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

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62 TABLE 45 Clinical effectiveness ATX high dose (≥ 1.5 mg/kg/day) versus placebo Study Design Intervention – N Age Duration Core outcomes (years) (weeks) Administered once daily Weiss, 2004 94 P ATX (max. 1.8 mg/kg/day, o.d.) – 153 8–12 7 Core: ADHD-RS-IV – Teacher: Inv: hyperactive/impulsive; CPRS-R: hyperactivity QoL: CGI (teacher/investigator) AE: open-ended discussion Administered twice daily Michelson, 2001 73 P ATX (max. 1.8 mg/kg/day, b.d.) – 297 8–18 8 Core: CPRS-R: hyperactive; ADHD-RS-IV–Parent: Inv hyperactivity/impulsivity QoL: CGI AE: open-ended questioning; weight Spencer, 2002 89 P ATX (max. 2.0 mg/kg/day, b.d.) – 147 7–13 9 Core: ADHD-RS: hyperactive/impulsive QoL: CGI AE: Unsolicited adverse events Spencer, 2002 89 P ATX (max. 2.0 mg/kg/day, b.d.) – 144 7–13 9 Core: ADHD-RS: hyperactive/impulsive QoL: CGI AE: Unsolicited adverse events Michelson, 2004 75 P ATX (mean 1.56 mg/kg/day, b.d.) – 416 6–15 9 months Core: ADHD-RS: hyperactive/impulsive; CPRS/CTRS: hyperactivity QoL: CGI AE: Some adverse events reported P ATX (max. 2.0 mg/kg/day, b.d.) – 194 7–12 9 Core: no hyp; ADHD-RS: total score QoL: not reported AE: Berkley Behaviour and Adverse Events Questionnaire – Modified; open-ended questions Wernicke, 2004 95 ADHD-RS-IV, Attention Deficit/Hyperactivity Disorder Rating Scale IV–Parent (or Teacher) Version: investigator-administered and scored; CGI, Clinical Global Impression; CPRS, Conners’ Parent Rating Scale; CPRS-R, Conners’ Parent Rating Scale – Revised; CTRS, Conners’ Teacher Rating Scale; P, parallel trial.
Hyperactivity Five trials (published in four papers) evaluated hyperactivity/impulsivity using the ADHD Rating Scale (Table 46). Three of these studies also used a Conners’ scale to measure hyperactivity. 73,75,94 All results were significantly in favour of ATX, except when the CTRS was used in the study by Michelson and colleagues. 75 The mean differences for ADHD Rating Scale are presented for each of the five studies in Figure 17. TABLE 46 Results for hyperactivity [ATX high dose (≥ 1.5 mg/kg/day) versus placebo] © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 Quality of life Weiss and colleagues 94 presented results for CGI Severity and Clinical Global Improvement. For both measures, children in the ATX group had better behaviour than children in the placebo group (p < 0.001). Similar results were observed in the study by Michelson and colleagues 73 (CGI ADHD Severity: p < 0.05), Spencer and colleagues 89 (CGI ADHD Severity: p = 0.003) and Michelson and colleagues 75 (CGI Severity: p = 0.003). Study Scale ATX high dose: Placebo: Mean mean (SD) mean (SD) difference a 6–15 years Michelson, 2004 75 Baseline/change from Baseline/change baseline from baseline MD (95% CI) ADHD-RS-IV (hyperactive/impulsive) 7.2 (5.5)/3.1 (7.0) 7.1 (5.5)/5.9 (7.4) See Figure 17 CPRS (hyperactivity) 4.5 (3.8)/1.5 (4.7) 4.6 (4.2)/3.1 (4.9) –1.60 (–2.62 to –0.58) CTRS (hyperactivity) 7.7 (5.1)/0.4 (5.2) 8.1 (5.5)/1.4 (4.6) –1.00 (–2.15 to 0.15) 7–13 years Spencer, 2002 89 ADHD-RS (hyperactive/impulsive) 19.3 (6.1)/–8.0 (7.4) 19.2 (5.5)/–2.5 (5.9) See Figure 17 Spencer, 2002 89 8–12 years ADHD-RS (hyperactive/impulsive) 16.8 (6.5)/–6.9 (6.6) 16.5 (6.1)/–2.9 (7.1) See Figure 17 Weiss, 2004 94 8–18 years ADHD-RS-IV–Teacher: Inv: (hyperactive/impulsive) CPRS-R (hyperactivity) subscale mean score (SD) [Confidential information removed] Michelson, 2001 73 ADHD-RS-IV (hyperactive/impulsive) 17.6 (6.2)/–6.7 (7.5) 16.9 (6.6)/–3.2 (5.6) see Figure 17 CPRS-R (hyperactivity) 10.6 (4.6)/–4.3 (4.6) 10.3 (4.9)/–1.1 (3.9) –3.20 (–4.59 to –1.81) a Note that owing to the overall poor reporting of study methodology, values should be interpreted with caution (with the exception of Spencer and colleagues; 89 [Confidential information removed]. Lower scores represent a better behavioural outcome. ADHD-RS-IV: Attention Deficit/Hyperactivity Disorder Rating Scale IV–Parent Version: investigator-administered and scored; CPRS, Conners’ Parent Rating Scale; CTRS, Conners’ Teacher Rating Scale; CPRS-R, Conners’ Parent Rating Scale – Revised. Study Michelson 2001 Spencer 2002a Spencer 2002b Michelson 2004 Weiss 2004 FIGURE 17 Mean differences: ATX high dose versus placebo ATX (high dose) Placebo WMD (fixed) WMD (fixed) N Mean (SD) N Mean (SD) 95% CI 95% CI 82 –6.70 (7.50) 83 –3.20 (5.60) –3.50 (–5.52 to –1.48) 64 –8.00 (7.40) 61 –2.50 (5.90) –5.50 (–7.84 to –3.16) 63 –6.90 (6.60) 60 –2.90 (7.10) –4.00 (–6.43 to –1.57) 290 3.10 (7.00) 123 5.90 (7.40) –2.80 (–4.34 to –1.26) [Confidential information removed] –10 –5 0 5 10 Favours ATX Favours placebo 63
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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
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 and 76: TABLE 38 DEX medium dose (10-20 mg/
Page 77 and 78: TABLE 41 DEX-SR plus non-drug inter
Page 79: Study Michelson 2001 [0.5] Michelso
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
Page 127 and 128: not fully probabilistic. The averag
Page 129 and 130: 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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