HRQL and medication satisfaction in children with ADHD treated with the methylphenidate transdermal system.
OBJECTIVE
To evaluate the impact of methylphenidate transdermal system (MTS) on health-related quality of life (HRQL) and medication satisfaction in children with attention-deficit/hyperactivity disorder (ADHD) as well as to identify potential moderators of HRQL and medication satisfaction.


METHODS
Children aged 6-12 years diagnosed with ADHD were enrolled (N = 128) and 115 children completed the study. MTS dose was optimized over 5 weeks using 10-, 15-, 20-, or 30-mg patches worn for 9 hours. The efficacy of 4- and 6-hour wear times was then assessed in an analog classroom setting in a randomized, placebo-controlled, double-blind, three-way crossover design study.


METHODS
The ADHD Impact Module-Children (AIM-C), a validated HRQL instrument, was used to assess the impact of ADHD symptoms on children and their families. Satisfaction with MTS use was assessed via a Medication Satisfaction Survey (MSS). A parent or legally appointed representative (LAR) completed the measures. Tolerability was monitored by spontaneous adverse event reporting.


RESULTS
Mean scores on AIM-C child and family HRQL scales improved from baseline to endpoint across all MTS doses and the magnitude of improvement increased with time from baseline. Improvement was noted for behavior, missed doses, worry, and economic impact AIM-C scores. Overall, parents/LARs indicated a high level of satisfaction with their child's use of MTS (Visit 7 [92.1%]; Visit 10 [89.1%]). Most treatment-emergent adverse events (TEAEs) were mild to moderate. The most frequent TEAEs included decreased appetite (28%), headache (21%), insomnia (20%), and abdominal pain (12%).


CONCLUSIONS
At study endpoint, MTS treatment of ADHD was associated with robust improvement in child and family HRQL, key economic impact items, and overall medication satisfaction with the effectiveness and ease of use of MTS as an ADHD treatment. Also, the majority of MTS TEAEs were mild to moderate in severity. Limitations of this study included the potential for a significant halo effect when measuring HRQL and medication satisfaction as well as the uncertainty regarding whether the improvements seen over this relatively short study duration would be sustainable long term.


BACKGROUND
#NCT00151970.
Manos
Michael
M
Cleveland Clinic, Cleveland, OH, USA. manosm@ccf.org
Frazier
Thomas W
TW
Landgraf
Jeanne M
JM
Weiss
Margaret
M
Hodgkins
Paul
P
D000279:Administration, Cutaneous; D000465:Algorithms; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000523:psychology; D000697:Central Nervous System Stimulants / Q000008:administration & dosage; D002648:Child; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006262:Health; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage*; D017060:Patient Satisfaction; D010919:Placebos; D011788:Quality of Life; D016896:Treatment Outcome
D000697:Central Nervous System Stimulants; D010919:Placebos; D008774:Methylphenidate