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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204<br />
Appendix 12<br />
Study Intervention Participants Outcomes<br />
Core symptoms<br />
Parents’ Behaviour Checklist: inattentive<br />
unproductiveness, hyperactivity<br />
Conners’ Teachers’ Behaviour Checklist:<br />
daydreaming-inattentive, hyperactivity<br />
Davids’ Hyperkinetic Rating Scale (teachers,<br />
parents): hyperactivity, short attention span,<br />
impulsiveness<br />
Target Symptom Assessment<br />
Inclusion criteria<br />
1. Diagnosable minimal brain dysfunction with such signs <strong>and</strong><br />
symptoms as hyperactivity, distractability, short attention span,<br />
incorrigibility, lability, explosiveness, incoordination, perceptual<br />
motor dysfunction, <strong>and</strong> o<strong>the</strong>r minor neurological signs<br />
2. A total score = 24 on <strong>the</strong> first six items <strong>of</strong> <strong>the</strong> Davids’<br />
Hyperkinetic Ratings Scale<br />
3. Aged ≤ 12 years<br />
4. Enrolment in some sort <strong>of</strong> school setting (in order to obtain<br />
teachers’ ratings)<br />
5. No psychoactive medication for <strong>the</strong> preceding month<br />
6. Parental <strong>and</strong> child’s consent<br />
Arm 1<br />
DEX<br />
Ascending dosage schedule<br />
beginning with one tablet <strong>the</strong> first<br />
morning to maximum benefit or<br />
intolerable side-effects; mean daily<br />
dose 21.75 mg (? unclear)<br />
(Administered by parent)<br />
Reference<br />
Arnold et al., 1976 36<br />
Source<br />
AHRQ Report<br />
Setting<br />
USA<br />
Design<br />
Crossover trial<br />
Co-existent problems<br />
Parents’ Behaviour Checklist: unsocialised<br />
aggression, sociopathy<br />
Conners’ Teachers’ Behaviour Checklist:<br />
defiance <strong>and</strong> aggressive misconduct<br />
Davids’ Hyperkinetic Rating Scale (teachers,<br />
parents): variability, irritability, explosiveness<br />
Diagnostic criteria<br />
See inclusion criteria<br />
Arm 2<br />
Levoamphetamine<br />
Ascending dosage schedule<br />
beginning with one tablet <strong>the</strong> first<br />
morning to maximum benefit or<br />
intolerable side-effects; mean daily<br />
dose 24.25 mg (? unclear)<br />
(Administered by parent)<br />
Duration<br />
Treatment periods:<br />
4 weeks per treatment<br />
condition. Total<br />
treatment time:<br />
12 weeks<br />
Number<br />
Total r<strong>and</strong>omised = 31 (male = 26)<br />
Total withdrawals reported<br />
Educational performance<br />
Davids’ Hyperkinetic Rating Scale (teachers,<br />
parents): school work<br />
Age<br />
8 years (mean), 4 1 / 2–12 years (range)<br />
IQ<br />
Not reported<br />
Arm 3<br />
Placebo<br />
Ascending dosage schedule<br />
beginning with one tablet <strong>the</strong> first<br />
morning to maximum benefit or<br />
intolerable side-effects; mean daily<br />
dose 26.25 mg (? unclear)<br />
(Administered by parent)<br />
Purpose<br />
To compare placebo,<br />
dextroamphetamine<br />
<strong>and</strong> levoamphetamine in<br />
children with minimal<br />
brain dysfunction<br />
Psychological function<br />
Not reported<br />
Depression or anxiety<br />
Parents’ Behaviour Checklist: withdrawaldepression<br />
Conners’ Teachers’ Behaviour Checklist:<br />
anxious-fearful<br />
Quality <strong>of</strong> life<br />
Global ratings (clinicians)<br />
Adverse events<br />
Parents’ Behaviour Checklist: somatic<br />
complaints<br />
Conners’ Teachers’ Behaviour Checklist: lack<br />
<strong>of</strong> health<br />
Co-morbid disorders<br />
Not reported<br />
Diagnostic subtypes<br />
Hyperkinetic n = 13; overanxious n = 8; unsocialised aggressive<br />
n = 10<br />
Additional information<br />
Previous medication:<br />
21/31 had never previously received medication for <strong>the</strong>ir<br />
behaviour problems. Participants were required to be<br />
(psychoactive) medication free for <strong>the</strong> month preceding <strong>the</strong> trial<br />
Additional outcomes<br />
Weight<br />
Blood pressure