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

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234 Appendix 12 Study Intervention Participants Outcomes Core symptoms Behaviour ratings (teacher, parent) SHS Judgements of distractibility Judgements of motor activity Arm 1 Placebo 5 mg/day; daily dosage increased by 5 mg at weekly intervals until undesirable side-effects or maximum positive response achieved; majority maintained on 10–20 mg/day (Administered by parent) Reference Conrad et al., 1971 47 Source AHRQ Report Co-existent problems Not reported Educational performance WISC: Information, Comprehension, Arithmetic, Similarities, Digit Span, Picture Completion, Picture Arrangement, Block Design, Object Assembly, Coding; Verbal IQ, Performance IQ, Full Scale IQ Temporal Order test Recall test WRAT: Arithmetic and Reading Subtests Bender–Gestalt Visual Motor Test Frostig Developmental Test of Visual Perception: I-V, PQ and Stars Inclusion criteria 1. Rated hyperactive (19th percentile or lower) on Schenectady Hyperkinetic Scale (SHS). 2. Significant evidence of perceptual–cognitive impairment, defined as any of the following: (a) a perceptual age on the Bender–Gestalt ≥ 1 year or below the chronological age of the child (b) a Frostig Perceptual Quotient of ≤ 90 (c) three or more errors on the Bender Gestalt (d) a discrepancy between Verbal IQ and Performance IQ on the WISC of ≥ 5 points (e) variability among subscores on the WISC of ≥ 6 points 3. Not currently receiving medication 4. Parental consent 5. Able to be contacted Setting USA Design Parallel trial Arm 2 Placebo plus prescriptive tutoring 5 mg/day; daily dosage increased by 5 mg at weekly intervals until undesirable side–effects or maximum positive response achieved; majority maintained on 10–20 mg/day Tutoring sessions twice per week; average of 39.2 tutorial sessions (Administered by parent and tutor) Duration DEX treatment period: 4–6 months; tutoring: average of 20 weeks Psychological function Not reported Diagnostic criteria SHS Number Total randomised = 81 (male/female split not reported) Arm 1 = 18 Arm 2 = 17 Arm 3 = 17 Arm 4 = 16 Depression or anxiety Not reported Total withdrawals = 13 Quality of life Not reported Details are only given for the 68 children who completed the study Arm 3 DEX 5 mg/ day; daily dosage increased by 5 mg at weekly intervals until undesirable side-effects or maximum positive response achieved; majority maintained on 10–20 mg/day (Administered by parent) Age Children were of kindergarten, first and second grade age Purpose 1. To evaluate the relatively long-term (4–6 months) effects of dextroamphetamine on the behaviour, achievement and perceptual–cognitive functioning of hyperkinetic children 2. To compare the effects of dextroamphetamine and prescriptive perceptual–cognitive tutoring Adverse events Not reported Additional outcomes Judgements of motor coordination Judgements of visual tracking Spatial orientation test Motor pattern repetition test IQ Not reported Co-morbid disorders Not reported Diagnostic subtypes All included participants were hyperkinetic Arm 4 DEX plus prescriptive tutoring 5 mg/day; daily dosage increased by 5 mg at weekly intervals until undesirable side-effects or maximum positive response achieved; majority maintained on 10–20 mg/day Tutoring sessions twice per week; average of 39.9 tutorial sessions (Administered by parent and tutor) Additional information Previous/concurrent medication: To be included in the trial, individuals were not to be currently receiving medication
Core symptoms Educational performance Quality of life Adverse events Not reported Not reported WISC – Information Subtest: Arm 1: ?–1.17, Arm 2: ?0.88, Arm 3: ?-0.06, Arm 4: ?1.06 F ratio: 4.49, p = 0.005 SHS score (no variance reported): Arm 1: ?2.28, Arm 2: ?5.59, Arm 3: ?9.29, Arm 4: ?6.25 F ratio: 2.44; p = 0.08 WISC – Other subtests: No significant differences. Behaviour rating by teacher: Arm 1: ?3.00, Arm 2: ?2.77, Arm 3: ?2.59, Arm 4: 2.19 F ratio: 5.74, p = 0.001 WISC – Full Scale IQ: Arm 1: ?2.11, Arm 2: ?4.41, Arm 3: ?6.24, Arm 4: ?7.43 F ratio: 2.10, p = 0.12 Behaviour rating by parent: Arm 1: ?2.94, Arm 2: ?2.77, Arm 3: ?2.06, Arm 4: ?1.94 F ratio=10.23, p = 0.001 WISC – other IQ scores: No significant differences Judgements of distractibility: Arm 1: ?0.22, Arm 2: ?0.35, Arm 3: ?0.59, Arm 4: ?0.44 F ratio: 0.67; p > 0.50 Judgements of motor activity: Arm 1: ?–0.06, Arm 2: ?0.18, Arm 3: ?0.65, Arm 4: ?0.69 F ratio: 4.17; p = 0.01 © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 Conclusions Authors’ conclusions: DEX contributed to a reduction of hyperkinetic behavioural symptoms and to improvement in performance on various measures of perceptual motor and cognitive development. Tutoring resulted in gains on some WISC subtests but was clearly not as effective as medication. Neither experimental condition significantly influenced academic achievement Reviewer’s comments: The authors’ conclusions regarding reduction in hyperkinetic behaviour are based primarily on behaviour ratings made by parents and teachers on a four-point scale: dramatic improvement, definite improvement, no change and worse 235
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366 Appendix 13 Study characteristi
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