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Systematic Review of Quality of Life and Functional Outcomes in Randomized Placebo-Controlled Studies of Medications for Attention-Deficit/Hyperactivity Disorder

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David R Coghill1, 2, 3, Tobias Banaschewski 4 César Soutullo 5 Matthew G Cottingham6 Alessandro Zuddas7

Department of Paediatrics, Faculty of Medicine, Dentistry and Health Science, University of Melbourne, Melbourne, VIC, Australia.
Department of Psychiatry, Faculty of Medicine, Dentistry and Health Science, University of Melbourne, Melbourne, VIC, Australia.
Division of Neuroscience, University of Dundee, Dundee, UK.
Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
Child and Adolescent Psychiatry Unit, Department of Psychiatry and Medical Psychology, University of Navarra Clinic, Pamplona, Spain.
Oxford PharmaGenesis, Oxford, UK.
Child and Adolescent Psychiatry Unit, Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.

European Child & Adolescent Psychiatry

Nov 2017 12


Children, adolescents and adults with attention-deficit/hyperactivity disorder (ADHD) experience functional impairment and poor health-related quality of life (HRQoL) in addition to symptoms of inattention/hyperactivity-impulsivity. To synthesize qualitatively the published evidence from randomized, double-blind, placebo-controlled trials of the effectiveness of pharmacotherapy on functional impairment or HRQoL in patients with ADHD, a systematic PubMed searching and screening strategy was designed to identify journal articles meeting pre-specified criteria. Post hoc analyses and meta-analyses were excluded. HRQoL outcomes, functional outcomes and the principal ADHD symptom-based outcome were extracted from included studies. An effect size of 0.5 versus placebo was used as a threshold for potential clinical relevance (unreported effect sizes were calculated when possible). Of 291 records screened, 35 articles describing 34 studies were included. HRQoL/functioning was usually self-rated in adults and proxy-rated in children/adolescents. Baseline data indicated substantial HRQoL deficits in children/adolescents. Placebo-adjusted effects of medication on ADHD symptoms, HRQoL and functioning, respectively, were statistically or nominally significant in 18/18, 10/12 and 7/9 studies in children/adolescents and 14/16, 9/11 and 9/10 studies in adults. Effect sizes were ≥0.5 versus placebo for symptoms, HRQoL and functioning, respectively, in 14/16, 7/9 and 4/8 studies in children/adolescents; and 6/12, 1/6 and 1/8 studies in adults. Effect sizes were typically larger for stimulants than for non-stimulants, for symptoms than for HRQoL/functioning, and for children/adolescents than for adults. The efficacy of ADHD medication extends beyond symptom control and may help reduce the related but distinct functional impairments and HRQoL deficits in patients with ADHD.

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