Measures of treatment effect
Dichotomous data
For dichotomous data, we will present results as summary risk
ratio with 95% confidence intervals.
Continuous data
For continuous data, we will use the mean difference if outcomes
are measured in the same way between trials. We will use the
standardised mean difference to combine trials that measure the
same outcome, but use different methods.
Unit of analysis issues
Cluster-randomised trials
We will include cluster-randomised trials in the analyses along
with individually-randomised trials. Their sample sizes will be adjusted
using the methods described in Higgins 2008 using an estimate
of the intracluster correlation co-efficient (ICC) derived
from the trial (if possible), or from another source. If ICCs from
other sources are used, this will be reported and sensitivity analyses
conducted to investigate the effect of variation in the ICC. If
we identify both cluster-randomised trials and individually-randomised
trials, we plan to synthesise the relevant information.
We will consider it reasonable to combine the results from both
if there is little heterogeneity between the study designs and the
interaction between the effect of intervention and the choice of
randomisation unit is considered to be unlikely.
We will also acknowledge heterogeneity in the randomisation unit
and perform a separate meta-analysis.
Measures of treatment effectDichotomous dataFor dichotomous data, we will present results as summary riskratio with 95% confidence intervals.Continuous dataFor continuous data, we will use the mean difference if outcomesare measured in the same way between trials. We will use thestandardised mean difference to combine trials that measure thesame outcome, but use different methods.Unit of analysis issuesCluster-randomised trialsWe will include cluster-randomised trials in the analyses alongwith individually-randomised trials. Their sample sizes will be adjustedusing the methods described in Higgins 2008 using an estimateof the intracluster correlation co-efficient (ICC) derivedfrom the trial (if possible), or from another source. If ICCs fromother sources are used, this will be reported and sensitivity analysesconducted to investigate the effect of variation in the ICC. Ifwe identify both cluster-randomised trials and individually-randomisedtrials, we plan to synthesise the relevant information.We will consider it reasonable to combine the results from bothif there is little heterogeneity between the study designs and theinteraction between the effect of intervention and the choice ofrandomisation unit is considered to be unlikely.We will also acknowledge heterogeneity in the randomisation unitand perform a separate meta-analysis.
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