Introduction
Psychiatric, Attention-deficit/hyperactivity disorder, hyperactivity/impulsivity, Attention Deficit/Hyperactivity Disorder, ADHD, neurodevelopmental disorder
DIFFICULTY SWALLOWING, SECONDARY
Attention-deficit/hyperactivity disorder (ADHD) is a chronic neurodevelopmental disorder characterized by persistent inattention and/or hyperactivity/impulsivity that interferes with function or development and negatively impacts social, academic, and occupational activities (American Psychiatric Association, 2013; Bélanger et al., Stimulants such as methylphenidate and amphetamine are recognized as the most commonly prescribed and effective treatments for ADHD in children and adolescents (Cortese et al., Transdermal formulations offer a number of features that patients and caregivers may view as advantages over oral formulations, including easier treatment of individuals who have difficulty swallowing oral medications, potential for fewer gastrointestinal side effects, flexibility in treatment duration by varying patch wear times, and visual confirmation of adherence to treatment (Findling and Dinh, The dextroamphetamine transdermal system (d-ATS) was developed as an alternative to oral amphetamine formulations and is the first and only transdermal amphetamine patch approved by the Food and Drug Administration (FDA) for use in adults and pediatric patients (children and adolescents) 6 years and older (Noven Therapeutics, 2022).A pivotal randomized controlled trial of d-ATS in children and adolescents with ADHD was conducted, and its primary endpoint (efficacy of d-ATS compared with placebo, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham scale [SKAMP] total score) and key secondary endpoints were met (Cutler et al., When considering treatment options for ADHD, clinicians must weigh the potential benefit of a given treatment, which is generally indicated by response, against its potential risks, such as safety and/or tolerability issues. Measures such as effect size and number needed to treat (NNT) can be used to quantify these potential benefits by providing clinical meaningfulness to changes in rating scale scores. Effect sizes estimate the efficacy of an active intervention to quantify and communicate the clinical relevance of statistically significant trial results. Cohen's effect size for comparison between two groups (active vs. placebo) is classified as small (0.20), medium (0.50), or large (0.80) (Cohen, To further assess the efficacy and safety of d-ATS in the treatment of 6–17-year-old children and adolescents with ADHD in a randomized laboratory classroom study, we report additional secondary endpoints from the pivotal study, including Attention Deficit/Hyperactivity Disorder Rating Scale IV (ADHD-RS-IV), Conners' Parent Rating Scale Revised Short Form (CPRS-R:S), and Clinical Global Impression-Improvement (CGI-I) and -Severity (CGI-S) scores. In a 