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54 Clinical effectiveness TABLE 32 DEX high dose (>20 mg/day) versus placebo Study Design Intervention – N Age Duration Core outcomes (years) (weeks) Administered once daily Arnold, 1976 36 C (3×) DEX (mean 21.75 mg/day, 4.6–12 12 Core: Parents’ Behaviour o.d.?) – 31 Checklist: hyperactivity; Conners’ Teachers’ Behaviour Checklist: hyperactivity QoL: global ratings (clinicians) AE: Parents’ Behaviour Checklist: somatic complaints; Conners’ Teachers’ Behaviour Checklist: lack of health; weight Conrad, 1971 47 P DEX (10–20 mg/day, o.d.?) – 17 4–6 4–6 months Core: no hyp; behaviour ratings (teacher and parent) QoL: not reported AE: not reported Administered two or more times daily Greenberg, P DEX (mean 25 mg/day, b.d.) – 17 6.5–11 8 Core: not reported 1972 58 QoL: not reported AE: incidence of side-effects C, crossover trial (number of crossovers); P, parallel trial. Quality of life Conners and colleagues 45 evaluated Clinical Global Improvement as measured by a clinician. The authors reported that after 8 weeks, 33% were much improved in the DEX group compared with 9% in the placebo group. Adverse events No significant differences in the incidence of headache, loss of appetite, stomach ache or insomnia were detected between participants of the trial adequately reporting these outcomes. 56 Data on weight were not reported separately for those on DEX versus those on placebo. Summary One study presented reproducible results for hyperactivity. 45 In this study, the results were significant when assessed using the symptom checklist, but not when assessed using the parent questionnaire. This study also reported on Clinical Global Improvement, and reported that children in the DEX group were more often improved compared with the placebo group. No significant differences in the incidence of headache, loss of appetite, stomach ache or insomnia were reported in the one study that presented data on these adverse events. 56 The studies did not score very well in the quality assessment, and the results should be interpreted with caution. DEX high dose (>20 mg/day) versus placebo Three studies evaluated high dose (>20 mg/day) DEX compared with placebo (Table 32; with additional information in Appendix 12). Of these, two appeared to have examined DEX administered once daily and one examined DEX administered twice per day. Only one of the studies evaluated hyperactivity as a core outcome, using a number of different scales. 36 In this study, children in the DEX group had consistently better scores than children in the placebo group; however, the authors did not report results for any statistical comparisons (see Table 33). Another study reported on behaviour ratings as assessed by teachers and parents 47 (see Appendix 12) and the final study reported only on adverse events (discussed separately below). 58 Quality of life Arnold and colleagues 36 reported on global ratings as assessed by clinicians. They reported that children in the DEX group rated better than those in the placebo group (p < 0.01). Adverse events Of the three trials comparing a high dose of DEX with placebo, one reported adequate data for the analysis of adverse events. 58 In this trial, participants assigned to DEX suffered from loss of
TABLE 33 Results for hyperactivity [DEX high dose (>20 mg/day) versus placebo] appetite to a significantly greater extent than those assigned to placebo (RR = 3.82; 95% CI 1.08 to 13.58). Participants did not, however, suffer from headache, stomach ache or insomnia significantly more often when assigned to DEX. Data on weight were inadequately reported. Summary One study that evaluated hyperactivity reported that children in the DEX group had improved behaviour compared with the placebo group. 36 However, no statistical analyses were presented. The same study presented results for global ratings (as assessed by clinicians) and reported improvements with medication. Generally, this study rated well in the quality assessement, whereas the other studies did not score very well. One of these other studies reported usable data on adverse events. 58 Loss of appetite was significantly greater in the DEX group compared with placebo, but this was not observed for headache, stomach ache or insomnia. DEX-TR versus placebo One study evaluated 10–15 mg/day time-release DEX (DEX-TR) administered once daily (Table 34; with additional information in Appendix 12). Health Technology Assessment 2006; Vol. 10: No. 23 Study Scale DEX high dose: Placebo: p-Value mean (SD) mean (SD) (if reported) 4–12 years Arnold, 1976 36 Parents’ Behaviour 16.68 (6.59) 20.81 (6.83) NR Checklist (hyperactivity) Conners’ Teachers 16.80 (5.54) 21.27 (5.63) NR Behaviour Checklist (hyperactivity) Davids’ Hyperkinetic Rating Scale (hyperactivity) (parents) 3.97 (1.40) 4.58 (1.26) NR (teachers) 3.70 (1.49) 4.90 (1.30) NR Lower scores represent a better behavioural outcome. NR, not reported. TABLE 34 DEX-TR versus placebo Study Design Intervention – N Age Duration Core outcomes (years) (months) Administered once daily Arnold, 1989 38 C (3×) DEX-TR (10–15 mg/day, 6–12 3 Core: CTRS Hyperactivity Index o.d.) – 18 QoL: global ratings (psychiatrist) AE: weight C, crossover trial (number of crossovers); CTRS, Conners’ Teacher Rating Scale. © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Hyperactivity Arnold and colleagues 38 reported that DEX time-release capsules were significantly better than placebo using the Hyperactivity Index of the CTRS (Table 35). Quality of life Arnold and colleagues 38 also reported that global ratings, as assessed by a psychiatrist, were improved in the treatment group compared with the placebo group (p < 0.05) (see Appendix 12). Adverse events Data on weight were not adequately presented in this trial. Summary One study evaluated DEX-TR compared with placebo. 38 This study reported significant improvements in the treatment group compared with the placebo group for both hyperactivity and psychiatrist-assessed global ratings. Owing to the poor reporting of some methodological criteria, the results from this study should be interpreted with caution. 55
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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
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 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 69 and 70: TABLE 27 Results for hyperactivity
Page 71: 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
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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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