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

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310 Appendix 12 Study Intervention Participants Outcomes Core symptoms Abbreviated ACTRS (teachers, counsellors) Inclusion criteria Inclusion criteria are not explicitly reported Reference Pelham et al., 1990 78 Co-existent problems Appropriate/inappropriate behaviour ratings: following rules, positive peer behaviours, noncompliance, conduct problems, negative verbalisations (counsellors) Rule-following behaviour (teachers) Diagnostic criteria DSM-III Arm 1 MPH plus non-drug intervention Standard; 10 mg administered twice daily (a.m., noon); broad spectrum behaviour modification intervention (Administered by parent and programme staff) Source AHRQ Report Number Total randomised = 22 (male = 22) No withdrawals reported Setting USA (STP) Educational performance Arithmetic drill: number of questions attempted, percentage completed correctly Timed reading task: number of questions attempted, percentage completed correctly Randomisation procedure: Note that placebo, standard MPH, sustained-release MPH and DEX were randomised over single days whereas PEM was randomised in triplets of days, with only the last two days of the three being used to record data Arm 2 MPH plus non-drug intervention Sustained release 20 mg administered once daily with midday placebo; broad spectrum behaviour modification intervention (Administered by parent and programme staff) Design Crossover trial Psychological function Continous Performance Task: errors of commission, errors of omission Age 10.39 years (mean); 8.08–13.17 years (range); 1.38 years (SD) Duration STP: 8 weeks; drug treatment period: 6 1 – 2 weeks; baseline assessment period: 1 1 – 2 weeks Depression or anxiety Not reported Quality of life Not reported. IQ 105.68 (mean) Co-morbid disorders ODD: n = 9/22; CD: n = 4/22; learning disability suggested: n = 13/22; Concurrent seizure disorder: n = 1/22. Diagnostic subtypes Not reported Arm 3 DEX plus non-drug intervention Sustained release 10 mg administered once daily (a.m.) with midday placebo; broad spectrum behaviour modification intervention (Administered by parent and programme staff) Adverse events Side-effects checklists (parents, teachers, counsellors) Additional information No relevant information reported Purpose To evaluate the relative efficacy of comparable doses of the three longacting forms of stimulant – PEM, dextroamphetamine and MPH – with the standard MPH preparation Additional outcomes Daily report cards: percentage of days child reached academic and behavioural criteria Arm 4 PEM plus non-drug intervention 56.25 mg administered once daily (a.m.) with midday placebo; broad spectrum behaviour modification intervention (Administered by parent and programme staff)
Core symptoms Educational performance Quality of life Adverse events Not reported Side-effects checklists (staff rating): % of children rated as showing side-effects or placebo/MPH/MPH-SR/DEX: Crabby, touchy: 22.7/0.0/9.1/0.0 Whiny: 22.7/ 4.8/9.1/18.2 Worried, anxious: 4.5/0.0/0.0/0.0 Withdrawn: 0.0/10.0/0.0/13.6 Dull, not alert: 4.5/14.3/4.3/9.0 Drowsy, tired: 4.5/ 9.5/4.5/13.6 Tearful, cries a lot: 13.6/ 4.8/4.5/ 0.0 Jittery: 0.0/0.0/0.0/4.5 Sad, depressed: 4.5/0.0/0.0/4.5 Stomach aches, nausea: 13.6/14.3/9.1/22.7 Headaches: 9.1/0.0/0.0/22.7 Muscle aches: 4.5/9.5/4.5/0.0 Rash: 0.0/0.0/0.0/0.0 Weakness: 4.5/0.0/4.5/0.0 Dry mouth: 4.5/4.8/4.5/0.0 Loss of appetite: 45.0/61.9/76.2/77.3 Vomiting: 0.0/0.0/0.0/4.5 Fainting, dizziness: 0.0/0.0/0.0/4.5 Eye/muscle twitches: 4.5/4.8/9.1/4.5 Fingernail biting: 9.1/4.8/4.5/4.5 Repetitive tongue movements: 9.1/4.8/0.0/4.5 Picking: 0.0/0.0/0.0/4.5 Distortion of vision: 0.0/0.0/0.0/0.0 Timed reading task: number of questions attempted Placebo: 14.3 (8.0) MPH 10mg: 18.0 (8.3) MPH SR-20: 16.4 (7.3) DEX: 17.5 (8.9) Post hoc analyses: MPH 10 mg > placebo, p < 0.01; DEX > placebo, p < 0.005 Abbreviated CTRS (teachers): mean (SD) Baseline: 15.5 (6.52) Placebo: 3.8 (4.6) MPH 10 mg: 2.3 (2.0) MPH SR-20: 2.3 (2.1) DEX: 1.7 (1.4) Post hoc analyses: DEX > placebo, p < 0.05 Timed reading task: percentage completed correctly Placebo: 69 (18) MPH 10 mg: 73 (18) MPH SR-20: 73 (13) DEX: 74 (16) No significant differences compared with placebo Abbreviated CTRS (counsellors) Baseline: Not reported Placebo: 6.3 (4.8) MPH, 10 mg: 4.8 (3.2) MPH, SR-20: 5.0 (3.6) DEX: 4.5 (3.0) Post hoc analyses: MPH 10 mg > placebo, p < 0.05; MPH, SR-20 > placebo, p < 0.05; DEX > placebo, p < 0.05 © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Arithmetic drill (seatwork): percentage completed Placebo: 70 (24) MPH 10 mg: 78 (17) MPH SR-20: 77 (18) DEX: 76 (16) Post hoc analyses: MPH, 10 mg > placebo, p < 0.05; MPH, SR-20 > placebo, p < 0.05 Health Technology Assessment 2006; Vol. 10: No. 23 Side-effects checklists (parents rating): % of children rated as showing side effects or placebo/MPH/MPH- SR/DEX Difficulty falling asleep: 5.3/5.9/18.8/20.0 Awake during the night: 5.3/12.5/13.3/14.3 Nightmares: 0.0/0.0/0.0/0.0 Bed wetting: 0.0/5.6/0.0/6.3 Arithmetic drill (seatwork): percentage completed correctly Placebo: 84 ( 8) MPH 10 mg: 84 (10) MPH SR-20: 87 ( 9) DEX: 86 ( 8) Post hoc analyses: MPH SR-20 > placebo, p < 0.10 Conclusions Authors’ conclusions: The authors noted generally equivalent and beneficial effects of all four medications Reviewer’s comments: No comments noted 311
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Appendices A systematic review and
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366 Appendix 13 Study characteristi
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