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

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x Glossary and list of abbreviations Glossary continued Randomised controlled trial (synonym: randomised clinical trial) An experiment in which investigators randomly allocate eligible people into intervention groups to receive or not to receive one or more interventions that are being compared. The results are assessed by comparing outcomes in the treatment and control groups. Relative risk (synonym: risk ratio) The ratio of risk in the intervention group to the risk in the control group. The risk (proportion, probability or rate) is the ratio of people with an event in a group to the total in the group. RR = 1 indicates no difference between comparison groups. For undesirable outcomes an RR that is
Glossary continued point between two anchor states appearing at either end of the line. It is used as a method of valuing health states. Washout period The stage in a crossover trial when treatment is withdrawn before the second treatment is given. Washout periods are usually necessary because of the possibility that the List of abbreviations ACTeRS ADD-H Comprehensive Teachers’ Rating Scale ADD attention deficit disorder ADD-H attention deficit disorder with hyperactivity AE adverse event ADHD attention deficit hyperactivity disorder AHRQ Agency for Healthcare Research and Quality ARS ADHD Rating Scale ASQ Abbreviated Symptoms Questionnaire ATX atomoxetine hydrochloride BM behaviour modification BNF British National Formulary BSEQ Barkley Side Effects Questionnaire BT behavioural therapy CBCL Child Behaviour Checklist CBT cognitive behavioural therapy CCOHTA Canadian Coordinating Office for Health Technology Assessment CCT Children’s Checking Test CCT clinically controlled trial CD conduct disorder CEAC cost-effectiveness acceptability curve C-GAS Children’s Global Assessment Scale © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 intervention administered first can affect the outcome variable for some time after treatment ceases. A run-in period before a trial starts is sometimes called a washout period if treatments that participants were using before entering the trial are discontinued. CGI Clinical Global Impression CGI-I Clinical Global Impression improvement subscale CGI-S Clinical Global Impression severity subscale CHQ Child Health Questionnaire CI confidence interval CIC commercial-in-confidence CNS central nervous system CON concerta CPRS-R Conners’ Parent Rating Scale – Revised CPRS Conners’ Parent Rating Scale CPRS-H Conners’ Parent Hyperactivity Subscale CTRS-R Conners’ Teacher Rating Scale – Revised CTRS Conners’ Teacher Rating Scale CTRS-H Conners’ Teacher Hyperactivity Subscale DEC Development and Evaluation Committee DEX dexamfetamine sulphate DEX-SR sustained-release dexamfetamine sulphate DEX-TR time-release dexamfetamine sulphate DSM-III Diagnostic and Statistical Manual of Mental Disorders (3rd edition) continued xi
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: Glossary continued effects. Sometim
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 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
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TABLE 24 MPH medium dose (15-30 mg/
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assessed by parents and teachers. I
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TABLE 27 Results for hyperactivity
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TABLE 30 DEX medium dose (10-20 mg/
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TABLE 33 Results for hyperactivity
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TABLE 38 DEX medium dose (10-20 mg/
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TABLE 41 DEX-SR plus non-drug inter
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Study Michelson 2001 [0.5] Michelso
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Hyperactivity Five trials (publishe
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TABLE 47 IR-MPH low-dose (≤ 15 mg
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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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