Data integrity of randomized controlled trial in TCM_Chinese Journal of Evidence-Based Medicine

Authors：

HUANG Zhongying ¹ ,  SUN Weiqiang ¹ , DENG Hongyong ² , LAI Jiaqi ³ , LIU Shaonan ³ , YANG Lihong ³ ,  GUO Xinfeng ³ , WU Darong ³ , SHANG Hongcai ⁴

1. Shanghai Jiao Tong University, Shanghai 200240, P.R.China;
2. Shanghai University of Traditional Chinese Medicine, Shanghai 201203, P.R.China;
3. Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, P.R.China;
4. Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing 100700, P.R.China;

Corresponding author：

SUN Weiqiang, Email: sunwq@sjtu.edu.cn; GUO Xinfeng, Email: guoxinfeng@gzucm.edu.cn

Keywords：

Traditional Chinese medicine; Randomized controlled trial; Data integrity; Metadata interface specification

DOI：

10.7507/1672-2531.202106018

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective To define an objective evaluation model for metadata integrity of randomized controlled trials (RCTs) in traditional Chinese medicine (TCM), and to evaluate the data integrity of RCT reports published in TCM journals. Methods Retrieving Chinese medicine RCT literature and extracting data, using the metadata specification list and customized evaluation model defined in the project "Intelligent Construction and Application Demonstration of the Evidence System of Chinese Medicine Dominant Diseases" to analyze RCTs from the perspective of data integrity. Results A metadata interface specification and an objective evaluation model for RCT metadata integrity were proposed. A total of 37 361 articles of 10 diseases from 1986 to 2020 were evaluated. Among them, 6 743 reports failed to meet the basic requirements of metadata specifications. The proportion of reports with no missing required items was between 73% and 97%. "tcm_disease" and "num_drop_total" had a greater impact on completeness for the required items. The reporting rates of the items in the "age_sd" and "history_sd" in the "group" section, and "dosage", "dosage_form" and "dosage_freq" in the "interventions" section were low. The average score of RCT report was 71.39 points. Conclusions There is room for improvement in the integrity of RCT data in TCM, and data reporting is urgently required to be standardized. The metadata specification and completeness objective evaluation model proposed in this study can provide references for improving the data integrity of clinical trial reports of TCM.

Citation： HUANG Zhongying, SUN Weiqiang, DENG Hongyong, LAI Jiaqi, LIU Shaonan, YANG Lihong, GUO Xinfeng, WU Darong, SHANG Hongcai. Data integrity of randomized controlled trial in TCM. Chinese Journal of Evidence-Based Medicine, 2021, 21(10): 1211-1218. doi: 10.7507/1672-2531.202106018 Copy

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13.	闵婕, 毛兵, 刘艾然. 《中国循证医学杂志》发表的中医药随机对照试验质量评价. 中国循证医学杂志, 2010, 10(3): 362-366.
14.	于丹丹, 谢雁鸣, 廖星, 等. 《中国中药杂志》发表随机对照试验方法学和报告质量评价研究. 中国中药杂志, 2018, 43(4): 833-839.
15.	赵君, 廖星, 赵晖, 等. 中药治疗亚健康随机对照试验的方法学和质量评价研究. 中国中药杂志, 2016, 41(21): 4041-4050.
16.	吴泰相, 李幼平, 卞兆祥, 等. 中医药临床随机对照试验报告规范. 中国循证医学杂志, 2007, 7(8): 601-605.
17.	Paul J, Seib R, Prescott T. The internet and clinical trials: background, online resources, examples and issues. J Med Internet Res, 2005, 7(1): e5.
18.	Kawado M, Hinotsu S, Matsuyama Y, et al. A comparison of error detection rates between the reading aloud method and the double data entry method. Control Clin Trials, 2003, 24(5): 560-569.
19.	Kannry J. Effect of e-prescribing systems on patient safety. Mt Sinai J Med, 2011, 78(6): 827-833.
20.	Kabir ME, Wang H, Bertino E. A role-involved purpose-based access control model. Inform Sys Front, 2012, 14(3): 809-822.
21.	Wang H, Yi X, Bertino E, et al. Protecting outsourced data in cloud computing through access management. Concurr Comput, 2016, 28(3): 600-615.
22.	Vimalachandran P, Wang H, Zhang Y, et al. Ensuring data integrity in electronic health records: a quality health care implication. IEEE: International Conference on Orange Technologies (ICOT), 2016: 20-27.
23.	Pavlović I, Kern T, Miklavcic D. Comparison of paper-based and electronic data collection process in clinical trials: costs simulation study. Contemp Clin Trials, 2009, 30(4): 300-316.
24.	张明妍, 杨丰文, 李越, 等. 《中国中西医结合杂志》刊载中医药随机对照试验报告质量的研究. 中国循证医学杂志, 2017, 17(3): 357-363.

1. Moher D, Pham B, Jones A, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet, 1998, 352(9128): 609-613.
2. Mulrow CD, Cook DJ, Davidoff F. Systematic reviews: critical links in the great chain of evidence. Ann Intern Med, 1997, 126(5): 389-391.
3. Levin KA. Study design VII. Randomised controlled trials. Evid Based Dent, 2007, 8(1): 22-23.
4. Needleman I, Moher D, Altman DG, et al. Improving the clarity and transparency of reporting health research: a shared obligation and responsibility. J Dent Res, 2008, 87(10): 894-895.
5. Fan FF, Xu Q, Sun Q, et al. Assessment of the reporting quality of randomized controlled trials on treatment of coronary heart disease with traditional chinese medicine from the chinese journal of integrated traditional and Western medicine: a systematic review. PLoS One, 2014, 9(1): e86360.
6. Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials, 2010, 11: 32.
7. Cheng CW, Wu TX, Shang HC, et al. CONSORT Extension for Chinese herbal medicine formulas 2017: recommendations, explanation, and elaboration. Ann Intern Med, 2017, 167(2): 112-121.
8. CONSORT for TCM 小组. 创建中医药临床试验统一报告标准, 促进中医药现代化. 中国循证医学杂志, 2006, 6(4): 233-235.
9. Correia LCL, Correia VCA, Souza TMB, et al. Inconsistency prevents the valuable synergism of explanatory and pragmatic trials. J Evid Based Med, 2018, 11(2): 105-111.
10. Pavlović I, Miklavcic D. Web-based electronic data collection system to support electrochemotherapy clinical trial. IEEE Trans Inf Technol Biomed, 2007, 11(2): 222-230.
11. Jordan VM, Lensen SF, Farquhar CM. There were large discrepancies in risk of bias tool judgments when a randomized controlled trial appeared in more than one systematic review. J Clin Epidemiol, 2017, 81: 72-76.
12. 董冲亚, 阎小妍, 田然, 等. 强化临床试验过程报告, 推进临床试验全程透明化. 中国循证医学杂志, 2018, 18(7): 648-650.
13. 闵婕, 毛兵, 刘艾然. 《中国循证医学杂志》发表的中医药随机对照试验质量评价. 中国循证医学杂志, 2010, 10(3): 362-366.
14. 于丹丹, 谢雁鸣, 廖星, 等. 《中国中药杂志》发表随机对照试验方法学和报告质量评价研究. 中国中药杂志, 2018, 43(4): 833-839.
15. 赵君, 廖星, 赵晖, 等. 中药治疗亚健康随机对照试验的方法学和质量评价研究. 中国中药杂志, 2016, 41(21): 4041-4050.
16. 吴泰相, 李幼平, 卞兆祥, 等. 中医药临床随机对照试验报告规范. 中国循证医学杂志, 2007, 7(8): 601-605.
17. Paul J, Seib R, Prescott T. The internet and clinical trials: background, online resources, examples and issues. J Med Internet Res, 2005, 7(1): e5.
18. Kawado M, Hinotsu S, Matsuyama Y, et al. A comparison of error detection rates between the reading aloud method and the double data entry method. Control Clin Trials, 2003, 24(5): 560-569.
19. Kannry J. Effect of e-prescribing systems on patient safety. Mt Sinai J Med, 2011, 78(6): 827-833.
20. Kabir ME, Wang H, Bertino E. A role-involved purpose-based access control model. Inform Sys Front, 2012, 14(3): 809-822.
21. Wang H, Yi X, Bertino E, et al. Protecting outsourced data in cloud computing through access management. Concurr Comput, 2016, 28(3): 600-615.
22. Vimalachandran P, Wang H, Zhang Y, et al. Ensuring data integrity in electronic health records: a quality health care implication. IEEE: International Conference on Orange Technologies (ICOT), 2016: 20-27.
23. Pavlović I, Kern T, Miklavcic D. Comparison of paper-based and electronic data collection process in clinical trials: costs simulation study. Contemp Clin Trials, 2009, 30(4): 300-316.
24. 张明妍, 杨丰文, 李越, 等. 《中国中西医结合杂志》刊载中医药随机对照试验报告质量的研究. 中国循证医学杂志, 2017, 17(3): 357-363.

Chinese Journal of Evidence-Based Medicine

Data integrity of randomized controlled trial in TCM

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