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Quality assessment of the reports of randomized controlled trials concerning diabetes published in China in 2012 by Consolidated Standards of Reporting Trials Statement 2010

作者
Bo Wang,Zunhai Zhou,Xiaomin Song,Lei Gu,Xuane Zhang
出处
期刊:Chinese Journal of Endocrinology and Metabolism [Chinese Medical Association]
卷期号:30 (06): 529-533
标识
DOI:10.3760/cma.j.issn.1000-6699.2014.06.021
摘要

To explore the quality of methodology about the reports of randomized controlled trials about diabetes published in China in 2012 by CONSORT statement.The reporting of randomized controlled trials related to diabetes in Chinese academic journals were searched through WANFANG full-text database.The quality of randomized controlled trials was assessed according to the CONSORT 2010 statement.The series of magazines of Chinese Medical Association and Chinese Journal of diabetes of Chinese Medical Association were compared with other magazines.After screening,2 591 articles among 5 269 articles were included,including 70 articles published in series of magazines of Chinese Medical Association and Chinese Journal of diabetes,and the other 2 521 articles.In 2 591 RCTs,19 (0.7%) RCTs could be identified as a randomized trial in the title,2 574 (99.3%) RCTs had structured abstract,2 510 (96.9%) RCTs described the background,2 053 (79.2%) RCTs described the experimental design,1 936 (74.7%) RCTs described subjects eligibility criteria,2 588 (99.9%) RCTs described interventions,10 (0.39%) RCTs pre-set the primary and secondary outcome measures,120 (4.6%) RCTs elaborated generate a random sequence,0 (0.0%) RCTs described allocation concealment,28 (1.1%) RCTs implementation blinded,308 (1 1.9%) of baseline information described in a table,941 (36.3%) RCTs described the hazards and accidental effects,385 (14.9%) RCTs described limitations,2 505 (96.7%) interpreted the results.Compared with other magazines,there was higher proportion of reports in the description of design of experiment (x2 =16.348,P<0.01),eligible subjects standard (x2 =21.667,P<0.01),set the primary and secondary outcome indicators (x2 =53.128,P<0.01),random sequence generation method (x2 =187.63,P< 0.01),subjects process (x2 =16.969,P<0.01),description of recruitment period and the follow-up period (x2 =8.938,p =0.001),baseline data (x2 =140.67,P<0.01),discussion of limitations (x2 =8.581,P<0.01),and extension (x2 =146.29,P<0.01) in series of magazines of Chinese Medical Association and Chinese Journal of diabetes.The quality of the reports of RCT in academic journals of diabetes in 2012 in China was still poor,although there was higher proportion of reports in series of magazines of Chinese Medical Association and Chinese Journal of diabetes,and the CONSORT statement should be widely used in reports of RCT. Key words: Randomized controlled trials;  Diabetes mellitus;  CONSORT statement

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