目的:通过对近10年中国发表的真实世界临床研究相关文献进行分析,试图展现这一时期国内真实世界临床研究的基本情况、热点和前沿趋势。方法:计算机检索国家知识基础设施数据库(CNKI)、中文科技期刊数据库(CCD)、中国学术期刊数据库(CSPD...目的:通过对近10年中国发表的真实世界临床研究相关文献进行分析,试图展现这一时期国内真实世界临床研究的基本情况、热点和前沿趋势。方法:计算机检索国家知识基础设施数据库(CNKI)、中文科技期刊数据库(CCD)、中国学术期刊数据库(CSPD)、SinoMed、Web of science及Pubmed等数据库有关国内学者发表的关于真实世界临床研究的文章,时间从2011年9月至2021年9月,运用文献计量工具CiteSpace进行数据挖掘,在中华中医药学会、世界中医药学会联合会、国家药品监督管理局以及美国FDA等网站查找近10年发表的有关真实世界的规范性文件。结果:共纳入有效文献1525篇,文献发表整体呈现增长趋势,研究范围较广,关键词演化分析表明研究热点主要集中于中药注射剂疗效分析和基于医疗大数据的临床用药特征分析等方面,研究设计类型主要是观察性研究。结论:通过梳理国内真实世界临床研究的发展脉络、方法学、政策支持和证据评估方法,有助于研究人员和临床医生更好地了解真实世界临床研究和提高真实世界证据质量,以期为我国开展高质量真实世界临床研究提供借鉴。展开更多
Acupuncture and moxibustion,which are important treatment modalities in traditional Chinese medicine,have gained global recognition and research interest due to their effectiveness.While the number of acupuncture and ...Acupuncture and moxibustion,which are important treatment modalities in traditional Chinese medicine,have gained global recognition and research interest due to their effectiveness.While the number of acupuncture and moxibustion studies continues to increase,the quality vary widely.This inconsistency can have a negative effect on production of high-quality evidence and development of acupuncture and moxibustion science.In 2022,the China Association of Acupuncture-Moxibustion published the Guideline for Acupuncture-Moxibustion Clinical Research Registration.This guideline standardizes methods and approaches used in the clinical research of acupuncture and moxibustion in China,and aims at improving data quality and enhancing transparency,thereby promoting the normalization of clinical studies on acupuncture and moxibustion and improving the quality of evidence.This study aimed to present interpretations of the contents of the Guideline for Acupuncture-Moxibustion Clinical Research Registration to facilitate a better understanding and application among researchers.展开更多
In recent years,the importance of real-world research based on real-world data has been widely recognized in many countries and regions around the world.Oriented by real-world data,real-world research is conducted to ...In recent years,the importance of real-world research based on real-world data has been widely recognized in many countries and regions around the world.Oriented by real-world data,real-world research is conducted to obtain real-world evidence,which becomes a hot spot in clinical study.In such circumstances,how to use the diagnosis and treatment data of clinical practice to evaluate the effect and safety of acupuncture becomes future direction of acupuncture research.This paper analyzed the current situation of the real-world research in the field of acupuncture and put forward the influencing factors and the countermeasures to provide the references for the real-world research of acupuncture.展开更多
真实世界观察性研究评估工具(Assessment of Real World Observational Studies,ArRoWS)是由英国莱斯特大学糖尿病研究中心莱斯特真实世界证据工作组研发的用于评估真实世界证据研究质量的工具,具有较好的实用性。ArRoWS能快速和具体地...真实世界观察性研究评估工具(Assessment of Real World Observational Studies,ArRoWS)是由英国莱斯特大学糖尿病研究中心莱斯特真实世界证据工作组研发的用于评估真实世界证据研究质量的工具,具有较好的实用性。ArRoWS能快速和具体地评估使用电子健康记录信息的真实世界证据研究的质量,ArRoWS共包含16个条目,其中9个条目为通用条目,另外7个条目为与特定研究设计相关的条目。本文就ArRoWS的制订背景、制订过程、评价条目、评价标准和使用方法等进行介绍,以期为国内的真实世界研究者提供参考。展开更多
Objective:To assess the reliability of the methodological quality and outcome measures of systematic reviews(SR)/meta-analysis of premature ovarian insufficiency(POI) treated with acupuncture.Methods:SR/meta-analysis ...Objective:To assess the reliability of the methodological quality and outcome measures of systematic reviews(SR)/meta-analysis of premature ovarian insufficiency(POI) treated with acupuncture.Methods:SR/meta-analysis of POI treated with acupuncture were searched on POI from the databases including PubMed,Web of Science,EMBase,the Cochran Library,Chinese biomedical literature database(SinoMed),China journal full-text database(CNKI),Wanfang data knowledge service platform(Wanfang)and VIP information Chinese periodical service platform(VIP),from inception to 1 st May 2021.Using A Measurement Tool to Assess Systematic Reviews 2(AMSTAR 2) scale and Grades of Recommendations Assessment,Development and Evaluation(GRADE) system,the methodological quality and outcome measures of the included studies were appraised.Results:Ten articles of SR/meta-analysis were included,published from 2015 to 2020.Using AMSTAR 2,5 articles of SR/meta-analysis were rated as critical low quality in methods,3 articles as low quality,and2 articles as moderate quality.The results of GRADE showed that among the 50 outcomes the quality of evidence of 22 outcomes was very low,that of 25 outcomes was low and that of 3 outcomes was moderate.Conclusion:The methodological quality and the reliability of outcome measures were not high in existing SR/meta-analysis on POI treated with acupuncture,which may affect the translation of the SR/metaanalysis findings into clinical practice.It is necessary to further strengthen the methodological quality and reporting standard of SR/meta-analysis,as well as the robustness of design and implementation of randomized controlled trials(RCTs),in order to generate high quality evidences for clinical decision-making and practice.展开更多
文摘目的:通过对近10年中国发表的真实世界临床研究相关文献进行分析,试图展现这一时期国内真实世界临床研究的基本情况、热点和前沿趋势。方法:计算机检索国家知识基础设施数据库(CNKI)、中文科技期刊数据库(CCD)、中国学术期刊数据库(CSPD)、SinoMed、Web of science及Pubmed等数据库有关国内学者发表的关于真实世界临床研究的文章,时间从2011年9月至2021年9月,运用文献计量工具CiteSpace进行数据挖掘,在中华中医药学会、世界中医药学会联合会、国家药品监督管理局以及美国FDA等网站查找近10年发表的有关真实世界的规范性文件。结果:共纳入有效文献1525篇,文献发表整体呈现增长趋势,研究范围较广,关键词演化分析表明研究热点主要集中于中药注射剂疗效分析和基于医疗大数据的临床用药特征分析等方面,研究设计类型主要是观察性研究。结论:通过梳理国内真实世界临床研究的发展脉络、方法学、政策支持和证据评估方法,有助于研究人员和临床医生更好地了解真实世界临床研究和提高真实世界证据质量,以期为我国开展高质量真实世界临床研究提供借鉴。
基金Supported by the Innovative Project of the China Academy of Chinese Medical Sciences:CI2021A05408Innovative research team of the China Academy of Chinese Medical Sciences+1 种基金National Key Research and Development Program of China:2019YFC1712205National Key Research and Development Program of China:2017YFC1703600
文摘Acupuncture and moxibustion,which are important treatment modalities in traditional Chinese medicine,have gained global recognition and research interest due to their effectiveness.While the number of acupuncture and moxibustion studies continues to increase,the quality vary widely.This inconsistency can have a negative effect on production of high-quality evidence and development of acupuncture and moxibustion science.In 2022,the China Association of Acupuncture-Moxibustion published the Guideline for Acupuncture-Moxibustion Clinical Research Registration.This guideline standardizes methods and approaches used in the clinical research of acupuncture and moxibustion in China,and aims at improving data quality and enhancing transparency,thereby promoting the normalization of clinical studies on acupuncture and moxibustion and improving the quality of evidence.This study aimed to present interpretations of the contents of the Guideline for Acupuncture-Moxibustion Clinical Research Registration to facilitate a better understanding and application among researchers.
基金Supported by Scientific and technological innovation project of China Academy of Chinese Medical Sciences:CI2021B003Research on the real-world"virtual control"clinical research method of traditional Chinese medicine:2023015。
文摘In recent years,the importance of real-world research based on real-world data has been widely recognized in many countries and regions around the world.Oriented by real-world data,real-world research is conducted to obtain real-world evidence,which becomes a hot spot in clinical study.In such circumstances,how to use the diagnosis and treatment data of clinical practice to evaluate the effect and safety of acupuncture becomes future direction of acupuncture research.This paper analyzed the current situation of the real-world research in the field of acupuncture and put forward the influencing factors and the countermeasures to provide the references for the real-world research of acupuncture.
文摘真实世界观察性研究评估工具(Assessment of Real World Observational Studies,ArRoWS)是由英国莱斯特大学糖尿病研究中心莱斯特真实世界证据工作组研发的用于评估真实世界证据研究质量的工具,具有较好的实用性。ArRoWS能快速和具体地评估使用电子健康记录信息的真实世界证据研究的质量,ArRoWS共包含16个条目,其中9个条目为通用条目,另外7个条目为与特定研究设计相关的条目。本文就ArRoWS的制订背景、制订过程、评价条目、评价标准和使用方法等进行介绍,以期为国内的真实世界研究者提供参考。
基金Supported by National Key R&D Program of China2019YFC1712200International standards research on clinical research and service of AcupunctureMoxibustion2019YFC1712205。
文摘Objective:To assess the reliability of the methodological quality and outcome measures of systematic reviews(SR)/meta-analysis of premature ovarian insufficiency(POI) treated with acupuncture.Methods:SR/meta-analysis of POI treated with acupuncture were searched on POI from the databases including PubMed,Web of Science,EMBase,the Cochran Library,Chinese biomedical literature database(SinoMed),China journal full-text database(CNKI),Wanfang data knowledge service platform(Wanfang)and VIP information Chinese periodical service platform(VIP),from inception to 1 st May 2021.Using A Measurement Tool to Assess Systematic Reviews 2(AMSTAR 2) scale and Grades of Recommendations Assessment,Development and Evaluation(GRADE) system,the methodological quality and outcome measures of the included studies were appraised.Results:Ten articles of SR/meta-analysis were included,published from 2015 to 2020.Using AMSTAR 2,5 articles of SR/meta-analysis were rated as critical low quality in methods,3 articles as low quality,and2 articles as moderate quality.The results of GRADE showed that among the 50 outcomes the quality of evidence of 22 outcomes was very low,that of 25 outcomes was low and that of 3 outcomes was moderate.Conclusion:The methodological quality and the reliability of outcome measures were not high in existing SR/meta-analysis on POI treated with acupuncture,which may affect the translation of the SR/metaanalysis findings into clinical practice.It is necessary to further strengthen the methodological quality and reporting standard of SR/meta-analysis,as well as the robustness of design and implementation of randomized controlled trials(RCTs),in order to generate high quality evidences for clinical decision-making and practice.
