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.	閔婕, 毛兵, 劉艾然. 《中國循證醫學雜志》發表的中醫藥隨機對照試驗質量評價. 中國循證醫學雜志, 2010, 10(3): 362-366.
14.	于丹丹, 謝雁鳴, 廖星, 等. 《中國中藥雜志》發表隨機對照試驗方法學和報告質量評價研究. 中國中藥雜志, 2018, 43(4): 833-839.
15.	趙君, 廖星, 趙暉, 等. 中藥治療亞健康隨機對照試驗的方法學和質量評價研究. 中國中藥雜志, 2016, 41(21): 4041-4050.
16.	吳泰相, 李幼平, 卞兆祥, 等. 中醫藥臨床隨機對照試驗報告規范. 中國循證醫學雜志, 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.	Pavlovi? 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.	張明妍, 楊豐文, 李越, 等. 《中國中西醫結合雜志》刊載中醫藥隨機對照試驗報告質量的研究. 中國循證醫學雜志, 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 小組. 創建中醫藥臨床試驗統一報告標準, 促進中醫藥現代化. 中國循證醫學雜志, 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. Pavlovi? 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. 董沖亞, 閻小妍, 田然, 等. 強化臨床試驗過程報告, 推進臨床試驗全程透明化. 中國循證醫學雜志, 2018, 18(7): 648-650.
13. 閔婕, 毛兵, 劉艾然. 《中國循證醫學雜志》發表的中醫藥隨機對照試驗質量評價. 中國循證醫學雜志, 2010, 10(3): 362-366.
14. 于丹丹, 謝雁鳴, 廖星, 等. 《中國中藥雜志》發表隨機對照試驗方法學和報告質量評價研究. 中國中藥雜志, 2018, 43(4): 833-839.
15. 趙君, 廖星, 趙暉, 等. 中藥治療亞健康隨機對照試驗的方法學和質量評價研究. 中國中藥雜志, 2016, 41(21): 4041-4050.
16. 吳泰相, 李幼平, 卞兆祥, 等. 中醫藥臨床隨機對照試驗報告規范. 中國循證醫學雜志, 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. Pavlovi? 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. 張明妍, 楊豐文, 李越, 等. 《中國中西醫結合雜志》刊載中醫藥隨機對照試驗報告質量的研究. 中國循證醫學雜志, 2017, 17(3): 357-363.

Chinese Journal of Evidence-Based Medicine

Data integrity of randomized controlled trial in TCM

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