo Maia Ferreira 《World Journal of Methodology》 2023年第5期384-389,共6页
The concept of evidence-based practice has persisted over several years and remains a cornerstone in clinical practice,representing the gold standard for optimal patient care.However,despite widespread recognition of ... The concept of evidence-based practice has persisted over several years and remains a cornerstone in clinical practice,representing the gold standard for optimal patient care.However,despite widespread recognition of its significance,practical application faces various challenges and barriers,including a lack of skills in interpreting studies,limited resources,time constraints,linguistic competencies,and more.Recently,we have witnessed the emergence of a groundbreaking technological revolution known as artificial intelligence.Although artificial intelligence has become increasingly integrated into our daily lives,some reluctance persists among certain segments of the public.This article explores the potential of artificial intelligence as a solution to some of the main barriers encountered in the application of evidence-based practice.It highlights how artificial intelligence can assist in staying updated with the latest evidence,enhancing clinical decision-making,addressing patient misinformation,and mitigating time constraints in clinical practice.The integration of artificial intelligence into evidence-based practice has the potential to revolutionize healthcare,leading to more precise diagnoses,personalized treatment plans,and improved doctor-patient interactions.This proposed synergy between evidencebased practice and artificial intelligence may necessitate adjustments to its core concept,heralding a new era in healthcare. 展开更多
关键词 evidence CLINICIANS PATIENTS Artificial intelligence evidence-based practice
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基于英语原意的“Evidence-Based Medicine”译名:“循证医学”与“证据医学”
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作者 黄莚庭 《中国临床营养杂志》 2002年第3期151-151,共1页
关键词 evidence-based medicing” “循证医学” “证据医学”
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Evidence-Based Medicine Research on Prescriptions in Synopsis of the Golden Chamber in the Treatment of Pelvic Inflammatory Disease 被引量:2
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作者 Mengkui Li Junsheng Song +1 位作者 Rong Shang Xishun Pan 《Open Journal of Obstetrics and Gynecology》 2017年第1期61-70,共10页
Purpose: Based on the National Natural Science Foundation of China, we collect and sort out the literature published in approximately the last 30 years, which use prescriptions in Synopsis of the Golden Chamber to tre... Purpose: Based on the National Natural Science Foundation of China, we collect and sort out the literature published in approximately the last 30 years, which use prescriptions in Synopsis of the Golden Chamber to treat pelvic inflammatory disease (PID). This study provides theoretical basis for the treatment of PID;we recommend this achievement to colleagues. Method: Firstly, we searched and collected the literatures from last three decades in CNKI, Wanfang and VIP databases, which are about classical prescriptions treating endometriosis. Then, by screening all the literatures, we obtained the clinical research literatures and individual case reports. Finally, we went through the internal quality of the two categories of literatures to get the dominant prescriptions. Using a retrospective study of evidence-based medicine research, we comprehensively collect literature, standardize the disease spectrum, classify the evidence, and then evaluate the internal quality. Results: We refine 4 prescriptions which commonly are used in the treatment of PID;in other words, they are also the clinical symptoms of PID: Gui Zhi Fu Ling Wan symptom, which manifests blood stasis and cold-damp stagnancy;Dang Gui Shao Yao San symptom, which manifests disharmony of liver and spleen, qi-blood stasis and damp obstruction;Da Huang Mu Dan Tang symptom, which manifests the gathering toxic heat and qi-blood stasis;Yi Yi Fu Zi Bai Jiang San symptom, which manifests the internal toxic heat and qi-blood injury. Conclusion: This study is gospel for the patients with recurrent episodes of PID who can’t often use antibiotics. At the same time, it is also a green therapeutics which Chinese ancients dedicated to human medicine. 展开更多
关键词 Traditional Chinese medicINE evidence-based medicINE Quality of evidence PRESCRIPTIONS in SYNOPSIS of Golden Chamber The TREATMENT of PELVIC Inflammatory Disease
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The Practice and Exploration of Applying EBM to Bilingual Teaching of Medical Genetics at OSBCM
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作者 Rong Liu Huaming Zuo 《Open Journal of Applied Sciences》 2024年第4期983-990,共8页
In the process of teaching medical genetics of undergraduate clinical medicine, the practice and exploration of applying EBM to the bilingual teaching of OSBCM medical genetics are carried out. Using CBL and PBL as th... In the process of teaching medical genetics of undergraduate clinical medicine, the practice and exploration of applying EBM to the bilingual teaching of OSBCM medical genetics are carried out. Using CBL and PBL as the carrier can make up for the shortcomings of a single teaching mode, synthesize the advantages of multiple teaching modes. It starts from integrating the basic theoretical knowledge of medicine and clinical practice knowledge, improving students’ bilingual level of medical genetics, cultivating students’ literature retrieval ability, and promoting early clinical, multi-clinical and repeated clinical consciousness for medical students. Therefore, it is more conducive to cultivate students’ ability to learn independently, accurately analyze and solve problems, improve medical students’ clinical thinking ability and scientific research awareness, improve medical students’ ability of international communication, and lay a solid foundation for improving medical students’ future post competence, innovative spirit and lifelong learning ability. 展开更多
关键词 medical Genetics evidence Based medicine Organ-System-Based Curriculum Model Problem Based Learning Case-Based Learning
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Application of Real-World Evidence in Regulatory Decision-Making for Medical Devices 被引量:1
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作者 Huang Xianqin Chen Chuhan Dong Li 《Asian Journal of Social Pharmacy》 2021年第3期230-237,共8页
Objective To understand the real-world study(RWS)and its application in domestic and foreign pharmaceutical device regulatory decision-making,so as to promote its further application in the decision-making of medical ... Objective To understand the real-world study(RWS)and its application in domestic and foreign pharmaceutical device regulatory decision-making,so as to promote its further application in the decision-making of medical devices supervision in China.Methods Literature analysis and comparative analysis were used to compare the real-world evidence(RWE)and randomized controlled trials to obtain the development status of medical devices in China and the United States.Results and Conclusion It is found that the application of RWS in the field of medical devices has many advantages,which can make up for the deficiencies of traditional clinical data.In addition,the RWE has a wide range of applications in the field of medical devices in China.In recent years,the RWE has received extensive attention in the medical field in the United States.The FDA has issued related guidelines,and its applications have gradually formed a complete system.Research on RWE will become the development trend of clinical evaluation of medical devices in the future.While attaching importance to the development of the RWE,China should learn from the specifications of relevant foreign organizations to improve its development in the field of health. 展开更多
关键词 real-world evidence randomized controlled trial medical device supervision
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Investigation on the Clinical Readiness of Nurses’Evidence-Based Practice in a 3A-Level General Hospital in Beijing
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作者 Luo YANG Hong GUO +6 位作者 Yan-Ling SHEN Li LI You-Hua LIU Dan ZHAO Hai-Yan WANG Shao-Hua GONG Xiao-Ping YI 《Journal of Integrative Nursing》 2019年第1期1-8,共8页
Objective:To understand the evidence-based practice readiness of developing evidence application projects in a 3A-level general hospital in Beijing,to identify barriers to evidence-based practice and to promote the su... Objective:To understand the evidence-based practice readiness of developing evidence application projects in a 3A-level general hospital in Beijing,to identify barriers to evidence-based practice and to promote the successful application of evidence.Methods:All the clinical nurses who were going to participate in the application units of the evidence-based practice project were selected as the survey objects,and the self-made“Basic Information Questionnaire”and“Clinical Readiness to Evidence-based Nursing Assessment(CREBNA)”were used to conduct the survey.The total amounts and subscales were calculated.The factors that influence the score of the total scale were scored and analyzed.Results:The CREBNA total score was(119.87±19.18),the evidence subscale score was(47.94±8.54),the organizational environmental subscale score was(36.09±6.11),and the facilitator subscale score was(35.83±7.56).Univariate analysis showed that the total score of the scale was related to years of work,scientific research experience,knowledge of evidence-based care,and participation in evidence-based practice.Conclusion:The current evidence-based practice preparation situation is good.It is feasible to carry out evidence-based practice activities in the hospital.The follow-up development plan should be made based on the corresponding obstacle factors. 展开更多
关键词 Readiness for evidenced-based practice evidence-based nursing evidence application
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The Enlightenment of EU Real-World Evidence Supporting the Inclusion of Rare Disease Drugs in Medical Insurance Decisions to China
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作者 Yu Zhongyi Xu Fengxiang 《Asian Journal of Social Pharmacy》 2021年第3期209-213,共5页
Objective To study the use of real-world evidence by EU and its member states for establishing a strategy for rare diseases and provide references for the inclusion of orphan drugs in China’s medical insurance.Method... Objective To study the use of real-world evidence by EU and its member states for establishing a strategy for rare diseases and provide references for the inclusion of orphan drugs in China’s medical insurance.Methods A case analysis method was used to introduce the EU’s decision to include rare disease drugs in medical insurance by using real-world evidence because clinical data of rare diseases were difficult to obtain.Results and Conclusion China can use real-world evidence to make medical insurance decisions based on the experience of the EU and continue to invest more in rare diseases,which can solve the problem of few drugs for patients with rare disease. 展开更多
关键词 EU real-world evidence rare disease medical insurance
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Summary of the Best Evidence for the Evaluation and Management of Chemotherapy-Related Nausea and Vomiting in Cancer Patients
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作者 Panpan Zheng Yongsheng Ou +3 位作者 Jinyan Jiang Hongting Liu Xinxia Mo Jinling Li 《Yangtze Medicine》 2023年第1期27-42,共16页
Objective: To summarize the best evidence for the evaluation and management of chemotherapy-related nausea and vomiting in cancer patients, so as to promote the standardized management of chemotherapy-related nausea a... Objective: To summarize the best evidence for the evaluation and management of chemotherapy-related nausea and vomiting in cancer patients, so as to promote the standardized management of chemotherapy-related nausea and vomiting in cancer patients. Methods: A computer search was conducted for all evidence on chemotherapy-associated nausea and vomiting interventions, including guidelines, expert consensus, best clinical practice information booklet, recommended practice, evidence summary, and systematic review. The search period is from April 30, 2022. After the literature quality evaluation, the evidence extraction and summary of the literature meeting the quality standards. Results: A total of 16 literatures were included, including 9 guidelines, 5 systematic reviews and 2 expert consensus papers. 46 pieces of best evidence on the assessment and management of chemotherapy related nausea and vomiting in cancer patients were summarized, including 6 aspects including risk assessment and management, non-drug management, drug management, multidisciplinary cooperation, education and training, and health education. Conclusion: This study summarized the current best evidence on the assessment and management of chemotherapy-related nausea and vomiting in cancer patients. Clinical staff should apply evidence according to specific clinical scenarios, professional skills and patients’ wishes in order to reduce the degree and incidence of chemotherapy-related nausea and vomiting in cancer patients and improve the quality of care. 展开更多
关键词 Cancer Patients CHEMOTHERAPY NAUSEA VOMIT evidence-based Nursing Summary of evidence
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Evidence-based practices in sustainable travel behavior intervention: A knowledge graph-based systematic review
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作者 Jian Li Chenjie Xu 《Journal of Traffic and Transportation Engineering(English Edition)》 EI CSCD 2024年第2期293-311,共19页
Sustainable travel behavior intervention is an essential strategy to promote the development of urban transportation.The interventions offer personalized strategies based on certain scenario and participants to promot... Sustainable travel behavior intervention is an essential strategy to promote the development of urban transportation.The interventions offer personalized strategies based on certain scenario and participants to promote its effectiveness over hard travel restrictions.However,personalized strategies may also bring about difficulties to identify the actual effect of the measures.Furthermore,based on current practice,to make full use of travel behavior interventions,it is necessary to construct a unified methodological evidencebased framework to assess the reliability and effectiveness of travel behavior intervention studies.In response to these issues,we applied evidence-based knowledge graph to the field of sustainable travel behavior interventions to help decision supporters design sustainable travel behavior interventions wisely and in turn avoid excessive use of hard travel restrictions.We introduced concept of evidence-based practice to conduct a systematic analysis concerning reliability and validity of current full volume empirical studies by dimensions of scenarios,types of interventions and targets.In addition,we took advantage of high extensivity and integrability of knowledge graph to organize evidence-based related elements.Result of the systematic analysis shows that in terms of reliability of evidence,school intervention is the best scenario,knowledge incentive is the best intervention type and promoting public transit and walking proportion are the best targets.Oppositely,the reliability of interventions in workplace,belonging to reward and threat along with aiming at changing travel patterns generally and lowering travel carbon emission need to be enhanced.From the study,various research prospects are raised to promote evidence quality in the field of travel behavior intervention implementation.As a pioneer study,our research contributes to the field of urban transportation in introducing concepts of evidence-based practice and enabling optimization and extension of our achievement via the usage of knowledge graph,enhancing reliability and objectivity in urban transportation decision-making. 展开更多
关键词 evidence-based decision-making evidence assessment Knowledge graph Travel behavior intervention Sustainable travel
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Current Situation and Prospect of the Application of Real-World Evidence in Health Care
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作者 Xiao Feiyi Zhang Fang +1 位作者 Li Xue Dong Li 《Asian Journal of Social Pharmacy》 2023年第4期374-386,共13页
Objective To summarize the application of real-world evidence(RWE)in the medical and healthcare field of various countries,including relevant policies,application scenarios and application methods.Methods Relevant pol... Objective To summarize the application of real-world evidence(RWE)in the medical and healthcare field of various countries,including relevant policies,application scenarios and application methods.Methods Relevant policies and application scenarios were obtained by consulting the official websites and public documents of various countries’healthcare institutions.Systematic literature retrieval was adopted to search PubMed,EMBASE,Cochrane Library,CNKI,CBM and Wanfang databases,and all papers related to real-world study and application were included.Then,these papers were classified and analyzed by country and application method.Results and Conclusion The RWE was mainly applied to supporting the preliminary approval of a new drug,expanding drug indications,accelerating approval or supporting conditional marketing authorizations and drug safety evaluation,etc.The United Kingdom,the United States,Germany,the Netherlands,Italy,Sweden,and France admitted RWE,but they treated the data obtained from RWE with caution.After systematic literature retrieval,a total of 701 articles were obtained,including relevant studies from 36 countries,among which the United States published 264 in total.The most common study was about using real-world data(RWD)to calculate treatment-related costs,which had a total of 259 studies.Secondly,158 articles were used for epidemiological analysis.Then,138 articles were about establishing risk models to analyze disease risk factors.A total of 70 articles were real-world efficacy evaluation of the drug treatment schemes,54 articles were about pharmacoeconomic evaluation with RWD as parameters.A total of 29 articles used RWD to build predictive models,and 15 articles used RWD to evaluate the health-related quality of life in patients.The application of RWE has been used widely in the medical and healthcare field of various countries.The application scenarios are gradually diversified,the application methods of RWD become mature,and the evidence quality of RWE is also improved greatly. 展开更多
关键词 real-world data real-world evidence real-world study medical and health care
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Joint Development of Evidence-Based Medical Record by Doctors and Patients through Integrated Chinese and Western Medicine on Digestive System Diseases 被引量:29
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作者 李博 高洪阳 +5 位作者 高蕊 赵迎盼 李庆娜 赵阳 唐旭东 商洪才 《Chinese Journal of Integrative Medicine》 SCIE CAS CSCD 2016年第2期83-87,共5页
Building the clinical therapeutic evaluation system by combing the evaluation given by doctors and patients can form a more comprehensive and objective evaluation system.A literature search on the practice of evidence... Building the clinical therapeutic evaluation system by combing the evaluation given by doctors and patients can form a more comprehensive and objective evaluation system.A literature search on the practice of evidence-based evaluation was conducted in key biomedical databases,i.e.PubMed,Excerpt Medica Database,China Biology Medicine disc and China National Knowledge Infrastructure.However,no relevant study on the subjects of interest was identified.Therefore,drawing on the principles of narrative medicine and expert opinion from systems of Chinese medicine and Western medicine,we propose to develop and pilot-test a novel evidence-based medical record format that captures the perspectives of both patients and doctors in a clinical trial.Further,we seek to evaluate a strategic therapeutic approach that integrates the wisdom of Chinese medicine with the scientific basis of Western medicine in the treatment of digestive system disorders.Evaluation of therapeutic efficacy of remedies under the system of Chinese medicine is an imperative ongoing research.The present study intends to identify a novel approach to assess the synergistic benefits achievable from an integrated therapeutic approach combining Chinese and Western system of medicine to treat digestive system disorders. 展开更多
关键词 evidence-based medicine narrative medicine integrative medicine therapeutic evaluation evidencebased medical record
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Semantic Representation of Evidence-Based Medical Guidelines and Its Use Cases
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作者 HU Qing HUANG Zhisheng GU Jinguang 《Wuhan University Journal of Natural Sciences》 CAS CSCD 2015年第5期397-404,共8页
Semantic representation of evidence-based medical guidelines provides the support for the data inter-operability and has been found many applications in the medical domain. In this paper, we describe a semantic repres... Semantic representation of evidence-based medical guidelines provides the support for the data inter-operability and has been found many applications in the medical domain. In this paper, we describe a semantic representation approach of evidence-based medical guidelines, which is based on the Semantic Web Technology standards. We discuss several use cases of that semantic representation of evidence-based medical guideline, and show that they are potentially useful for medical applications. 展开更多
关键词 evidence-based medical guidelines semantic repre- sentation semantic technology use cases
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Clinical surgery-oriented subject librarian services in medical colleges and schools
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作者 Qiang He 《Frontiers of Nursing》 CAS 2018年第4期257-263,共7页
Regarding subject librarian services for clinical studies, researchers outside China have been focusing on subject service performance,evidence-based medicine, and comprehensive consulting services. In contrast, Chine... Regarding subject librarian services for clinical studies, researchers outside China have been focusing on subject service performance,evidence-based medicine, and comprehensive consulting services. In contrast, Chinese researchers have concentrated on service systems and methods but have not established mature systems and methods for clinical surgery-oriented services. Therefore,subject librarians in medical schools should become involved in clinical research and expand their perspective on medical library research. In addition, they should collaborate with clinicians to improve the overall level of research in hospitals while increasing the impact of subject librarian services in medical colleges and schools. 展开更多
关键词 subject librarian SURGERY medical schools evidence-based medicine BIBLIOMETRICS REVIEW
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中国医院临床科主任、护士长胜任力研究现状的循证分析
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作者 李庆瑜 康婉星 +2 位作者 张惠琴 陈隆福 张建荣 《现代医院》 2024年第7期1091-1095,共5页
目的循证分析我国临床科主任和护士长胜任力研究进展与管理现状,为促进临床科主任、护士长管理研究进一步发展和完善我国医院人力资源管理提供可靠参考。方法利用VIP、CNKI、WANFANG中文数据库、网络资源及相关官方网站检索我国临床科... 目的循证分析我国临床科主任和护士长胜任力研究进展与管理现状,为促进临床科主任、护士长管理研究进一步发展和完善我国医院人力资源管理提供可靠参考。方法利用VIP、CNKI、WANFANG中文数据库、网络资源及相关官方网站检索我国临床科主任和护士长胜任力相关文献,并运用文献计量学方法、循证科学的原理和方法,对检索文献进行描述性分析。结果共纳入文献82篇,主要涉及临床科主任、护士长相关概念理论的阐述、胜任力模型的构建、应用研究等内容;我国科主任、护士长胜任力的研究起步较晚且呈先增长后下降的趋势,期刊分布较分散;文献主要来源于各级高校院所和医疗机构;发展停滞于实证研究阶段,未发展向评价研究阶段。结论我国临床科主任和护士长胜任力研究处于应用实践阶段,缺乏系统化研究,主要以高等院所、医疗机构为主导,国家、政府在医院临床科主任、护士长胜任力方面的的关注有待加强。 展开更多
关键词 科主任 护士长 胜任力 循证分析 医疗机构
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老年人药物相关性跌倒预防与管理的证据总结
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作者 韩辉武 雷雨洁 +1 位作者 卓红霞 岳丽青 《中国护理管理》 CSCD 北大核心 2024年第3期336-341,共6页
目的 :检索并总结老年人药物相关性跌倒预防与管理的相关证据,为降低老年人药物相关性跌倒发生率提供循证依据。方法 :按照证据资源“6S”模型自上而下依次系统检索国内外相关数据库和网站中关于老年人药物相关性跌倒预防与管理的临床... 目的 :检索并总结老年人药物相关性跌倒预防与管理的相关证据,为降低老年人药物相关性跌倒发生率提供循证依据。方法 :按照证据资源“6S”模型自上而下依次系统检索国内外相关数据库和网站中关于老年人药物相关性跌倒预防与管理的临床决策、指南、专家共识、证据总结和系统评价,检索时限为从建库至2023年12月1日,对纳入文献进行质量评价和资料提取,根据证据汇总原则提取并整合证据。结果 :共纳入16篇文献,包括1篇临床决策、3篇指南、5篇专家共识、2篇证据总结和5篇系统评价。从跌倒风险评估、跌倒相关用药评估、预防策略、使用管理和健康教育5个方面形成了21条证据。结论 :本研究总结的老年人药物相关性跌倒预防与管理的证据内容可协助医护人员结合患者实际情况制定个性化干预方案,降低老年人药物相关性跌倒发生率。 展开更多
关键词 老年人 增加跌倒风险的药物 药物相关性跌倒 用药安全 证据总结
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某院托法替布超说明书适应证用药循证医学评价
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作者 孙超 《实用药物与临床》 CAS 2024年第9期682-688,共7页
目的了解某院门诊托法替布超说明书适应证用药情况,为该药的合理使用提供参考。方法调取某院2022年6月1日-2023年12月31日开具枸橼酸托法替布片的门诊患者的所有处方,对患者基本情况、诊断等进行统计分析,将诊断与最新版药品说明书进行... 目的了解某院门诊托法替布超说明书适应证用药情况,为该药的合理使用提供参考。方法调取某院2022年6月1日-2023年12月31日开具枸橼酸托法替布片的门诊患者的所有处方,对患者基本情况、诊断等进行统计分析,将诊断与最新版药品说明书进行比对,将所有超说明书适应证用药诊断与美国食品药品监督管理局(FDA)批准的适应证、Micromedex数据库、国内外指南与专家共识、《马丁代尔大药典》等进行比对,同时在PubMed、Cochrane数据库、中国知网(CNKI)等收集循证医学证据,参照Micromedex数据库的Thomson分级系统,对超说明书适应证用药进行循证医学等级评价并提出分级管理建议。结果共收集到使用托法替布的门诊处方1024张,其中符合说明书适应证用药的有946例(92.38%),超说明书适应证用药78例(7.62%)。超说明书适应证用药临床诊断有14种,系统性红斑狼疮、斑秃(普秃)和干燥综合征居前3位。超说明书适应证用药有1种已被FDA批准,1种循证医学证据存在冲突,9种存在不同级别的循证医学证据支持,其余3种(干燥综合征、结缔组织病、慢性肾炎)未能查询到循证医学证据。最终参考Thomson分级标准判定溃疡性结肠炎证据等级为Category A,有效性及推荐等级为Class IIb或以上,建议同意使用;斑秃(普秃)等4种适应证证据等级为Category B,有效性及推荐等级为Class IIb或以上,建议限制使用;皮肌炎等5种适应证证据等级为Category C,有效性及推荐等级为Class IIb或以上,建议特殊使用;系统性红斑狼疮等4种适应证循证医学证据冲突或不足,建议禁止使用。结论该院托法替布超说明书适应证用药现象普遍,虽多数有循证医学证据支持,但仍需进一步规范,从而促进临床合理用药。 展开更多
关键词 托法替布 循证医学 超说明书 合理用药
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医疗机构基于“三结合”中药新药研发及管理体系的构建
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作者 路遥 申琳 +3 位作者 鲁雨荍 刘殿娜 王乐 陈旭 《中国药事》 CAS 2024年第2期147-151,共5页
目的:在中药审评审批制度改革的政策背景下,围绕医疗机构,探索中医药理论、人用经验和临床试验相结合(简称“三结合”)的审评证据体系落地举措,为医疗机构中药制剂及中药新药研发提供参考。方法:根据“三结合”审评证据体系下中药新药... 目的:在中药审评审批制度改革的政策背景下,围绕医疗机构,探索中医药理论、人用经验和临床试验相结合(简称“三结合”)的审评证据体系落地举措,为医疗机构中药制剂及中药新药研发提供参考。方法:根据“三结合”审评证据体系下中药新药研发的相关要求,从机构层面加强人用经验研究相关配套建设,从管理层面搭建中药研发、成果转化服务平台,从临床层面规范开展人用经验研究,构建医疗机构中药新药研发及管理体系。结果:医疗机构中药新药研发及管理体系的构建,有助于将临床诊疗数据转变为支持中药新药注册的人用经验证据,通过提高中药研发水平促进中药新药转化。结论:在医疗机构构建基于“三结合”的中药新药研发及管理体系,是“三结合”审评证据体系落地、政策引导研发实践的路径之一。 展开更多
关键词 “三结合”审评证据体系 人用经验 医疗机构 中药新药研发 中药新药转化 医疗机构中药制剂
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Standardizing Individualized Efficacy Evaluation to Optimize Evidence-Using Pattern in Traditional Chinese Medicine-Preliminarily Establishing Traditional Chinese Medicine Evidence-based Case Reporting System 被引量:6
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作者 Chen Zhao Zhi Liu +3 位作者 Jia Lin Yan-Ping Wang Yong-Yan Wang Hong-Cai Shang 《World Journal of Traditional Chinese Medicine》 2016年第4期49-54,共6页
Individualized treatment is a basic feature of Traditional Chinese Medicine(TCM), and individualized efficacy evaluation is also emphasized in TCM clinical practice. Individualized evaluation is in favor of improving ... Individualized treatment is a basic feature of Traditional Chinese Medicine(TCM), and individualized efficacy evaluation is also emphasized in TCM clinical practice. Individualized evaluation is in favor of improving intervention continuously, and optimizing the TCM evidenceusing pattern gradually. Traditional case reports can better demonstrate the efficacy of individual, but lack of standardized design, making such evidence show a lower quality. Meanings, objectives and design elements of TCM individualized evaluation were discussed in this paper.Then based on the original work, design ideas and framework of TCM evidence-based case reporting system were established preliminarily.This work will improve the methodology of TCM individualized evaluation to realize the goal of optimizing TCM clinical evidence-using pattern. 展开更多
关键词 Individualized evaluation Transformation and using of evidence TCM evidence-based case report system STANDARDIZATION
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