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

Study Intervention Participants Outcomes
Core symptoms
Home Situations Questionnaire (parents):
total number of problematic settings, mean
severity score
CPRS-R: hyperactivity index,
impulsivity–hyperactivity
CBCL (parents)
School Situations Questionnaire (teachers):
number of problem settings, mean severity
ratings
CTRS-R: hyperactivity index, hyperactivity,
inattention–passivity
CBCL-TRF
Inclusion criteria
1. Diagnosis according to diagnostic criteria detailed
2. No history of mental retardation
3. No gross brain damage, gross sensory deficits, or severe emotional
disturbance
4. No history of tic disorders or Tourette’s syndrome, cardiovascular
problems
5. No previous poor response to MPH after 5 years of age
Arm 1
MPH
0.2 mg/kg twice daily; modal
dose 7.5 mg twice daily (daily:
15 mg)
(Individual administering
medication not reported)
Reference
Fischer and Newby,
1991 54
Source
CCOHTA Report
Setting
USA
Arm 2
MPH
0.4 mg/kg twice daily; modal
dose 12.5 mg twice daily
(daily: 25 mg)
(Individual administering
medication not reported)
Design
Crossover trial
Co-existent problems
CPRS-R: conduct problems
CTRS-R: conduct problems
Diagnostic criteria
1. Parent and/or teacher complaints of poor sustained attention,
impulsivity and restlessness
2. Behaviour problems for at least 12 months
3. Onset of problems by 6 years of age
4. Scores of 1.5 SDs above mean for same age, normal children:
(a) on one of two factors: CPRS-R: impulsivity–hyperactivity factor
or Achenbach CBCL: hyperactive factor;
(b) and/or two of four factors: CTRS-R: hyperactivity factor; CTRS-
R: inattention-passivity factor; Achenbach CBCL – Teacher
Report Form (TRF): inattentive factor; Achenbach CBCL-TRF:
nervous overactive factor
Educational performance
Not reported
Psychological function
GDS Vigilance Task
Restricted Academic Task: total, off-task,
fidgeting, vocalising, playing with objects out
of seat
Arm 3
Placebo
Lactose placebo
(Individual administering
medication not reported)
Duration
Treatment period:
1 week per treatment
Purpose
The authors used a
refined multimethod
clinical protocol to
assess stimulant drug
response in clinicreferred
ADHD
children. The utility and
any placebo/practice
effect of the dependent
measures was also
evaluated
© Queen’s Printer and Controller of HMSO 2006. All rights reserved.
Number
Total randomised = 161 (male = 141)
Total withdrawals = 7
Health Technology Assessment 2006; Vol. 10: No. 23
Depression or anxiety
CPRS-R: anxiety
Reasons for withdrawal:
These children did not complete the entire protocol: parents changed
mind about trial: n = 2; parents desired open trial: n = 1; experienced
marked side effects: n = 3; parent noncompliant/possibly abusing
medication: n = 1
Quality of life
Adverse events
CPRS-R: psychosomatic
SERS (parents, teachers): number of sideeffects,
mean severity rating
Age
8.9 years (mean); 2.4–17.2 years (range); 2.9 years (SD)
Additional outcomes
Reaction time
IQ
Not reported
Co-morbid disorders
Elevated scores on CBCL: aggression and delinquency factors
(mean = 69.0 and 65.8, respectively) are indicative of conduct
problems
Diagnostic subtypes
Not reported
Additional information
No relevant information reported
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