WEN Wanxin, LU Jingmin, LU Liming, et al. Analysis of the Current Status of RCTs Evaluation with CONSORT Statement and STRICTA in China[J]. Journal of Traditional Chinese Medicine2015, 56(18): 1559-1563.
WEN Wanxin, LU Jingmin, LU Liming, et al. Analysis of the Current Status of RCTs Evaluation with CONSORT Statement and STRICTA in China[J]. Journal of Traditional Chinese Medicine2015, 56(18): 1559-1563.DOI: 10.13288/j.11-2166/r.2015.18.009.
Analysis of the Current Status of RCTs Evaluation with CONSORT Statement and STRICTA in China
Objective To make systemic summary on the status and problems of randomized controlled trials( RCTs) evaluation with Consolidated Standards of Reporting Trials( CONSORT) statement
which is the unified standard of clinical trial reports
and Standards for Reporting Interventions in Clinical Trials of Acupuncture( STRICTA)
which is expanded standards for reporting interventions in controlled trials of acupuncture interiorly
in China.Methods Studies on RCTs evaluated with CONSORT and STRICTA were searched in China Biomedical Bibliographic Database( CBM)
China National Knowledge Infrastructure( CNKI)
VIP Database
and Wanfang Database. The application of CONSORT and STRICTA was analyzed
and the evaluation methods
reporting styles
and ways of showing results were summarized. Results 109 papers were included in. Among them
CONSORT of 2001 edition was applied in 75 papers( 68. 8%)
CONSORT of 2010( latest revised) edition was applied in 31 papers( 28. 4%); 74 papers( 67. 9%) were about evaluation on Chinese Medicine RCTs or integrated Chinese Medicine and Western Medicine treatments RCTs; 81. 7% of evaluations( 89 papers) were made by two researchers independently
and different opinions were solved by consultation or a third researcher; two-level evaluation( reported
unreported) was adopted in 72 papers( 66. 1%)
and three-level evaluation( fully reported
partly reported
unreported)was used in 6 papers( 5. 5%); and 75 papers( 68. 8%) showed results by list or list combined with text description.Conclusion Researches on RCT evaluation by CONSORT and STRICTA have attracted more and more attention.The quality of clinical research reports is getting better
but the evaluation methods need to be improved and regulated urgently.
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