Impact of the Consolidated Standards of Reporting Trials (CONSORT) checklist on reporting of randomized clinical trials in traditional Chinese medicine

Liu, Xue‐ting; Zhang, Xin; Wen, Shu; Peng, Le; Hong, Qi; Kang, Deying

doi:10.1111/jebm.12173

Cited by 22Meta-analysis and systematic reviewsStatistical Methods in Clinical TrialsAcademic Publishing and Open Access

Impact of the Consolidated Standards of Reporting Trials (CONSORT) checklist on reporting of randomized clinical trials in traditional Chinese medicine

Liu, Xue‐ting, Zhang, Xin, Wen, Shu, Peng, Le, Hong, Qi, Kang, Deying·2015·Journal of Evidence-Based Medicine

DOI 10.1111/jebm.12173

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Abstract

Objective: To examine the reporting characteristics and key methodological factors of randomized controlled trials (RCTs) in the field of traditional Chinese medicine and assess whether use of the Consolidated Standards of Reporting Trials (CONSORT) statement is associated with improvement in the quality of reports of RCTs. Method: RCTs published in two major traditional Chinese medicine journals were retrieved and were systematically reviewed. Of those journals, one adopted the CONSORT statement (Journal of Chinese Integrative Medicine (JCIM)) and one did not (Chinese Journal of Integrative Medicine (CJIM)). Items within the CONSORT 2001 and the CONSORT 2010 statements were taken to develop a 63‐item coding manual. The Jadad scale was also used to assess methodological quality of RCTs. Two observers assessed the reporting of reports and extracted data independently. P < 0.05 was considered statistically significant. SPSS was used for all analyses. Results: A total of 76 RCTs were included for the analysis (38 from JCIM and 38 from CJIM). S ignificant improvements both in the overall quality of reporting (CONSORT score) and reporting of methodological items (Jadad scale) over time were observed in adopter journal (JCIM) (P = 0.001). Overall CONSORT score of studies published during 2010 to 2011 (post‐CONSORT) increased 15.30 averagely with 95%CI 8.34 to 22.26 (P = 0.001). Of those, items addressed on reporting of methodological quality were different significantly too. JCIM had more 1.30 items addressed than CJIM in average (95% CI 0.52 to 2.08, P = 0.003). In the multivariate analysis regression, the page length and CONSORT‐promoting status have statistically significant associated with the (P = 0.001 and P = 0.040, respectively). Conclusion: Although a large room needs to improve the reporting of randomized clinical trials in traditional Chinese medicine, the impact for improvement of reporting of TCM RCTs has been proven in some extent.

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Recent investigations into the quality of Chinese clinical trials have been based only on the published reports.
“However, recent investigations into the quality of Chinese clinical trials have been based only on the published reports [1–4, 16, 17], which may not always accurately reflect the actual conduct of the trials because of poor reporting [11, 16, 17].”
From Quality of randomized controlled trials of new generation antidepressants and antipsychotics identified in the China National Knowledge Infrastructure (CNKI): a literature and telephone interview study (2018) · cites this paper as [16]
Published reports may not always accurately reflect the actual conduct of trials because of poor reporting.
“However, recent investigations into the quality of Chinese clinical trials have been based only on the published reports [1–4, 16, 17], which may not always accurately reflect the actual conduct of the trials because of poor reporting [11, 16, 17].”
From Quality of randomized controlled trials of new generation antidepressants and antipsychotics identified in the China National Knowledge Infrastructure (CNKI): a literature and telephone interview study (2018) · cites this paper as [16]

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The quality of reports of randomized clinical trials on traditional Chinese medicine treatments: a systematic review of articles indexed in the China National Knowledge Infrastructure database from 2005 to 2012
Li, J.-N., Liu, Z., Chen, R., Hu, D., Li, W., Li, X., Chen, X., Huang, B., & Liao, L. (2014) · BMC Complementary and Alternative Medicine · doi:10.1186/1472-6882-14-362 · Cited by 51 · see citing works
Quality Assessment of Randomized Controlled Trials Related to Traditional Chinese Medicine Published in the Chinese Journal of Evidence-Based Medicine
Liu, A. (2010) · Zhongguo xunzheng yixue zazhi · Cited by 1 · see citing works
Assessing the Quality of Reporting of Randomized Controlled Trials in Traditional Chinese Medicine
Mao, B. (2007) · Zhongguo xunzheng yixue zazhi · Cited by 13 · see citing works
The Quality of Reporting of Randomized Controlled Trials of Traditional Chinese Medicine: A Survey of 13 Randomly Selected Journals from Mainland China
Wang, G., Mao, B., Xiong, Z., Fan, T., Chen, X.-D., Wang, L., Liu, G., Liu, J., Guo, J., Chang, J., et al. (2007) · Clinical Therapeutics · doi:10.1016/j.clinthera.2007.07.023 · Cited by 140 · see citing works
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
Fan, F.-F., Qin, X., Sun, Q., Sheng-jun, Z., Wang, P., & Guo, X.-R. (2014) · PLoS ONE · doi:10.1371/journal.pone.0086360 · Cited by 21 · see citing works

Authors: Liu, X., Zhang, X., Wen, S., Peng, L., Hong, Q., & Kang, D.
Affiliations: Sichuan University (CN)
Department of Evidence‐based Medicine and Clinical Epidemiology, West China Hospital Sichuan University Chengdu China
Corresponding author: Kang, Deying
ORCID: Peng, Le
Kang, Deying
Venue: Journal of Evidence-Based Medicine
Publisher: Wiley
Published: 2015-11
Volume: 8
Issue: 4
Pages: 192-208
ISSN: 1756-5383 (ISSN-L)
1756-5391
DOI: 10.1111/jebm.12173
OpenAlex: W1902675027
Cited by: 22
References: 64
Citations by year: 2024: 6 · 2023: 4 · 2021: 1 · 2020: 1 · 2019: 1 · 2018: 5 · 2017: 2 · 2016: 1 · 2015: 1
FWCI: 2.73
Type: journal article
Language: en
Open access: closed
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor, 26 d)
Locations: Journal of Evidence-Based Medicine (publishedVersion)
PubMed (publishedVersion)
Topics: Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
Keywords: CONSORT statement, reporting quality, randomized controlled trials, traditional Chinese medicine, trial reporting guidelines, methodological quality, Jadad scale
MeSH terms: Humans, Medicine, Chinese Traditional, Research Design, Randomized Controlled Trials as Topic, Checklist

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Impact of the Consolidated Standards of Reporting Trials (CONSORT) checklist on reporting of randomized clinical trials in traditional Chinese medicine

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