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

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222 Appendix 12 Core symptoms Educational performance Quality of life Adverse events Not reported Not reported WRAT: Reading. Mean (SD) at baseline/post-treatment (3 months)/3-month follow-up Arm 1: 60.00 (10.68)/61.88 (13.25)/65.57 (11.05) Arm 2: 57.70 (17.58)/59.20 (16.54)/59.60 (16.46) Arm 3: 53.78 (19.92)/56.56 (20.02)/54.33 (23.60) Arm 4: 45.88 (15.56)/47.75 (10.19)/51.86 (11.70) CPRS: Hyperactivity Index. Unadjusted means (SD) at baseline/post-treatment (3m)/3m follow-up Arm 1: 20.25 (6.20)/15.88 (6.36)/14.71 (4.47); n = 7 Arm 2: 20.20 (6.83)/21.10 (5.65)/14.50 (5.31); n = 10 Arm 3: 18.22 (6.04)/13.78 (8.14)/15.33 (5.79); n = 9 Arm 4: 21.38 (5.00)/17.25 (7.50)/17.71 (4.15); n = 7 WRAT: Arithmetic. Mean (SD) at baseline/posttreatment (3 months)/3-month follow-up Arm 1: 30.13 (5.06)/35.00 (9.47)/30.43 (5.53) Arm 2: 26.40 (4.50)/29.40 (5.80)/29.10 (5.07) Arm 3: 25.00 (5.39)/28.33 (5.63)/27.67 (8.51) Arm 4: 20.50 (5.63)/24.75 (5.60)/25.14 (5.67) ACTeR: attention. Unadjusted means (SD) at baseline/post-treatment (3m)/3m follow-up Arm 1: 20.63 (4.17)/22.00 (2.45)/22.20 (1.48); n = 7 Arm 2: 15.30 (5.01)/15.90 (6.01)/17.00 (7.24); n = 10 Arm 3: 17.55 (6.00)/16.33 (5.57)/17.29 (7.23); n = 9 Arm 4: 18.75 (4.30)/19.50 (5.47)/19.43 (5.71); n = 7 WRAT: Spelling. Mean (SD) at baseline/post-treatment (3 months)/3-month follow-up Arm 1: 38.88 (7.16)/40.13 (7.28)/41.29 (6.47) Arm 2: 34.90 (8.24)/36.10 (8.60)/38.60 (8.37) Arm 3: 35.11 (11.90)/37.89 (12.29)/35.78 (14.18) Arm 4: 27.13 (6.42)/30.00 (8.28)/30.14 (7.31) ACTeR: hyperactivity. Unadjusted means (SD) at baseline/post-treatment (3m)/3m follow-up Arm 1: 18.25 (5.50)/14.25 (5.60)/17.00 (5.79); n = 7 Arm 2: 18.80 (2.35)/19.60 (2.63)/16.83 (2.23); n = 10 Arm 3: 16.11 (4.88)/14.33 (4.66)/16.43 (5.88); n = 9 Arm 4: 17.38 (4.50)/17.50 (4.41)/19.71 (3.15); n = 7 Durell Listening Comprehension. Mean (SD) at baseline/post-treatment (3 months)/3-month followup Arm 1: 27.25 (10.87)/33.00 (9.29)/30.14 (10.81) Arm 2: 25.10 (9.79)/ 25.50 (11.65)/28.50 (7.49) Arm 3: 18.00 (14.33)/24.44 (15.56)/20.89 (14.70) Arm 4: 20.00 (13.35)/19.00 (6.50)/26.57 (12.96) Abbreviated CTRS. Unadjusted means (SD) at baseline/post-treatment (3m)/3m follow-up Arm 1: 13.50 (6.16)/9.88 (3.18)/10.80 (7.09); n = 7 Arm 2: 16.90 (3.31)/16.50 (5.38)/15.50 (5.54); n = 10 Arm 3: 14.00 (7.50)/12.56 (4.07)/12.00 (7.23); n = 9 Arm 4: 14.38 (6.26)/13.63 (6.26)/14.57 (4.54); n = 7 Teacher ratings: impulsivity. Unadjusted means (SD) at baseline/post-treatment (3m)/3m follow-up Arm 1: 3.46 (0.29)/3.28 (0.49)/3.09 (1.43); n = 7 Arm 2: 3.53 (0.25)/3.47 (0.18)/3.05 (1.19); n = 10 Arm 3: 3.21 (0.82)/3.30 (0.70)/3.19 (0.64); n = 9 Arm 4: 3.34 (0.37)/3.21 (0.52)/3.16 (0.49); n = 7 Teacher ratings: attention. Unadjusted means (SD) at baseline/post-treatment (3m)/3m follow-up Arm 1: 50.25 (8.73)/45.38 (3.20)/44.40 (12.78); n = 7 Arm 2: 51.70 (4.11)/51.60 (7.93)/49.00 (9.25); n = 10 Arm 3: 51.56 (9.77)/47.00 (6.08)/47.14 (8.63); n = 9 Arm 4: 51.88 (6.92)/48.00 (8.23)/52.29 (8.14); n = 7 Conclusions Authors’ conclusions: The results of this study, except for the marginal trend on a single laboratory measure, failed to support the efficacy of such treatment combinations Reviewer’s comments: No comments noted
Study Intervention Participants Outcomes Core symptoms CPRS-R: impulsive-hyperactive Teacher Hyperactivity Index (ATR) ACTeRS: attention, hyperactivity Inclusion criteria 1. Sexual maturity rating = 3 on Tanner’s scale. 2. Long history of symptoms associated with attention deficit disorder 3. Score = 15 on Abbreviated CTRS 4. No mental retardation or gross neurological disorders Reference Brown and Sexton, 1988 43 Co-existent problems CPRS-R: conduct problems ACTeRS: oppositional behaviour, social skills, peer acceptance, dependence on and solicitation from teacher Arm 1 MPH 0.15 mg/kg/dose administered twice daily (8 a.m., 12 p.m.); mean dose 4.38 mg/dose (Administered by parent/teacher/clinic staff) Source CCOHTA Report Diagnostic criteria DSM-III Setting USA Arm 2 MPH 0.30 mg/kg/dose administered twice daily (8 a.m., 12 p.m.); mean dose 12.55 mg/dose (Administered by parent/teacher/clinic staff) Design Crossover trial Educational performance CPRS-R: learning problems Arithmetic task: no. of questions attempted, no. of questions completed correctly, accuracy score, time spent Number Total randomised = 11 (male = 11) No withdrawals reported Duration Total treatment period: 8 weeks (2 weeks per treatment arm) Psychological function MFFT Gordon Diagnostic System (GDS) Depression or anxiety CPRS-R: anxiety Age 13 years 7 months (mean); 12 years 10 months – 14 years 10 months (range) IQ 92.91 (mean) Co-morbid disorders Conduct disorder, socialised aggressive: 5/11 (DSM-III) Arm 3 MPH 0.50 mg/kg/dose administered twice daily (8 a.m., 12 p.m.); mean dose 21.28 mg/dose (Administered by parent/teacher/clinic staff) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Quality of life Not reported Diagnostic subtypes Not reported Health Technology Assessment 2006; Vol. 10: No. 23 Adverse events SERS: (parents) Additional information Previous medication: none of the participants had been treated with stimulants in the preceding year Additional outcomes Cardiovascular measures Weight Arm 4 Placebo Administered twice daily (8 a.m., 12 p.m.) (Administered by parent/teacher/clinic staff) Purpose 1. To examine the efficacy of MPH, with ADD-H black adolescents 2. To examine differential responses on laboratory and behavioural measures according to varying dosages 3. To examine sideeffects according to varying dosages 4. To examine the effect of MPH on academic performance 223
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366 Appendix 13 Study characteristi
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