Statistical Methods
We conducted an intention-to-treat analysis for all randomized participants. Rubin’s method of multiple imputations was used to estimate the treatment effect by combining five imputed values to complete missing data. Continuous parameters were compared using the Wilcoxon Mann-Whitney test; Hodges-Lehmann estimate was used to calculate a 95.0% confidence interval. Categorical variables were compared using the Fisher Exact test.
We also performed ancillary analysis by comparing THI subscales, using a multivariate regression model to adjust for the possible effect of ‘education level’ and ‘guardian help to fill the THI score’ on THI responsiveness, as well as ‘mild hearing loss’ and ‘psychiatric illness’ on clinical performance, and performed a sensitivity analysis to test the efficacy in those participants who completed the study, the per-protocol population.
We used Stata software (version 16.1) for all statistical analyses.