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

Core symptoms Educational performance Quality of life Adverse events
Adverse events seen in at least 2% of children in any
treatment group: n (%) in placebo/ t.d.s.
IR-MPH/Concerta/total
Headache
16 (23.2%)/11 (15.9%)/8 (11.8%)/22 (31.4%)
Abdominal pain
8 (11.6%)/12 (17.4%)/9 (13.2%)/20 (28.6%)
Upper respiratory tract infection
3 (4.3%)/3 (4.3%)/2 (2.9%)/8 (11.4%)
Accidental injury 2 (2.9%)/3 (4.3%)/1 (1.5%)/6 (8.6%)
Vomiting 2 (2.9%)/2 (2.9%)/2 (2.9%)/5 (7.1%)
Twitching 0 (0.0%)/4 (5.8%)/0 (0.0%)/4 (5.7%)
Diarrhoea 1 (1.4%)/2 (2.9%)/0 (0.0%)/3 (4.3%)
Pharyngitis
0(0.0%)/ 2(2.9%)/1 (1.5%)/3 (4.3%)
Rhinitis 0 (0.0%)/2 (2.9%)/1 (1.5%)/3 (4.3%)
Dizziness 0 (0.0%)/1 (1.4%)/2 (2.9%)/2 (2.9%)
Urinary Incontinence 2 (2.9%)/1 (1.4%)/0 (0.0%)
2 (2.9%)
Global effectiveness (parent):
Arm 1: poor: 73.5%; fair:
22.1%; good: 2.9%;
excellent: 1.5%
Arm 2: poor: 8.8%; fair:
26.5%; good: 50.0%;
excellent: 14.7%
Arm 3: poor: 5.9%; fair:
27.9%; good: 39.7%;
excellent: 26.5%
Significant differences
between Arms 1 and 2 and
between Arms 1 and 3
(p < 0.001)
Timed Maths Task: graphical
presentation only
Daily Individualised Report Cards: %
positive:
Arm 1: 61.17 (24.22); Arm 2: 84.36
(15.76); Arm 3: 86.06 (13.52)
Significant differences between Arms
1 and 2 and between Arms 1 and 3
(p < 0.001)
Natural setting: IOWA Conners’ Rating Scale
(inattention–overactivity), teacher rated: mean
(SD)
Placebo:10.34 (4.21)
t.d.s. IR-MPH: 5.00* (3.69) *significantly
different from placebo (p < 0.001)
Concerta 4.69* (3.31) *significantly different
from placebo (p < 0.001)
Natural setting: IOWA Conners’ rating scale
(inattention–overactivity), parent rated: mean
(SD)
Placebo: 10.59 (3.28)
t.d.s. IR-MPH: 5.93* (3.09) *significantly
different from placebo (p < 0.001)
Concerta: 4.78** (2.86) **significantly
different from placebo (p < 0.001) and tid
MPH (p < 0.05; effect size = 0.4)
Occurrences of adverse events were similar across
conditions
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Global effectiveness (teacher):
Arm 1: poor: 69.1%; fair:
14.7%; good: 14.7%;
excellent: 1.5%
Arm 2: poor: 10.3%; fair:
32.4%; good: 36.8%;
excellent: 20.6%
Arm 3: poor: 10.4%; fair:
22.4%; good: 44.8%;
excellent: 22.4%
Significant differences
between Arms 1 and 2 and
between Arms 1 and 3
(p < 0.001)
Laboratory session: IOWA Conners’ Rating
scale (inattention–overactivity), teacher rated:
mean (SD)
Placebo: 5.01 (4.48)
t.d.s. IR-MPH: 2.75* (3.73) *significantly
different from placebo
Concerta: 2.59* (3.91) *significantly different
from placebo
Health Technology Assessment 2006; Vol. 10: No. 23
Withdrawals:
None due to adverse events
Tics:
3 reported moderate motor tics during study, 1 reported
a mild vocal tic. Two of these were new or worsened
cases
Sleep:
Arm 1: poor: 10%; fair: 21%; good: 57%;
excellent:12%
Arm 2: poor: 7%; fair: 21%; good: 65%; excellent: 7%
Arm 3: poor: 16%; fair: 24%; good: 47%; excellent:
13%
No significant differences between treatment arms
Laboratory session: IOWA Conners’ Rating
scale (inattention–overactivity) counsellor
rating: mean (SD)
Placebo: 7.95 (3.85)
t.d.s. IR-MPH: 6.31* (3.24) *significantly
different from placebo
Concerta: 6.10* (3.10) *significantly different
from placebo
Appetite:
Arm 1: usual: 59%; increased: 37%; decreased: 4%
Arm 2: usual: 66%; increased: 6%; decreased: 24%
Arm 3: usual: 77%; increased: 10%; decreased: 18%
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