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

More documents

Recommendations

Info

358 Appendix 12 Core symptoms Educational performance Quality of life Adverse events 306 participants were included in analyses of safety Any adverse event: occurrence Total: n = 126 (41.2%) OROS: 42.3% IR-MPH: 46.2% Placebo: 34.7% Not reported Mean CGI (investigator rated) Mean (SD), OROS MPH/IR- MPH/placebo End of study (n = 263): 4.24* (1.34)/4.19* (1.45)/2.48 (1.67) Overall treatment effect: F(2,260) = 39.35, *p < 0.001 compared with placebo Withdrawals: OROS: n = 1, depression IR-MPH: n = 1, emotional lability Placebo: n = 1, tics CGI: % much or very much improved at end of study (n = 192) OROS MPH: 46.7%; IR-MPH: 47.2%; placebo: 16.7% Headache: occurrence OROS: 14.4% IR-MPH: 5.8% Placebo: 10.2% Abdominal pain: occurrence OROS: 6.7% IR: 5.8% Placebo: 1.0% Global Efficacy (parent) end of study: mean (SD) (n = 247) OROS: 1.47 (1.07); significantly different from placebo (p < 0.05) IR-MPH: 1.28 (0.93); significantly different from placebo (p < 0.05) Placebo: 0.61 (0.93) Overall treatment effect: F(2,244) = 16.71 (p < 0.001) IOWA-C mean scores: Inattention/overactivity (teacher rated) Mean (SD), OROS MPH/IR-MPH/placebo Baseline (n = 276): 9.74 (4.1)/9.94 (3.7)/10.28 (3.8) Week 1 (n = 238): 5.58* (3.64)/5.70* (3.84)/9.87 (4.09) *p < 0.05 compared with placebo; no significant differences between OROS and IR-MPH (p = 0.838) End of study (n = 271): 5.98* (3.91)/6.35* (4.31)/9.77 (4.02) *p < 0.05 compared with placebo; no significant differences between OROS and IR-MPH (p = 0.539) Overall treatment effect (week 1): F(2,235) = 30.59, p < 0.001 Overall treatment effect (end of study): F(2,258) = 21.95, p < 0.001 Sleep: At baseline, most were assessed as having good or excellent sleep: 70.5, 72.8 and 76.6% in OROS, IR and placebo groups. On days 14 and 28, >65% continued to have good or excellent sleep quality. There appeared to be no significant differences between groups Appetite: At day 14, 22.5, 18.8 and 12.0% in the OROS, IR-MPH and placebo groups, respectively had eaten less than usual in the preceding 2 weeks. There were significant differences between the active and placebo arms (p < 0.001). Percentages were similar on day 28 Global Efficacy (teacher) end of study: mean (SD) (n = 233) OROS: 1.42 (0.97); significantly different from placebo (p < 0.05) IR-MPH: 1.43 (1.01); significantly different from placebo (p < 0.05) Placebo: 0.62 (0.81) Overall treatment effect: F(2,230) = 17.64, p < 0.001 Global efficacy (teacher): % rated good or excellent OROS: 42.9% IR: 46.9% Placebo: 17.7% IOWA-C mean scores: Inattention/overactivity (parent rated) Mean (SD), OROS MPH/IR-MPH/placebo Baseline (n = 281): 11.08* (2.6)/9.90 (3.2)/10.44 (3.0) *p < 0.01 compared with IR-MPH Week 1 (n = 243): 5.38* (3.38)/5.44* (3.22)/9.48 (3.78) *p < 0.05 compared with placebo End of study (n = 265): 6.29* (3.54)/6.17* (3.19)/ 10.11 (3.92) *p < 0.05 compared with placebo Overall treatment effect (week 1): F(2,240) = 36.49, p < 0.001 Overall treatment effect (end of study): F(2,262) = 34.22, p < 0.001 Tics: New onset or clinically significant increase IR-MPH: n = 1 Placebo: n = 4 SNAP-IV Inattention (teacher rated) Mean (SD), OROS MPH/IR-MPH/placebo Baseline (n = 274): 2.03 (0.7)/2.06 (0.6)/2.04 (0.7) End of study (n = 236): 1.34* (0.84)/1.26* (0.79)/1.97 (0.79) continued
Core symptoms Educational performance Quality of life Adverse events Global efficacy (parent): % rated good or excellent OROS: 54.0% IR: 46.5% Placebo: 20.3% *p < 0.05 compared with placebo; no significant differences between OROS and IR-MPH Overall treatment effect F(2,233) = 16.40, p < 0.001 SNAP-IV Hyperactivity/Impulsivity (teacher rated) Mean (SD), OROS MPH/IR-MPH/placebo Baseline (n = 274): 1.60 (0.9)/1.62 (0.8)/1.00 (0.8) End of study (n = 236): 0.96* (0.79)/0.93* (0.79)/1.57 (0.89) *p < 0.05 compared with placebo; no significant differences between OROS and IR-MPH Overall treatment effect F(2,233) = 4.23, p < 0.001 SNAP-IV Inattention (parent rated) Mean (SD), OROS MPH/IR-MPH/placebo Baseline (n = 276): 2.29 (0.5)/2.16 (0.6)/2.18 (0.5) End of study (n = 250): 1.38* (0.68)/1.39* (0.73)/2.00 (0.78) *p < 0.05 compared with placebo; no significant differences between OROS and IR-MPH Overall treatment effect F(2,247) = 19.15, p < 0.001 © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 SNAP-IV Hyperactive/impulsivity (parent rated) Mean (SD), OROS MPH/IR-MPH/placebo Baseline (n = 276): 2.02 (0.6)/1.84 (0.7)/1.99 (0.7) End of study (n = 250): 1.11* (0.65)/1.10* (0.69)/1.83 (0.89) *p < 0.05 compared with placebo; no significant differences between OROS and IR-MPH Overall treatment effect F(2,248) = 24.79, p < 0.001 Conclusions Authors’ conclusions: For the treatment of core ADHD symptoms, OROS MPH dose once daily and IR-MPH dose t.d.s. were superior to placebo and were not significantly different from each other Reviewer’s comments: No comments noted 359
Page 1 and 2:
Appendices A systematic review and
Page 3 and 4:
Clinical effectiveness information
Page 5 and 6:
Searches for systematic reviews in
Page 7 and 8:
19. methyl phenidate.mp. 20. methyl
Page 9 and 10:
43. attention deficit$.mp. 44. 42 o
Page 11 and 12:
MEDLINE in-process and other non-in
Page 13 and 14:
PsycINFO (1967-July 2004) Searched:
Page 15 and 16:
next aminopropane) or dynaphenyl or
Page 17 and 18:
or ritaline or riphenidate or rital
Page 19:
System for Information on Grey Lite
Page 22 and 23:
166 Appendix 2 S hyperkinetic S imp
Page 24 and 25:
168 Appendix 2 19. (eq5d or eq 5d o
Page 26 and 27:
170 Appendix 2 14. (person trade of
Page 28 and 29:
172 Appendix 3 Reference Reason for
Page 31:
Appendix 4 © Queen’s Printer and
Page 34 and 35:
178 Appendix 5 8. Was the statistic
Page 36 and 37:
180 Appendix 6 Cost-effectiveness R
Page 38 and 39:
182 Appendix 7 Appropriateness of m
Page 40 and 41:
184 Appendix 7 Sensitivity analysis
Page 42 and 43:
186 Appendix 7 Sensitivity analysis
Page 44 and 45:
188 Appendix 8 Probability cost-eff
Page 47 and 48:
Appendix 10 © Queen’s Printer an
Page 49 and 50:
Health state Responder to ATX, no s
Page 51 and 52:
Health state Responder to IR-MPH, R
Page 53 and 54:
Health state Responder to ER-MPH, R
Page 55:
#Baseline shift random effects mode
Page 58 and 59:
202 Appendix 12 Study Intervention
Page 60 and 61:
Page 62 and 63:
206 Appendix 12 Core symptoms Educa
Page 64 and 65:
Page 66 and 67:
Page 68 and 69:
Page 70 and 71:
Page 72 and 73:
Page 74 and 75:
Page 76 and 77:
Page 78 and 79:
Page 80 and 81:
Page 82 and 83:
Page 84 and 85:
Page 86 and 87:
Page 88 and 89:
Page 90 and 91:
Page 92 and 93:
Page 94 and 95:
Page 96 and 97:
Page 98 and 99:
Page 100 and 101:
Page 102 and 103:
Page 104 and 105:
Page 106 and 107:
Page 108 and 109:
Page 110 and 111:
Page 112 and 113:
Page 114 and 115:
Page 116 and 117:
Page 118 and 119:
Page 120 and 121:
Page 122 and 123:
Page 124 and 125:
Page 126 and 127:
Page 128 and 129:
Page 130 and 131:
Page 132 and 133:
Page 134 and 135:
Page 136 and 137:
Page 138 and 139:
Page 140 and 141:
Page 142 and 143:
Page 144 and 145:
Page 146 and 147:
Page 148 and 149:
Page 150 and 151:
Page 152 and 153:
Page 154 and 155:
Page 156 and 157:
Page 158 and 159:
Page 160 and 161:
Page 162 and 163:
Page 164 and 165: 308 Appendix 12 Core symptoms Educa
Page 166 and 167: 310 Appendix 12 Study Intervention
Page 222: 366 Appendix 13 Study characteristi
show all

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

Create successful ePaper yourself

Delete template?

Save as template?