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

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326 Appendix 12 Core symptoms Educational performance Quality of life Adverse events [Confidential information removed] Conclusions Authors’ conclusions: [Confidential information removed] Reviewer’s comments: [Confidential information removed] Study Intervention Participants Outcomes Core symptoms Abbreviated CTRS: total score On-task behaviour Reference Rapport et al., 1989 85 Co-existent problems Not reported Arm 1 MPH 5 mg (range: 0.14–0.22 mg/kg); once daily (breakfast) (Individual administering medication not reported) Source CCOHTA Report Educational performance Academic efficiency score Inclusion criteria 1. ADHD using DSM-III-R criteria 2. Maternal report of a developmental history consistent with ADHD 3. 2 SD above mean on the Werry–Weiss–Peters Activity Scale (maternal rating) 4. ACTRS > 15 (teacher rating) 5. No gross neurological, sensory or motor impairment 6. No current medication Setting USA Psychological function Not reported Arm 2 MPH 10 mg (range: 0.28–0.44 mg/kg); once daily (breakfast) (Individual administering medication not reported) Design Crossover trial Diagnostic criteria DSM-III-R Depression or anxiety Not reported Number Total randomised = 45 (male = 45) No withdrawals reported Quality of life Not reported Age 7.8 years (mean); 5–15 years (range), 1.5 years (SD) Adverse events Not reported IQ 100 (mean) Arm 3 MPH 15 mg (range: 0.42–0.66 mg/kg); once daily (breakfast) (Individual administering medication not reported) Additional outcomes Not reported Co-morbid disorders Not reported Duration Treatment periods: 6 consecutive days; washout period: 1 day Purpose To examine directly the dose–response relationship between MPH and gross body weight in a large sample of children with ADHD Diagnostic subtypes Not reported Arm 4 MPH 20 mg (range: 0.56–0.88 mg/kg); once daily (breakfast) (Individual administering medication not reported) Additional information Randomisation method: Three groups of 15 children were each randomised: low-weight group (22–26 kg), mid-weight group (27–31 kg), high-weight group (32–36 kg) Concurrent medication: Participants were required not to be receiving concurrent medication
Core symptoms Educational performance Quality of life Adverse events Not reported Not reported Academic efficiency score, mean (SD) Low-weight group: Arm 1: 69.8 (19.1); Arm 2: 78.6 (16.3); Arm 3: 82.6 (17.2); Arm 4: 79.0 (13.2); placebo: 54.0 (19.2) Abbreviated CTRS: total score, mean (SD) Low-weight group: Arm 1: 10.2 (5.2); Arm 2: 7.4 (4.0); Arm 3: 5.8 (4.1); Arm 4: 5.0 (4.6); placebo: 15.7 (5.8) Mid-weight group: Arm 1: 63.9 (24.2); Arm 2: 78.4 (12.3); Arm 3: 74.3 (21.4); Arm 4: 87.4 (9.3); placebo: 56.9 (25.7) Mid-weight group: Arm 1: 13.9 (6.8); Arm 2: 8.4 (6.4); Arm 3: 8.2 (4.7); Arm 4: 7.5 (4.4); placebo: 15.9 (5.9) High-weight group: Arm 1: 57.9 (30.4); Arm 2: 69.2 (21.2); Arm 3: 65.7 (20.6); Arm 4: 70.0 (20.7); placebo: 48.7 (18.4) Each MPH dose > placebo, p < 0.01 High-weight group: Arm 1: 10.1 (6.2); Arm 2: 9.1 (6.4); Arm 3: 7.5 (5.0); Arm 4: 7.1 (5.4); placebo: 13.8 (6.1) The authors state that each of the MPH doses results in statistically significant improvement (p < 0.01) relative to placebo. In addition, the 10, 15 and 20-mg doses led to greater improvement (p < 0.01) than the 5-mg dose © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 On-task behaviour, mean (SD) Low-weight group: Arm 1: 72.4 (16.7); Arm 2: 78.1 (11.0); Arm 3: 79.6 (14.2); Arm 4: 81.7 (12.1); placebo: 60.9 (19.5) Mid-weight group: Arm 1: 65.6 (20.9); Arm 2: 81.0 (9.1); Arm 3: 76.5 (13.6); Arm 4: 81.7 (8.5); placebo: 59.9 (19.2) High-weight group: Arm 1: 68.0 (24.1); Arm 2: 75.3 (20.1); Arm 3: 76.3 (19.4); Arm 4: 84.8 (9.8); placebo: 62.0 (22.1) Each MPH dose > placebo, p < 0.01 Conclusions Authors’ conclusions: There were significant improvements in the classroom performance of children with ADHD as a result of treatment with MPH. At a group level, the relationship between dose and behavioural response was primarily linear and unrelated to factors such as gross body weight, body surface area or age Reviewer’s comments: No comments noted 327
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Appendices A systematic review and
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