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

More documents

Recommendations

Info

10 Methods for reviewing effectiveness and cost-effectiveness ● analyse safety and/or tolerability as a primary objective ● examine children and/or adolescents with ADHD ● present data by individual drug type: MPH, DEX or ATX. Of the studies that met our inclusion criteria, we subsequently chose only to assess those with primary studies not already included in our review. The BNF 29 was used to provide information on the side-effect profiles of MPH, DEX and ATX. Data extraction strategy: clinical effectiveness Data relating to both study design and quality were extracted by one reviewer into an Access database and independently checked for accuracy by a second reviewer. Any discrepancies were resolved by consensus and, if necessary, a third reviewer was consulted. Data from studies with multiple publications were extracted and reported as a single study. Quality assessment strategy: clinical effectiveness The quality of the clinical effectiveness studies was assessed using modified criteria based on CRD Report No. 4 31 (see Appendix 5). Each study was assessed by one reviewer and independently checked for agreement with a second reviewer. Disagreements were resolved by consensus and, if necessary, a third reviewer was consulted. Analysis strategy: clinical effectiveness Clinical effectiveness data were reported separately for each drug and by the type of comparison. Data for MPH were also analysed separately based on immediate-release or extended-release formulation. For all drugs, the data were examined by dose. The cut-offs used for defining low, medium and high for each type of drug were those presented by Swanson and colleagues. 32 Data for the outcomes of hyperactivity (using any scale that measured hyperactivity specifically), Clinical Global Impression (CGI) (as a proxy of QoL) and adverse events were analysed. Owing to time constraints, information on other core outcomes and academic performance were not analysed; however, this information was extracted and is presented in the data extraction tables (Appendix 12). Any scale that appeared to have assessed pure hyperactivity was included in the analysis. Results from scales that may incorporate hyperactivity, but also include other symptoms (for example, the Conners’ Abbreviated Rating Scale) were not analysed but are included in the data extraction tables (Appendix 12). The type/version of the scale used to assess hyperactivity has been reported as presented in the original papers. Many different scales and versions of the same scales (e.g. the Conners’ scales) were used in the trials. Owing to their complexity, no attempt was made to combine results from data using different scales, different versions of a scale or scales which may be the same but have different names. For crossover studies, the mean and standard deviation (SD) for each outcome were data extracted for end of trial data (i.e. baseline data were not considered). Where possible, we aimed to calculate mean difference and standard errors for crossover studies in order to facilitate metaanalysis where possible. 33 However, owing to the lack of data information needed to calculate mean differences in many of the studies, this was not possible. For parallel studies, change scores were reported where given, otherwise means and SDs were presented for end of trial data. In addition, mean differences with 95% confidence intervals (CIs) were calculated for each study. For adverse events, self-ratings were reported when used, otherwise parent reports were utilised. Percentages of participants reporting adverse events were used to calculate numbers of events in each treatment arm. Where actual numbers of participants included in safety analyses were unclear, denominators were based on numbers of participants originally randomised to each treatment arm. Relative risks (RRs) were examined within predefined subgroups (based on drug, dosage and inclusion of a behavioural intervention). Data on weight were also analysed in view of recent concerns regarding the effects of stimulants on growth in children. Mean differences (with 95% CIs) were calculated for each study. Where results were highly variable, possible causes of this were explored in terms of participant age, duration of intervention and method of outcome measurement.
Cost-effectiveness HRQoL studies were selected if they contained health outcomes data for use in economic evaluations of ADHD. The review of the economic evaluation literature included studies that compared two or more ADHD interventions in terms of their costs and outcomes and where at least one drug intervention was assessed. Economic evaluations could include cost–consequence, cost–utility, cost–effectiveness, cost–minimisation and cost–benefit analyses. Economic evaluations reported as conference proceedings or abstracts were excluded since the data they contain may not be complete. A data extraction form was used to abstract data on all economic evaluations selected in the literature review. The data extraction form used has been used in previous Technology Assessment Reviews. © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 Each economic evaluation selected for the literature review was quality assessed independently by two health economists based on an economic evaluation checklist. 34 Any discrepancies in quality assessment were resolved through reaching a consensus between the two health economists involved. In Chapter 5, a systematic review of the HRQoL and cost-effectiveness literature is conducted, followed by a review of the company submissions to NICE. Following this, in Chapter 6, a new model is constructed, drawing on data obtained from the literature review and the company submissions. The methods used to review the literature, construct the new model and analyse the cost-effectiveness data are described in detail in the relevant sections. 11
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 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 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
Page 157 and 158:
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
Page 163 and 164:
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
show all

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

Create successful ePaper yourself

Delete template?

Save as template?