The status of registrations, ethical reviews and informed consent forms in RCTs of high impact factor Chinese medical journals_Chinese Journal of Evidence-Based Medicine

Authors：

ZHAO Hongjie ¹ ,  ZHANG Junhua ¹ , GUO Liping ² , YANG Fengwen ¹ , ZHANG Mingyan ¹ , LI Yue ¹ , WANG Hucheng ¹ , ZHANG Lishuang ¹ , JIN Xinyao ¹

1. Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, P.R.China;
2. Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, P.R.China;

Corresponding?author：

ZHANG Junhua, Email: zjhtcm@foxmail.com

Keywords：

RCT; Registration; Ethical review; Informed consent; Reporting quality

DOI：

10.7507/1672-2531.201802027

Video：

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ObjectivesTo investigate the status of clinical trial registrations (CTRs), ethical reviews (ERs) and informed consent forms (ICFs) of randomized controlled trials (RCTs), which were published in the top 20 journals included by Chinese Science Citation Database (CSCD), and evaluate the methodological quality of RCTs.MethodsWe selected top 20 high impact factor Chinese medical journals indexed by CSCD, the RCTs published between 2016 and 2017 were searched. The CTR, ER and ICFs for all RCTs were analyzed.ResultsA total of 395 RCTs were included for data analysis. Nineteen RCTs (4.8%) reported the information of registration. For the 4 traditional Chinese medicine journals, only 4 (1.9%) of 207 RCTs reported the registered information. For the 16 western medical journals, only 15 (8%) of 188 RCTs reported the registered information. There were 185 RCTs (46.8%) which reported the information of ethical review. Among them, 66 RCTs (31.9%) were published in traditional Chinese medical journals and 119 RCTs (63.3%) were published in western medical journals. There were 253 RCTs (64.1%) which reported the information of informed consent. Among them, 154 RCTs (74.4%) were published in Chinese medical journals and 199 RCTs (52.7%) were in western medical journals. In terms of methodology, approximately 299 RCTs (75.7%) reported the type of randomization where 60 RCTs (15.2%) reported the information of allocation concealment and 38 RCTs (59.6%) reported blinding.ConclusionsThe proportion of RCTs registration, ethical review and informed consent is still low and the methodological quality of the studies require to be improved. Therefore, it is necessary to strengthen the training of clinical trial methodology.

Citation： ZHAO Hongjie, ZHANG Junhua, GUO Liping, YANG Fengwen, ZHANG Mingyan, LI Yue, WANG Hucheng, ZHANG Lishuang, JIN Xinyao. The status of registrations, ethical reviews and informed consent forms in RCTs of high impact factor Chinese medical journals. Chinese Journal of Evidence-Based Medicine, 2018, 18(7): 735-739. doi: 10.7507/1672-2531.201802027 Copy

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10.	Pinto RZ, Elkins MR, Moseley AM, et al. Many randomized trials of physical therapy interventions are not adequately registered: a survey of 200 published trials. Phys Ther, 2013, 93(3): 299-309.
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12.	Mathieu S, Chan AW, Ravaud P. Use of trial register information during the peer review process. PLoS One, 2013, 8(4): e59910.
13.	David Moher, Sally Hopewell, Kenneth F Schulz, 等. CONSORT 2010說明與詳述: 報告平行對照隨機臨床試驗指南的更新. 中西醫結合學報, 2010, 8(8): 701-741.
14.	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.
15.	田冬霞, 張金鐘, 侯軍儒. 中國倫理委員會運作現狀的一個縮影-天津市三級醫院倫理委員會的調查與分析. 中國醫學倫理學, 2008, 21(1): 44-47.
16.	吳曉瑞, 李義庭, 趙學志, 等. 北京地區機構倫理審查委員會現狀的調查分析. 醫學與哲學, 2010, 31(5): 11-13.
17.	周吉銀, 鄧璠, 劉丹, 等. 我國醫學倫理委員會存在的問題及建議. 中國臨床藥理學雜志, 2017, 33(4): 365-368.

1. General Assembly of the World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dent, 2014, 81(3): 14-18.
2. Tonks A. Registering clinical trials. BMJ, 1999, 319(7224): 1565-1568.
3. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication (2010-04). Available at: http://www.icmje.org/urm-full.pdf.
4. 吳泰相, 李幼平, 劉關鍵, 等. 臨床試驗注冊制度與循證醫學. 中國循證醫學雜志, 2007, 7(4): 239-243.
5. 吳泰相, 李幼平, 劉關鍵, 等. 中國臨床試驗注冊中心及中國循證醫學中心提高我國臨床試驗質量的策略和措施. 中國循證醫學雜志, 2010, 10(11): 1243-1248.
6. Logvinov I. Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act. Contemp Clin Trials, 2014, 37(2): 219-224.
7. Tharyan P, Ghersi D. Registering clinical trials in India: a scientific and ethical imperative. Natl Med J India, 2008, 21(1): 31-34.
8. Huser V, Cimino JJ. Evaluating adherence to the international committee of medical journal editors' policy of mandatory, timely clinical trial registration. J Am Med Inform Assoc, 2013, 20(e1): e169-e174.
9. vande Wetering FT, Scholten RJ, Haring T, et al. Trial registration numbers are underreported in biomedical publications. PLoS One, 2012, 7(11): e49599.
10. Pinto RZ, Elkins MR, Moseley AM, et al. Many randomized trials of physical therapy interventions are not adequately registered: a survey of 200 published trials. Phys Ther, 2013, 93(3): 299-309.
11. Hooft L, Korevaar DA, Molenaar N, et al. Endorsement of ICMJE's clinical trial registration policy: a survey among journal editors. Neth J Med, 2014, 72(7): 349-355.
12. Mathieu S, Chan AW, Ravaud P. Use of trial register information during the peer review process. PLoS One, 2013, 8(4): e59910.
13. David Moher, Sally Hopewell, Kenneth F Schulz, 等. CONSORT 2010說明與詳述: 報告平行對照隨機臨床試驗指南的更新. 中西醫結合學報, 2010, 8(8): 701-741.
14. 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.
15. 田冬霞, 張金鐘, 侯軍儒. 中國倫理委員會運作現狀的一個縮影-天津市三級醫院倫理委員會的調查與分析. 中國醫學倫理學, 2008, 21(1): 44-47.
16. 吳曉瑞, 李義庭, 趙學志, 等. 北京地區機構倫理審查委員會現狀的調查分析. 醫學與哲學, 2010, 31(5): 11-13.
17. 周吉銀, 鄧璠, 劉丹, 等. 我國醫學倫理委員會存在的問題及建議. 中國臨床藥理學雜志, 2017, 33(4): 365-368.

Chinese Journal of Evidence-Based Medicine

The status of registrations, ethical reviews and informed consent forms in RCTs of high impact factor Chinese medical journals

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