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Open Access Research article

10-year trend in quantity and quality of pediatric randomized controlled trials published in mainland China: 2002–2011

Chun-Song Yang, Ling-Li Zhang*, Li-Nan Zeng, Yi Liang, Lu Han and Yun-Zhu Lin

Author Affiliations

Pharmacy Department, West China Second Hospital, Sichuan University, No. 20, Section 3, Renmin South Road, Cheng du 610041, Sichuan Province, China

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BMC Pediatrics 2013, 13:113  doi:10.1186/1471-2431-13-113

Published: 2 August 2013

Abstract

Background

Quality assessment of pediatric randomized controlled trials (RCTs) in China is limited. The aim of this study was to evaluate the quantitative trends and quality indicators of RCTs published in mainland China over a recent 10-year period.

Methods

We individually searched all 17 available pediatric journals published in China from January 1, 2002 to December 30, 2011 to identify RCTs of drug treatment in participants under the age of 18 years. The quality was evaluated according to the Cochrane quality assessment protocol.

Results

Of 1287 journal issues containing 44398 articles, a total of 2.4% (1077/44398) articles were included in the analysis. The proportion of RCTs increased from 0.28% in 2002 to 0.32% in 2011. Individual sample sizes ranged from 10 to 905 participants (median 81 participants); 2.3% of the RCTs were multiple center trials; 63.9% evaluated Western medicine, 32.5% evaluated traditional Chinese medicine; 15% used an adequate method of random sequence generation; and 10.4% used a quasi-random method for randomization. Only 1% of the RCTs reported adequate allocation concealment and 0.6% reported the method of blinding. The follow-up period was from 7 days to 96 months, with a median of 7.5 months. There was incomplete outcome data reported in 8.3%, of which 4.5% (4/89) used intention-to-treat analysis. Only 0.4% of the included trials used adequate random sequence allocation, concealment and blinding. The articles published from 2007 to 2011 revealed an improvement in the randomization method compared with articles published from 2002 to 2006 (from 2.7% to 23.6%, p = 0.000).

Conclusions

In mainland China, the quantity of RCTs did not increase in the pediatric population, and the general quality was relatively poor. Quality improvements were suboptimal in the later 5 years.

Keywords:
Children; Drugs; Randomized controlled trials; Quality assessment