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

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270 Appendix 12 Study Intervention Participants Outcomes Core symptoms CTRS: conduct problems, hyperactivity, inattention–passivity, hyperactivity index Preschool Behaviour Questionnaire: Hyperactive–distractible Inclusion criteria 1. No diagnosis of autism/pervasive development disorder 2. No previously prescribed stimulant medication Arm 1 MPH 0.3 mg/kg dose (up to 3 times daily) for 1 week (Individual administering medication not reported) References Handen et al., 1999; 60 Handen et al., 2003303 Source Updated search Co-existent problems Preschool Behaviour Questionnaire: hostile–aggressive, anxious Diagnostic criteria DSM-III Number Total randomised = 11 (male = 9) Total withdrawals = 1 Arm 2 MPH 0.6 mg/kg dose (up to 3 times daily) for 1 week (Individual administering medication not reported) Setting USA Educational performance Not reported Design Crossover trial Psychological function Not reported Reasons for withdrawals: One child experienced significant adverse side-effects and was not given a 0.6 mg/kg dose Arm 3 Placebo 1 week (Individual administering medication not reported) Duration 3 weeks (+ 1 week baseline measures) Depression or anxiety Not reported Randomisation procedure: Seven children received two doses, two children received a third MPH dose in mid-afternoon. Lower dose always preceded higher dose Quality of life Not reported Adverse events Side-effects checklist administered to preschool teachers and parents. Mean severity rating 0–6 Age 58.9 months (mean); 4–5.11 years (range) IQ 60 (mean) Co-morbid disorders ODD: n = 2/9 (9/11 met criteria for ADHD) Additional outcomes Waiting task Resistance to temptation Play session Compliance task Clean-up task Diagnostic subtypes Not reported Purpose To extend knowledge of safety and efficacy of MPH among preschool children with developmental disabilities as a first step towards establishing guidelines for use. To examine the rate of positive responding to MPH among the group of children Additional information No individuals having previously received stimulant medication were included in the trial
Core symptoms Educational performance Quality of life Adverse events © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 Not reported Not reported Teacher-rated side-effects: mean (SD) and number of subjects experiencing adverse sideeffects for placebo, 0.3 mg/kg, 0.6 mg/kg Repetitive tongue movements 0.3 (1.0) 1, 0.3 (0.7) 2, 0.4 (1.0) 2 Motor or vocal twitches 0.3 (1.0) 1, 0.3 (0.7) 2, 0.2 (0.6) 1 Nervous movements 0.4 (1.0) 2, 0.6 (1.1) 3, 0.2 (0.4) 2 Tearful, prone to crying 0.8 (1.5) 3, 0.7 (1.6) 3, 0.1 (0.3) 1 Dull, not alert 0.4 (0.7) 3, 1.5 (1.7) 6, 2.2 (2.0) 7 Sad, unhappy, depressed 0.2 (0.4) 2, 0.5 (1.6) 1, 0.6 (1.1) 3 Staring, daydreaming 1.8 (2.1) 6, 2.0 (1.6) 7, 1.7 (2.2) 5 Social withdrawal, talks less 0.4 (1.0) 2, 1.3 (1.9) 6, 2.1 (2.4) 5 Irritable 0.6 (1.0) 4, 0.9 (1.5) 3, 1.2 (1.9) 4 Poor appetite 0.1 (0.3) 1, 1.9 (2.4) 5, 3.2 (2.9) 6 Dizzy, balance unstable 0.0 (0.0) 0, 0.2 (0.7) 2, 0.0 (0.0) 0 Anxiety 0.0 (0.0) 0, 0.1 (0.3) 1, 0.3 (0.5) 3 Headaches 0.0 (0.0) 0, 0.1 (0.3) 1, 0.0 (0.0) 0 Stomach aches, nausea 0.0 (0.0) 0, 0.1 (0.3) 1, 0.0 (0.0) 0 Restless, high activity level 5.0 (1.1) 9, 3.0 (1.6) 6, 1.1 (1.6) 5 Crabby, touchy, whiny 1.0 (1.4) 4, 1.0 (1.7) 3, 0.7 (1.3) 4 Excessive talking 2.8 (2.4) 7, 1.0 (1.2) 5, 0.6 (1.1) 3 Drowsiness 0.0 (0.0) 0, 1.1 (1.8) 3, 0.6 (0.8) 4 CTRS: mean (SD) for placebo,0.3 mg/kg, 0.6 mg/kg Hyperactivity 14.0 (3.7), 9.0 (5.1), 6.2 (3.4), p =0.001 (post hoc: 0.6 mg/kg > placebo, p < 0.05) Inattention–Passivity 12.8 (4.3), 9.9 (3.9), 8.9 (3.7), p = 0.03 (post hoc: 0.6 mg/kg > placebo, p < 0.05) Hyperactivity Index 17.4 (6.0), 11.9 (5.7), 9.2 (3.8), p = 0.006 (post hoc: 0.6 mg/kg > Placebo, p < 0.05) Preschool Behaviour Questionnaire: mean (SD) for placebo, 0.3 mg/kg, 0.6 mg/kg Hyperactive–distractible 7.0 (1.5), 4.7 (2.5), 3.8 (1.5), p = 0.001 (post hoc: 0.6 mg/kg > placebo, p < 0.05) continued 271
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Appendices A systematic review and
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Clinical effectiveness information
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Searches for systematic reviews in
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178 Appendix 5 8. Was the statistic
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180 Appendix 6 Cost-effectiveness R
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182 Appendix 7 Appropriateness of m
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184 Appendix 7 Sensitivity analysis
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186 Appendix 7 Sensitivity analysis
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188 Appendix 8 Probability cost-eff
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Appendix 10 © Queen’s Printer an
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Health state Responder to ATX, no s
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Health state Responder to IR-MPH, R
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Health state Responder to ER-MPH, R
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#Baseline shift random effects mode
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202 Appendix 12 Study Intervention
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366 Appendix 13 Study characteristi
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