Review of Clinical Outcome Assessments in Pediatric Attention-Deficit/Hyperactivity Disorder
Received 7 February 2020
Accepted for publication 28 May 2020
Published 1 July 2020 Volume 2020:16 Pages 1619—1643
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Editor who approved publication: Dr Roger Pinder
Jessica T Markowitz,1 Dorothee Oberdhan,2 Anna Ciesluk,1 Alissa Rams,1 Sharon B Wigal3
1Research Department, Modus Outcomes, Cambridge, MA 02142, USA; 2HEOR and Outcomes Management, Otsuka America Pharmaceutical, Inc, Rockville, MD 20850, USA; 3Department of Pediatrics, University of California School of Medicine, Irvine, CA 92697– 4089, USA
Correspondence: Dorothee Oberdhan Email email@example.com
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: clinical outcome assessment, attention-deficit/hyperactivity disorder, children, adolescents, pediatrics, assessment scales, efficacy
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