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66 Clinical effectiveness TABLE 49 IR-MPH high dose (>30 mg/day) versus ER-MPH medium dose (20–40 mg/day) Study Design Intervention – N Age Duration Core outcomes (years) (weeks) Administered twice daily Wolraich, 2001 97 P MPH (15, 30 or 45 mg/day, 6–12 4 Core: SNAP-IV: hyperactivity/ t.d.s.) vs OROS MPH (Concerta) impulsivity (parent, teacher) (18, 36 or 54 mg/day, o.d.) – 312 QoL: CGI improvement (investigators) AE: solicited and spontaneous reports: focus on sleep quality, tics and appetite (parent) Quinn, 2003 84 [Confidential information removed] Steele, 200490 [Confidential information removed] P, parallel trial. TABLE 50 Results for hyperactivity [IR-MPH high dose (>30 mg/day) versus ER-MPH medium dose (20–40 mg/day)] Study Scale IR-MPH high dose: ER-MPH medium Mean mean (SD) dose: mean (SD) difference 6–12 years Wolraich, 2001 97 MD (95% CI) SNAP-IV (hyperactivity/ 0.93 (0.79) 0.96 (0.79) –0.05 (–0.24 to 0.14) impulsivity) (teacher rated) SNAP-IV (hyperactivity/ 1.10 (0.69) 1.11 (0.65) 0.17 (0.03 to 0.31) impulsivity) (parent rated) Lower scores represent a better behavioural outcome. Study MPH (high dose) n/N Quinn 2003 Steele 2004 Wolraich 2001 6/107 non-confidential study showed similar improvement between treatment groups. Regarding adverse events, the non-confidential trial found no differences between the treatment groups with regard to loss of appetite or stomach ache. However, this trial reported a higher incidence of headache with ER-MPH. The one study that examined hyperactivity rated poorly in the quality assessment. [Confidential information removed]. ER-MPH (medium dose) n/N 15/106 FIGURE 20 Relative risks of headache: MPH high dose versus ER-MPH medium dose RR (fixed) 95% CI [Confidential information removed] [Confidential information removed] 0.1 0.2 0.5 1 2 5 10 Favours MPH-IR Favours ER-MPH RR (fixed) 95% CI 0.40 (0.16 to 0.98) IR-MPH medium dose (15–30 mg/day) plus non-drug intervention versus ER-MPH low dose (≤ 20 mg/day) plus non-drug intervention Two studies evaluated medium-dose (15–30 mg/day) IR-MPH plus non-drug intervention compared with low-dose (≤ 20 mg/day) ER-MPH plus non-drug intervention (Table 51; with additional information in Appendix 12). These studies were both conducted by Pelham and colleagues and involved behaviour modification during an
STP. 77,78 Neither examined hyperactivity or CGI as core outcomes. Behaviour was assessed using the teacher-rated Abbreviated CTRS, and both studies reported no significant differences between the treatment groups (see Appendix 12). Adverse events Both trials reported on the incidence of insomnia; neither detected significant differences between treatments. Pelham and colleagues 77 reported the incidence of anorexia; however, no significant differences were found between treatments. No further data of interest were reported. Summary No studies in this category evaluated hyperactivity or CGI as outcomes. Two studies did report some Health Technology Assessment 2006; Vol. 10: No. 23 TABLE 51 IR-MPH medium dose (15–30 mg/day) plus non-drug intervention versus ER-MPH low dose (≤ 20 mg/day) plus non-drug intervention Study Design Intervention – N Age Duration Core outcomes (years) (weeks) Administered twice daily Pelham, 1987 77 C (3×) MPH (20 mg/day, b.d.) vs 6.5–11 7 Core: no hyp; Abbreviated CTRS sustained-release MPH (Slow (teacher) Release Ritalin, SR-20) (20 mg/day, QoL: not reported o.d.) plus behaviour modification AE: Side Effects Checklists (STP, 7 weeks) – 13 (parents, teachers, counsellors) Pelham, 1990 78 C (5×) MPH (20 mg/day, b.d.) vs 8.1–13.2 8 Core: no hyp; Abbreviated CTRS sustained-release MPH (Slow (teachers/counsellors) Release Ritalin, SR-20) (20 mg/day, QoL: not reported o.d.) plus behaviour modification AE: Side Effects Checklists (STP, 8 weeks) – 22 (parents, teachers, counsellors) C, crossover trial (number of crossovers); STP, Summer Treatment Programme. TABLE 52 MPH high dose (>40 mg/day) plus non-drug intervention versus ER-MPH medium dose (20–40 mg/day) plus non-drug intervention Study Design Intervention – N Age Duration Core outcomes (years) (weeks) Administered twice or more daily Pelham, 2001 82 C (3×) MPH (15, 30 or 45 mg/day, t.d.s.) 6–12 3 Core: no hyp; IOWA-C: vs OROS MPH (Concerta) inattention/overactivity (teacher (18, 36 or 54 mg/day, o.d.) plus and parent) parent training, teacher QoL: no CGI; global effectiveness consultation and point systems (parent and teacher) (3 weeks) – 70 AE: questions regarding adverse events, sleep quality, appetite, and tics (parents); spontaneous reports of adverse events C, crossover trial (number of crossovers); CGI, Clinical Global Impression. © Queen’s Printer and Controller of HMSO 2006. All rights reserved. adverse event data, and found no difference in insomnia or anorexia. IR-MPH high dose (>40 mg/day) plus non-drug intervention versus ER-MPH medium dose (20–40 mg/day) plus non-drug intervention One crossover study evaluated high-dose (>40 mg/day) IR-MPH plus non-drug intervention compared with medium-dose (20–40 mg/day) ER-MPH plus non-drug intervention (Table 52; with additional information in Appendix 12). The non-drug intervention involved a behavioural programme incorporating parent training, teacher consultation and a point system. This study by Pelham and colleagues 82 did not evaluate hyperactivity or CGI, but did assess a number of other core outcomes. For some outcomes, ER- MPH was superior to IR-MPH (see Appendix 12), but this was not the case when inattention/ 67
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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
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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 and 80: Study Michelson 2001 [0.5] Michelso
Page 81 and 82: Hyperactivity Five trials (publishe
Page 83: TABLE 47 IR-MPH low-dose (≤ 15 mg
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
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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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