| 彭晓霞,苏健,蔡思雨,彭瑞玲,彭亚光,马晓莉,倪鑫.开发专病临床数据交换标准协会病例报告表助力我国真实世界数据生态建设[J].Chinese journal of Epidemiology,2021,42(12):2201-2207 |
| 开发专病临床数据交换标准协会病例报告表助力我国真实世界数据生态建设 |
| Development of case report form based on clinical data interchange standards consortium on special diseases to promote the ecology construction of real-world data in China |
| Received:June 29, 2021 |
| DOI：10.3760/cma.j.cn112338-20210629-00505 |
| KeyWord: 真实世界数据 临床数据交换标准协会 病例报告表 |
| English Key Word: Real world data Clinical data interchange standards consortium Clinical report form |
| FundProject:国家重点研发计划（2016YFC1000105）；国家科技重大专项（2017ZX09304029）；北京市医院管理局儿科医学协同发展专项（XTCX201812） |
| Author Name | Affiliation | E-mail | | Peng Xiaoxia | Center for Clinical Epidemiology and Evidence-Based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children Health, Beijing 100045, China
Hainan Real World Data Research Institute, Haikou 571435, China | pengxiaoxia@bch.com.cn | | Su Jian | Center for Clinical Epidemiology and Evidence-Based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children Health, Beijing 100045, China | | | Cai Siyu | Center for Clinical Epidemiology and Evidence-Based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children Health, Beijing 100045, China | | | Peng Ruiling | Beijing Improve-Quality Technology Co., Ltd. Beijing 100089, China | | | Peng Yaguang | Center for Clinical Epidemiology and Evidence-Based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children Health, Beijing 100045, China | | | Ma Xiaoli | Center for Clinical Epidemiology and Evidence-Based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children Health, Beijing 100045, China | | | Ni Xin | Center for Clinical Epidemiology and Evidence-Based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children Health, Beijing 100045, China | |
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| Abstract: |
| 真实世界数据是指在日常医疗活动、生活与工作等环境下产生的数据。真实世界数据在临床与公共卫生研究中一直被广泛应用，但真实世界数据质量相关问题，如不完整性、不一致性和准确性等会影响真实世界研究的真实性。为了应对真实世界源数据缺乏标准化带来的挑战，本文基于当前被广泛应用的数据标准，即临床数据交换标准协会（CDISC）开发的CDISC标准开发了专病CDISC-病例报告表（CRF），以提高真实世界源数据标准化水平，助力我国真实世界数据生态建设。我们阐述了如何应用数据标准弥补真实世界数据到真实世界证据之间的裂痕；设计了基于专病CDISC-CRF建设真实世界数据生态的流程，重点介绍了CDISC-CRF表单的开发技术；并就基于专病CDISC-CRF建设真实世界数据的应用前景及意义进行了描述。 |
| English Abstract: |
| Real world data (RWD) refers to the data generated in routine clinical practices, daily life, and real work environment and has been widely used in clinical or public health research. Still, issues related to the quality of RWD, such as incompleteness, inconsistency, and inaccuracy, would affect the validity of real-world research. To overcome the challenges due to the lack of standardization of real world source data, case report form based on clinical data interchange standards consortium (CDISC-CRF) on certain diseases was developed to promote the ecology construction of RWD based on the data standards set by the CDISC which has been widely used. Firstly, we described how to apply data standards to make up the gap between RWD and real world evidence. Then, the process was designed to build RWD ecology based on CDISC-CRF, in which the development technology of CDISC-CRF form is mainly introduced. Finally, the application prospect and significance of building real-world data based on disease-specific CDISC-CRF are described. It is believed that the present paper can provide a new idea for promoting the ecology construction of RWD in China. |
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