Statistical analysis
Descriptive statistics were employed to determine numerical and
categorical variables. Numerical variables were presented using measures
of central tendency and dispersion (mean, median, standard deviation
(SD) and interquartile range (IQR), as appropriate). Absolute and
relative frequencies were presented for categorical variables. Overall
interrater agreement, among three judges, was calculated using Fleiss’
kappa coefficient.[10] Cohen’s kappa coefficient with linear
weighting[11] was used to measure pairwise judge concordance. For
both kappa coefficient measures, all cases in which ADR were classified
as unassessable by at least one judge were excluded. We considered 95%
of confidence interval for all the analyses. The assessment of
concordance was based on the quantitative scale proposed by Landis and
Koch[12]: <0=poor, 0.00-0.20=slight, 0.21-0.40=fair,
0.41-0.60=moderated, 0.61-0.80=substantial, 0.81-0.99=almost perfect and
1.00=perfect.