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

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352 Appendix 12 Core symptoms Educational performance Quality of life Adverse events Not reported Not reported Not reported CBCL parent rated: mean (SE) ADHD (placebo/low dose/high dose) 68.76 (3.2)/61.6 (2.9)/56.37 (2.7) Teacher report form: mean (SE) ADHD (placebo/low dose/high dose) 65.03 (2.8)/50.21 (1.9)/51.34 (1.9) The authors state that the children had a significant linear response to medication [F(2,46), p = 0.001] Conclusions Authors’ conclusions: Both ADHD and ADHD-MD are psychostimulant responders whose hyperactive/impulsive behaviour responds well to low-dose medication. Both groups of children had a linear dose–response to medication (placebo, low, high) and there was no evidence of a group by dose interaction or an overall group effect at home or school Reviewer’s comments: Publication results focus on difference in behavioural outcomes in ADHD and ADHD-MD. Treatment outcomes are a very small part of this publication Study Intervention Participants Outcomes [Confidential information removed] Reference Weiss et al., 2004 94 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 ADHD Rating Scale IV, Parent Version: total score Inclusion criteria 1. School-aged children, aged 7–12 years 2. ADHD diagnosis Reference Wernicke et al., 2004 95 Co-existent problems Not reported Diagnostic criteria DSM-IV Source Updated search Educational performance Not reported Arm 1 ATX Titrated to maximum of 2.0 mg/kg/day; administered twice daily in evenly divided doses (Individuals administering medication not reported) Setting USA Psychological function Not reported Number Total = 194 (male/female split not reported) Arm 1 = 102 Arm 2 = 92 Arm 2 Placebo (Individuals administering medication not reported) Design Parallel trial Depression or anxiety Not reported Two studies are reported on in this paper. 194 children completed the discontinuation phase of either study and are reported on here Quality of life Not reported Age Mean not reported; 7–12 years (range) Duration Wash-out period: 2 weeks; treatment period: 9 weeks; discontinuation phase: 1 week placebo Adverse events Barkley Behaviour and Adverse Events Questionnaire – Modified Open-ended questions IQ Not reported Co-morbid disorders Not reported Purpose To assess the effect of discontinuing ATX in children with ADHD © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Additional outcomes Vital signs Laboratory measures including hepatic function, full blood count, ECG Diagnostic subtypes Not reported Health Technology Assessment 2006; Vol. 10: No. 23 Additional information No relevant information reported Core symptoms Educational performance Quality of life Adverse events Not reported Not reported Only reported for the discontinuation phase – not relevant to our review ADHD Rating Scale IV, Parent Version: mean (SD) Arm 1: pre-treatment to end of treatment phase: –17.2 (12.6) Arm 2: pre-treatment to end of treatment phase: –6.4 (12.4) Arm 1 had significantly lower mean values at end of treatment phase Conclusions Authors’ conclusions: It appears that ATX can be stopped without the risk of symptom rebound or discontinuation emergent adverse events Reviewer’s comments: No comments reported 353
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