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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17.	劉佳, 何麗云, 趙玉鳳, 等. 基于真實世界國際針灸病例注冊登記研究的關鍵技術. 世界科學技術-中醫藥現代化, 2017, 19(12): 1920-1923.
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20.	陳建國, 朱健, 張永輝, 等. 肝癌流行趨勢的改變: 基于啟東40年癌癥登記資料的分析. 中國腫瘤, 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. 楊星月, 劉佳, 何麗云, 等. 病例注冊登記研究的應用進展. 中國循證醫學雜志, 2016, 16(12): 1481-1484.
3. 國家消化系疾病臨床醫學研究中心. 國家消化道腫瘤篩查計劃啟動. Available at: http://www.ncrcgastro.org/newsalerts/news/xw357.html.
4. 國家神經系統疾病臨床醫學研究中心. 建立4個國家級腦血管病登記研究平臺. Available at: http://ncrcnd.org.cn/plus/view.php?aid=102.
5. 陳薇, 劉建平. 注冊研究的定義, 設計及國內外進展. 現代中醫臨床, 2014, 21(6): 23-26.
6. 吳以嶺, 魏聰. 通絡藥物治療心腦血管病現狀與展望. 疑難病雜志, 2015, 14(1): 1-5.
7. 譚婧, 程亮亮, 王雯, 等. 患者登記研究的策劃與患者登記數據庫構建: 基于觀察性設計的真實世界研究. 中國循證醫學雜志, 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. 張健, 張宇輝. 多中心、前瞻性中國心力衰竭注冊登記研究-病因、臨床特點和治療情況初步分析. 中國循環雜志, 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, 蕭偉, 謝雁鳴, 等. 基于巢式設計的熱毒寧注射液不良反應特征及影響因素分析. 中醫雜志, 2014, 55(9): 786-790.
15. 廖星, 于丹丹, 謝雁鳴, 等. 碟脈靈苦碟子注射液上市后安全性監測: 一項30233例真實世界注冊登記研究. 中國中藥雜志, 2017, 42(15): 2857-2863.
16. 姜俊杰, 謝雁鳴, 張寅, 等. 32546例疏血通注射液醫院集中監測研究. 中國中藥雜志, 2016, 41(20): 3852-3858.
17. 劉佳, 何麗云, 趙玉鳳, 等. 基于真實世界國際針灸病例注冊登記研究的關鍵技術. 世界科學技術-中醫藥現代化, 2017, 19(12): 1920-1923.
18. 裴正存, 詹思延. 病例注冊登記的行動計劃. 藥物流行病學雜志, 2016, 25(9): 583-585.
19. 廖星, 謝雁鳴, 楊薇, 等. 將注冊登記研究引入到中醫藥上市后再評價研究領域的意義. 中國中西醫結合雜志, 2014, 34(3): 261-266.
20. 陳建國, 朱健, 張永輝, 等. 肝癌流行趨勢的改變: 基于啟東40年癌癥登記資料的分析. 中國腫瘤, 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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