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

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314 Appendix 12 Study Intervention Participants Outcomes Core symptoms Classroom measures: on-task behaviour Individual target measures (Daily Report Cards) IOWA Conners’ Rating Scale: inattention–overactivity (counsellors, teachers, parents) Inclusion criteria Informed consent of parents and participants Reference Pelham et al., 1999 80 Diagnostic criteria DSM-IV Source NICE Report Number Total randomised = 26 (male = 22) Total withdrawals = 1 Arm 1 MPH plus non-drug intervention 10 mg/dose administered at 7.45 a.m. and 12.15 p.m. Monday to Thursday for 6 weeks in random order with conditions changing daily for 24 days; comprehensive behavioural programme incorporating parental training and a BM system (Individual administering medication not reported) Setting USA (STP) Co-existent problems Point system measures: following activity rules, non-compliance, interrupting, complaining, positive peer behaviours, conduct problems and negative verbalisations Classroom measures: rule-following behaviour and disruptive behaviour IOWA Conners’ Rating Scale: oppositional/defiance (counsellors, teachers, parents) Recess rule violations Reasons for withdrawals: Child removed owing to uncontrollable behaviour not ameliorated by medication Arm 2 MPH plus non-drug intervention 17.5 mg/dose administered at 7.45 a.m. and 12.15 p.m. Monday to Thursday for 6 weeks in random order with conditions changing daily for 24 days; comprehensive behavioural programme incorporating parental training and a BM system (Individual administering medication not reported) Design Crossover trial Age 9.6 years (mean); range 5.8–12.7 years; 1.6 years (SD) Duration Treatment period: 6 weeks IQ Not reported Co-morbid disorders ODD: n = 13; CD: n = 8 Educational performance Classroom measures: accuracy and productivity of seatwork tasks Point system measures: attention questions answered correctly Diagnostic subtypes Not reported Arm 3 Adderall plus non-drug intervention 7.25 mg/dose administered at 7.45 a.m. and 12.15 p.m. Monday to Thursday for 6 weeks in random order with conditions changing daily for 24 days; comprehensive behavioural programme incorporating parental training and a BM system (Individual administering medication not reported) Purpose To compare two doses of Ritalin and Adderall in the treatment of ADHD in children in an acute study and assess the medications’ time courses Additional information No relevant information reported Psychological function Not reported Depression or anxiety Not reported Quality of life Not reported Adverse events Side-effects checklist (teachers, counsellors, parents) Arm 4 Adderall plus non-drug intervention 12.5 mg/dose administered at 7.45 a.m. and 12.15 p.m. Monday to Thursday for 6 weeks in random order with conditions changing daily for 24 days; comprehensive behavioural programme incorporating parental training and a BM system (Individual administering medication not reported) Additional outcomes Global impression of effectiveness of medication (counsellors, teachers, parents)
Core symptoms Educational performance Quality of life Adverse events Not reported Side-effects checklist (teachers, counsellors, parents): teachers not reported % of children with moderate or severe side-effects ‘on at least 1-day’: ‘on average’, for placebo/MPH (10 mg)/MPH (17.5 mg), rated by parents: Motor tics: 8:0/4:0/0:0 Buccal–lingual movement.: 4:0/0:0/4:0 Picking, nail-biting: 4:0/0:0/0:0 Worried/anxious: 4:0/4:4/4:0 Dull, tired, listless: 28:0/8:0/12:0 Headaches: 4:0/12:0/16:0 Stomach ache: 0:0/4:0/8:0 Crabby, irritable: 32:4/24:4/16:0 Tearful, sad, depressed: 8:4/20:0/16:0 Socially withdrawn: 12:0/0:0/8:0 Hallucinations: 0:0/0:0/0:0 Trouble sleeping: 12:4/32:8/24:4 Loss of appetite: 8:0/8:0/20:4 Seatwork completion: mean (SD) Placebo: 58.0 (25.8) MPH 10 mg: 69.5 (15.4) MPH 17.5 mg: 69.2 (19.5) Seatwork accuracy: mean (SD) Placebo: 89.0 (9.6) MPH 10 mg: 87.9 (9.8) MPH 17.5 mg: 87.1 (12.4) Post-treatment means (SD) for: placebo/MPH (10 mg)/MPH (17.5 mg) Baseline (teachers only): 11.8 (2.3) IOWA Conners’ Rating Scale: inattention–overactivity (teachers): 3.7 (2.6)/1.8 (1.4)/1.1 (1.2) IOWA Conners’ Rating Scale: inattention–overactivity (parents, 5-6 p.m.) 3.0 (2.9)/1.9 (1.4)/1.0 (1.1) IOWA Conners Rating Scale: inattention–overactivity (counsellors) 5.6 (2.9)/3.4 (1.8)/2.6 (1.4) Point system measures: attention: mean (SD) Placebo: 62.9 (14.9) MPH 10 mg: 64.0 (15.7) MPH 17.5 mg: 64.3 (15.4) Individual target measures (daily report cards) 50.5 (20.7)/76.4 (9.7)/81.7 (12.3) Classroom measures: on-task behaviour 78.9 (15.4)/89.2 (10.5)/89.6 (8.6) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 % of children with moderate or severe side-effects ‘on at least 1day’: ‘on average’, for: placebo/MPH (10 mg)/ MPH (17.5 mg), rated by counsellors: Motor tics: 0:0/8:0/4:0 Buccal–lingual movement: 0:0/12:0/4:4 Picking, nail-biting: 4:0/4:0/8:0 Worried/anxious: 8:0/8:0/8:0 Dull, tired, listless: 8:0/0:0/20:0 Headaches: 4:0/8:0/8:0 Stomach ache: 12:0/8:0/28:0 Crabby, irritable: 32:4/4:0/8:0 Tearful, sad, depressed: 8:0/16:0/24:0 Socially withdrawn: 0:0/8:0/16:0 Hallucinations: 0:0/0:0/0:0 Trouble sleeping: –:–/-:–/–:– Loss of appetite: 60:4/60:4/68:12 Conclusions Authors’ conclusions: The authors conclude that Adderall is at least as effective as Ritalin in improving acutely the behaviour and academic productivity of children with ADHD Reviewer’s comments: No comments noted 315
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Appendices A systematic review and
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