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Obstacles in employing evidence-based practice by nurses in their clinical settings: a descriptive study
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作者 Manal Hamed Mahmoud Zizi Fikry Mohamed Abdelrasol 《Frontiers of Nursing》 CAS 2019年第2期123-133,共11页
Objective: The challenge of employing evidence-based practice (EBP) is multifarious and varied. Nursing interventions supported by research evidence have been exposed to progress positive patient outcomes, while its i... Objective: The challenge of employing evidence-based practice (EBP) is multifarious and varied. Nursing interventions supported by research evidence have been exposed to progress positive patient outcomes, while its implementation is faced with various obstacles. This study aimed to identify obstacles in employing EBP by nurses in their clinical settings. Methods: This descriptive design study was conducted at Benha University Hospital with a convenient sample of 154 nurses. Two tools were utilized: (Ⅰ) sociodemographic data sheet, which included sociodemographic characteristics of the participants, and (Ⅱ) interview scale, which contained two parts: (1) obstacles scale, which contained obstacles that impede nurses from the utilization of EBP, and (2) questions to rank the three greatest obstacles in employing EBP by nurses. Results: The greatest EBP obstacle ranked by nurses was the organizational limitations (90.9%), followed by research quality (86.9%) and research accessibility (51.0%), while individual characteristics (35.9%) were ranked as the least obstacle. There was a significant statistical correlation between organizational limitations, research quality as well accessibility-related obstacles and nurses' age, level of education, as well their years of work experience (P<0.05). Conclusions: Findings of this study showed series of obstacles in employing EBP by nurses in their clinical settings, stressing the call for expansion of nurses' capabilities related to EBP utilization in patients' care. 展开更多
关键词 evidence-based PRACTICE clinical SETTINGS obstacles
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An Exploration of Perceived Barriers to Evidence-Based Practice among Physiotherapy Students during Clinical Placement—A Descriptive Cross-Sectional Study
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作者 Sonja Hlebš 《Open Journal of Therapy and Rehabilitation》 2022年第4期198-210,共13页
Introduction: Teaching evidence-based practice (EBP) has become part of the standard curriculum for health care students and professionals. Teaching EBP skills should be emphasized in entry level physiotherapy educati... Introduction: Teaching evidence-based practice (EBP) has become part of the standard curriculum for health care students and professionals. Teaching EBP skills should be emphasized in entry level physiotherapy education as physiotherapists are expected to practice in an evidence-based way. Identifying barriers to the application of EBP in clinical placement plays an important role in developing physiotherapy programs. The present study aimed to explore physiotherapy students’ perceived barriers toward the use of EBP during their clinical placements. Methods: A cross-sectional study was conducted among third-year physiotherapy students at the Faculty of Health Sciences University of Ljubljana, Slovenia. Participants were asked to complete a self-reported questionnaire that was developed by the researcher based on previously developed surveys. The analyses applied included descriptive statistics and calculation of frequencies, percentages, means and standard deviations of the participating students’ scores. Results: Fifty final-year undergraduate students with a mean age of 23.7 (±4.3, range 23 - 27) years participated in the study. Majority of participants reported lack of formal training, poor ability to critically appraise research evidence, insufficient time, their clinical supervisors, or other therapists not using EBP when treating patients as barriers towards practicing EBP. Conclusions: Physiotherapy students face many challenges in terms of training, organizational, and personal barriers toward the use of EBP during clinical placement. Lack of formal training, lack of research skills, insufficient time and their clinical supervisors or other therapists not using EBP when treating patients, emerged as top barriers. This fact underlines the importance of teaching students EBP skills, which would enable them to use EBP when working with patients. 展开更多
关键词 evidence-based Practice PHYSIOTHERAPY STUDENTS Education clinical Place-ment
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Application of evidence-based medicine methods in integrative oncology research
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作者 Jianping Liu Sijia Zhu Nicola Robinson 《Journal of Traditional Chinese Medical Sciences》 CAS 2023年第2期129-132,共4页
To present the advances of evidence-based medicine and clinical research methodology in integrative oncology,we conducted a literature review of real-world studies of traditional Chinese medicine(TCM)in cancer care an... To present the advances of evidence-based medicine and clinical research methodology in integrative oncology,we conducted a literature review of real-world studies of traditional Chinese medicine(TCM)in cancer care and summarized the available evidence.Pragmatic randomized controlled trials(pRCTs)and clinical registry studies are becoming more popular as they could compensate for the limitations of RCTs.Many RCTs of TCM for cancer treatment as well as systematic reviews have been published.The most investigated therapies are based on acupuncture,Chinese herbal compounds,and Chinese patent medicines.Acupuncture has a significant advantage in relieving cancer-related symptoms.Published studies focus more on improving clinical symptoms and laboratory indicators.However,the patient's quality of life deserves more attention. 展开更多
关键词 evidence-based medicine Integrative oncology Traditional Chinese medicine Research design Pragmatic clinical trial REGISTRIES
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The artificial intelligence evidence-based medicine pyramid
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作者 Valentina Bellini Federico Coccolini +1 位作者 Francesco Forfori Elena Bignami 《World Journal of Critical Care Medicine》 2023年第2期89-91,共3页
Several studies exist in the literature regarding the exploitation of artificial intelligence in intensive care.However,an important gap between clinical research and daily clinical practice still exists that can only... Several studies exist in the literature regarding the exploitation of artificial intelligence in intensive care.However,an important gap between clinical research and daily clinical practice still exists that can only be bridged by robust validation studies carried out by multidisciplinary teams. 展开更多
关键词 Artificial intelligence Intensive care Intensive care unit evidence-based medicine clinical research
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The concept of narrative evidence-based medicine and shared decision-making in traditional Chinese medical practice 被引量:3
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作者 Wei Mu Hong-Cai Shang +6 位作者 Xu-Fang Gu Li Zhang Yan-Fen Li Jie Li Rui-Hua Wang Yu-Hong Huang Bao-He Wang 《TMR Integrative Medicine》 2018年第3期99-104,共6页
For the explosive development of emerging diagnostic and therapeutic technologies brought by the advancement of precision medicine strategy, shared decision-making could improve the quality of clinical decision-making... For the explosive development of emerging diagnostic and therapeutic technologies brought by the advancement of precision medicine strategy, shared decision-making could improve the quality of clinical decision-making and promote the transformation of clinical research evidence in TCM. Paying attention to patients' narrative needs and strengthening medical humanistic concerns could improve clinical outcome and patient satisfaction. We described the origins and development of evidence-based medicine, narrative medicine and shared decision-making, and analyzed the existing problems in TCM clinical decision-making. Further, we put forward the model of shared decision-making between clinicians and patients under the guidance of narrative evidence-based medicine concepts and methods. 展开更多
关键词 Narrative evidence-based medicine clinical practice of TCM shared decision-making Decision aids
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Clinical audit,a valuable tool to improve quality of care:General methodology and applications in nephrology 被引量:1
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作者 Pasquale Esposito Antonio Dal Canton 《World Journal of Nephrology》 2014年第4期249-255,共7页
Evaluation and improvement of quality of care provided to the patients are of crucial importance in the daily clinical practice and in the health policy planning and fnancing. Different tools have been developed, incl... Evaluation and improvement of quality of care provided to the patients are of crucial importance in the daily clinical practice and in the health policy planning and fnancing. Different tools have been developed, includ-ing incident analysis, health technology assessment and clinical audit. The clinical audit consist of mea-suring a clinical outcome or a process, against well-defined standards set on the principles of evidence-based medicine in order to identify the changes needed to improve the quality of care. In particular, patients suffering from chronic renal diseases, present many problems that have been set as topics for clinical audit projects, such as hypertension, anaemia and mineral metabolism management. Although the results of these studies have been encouraging, demonstrating the ef-fectiveness of audit, overall the present evidence is not clearly in favour of clinical audit. These findings call attention to the need to further studies to validate this methodology in different operating scenarios. This review examines the principle of clinical audit, focusing on experiences performed in nephrology settings. 展开更多
关键词 clinical audit evidence-based medicine Quality improvement NEPHROLOGY HEMODIALYSIS
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Current State of Clinical Studies on Diagnosis and Treatment of Sudden Deafness in China
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作者 YU Yaping, YANG Shiming, GUO Wei, YANG Weiyan, GU RuiDepartment of Otolaryngology, Head and Neck Surgery, Institute of Otolaryngology, Chinese PLAGeneral Hospital, Beijing 100853, China. 《Journal of Otology》 2006年第1期22-24,共3页
Objective To evaluate the current status of clinical studies on diagnosis and treatment of sudden deafness (SD) in China by retrospective reviewing articles on SD published in Chinese journals in the past 5 years. Spe... Objective To evaluate the current status of clinical studies on diagnosis and treatment of sudden deafness (SD) in China by retrospective reviewing articles on SD published in Chinese journals in the past 5 years. Special attention is given to whether the diagnosis and treatment standards established in 1996 by the otolaryngology branch of Chinese Medical Association (the'1996 standard') were followed. Methods The terms of 'Sudden deafness' and 'treatment' were used as the keywords in searching articles published between 2000 and 2004 in the Chinese biomedicine literature database and Chinese journal network. Principles of evidence-based medicine were applied in reviewing the articles. Results Two hundreds and thirty- four articles were identified, including 176 between 2000 and 2002 and 58 between 2003 and 2004. Among the 176 articles published between 2000 and 2002, effects of medications were studies in 126 articles, of which only 26 (20.6%) followed the'1996 standards'. Eighty-nine (70.6%) were reported based on controlled clinical trials (CCT) and 36 (28.5%) met the criteria of randomized controlled trails (RCT). Of the 58 articles published between 2003 and 2004, drug effects were evaluated in 25 articles, which were all based on the '1996 standards'. However, there lacked placebo control, follow-up data or statistical analysis in these papers. Only 6 articles reported side-effects from pharmacological treatment. Conclusions While a significant number of articles on SD were published in the past 5 years, the '1996 standards' were followed only in a small number of them. The standards may not be appropriate in guiding research and need to be modified for improved guidance to SD management. Multi-center, RCTs should be a crucial part in studies on SD. 展开更多
关键词 sudden deafness THERAPY evidence-based medicine randomized controlled trails
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Reality of evidence-based practice in palliative care
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作者 Claire Visser Gina Hadley Bee Wee 《Cancer Biology & Medicine》 SCIE CAS CSCD 2015年第3期193-200,共8页
There has been a paradigm shift in medicine away from tradition, anecdote and theoretical reasoning from the basic sciences towards evidence-based medicine(EBM). In palliative care however, statistically significant b... There has been a paradigm shift in medicine away from tradition, anecdote and theoretical reasoning from the basic sciences towards evidence-based medicine(EBM). In palliative care however, statistically significant benefits may be marginal and may not be related to clinical meaningfulness. The typical treatment vs. placebo comparison necessitated by ‘gold standard' randomised controlled trials(RCTs) is not necessarily applicable. The complex multimorbidity of end of life care involves considerations of the patient's physical, psychological, social and spiritual needs. In addition, the field of palliative care covers a heterogeneous group of chronic and incurable diseases no longer limited to cancer. Adequate sample sizes can be difficult to achieve, reducing the power of studies and high attrition rates can result in inadequate follow up periods. This review uses examples of the management of cancer-related fatigue and death rattle(noisy breathing) to demonstrate the current state of EBM in palliative care. The future of EBM in palliative care needs to be as diverse as the patients who ultimately derive benefit. Non-RCT methodologies of equivalent quality, validity and size conducted by collaborative research networks using a ‘mixed methods approach' are likely to pose the correct clinical questions and derive evidencebased yet clinically relevant outcomes. 展开更多
关键词 Palliative care evidence-based medicine (EBM) MULTIMORBIDITY clinical meaningfulness
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Clinical Dissemination and Implementation of EBTs From the Ground Up:How to Develop a Multi-Site CBT“Clinical Dissemination Practice”The Case Example of the Child&Family Institute
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作者 Adam S.Weissman 《Psychology Research》 2020年第3期89-93,共5页
The recent proliferation of empirically-supported treatments(ESTs)into the private sector has led to more U.S.children and families receiving high quality treatments and improved treatment outcomes.However,there remai... The recent proliferation of empirically-supported treatments(ESTs)into the private sector has led to more U.S.children and families receiving high quality treatments and improved treatment outcomes.However,there remains a significant dearth of evidence-based clinics,service providers,and training programs nationally,particularly in more remote communities.The Child&Family Institute(CFI)was founded in 2011 as the world’s first Clinical Dissemination Practice and training institute,comprising five core unifying stages and initiatives:(1)Dissemination Through Training,(2)Dissemination Through Community Partnership,(3)Dissemination Through Integrated Behavioral Health,(4)Dissemination Through Technology,and(5)Dissemination Through Multi-State,Multi-Site Program Development and Implementation,all with a common goal of raising awareness and leveraging local and national resources to disseminate and implement accessible,affordable,evidence-based care to children,families,and communities across the United States,and beyond.Perhaps most central and unique to CFI’s five initiatives,and its overall core values and mission,is the accessibility and affordability of services for each and every child.Preliminary feedback from patients,students,collaborators,local politicians and stakeholders,partner organizations,and the broader communities in the regions served has been enthusiastic,and several grant submissions and research partnerships are underway,to test the effectiveness of CFI programming and evidence-based treatments in“real-world”clinics nationwide. 展开更多
关键词 evidence-based treatment clinical dissemination and implementation child and adolescent mental health effectiveness research interdisciplinary behavioral health
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Application of Evidence-based Nursing in Elderly Patients with Arrhythmia after Acute Myocardial Infarction
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作者 Xiongxin Wang Man Xu 《Journal of Geriatric Medicine》 2019年第1期25-28,共4页
Objective: To investigate the effect of evidence-based nursing intervention in elderly patients with arrhythmia after acute myocardial infarction. Methods: 146 elderly patients with arrhythmia after acute myocardial i... Objective: To investigate the effect of evidence-based nursing intervention in elderly patients with arrhythmia after acute myocardial infarction. Methods: 146 elderly patients with arrhythmia after acute myocardial infarction treated in our hospital from February 2016 to March 2017 were selected as research objects. According to the random number method, patients were divided into control group (73 cases, traditional nursing) and observation group (73 cases, evidence-based nursing intervention). The clinical effects and nursing satisfaction of the two groups were compared. Results: The hospital stay, average bed rest time, hospitalization cost, and incidence of arrhythmia complications in the observation group were significantly lower than those in the control group. The difference was statistically significant (P<0.05). After nursing, the four grades of heart function and satisfaction of nursing in the observation group were significantly higher than those in the control group. The difference was statistically significant (P<0.05). Conclusions: In elderly patients with arrhythmia after acute myocardial infarction, evidence-based nursing intervention was adopted. The patient's health has been greatly improved and the doctor-patient relationship has been significantly improved. This method is worth promoting. 展开更多
关键词 Elderly acute MYOCARDIAL INFARCTION ARRHYTHMIA evidence-based NURSING clinical effect
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Developing evidence-based medicine in Persian medicine: obstacles, challenges, and solutions andsolutions
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作者 Fataneh Hashem-Dabaghian Aida Asghari Marzieh Qaraaty 《TMR Integrative Medicine》 2022年第27期1-7,共7页
Introduction:Considering the importance of evidence-based medicine(EBM)and the emphasis of Persian medicine(PM)experts on its use,this study was designed;to investigate the practice of PM specialists,the obstacles,cha... Introduction:Considering the importance of evidence-based medicine(EBM)and the emphasis of Persian medicine(PM)experts on its use,this study was designed;to investigate the practice of PM specialists,the obstacles,challenges,and solutions of developing and using EBM in PM were also the aims of the present study.Method:In the present study,98 PM specialists,who work in Iran completed the electronic Persian version of the evidence-based medicine.The effective factors in the practice of specialists were assessed by Spearman correlation and Mann-Whitney U tests.Results:The mean±standard deviation of age,graduation time,and clinical experience were 44.52±6.45,3.26±2.28,and 6.76±5.27 years,respectively.Evaluating the data showed,that 52 participants(53.1%)had not passed any EBM training courses.Social media,general and medical databases,textbooks,colleagues,and journal articles were used frequently in clinical practices,but the specific EBM-specific resources were neglected.Conclusions:More attention must be paid to produce scientific evidence,improving the infrastructures and health policies,and empowering PM specialists to apply EBM in their clinical practices. 展开更多
关键词 evidence-based medicine clinical practice Persian medicine obstacles and solutions Iran
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针刺联合常规治疗干预慢性心力衰竭疗效的Meta分析
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作者 刘岱岳 刘新灿 +5 位作者 陈志豪 成丽 胡婷 张高静 兰真真 陈云 《中西医结合心脑血管病杂志》 2024年第17期3090-3099,共10页
目的:采用Meta分析评价针刺联合常规治疗干预慢性心力衰竭(CHF)的临床疗效。方法:检索中国知网(CNKI)、万方、维普(VIP)、中国生物医学文献数据库(CBM)、PubMed、the Cochrane Library、EMbase等数据库自建库至2024年5月1日有关针刺联... 目的:采用Meta分析评价针刺联合常规治疗干预慢性心力衰竭(CHF)的临床疗效。方法:检索中国知网(CNKI)、万方、维普(VIP)、中国生物医学文献数据库(CBM)、PubMed、the Cochrane Library、EMbase等数据库自建库至2024年5月1日有关针刺联合常规治疗慢性心力衰竭的随机对照试验(RCTs)。采用Stata 16.0软件进行Meta分析。结果:共纳入26项研究,均为RCTs,涉及2243例CHF病人。Meta分析结果显示,针刺联合常规治疗方法可改善CHF病人心力衰竭总有效率[RR=1.23,95%CI(1.17,1.30),P<0.001]、提高左室射血分数(LVEF)[WMD=4.43,95%CI(2.33,6.53),P<0.001]、延长6 min步行试验(6MWT)距离[WMD=46.48,95%CI(29.93,63.03),P<0.001]、降低血清脑钠肽水平(BNP)[WMD=-143.10,95%CI(-204.86,-81.33),P<0.001]、降低明尼苏达心力衰竭生活质量调查表(MLHFQ)评分[WMD=-5.33,95%CI(-9.88,-0.79),P<0.001]。结论:现有证据表明,针刺联合常规治疗可显著改善CHF病人的临床疗效。 展开更多
关键词 慢性心力衰竭 针刺 随机对照试验 临床疗效 META分析
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某三甲综合性医院临床试验项目伦理审查效率分析及策略探讨
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作者 陈梅男 胡怡然 杭天依 《安徽医专学报》 2024年第3期8-11,共4页
目的:通过对伦理委员会临床试验项目伦理审查各环节的耗时情况进行分析,探讨进一步提高医学伦理审查效率的策略。方法:分析某三甲综合性医院医学研究伦理委员会2023年受理的278项初始审查项目和522项修正案审查项目在各环节的耗时情况,... 目的:通过对伦理委员会临床试验项目伦理审查各环节的耗时情况进行分析,探讨进一步提高医学伦理审查效率的策略。方法:分析某三甲综合性医院医学研究伦理委员会2023年受理的278项初始审查项目和522项修正案审查项目在各环节的耗时情况,包括不同审查类型、不同审查方式的等待耗时、审查耗时及审批耗时等。结果:药物/医疗器械临床试验项目初始审查的等待耗时和审批耗时平均为12天和22天;体外诊断试剂临床试验项目初始审查的等待耗时和审批耗时平均为3天和9.5天;修正案审查方式为快速审查时等待耗时和审批耗时平均为6天和11天,审查方式为会议审查时等待耗时和审批耗时平均为13天和15.5天。结论:建议通过加强形式审查,提高会议审查项目的一次性通过率;优化伦理审查管理及审查流程,提升快审审批效率;加强研究项目申办者与伦理办公室的沟通交流等,进一步提高伦理审查效率。 展开更多
关键词 伦理审查 临床试验 伦理委员会 审查效率
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Making Evidence-based Decisions in the Clinical Practice of Integrative Medicine 被引量:10
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作者 徐浩 陈可冀 《Chinese Journal of Integrative Medicine》 SCIE CAS 2010年第6期483-485,共3页
In 1948, the first clinical paper adopting the protocol of randomized and controlled design was published in British Medical Journal by Bradford Hill,a noted British biostatistician, who introduced rigorous theory of ... In 1948, the first clinical paper adopting the protocol of randomized and controlled design was published in British Medical Journal by Bradford Hill,a noted British biostatistician, who introduced rigorous theory of mathematical statistics into clinical design the first time and successfully evaluated the therapeutic effect of streptomycin on tuberculosis. 展开更多
关键词 In EBM Making evidence-based Decisions in the clinical Practice of Integrative Medicine CAM
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Assessing the Quality of the First Batch of Evidence-Based Clinical Practice Guidelines in Traditional Chinese Medicine 被引量:8
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作者 宇文亚 徐建龙 +4 位作者 史楠楠 王丽颖 韩学杰 王永炎 吕爱平 《Journal of Traditional Chinese Medicine》 SCIE CAS CSCD 2011年第4期376-381,共6页
Objective: To assess the quality of the first batch of Chinese evidence-based clinical practice guidelines (CPGs) in Traditional Chinese Medicine (TCM) using the Appraisal of Guidelines for Research and Evaluation (AG... Objective: To assess the quality of the first batch of Chinese evidence-based clinical practice guidelines (CPGs) in Traditional Chinese Medicine (TCM) using the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. Methods: Evidence-based CPGs in TCM supported by the World Health Organization Western Pacific Regional Office (WHO/WPRO) and whose development was organized by the China Academy of Chinese Medical Sciences were identified and manually retrieved. CPGs were assessed using the AGREE instrument, and the data in each CPG were analyzed in terms of the six domains in the AGREE instrument: scope and purpose, stakeholder involvement, rigor of development, clarity and presentation, applicability, and editorial independence. Results: Twenty-eight CPGs were identified, of which 26 were included in the study. The AGREE instrument rated the 26 CPGs in terms of the six domains. The assessment results showed the following average scores: for editorial independence, 84.16%; for rigor of development, 80.95%; for scope and purpose, 79.96%; for clarity and presentation, 70.88%; for stakeholder involvement, 61.28%; for applicability, the average score was only 27.09%. In summary, nine CPGs were rated as "strongly recommended", six as "recommended with provision or alternation", and 11 as "unsure". Conclusion: Most of the first batch of Chinese evidence-based CPGs in TCM had significant shortcomings in applicability. It is suggested that special attention be paid to enhancing the quality of applicability when developing evidence-based CPGs in TCM. 展开更多
关键词 clinical practice guideline Traditional Chinese Medicine evidence-based medicine AGREE instrument quality assessment
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Significance of Evidence-based Medicine in the Assessment of Chinese Medicine Clinical Efficacy 被引量:2
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作者 王吉耀 《Chinese Journal of Integrative Medicine》 SCIE CAS 2010年第5期392-393,共2页
Evidence-base dmedicine (EBM) requires the integration of the best research evidence with our clinical expertise and our patient's unique values and circumstances. Thebest evidence is valid and clinically relevant,... Evidence-base dmedicine (EBM) requires the integration of the best research evidence with our clinical expertise and our patient's unique values and circumstances. Thebest evidence is valid and clinically relevant, especially from patient-centered clinical research. The clinical expertise means the ability to use our clinical skills and past experiences to rapidly identify each patient's unique health state and diagnosis, their individual risks, 展开更多
关键词 Significance of evidence-based Medicine in the Assessment of Chinese Medicine clinical Efficacy EBM
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Study on the Methodology of Developing Evidence-Based Clinical Practice Guidelines of Chinese Medicine
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作者 陈争光 罗卉 +2 位作者 徐珊 杨燕 汪受传 《Chinese Journal of Integrative Medicine》 SCIE CAS CSCD 2015年第11期874-880,共7页
At present, evidence-based clinical practice guideline (EBCPG) is the main mode of developing clinical practice guidelines (CPGs) in the world, but in China, most of CPGs of Chinese medicine (CM) are still guide... At present, evidence-based clinical practice guideline (EBCPG) is the main mode of developing clinical practice guidelines (CPGs) in the world, but in China, most of CPGs of Chinese medicine (CM) are still guidelines based on expert consensus. The objective of this study is to construct initially the methodology of developing EBCPGs of CM and to promote the development of standardization of CM. Based on the development of "Guideline for Diagnosis and Treatment of Common Pediatric Diseases in CM", the methodology of developing EBCPG of CM was explored by analyzing the pertinent literature and considering the characteristics of CM. In this study, the key problem was to put forward the suggestion and strategies. However, due to the methodology study of developing EBCPG of CM is still in the initial stage, there are still some problems which need further study. 展开更多
关键词 evidence-based clinical practice guideline Chinese medicine Delphi method methodological study
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药物临床试验用药品全流程管理分析探讨 被引量:1
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作者 曹永仓 《中国药事》 2023年第12期1375-1380,共6页
目的:研究国内外关于试验用药品的相关法规和文献,分析相关问题和解决办法。方法:从中国知网、万方、维普等数据库,检索临床试验用药品相关文献,按照试验流程,分析试验各方如申办者/合同研究组织、研究者、药物临床试验机构、伦理审查... 目的:研究国内外关于试验用药品的相关法规和文献,分析相关问题和解决办法。方法:从中国知网、万方、维普等数据库,检索临床试验用药品相关文献,按照试验流程,分析试验各方如申办者/合同研究组织、研究者、药物临床试验机构、伦理审查委员会等职责和问题。结果:药物临床试验质量体系建设是临床试验质量保证的重要内容,从试验用药品生产、运输、使用、药物安全性等环节进行阐述,现已得到较全面的研究成果。结论:通过分析研究临床试验用药品管理流程中的政策和法规,提出相关问题和解决办法,有利于提高试验用药品管理质量,保护受试者权益和安全,保证试验顺利开展,并有重要的借鉴学习作用。 展开更多
关键词 临床试验 药品管理 全流程管理 质量控制 试验风险
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中国临床试验受试者隐私权保护的相关问题及解决策略 被引量:2
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作者 杨秀巧 文萍 +2 位作者 林泓 陈汶澴 陈玉文 《中国当代医药》 CAS 2023年第3期140-144,共5页
受试者的权益是临床试验首要考虑的问题,其中受试者隐私权的保护贯穿临床试验的整个过程。本文通过对中国受试者隐私保护相关的法规研究及大数据背景下受试者隐私权保护相关内容的检索和汇总发现,中国受试者隐私保护存在缺少具有指导意... 受试者的权益是临床试验首要考虑的问题,其中受试者隐私权的保护贯穿临床试验的整个过程。本文通过对中国受试者隐私保护相关的法规研究及大数据背景下受试者隐私权保护相关内容的检索和汇总发现,中国受试者隐私保护存在缺少具有指导意义的法规、研究者对于受试者隐私保护意识不强、伦理委员会对数据审查能力不足以及大数据背景下受试者健康数据和遗传数据存在泄露风险的问题。因此,在国家层面,应根据国情制订适用于临床试验受试者隐私保护的相关法规;在伦理委员会层面,应加强数据使用的伦理审查;在技术层面,可探索将去识别化的手段和去中心化的区块链系统应用于受试者健康数据和临床试验数据的管理,从而探索平衡医学研究和隐私保护的策略,推动中国医药研发产业的发展。 展开更多
关键词 临床试验 受试者 隐私权 大数据
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国产奈达铂治疗食管癌的Ⅱ期临床试验报告 被引量:44
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作者 徐瑞华 史艳侠 +12 位作者 管忠震 姜文奇 黄河 马智勇 王建华 胡晓桦 谢伟敏 李星庚 刘亚利 潘良熹 戴爱娣 庄武 张春 《癌症》 SCIE CAS CSCD 北大核心 2006年第12期1565-1568,共4页
背景与目的:奈达铂是第二代有机铂类抗癌药,国外的临床研究显示该药是一个广谱、高效的抗癌药物,治疗食管癌有效率较高,但是国产奈达铂的临床疗效及其不良反应尚不清楚。本研究目的是观察Ⅱ类新药国产奈达铂对晚期食管癌的疗效及其不良... 背景与目的:奈达铂是第二代有机铂类抗癌药,国外的临床研究显示该药是一个广谱、高效的抗癌药物,治疗食管癌有效率较高,但是国产奈达铂的临床疗效及其不良反应尚不清楚。本研究目的是观察Ⅱ类新药国产奈达铂对晚期食管癌的疗效及其不良反应。方法:本研究为多中心、前瞻性、随机对照Ⅱ期临床研究。对52例未接受过化疗的初治食管癌患者进行随机分组,试验组30例,接受奈达铂联合5-FU治疗。对照组22例,接受DDP联合5-FU治疗。结果:30例试验组患者中,27例可评价疗效,30例可评价不良反应。22例对照组患者均可评价疗效和不良反应。在疗效方面,试验组的总有效率高于对照组,分别为29.63%与22.73%(P<0.05)。其中试验组的CR率为18.51%,而对照组为4.55%。在骨髓抑制方面,Hb下降的发生率两组基本一致;试验组WBC下降和血小板抑制的发生率明显高于对照组,特别是Ⅲ、Ⅳ度血小板下降(20.68%vs.0%,P<0.01)。试验组消化道反应的总发生率低于对照组,其中呕吐的发生率和严重程度两组之间存在显著性差异(P<0.05)。两组其他不良反应发生率相比无显著性差异。结论:奈达铂对晚期食管癌有一定的疗效,与5-FU联合的有效率较DDP+5-FU联合方案有一定优势,临床耐受性较好,主要不良反应为骨髓抑制,特别是严重的血小板下降。 展开更多
关键词 食管肿瘤 化学疗法 奈达铂 临床试验
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