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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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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17.	陳發展, 趙旭東. 心理治療的不良反應. 中國心理衛生雜志, 2017, 31(1): 72-76.
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19.	中國醫師協會神經內科醫師分會中華醫學會神經病學分會帕金森病及運動障礙學組. 中國帕金森病重復經顱磁刺激治療指南. 中國神經精神疾病雜志, 2021, 47(10): 577-585.
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21.	張蘭蘭, 王美娟, 錢潔, 等. 1993-2006年國內與焦慮障礙治療相關的臨床研究文獻質量. 中國心理衛生雜志, 2011, 25(3): 191-195.
22.	楊勇, 袁穎, 金斌, 等. 臨床試驗報告的統一標準聲明評價2009—2010年國內五種精神科期刊隨機對照試驗文獻質量. 中華精神科雜志, 2013, (1): 52.
23.	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.
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.
25.	來保勇, 賈麗燕, 梁士兵, 等. 針刺治療勃起功能障礙隨機對照臨床試驗的文獻報告質量評價. 現代中醫臨床, 2019, 26(5): 14-20.
26.	欒嘉, 鄧強庭, 黃超, 等. 我國醫學期刊臨床研究論文質量控制策略. 中國科技期刊研究, 2019, 30(12): 1281-1288.

1. 顏虹, 徐勇勇, 趙耐青, 等. 醫學統計學(第3版). 北京: 人民衛生出版社, 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, G?tzsche 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. 蘇旻, 張蘭蘭, 李春波. 臨床試驗報告的統一標準聲明評價2004-2008年國內五種精神科期刊隨機對照試驗文獻報告質量. 中華精神科雜志, 2012, 45(5): 263-267.
6. David M, Sally H, Kenneth FS, 等. CONSORT2010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.
7. 馮雪, 方賽男, 高雨鑫, 等. 根據CONSORTHARMs聲明評價雷公藤制劑相關腎毒性RCT的報告質量. 中國中藥雜志, 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. 《藥學與臨床研究》編輯部. 如何正確運用組內相關系數進行一致性檢驗——藥物研究中的統計學(一). 藥學與臨床研究, 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. 董穩航, 李春潔, 項陳洋, 等. 我國口腔頜面外科臨床隨機對照試驗的報告質量評價. 華西口腔醫學雜志, 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. 陳發展, 趙旭東. 心理治療的不良反應. 中國心理衛生雜志, 2017, 31(1): 72-76.
18. 中國醫師協會神經調控專業委員會電休克與神經刺激學組. 重復經顱磁刺激治療專家共識. 轉化醫學雜志, 2018, 7(1): 4-9.
19. 中國醫師協會神經內科醫師分會中華醫學會神經病學分會帕金森病及運動障礙學組. 中國帕金森病重復經顱磁刺激治療指南. 中國神經精神疾病雜志, 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. 張蘭蘭, 王美娟, 錢潔, 等. 1993-2006年國內與焦慮障礙治療相關的臨床研究文獻質量. 中國心理衛生雜志, 2011, 25(3): 191-195.
22. 楊勇, 袁穎, 金斌, 等. 臨床試驗報告的統一標準聲明評價2009—2010年國內五種精神科期刊隨機對照試驗文獻質量. 中華精神科雜志, 2013, (1): 52.
23. 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.
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.
25. 來保勇, 賈麗燕, 梁士兵, 等. 針刺治療勃起功能障礙隨機對照臨床試驗的文獻報告質量評價. 現代中醫臨床, 2019, 26(5): 14-20.
26. 欒嘉, 鄧強庭, 黃超, 等. 我國醫學期刊臨床研究論文質量控制策略. 中國科技期刊研究, 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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