Analysis of the current situation of registry studies in China_Chinese Journal of Evidence-Based Medicine

Authors：

ZHOU Li ¹ , OUYANG Wenwei ¹ , LI Geng ¹ , LIU Aolin ¹ ,  WEN Zehuai ^1,2

1. Key Unit of Methodology in Clinical Research of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, 510120, P.R.China;
2. DME Center of Guangzhou University of Chinese Medicine, Guangzhou, 510405, P.R.China;

Corresponding author：

WEN Zehuai, Email: wenzh@gzucm.edu.cn

Keywords：

Registry study; Clinical research registry platform; Study design; Current situation

DOI：

10.7507/1672-2531.201811126

Video：

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Objective To investigate the current situation of domestic registry studies, and to provide basis for future research.Methods World Health Organization (WHO) registration platform, ClinicalTrials.gov registration platform and other registration platforms were searched to collect the registered registration studies in Mainland China from inception to July 31^st, 2018. Two researchers collected and collated data, analyzed by descriptive statistical methods, and then python-igraph package in Python 3.5 was used to draw the network diagram.Results A total of 247 studies were retrieved, mainly for disease registry and pharmaceutical product registry. Cohort and case-series were the principally study design. The research focused on chronic diseases such as cardiovascular and cerebrovascular diseases, and research sites were based on the economically developed area, for example, Beijing, Shanghai and Guangdong. The network diagram of study design and disease system shows that cohort research design is widely used in the nervous system and circulatory system; the network diagram of the research sites and disease system found that Beijing mainly studied circulatory and nervous system diseases, Shanghai mainly studied circulatory system diseases, and Guangdong relatively studied more on nervous system and urinary system diseases.Conclusion The increasing number of registry studies in China reflects the importance of long-term outcome assessment of diseases.

Citation： ZHOU Li, OUYANG Wenwei, LI Geng, LIU Aolin, WEN Zehuai. Analysis of the current situation of registry studies in China. Chinese Journal of Evidence-Based Medicine, 2019, 19(6): 702-707. doi: 10.7507/1672-2531.201811126 Copy

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16.	姜俊杰, 谢雁鸣, 张寅, 等. 32546例疏血通注射液医院集中监测研究. 中国中药杂志, 2016, 41(20): 3852-3858.
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20.	陈建国, 朱健, 张永辉, 等. 肝癌流行趋势的改变: 基于启东40年癌症登记资料的分析. 中国肿瘤, 2014, 23(8): 621-628.

1. Gliklich R, Dreyer N, Leavy M, et al. Registries for evaluating patient outcomes: a user’s guide. Third edition. Available at: http://www.effectivehealthcare.ahrq.gov/registries-guide-3.cfm.
2. 杨星月, 刘佳, 何丽云, 等. 病例注册登记研究的应用进展. 中国循证医学杂志, 2016, 16(12): 1481-1484.
3. 国家消化系疾病临床医学研究中心. 国家消化道肿瘤筛查计划启动. Available at: http://www.ncrcgastro.org/newsalerts/news/xw357.html.
4. 国家神经系统疾病临床医学研究中心. 建立4个国家级脑血管病登记研究平台. Available at: http://ncrcnd.org.cn/plus/view.php?aid=102.
5. 陈薇, 刘建平. 注册研究的定义, 设计及国内外进展. 现代中医临床, 2014, 21(6): 23-26.
6. 吴以岭, 魏聪. 通络药物治疗心脑血管病现状与展望. 疑难病杂志, 2015, 14(1): 1-5.
7. 谭婧, 程亮亮, 王雯, 等. 患者登记研究的策划与患者登记数据库构建: 基于观察性设计的真实世界研究. 中国循证医学杂志, 2017, 17(12): 1365-1372.
8. Qiao YL, Dawsey SM, Kamangar F, et al. Total and cancer mortality after supplementation with vitamins and minerals: follow-up of the linxian general population nutrition intervention trial. J Natl Cancer Inst, 2009, 101(7): 507-518.
9. Abnet CC, Freedman ND, Hu N, et al. A shared susceptibility locus in PLCE1 at 10q23 for gastric adenocarcinoma and esophageal squamous cell carcinoma. Nat Genet, 2010, 42(9): 764-767.
10. Hosgood HD 3rd, Liu CS, Rothman N, et al. Mitochondrial DNA copy number and lung cancer risk in a prospective cohort study. Carcinogenesis, 2010, 31(5): 847-849.
11. Benza RL, Miller DP, Gomberg-Maitland M, et al. Predicting survival in pulmonary arterial hypertension: insights from the Registry to Evaluate Early and Long-Term Pulmonary Arterial Hypertension Disease Management (REVEAL). Circulation, 2010, 122(2): 164-172.
12. 张健, 张宇辉. 多中心、前瞻性中国心力衰竭注册登记研究-病因、临床特点和治疗情况初步分析. 中国循环杂志, 2015, 30(5): 413-416.
13. Huang Y, Li J, Zhu X, et al. Relationship between healthy lifestyle behaviors and cardiovascular risk factors in Chinese patients with type 2 diabetes mellitus: a subanalysis of the CCMR-3B STUDY. Acta Diabetol, 2017, 54(6): 569-579.
14. 黎明全, 萧伟, 谢雁鸣, 等. 基于巢式设计的热毒宁注射液不良反应特征及影响因素分析. 中医杂志, 2014, 55(9): 786-790.
15. 廖星, 于丹丹, 谢雁鸣, 等. 碟脉灵苦碟子注射液上市后安全性监测: 一项30233例真实世界注册登记研究. 中国中药杂志, 2017, 42(15): 2857-2863.
16. 姜俊杰, 谢雁鸣, 张寅, 等. 32546例疏血通注射液医院集中监测研究. 中国中药杂志, 2016, 41(20): 3852-3858.
17. 刘佳, 何丽云, 赵玉凤, 等. 基于真实世界国际针灸病例注册登记研究的关键技术. 世界科学技术-中医药现代化, 2017, 19(12): 1920-1923.
18. 裴正存, 詹思延. 病例注册登记的行动计划. 药物流行病学杂志, 2016, 25(9): 583-585.
19. 廖星, 谢雁鸣, 杨薇, 等. 将注册登记研究引入到中医药上市后再评价研究领域的意义. 中国中西医结合杂志, 2014, 34(3): 261-266.
20. 陈建国, 朱健, 张永辉, 等. 肝癌流行趋势的改变: 基于启东40年癌症登记资料的分析. 中国肿瘤, 2014, 23(8): 621-628.

Chinese Journal of Evidence-Based Medicine

Analysis of the current situation of registry studies in China

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