A survey on the reporting quality of clinical randomized controlled trials in 5 Chinese psychiatric journals from 2016 to 2020_Chinese Journal of Evidence-Based Medicine

Authors：

HAI Fan ^1,2 , JIANG Dan ³ , DONG Yu ⁴ , LI Hui ⁵ , YANG Shichang ² ,  LI Chunbo ^4,6,7

1. The Eighth People's Hospital of Zhengzhou, Zhengzhou 450000, P. R. China;
2. The 2^nd Affiliated Hospital, Xinxiang Medical University, Xinxiang 453002, P. R. China;
3. Chengdu Jin Xin Psychiatric Hospital, Chengdu 610000, P. R. China;
4. Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai 200030, P. R. China;
5. Huangpu District Mental Health Center, Shanghai 200023, P. R. China;
6. Shanghai Key Laboratory of Psychotic Disorders, Shanghai 200030, P. R. China;
7. Institute of Psychology and Behavioral Science, Shanghai Jiaotong University, Shanghai 200030, P. R. China;

Corresponding author：

LI Chunbo, Email: licb@smhc.org.cn

Keywords：

Psychiatric journal; Randomized controlled trial; CONSORT 2010 statement; Reporting quality

DOI：

10.7507/1672-2531.202205005

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective To evaluate the reporting quality of clinical randomized controlled trials (RCTs) published in five Chinese psychiatric journals from 2016 to 2020 and to compare the reporting quality with that from 2004 to 2008. Methods RCTs in five Chinese psychiatric journals were collected through a computerized search of the CNKI, WanFang Data, and CBM databases and manual searches of paper journals, all with a search timeframe from 2016 to 2020. The CONSORT 2010 statement and two extensions (CONSORT extension for abstracts and CONSORT harms extension) were used to evaluate the RCTs. The criteria for reporting quality were the evaluation score, reporting proportion, and compliance proportion. The reporting quality of RCTs in the past 5 years was compared by year group. In addition, the RCT reporting quality from 2004 to 2008 was compared with that from 2016 to 2020. Results In total, 226 RCTs were included. There was no statistically significant difference in the total evaluation score or abstract score from 2016 to 2020 (F=0.54, P=0.71; H=1.49, P=0.83). However, there were statistically significant differences in the harm scores from 2016 to 2020 (H=10.78, P=0.03). Further analysis of the items revealed statistically significant differences in the reporting proportion of items 16 and 19 (Fisher’s=8.61, P=0.04; χ²=11.63, P=0.02) and no significant differences in the other items (P>0.05). The reporting proportion of defined primary and secondary outcome indicators, allocation concealment, randomization implementation, outcomes and estimation, generalization, trial registration, and flow chart was <10% in each year. There was a statistically significant difference in the compliance proportion of RCT reporting quality from 2016 to 2020 versus 2004 to 2008 (39.54%±8.92% vs. 34.76%±9.16%, t=6.60, P<0.001). Conclusion The reporting quality of RCTs in five Chinese psychiatric journals from 2016 to 2020 is better than that from 2004 to 2008. However, the reporting quality of RCTs within the latter 5 years still have reporting deficiencies in important items, and many aspects still are needed to be improved and enhanced.

Citation： HAI Fan, JIANG Dan, DONG Yu, LI Hui, YANG Shichang, LI Chunbo. A survey on the reporting quality of clinical randomized controlled trials in 5 Chinese psychiatric journals from 2016 to 2020. Chinese Journal of Evidence-Based Medicine, 2022, 22(9): 1048-1054. doi: 10.7507/1672-2531.202205005 Copy

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25.	来保勇, 贾丽燕, 梁士兵, 等. 针刺治疗勃起功能障碍随机对照临床试验的文献报告质量评价. 现代中医临床, 2019, 26(5): 14-20.
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1. 颜虹, 徐勇勇, 赵耐青, 等. 医学统计学(第3版). 北京: 人民卫生出版社, 2015.
2. Hopewell S, Clarke M, Moher D, et al. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med, 2008, 5(1): e20.
3. Ioannidis JP, Evans SJ, Gøtzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med, 2004, 141(10): 781-788.
4. Turner L, Shamseer L, Altman DG, et al. Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals. A Cochrane review. Syst Rev, 2012, 1: 60.
5. 苏旻, 张兰兰, 李春波. 临床试验报告的统一标准声明评价2004-2008年国内五种精神科期刊随机对照试验文献报告质量. 中华精神科杂志, 2012, 45(5): 263-267.
6. David M, Sally H, Kenneth FS, 等. CONSORT2010说明与详述: 报告平行对照随机临床试验指南的更新. 中西医结合学报, 2010, 8(8): 701-741.
7. 冯雪, 方赛男, 高雨鑫, 等. 根据CONSORTHARMs声明评价雷公藤制剂相关肾毒性RCT的报告质量. 中国中药杂志, 2018, 43(3): 440-445.
8. Rikos D, Dardiotis E, Aloizou AM, et al. Reporting quality of randomized controlled trials in restless legs syndrome based on the CONSORT statement. Tremor Other Hyperkinet Mov (N Y), 2019, DOI: 10.7916/d8-0f2v-aq62.
9. 《药学与临床研究》编辑部. 如何正确运用组内相关系数进行一致性检验——药物研究中的统计学(一). 药学与临床研究, 2018, 26(1): 7-8.
10. Susvirkar A, Gada P, Figer B, et al. An assessment of the compliance of randomized controlled trials published in two high impact journals with the CONSORT statement. Natl Med J India, 2018, 31(2): 79-82.
11. Vassar M, Jellison S, Wendelbo H, et al. Using the CONSORT statement to evaluate the completeness of reporting of addiction randomised trials: a cross-sectional review. BMJ Open, 2019, 9(9): e032024.
12. 董稳航, 李春洁, 项陈洋, 等. 我国口腔颌面外科临床随机对照试验的报告质量评价. 华西口腔医学杂志, 2012, 30(5): 505-508.
13. Zhang Y, Becker T, Ma Y, et al. A systematic review of Chinese randomized clinical trials of SSRI treatment of depression. BMC Psychiatry, 2014, 14: 245.
14. Wang L, Li Y, Li J, et al. Quality of reporting of trial abstracts needs to be improved: using the CONSORT for abstracts to assess the four leading Chinese medical journals of traditional Chinese medicine. Trials, 2010, 11: 75.
15. Kumar S, Mohammad H, Vora H, et al. Reporting quality of randomized controlled trials of periodontal diseases in journal abstracts-a cross-sectional survey and bibliometric analysis. J Evid Based Dent Pract, 2018, 18(2): 130-141.
16. Hardy GE, Bishop-Edwards L, Chambers E, et al. Risk factors for negative experiences during psychotherapy. Psychother Res, 2019, 29(3): 403-414.
17. 陈发展, 赵旭东. 心理治疗的不良反应. 中国心理卫生杂志, 2017, 31(1): 72-76.
18. 中国医师协会神经调控专业委员会电休克与神经刺激学组. 重复经颅磁刺激治疗专家共识. 转化医学杂志, 2018, 7(1): 4-9.
19. 中国医师协会神经内科医师分会中华医学会神经病学分会帕金森病及运动障碍学组. 中国帕金森病重复经颅磁刺激治疗指南. 中国神经精神疾病杂志, 2021, 47(10): 577-585.
20. McClintock SM, Reti IM, Carpenter LL, et al. Consensus recommendations for the clinical application of repetitive transcranial magnetic stimulation (rTMS) in the treatment of depression. J Clin Psychiatry, 2018, 79(1): 16cs10905.
21. 张兰兰, 王美娟, 钱洁, 等. 1993-2006年国内与焦虑障碍治疗相关的临床研究文献质量. 中国心理卫生杂志, 2011, 25(3): 191-195.
22. 杨勇, 袁颖, 金斌, 等. 临床试验报告的统一标准声明评价2009—2010年国内五种精神科期刊随机对照试验文献质量. 中华精神科杂志, 2013, (1): 52.
23. 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.
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.
25. 来保勇, 贾丽燕, 梁士兵, 等. 针刺治疗勃起功能障碍随机对照临床试验的文献报告质量评价. 现代中医临床, 2019, 26(5): 14-20.
26. 栾嘉, 邓强庭, 黄超, 等. 我国医学期刊临床研究论文质量控制策略. 中国科技期刊研究, 2019, 30(12): 1281-1288.

Chinese Journal of Evidence-Based Medicine

A survey on the reporting quality of clinical randomized controlled trials in 5 Chinese psychiatric journals from 2016 to 2020

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