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

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 Scho...

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Autores principales:	Markowitz JT, Oberdhan D, Ciesluk A, Rams A, Wigal SB
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2020
Materias:	clinical outcome assessment attention-deficit/hyperactivity disorder children adolescents pediatrics assessment scales efficacy Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/1a233d54f7084c93b751a4c98b297cdd
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spelling	oai:doaj.org-article:1a233d54f7084c93b751a4c98b297cdd2021-12-02T09:54:56ZReview of Clinical Outcome Assessments in Pediatric Attention-Deficit/Hyperactivity Disorder1178-2021https://doaj.org/article/1a233d54f7084c93b751a4c98b297cdd2020-07-01T00:00:00Zhttps://www.dovepress.com/review-of-clinical-outcome-assessments-in-pediatric-attention-deficith-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Jessica 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, USACorrespondence: Dorothee Oberdhan Email dorothee.oberdhan@otsuka-us.comPurpose: 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, efficacyMarkowitz JTOberdhan DCiesluk ARams AWigal SBDove Medical Pressarticleclinical outcome assessmentattention-deficit/hyperactivity disorderchildrenadolescentspediatricsassessment scalesefficacyNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 16, Pp 1619-1643 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	clinical outcome assessment attention-deficit/hyperactivity disorder children adolescents pediatrics assessment scales efficacy Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	clinical outcome assessment attention-deficit/hyperactivity disorder children adolescents pediatrics assessment scales efficacy Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Markowitz JT Oberdhan D Ciesluk A Rams A Wigal SB Review of Clinical Outcome Assessments in Pediatric Attention-Deficit/Hyperactivity Disorder
description	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, USACorrespondence: Dorothee Oberdhan Email dorothee.oberdhan@otsuka-us.comPurpose: 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
format	article
author	Markowitz JT Oberdhan D Ciesluk A Rams A Wigal SB
author_facet	Markowitz JT Oberdhan D Ciesluk A Rams A Wigal SB
author_sort	Markowitz JT
title	Review of Clinical Outcome Assessments in Pediatric Attention-Deficit/Hyperactivity Disorder
title_short	Review of Clinical Outcome Assessments in Pediatric Attention-Deficit/Hyperactivity Disorder
title_full	Review of Clinical Outcome Assessments in Pediatric Attention-Deficit/Hyperactivity Disorder
title_fullStr	Review of Clinical Outcome Assessments in Pediatric Attention-Deficit/Hyperactivity Disorder
title_full_unstemmed	Review of Clinical Outcome Assessments in Pediatric Attention-Deficit/Hyperactivity Disorder
title_sort	review of clinical outcome assessments in pediatric attention-deficit/hyperactivity disorder
publisher	Dove Medical Press
publishDate	2020
url	https://doaj.org/article/1a233d54f7084c93b751a4c98b297cdd
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Review of Clinical Outcome Assessments in Pediatric Attention-Deficit/Hyperactivity Disorder

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