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

Study Intervention Participants Outcomes
Core symptoms
Abbreviated Conners’
Hyperactivity Questionnaire
(parents, teachers)
IOWA Conners’ Scales:
inattention/overactivity (parents,
teachers)
TOTS: hyperactivity, attention
(parents, teachers)
Inclusion criteria
(Unclear whether the following were inclusion criteria or a description of the sample)
1. 5.6–11.9 years old
2. Scheduled by their physicians for a trial of stimulants for problems related to ADD
3. No organic brain disease, psychosis or uncorrected sensory deficits
4. No current medication except treatment for allergies
5. IQ score >80 on WISC-R within preceding year
6. No previous psychotropic treatment
Diagnostic criteria
Parent and teacher rating scales were employed: Home Activity Scale, IOWA Conners’
Scale and Conners’ Hyperactivity Questionnaire
Arm 1
MPH
MPH plus placebo
assigned on the basis of
body weight; increased
each week to a maximum
average dose of
22.3 mg/day or 0.76
mg/kg/day; administered
three times daily (a.m.,
noon, 4 p.m.)
(Administered by school
staff and parent)
Reference
Klorman et al., 1994 68
Source
CCOHTA Report
Setting
USA
Design
Crossover trial
Co-existent problems
IOWA Conners’ Scales:
aggression/compositionality
(parents, teachers)
TOTS: aggression (parents,
teachers)
Child Psychiatric Scale: global
disruptiveness (experimenter)
Number
Total randomised = 114 (male = 85% of 107)
Total withdrawals = 7
Duration
Referral period: 5 years;
Treatment period:
21 days per treatment
arm
Reasons for withdrawals:
Withdrawn from trial: n = 2; consistently uncooperative in laboratory tasks: n = 2;
experienced significant life events (remarriage or separation by parents) during trial:
n = 2; incorrect dosage: n = 1
Educational performance
Not reported
Arm 2
Placebo
Administered three times
daily (a.m., noon, 4 p.m.)
(Administered by school
staff and parent)
In addition, some outcomes were only reported for part of the sample, owing to
incomplete returns or late introduction of some measures
Purpose
To investigate the
impact of stimulant
therapy on ADD
children’s clinical
response and specific
aspects of cognitive
processing during
memory search
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Psychological function
Sternberg task: performance
Health Technology Assessment 2006; Vol. 10: No. 23
Depression or anxiety
Not reported
Age
8.51 years (NC mean); 8.63 years (ADD mean); 8.62 years (ADD/O mean); 1.48 years
(NC SD); 1.56 years (ADD SD); 1.64 years (ADD/O SD)
Quality of life
Teacher ratings
Parent ratings
IQ
109 (NC mean); 108.84 (ADD mean); 108.97 (ADD/O mean)
Adverse events
Somatic complaints (parents)
Mood problems (parents)
Co-morbid disorders
“… highly unlikely that any subject would have met DSM-III or DSM-III-R criteria for
Conduct Disorder”; 1 subject met dual criteria for learning disorder
Additional outcomes
Weight
EEG and EOG (electroculargraph)
readings
Diagnostic subtypes
44/107 designated as ADD; 34/107 designated as ADD and oppositional disturbance
(not CD) (ADD/O); 29/107 classified as meeting neither criterion (NC)
Additional information
Previous medication:
None of the participants had received previous psychotropic treatment. This was a
requirement for entry into the trial
Concurrent medication:
All of the participants were drug free, except for occasional use of anti-allergy
medication
287