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

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290 Appendix 12 Study Intervention Participants Outcomes Core symptom Abbreviated IOWA/Conners’ Rating Scale: inattentive/overactive (evaluated in the classroom and enrichment room) Inclusion criteria 1. 7–13 years of age 2. No concurrent medication Arm 1 MPH plus non-drug intervention Low-dose MPH (0.3 mg/kg) and high dose MPH (0.6 mg/kg). Each MPH condition was administered twice daily (8 and 11.30 a.m.) one day per week for six weeks (a total of 6 days). Behaviour modification (BM) consisted of the STEP programme: a 5 days/week, 8 hours/day programme consisting of hourly, structured therapeutic, educational and recreational activities (e.g. skills group, classroom enrichment, gym). BM was alternated with no behaviour modification on a weekly basis for a total of 3 weeks each (Administered by medical personnel) Reference Kolko et al., 1999 69 Source Updated search Co-existent problems Abbreviated IOWA/Conners’ Rating Scale: oppositional/defiant Overt Aggression Scale (verbal aggression, physical aggression against objects, physical aggression against people) Peer conflicts Positive mood/behaviour (social skills group, gym and field) Diagnostic criteria DSM-III-R Number Total randomised = 22 (male = 22) Total withdrawals = 6 Setting USA (Partial hospitalisation – STP) Reasons for withdrawals: 2 were hospitalised for aggressive and unmanageable behaviour, 2 had serious side-effects in the first week and 2 later declined to take MPH Design Crossover trial Educational performance Not reported Randomisation procedure: Note that each drug treatment was administered for 6 days over the 6-week trial (randomly administered on a daily basis, each once per week, across a 3-day period) Psychological function Not reported Age 9.6 years (mean); 1.9 years (SD) Depression or anxiety Not reported IQ Not reported Co-morbid disorders CD: n = 7/16 (44%); ODD: n = 9/16 (56%); three children also had an anxiety disorder, 2 had major depressive disorder, 1 had dysthymia and 1 had intermittent explosive disorder Arm 2 MPH Doses as above with no BM (Administered by medical personnel) Duration 6 weeks Purpose To evaluate the separate and incremental effects of two doses of MPH and behaviour modification in children with ADHD and comorbid disorders across multiple settings Quality of life Not reported Adverse events Stimulant Drug Side Effects Rating Scale Arm 3 Placebo plus non-drug intervention Placebo with BM (Administered by medical personnel) Additional outcomes Not reported Diagnostic subtypes Not reported Additional information Previous medication: Before the trial began, there was a 2-week baseline during which no MPH was given. All patients had failed to respond to less intensive outpatient treatment Arm 4 Placebo Placebo only (Administered by medical personnel) Concurrent medication: Individuals receiving other medication were excluded from the trial
Core symptoms Educational performance Quality of life Adverse events Not reported Not reported No specific effects were reported. The authors state that MPH was associated with more side-effects than placebo. Serious side-effects were found in 2/22 of children (who were omitted from the analysis) Abbreviated IOWA/Conners’ Rating Scale: inattentive/overactive (results from classroom) Low-dose MPH + BM: 1.8 (3.5) High-dose MPH + BM: 3.2 (2.8) Placebo + BM: 3.3 (3.9) Low-dose MPH + no BM: 4.1 (4.4) High-dose MPH + no BM: 3.3 (2.9) Placebo + no BM: 9.9 (3.8) (Low/high MPH > placebo, p < 0.0001). The two MPH conditions did not differ from each other. Behaviour modification was associated with reductions in inattentive/overactive Abbreviated IOWA/Conners’ Rating Scale: inattentive/overactive Effect sizes: MPH (low and high dose): 1.63 (1.24) BM: 1.29 (0.80) MPH (low and high dose) + BM: 1.88 (0.83) (MPH + BM > BM, p < 0.01); MPH alone and BM alone were not significantly different from each other © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Data also presented for enrichment room, but not extracted Health Technology Assessment 2006; Vol. 10: No. 23 Conclusions Authors’ conclusions: The authors state that core symptoms of ADHD and positive behaviour showed significant improvements with high- and low-dose MPH Reviewer’s comments: No comments noted 291
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366 Appendix 13 Study characteristi
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