Are randomised controlled trials involving adenotonsillectomy well reported?

INTRODUCTION

Evidence-based medicine guides clinical practice. Currently, the evidence base on adenotonsillectomy is under scrutiny to establish clinical guidelines. It is therefore important that reports of clinical trials are of high quality. Guidance on reporting of randomised controlled trials (RCTs) are available in the Consolidated Standards for Reporting Trials (CONSORT) statement first published in 1996 and revised in 2001 and 2010.

METHODS

A review of randomised controlled trials on adenotonsillectomy published after 2001 was undertaken. Each report was systematically assessed using the checklist of items from the CONSORT statement.

RESULTS

Twenty-five trials were identified. All trials, except one, were identified as a randomised controlled trial by title or abstract. Twenty percent of trials reported a sample size calculation. A third of trials reported their method of generating a random allocation sequence. Similarly, a third stated the method of implementing the random allocation. A fifth of trials reported a clear flow of trial participants, with only a single trial reporting this with the aid of a diagram.

CONCLUSION

This review shows the quality of reporting needs to be improved. Critical appraisal of poorly reported trials may result in erroneous conclusions, even though these trials may have been carried out with rigorous adherence to a protocol of high standard. Authors of clinical trial reports should be encouraged to consult the CONSORT statement.