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

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14 Clinical effectiveness Excluded papers: n = 28 Unavailable/not received: n = 16 Excluded (first screen): Background or commentary: n = 60 Excluded: n = 158 Total n = 218 Previously included papers identified: n = 70 RCTs of clinical effectiveness meeting inclusion criteria from previous reviews: n = 40 [42 papers] FIGURE 3 Process of study selection for clinical effectiveness MPH administered once daily Of the studies that examined MPH administered once daily, only one examined hyperactivity (discussed below). 96 The two other studies both used the Abbreviated Conners’ Teacher Rating Scale (CTRS) total score to evaluate low-dose MPH. 49,85 In the study by Rapport and colleagues 85 three groups of children were randomised: a low-weight group (22–26 kg), a mid- References identified: n = 5718 References identified (following de-duplication) and screened: n = 2515 Full papers ordered: n = 423 Studies meeting inclusion criteria: n = 20 RCTs plus n = 1 SR In addition, the MTA trial was discussed in the review (with 20 papers/abstracts referring to this trial) and 33 papers were identified that related to all the trials included in the review RCTs of clinical effectiveness: n = 65 (20 plus MTA plus 40 plus 4 industry) SRs of adverse events: n = 1 Excluded (second screen): (RCTs) Alternative condition: n = 1 Co-morbid condition: n = 20 Unlicensed comparator: n = 3 Irrelevant outcomes: n = 23 Inadequate data presentation: n = 8 Abstract only: n = 33 Inadequate trial duration: n = 8 Translation required: n = 2 Delayed receipt of paper: n = 4 (Systematic reviews) Primary studies assessed for inclusion: n = 7 Inappropriate outcomes/comparators: n = 1 Inappropriate outcomes/population: n = 1 Inadequate data presentation: n = 4 Total: n = 115 Industry submission: n = 4 weight group (27–31 kg) and a high-weight group (32–36 kg). All three MPH low doses (5, 10 and 15 mg/day) resulted in statistically significant improvements compared to placebo for all weight groups (p < 0.01). Similarly, in the study by DuPaul and Rapport, 49 all low-dose MPH treatment groups (5, 10 and 15 mg/day) were significantly better than placebo for Abbreviated CTRS total score but the level of significance was not clear.
TABLE 1 The quality of included studies Study Was the method used to assign participants to the treatment groups really random? Was the sequence of randomisation concealed? Was blinding carried out? Who was blinded? © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 Ahmann, 1993 35 Poor Poor Yes P/#2 Unclear No No Yes Yes Arnold, 1976 36 Good Good Yes NR Unclear Unclear Unclear Yes Yes Arnold, 1978 37 Good Good Yes CL/#2 Unclear Unclear Unclear Yes Yes Arnold, 1989 38 Good Poor Yes NR Unclear Unclear Unclear Unclear Yes Barkley, 1990 39 Poor Poor Yes C/P/T/I Unclear Unclear Yes Yes? No Barkley, 2000 40 Poor Poor Yes C/P/T/I Unclear No Yes No No Brown, 1985 41 Poor Poor NR NA Unclear NA NA Yes No Brown, 1986 42 Poor Poor Yes P/T/I Unclear Unclear Partially Yes No Brown, 1988 43 Poor Poor Yes NR Unclear Unclear Unclear Yes No Buitelaar, 1996 44 Poor Poor Yes NR Unclear Yes NA Unclear No Conners, 1972 45 Poor Poor NR NA Unclear Unclear No Yes No Conners, 1980 46 Poor Poor Yes C/P/I Unclear Unclear Unclear Yes No Conrad, 1971 47 Poor Poor Yes P/T/CL/I Unclear Unclear No Yes No Dopfner, 2003 48 Poor Poor Yes NR Unclear No Yes Yes No DuPaul, 1993 49 Poor Poor Yes T/I Unclear No No Poor No Efron, 1997 50 Poor Poor Yes C/P/T/I Unclear Unclear Unclear Unclear No Elia, 1991 51 Poor Poor Yes NR Unclear Unclear Unclear No No Fine, 1993 52 Poor Poor Yes C/P/T/I Unclear NA NA No Yes Firestone, 1986 53 Poor Poor Yes P/T/CL Unclear Unclear Partially Yes? No Fischer, 1991 54 Poor Poor Yes C/P/T/I Unclear Unclear Yes Unclear No Fitzpatrick, 1992 55 Good Poor Yes #1 Unclear Unclear Unclear Partially No Gillberg, 1997 56 Poor Poor Yes C/P Unclear Yes Partially Yes No Gittelman-Klein, 1976 57 Poor Poor Yes NR Unclear Unclear Yes No Yes Greenberg, 1972 58 Poor Poor Yes NR Unclear Unclear Partially Yes? Yes Greenhill, 2002 59 Poor Poor Yes NR Unclear Yes/LOCF Partially Yes Yes Handen, 1999 60 Poor Poor Yes #6 Unclear Unclear Yes No No Hoeppner, 1997 61 Poor Poor Yes NR Unclear Unclear Unclear No No James, 2001 62 Poor Good Yes NR Unclear Unclear NA No Yes Kelsey, 2004 63 Poor Poor Yes NR Unclear Yes Yes Yes Yes Kemner, 2004 64 [Confidential information removed] Klein, 1997 65 Poor Poor Yes #4 Unclear Unclear Partially Yes No Klorman, 1987 66 Poor Poor Yes NR Unclear Unclear Unclear Poor No Klorman, 1990 67 Poor Poor Yes NR Unclear Unclear Unclear No No Klorman, 1994 68 Poor Poor Yes I/#2 Unclear Unclear Yes Unclear No Kolko, 1999 69 Poor Poor Yes #5 Unclear No Yes Unclear No Kratochvil, 2002 70 Poor Poor No NA Yes/LOCF Yes Yes Yes Kupietz, 1988 71 Poor Poor Yes P/T/I Unclear Unclear Partially Yes No Manos, 1999 72 Poor Poor Yes #3 Unclear Unclear NA No No Michelson, 2001 73 Good Good Yes NR Unclear Unclear Yes Yes Yes Michelson, 2002 74 Poor Poor Yes C/CL/I Unclear Yes/LOCF Partially Yes Yes Michelson, 2004 75 Poor Good Yes C/I Unclear Yes? Partially Yes Yes MTA, 1999 76 Poor Good Yes #7 Unclear Yes Partially Unclear No Pelham, 1987 77 Poor Poor Yes I/#2 Unclear Unclear Unclear Yes No Pelham, 1990 78 Poor Poor Yes NR Unclear Unclear Unclear Unclear No Pelham, 1993 79 Poor Poor Yes NR Unclear Unclear Unclear Unclear No Pelham, 1999 80 Poor Poor Yes P/T/I/CL Unclear Unclear Yes Unclear Yes Was blinding successful? Was an ITT analysis performed? Was a complete description of any withdrawals given? Was the statistical analysis appropriate? Was an association with industry reported by the authors? continued 15
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: Quantity and quality of research av
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 and 84:
TABLE 47 IR-MPH low-dose (≤ 15 mg
Page 85 and 86:
STP. 77,78 Neither examined hyperac
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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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