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

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232 Appendix 12 Core symptoms Educational performance Quality of life Adverse events Physician Rating Sheet: incidence (MPH, placebo) Insomnia and sleep problems: 3, 5 Anorexia and appetite problems: 8, 5 Increased crying: 10, 5 Stomach ache: 9, 7 Headache: 5, 2 Increased irritability: 2, 0 Increased nervousness: 1, 1 Nausea: 1, 2 Dizziness: 1, 2 Rash: 0, 3 Moodiness: 2, 0 Temper tantrums: 0, 0 Thirsty: 1, 0 Itching: 2, 0 Depression: 1, 1 Increased appetite: 1, 1 Glassy eyed: 1, 1 Nose bleed: 1, 1 Enuresis: 0, 2 Argumentative: 0, 0 Sensitive to light: 0, 0 Night terrors: 0, 0 Stares glassily: 0, 0 Fine tremors: 0, 0 Dilated pupils: 0, 0 Leg cramps: 0, 0 Odd mannerism of mouth: 0, 0 Bad dreams: 0, 0 Increased sensitivity: 0, 0 Diarrhoea: 0, 0 Palpitations: 1, 0 Stuttering: 1, 0 Negativism: 1, 0 Nocturnal fears: 1, 0 Eyes reddened: 1, 0 Speech incoherent: 1, 0 Eating erratic: 0, 1 Grouchy: 0, 1 Parent global judgements of improvement (how serious a problem does your child have? no/minor/serious problem): At week 8, % responding ‘serious problem’: PEM: 17.6%; MPH: 27.8%; PLA: 50% (2 =6.67, p < 0.155) Wide Range Achievement: reading: mean (SEM) MPH: baseline 2.33 (0.25) (n = 20), 8 weeks 2.66 (0.25) (n = 20) Placebo: baseline 2.35 (0.26) (n = 20), 8 weeks 2.56 (0.26) (n = 20) No significant differences Conners’ Parent Questionnaire: hyperactivity: mean (SD) MPH: baseline 0.99 (0.36) (n = 20), 8 weeks 0.46 (0.23) (n = 20) Placebo: baseline 0.98 (0.36) (n = 21), 8 weeks 0.75 (0.36) (n = 20) Not significant, p = 0.069 Parent rating of problems compared with peers (much worse, worse, same, better, much better) at baseline no differences between groups: at 8 weeks % ‘same or better’: PEM: 71%; MPH: 90%; PLA: 37% (2 =18.422, p < 0.019) Wide Range Achievement: spelling: mean (SEM) MPH: baseline 2.09 (0.19) (n = 20), 8 weeks 2.37 (0.24) (n = 20) Placebo: baseline 2.07 (0.20) (n = 20), 8 weeks 2.14 (0.20) (n = 20) No significant differences. Conners’ Parent Questionnaire: impulsivity: mean (SD) MPH: baseline 1.53 (0.56) (n = 20), 8 weeks 0.69 (0.52) (n = 20) Placebo: baseline 1.45 (0.51) (n =21), 8 weeks 1.31 (0.57) (n = 20) MPH > Placebo, p < 0.001 Teacher rating of problems compared with peers (much worse, worse, same, better, much better): at 8 weeks no significant difference between groups Wide Range Achievement: arithmetic: mean (SD) MPH: baseline 2.24 (0.17) (n = 20), 8 weeks 2.58 (0.17) (n = 20) Placebo: baseline 1.93 (0.19) (n = 20), 8 weeks 2.22 (0.22) (n = 20) No significant differences Conners’ Teacher Questionnaire: inattentive–passive: mean (SD) MPH: baseline 1.86 (0.49) (n = 20), 8 weeks 1.20 (0.73), (n = 19) Placebo: baseline 1.65 (0.80) (n = 21), 8 weeks 1.25 (0.73) (n = 19) Not significant, p-value not reported Conners’ Teacher Questionnaire: hyperactivity: mean (SD) MPH: baseline 2.24 (0.55) (n = 20), 8 weeks 1.28 (0.67) (n = 19) Placebo: baseline 1.90 (0.50) (n = 21), 8 weeks 1.45 (0.63) (n =19) MPH > Placebo, p = 0.039 continued
Core symptoms Educational performance Quality of life Adverse events Pains in ribs: 0, 1 Sluggishness: 0, 1 No. of different side-effects: 65, 42 No. of patients with side-effects: 20, 14 Little difference between groups overall Conclusions Authors’ conclusions: Both drugs produced improvement in all areas except the achievement measures Reviewer’s comments: No comments noted © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 233
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Appendices A systematic review and
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Clinical effectiveness information
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366 Appendix 13 Study characteristi
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