PT  - JOURNAL ARTICLE
AU  - Yi Lu
AU  - Qiuju Yao
AU  - Jie Gu
AU  - Ce Shen
TI  - Methodological reporting of randomized clinical trials in respiratory research in 2010
AID  - 10.4187/respcare.01877
DP  - 2013 Jan 08
TA  - Respiratory Care
PG  - respcare.01877
4099  - http://rc.rcjournal.com/content/early/2013/01/08/respcare.01877.short
4100  - http://rc.rcjournal.com/content/early/2013/01/08/respcare.01877.full
AB  - Background: Although randomized controlled trials (RCTs) are considered as the highest level of evidence, they are also subjected to bias due to a lack of adequately reported randomization and therefore the reporting should be as explicit as possible for readers to determine the significance of contents. Our aim is to evaluate the methodological quality of published RCTs in respiratory research from high ranking clinical journals in 2010. Methods: The methodological quality, including generation of the allocation sequence, allocation concealment, double-blinding, sample size calculation, intention-to-treat analysis, and flow diagram in RCTs published in twelve top ranking clinical respiratory journals and five top ranking general medical journals were assessed. The number of medical centers involved, sample size, disease areas, type of the funding source, type of the intervention, registration status, times cited count, journal impact factor, journal type, and CONSORT endorsed status of each trial were also retrieved. Results: 176 trials were included in the final analysis, in which 93 (53%) reported adequate generation of the allocation sequence, 66 (38%) reported adequate allocation concealment, 79 (45%) were double-blind, 123 (70%) reported adequate sample size calculation, 88 (50%) reported intention-to-treat analysis, and 122 (69%) reported flow diagram. Multivariate logistic regression analysis revealed that impact factor≥5 was the important factor influencing the adequate allocation sequence generation. Registration and impact factor≥5 were the important factors influencing the adequate allocation concealment. Medical intervention, registration and journals endorsed CONSORT were the important factors influencing the adequate double-blinding. General medical journals publication was the important factor influencing the adequate sample size calculation. Conclusions: This study shows that the reported methodological quality of RCTs in respiratory research still needs improvement. Stricter adoption of the CONSORT statement might enhance the reporting quality of RCTs.