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

More documents

Recommendations

Info

258 Appendix 12 Study Intervention Participants Outcomes Core symptoms CPRS: impulsivity/hyperactivity CTRS: inattentive–passive; hyperactivity CPRS: total score CTRS: total score Inclusion criteria 1. 6–11 years of age 2. Met at least 8 of the 14 DSM-III-R criteria for ADHD 3. IQ > 50 4. No chronic medical conditions 5. No receipt of ongoing medication (except antiepileptic drug) 6. No substandard height (below –2 SD of the norm) 7. No major psychosocial problems 8. No history of alcohol or drug abuse themselves or of their principal caretaker Arm 1 Amphetamine sulphate Dosage was titrated from 5 mg twice daily (breakfast, lunch) to a max. of 45 mg/day. Mean dose 0.52 mg/kg/day (0.20–1.10). (Individual administering medication not reported) Reference Gillberg et al., 1997 56 Source AHRQ Report Setting Sweden Co-existent problems CPRS: conduct problems CTRS: conduct problems Design Parallel trial Educational performance CPRS: inattention/learning problems CTRS: inattention/learning problems Diagnostic criteria DSM-III-R Number Total randomised = 62 (male = 51) Arm 1 = 32 Arm 2 = 30 Arm 2 Placebo All children received amphetamine for the first 3 months of the study (titration phase); at 3 months they were randomised to DEX or placebo. Those in the placebo group had the active drug withdrawn gradually over a 2-week period (Individual administering medication not reported) Duration Treatment period: 15 months Psychological function WISC-R Depression or anxiety CTRS: anxious–fearful Birleson Depression Self-report Scale McGrath Test Total withdrawals = 30 Arm 1 = 8 Arm 2 = 22 Purpose To evaluate the effects of amphetamine sulphate on behaviour and cognition, and adverse effects during 15 months of treatment Quality of life Not reported Randomisation procedure: Randomisation was balanced within each site and stratified for age Adverse events Incidence of 20 adverse events Additional outcomes Height, weight, pulse, blood pressure Age 9 years (mean); 6–11 years (range); 1.6 (SD) IQ 51–72 (range) Co-morbid disorders Autistic disorder (1); mild mental retardation (10); ODD (8); CD (3); separation anxiety disorder (2); tics or Tourette syndrome (3). 32/62 had academic problems or special educational needs Diagnostic subtypes Not reported Additional information Previous/concurrent medication: All participants had interventions prior to the study: 2 had amphetamine therapy, 8 had been taking other drugs (neuroleptics, -linolenic–butyric acid and folic acid); 3 were taking carbamazepine and 1 was taking volproic acid throughout study. Participants were not to receive ongoing medication (except antiepileptic drug) during the trial
Core symptoms Educational performance Quality of life Adverse events Withdrawals: severe tics and hallucinations (n = 1), hallucinations only (n =2) Not reported CPRS: total score (DEX > placebo, p < 0.001) CTRS: total score (DEX > placebo, p < 0.01) Results were presented in graph form and actual scores could not be extracted; no SDs presented CPRS: impulsivity/hyperactivity (DEX > placebo, p < 0.001) CTRS: inattentive–passive; hyperactivity (DEX > placebo, p < 0.01 for both) Results were presented in graph form and actual scores could not be extracted; no SDs presented CPRS: total score (DEX > placebo, p < 0.001) CTRS: total score (DEX > placebo, p < 0.01) Results were presented in graph form and actual scores could not be extracted; no SDs presented © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 Adverse events (patients reporting as occasionally or often) baseline/6 months for amphetamine (n = 40)/placebo (n = 16) (No. (%): Difficulty falling asleep: 18 (33%)/14 (35%)/3 (19%) Early awakenings: 13 (25%)/6 (15%)/4 (25%) Disturbed sleep: 15 (28%)/9 (23%)/2 (12%) Increased need to sleep: 6 (11%)/1 (2%)/2 (12%) Headache: 7 (13%)/10 (25%)/3 (19%)a Abdominal pain: 9 (17%)/5 (12%)/1 (6%) Diarrhoea: 3 (6%)/1 (2%)/1 (6%) Constipation: 3 (6%)/1 (2%)/0 (0%) Dry mouth: 4 (7%)/5 (12%)/1 (6%) Nausea, vomiting: 3 (6%)/5 (12%)/1 (6%) Tics: 9 (17%)/8 (20%)/5 (31%) Stereotypes: 2 (4%)/5 (12%)/1 (6%) Anxiety, nervousness: 18 (33%)/11 (28%)/7 (44%) Dysthymia: 4 (7%)/9 (23%)/2 (13%) Euphoria, hypomania: 22 (41%)/4 (10%)/4 (25%) Palpitation: 0 (0%)/2 (5%)/0 (0%) continued 259
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: 208 Appendix 12 Core symptoms Educa
Page 72 and 73: 216 Appendix 12 Study Intervention
Page 164 and 165:
Page 166 and 167:
Page 168 and 169:
Page 170 and 171:
Page 172 and 173:
Page 174 and 175:
Page 176 and 177:
Page 178 and 179:
Page 180 and 181:
Page 182 and 183:
Page 184 and 185:
Page 186 and 187:
Page 188 and 189:
Page 190 and 191:
Page 192 and 193:
Page 194 and 195:
Page 196 and 197:
Page 198 and 199:
Page 200 and 201:
Page 202 and 203:
Page 204 and 205:
Page 206 and 207:
Page 208 and 209:
Page 210 and 211:
Page 212 and 213:
Page 214 and 215:
Page 216 and 217:
Page 218 and 219:
Page 220 and 221:
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?