Improving the quality of reporting randomized controlled trials in cardiothoracic surgery: the way forward.
OBJECTIVE
To evaluate the quality of reporting of randomized controlled trials in cardiothoracic surgery, to identify factors associated with good reporting quality, and to assess the awareness of the Consolidated Standards for Reporting of Trials statement and ascertain the views of authors reporting randomized controlled trials on the difficulties in conducting randomized controlled trials and the possible ways to further improve the reporting quality of randomized controlled trials in cardiothoracic surgery.


METHODS
Randomized controlled trials of cardiothoracic surgery published in principal cardiothoracic and 4 general medical journals in 2003 were included. The quality of reporting of randomized controlled trials was assessed by using allocation concealment, the Jadad score, and a Consolidated Standards for Reporting of Trials checklist devised for the purpose. A questionnaire survey of authors reporting randomized controlled trials in principal cardiothoracic journals in 2003 was conducted.


RESULTS
The overall reporting quality of the 64 randomized controlled trials included in the analysis was suboptimal as assessed by the 3 methods adopted. Most of the authors (63.5%) were not aware of the Consolidated Standards for Reporting of Trials statement; however, awareness was not associated with reporting quality. More than 65% of the authors responded that conducting randomized controlled trials in surgical specialties was difficult, and the main difficulties were blinding and obtaining a large-enough sample size to detect statistically significant differences. Fifty-four percent of the authors responded that endorsement of the Consolidated Standards for Reporting of Trials statement by the cardiothoracic journals may improve the reporting quality.


CONCLUSIONS
The quality of reporting randomized controlled trials in cardiothoracic surgery is suboptimal. Endorsement of the Consolidated Standards for Reporting of Trials statement by the cardiothoracic journals may improve the quality of reporting.
Tiruvoipati
Ravindranath
R
Department of Cardiac Surgery and ECMO, Glenfield Hospital, Leicester, Leicester, United Kingdom. rtiruvoipati@yahoo.co.uk
Balasubramanian
Sabapathy P
SP
Atturu
Gnaneswar
G
Peek
Giles J
GJ
Elbourne
Diana
D
D006801:Humans; D017712:Peer Review, Research / Q000592:standards*; D010506:Periodicals as Topic / Q000592:standards; D011643:Publishing / Q000592:standards*; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000592:standards* / Q000706:statistics & numerical data; D012107:Research Design / Q000592:standards; D011795:Surveys and Questionnaires; D013903:Thoracic Surgery