Mediation Analyses
distress behavior, behavioral distress, pain
REGRESSION, PHYSIOLOGICAL STRESS, SECONDARY
We proposed to test the hypothesis that a favorable difference in secondary outcomes (distress behavior, pain, sensory discomfort) between SADE and RDE was mediated by physiological stress (SCL or NS-SCR frequency). For physiological stress to mediate the difference between SADE and RDE outcomes, outcomes would need to differ for SADE vs RDE, and physiological stress would need to be associated with both SADE and RDE and the outcome. If there were no significant differences between SADE and RDE for most of the secondary outcomes (pain, sensory discomfort, behavioral distress measured by CDBRS), there would be no mediation of these outcomes. Nevertheless, understanding whether lack of association between the treatment and those outcomes was due to lack of association between the treatment and the mediators or lack of association between the mediators and the outcomes would be informative; such analyses used mixed-effects regression with adjustment for attained age and first and second clinic visit, with EDA values square-root transformed (eMethods in 