- *The risk in the intervention group (and its 95Â % confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95Â % CI).
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CI confidence interval, RR risk ratio, OR odds ratio, RCT randomized controlled trial, MD mean difference
- GRADE Working Group grades of evidence
- High quality: we are very confident that the true effect lies close to that of the estimate of the effect
- Moderate quality: we are moderately confident in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
- Low quality: our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect
- Very low quality: we have very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate of effect
- Justifications for grading
- 1. Study data from single RCT with high risk of bias
- 2. Single RCT used cluster randomization, which may have artificially narrowed the confidence interval
- 3. Statistically significant heterogeneity; however, between large and small effects rather than between positive and negative effects
- 4. Half of studies are cohort studies of poor rather than good quality according to the Newcastle-Ottawa scale
- 5. Marked clinical heterogeneity between populations, confirmed with statistical heterogeneity, with inconsistent results crossing the line of no effect
- 6. One of the two included trials used cluster randomization, which may have artificially narrowed the confidence interval; the resulting pooled estimate may thus be overly precise despite our statistical adjustment using intraclass correlation coefficients (ICCs); however, the direction of effect did not change with large or small ICCs as the pooled effect is near the line of no effect
- 7. Data reported as median and interquartile range; statistical adjustment needed to obtain mean and standard deviation for pooled results
- 8. Type of cost reported in study (fixed, variable or total) varied, limiting precision of estimate