A QUALITATIVE ASSESSMENT OF RANDOMIZED CONTROLLED TRIALS IN OTOLARYNGOLOGY

In 1996 the CONSORT statement made recommendations on the strict repor ting of randomized controlled trials (RCT). This will facilitate the f uture assessment of such trials and will highlight those trials that h ave been performed suboptimally and whose results may be biased. We ha ve devised a scoring system, based on CONSORT, to assess RCT quality a nd by reading each original paper in full we have now assessed the qua lity of trials published from 1966 to 1995. The mean score for trials identified was 7.3 out of a maximum 12 points. No one journal was sign ificantly better than the others. Trials in rhinology are reported bet ter than head and neck oncology trials (mean scores 7.6 and 6.5 respec tively). The past 30 years has not seen an improvement in the quality of the trials. The reporting of RCTs in the ENT literature is poor. CO NSORT guidelines now exist and trialists are encouraged to adopt them when conducting future clinical trials.