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NHS R&D HTA Programme The research findings from the NHS R&D Health Technology Assessment (HTA) Programme directly influence key decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC) who rely on HTA outputs to help raise standards of care. HTA findings also help to improve the quality of the service in the NHS indirectly in that they form a key component of the ‘National Knowledge Service’ that is being developed to improve the evidence of clinical practice throughout the NHS. The HTA Programme was set up in 1993. Its role is to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and provide care in the NHS. ‘Health technologies’ are broadly defined to include all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care, rather than settings of care. The HTA Programme commissions research only on topics where it has identified key gaps in the evidence needed by the NHS. Suggestions for topics are actively sought from people working in the NHS, the public, service-users groups and professional bodies such as Royal Colleges and NHS Trusts. Research suggestions are carefully considered by panels of independent experts (including service users) whose advice results in a ranked list of recommended research priorities. The HTA Programme then commissions the research team best suited to undertake the work, in the manner most appropriate to find the relevant answers. Some projects may take only months, others need several years to answer the research questions adequately. They may involve synthesising existing evidence or conducting a trial to produce new evidence where none currently exists. Additionally, through its Technology Assessment Report (TAR) call-off contract, the HTA Programme is able to commission bespoke reports, principally for NICE, but also for other policy customers, such as a National Clinical Director. TARs bring together evidence on key aspects of the use of specific technologies and usually have to be completed within a short time period. Criteria for inclusion in the HTA monograph series Reports are published in the HTA monograph series if (1) they have resulted from work commissioned for the HTA Programme, and (2) they are of a sufficiently high scientific quality as assessed by the referees and editors. Reviews in Health Technology Assessment are termed ‘systematic’ when the account of the search, appraisal and synthesis methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others. The research reported in this monograph was commissioned and funded by the HTA Programme on behalf of NICE as project number 03/33/01. The protocol was agreed in July 2004. The assessment report began editorial review in May 2005 and was accepted for publication in July 2005. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the referees for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report. The views expressed in this publication are those of the authors and not necessarily those of the HTA Programme, NICE or the Department of Health. Editor-in-Chief: Professor Tom Walley Series Editors: Dr Aileen Clarke, Dr Peter Davidson, Dr Chris Hyde, Dr John Powell, Dr Rob Riemsma and Dr Ken Stein Managing Editors: Sally Bailey and Sarah Llewellyn Lloyd ISSN 1366-5278 © Queen’s Printer and Controller of HMSO 2006 This monograph may be freely reproduced for the purposes of private research and study and may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to NCCHTA, Mailpoint 728, Boldrewood, University of Southampton, Southampton, SO16 7PX, UK. Published by Gray Publishing, Tunbridge Wells, Kent, on behalf of NCCHTA. Printed on acid-free paper in the UK by St Edmundsbury Press Ltd, Bury St Edmunds, Suffolk. T
Objectives: To assess the clinical and costeffectiveness of oral methylphenidate hydrochloride (MPH), dexamfetamine sulphate (DEX) and atomoxetine (ATX) in children and adolescents (
Page 1 and 2: A systematic review and economic mo
Page 3: A systematic review and economic mo
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 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
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TABLE 11 MPH high dose (>30 mg/day)
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TABLE 14 ER-MPH medium dose (20-40
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Study Crossover trials Stein 2003 S
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TABLE 19 Results for hyperactivity
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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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Page 71 and 72:
TABLE 30 DEX medium dose (10-20 mg/
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Page 75 and 76:
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.
Page 161 and 162:
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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