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J Thorac Cardiovasc Surg 2006;132:233-240
© 2006 The American Association for Thoracic Surgery

Statistics for the Rest of Us

Improving the quality of reporting randomized controlled trials in cardiothoracic surgery: The way forward

^a Department of Cardiac Surgery and ECMO, Glenfield Hospital, Leicester, Leicester, United Kingdom
^b Academic Unit of Surgical Oncology, University of Sheffield, Sheffield, United Kingdom
^c London School of Hygiene and Tropical Medicine, University of London, London, United Kingdom

Received for publication June 27, 2005; revisions received September 13, 2005; accepted for publication October 28, 2005.

^_* Address for reprints: Ravindranath Tiruvoipati, FRCSEd, Department of ECMO, Glenfield Hospital, Groby Rd, Leicester, LE3 9QP, UK (Email: rtiruvoipati{at}yahoo.co.uk).

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.

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