Standards of reporting of randomized controlled trials in general surgery: can we do better?
OBJECTIVE
To evaluate the quality of reporting of surgical randomized controlled trials published in surgical and general medical journals using Jadad score, allocation concealment, and adherence to CONSORT guidelines and to identify factors associated with good quality.


BACKGROUND
Randomized controlled trials (RCTs) provide the best evidence about the relative effectiveness of different interventions. Improper methodology and reporting of RCTs can lead to erroneous conclusions about treatment effects, which may mislead decision-making in health care at all levels.


METHODS
Information was obtained on RCTs published in 6 general surgical and 4 general medical journals in the year 2003. The quality of reporting of RCTs was assessed under masked conditions using allocation concealment, Jadad score, and a CONSORT checklist devised for the purpose.


RESULTS
Of the 69 RCTs analyzed, only 37.7% had a Jadad score of > or =3, and only 13% of the trials clearly explained allocation concealment. The modified CONSORT score of surgical trials reported in medical journals was significantly higher than those reported in surgical journals (Mann-Whitney U test, P < 0.001). Overall, the modified CONSORT score was higher in studies with higher author numbers (P = 0.03), multicenter studies (P = 0.002), and studies with a declared funding source (P = 0.022).


CONCLUSIONS
The overall quality of reporting of surgical RCTs was suboptimal. There is a need for improving awareness of the CONSORT statement among authors, reviewers, and editors of surgical journals and better quality control measures for trial reporting and methodology.
Balasubramanian
Sabapathy P
SP
Academic Unit of Surgical Oncology, K Floor, Royal Hallamshire Hospital, University of Sheffield, S10 2JF, UK. s.p.balasubramanian@sheffield.ac.uk
Wiener
Martin
M
Alshameeri
Zeiad
Z
Tiruvoipati
Ravindranath
R
Elbourne
Diana
D
Reed
Malcolm W
MW
D013502:General Surgery; D006801:Humans; D017712:Peer Review, Research / Q000592:standards*; D011643:Publishing / Q000592:standards*; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000592:standards* / Q000706:statistics & numerical data; D012189:Retrospective Studies; D011795:Surveys and Questionnaires