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

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20 TABLE 3 Clinical effectiveness MPH low dose (≤15 mg/day) versus placebo Study Design Intervention – N Age Duration Core outcomes (years) (weeks) C (5×) MPH (5 mg/day, o.d.) – 45 5–12 5 Core: no hyp; Abbreviated CTRS: total score MPH (10 mg/day, o.d.) – 45 QoL: not reported MPH (15 mg/day, o.d.) – 45 AE: not reported Administered once daily Rapport, 1989 85 C (5×) MPH (5 mg/day, o.d.) – 31 6–11 6 Core: No hyp; Abbreviated CTRS: total score MPH (10 mg/day, o.d.) – 31 QoL: not reported MPH (15 mg/day, o.d.) – 31 AE: not reported DuPaul, 1993 49 C (3×) MPH (0.40 mg/kg, o.d.) – 30 5.5–12.5 4 Core: Conners’ Teacher Questionnaire: hyperactivity; Conners’ Parent Questionnaire: hyperactivity QoL: CGI (physician) AE: weight Werry, 1980 96 Administered two or more times daily Brown, 1988 43 C (4×) MPH (8.76 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 C (3×) MPH (0.40 mg/kg/day, b.d.) – 161 2.4–17.2 3 Core: CPRS-R: Hyperactivity Index; CTRS-R: hyperactivity index; CTRS-R: hyperactivity QoL: not reported AE: CPRS-R: psychosomatic; SERS (parents, teachers): number of side-effects, mean severity rating Fischer, 1991 54 C (4×) MPH (10–15 mg/day, b.d.) – 19 6.9–11.5 8 Core: Conners’ Hyperactivity Index (parents and teacher); TOTS: hyperactivity (parents and teachers) QoL: no CGI; comments ratings (parent/teacher) AE: STESS (parents); weight Fitzpatrick, 1992 55 C (3×) MPH [0.30 mg/kg/day (unclear), b.d.] – 12 6–10 3 Core: not reported QoL: not reported AE: side-effects questionnaire Fine, 1993 52 C (3×) MPH (0.30 mg/kg/day, b.d.) – 50 6.1–18.2 4 Core: CPRS: Hyperactivity Index; CTRS: Hyperactivity Index QoL: not reported AE: not reported Hoeppner, 1997 61 continued
TABLE 3 MPH low dose (≤15 mg/day) versus placebo (cont’d) Study Design Intervention – N Age Duration Core outcomes (years) (weeks) Handen, 199960 C (3×) MPH (12–15 mg/day, max. 3×) – 11 4–5.1 3 Core: CTRS: Hyperactivity Index; CTRS: hyperactivity QoL: not reported AE: Side Effects Checklist (teachers, parents); mean severity rating 0–6 Manos, 1999 72 C (4×) MPH (10 mg/day, b.d.) – 42 5–17 4 Core: no hyp; ASQ (parents and teachers); ARS (parent) QoL: no CGI; composite ratings (clinician) AE: Side Effects Behaviour Monitoring Scale (parents) Barkley, 2000 40 C (5×) MPH (10 mg/day, b.d.) – 38 12–17 5 Core: no hyp; ADHD Total Parent/Teacher rating QoL: not reported AE: number and severity of side-effects (teachers, parents, self) Tervo, 2002 93 C (3×) MPH (0.10 mg/kg/day, b.d.) – 41 M=9.9 (2.9) 3 Core: no hyp; CBCL (parent) QoL: not reported AE: not reported ACTeRS, ADD-H Comprehensive Teachers’ Rating Scale; AE, adverse effects; ARS, ADHD Rating Scale; ASQ, Abbreviated Symptoms Questionnaire; b.d., twice daily; C, crossover trial (number of crossovers); CBCL, Child Behaviour Checklist; CGI, Clinical Global Impression; CPRS, Conners’ Parent Rating Scale; CTRS, Conners’ Teacher Rating Scale; o.d., once daily; P, parallel trial; hyp, hyperactivity; PACS, Parental Account of Childhood Symptoms; SERS, Side Effects Rating Scale. © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 21
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: TABLE 2 An overview of trials inclu
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 and 86: STP. 77,78 Neither examined hyperac
Page 87 and 88: Adverse events No significant diffe
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did report that there were no signi
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Summary The one study in this categ
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showed persisting significant super
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easily rectified with dosage adjust
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Aim The aim of this chapter is to r
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only level of social disability tha
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did not include a ‘global’ HRQo
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might decrease but costs would be e
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1st line pharmacotherapy Response,
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TABLE 70 Data for weighted average
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The probabilistic results were used
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The review also uncovered a mis-ref
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TABLE 77 Results of sensitivity ana
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TABLE 80 Response a rates (%) estim
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TABLE 82 Drug costs used in the cos
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The review of the economic evidence
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Extrapolation A secondary analysis
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economic model rests on the assumpt
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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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