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

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236 Appendix 12 Study Intervention Participants Outcomes Core symptoms Peer Assessment for Hyperkinetic Disorders (FBB/HKS) (teachers) 5-point effectiveness scale (parents, physicians) Reference Dopfner et al., 2003 48 Source Updated search Co-existent problems Not reported Arm 1 MPH 2 × 5-mg immediate-release capsules for first 2 days; subsequent dose began at 20-mg sustainedrelease capsules (for children of 20–30 kg) and could be increased to a maximum of 60 mg; children of heavier weights began at higher dosages and could be increased to a maximum of 60 mg (20–30 kg: max. 20 mg; 31–50 kg: max. 40 mg; >50 kg: max 60 mg); once daily (a.m.) (Individual administering medication not reported) Setting Germany Educational performance Not reported Inclusion criteria 1. Boys and girls 6–16 years old 2. Attending school 3. IQ = 85 4. Body weight = 20 kg 5. No strong depressive disorder or anxiety disorder 6. No tic or Tourette’s disorder 7. No familial tic disorder 8. No profound developmental disorder or psychosis 9. No previous seizures and no indication of seizure potential on EEG 10. No MPH or other psychostimulant treatment in the 3 weeks preceding trial 11. Sufficient knowledge of German Design Parallel trial Psychological function Not reported Duration Treatment periods: 4 weeks. Depression or anxiety Not reported Quality of life Not reported Diagnostic criteria DSM-IV Number Total randomised = 85 (male/female split not reported.) Arm 1 = 43 Arm 2 = 42 Purpose To test the efficacy and safety of MPH during school-time in children with ADHD Adverse events No specific scale reported Arm 2 Placebo No details reported (Individual administering medication not reported) Additional outcomes EEG Blood pressure Heart rate Biochemical levels Total withdrawals = 7 Arm 1 = 3 Arm 2 = 4 Reasons for withdrawals: Arm 1: treatment not effective n = 1, unforeseen circumstances n =2 Arm 2: treatment not effective n =3 In addition, one patient was not included in the final analysis; it appears that this was because s/he was receiving treatment for depression (imipramine) Randomisation procedure: Participants were randomised across four strata: age, sex, severity of disorder and centre Age Arm 1: 9.8 years (mean); Arm 2: 9.8 years (mean); Arm 1: 2.4 (SD); Arm 2: 2.1 (SD) continued
Study Intervention Participants Outcomes IQ Arm 1: 104.8 (mean); Arm 2: 102.7 (mean) Co-morbid disorders Arm 1: ODD: n = 21/43; social behaviour disorder: n = 2/43; other social behavioural disorders: n = 2/43; dysthymia: n = 0/43 Arm 2: ODD: n = 23/42; social behaviour disorder: n = 6/42; other social behavioural disorders: n = 1/42; dysthymia: 1/42 Diagnostic subtypes Arm 1: hyperactive/impulsive subtype: n = 32/43; inattentive subtype: n = 11/43 Arm 2: Hyperactive/impulsive subtype: n = 31/42; inattentive subtype: n=10/42; unknown subtype: n = 1/42 Additional information Previous medication: Arm 1: 16/43 had previously received treatment for ADHD Arm 2: 11/42 had previously received treatment for ADHD Participants were required to be free of MPH or other psychostimulant treatment in the 3 weeks preceding the trial © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 237
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Clinical effectiveness information
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366 Appendix 13 Study characteristi
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