%0 Journal Article
%T An assessment of the quality of randomised controlled trials conducted in China
%A Dalu Zhang
%A Peng Yin
%A Nick Freemantle
%A Rachel Jordan
%A Nanshan Zhong
%A KK Cheng
%J Trials
%D 2008
%I BioMed Central
%R 10.1186/1745-6215-9-22
%X A systematic review and critical appraisal of randomised controlled trials (RCTs) conducted in China and published in 2004 was undertaken to describe their characteristics, assess the quality of their reporting, and where possible, the quality of their conduct. Randomised controlled trials in all disease areas and types of interventions, which took place in China and included Chinese citizens were identified using PubMed and hand searching the Journal Series of the Chinese Medical Association. Quality was assessed against a subset of criteria adapted from the CONSORT statement.Three hundred and seven RCTs were included. One hundred and ninety-nine (64.8%) failed to report methods of randomization and 254 (82.4%) did not mention blinding of either participants or investigators. Reporting of baseline characteristics, primary outcome and length of follow-up was inadequate in a substantial proportion of studies. Fewer than 11% of RCTs mentioned ethical approval and only 18.0% adequately discussed informed consent. However, dropout rates were very favourable with nearly 44% of trials reporting a zero dropout rate.Reporting of RCTs in China requires substantial improvement to meet the targets of the CONSORT statement. The conduct of Chinese RCTs cannot be directly inferred from the standard of reporting; however without good reporting the methods of the trials cannot be clearly ascertained.Randomised controlled trials (RCTs) are considered the 'gold standard' for assessing the effectiveness of pharmacological and other interventions in the field of medicine [1-4]. They are widely accepted as the best research design because they distribute both known and unknown prognostic factors between treatment groups by the play of chance [5-8] thereby minimizing the possibility that any treatment effect is due to bias or confounding, and providing the basis for valid statistical comparison [8].However, RCTs vary in their methodological rigour, and it is well known that poor quality
%U http://www.trialsjournal.com/content/9/1/22