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

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348 Appendix 12 Core symptoms Educational performance Quality of life Adverse events Prone to crying 4.5/8.5/13/13.6 Anxious 11.4/4.3/10.9/4.5 Bites fingernails 4.5/4.3/13/6.8 Euphoric/unusually happy 0/2.1/4.3/0 Dizziness 0/0/0/0 Tics or nervous movements 0/0/4.3/4.5 Conclusions Authors’ conclusions: In children with ADHD–Combined type, the most common subtype of ADHD, increasing doses of stimulant medication were associated with increased improvement of inattention and hyperactivity symptoms. In children with ADHD–Inattentive subtype, symptom improvement occurred at lower doses and less benefit was derived from higher doses. In both ADHD subtypes, higher doses were associated with parent ratings of increased insomnia and decreased appetite Reviewer’s comments: The authors report that it was not possible to ensure identical appearance of placebo and active drug Study Intervention Participants Outcomes Core symptoms SKAMP: deportment; attention (measured by two trained observers) Reference Swanson et al., 2004 32 Co-existent problems Not reported Source Updated search Educational performance Not reported Inclusion criteria 1. 6–12 years of age 2. Children with a clinical diagnosis being treated with MPH in doses of 10–60 mg/day 3. IQ >80 (had to follow and understand study instructions) 4. Not pregnant 5. No history of seizure or tic disorder 6. No family history of seizure or Tourette’s syndrome 7. No congenital cardiac abnormality, history of cardiac disease including myocardial infarction within 3 months of study entry, glaucoma or hyperthyroidism 8. No history of substance abuse 9. No concurrent chronic or acute illness or other condition that might confound the study rating measures 10. No documented allergy or intolerance to MPH 11. No use of concomitant medication that could interfere with the assessment of efficacy and safety of study treatments Arm 1 MPH Metadate CD (MCD) – Participants were assigned to a dose level according to their pre-existing dosing requirement for MPH: 20, 40 or 60 mg/day (Individual administering medication not reported) Setting USA (laboratory school) Psychological function Not reported Design Crossover trial Depression or anxiety Not reported Arm 2 MPH Concerta (CON) – Participants were assigned to a dose level according to their pre-existing dosing requirement for MPH: 18, 36 or 54 mg/day (Individual administering medication not reported) Duration Each treatment for 7 days; no washout period Quality of life Not reported Adverse events Side-effects on the Barkley Scale Diagnostic criteria DSM-IV Purpose To evaluate differences in the pharmacodynamic profile of Metadate CD continued
Study Intervention Participants Outcomes Additional outcomes SKAMP – 10-minute math test to provide an objective measure from its permanent product, defined as the number of problems answered correctly Blood pressure and pulse rate Number Total randomised = 184 (male = 74%) Total withdrawals = 27 Randomisation procedure: Patients were stratified by previous MPH dose, creating the following comparisons: MCD 20 mg vs CON 18 mg vs placebo, MCD 40 mg vs CON 36 mg vs placebo, MCD 60 mg vs CON 54 mg vs placebo Arm 3 Placebo (Individual administering medication not reported) and Concerta. The authors assessed the various treatments at different hours postdose Age 9.7 years (mean); 1.8 years (SD) IQ Not reported Co-morbid disorders 25% had a co-morbid condition including anxiety and ODD (other conditions not reported) Diagnostic subtypes Inattentive: 13%; hyperactive/impulsive: 5%; combined: 82% © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Additional information Previous medication: All participants were taking MPH before the study – this was part of the inclusion criteria. 1% of the participants were taking Focalin Health Technology Assessment 2006; Vol. 10: No. 23 Concurrent medication: Individuals taking additional medication that could interfere with the assessment of efficacy and safety of study treatments were excluded from the trial 349
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Appendices A systematic review and
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Clinical effectiveness information
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184 Appendix 7 Sensitivity analysis
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186 Appendix 7 Sensitivity analysis
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