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

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294 Appendix 12 Core symptoms Educational performance Quality of life Adverse events Weight (kg) baseline/end-point/mean change ATX (n = 179): 41.36 (16.05)/40.72 (16.05)/–0.63 (1.64) MPH (n = 40): 40.74 (17.2)/40.60 (18.14)/–0.13 (1.89) (NS, p = 0.089, 95% CI: –0.1 to 1.1) Conclusions Authors’ conclusions: Similar reductions in ADHD symptoms were seen in both the ATX and MPH treatment groups. Both drugs were generally well tolerated, with few discontinuations due to adverse events. Vomiting and somnolence were more frequently reported among participants randomised to ATX Reviewer’s comments: Participants were randomised to open-label treatment
Study Intervention Participants Outcomes Core symptoms CTRS: inattentiveness and hyperactivity Devereux Elementary School Behaviour Rating Scale Conners’ Abbreviated Rating Scale (parents) Devereux Child Behaviour Rating Scale (parents) Werry–Weiss–Peters Activity Scale Inclusion criteria 1. 7–13 years old 2. IQ 80 3. Diagnosis of both ADDH and Developmental Reading Disorder according to DSM-III criteria 4. No additional Axis I psychiatric diagnosis 5. No uncorrected hearing or visual deficits Arm 1 Placebo plus non-drug intervention Placebo administered once daily One-to-one reading therapy programme during weeks 3–14 and 16–27: weekly with reading therapist and 5 days/week at home with parent (Administered by parent) Reference Kupietz et al., 1988 71 Source AHRQ Report Setting USA Design Parallel trial Co-existent problems CTRS: aggressiveness Educational performance Not reported Arm 2 MPH plus non-drug intervention 0.3 mg/kg/day administered in one dose for weeks 1–14 and 16–27; placebo during week 15. One-to-one reading therapy programme during weeks 3–14 and 16–27: weekly with reading therapist and 5 days/week at home with parent (Administered by parent) Duration Study length: 8 weeks; total treatment period: 6 months Psychological function Paired-Associated Learning task Short-term Memory task Diagnostic criteria DSM-III Number Total randomised = 58 (male/female split not reported) Arm 1 = 16 Arm 2 = 19 Arm 3 = 12 Arm 4 = 11 Depression or anxiety Not reported Quality of life Not reported Total withdrawals = 11 Arm 1 = 4 Arm 2 = 5 Arm 3 = 1 Arm 4 = 1 Age 116.9 months (mean); 20.1 months (SD) Purpose To investigate the effects of 6-month MPH treatment on home and school behaviour and on cognitive performance in hyperactive, readingdisabled children © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Adverse events Not reported Health Technology Assessment 2006; Vol. 10: No. 23 Additional outcomes Plasma assay using gas chromatography IQ 93.8 (mean) Co-morbid disorders All children received a dual diagnosis of ADDH and Developmental Reading Disorder (Reading Grade Level: mean = 2.3, SD = 1.0) Arm 3 MPH plus non-drug intervention 0.5 mg/kg/day administered in one dose for weeks 1–14 and 16–27; placebo during week 15. One-to-one reading therapy programme during weeks 3–14 and 16–27: weekly with reading therapist and 5 days/week at home with parent (Administered by parent) Diagnostic subtypes Not reported Additional information No relevant information reported Arm 4 MPH plus non-drug intervention 0.7 mg/kg/day administered in one dose for weeks 1–14 and 16–27; placebo during week 15. One-to-one reading therapy programme during weeks 3–14 and 16–27: weekly with reading therapist and 5 days/week at home with parent (Administered by parent) 295
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366 Appendix 13 Study characteristi
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