Muir G., Agha R.

Presented on March 22, 2007

INTRODUCTION & OBJECTIVES: The CONSORT statement on randomised trials (RCT’s) is accepted by the leading biomedical journals as the minimum standard for reporting. To assess compliance with the CONSORT statement, and quantify trends and patterns of compliance, we examined the reporting quality of RCT's, involving urological surgical techniques (as the intervention) published in the years 2000-2003.. Following our initial findings in urology, we extended the methodology to a number of other specialties to assess whether our findings in urology could be generalised to other surgical disciplines.

MATERIAL & METHODS: The Royal Society of Medicine (RSM) Library was commissioned to search the Medline and Cochrane databases for RCTs published in English. Additional analyses of five other specialties (non-urological trials: cardiovascular, gastrointestinal, hepatobiliary, orthopaedic and vascular) were also made: 15 English language trials (from each specialty) were randomly picked from a blast search conducted by the RSM for the year 2003.
The RCTs were given a score out of 22, reflecting how many of the CONSORT items were complied with (with each item being given equal weighting), this score was termed the "CONSORT score".

RESULTS: In total 122 RCT abstracts were identified which met the inclusion criteria for this study. From these, 32 were excluded as they were follow-up studies, involved a virtual procedure or were a cost analysis, leaving 90 RCTs (68.2%) published across 35 different journals which were analysed. The range of scores was 6-18 (mean 11.1). No trials reported how they implemented their randomisation process. Only 46% of RCTs stated that they had permission from an ethics review board. 20% had declared sources of funding, 14% stated whether there were any conflicts of interest and only 1.1% stated their trial registry number.
For non-urological studies, an average CONSORT score of 11.2 was obtained.

CONCLUSIONS: RCTs in Urology and other surgical disciplines demonstrate poor compliance with the CONSORT statement. We would recommend that urological and other surgical Journals consider supporting the CONSORT statement and  have compliance 'hard-wired' into their submission, editorial and peer-review processes.
Since it seems the best researchers are unable to produce RCT results which enable surgical techniques to be critically assessed, we feel an open debate is needed on the possible role of other research designs such as tracker studies.

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