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32 TABLE 7 Clinical effectiveness MPH high dose (>30 mg/day) versus placebo Study Design Intervention – N Age Duration Core outcomes (years) (weeks) Administered two or more times daily Gittelman-Klein, 197657 P MPH (max. 60 mg/day, b.d.) – 166 6–12 12 Core: no core symptoms reported QoL: not reported AE: side effects standardised form: severity and consistency C (2×) MPH (25–40 mg/day, t.d.s.) – 19 12–19 6 Core: no hyp; Abbreviated Conners’ Questionnaire QoL: no CGI; Loney and Ordona Scale: response (patients and parents) AE: STESS (based on interview with parent and patient) Klorman, 1987 66 Brown, 198843 C (4×) MPH (42.56 mg/day, b.d.) –11 13–15 8 Core: CPRS: Hyperactivity Index; Conners’ Teacher Hyperactivity Index; ACTeRS: hyperactivity QoL: not reported AE: SERS (parents); weight Barkley, 199039 C (3×) MPH (1.0 mg/kg/day, b.d.) – 83 5–13 3 Core: not reported QoL: not reported AE: Stimulant Drug Side Effects Questionnaire: 17-item list Klorman, 199067 C (2×) MPH (35.21 mg/day, t.d.) – 48 12–18 6 Core: Abbreviated Conners’ Hyperactivity Questionnaire (parents, teachers); IOWA inattention/overactivity scale (parents, teachers); TOTS: hyperactivity and attention scales (parents, teachers) QoL: no CGI; ratings of global outcome (parents/patients) AE: STESS (patients, parents); Nowlis Mood Scale: fatigue (patients); weight Pelham, 199379 C (3×) MPH (32 mg/day, b.d.) – 31 5.4–9.9 6 Core: no hyp; IOWA CTRS: inattention/overactivity QoL: not reported AE: not reported Ahmann, 199335 C (3×) MPH (1.5 mg/kg/day, t.d.) – 234 5–15 4 Core: not reported QoL: not reported AE: BSEQ C (4×) MPH (1.2 mg/kg/day, b.d.) – 22 7–13 6 Core: no hyp; IOWA CTRS: inattention/overactivity QoL: not reported Kolko, 1999 69 AE: SSERS P MPH (15, 30 or 45 mg/day, t.d.) – 312 6–12 4 Core: SNAP-IV Hyperactivity/Impulsivity (teacher rated) (parent rated) QoL: CGI (investigator rated) AE: solicited and spontaneous reports: focus on sleep quality, tics and appetite (parent) Wolraich, 2001 97 Quinn, 2003 84 [Confidential information removed] ACTeRS, ADD-H Comprehensive Teachers’ Rating Scale; b.d., twice daily; BSEQ, Barkley Side Effects Questionnaire; C, crossover trial (number of crossovers); CGI, Clinical Global Impression; CPRS, Conners’ Parent Rating Scale; CTRS, Conners’ Teacher Rating Scale; P, parallel trial; SNAP, Swanson, Nolan and Pelham (scale); SSERS, Stimulant Drug Side Effects Rating Scale; t.d.s., three times daily.
TABLE 8 Results for hyperactivity [MPH High dose (>30 mg/day) versus placebo] Study Scale MPH high dose: Placebo: mean (SD) p-Value (if reported) or mean (SD) mean differencea 6–12 years Wolraich, 2001 97 MD (95%CI) SNAP-IV Hyperactivity/Impulsivity (teacher) 0.93 (0.79) 1.57 (0.89) –1.26 (–1.44 to –1.08) SNAP-IV Hyperactive/Impulsivity (parent) 1.10 (0.69) 1.83 (0.89) –0.58 (–0.73 to –0.43) 13–15 years Brown, 1988 43 CPRS (Hyperactivity Index) 9.33 (2.06) 12.66 (4.13) NS Conners’ Teacher Hyperactivity Index 17.33 (3.72) 24.50 (2.81)
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: Study Parallel trials Buitelaar 199
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 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.
Page 161 and 162:
235. Rhodes SM, Coghill DR, Matthew
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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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