APPENDICES. A systematic review and economic model of the ...
APPENDICES. A systematic review and economic model of the ...
APPENDICES. A systematic review and economic model of the ...
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Study Intervention Participants Outcomes<br />
Core symptoms<br />
ADHD Rating Scale IV, Parent<br />
Version: total score<br />
Inclusion criteria<br />
1. School-aged children, aged 7–12 years<br />
2. ADHD diagnosis<br />
Reference<br />
Wernicke et al., 2004 95<br />
Co-existent problems<br />
Not reported<br />
Diagnostic criteria<br />
DSM-IV<br />
Source<br />
Updated search<br />
Educational performance<br />
Not reported<br />
Arm 1<br />
ATX<br />
Titrated to maximum <strong>of</strong><br />
2.0 mg/kg/day; administered twice<br />
daily in evenly divided doses<br />
(Individuals administering medication<br />
not reported)<br />
Setting<br />
USA<br />
Psychological function<br />
Not reported<br />
Number<br />
Total = 194 (male/female split not reported)<br />
Arm 1 = 102<br />
Arm 2 = 92<br />
Arm 2<br />
Placebo<br />
(Individuals administering medication<br />
not reported)<br />
Design<br />
Parallel trial<br />
Depression or anxiety<br />
Not reported<br />
Two studies are reported on in this paper. 194 children completed <strong>the</strong><br />
discontinuation phase <strong>of</strong> ei<strong>the</strong>r study <strong>and</strong> are reported on here<br />
Quality <strong>of</strong> life<br />
Not reported<br />
Age<br />
Mean not reported; 7–12 years (range)<br />
Duration<br />
Wash-out period:<br />
2 weeks; treatment<br />
period: 9 weeks;<br />
discontinuation phase:<br />
1 week placebo<br />
Adverse events<br />
Barkley Behaviour <strong>and</strong> Adverse<br />
Events Questionnaire – Modified<br />
Open-ended questions<br />
IQ<br />
Not reported<br />
Co-morbid disorders<br />
Not reported<br />
Purpose<br />
To assess <strong>the</strong> effect <strong>of</strong><br />
discontinuing ATX in<br />
children with ADHD<br />
© Queen’s Printer <strong>and</strong> Controller <strong>of</strong> HMSO 2006. All rights reserved.<br />
Additional outcomes<br />
Vital signs<br />
Laboratory measures including<br />
hepatic function, full blood count,<br />
ECG<br />
Diagnostic subtypes<br />
Not reported<br />
Health Technology Assessment 2006; Vol. 10: No. 23<br />
Additional information<br />
No relevant information reported<br />
Core symptoms Educational performance Quality <strong>of</strong> life Adverse events<br />
Not reported Not reported Only reported for <strong>the</strong> discontinuation phase – not<br />
relevant to our <strong>review</strong><br />
ADHD Rating Scale IV, Parent Version:<br />
mean (SD)<br />
Arm 1: pre-treatment to end <strong>of</strong><br />
treatment phase: –17.2 (12.6)<br />
Arm 2: pre-treatment to end <strong>of</strong><br />
treatment phase: –6.4 (12.4)<br />
Arm 1 had significantly lower mean<br />
values at end <strong>of</strong> treatment phase<br />
Conclusions Authors’ conclusions: It appears that ATX can be stopped without <strong>the</strong> risk <strong>of</strong> symptom rebound or discontinuation emergent adverse<br />
events<br />
Reviewer’s comments: No comments reported<br />
353