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

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254 Appendix 12 Core symptoms Educational performance Quality of life Adverse events School Situations Questionnaire (teachers): mean severity ratings Baseline: 4.3 (1.9), n = 161, range: 0–7.6 MPH 0.2: 3.1 (2.0) MPH 0.4: 2.7 (1.9) Placebo: 4.0 (2.3) F = 32.14, p < 0.001. Pairwise comparison: H/L > P Conclusions Authors’ conclusions: The authors conclude that the data indicate a statistically significant medication reponse on most measures, in addition to a significant difference between the low and moderate doses on some measures Reviewer’s comments: No comments noted
Study Intervention Participants Outcomes Core symptoms Conners’ Hyperactivity Index (parents, teacher) IOWA Inattention/Overactivity Scale (parents, teacher) TOTS: Hyperactivity, Attention Inclusion criteria Fulfils criteria for diagnosis of ADD Reference Fitzpatrick et al., 1992 55 Diagnostic criteria DSM-III Source AHRQ Report Number Total randomised = 19 (male = 17) No withdrawals reported Setting USA Co-existent problems IOWA Aggression/Noncompliance Scale (parents, teacher) TOTS: Aggression Child Psychiatric Scale: silly/inappropriate, negative/resistant/uncooperative, loud voice, low voice Age 8.71 years (mean); 6.9–11.5 years (range); 1.33 years (SD) Arm 1 MPH 30 kg: 2 capsules (a.m.): 1 × 10 mg standard MPH, 1 x placebo matching sustainedrelease MPH; 1 capsule (p.m.): 1 × 10 mg standard MPH Mean dose 0.6 ± 0.08 mg/kg/day (Administered by parent and school nurse) Design Crossover trial IQ 114.11 (mean) Duration Total treatment period: 8 weeks (2 weeks per treatment arm) Educational performance Not reported Psychological function Continuous Performance Test (CPT) Paired-associate Learning Test (PAL) Co-morbid disorders Oppositional disorder: n = 12/19; CD and ODD: n = 1/19; enuresis: n = 2/19: encopresis: n = 2/19; phobia: n = 1/19; overanxious disorder: n = 1/19; adjustment disorder: n = 1/19. Arm 2 MPH 2 capsules (a.m.): 1 × 20 mg sustained-release MPH, 1 × placebo matching standard MPH; 1 capsule (p.m.): 1 x placebo matching standard MPH Mean dose 0.7 ± 0.14 mg/kg/day (Administered by parent and school nurse) Purpose The authors compared the relative effectiveness of standard and sustainedrelease MPH and investigated the hypothesis that a combined regimen is superior to either individual preparation © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Diagnostic subtypes ADD with hyperactivity: n = 16/19; ADD without hyperactivity: n = 3/19 (cut-off defined as at least 2 positive responses to eight DICA questions on hyperactivity) Health Technology Assessment 2006; Vol. 10: No. 23 Depression or anxiety Child Psychiatric Scale: withdrawn/unspontaneous, crying Quality of life Parent and teacher comments ratings Parent improvement rankings Adverse events STESS (parents) Weight Additional information Previous medication: 18/19 participants had never received psychotropic medication Additional outcomes EEG and EOG (electroculograph) readings Intervention medication: 4 participants had slightly adjusted dosage schedules Arm 3 MPH 30 kg: 2 capsules (a.m.): 1 × 7.5 mg standard MPH; 1 x 20 mg sustained-release MPH; 1 capsule (p.m.): 1 × 7.5 mg standard MPH Mean dose 0.4 ± 0.07 mg/kg/day for standard MPH, 0.7 ± 0.14 mg/kg/day for sustainedrelease MPH (Administered by parent and school nurse) Arm 4 Placebo 2 capsules (a.m.): 1 × matching standard MPH, 1 × matching sustained-release MPH; 1 capsule (p.m.): matching standard MPH (Administered by parent and school nurse) 255
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366 Appendix 13 Study characteristi
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