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

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Appendix 12
Study Intervention Participants Outcomes
Depression or anxiety
Symptom Checklist: anxiety
Parent Questionnaire: anxiety
Co-morbid disorders
Behaviour and academic problems at referral: 59/84; primarily
academic problems at referral: 6/84; history of febrile seizures:
10%
Quality of life
Clinical global improvement
Teacher global ratings of overall behaviour
Diagnostic subtypes
Not reported
Additional information
No additional information reported
Adverse events
No specific scale reported
Additional outcomes
Lincoln–Oseretsky Test of Motor
Development: selected items (not specified)
Measure of hand–arm steadiness
Physiological measures
Psychiatric examination
Core symptoms Educational performance Quality of life Adverse events
The major side-effects of both drugs were
insomnia and anorexia.
Insomnia:
At day 28, insomnia in DEX and Cylert group
was significantly worse than in the placebo
group. At 8 weeks, < 5% of patients were
experiencing moderate or severe insomnia on
DEX
Clinical global improvement
(clinician; % much worse; worse;
unchanged; improved; much
improved)
Arm 1:
0.0; 11.5; 23.1; 57.7; 7.7 (n = 26)
(4 weeks)
0.0; 7.4; 14.8; 59.3; 18.5 (n = 27)
(8 weeks)
Arm 2:
0.0; 0.0; 11.1; 77.8; 11.1 (n = 27)
(4 weeks)
0.0; 0.0; 3.7; 63.0; 33.3 (n = 27)
(8 weeks)
Arm 3: 0.0; 7.4; 63.0; 29.6; 0.0
(n = 27) (4 weeks)
0.0; 3.7; 66.7; 29.6; 0.09 (n = 27)
(8 weeks)
Teacher global ratings of classroom
performance
(% much worse; worse; same;
improved; much improved)
Arm 1:
0.0; 11.5; 38.5; 46.2; 3.8 (n = 26)
(4 weeks) 4.5; 9.1; 22.7; 50.0; 13.6
(n = 22) (8 weeks)
Arm 2:
0.0; 0.0; 7.7; 73.1; 19.2 (n = 26)
(4 weeks)
4.8; 4.8; 14.3; 42.9; 33.3 (n = 21)
(8 weeks)
Arm 3:
3.8; 11.5; 38.5; 46.2; 0.0 (n = 26)
(4 weeks)
8.7; 17.4; 39.1; 34.8; 0.0 (n = 23)
(8 weeks)
Symptom Checklist: inattentiveness, factor
scores at 0/4/8 weeks (mean, SD not reported)
Arm 1: 11.5/8.9/7.7 (n = 20)
Arm 2: 11.1/7.1/6.4 (n = 23)
Arm 3: 11.1/9.3/9.8 (n = 20)
F(4,132) = 3.64, p = 0.008
Anorexia (range):
At day 14, 14% of participants on DEX were
suffering from severe anorexia. At day 56, 4%
of participants on either drug were suffering
from severe anorexia
Symptom Checklist: hyperactivity, factor scores
at 0/4/8 weeks (mean, SD not reported)
Arm 1: 16.5/11.2/9.8 (n = 20)
Arm 2: 15.4/6.9/6.2 (n = 23)
Arm 3: 16.4/12.7/13.3 (n = 20)
F(4,132) = 5.52, p = 0.001
Sadness and irritability:
Participants suffered significantly more sadness
and irritability on DEX than on placebo.
However incidence was low
Parent Questionnaire: impulsiveness , factor
scores at 0/4/8 weeks (mean, SD not reported)
Arm 1: 22.9/15.3/13.2 (n = 25)
Arm 2: 22.5/11.2/11.0 (n = 27)
Arm 3: 21.4/18.5/19.1 (n = 27)
F(4,152) = 7.65, p = 0.001
continued