Adherence to Therapy Using Neurostimulation Devices in the Treatment of Pediatric Attention-Deficit/Hyperactivity Disorder: Extraclinical Study.

Background: Pediatric and adolescent patients with attention-deficit/hyperactivity disorder (ADHD) present unique challenges in adherence to device-based therapies outside the clinical environment. The development, approval, and availability of neurostimulation devices for the treatment of ADHD have prompted extraclinical research (ie, outside the sphere of the clinic) on the real-world implementation of such therapies in a population that has difficulty remembering tasks and staying attentive to therapy. Objective: This study aims to explore the extraclinical pediatric ADHD treatment environment to ensure that design considerations and stakeholder contributions to future innovations are effective. Methods: Using the Lean LaunchPad methodology with its emphasis on customer discovery and the business model canvas, qualitative analysis methods were applied to elicit the most pertinent themes regarding ADHD treatment in children and the general perception of a new device-based treatment regimen. Results: Stakeholders expressed a desire that, for innovative ADHD therapies to appeal to children, they include a remote adherence monitoring component and maintain strong evidence of efficacy. Conclusions: Such barriers to access and desired design features should be strongly considered in the development of neurostimulation therapies for pediatric patients with ADHD. Pediatric and adolescent patients with ADHD require attentive device design considerations to achieve therapeutic adherence in a real-world setting.