基于医疗大数据的比较效果研究设计要点述评与应用
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摘要
随着医疗信息化建设进程加快,我国医疗卫生领域已进入大数据时代,这为开展基于真实世界的比较效果研究提供了充分条件。比较效果研究是一种评价不同医疗干预方案在真实世界中效果的研究,其结果可指导临床实践或为政策制定提供证据支持。基于医疗大数据开展比较效果研究时研究者需注意明确研究问题与研究设计、混杂和偏倚的可能来源以及控制混杂和偏倚的统计分析技术,从而增强因果关系推论。基于中国目前研究现状,我国应加强对医疗大数据的利用,同时还要提升研究设计和步骤的规范性,从而提高研究结论的可靠性和提供优质证据。
With the rapid development of the health informatization construction in China, health care has entered the era of big data, which provides sufficient condition for conducting comparative effectiveness research(CER) based on real world. CER is defined as a study for the evaluation of different medical intervention programs in ‘real world' settings, and its results can guide the clinical practice, providing evidence support for policy making. Researchers need to focus on clearing research questions and research design, possible sources of confounding and bias, and statistical analysis techniques to control confounding and biasing based on medical big data and to enhance the causality inference. Based on China's current research status, China should strengthen the use of medical big data, and meanwhile improve the standardization of research design and procedures, so as to improve the reliability of research conclusions and provide high-quality evidence.
With the rapid development of the health informatization construction in China, health care has entered the era of big data, which provides sufficient condition for conducting comparative effectiveness research(CER) based on real world. CER is defined as a study for the evaluation of different medical intervention programs in ‘real world' settings, and its results can guide the clinical practice, providing evidence support for policy making. Researchers need to focus on clearing research questions and research design, possible sources of confounding and bias, and statistical analysis techniques to control confounding and biasing based on medical big data and to enhance the causality inference. Based on China's current research status, China should strengthen the use of medical big data, and meanwhile improve the standardization of research design and procedures, so as to improve the reliability of research conclusions and provide high-quality evidence.
引文
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[9]肖芳,戴群,高硕聪.完全脱位年轻恒牙再植效果影响因素的回顾研究[J].口腔医学研究,2019,35(1):56-59.
[10]王密,李海波.伊立替康联合奈达铂对比联合顺铂二线治疗复发或难治性小细胞肺癌的疗效及毒副作用回顾分析[J].系统医学,2018,3(22):34-35,38.
[11]朱永,黎美琪,管健,等.回顾分析Lucas2心肺复苏仪对急诊心肺复苏的临床效果[J].吉林医学,2018,39(6):1120-1122.
[12]杨永涛,李连勇,陈琰,等.透明帽辅助的内镜黏膜下切除术与内镜黏膜下剥离术治疗直肠神经内分泌肿瘤效果的回顾性分析[J].胃肠病学和肝病学杂志,2018,27(3):269-272.
[13]贺子剑,张力,彭东,等.大血管手术中康斯特保护液与含血停搏液心肌保护效果比较[J].中国体外循环杂志,2014,12(4):222-225.
[14]李志.抗病毒药物静脉及局部应用治疗单纯疱疹角膜炎临床效果回顾[J].临床医药文献电子杂志,2019,6(4):163,166.
[2]Berger ML,Mamdani M,Atkins D,et al.Good Research Practices for Comparative Effectiveness Research:Defining,Reporting and Interpreting Nonrandomized Studies of Treatment Effects Using Secondary Data Sources:The ISPOR Good Research Practices for Retrospective Database Analysis Task Force ReportPart I[J].Value in Health,2009,12(8):1044-1052.
[3]Cox E,Martin BC,Van Staa T,et al.Good research practices for comparative effectiveness research:approaches to mitigate bias and confounding in the design of nonrandomized studies of treatment effects using secondary data sources:the International Society for Pharmacoeconomics and Outcomes Research Good Research Practices for Retrospective Database Analysis Task Force ReportPart II[J].Value Health,2009,12(8):1053-1061.
[4]Johnson ML,Crown W,Martin BC,et al.Good Research Practices for Comparative Effectiveness Research:Analytic Methods to Improve Causal Inference from Nonrandomized Studies of Treatment Effects Using Secondary Data Sources:The ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report-Part III[J].Value Health,2009,12(8):1062-1073.
[5]Etminan M,Samii A.Pharmacoepidemiology I:A Review of Pharmacoepidemiologic Study Designs[J].Pharmacotherapy,2004,24(8):964-969.
[6]Etminan M.Pharmacoepidemiology II:The Nested Case‐Control Study-A Novel Approach in Pharmacoepidemiologic Research[J].Pharmacotherapy,2004,24(9):1105-1109.
[7]D’Agostino RB Jr.Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group[J].Stat Med,1998,17(19):2265-2281.
[8]张淑青,王立峰,柳磊,等.非体外循环冠状动脉旁路移植术患者右美托咪啶联合地佐辛术后镇痛效果及对心肌酶谱影响的回顾性分析[J].中国药师,2018,21(8):1401-1404.
[9]肖芳,戴群,高硕聪.完全脱位年轻恒牙再植效果影响因素的回顾研究[J].口腔医学研究,2019,35(1):56-59.
[10]王密,李海波.伊立替康联合奈达铂对比联合顺铂二线治疗复发或难治性小细胞肺癌的疗效及毒副作用回顾分析[J].系统医学,2018,3(22):34-35,38.
[11]朱永,黎美琪,管健,等.回顾分析Lucas2心肺复苏仪对急诊心肺复苏的临床效果[J].吉林医学,2018,39(6):1120-1122.
[12]杨永涛,李连勇,陈琰,等.透明帽辅助的内镜黏膜下切除术与内镜黏膜下剥离术治疗直肠神经内分泌肿瘤效果的回顾性分析[J].胃肠病学和肝病学杂志,2018,27(3):269-272.
[13]贺子剑,张力,彭东,等.大血管手术中康斯特保护液与含血停搏液心肌保护效果比较[J].中国体外循环杂志,2014,12(4):222-225.
[14]李志.抗病毒药物静脉及局部应用治疗单纯疱疹角膜炎临床效果回顾[J].临床医药文献电子杂志,2019,6(4):163,166.