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

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Appendix 12
Study Intervention Participants Outcomes
Core symptoms
Telephone Interview Probe, parent
and teacher ratings: inattention;
hyperactivity-impulsiveness
IOWA-C, parent and teacher ratings:
hyperactivity–inattentiveness
Arm 1
MPH plus non-drug intervention
Titration to target of 0.7 mg/kg/dose
administered twice per day
(breakfast, lunch); parent training or
parent support; Final mean dose was
31.4 mg/day
(Administered by parent)
References
Schachar et al., 1997; 86
Law and Schachar;
1999 321
Diamond et al. 87
Co-existent problems
Telephone Interview Probe, parent
and teacher ratings: oppositional
behaviour
IOWA-C, parent and teacher ratings:
aggression
Inclusion criteria
1. 6–12 years of age
2. Pervasive ADHD
3. History of ADHD symptoms of at least 6 months duration before
the age of 7 years
4. IQ > 80 (full scale)
5. No primary anxiety or affective disorder
6. No prior treatment for ADHD or tics
7. No severe motor or vocal tic disorder or Tourette’s disorder
8. No regular medication for a medical problem
9. No chronic medical condition
10. No current attendance at a full-time residential or day treatment
programme
11. Willingness to participate in a study involving random assignment to
treatment
12. One parent able to communicate in English
Source
AHRQ Report
Arm 2
Placebo plus parent training or
support
Twice per day (breakfast, lunch);
parent training or parent support
(Administered by parent)
Setting
Canada
Design
Parallel trial
Educational performance
Not reported
Psychological function
Not reported
At 4-month point, children not taking
any medication were grouped with
those taking placebo
Duration
Titration phase:
3–4 weeks: Follow-up
period: 4 months
Depression or anxiety
Not reported
Quality of life
Not reported
Diagnostic criteria
DSM-III-R
Number (randomised/analysed)
Total randomised = 91 (male = 74)
Arm 1 = 46
Arm 2 = 45
Purpose
To determine the
behavioural, situational,
and temporal effects of
4 months of MPH
treatment for ADHD
Adverse events
Barkley 10-point scale: physiological,
affective, overfocus, tics (parents,
teachers)
Total withdrawals = 25
Arm 1 = 9
Arm 2 = 16
Additional outcomes
Telephone Interview Probe, parent
and teacher ratings: difficulty
experienced in the course of typical
daily problem situations
Height
Weight
Reasons for withdrawals:
Lack of effectiveness: Arm 1: 3/46; Arm 2: 14/45
Side-effects: Arm 1: 5/46, Arm 2: 1/45
Parents changed mind about need for medication: Arm 1: 1/46; Arm 2:
1/45
A further 11 participants in Arm 2 were no longer taking pills regularly at
4 months follow-up.
Diamond et al. 87 reported an additional 9 withdrawals, 3 from Arm 1
and 6 from Arm 2
Randomisation procedure:
Subjects were randomly assigned after stratification based on the
presence of co-morbid conduct or oppositional disorder
continued