[1] 郭然, 曾典, 胡裕涵, 等. 价值医疗视角下的中医药优势评价思路与方法[J]. 科技导报, 2023, 41(14): 14-21.
[2] 王一名, 代欣玥, 郭曼萍, 等. 中医药真实世界研究数据转化方法[J]. 中国循证医学杂志, 2023, 23(9): 1081- 1088.
[3] 田亚南, 张静, 范慧敏, 等. 中医药辨治冠心病心绞痛真实世界研究概述[J]. 中西医结合心脑血管病杂志, 2024, 22(7): 1262-1266.
[4] 李传朋, 董兴鲁, 冯路达, 等. 基于真实世界数据特点构建中医临床信息采集模式的对策[J]. 世界中医药, 2023, 18(13): 1822-1826.
[5] 张娜, 魏天睿, 张子彦, 等. 基于真实世界研究方法的中医药研究进展[J]. 内蒙古医科大学学报, 2023, 45(5): 552-556.
[6] 卫荣. 健康医疗大数据质量治理研究[J]. 中国卫生质量管理, 2020, 27(3): 5-8.
[7] 中华中医药学会《中医药真实世界研究技术规范》制订组. 中医药真实世界研究技术规范: 证据质量评价与报告[J]. 中医杂志, 2022, 63(3): 293-300.
[8] 国家药监局关于发布真实世界证据支持药物研发与审评 的指 导原 则( 试行)的通 告[EB/OL]. (2020-01-07)[2024-06-24]. https://www. nmpa. gov. cn/xxgk/ggtg/qtggtg/ 20200107151901190.html.
[9] 国家药监局药审中心关于发布《真实世界研究支持儿童药物研发与审评的技术指导原则(试行)》的通告[EB/ OL]. (2020-08-27)[2024-06-24]. https://www. nmpa. gov. cn/xxgk/ggtg/ypggtg/ypqtggtg/20200901104448101.html.
[10] 国家药监局药审中心关于发布《用于产生真实世界证据的真实世界数据指导原则(试行)》的通告[EB/OL]. (2021-04-13)[2024-06-24]. https://www. cde. org. cn/ main/news/viewInfoCommon/2a1c437ed54e7b838a7e86f- 4ac21c539.
[11] 张弘政, 刘迷迷, 李琳, 等. 基于通用数据模型的健康医疗大数据平台数据治理研究[J]. 医学信息学杂志, 2022, 43(6): 2-7.
[12] 杨忠奇, 高蕊, 胡思源, 等. 中药人用经验研究专家共识[J]. 中国中药杂志, 2022, 47(18): 4829-4834.
[13] 赵天易, 雒琳, 何丽云, 等. 多源异构数据整合在中医药真实世界临床研究中的应用及展望[J]. 世界中医药, 2022, 17(5): 614-619.
[14] 王晓丽, 万生芳, 魏昭晖, 等. 真实世界大数据下中医临床研究特点探析[J]. 世界最新医学信息文摘, 2019, 19(6): 244.
[15] Kahn M G, Brown J S, Chun A T, et al. Transparent reporting of data quality in distributed data networks[J]. EGEMs (Generating Evidence & Methods to Improve Patient Outcomes), 2015, 3(1): 7.
[16] 李姮. 医疗大数据质量评价指标体系研究[D]. 武汉: 华中科技大学, 2020.
[17] 袁莎, 沈丽宁. 医疗数据质量评价指标体系研究[J]. 卫生软科学, 2020, 34(12): 12-16.
[18] Zhong J, Zhang J, Fang H H, et al. Advancing the development of real-world data for healthcare research in China: Challenges and opportunities[J]. BMJ Open, 2022, 12(7): e063139.
[19] Lai J K, Liao X W, Yao C, et al. Existing barriers and recommendations of real-world data standardisation for clinical research in China: A qualitative study[J]. BMJ Open, 2022, 12(8): e059029.
[20] 甘伟谊. 基于医院集成平台的数据质量核查系统应用研究与实现[J]. 现代信息科技, 2020, 4(1): 97-101.
[21] 周雪忠, 王世华, 张迪, 等. 构建中医药特色真实世界临床研究新模式的实践与思考[J]. 科技导报, 2023, 41(14): 22-31.
[22] 国家市场监督管理总局, 国家标准化管理委员会. 信息技术数据质量评价指标: GB/T 36344—2018[S]. 北京: 中国标准出版社, 2018.
[23] 冯晨阳, 刘迷迷, 刘强, 等. 大数据背景下医院数据质量评价模型及监控管理模式探索[J]. 医学信息学杂志, 2022, 43(7): 26-31.
[24] Bian J, Lyu T C, Loiacono A, et al. Assessing the practice of data quality evaluation in a national clinical data research network through a systematic scoping review in the era of real-world data[J]. Journal of the American Medical Informatics Association, 2020, 27(12): 1999- 2010.
[25] Syed R, Eden R, Makasi T, et al. Digital health data quality issues: Systematic review[J]. Journal of Medical Internet Research, 2023, 25: e42615.
[26] Mashoufi M, Ayatollahi H, Khorasani-Zavareh D, et al. Data quality in health care: Main concepts and assessment methodologies[J]. Methods of Information in Medicine, 2023, 62(1/2): 5-18.
[27] 廖茜雯, 姚晨, 张军, 等. 真实世界数据和证据在我国临床决策中的应用现状[J]. 中国食品药品监管, 2023(10): 24-35.
[28] Weiskopf N G, Weng C H. Methods and dimensions of electronic health record data quality assessment: Enabling reuse for clinical research[J]. Journal of the American Medical Informatics Association, 2013, 20(1): 144- 151.
[29] Vanbrabant L, Martin N, Ramaekers K, et al. Quality of input data in emergency department simulations: Framework and assessment techniques[J]. Simulation Modelling Practice and Theory, 2019, 91: 83-101.
[30] Hripcsak G, Duke J D, Shah N H, et al. Observational health data sciences and informatics(OHDSI): Opportunities for observational researchers[J]. Studies in Health Technology and Informatics, 2015, 216: 574-578.
[31] Diaz-Garelli J F, Bernstam E V, Lee M, et al. DataGauge: A practical process for systematically designing and implementing quality assessments of repurposed clinical data[J]. EGEMs (Generating Evidence & Methods to Improve Patient Outcomes), 2019, 7(1): 32.
[32] Kapsner L A, Kampf M O, Seuchter S A, et al. Moving towards an EHR data quality framework: The MIRACUM approach[J]. Studies in Health Technology and Informatics, 2019, 267: 247-253.
[33] Khare R, Utidjian L H, Razzaghi H, et al. Design and refinement of a data quality assessment workflow for a large pediatric research network[J]. EGEMs (Generating Evidence & Methods to Improve Patient Outcomes), 2019, 7(1): 36.
[34] Estiri H, Klann J G, Weiler S R, et al. A federated EHR network data completeness tracking system[J]. Journal of the American Medical Informatics Association, 2019, 26(7): 637-645.
[35] Juárez D, Schmidt E E, Stahl-Toyota S, et al. A generic method and implementation to evaluate and improve data quality in distributed research networks[J]. Methods of Information in Medicine, 2019, 58(2/3): 86-93.
[36] Liaw S T, Guo J G N, Ansari S, et al. Quality assessment of real-world data repositories across the data life cycle: A literature review[J]. Journal of the American Medical Informatics Association, 2021, 28(7): 1591- 1599.
[37] 刘保延. 真实世界的中医临床科研范式[J]. 中医杂志, 2013, 54(6): 451-455.
[38] 刘保延, 文天才. 从信息科学与物质科学及其范式认识中西医学体系的科学原理[J]. 科技导报, 2023, 41(14): 5-13.