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Methodological Evaluation of Randomised Controlled Trials for Treatment of Heart Failure in Chinese Medical Literatures

Long Chiau Ming, X. Shi-yang

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Abstract

Objective To assess the quality of randomised controlled trials (RCTs) relevant to heart failure published in Chinese medical journal. Methods According to Cochrane system evaluation manual, the Chinese biomedical journals in 1999–2009 were machine-searched and 169 RCTs for heart failure were identified. Investigation contents included sample sise, exclusion criteria, randomised methods, blinding, groups of comparability, intervention measures and TCM syndrome type and so on. Results In the recent 10 years, the numbers of RCTs were 169 trials. There were 20.11% with explicit inclusion criteria for subject selection and 27.81% with exclusion criteria. No one literature shows adrenal estimation method. There were 15.38% have the random description and only one piece of RCTs adopted random distribution of hidden. Blindness were used in 6 RCTS. 4.14% RCT reporting lost to follow-up and exit. Jadad quality score high quality documents only six. Conclusions The quality of TCM treatment for heart failure RCTs is not good enough. Mainly for randomised method without explanation or application error, randomly assigned to hide not get enough attention, blind, ignore use low compliance, cases were analysed, and the small sample tests, so much more centre, large sample test research and sample no specific estimation method, a baseline data statistics, efficacy evaluation standard enough unity.

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Objective To assess the quality of randomised controlled trials (RCTs) relevant to heart failure published in Chinese medical journal. Methods According to Cochrane system evaluation manual, the Chinese biomedical journals in 1999–2009 were machine-searched and 169 RCTs for heart failure were identified. Investigation contents included sample sise, exclusion criteria, randomised methods, blinding, groups of comparability, intervention measures and TCM syndrome type and so on. Results In the recent 10 years, the numbers of RCTs were 169 trials. There were 20.11% with explicit inclusion criteria for subject selection and 27.81% with exclusion criteria. No one literature shows adrenal estimation method. There were 15.38% have the random description and only one piece of RCTs adopted random distribution of hidden. Blindness were used in 6 RCTS. 4.14% RCT reporting lost to follow-up and exit. Jadad quality score high quality documents only six. Conclusions The quality of TCM treatment for heart failure RCTs is not good enough. Mainly for randomised method without explanation or application error, randomly assigned to hide not get enough attention, blind, ignore use low compliance, cases were analysed, and the small sample tests, so much more centre, large sample test research and sample no specific estimation method, a baseline data statistics, efficacy evaluation standard enough unity.

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Available abstract

Objective To assess the quality of randomised controlled trials (RCTs) relevant to heart failure published in Chinese medical journal. Methods According to Cochrane system evaluation manual, the Chinese biomedical journals in 1999–2009 were machine-searched and 169 RCTs for heart failure were identified. Investigation contents included sample sise, exclusion criteria, randomised methods, blinding, groups of comparability, intervention measures and TCM syndrome type and so on. Results In the recent 10 years, the numbers of RCTs were 169 trials. There were 20.11% with explicit inclusion criteria for subject selection and 27.81% with exclusion criteria. No one literature shows adrenal estimation method. There were 15.38% have the random description and only one piece of RCTs adopted random distribution of hidden. Blindness were used in 6 RCTS. 4.14% RCT reporting lost to follow-up and exit. Jadad quality score high quality documents only six. Conclusions The quality of TCM treatment for heart failure RCTs is not good enough. Mainly for randomised method without explanation or application error, randomly assigned to hide not get enough attention, blind, ignore use low compliance, cases were analysed, and the small sample tests, so much more centre, large sample test research and sample no specific estimation method, a baseline data statistics, efficacy evaluation standard enough unity.

Key concepts: Medicine, Jadad scale, Blinding, Randomized controlled trial, Sample size determination, Physical therapy, Inclusion and exclusion criteria, Statistics

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