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

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334 Appendix 12 Study Intervention Participants Outcomes Core symptoms IOWA-C (inattention/overactivity) Smith et al., 1998; 88 Evans et al., 2001; 322 , Smith et al., 2000 323 Co-existent problems Frequency of negative behaviours IOWA-C (oppositional/defiant) Educational performance History worksheet correct History quiz correct History notes (main ideas recorded) History notes (details recorded) Written language (words written) Written language (sequence length) Written language (story idea) Homework completed Inclusion criteria 1. DSM-III-R criteria for ADHD 2. Participants to have 12th birthday before the protocol began 3. Verbal IQ >80 4. No conditions that precluded a trial of stimulant medication or full participation in the STP academic and athletic activities Arm 1 MPH plus non-drug treatment 10 mg twice per day (7.45 and 11.45 a.m.) plus 5 mg at 3.45 p.m. for 6 days. Behavioural treatment programme involved daily activities 5 days/week for 8 weeks including classroom, study hall, therapeutic recreation, social skills and problem-solving groups (Individual administering medication not reported) Source Updated search Diagnostic criteria DSM-III-R Setting USA (STP) Number Total = 49 (male = 41/46) Total withdrawals = 3 Design Crossover trial Duration 8 weeks Reasons for withdrawals: Two participants were discharged from the programme owing to poor attendance. Another participant withdrew against medical advice Psychological function Not reported Depression or anxiety Not reported Randomisation procedure: Medication conditions were randomised daily with condition occurring once per week Arm 2 MPH plus non-drug treatment 20 mg twice per day (7.45 and 11.45 a.m.) plus 10 mg at 3.45 p.m for 6 days. Behavioural therapy as above (Individual administering medication not reported) Quality of life Not reported Adverse events Side-effects rating from 0 (not troubling) to 3 (severe) (counsellor and parent rated) Age 13.8 years (mean); 12–17 years (range); 1.2 years (SD) IQ 101 (mean) Co-morbid disorders ODD: n = 23 (50%) CD: n = 7 (15%) Arm 3 MPH plus non-drug treatment 30 mg twice per day (7.45 and 11.45 a.m.) plus 15 mg at 3.45 p.m. for 6 days. Behavioural therapy as above (Individual administering medication not reported) Additional outcomes Not reported Purpose To describe the shape of the dose–response curves across multiple measures of social functioning. To determine the percentage of adolescents whose social behaviour improved in response to MPH and to assess the incremental gains that result from increases in dose Diagnostic subtypes Not reported Additional information Previous medication: 33 (72%) were taking stimulant medication, 2 (4%) were taking tricyclic antidepressants, 11 (24%) were not taking any psychoactive medication. All psychoactive medications were discontinued for at least 2 weeks before the beginning of the trial of stimulant medication Arm 4 Placebo plus non-drug treatment 3 times per day at 7.45 and 11.45 a.m. and 3.45 p.m. for 6 days Behavioural therapy as above (Individual administering medication not reported) Smith 323 : To assess the effects of MPH on academic performance and classroom behaviour
Core symptoms Educational performance Quality of life Adverse events Not reported % participants reporting moderate or severe sideeffects: Evans et al.: 322 mean (SD) Motor tics: placebo/10 mg/20 mg/30 mg Counsellor: 0/0.3/0/0.4 [F(3,135) = 0.48, p = 0.693] Parent: 0/0.4/0/0.4 [F(3,135) = 0.53, p = 0.660] Tearful: placebo/10 mg/20 mg/30 mg Counsellor: 6.4/3.0/3.3/3.0 [F(3,135) = 0.48, p = 0.695] Parent: 2.0/2.2/2.7/2.3 [F(3,135) = 0.13, p = 0.943) History worksheet correct Placebo: 53.2 (31.1) 10 mg: 70.2 (25.8) > placebo (no p-values reported) 20 mg: 79.8 (19.8) > placebo and 10 mg 30 mg: 78.5 (20.9) > placebo F(3,132) = 38.52, p < 0.0001 IOWA-C (inattention/overactivity), mean (SD) Placebo 4.2 (0.4) 10 mg 3.2 (0.3) 20 mg 2.7 (0.3) 30 mg 2.2 (0.2) The authors state that a significant difference was observed between all comparisons at the p < 0.05 level; no further detail is given Worried: placebo/10 mg/20 mg/30 mg Counsellor: 5.5/6.3/4.9/3.8 [F(3,135) = 1.29, p = 0.281] Parent: 3.3/1.8/0.4/2.7 [F(3,135) = 0.7, p = 0.556] History quiz correct Placebo: 46.6 (29.6) 10 mg: 63.8 (22.2) > placebo 20 mg: 71.0 (18.5) > placebo and 10 mg 30 mg: 72.1 (20.1) > placebo F(3,132) = 51.08, p < 0.0001 Headache: placebo/10 mg/20 mg/30 mg Counsellor: 3.8/3.3/3.4/5.7 [F(3,135) = 0.93, p = 0.429] Parent: 0.8/1.6/4.2/3.0 [F(3,135) = 2.18, p = 0.093] Picking at skin, fingers etc: placebo/10 mg/20 mg/30 mg Counsellor: 7.2/13.4/12.6/13.4* [F(3,135) = 2.14, p = 0.099] Parent: 6.6/5.4/4.0/5.9 [F(3,135) = 0.75, p = 0.526] *Rate of side-effects is significantly different from placebo History notes (main ideas recorded) Placebo: 69.8 (28.8) 10 mg: 77.3 (23.5) > placebo 20 mg: 85.1 (17.7) > placebo and 10 mg 30 mg: 83.2 (18.8) > placebo F(3,132) = 12.42, p < 0.0001 Evans et al.: 322 IOWA-C (inattention/overactivity), mean (SD) Placebo 4.4 (3.5) 10 mg 2.7 (2.7) > placebo 20 mg 1.7 (2.2) > placebo and 10 mg 30 mg 1.2 (1.5) > placebo and 20 mg No p-values reported © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 Buccal lingual movement: placebo/10 mg/20 mg/30 mg Counsellor: 7.9/4.0/4.3/2.7 [F(3,135) = 3.7, p = 0.030] Parent: 0.4/1.1/0.4/1.1 [F(3,135) = 0.27, p = 0.848] History notes (details recorded) Placebo: 41.1 (26.5) 10 mg: 52.8 (24.7) > placebo 20 mg: 58.9 (21.3) > placebo and 10 mg 30 mg: 60.0 (24.6) > placebo F(3,132) = 35.82, p < 0.0001 Crabby: placebo/10 mg/20 mg/30 mg Counsellor: 24.2/13.4*/10.5*/9.4* [F(3,135) = 11.0, p = 0.000] Parent: 8.4/6.3/5.0/4.3 [F(3,135) = 0.46, p = 0.710] *Rate of side-effects is significantly different from placebo Written language (words written) Placebo: 58.8 (47.6) 10 mg: 82.6 (53.4) > placebo 20 mg: 96.9 (49.4) > placebo and 10 mg 30 mg: 102.0 (54.5) > placebo F(3,132) = 32.76, p < 0.0001 Dull/tired/listless: placebo/10 mg/20 mg/30 mg Counsellor: 4.2/6.5/8.2/12.4** [F(3,135) = 6.03, p = 0.001] Parent: 1.8/4.0/4.4/5.0* [F(3,135) = 2.0, p = 0.118] **Rate of side-effects is significantly different from placebo and 10 mg condition *Rate of side-effects is significantly different from placebo Written language (sequence length) Placebo: 7.4 (7.6) 10 mg: 9.8 (8.5) > placebo 20 mg: 10.7 (7.9) > placebo 30 mg: 11.7 (10.6) > placebo F(3,132) = 11.25, p < 0.0001 continued 335
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Appendices A systematic review and
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Clinical effectiveness information
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Searches for systematic reviews in
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next aminopropane) or dynaphenyl or
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180 Appendix 6 Cost-effectiveness R
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184 Appendix 7 Sensitivity analysis
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186 Appendix 7 Sensitivity analysis
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188 Appendix 8 Probability cost-eff
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Appendix 10 © Queen’s Printer an
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Health state Responder to ATX, no s
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Health state Responder to IR-MPH, R
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Health state Responder to ER-MPH, R
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