Adherence of trials of operative intervention to the CONSORT statement extension for non-pharmacological treatments: a comparative before and after study

INTRODUCTION Use of the Consolidated Standards of Reporting Trials (CONSORT) statement has been shown to improve the reporting of randomised controlled trials and it is endorsed by leading surgical journals. The CONSORT statement for non-pharmacological treatment (CONSORT-NPT) provides specific items to aid in the reporting of trials of operative intervention. This study compares the reporting practice of trials of operative intervention published in time periods before and after publication of the CONSORT-NPT statement. METHODS A 30-point checklist containing the salient CONSORT-NPT items was designed and the adherence of trials meeting the inclusion criteria determined independently by two authors. RESULTS There was a significant improvement of 3.95 points in the mean CONSORT-NPT score from 2004 to 2010 (95% confidence interval: 3.61-4.29, p<0.001). This related specifically to items present in the original CONSORT statement rather than to CONSORT-NPT items, which remained poorly reported in 2010. The mean CONSORT-NPT score was 17.5 (standard deviation [SD]: 4.5) for trials published in CONSORT endorsing journals compared with 15.6 (SD: 4.0) for those that did not mention endorsement of the CONSORT statement although this was not a significant difference (p=0.064). CONCLUSIONS Although there has been a significant improvement in the reporting of trials of operative intervention published in the surgical literature since 2004, items specific to the CONSORT-NPT extension remain underreported. Improved awareness of this important addition to the CONSORT statement throughout the surgical community and its endorsement by surgical journals will help to improve the reporting practice of trials of operative intervention.