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

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206 Appendix 12 Core symptoms Educational performance Quality of life Adverse events Davids’ Hyperkinetic Rating Scale: overall (teachers; mean raw scores at end of treatment periods) Baseline: 32.60 (6.23); placebo: 31.30 (6.31); DEX: 25.37 (8.25) p-Values not reported Davids’ Hyperkinetic Rating Scale: overall (parents; mean standardised scores at 4 weeks) (Baseline: 4.99); placebo: 4.63; DEX: 3.93 DEX > placebo, p > 0.001 Davids’ Hyperkinetic Rating Scale: overall (teachers; mean standardised scores at 4 weeks) Baseline: 4.66; placebo: 4.47; DEX: 3.62 DEX > placebo, p > 0.001 Davids’ Hyperkinetic Rating Scale: hyperactivity (mean, SD) Baseline: 5.10 (1.14); placebo: 4.58 (1.26); DEX: 3.97 (1.40) (parents) Baseline: 4.57 (1.76); placebo: 4.90 (1.30); DEX: 3.70, (1.49) (teachers) p-Values not reported Davids’ Hyperkinetic Rating Scale: short attention span (mean, SD) Baseline: 5.13 (1.28); placebo: 4.52 (1.29); DEX: 3.84 (1.53) (parents) Baseline: 5.10 (1.49); placebo: 4.73 (1.55); DEX: 3.83 (1.62) (teachers) p-Values not reported. Davids’ Hyperkinetic Rating Scale: impulsiveness (mean, SD) Baseline: 4.90 (1.42); placebo: 4.87 (1.02); DEX: 4.06 (1.46) (parents) Baseline: 4.87 (1.14); placebo: 4.60 (1.30); DEX: 3.77 (1.41) (teachers) Target Symptom Assessment Baseline: 5.00; Placebo: 4.89 (1.22); DEX: 3.11 (1.52) Conclusions Authors’ conclusions: Both isomers showed significantly more benefit than placebo but were not significantly different from each other Reviewer’s comments: No comments noted
Study Intervention Participants Outcomes Core symptoms Problem Behaviour Checklist (parents): total, inattentive unproductiveness; hyperactivity Conners’ Teachers’ Behaviour Problem Checklist: total, daydreaming and inattention, hyperactivity Davids’ Hyperkinetic Rating Scale (parents, teachers): total, hyperactivity; short attention span, impulsiveness Arnold target symptom assessment (parents, psychiatrists) Reference Arnold et al., 1978 37 Source AHRQ Report Setting USA Co-existent problems Problem Behaviour Checklist (parents): unsocialised aggression; sociopathy Conners’ Teachers’ Behaviour Problem Checklist: aggressive misconduct Davids’ Hyperkinetic Rating Scale (parents, teachers): variability, irritability, explosiveness Inclusion criteria 1. Diagnosed with minimal brain dysfunction, with such signs and symptoms as hyperactivity, short attention span, distractibility, irritability, variability, explosiveness, aggression, inability to keep friends or function in a group, underachievement, visual-motor dysfunction and poor coordination or other minor neurological signs 2. Total score = 24 on first six items of Davids’ Hyperkinetic Rating Scale by parents and teacher 3. Indication for stimulant treatment as determined by psychiatrist 4. 5–12 years old 5. Attending school 6. No psychoactive treatment in preceding month 7. Parents’ and child’s consent 8. Insufficient benefit from an initial 2-week ‘placebo washout’ to be maintained without active drug Arm 1 MPH 10-mg capsules administered once or twice daily (a.m., noon); ascending dosage schedule, with individualised adjustments made by telephone consultation; mean optimum daily dose 1.25 ± 0.51 mg/kg (Individual administering medication not reported) Design Crossover trial Educational performance Davids’ Hyperkinetic Rating Scale (parents, teachers): poor schoolwork Diagnostic criteria See inclusion criteria Number Total randomised = 29 (male = 22) No withdrawals reported Arm 2 DEX 5-mg capsules administered once or twice daily (a.m., noon); ascending dosage schedule, with individualised adjustments made by telephone consultation; mean optimum daily dose 0.63 ± 0.24 mg/kg (Individual administering medication not reported) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Psychological function Not reported Depression or anxiety Problem Behaviour Checklist (parents): withdrawal-depression Conners’ Teachers’ Behaviour Problem Checklist: anxious and fearful Health Technology Assessment 2006; Vol. 10: No. 23 Age 8 years (mean) IQ Not reported Quality of life Not reported Co-morbid disorders Not reported Adverse events Problem Behaviour Checklist (parents): side-effects, somatic complaints Conners’ Teachers’ Behaviour Problem Checklist: lack of health Weight loss Diagnostic subtypes Fish categories: 308.0 hyperkinetic: n = 18; 308.2 overanxious: n = 5; 308.4 unsocialised aggressive: n =6 Arm 3 Caffeine 80-mg capsules administered once or twice daily (a.m., noon); ascending dosage schedule, with individualised adjustments made by telephone consultation; mean optimum daily dose 12.1 ± 4.2 mg/kg (Individual administering medication not reported) Duration Placebo washout period 2 weeks; treatment period 3 weeks Purpose The authors do not explicitly state the purpose of their study but appear to include the caffeine treatment arm owing to ‘the potential value of a nonprescription remedy considered by some “safer” than the prescription stimulants’ Additional outcomes Physiological outcomes: blood pressure, pulse Global rating of the value of the 3 drugs on a 9-point scale (benefits and side effects) (psychiatrists) Additional information Previous medication: 19/29 children had never received psychoactive treatment. 10/29 had tried MPH, amphetamine, anticonvulsants or some combination previously. Participants were required not to have been receiving psychoactive treatment in the month preceding the trial 207
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366 Appendix 13 Study characteristi
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