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EPA-1078 – The Child Health and Illness Profile as a Measure of Health-Related Quality of Life in Stimulant-Treated Children and Adolescents with ADHD

Published online by Cambridge University Press:  15 April 2020

T. Banaschewski ,
C. Soutullo ,
M. Lecendreux ,
M. Johnson ,
A. Zuddas ,
P. Hodgkins ,
B. Adeyi ,
L.A. Squires  and
D.R. Coghill
T. Banaschewski
Affiliation:
Child and Adolescent Psychiatry and Psychotherapy, University of Heidelberg, Mannheim, Germany
C. Soutullo
Affiliation:
Child and Adolescent Psychiatry Unit, University of Navarra Clinic, Pamplona, Spain
M. Lecendreux
Affiliation:
Paediatric Sleep Centre and National Reference Centre for Orphan Diseases: Narcolepsy Idiopathic Hypersomnia and Kleine-Levin Syndrome, Robert-Debré University Hospital, Paris, France
M. Johnson
Affiliation:
Child Neuropsychiatry Unit, Queen Silvia Children's Hospital, Gothenburg, Sweden
A. Zuddas
Affiliation:
Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy
P. Hodgkins
Affiliation:
Global Health Economics and Outcomes Research, Shire Development LLC, Wayne, USA
B. Adeyi
Affiliation:
Global Biostatistics, Shire Development LLC, Wayne, USA
L.A. Squires
Affiliation:
Global Clinical Development and Innovation, Shire Development LLC, Wayne, USA
D.R. Coghill
Affiliation:
Division of Neuroscience, University of Dundee, Dundee, United Kingdom

Abstract

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Introduction:

The Child Health and Illness Profile-Child Edition: Parent Report Form (CHIP-CE:PRF) is a generic measure of child health-related quality of life (HRQoL). Scores in the five domains and 12 subdomains are standardized to T-scores (mean=50, SD=10), based on US community data.

Objective:

Evaluate CHIP-CE:PRF results from two studies of lisdexamfetamine dimesylate (LDX) in children and adolescents with ADHD.

Methods:

Patients’ parents or guardians completed CHIP-CE:PRF assessments at baseline, and weeks 4 and 7 of SPD489-325, a 7-week randomized, placebo-controlled trial incorporating a reference treatment (osmotic-release oral system methylphenidate; OROS-MPH). The Achievement domain was pre-specified as the primary HRQoL outcome. Statistical comparison of LDX versus OROS-MPH was not pre-specified. In SPD489-326, CHIP-CE:PRF assessments were performed in the ≥26-week open-label period and the subsequent 6-week randomized-withdrawal period.

Results:

Pre-treatment CHIP-CE:PRF T-scores were ≥1 SD below 50 in Achievement, Risk Avoidance, Satisfaction and Resilience. In SPD489-325, LDX and OROS-MPH were both significantly more effective than placebo in these four domains, but not in Comfort. Effect sizes were largest (p<0.001) in Achievement (LDX, 1.280; OROS-MPH, 0.912) and Risk Avoidance (LDX, 1.079; OROS-MPH, 0.948). In SPD489-326, T-scores were improved or stable in the open-label period. In the randomized-withdrawal period, LDX was significantly more effective than placebo (p<0.001) in Achievement, Risk Avoidance and Satisfaction, with effect sizes of 0.696, 0.829 and 0.636, respectively.

Conclusions:

Short-term LDX or OROS-MPH treatment led to improved HRQoL scores. These benefits were maintained during long-term LDX treatment, and HRQoL scores declined following treatment withdrawal.

Supported by funding from Shire

Type
S537 – Effectiveness of stimulant treatment in attention-deficit/hyperactivity disorder: functional, health-related quality of life and health utility outcome measures
Information
European Psychiatry , Volume 29 , Issue S1: Abstracts of the 22nd European Congress of Psychiatry , 2014 , pp. 1
Copyright
Copyright © European Psychiatric Association 2014
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