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68 Clinical effectiveness overactivity was measured using the IOWA-C, except when assessed by parents. No significant differences between these two treatment arms were reported for global effectiveness (parent or teacher rated). Adverse events There were no significant differences between treatments in the incidence of headache, stomach ache, loss of appetite or insomnia. No data on weight were reported. Summary No studies in this category evaluated hyperactivity or CGI as outcomes. One study that reported adverse events data found no differences between the treatment groups. TABLE 53 MPH medium dose (15–30 mg/day) versus DEX low dose (
Adverse events No significant differences were detected between DEX and MPH treatments in the incidence of headache, stomach ache, loss of appetite or insomnia. Data on weight were not reported. Summary One study evaluated medium-dose MPH compared with low-dose MPH. 50 This study reported significant effects in favour of MPH when hyperactivity was assessed by teachers, but not when assessed by parents. They reported no significant differences between treatments in the incidence of headache, stomach ache, loss of appetite or insomnia. Owing to the poor reporting of some methodological criteria, the results from this study should be interpreted with caution. MPH medium dose (15–30 mg/day) versus DEX medium dose (10–20 mg/day) One study evaluated medium-dose (15–30 mg/kg/day) immediate release IR-MPH TABLE 55 MPH medium dose (15–30 mg/day) versus DEX medium dose (10–20 mg/day) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 compared with medium-dose (10–20 mg/day) DEX (Table 55; with additional information in Appendix 12). In this crossover study by Arnold and colleagues, 37 hyperactivity was assessed using four scales. The authors reported no differences between medium doses of MPH and DEX (Table 56). This study did not report on CGI. It generally scored well in the quality assessment. Adverse events Adverse event data were not reported adequately to be included in the analysis. Summary The one study that evaluated medium-dose MPH compared with medium-dose DEX reported no difference in hyperactivity scores between the treatment groups. 37 This study did not examine CGI or adequately report on adverse events data. It rated well in the quality assessment, hence the results for hyperactivity are likely to be reliable. Study Design Intervention – N Age Duration Core outcomes (years) (weeks) Administered two or more times daily Arnold, 1978 37 C (3×) MPH (1.25 mg/kg, 1 or 5–12 3 Core: Conners’ Teachers’ 2×) vs DEX (0.63 mg/kg/day, Behaviour Problem Checklist: 1 or 2×) – 29 hyperactivity; Problem Behaviour Checklist (parents): hyperactivity; Davids’ Hyperkinetic Rating Scale (parents and teachers) QoL: not reported AE: Problem Behaviour Checklist (parents): side-effects; weight loss C, Crossover trial (number of crossovers). TABLE 56 Results for hyperactivity [MPH medium dose (15–30 mg/day) versus DEX medium dose (10–20 mg/day)] Study Scale MPH medium dose: DEX medium p-Value (if mean (SD) dose: mean (SD) reported) 5–12 years Arnold, 1978 37 Problem Behaviour Checklist (parents) 18.21 (5.61) 17.21 (5.45) NR (hyperactivity) Conners’ Teachers’ Behaviour Problem 16.83 (5.50) 16.17 (4.64) NS Checklist (hyperactivity) Davids’ Hyperkinetic Rating Scale 4.31 (1.23) 4.28 (1.07) NS (parents) (hyperactivity) Davids’ Hyperkinetic Rating Scale 3.83 (1.49) 3.90 (1.54) NS (teachers) (hyperactivity) NR, not reported; NS, not significant. 69
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A systematic review and economic mo
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A systematic review and economic mo
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Objectives: To assess the clinical
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Glossary and list of abbreviations
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Glossary Adverse effect An abnormal
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Glossary continued effects. Sometim
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Glossary continued point between tw
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Background Attention deficit hypera
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mean differences with 95% confidenc
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This review examines the clinical a
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4 Background E. Symptoms should not
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6 Background Concerta XL Concerta X
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8 Methods for reviewing effectivene
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10 Methods for reviewing effectiven
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Quantity and quality of research av
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TABLE 1 The quality of included stu
Page 35 and 36: TABLE 2 An overview of trials inclu
Page 37 and 38: TABLE 2 An overview of trials inclu
Page 39 and 40: TABLE 3 MPH low dose (≤15 mg/day)
Page 41 and 42: Quality of life Only one of the 12
Page 43 and 44: TABLE 5 MPH medium dose (15-30 mg/d
Page 45 and 46: Hyperactivity All nine studies that
Page 47 and 48: TABLE 6 Results for hyperactivity [
Page 49 and 50: Study Parallel trials Buitelaar 199
Page 51 and 52: TABLE 8 Results for hyperactivity [
Page 53 and 54: Study Parallel trials Gittelman-Kle
Page 55 and 56: TABLE 11 MPH high dose (>30 mg/day)
Page 57 and 58: TABLE 14 ER-MPH medium dose (20-40
Page 59 and 60: Study Crossover trials Stein 2003 S
Page 61 and 62: TABLE 19 Results for hyperactivity
Page 63 and 64: TABLE 22 MPH low dose (≤ 15 mg/da
Page 65 and 66: TABLE 24 MPH medium dose (15-30 mg/
Page 67 and 68: assessed by parents and teachers. I
Page 71 and 72: TABLE 30 DEX medium dose (10-20 mg/
Page 75 and 76: TABLE 38 DEX medium dose (10-20 mg/
Page 77 and 78: TABLE 41 DEX-SR plus non-drug inter
Page 79 and 80: Study Michelson 2001 [0.5] Michelso
Page 81 and 82: Hyperactivity Five trials (publishe
Page 83 and 84: TABLE 47 IR-MPH low-dose (≤ 15 mg
Page 85: STP. 77,78 Neither examined hyperac
Page 89 and 90: did report that there were no signi
Page 91 and 92: Summary The one study in this categ
Page 93 and 94: showed persisting significant super
Page 95 and 96: easily rectified with dosage adjust
Page 97 and 98: Aim The aim of this chapter is to r
Page 99 and 100: only level of social disability tha
Page 101 and 102: did not include a ‘global’ HRQo
Page 103 and 104: might decrease but costs would be e
Page 105 and 106: 1st line pharmacotherapy Response,
Page 107 and 108: TABLE 70 Data for weighted average
Page 109 and 110: The probabilistic results were used
Page 111 and 112: The review also uncovered a mis-ref
Page 113 and 114: TABLE 77 Results of sensitivity ana
Page 115 and 116: TABLE 80 Response a rates (%) estim
Page 117 and 118: TABLE 82 Drug costs used in the cos
Page 119 and 120: The review of the economic evidence
Page 121 and 122: Extrapolation A secondary analysis
Page 123 and 124: economic model rests on the assumpt
Page 125 and 126: TABLE 87 Data used in calculating w
Page 127 and 128: not fully probabilistic. The averag
Page 129 and 130: Probability cost-effective 1.0 0.9
Page 131 and 132: TABLE 93 Results of sensitivity ana
Page 133 and 134: Base case model Responder to MPH Re
Page 135 and 136: TABLE 96 Results of the sensitivity
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The same method for synthesising th
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TABLE 103 Results of the economic m
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of the 64 identified in the clinica
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126 Discussion impact of active dru
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MPH, DEX and ATX improve hyperactiv
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1. National Institute for Clinical
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tutoring on the behavior and achiev
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91. Stein MA, Blondis TA, Schnitzle
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140. Hill P, Taylor E. An auditable
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189. Francis S, Fine J, Tannock R.
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235. Rhodes SM, Coghill DR, Matthew
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hyperactive boys: comparative and c
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This version of HTA monograph volum
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380 Health Technology Assessment Pr
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382 Health Technology Assessment Pr
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