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Issues of design and analysis are crucial in cluster randomised trials
| The first 150 words of the full text of this article appear below. |
EDITOR
We have concerns about the design and analysis of Shah et al's
cluster randomised trial of a peer led education programme for
asthma.1 Neither the printed nor the (longer) electronic version mentioned how clustering was accounted for in the trial design.
The sample size was not justified
neither the number of clusters (six)
nor numbers of children in them. This may seem unimportant since
confidence intervals were provided for the comparisons between arms,
but the omission is crucial.
The authors did not specify the magnitude of differences considered in
advance as clinically important. The small intracluster correlations
observed could just be fortuitous. With so few clusters, any estimate
of between-cluster variance (and hence intracluster correlation)
will be extremely imprecise. Without proper details of trial design,
the danger of publication bias remains, where a study with low power is
more likely to be published when significance is attained. The