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38 Clinical effectiveness TABLE 13 Results for hyperactivity [ER-MPH low dose (≤ 20 mg/day) versus placebo] Study Scale ER-MPH low dose: Placebo: p-Value (if mean (SD) mean (SD) reported) a 6–11 years Fitzpatrick, 1992 55 Conners’ Hyperactivity Index (parents) 0.98 (0.72) 1.75 (0.67)
TABLE 14 ER-MPH medium dose (20–40 mg/day) versus placebo Study Design Intervention – N Age Duration Core outcomes (years) (weeks) Administered once daily Wolraich, 2001 97 P OROS MPH (Concerta) (18, 36 or 6–12 4 Core: SNAP-IV: hyperactivity/impulsivity (parent, teacher) 54 mg/day, o.d.) – 312 QoL: CGI improvement (investigators) AE: solicited and spontaneous reports: focus on sleep quality, tics and appetite (parent) Greenhill, 2002 59 P MPH-Modified Release (Metadate CD) 5–15 3 Core: not reported (mean 40.7 mg/day, o.d.) – 321 QoL: CGI (teacher; parent); CGI improvement ratings AE: Teacher and Parent Side-Effect Questionnaires Quinn, 2003 84 [Confidential information removed] Dopfner, 200348 P MPH-Retard (Medikinet) (20–60 mg/day, 6–16 4 Core: no hyp; Peer Assessment for Hyperkinetic Disorders o.d.) – 85 (teachers); effectiveness scale (parents, physicians) QoL: not reported AE: no specific scale reported © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Stein, 2003 92 C (4×) OROS MPH (Concerta) (36 mg/day, 5.9–16 4 Core: no hyp; ADHD Rating Scale IV (parents)/ACTeRS o.d.) – 47 QoL: CGI AE: SERS (parents) Swanson, 2004 32 C (3×) OROS MPH (Concerta) (18, 36 or 6–12 3 Core: no hyp; SKAMP: deportment; attention (measured by 54 mg/day, o.d.) – 184 two trained observers) QoL: not reported MPH-Modified Release (Metadate CD) AE: side-effects on the Barkley Scale (20, 40 or 60 mg/day, o.d.) –184 Health Technology Assessment 2006; Vol. 10: No. 23 C, crossover trial (number of crossovers); CGI, Clinical Global Improvement; P, parallel trial; SKAMP, Swanson, Kotkin Agler, M-Flynn, Pelham (scale); SNAP, Swanson, Nolan and Pelham (scale). 39
Page 1 and 2:
A systematic review and economic mo
Page 3 and 4:
A systematic review and economic mo
Page 5 and 6: Objectives: To assess the clinical
Page 7 and 8: Glossary and list of abbreviations
Page 9 and 10: Glossary Adverse effect An abnormal
Page 11 and 12: Glossary continued effects. Sometim
Page 13 and 14: Glossary continued point between tw
Page 15 and 16: Background Attention deficit hypera
Page 17 and 18: mean differences with 95% confidenc
Page 19: This review examines the clinical a
Page 22 and 23: 4 Background E. Symptoms should not
Page 24 and 25: 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: TABLE 11 MPH high dose (>30 mg/day)
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 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
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
Page 137 and 138:
The same method for synthesising th
Page 139 and 140:
TABLE 103 Results of the economic m
Page 141:
of the 64 identified in the clinica
Page 144 and 145:
126 Discussion impact of active dru
Page 147:
MPH, DEX and ATX improve hyperactiv
Page 151 and 152:
1. National Institute for Clinical
Page 153 and 154:
tutoring on the behavior and achiev
Page 155 and 156:
91. Stein MA, Blondis TA, Schnitzle
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140. Hill P, Taylor E. An auditable
Page 159 and 160:
189. Francis S, Fine J, Tannock R.
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235. Rhodes SM, Coghill DR, Matthew
Page 163 and 164:
hyperactive boys: comparative and c
Page 165 and 166:
This version of HTA monograph volum
Page 167 and 168:
380 Health Technology Assessment Pr
Page 169:
382 Health Technology Assessment Pr
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