Reporting of Randomised Clinical Trials in Skull Base Surgery: A Fourteen-Year Review

Abstract

Skull base surgery has experienced dramatic advances in the last decade. Recently, various surgical disciplines have conducted reviews of quality of randomised controlled trials (RCTs). This is the first review to our knowledge regarding RCT quality within skull base surgery. Systematic review of skull base surgery RCTs published between 2000 and 2014 were conducted. Literature search provided 96 papers. Duplicates and trials which did not meet our inclusion criteria were excluded. This left 28 papers for analysis. A total of 1785 patients participated across trials. Consolidated Standards of Reporting Trials statement (CONSORT) and Jadad scale were used assess to the quality of reporting. These were our main outcome measures. The mean CONSORT score prior to 2011 was 16.9 (n = 17, range; 13 – 22), and post 2011 was 17.5 (n = 11, range; 12 – 22). The mean Jadad score was 3.1 (n = 28, range 2 – 5). CONSORT were found to increase significantly with both increasing sample size (rho=0.467, p=0.012) and Jadad scores (rho=0.540, p=0.003). Linear regression showed CONSORT increase by 0.36 (95% CI: 0.02 – 0.70, p=0.041) for each additional 10 patients included, and by 1.50 (95% CI: 0.58 – 0.24, p=0.002) for each increase of one in the JADAD score. There are common omissions related to randomization, sample size calculations and availability of protocols. RCTs in skull base surgery are comparable to other surgical disciplines. We recommend utilisation of the CONSORT statement during protocol formation of RCTs to improve reporting of trials.