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

More documents

Recommendations

Info

356 Appendix 12 Study Intervention Participants Outcomes Core symptoms IOWA Conners’ Rating Scale: inattention/overactivity subscale (teacher, parent) SNAP-IV: inattention, hyperactivity/impulsivity (parent, teacher) Arm 1 Placebo Administered three times daily (7.30 a.m., 11.30 a.m., 3.30 p.m.) (Individual administering medication not reported) References Wolraich et al., 2001 97 ; Wolraich, 2000 325 ; Wolraich et al., 2002 326 Source Updated search Co-existent problems IOWA Conners’ Rating Scale: oppositional subscale (teacher, parent) SNAP-IV: oppositional, peer interaction (parent, teacher) Inclusion criteria 1. Clinical diagnosis of ADHD (any subtype) 2. Aged 6–12 years 3. Patients who were taking MPH or had taken it in the past had to have been on a total daily MPH dose of at least 10 mg but not more than 60 mg (immediate or sustained release) 4. No acute or serious chronic disease 5. No hypersensitivity to MPH or previous significant adverse experiences from MPH 6. No medication that would interfere with safe administration of MPH 7. No glaucoma, Tourette’s syndrome, ongoing seizure disorder or psychotic disorder 8. No girls who had reached menarche 9. Consent to take study drug as only medication during 4-week trial Arm 2 MPH Participants were assigned to a dose level according to dose titration or pre-existing dose requirement for MPH: 15, 30, 45 mg/day given in 3 capsules (7.30 a.m., 11.30 a.m., 3.30 p.m.); mean daily dose: 0.9 ± 0.4 mg/kg/day (Individual administering medication not reported) Setting USA Design Parallel trial Duration Treatment period: 4 weeks Educational performance Not reported Psychological function Not reported Diagnostic criteria Confirmed by Diagnostic Interview Schedule for Children (version 4). Severity of ADHD symptoms rated both at school and at home using SNAP-IV, IOWA-C and C-GAS Depression or anxiety Not reported Quality of life Clinical Global Impression: improvement (investigators) Global efficacy (parent, teacher) Number Total randomised = 312 (male = 233/282) Arm 1 = 99 Arm 2 = 107 Arm 3 = 106 Arm 3 MPH Participants were assigned to a dose level according to dose titration or pre-existing dose requirement for MPH: 18, 36, 54 mg/day in one extended-release capsule (7.30 a.m.) plus placebo (11.30 a.m., 3.30 p.m.); 1.1 ± 0.5 mg/kg/day (Individual administering medication not reported) Purpose To compare the efficacy and safety of once-a-day investigational OROS extended-release MPH (Concerta) with conventional MPH three times a day (MPH t.d.s.) and placebo in children with ADHD Adverse events Solicited and spontaneous reports: focus on sleep quality, tics and appetite (parent) Additional outcomes Blood pressure Pulse rate Parent Satisfaction Questionnaire Total withdrawals = 106 Arm 1 = 53 Arm 2 = 26 Arm 3 = 27 Reasons for withdrawals: Site excluded: n = 30 Never received medication: n = 5 Adverse effects: n = 3; Arm 1: n = 1; Arm 2: n = 1, Arm 3: n = 1 Noncompliance: n = 3; Arm 1: n = 1; Arm 2: n = 1; Arm 3: n = 1 Lost to follow-up: n = 1; Arm 1: n = 0; Arm 2: n = 0; Arm 3: n = 1 Lack of efficacy: n = 59; Arm 1: n = 38; Arm 2: n = 10; Arm 3: n = 11 Could not swallow pills: n = 1; Arm 1: n = 0; Arm 2: n = 0; Arm 3: n = 1 Protocol violation: n = 2; Arm 1: n = 1; Arm 2: n = 1; Arm 3: n = 0 Did not return: n = 1; Arm 1: n = 1; Arm 2: n = 0; Arm 3: n = 0 continued
Study Intervention Participants Outcomes Mother gave child IR-MPH; n = 1; Arm 1: n = 1; Arm 2: n = 0; Arm 3: n = 0 Age 9.0 years (mean); 6–12 years (range); 1.8 years (SD) IQ Not reported Co-morbid disorders ODD: n = 118/282 (41.8%) CD: n = 32/282 (11.3%) Tic disorder: n = 15/282 (5.3%) Anxiety disorder: n = 4/282 (1.4%) Depression: n = 2/282 (0.7%) Total: n = 131/282 (46.5%) Diagnostic subtypes Combined: n = 207/282 (73.4%) Inattentive: n = 55/282 (19.5%) Hyperactive/impulsive: n = 20/282 (7.1%) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Additional information Previous medication: No previous MPH treatment: 102/312 (these were enrolled in a dose titration study immediately prior to the randomisation phase of this trial) Previous MPH treatment: 210/312 Health Technology Assessment 2006; Vol. 10: No. 23 Concurrent medication: Individuals in receipt of any medication that would interfere with the safe administration of MPH were excluded from the trial No previous stimulant therapy: 57/282 (20.2%); Arm 1: 19/90 (21.1%); Arm 2: 18/97 (18.6%); Arm 3: 20/95 (21.1%) No stimulant therapy in previous 4 weeks: 18/282 (6.4%); Arm 1: 6/90 (6.7%); Arm 2: 9/97 (9.3%); Arm 3: 3/95 (3.2%) Previous non-MPH therapy: 16/282 (5.7%); Arm 1: 5/90 (5.6%); Arm 2: 8/97 (8.2%); Arm 3: 3/95 (3.2%) Previous MPH therapy: 191/282 (67.7%); Arm 1: 60/90 (66.7%); Arm 2: 62/97 (63.9%); Arm 3: 69/95 (72.6%) Co-interventions: Patients were allowed to receive behavioural interventions during the trial provided that they had been initiated before the beginning of the study and did not change during the course of the study 357
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: 306 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?