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58 Clinical effectiveness Summary Only one study in this category examined hyperactivity as an outcome. 62 In this study, children who received DEX in combination with academic instruction and therapeutic recreation had better behaviour than those in the nonintervention group when assessed using the CTRS and the Children’s Psychiatric Rating Scale, but not when assessed using the CPRS. No studies in this category evaluated CGI. Owing to the poor reporting of some methodological criteria, the results from this study should be interpreted with caution. DEX high dose (>20 mg/day) plus non-drug intervention versus non-drug intervention One study evaluated high-dose (>20 mg/day) DEX plus non-drug intervention compared with a nondrug intervention (Table 40; with additional information in Appendix 12). In this crossover study, drug treatment was combined with a multidisciplinary behaviour modification programme and low monoamine diet. Although the authors evaluated hyperactivity and CGI (with results favouring the combined treatment group), data were presented in graph form only and could not be reproduced. Adverse events A significantly higher incidence of reduced appetite and insomnia was detected during the active drug phase of this trial (RR = 93.00; 95% CI 5.90 to 1467.03 and RR = 3.00; 95% CI 1.85 to 4.87, respectively). Data on headache, stomach ache or weight were not reported. Summary No studies in this category reported reproducible data on hyperactivity or CGI. The one study in this category reported significantly greater incidence of loss of appetite and insomnia in the combined treatment group. TABLE 40 DEX high dose (>20 mg/day) plus non-drug intervention versus non-drug intervention DEX-SR plus non-drug intervention versus nondrug intervention Two studies examined sustained-release DEX (DEX-SR) plus non-drug intervention compared with a non-drug intervention (Table 41; with additional information in Appendix 12). In the study by Pelham and colleagues 1990, 78 hyperactivity was not assessed, although the authors did evaluate behaviour using the Abbreviated CTRS. They reported that behaviour was improved in the combined treatment group compared with the behaviour modification group (p < 0.050). This study also reported data on adverse events (see below). In addition to evaluating immediate-release DEX, James and colleagues 62 examined DEX-SR administered once weekly in combination with formal academic instruction and therapeutic recreation. Hyperactivity was improved in the combined treatment group compared with the non-drug treatment group when assessed using the Children’s Psychiatric Rating Scale and the CPRS. Statistical comparisons for the CTRS were not reported (Table 42). This study did not examine CGI as an outcome measure. Adverse events Of the two trials comparing DEX-SR and nondrug intervention with a non-drug intervention alone, one provided adequate data regarding the adverse events of interest. 78 Differences in the incidence of insomnia were not found between treatment phases. Incidence of headache, stomach ache or loss of appetite was not rated by patients or parents. Neither study reported data on weight. Summary Of the two studies included in this category, one evaluated hyperactivity as an outcome measure. 62 In this study, DEX-SR in combination with formal academic instruction and therapeutic recreation Study Design Intervention – N Age Duration Core outcomes (years) (weeks) Administered two or more times a day Elia, 1991 51 C (3×) DEX (mean 10–45 mg/day, b.d.) 6–12 9 Core: CTRS: hyperactivity; vs multidisciplinary behaviour CPQ: hyperactivity modification programme and diet QoL: CGI (physician); C-GAS (twice daily, 11 weeks) – 48 AE: STESS (physician, parents) C, crossover trial (number of crossovers); C-GAS, Children’s Global Assessment Scale; CGI, Clinical Global Impression; CPQ, Conners’ Parent Questionnaire; CTRS, Conners’ Teacher Rating Scale; STESS, Subject Treatment Emergent Symptom Scale.
TABLE 41 DEX-SR plus non-drug intervention versus non-drug intervention resulted in improved behaviour compared with non-drug intervention alone. Owing to the poor reporting of some methodological criteria, the results from this study should be interpreted with caution. The other study reported on adverse events of interest. 78 In this study, no significant differences in the incidence of insomnia were observed. Neither study assessed CGI. ATX versus placebo ATX low/medium dose (
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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
Page 26 and 27: 8 Methods for reviewing effectivene
Page 28 and 29: 10 Methods for reviewing effectiven
Page 31 and 32: Quantity and quality of research av
Page 33 and 34: 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: TABLE 38 DEX medium dose (10-20 mg/
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 and 86: STP. 77,78 Neither examined hyperac
Page 87 and 88: Adverse events No significant diffe
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
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not fully probabilistic. The averag
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Probability cost-effective 1.0 0.9
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TABLE 93 Results of sensitivity ana
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Base case model Responder to MPH Re
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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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