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

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256 Appendix 12 Core symptoms Educational performance Quality of life Adverse events STESS (parents) Frequency (%) for sleep problem/appetite decrease/crying/sadness/unhappiness/anger/headaches/ increased thirst/dry mouth/nausea/stomach aches/shakiness: MPH, standard: 41.1/15.8/15.8/10.5/5.3/10.5/10.5/0.0/0.0/5.3/5.3/0.0 MPH, SR: 36.8/36.8/21.0/0.0/21.0/31.6/10.5/5.3/0.0/0.0/0.0/0.0 MPH, standard + SR: 63.2/26.3/26.3/0.0/15.8/26.3/5.3/0.0/0.0/0.0/0.0/5.3 Placebo: 15.8/5.3/31.6/5.3/26.3/42.1/10.5/10.5/0.0/0.0/0.0/0.0 Sleep problems increased with MPH: F(93,42) = 5.38, p < 0.01 (only significant for combined versus placebo) No significant differences for other side-effects Not reported Parent comments ratings MPH, standard: 0.17 (0.44) MPH, SR: –0.05 (0.55) MPH, standard + SR: 0.18 (0.41) Placebo: –0.43 (0.42) Teacher comments ratings MPH, standard: 0.19 (0.48) MPH, SR: 0.20 (0.44) MPH, standard + SR: 0.40 (0.37) Placebo: –0.40 (0.54) TOTS Attention: F(3,42) = 17.19, p < 0.0001 (Patients were rated by both teachers and parents as behaving better in all MPH conditions than placebo, but MPH conditions did not differ from one another) Conners’ Hyperactivity Index (parents) ( ?mean, ?SD) (range 0–3, lower scores = better behaviour) MPH, standard: 0.96 (0.50) MPH, sustained release (SR): 0.98 (0.72) MPH, standard + SR: 0.81 (0.46) Placebo: 1.75 (0.67) Wilcoxon pairwise comparisons did not identify significant differences among MPH conditions, but indicated that placebo was ranked lower than all of the active conditions (all p < 0.006) Weight (kg) MPH, standard: 31.41 (6.82) MPH, SR: 31.59 (7.25) MPH, standard + SR: 31.33 (7.00) Placebo: 31.94 (7.39) F(3,41)=10.29, p < 0.0006 (Placebo weights significantly higher than combined and standard) Parent improvement rankings MPH, standard: 2.18 (0.78) MPH, SR: 2.16 (1.09) MPH, standard + SR: 1.87 (0.86) Placebo: 3.79 (0.38) 2 (3) = 25.97, p < 0.0001 (No differences among MPH conditions, but placebo ranked lower than all active conditions: all p < 0.006) Conners’ Hyperactivity Index (teacher) (range 0–3, lower scores = better behaviour) MPH, standard: 0.73 (0.65) MPH, SR: 0.77 (0.63) MPH, standard + SR: 0.58 (0.40) Placebo: 1.36 (0.80) Conners’ Hyperactivity: F (3,42) = 21.96, p < 0.0001 (Patients were rated by both teachers and parents behaving better in all MPH conditions than placebo, but MPH conditions did not differ from one another) IOWA Inattention/Overactivity Scale (parents) (range 0–3, lower scores = better behaviour) MPH, standard: 1.01 (0.46) MPH, SR: 0.98 (0.61) MPH, standard + SR: 0.79 (0.48) Placebo: 1.90 (0.63) IOWA Inattention/Overactivity Scale (teacher) (range 0–3, lower scores = better behaviour) MPH, standard: 0.87 (0.63) MPH, SR: 0.92 (0.68) MPH, standard + SR: 0.70 (0.56) Placebo: 1.65 (0.90) IOWA Inattention/Overactivity Scale: F(3,42) = 23.82, p < 0.0001 (Patients were rated by both teachers and parents as behaving better in all MPH conditions than placebo, but MPH conditions did not differ from one another) continued
Core symptoms Educational performance Quality of life Adverse events TOTS: Hyperactivity (parents) (range 0–3, lower scores = better behaviour) MPH, standard: 0.20 (0.31) MPH, SR: 0.22 (0.50) MPH, standard + SR: 0.18 (0.49) Placebo: 0.70 (0.48) TOTS: Attention (parents) (range 0–3, higher scores = better behaviour) MPH, standard: 0.81 (0.41) MPH, SR: 0.72 (0.38) MPH, standard + SR: 0.91 (0.44) Placebo: 0.36 (0.41) TOTS: Hyperactivity (teacher) (range 0–3, lower scores = better behaviour) MPH, standard: –0.16 (0.44) MPH, SR: –0.12 (0.51) MPH, standard + SR: –0.29 (0.56) Placebo: 0.36 (0.69) TOTS, Hyperactivity: F(3,42) = 16.56, p < 0.0001 (Patients were rated by both teachers and parents as behaving better in all MPH conditions than placebo, but MPH conditions did not differ from one another) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 TOTS: Attention (teacher) (range 0–3, higher scores = better behaviour) MPH, standard: 1.01 (0.57) MPH, SR: 0.88 (0.62) MPH, standard + SR: 1.05 (0.52) Placebo: 0.67 (0.62) TOTS, Attention: F(3,42) = 11.12, p < 0.0001 (Patients were rated by both teachers and parents as behaving better in all MPH conditions than placebo, but MPH conditions did not differ from one another) Conclusions Authors’ conclusions: The authors conclude that the MPH conditions were superior to placebo and comparable to each other. They state that the findings suggest comparable effectiveness for sustained-release and standard preparations of MPH Reviewer’s comments: No comments noted 257
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Appendices A systematic review and
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Clinical effectiveness information
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178 Appendix 5 8. Was the statistic
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180 Appendix 6 Cost-effectiveness R
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182 Appendix 7 Appropriateness of m
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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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#Baseline shift random effects mode
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202 Appendix 12 Study Intervention
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366 Appendix 13 Study characteristi
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