Review of Clinical Outcome Assessments in Pediatric Attention-Deficit/Hyperactivity Disorder

Jessica T Markowitz; Dorothee Oberdhan; Anna Ciesluk; Alissa Rams; Sharon B Wigal

doi:10.2147/NDT.S248685

Review of Clinical Outcome Assessments in Pediatric Attention-Deficit/Hyperactivity Disorder

Neuropsychiatr Dis Treat. 2020 Jul 1:16:1619-1643. doi: 10.2147/NDT.S248685. eCollection 2020.

Authors

Jessica T Markowitz¹, Dorothee Oberdhan², Anna Ciesluk¹, Alissa Rams¹, Sharon B Wigal³

Affiliations

¹ Research Department, Modus Outcomes, Cambridge, MA 02142, USA.
² HEOR and Outcomes Management, Otsuka America Pharmaceutical, Inc, Rockville, MD 20850, USA.
³ Department of Pediatrics, University of California School of Medicine, Irvine, CA 92697-4089, USA.

Abstract

Purpose: Various clinical outcome assessments (COAs) are used in clinical research to assess and monitor treatment efficacy in pediatric attention-deficit/hyperactivity disorder (ADHD) trials. It is unclear whether the concepts assessed are those that are important to patients and their caregivers. The concepts measured by commonly used COAs in this population have not been explicitly compared.

Methods: We conducted reviews of the qualitative literature to extract information on pediatric ADHD-related concepts reported by pediatric patients, parents, and teachers. Using these concepts, we developed a conceptual framework of pediatric ADHD using both the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria and the additional symptoms and behavioral impacts identified in the literature. We searched for COAs that have been used in pediatric ADHD research and mapped their items based on their conceptual underpinning.

Results: Of the 27 COAs found in the empirical literature, 4 COAs assessed only DSM symptoms. The most comprehensive coverage of our conceptual framework was seen in the Swanson, Nolan, and Pelham Rating Scale-DSM-IV (SNAP-IV). Eighteen COAs were used in at least 1 clinical trial: ADHD-Rating Scale-IV (ADHD-RS-IV) was used most often (n=77), followed by SNAP-IV (n=50), Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP; n=31), Weiss Functional Impairment Rating Scale (WFIRS; n=24), and Vanderbilt ADHD Diagnostic Rating Scale (VADRS; n=15).

Conclusion: We identified symptoms and behavioral impacts from qualitative studies in pediatric ADHD that are not included in DSM-based criteria. Most COAs used in pediatric ADHD clinical trials measure only those symptoms listed in the DSM. While these COAs can measure symptom severity, they may not assess the full range of symptoms and impacts important to patients and their caregivers. Future research is needed to measure all concepts important to patients and caregivers within ADHD clinical trials.

Keywords: adolescents; assessment scales; attention-deficit/hyperactivity disorder; children; clinical outcome assessment; efficacy; pediatrics.