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A qualitative assessment of randomized controlled trials in otolaryngology

  • K. W. Ah-See (a1) and N. C. Molony (a1)


In 1996 the CONSORT statement made recommendations on the strict reporting of randomized controlled trials (RCT). This will facilitate the future assessment of such trials and will highlight those trials that have been performed suboptimally and whose results may be biased.

We have devised a scoring system, based on CONSORT, to assess RCT quality and by reading each original paper in full we have now assessed the quality 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 significantly better than the others. Trials in rhinology are reported better than head and neck oncology trials (mean scores 7.6 and 6.5 respectively). 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. CONSORT guidelines now exist and trialists are encouraged to adopt them when conducting future clinical trials.


Corresponding author

Address for correspondence: Dr Kim Ah-See M.D., F.R.C.S., Department of Otolaryngology, The Royal Infirmary of Edinburgh, Edinburgh EH3 9YW. Fax: 0131-536-6167


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Ah-See, K. W., Molony, N. C., Maran, A G. D. (1997) Trends in randomized controlled trials in ENT: a 30 year review. Journal of Laryngology and Otology 111: 611613.
Altman, D. G. (1996) Better reporting of randomised controlled trials: the CONSORT Statement. British Medical Journal 313: 570571.
Begg, C., Cho, M., Eastwood, S., Horton, R., Moher, D., Olkin, I., Pitkin, R., Rennie, D., Schulz, K. F., Simel, D., Stroup, D. F. (1996) Improving the quality of reporting of randomized controlled trials: the CONSORT statement. Journal of the American Medical Association 276: 637639.
Chalmers, I., Dickersin, K., Chalmers, T. C. (1992) Getting to grips with Archie Cochrane's agenda (editorial). British Medical Journal 305: 786788.
Journal Citation Reports (1992) Subject category listing, Otorhinolaryngology. In Science Citation Index, Institute for Scientific Information Inc., Philadelphia, USA, p 108.
Maran, A. G. D., Molony, N., Armstrong, M., Ah-See, K. W. (1997) Is there an evidence base for the practice of ENT surgery? Clinical Otolaryngology 22(2): 152157.
Rosenfeld, R. M., Rockette, H. E. (1991) Biostatistics in Otolaryngology journals. Archives of Otolaryngology – Head and Neck Surgery 117: 11721176.
SIGN, Scottish Intercollegiate Guidelines Network (SIGN). (1995) The Royal College of Physicians, Queen Street, Edinburgh.
Solomon, M. J., Laxamana, A., Devore, L., McLeod, R. S. (1994) Randomized controlled trials in surgery. Surgery 115(6): 707712.



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