Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000-8.

Five of the 14 reporting criteria showed a significant trend for improvement: reporting on loss of clusters to follow-up (P=0.01); identification as “cluster randomised” in title or abstract (P=0.038); providing a justification for the clustered design (P=0.038); reporting whether or not outcome assessors had been blinded (P=0.019); and reporting of the number of clusters randomised (P=0.035).

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