APPENDICES. A systematic review and economic model of the ...

Study Intervention Participants Outcomes
Core symptoms
CTRS: overall severity, inattention and hyperactivity
Hillside Behaviour Scale: concentration, interest in tasks,
impulse control and gross motor activity (teachers, mothers,
psychologists, blinded observers)
CPRS: impulsivity and hyperactivity
Home Hyperactivity Scale (parents)
Children’s Psychiatric Rating Scale: fidgetiness, hyperactivity
and distractibility
Classroom Code: off-task, minor and gross motor activity,
out of chair (blinded observers)
Overall Severity Index (blinded observers)
Inclusion criteria
1. 6 to 12 years
2. Attending elementary school
3. Free of neurological, tic and psychotic disorders plus no
CD
4. Verbal IQ or performance IQ of at least 85 on the WISC-R
5. Parental consent
6. No current or past psychostimulant treatment
7. Meeting severity criteria for hyperactivity (1.8–3.0)
Hyperactivity factor score on CTRS and parental reports of
behavioural problems at home or observation in clinic)
Arm 1
MPH
Gradual titration to a maximum
of 60 mg/day for optimal
efficacy provided no significant
side-effects occurred; mean
dosage (for first 8 weeks)
1.55 mg/kg/day
(Individual administering
medication not reported)
Reference
Klein and Abikoff,
1997 65
Source
AHRQ report
Setting
USA
Design
Parallel trial
Co-existent problems
CTRS: conduct problems, sociability
Hillside Behaviour Scale: frustration tolerance, initiating
aggressive behaviour with peers, joining aggressive activities,
cooperation, attitude towards work, attention seeking
behaviour and popularity (teachers, mothers, psychologists,
blinded observers)
CPRS: conduct problems, immaturity, psychosomatic,
obsessional and antisocial
Children’s Psychiatric Rating Scale: angry affect, temper
outbursts, negative and pressure of speech
Classroom Code: aggression, verbal aggression,
interference, non-compliance and solicitation (blinded
observers)
Diagnostic criteria
Other
Clinical psychiatric examinations to confirm pervasive ADHD
symptoms carried out with child and parent; school history
taken into account
Arm 2
MPH plus non-drug
intervention
Gradual titration to a maximum
of 60 mg/day for optimal
efficacy provided no signficant
side-effects occurred; mean
dosage (for first 8 weeks)
1.48 mg/kg/day; MPH for
8 weeks then 4 weeks of
placebo
BT included parent and teacher
education, individualised
assessment of child,
reinforcement via contract. No
formal programme weeks 9–12.
(Administered by parent,
therapist, teacher)
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Duration
Treatment
period:12 weeks
Purpose
To assess, in
hyperactive
children:
1. Relative
efficacy of
behaviour
therapy, MPH
and their
combination
2. Effects of MPH
withdrawal
after combined
treatment
3. Normalisation
effects of the
combination
Health Technology Assessment 2006; Vol. 10: No. 23
Educational performance
WRAT: Reading, Arithmetic, Spelling
Psychological function
MFFT
Paired-Associate Test
Depression or anxiety
CTRS: anxiety
CPRS: anxiety
Quality of life
CGI (teachers, mothers and psychiatrists)
Adverse events
No specific scale
Number
Total randomised = 86 (male = 81)
Arm 1 = 29
Arm 2 = 29
Arm 3 = 28
Total withdrawals = 3
[The dropouts are not included in the analyses or sample
information (i.e. 89 began the trial)]
Age
7.8 years (mean); 1.4 years (SD)
IQ
Not reported
Co-morbid disorders
‘Relatively free’ of co-morbid anxiety, depression and CD
(see Inclusion criteria)
Diagnostic subtypes
Not reported
Additional information
Previous medication:
Note that included subjects were required not to have been
on stimulant treatment in the past 4 weeks
Additional outcomes
WISC-R: verbal IQ, performance IQ, full-scale IQ
Arm 3
Placebo and non-drug
intervention
Behavioural intervention
incorporated parent and
teacher education,
individualised assessment of
child, reinforcement via
contract. No formal
programme weeks 9–12.
(Administered by parent,
therapist, teacher)
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