Paediatric adverse event rating scale: a measure of safety or efficacy? Novel analysis from the MADDY study.

ABSTRACT:

Objective

The Pediatric Adverse Event Rating Scale (PAERS) measured adverse events of children aged 6-12 years with ADHD and emotional dysregulation in the Micronutrients for ADHD in Youth (MADDY) study, an eight week multi-site randomized clinical trial of a broad-spectrum multinutrient treatment. Treatment sensitivity of the PAERS was assessed by calculating the treatment difference in change of the item scores from baseline to end of the RCT.

Methods

Principal component analysis retained 14 "adverse events" (out of 43 in the PAERS) that reflected ADHD symptoms and emotional dysregulation and was used to group the variables of interest. A combined score ranging from 0 to 5 was created based on symptom presence, functional impairment, and severity. Mean score change was cal

SUBMITTER: Leung BMY 

PROVIDER: S-EPMC10370369 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature