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

ehaviour is often (not always) apparent
immediately, but the impact on the social
adjustment of the child may well not be apparent
in the first days of therapy. We recognise,
however, that even 3 weeks is a short period in
which to examine the effect of a drug intended to
modify a chronic condition.]
Interventions
MPH (Ritalin, Equasym, Equasym XL, Concerta
XL), DEX (Dexedrine) and ATX (Strattera), used
alone or as part of a multi-modal treatment
programme (involving other drugs and/or nondrug
interventions), were included, provided that
effectiveness or adverse event data were presented
for the three drugs of interest. Non-drug
interventions included any type of psychological
and behavioural strategies [e.g. cognitive
behavioural therapy (CBT), child or parent
training, bibliotherapy] and/or nutritional
interventions.
Studies that compared MPH, DEX or ATX with
other drugs not licensed for ADHD in the UK
were excluded from the review, unless the study
also included a placebo group. In these studies,
data for comparisons between MPH, DEX and
ATX and placebo were extracted.
Participants
Participants included children and adolescents
6 years old and ATX is
indicated for children ≥ 6 years of age). The
diagnosis must have been made in an explicit way,
preferably using either the ICD-10 criteria or the
DSM-IV criteria.
Studies that included conditions other than ADHD
(e.g. Tourette’s syndrome) or children with ADHD
and mental retardation were only included here if
they reported separate analyses for patients with
ADHD alone. RCTs excluded from this review that
examined children with ADHD and other comorbid
conditions are presented in Appendices 3
and 4.
Outcomes
Given the large number of outcomes presented in
the literature, the inclusion criteria were restricted
to four broad outcome categories. These efficacy
measures are widely used and, after discussions
with a clinical expert, were recognised as the most
relevant clinical outcomes.
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Health Technology Assessment 2006; Vol. 10: No. 23
To be included in the review, trials had to report
results on one or more of the following:
● core symptoms (including measures of
inattention, hyperactivity, impulsivity)
● quality of life (QoL) (clinical global impression
or overall severity indices were used as a proxy
of QoL)
● adverse effects (including loss of appetite,
insomnia, headache, stomach ache and weight
loss).
Studies that also reported on educational
performance (including various tests of reading,
spelling, mathematics, or by accuracy and
productivity of seatwork tasks) were also included
in the first stage of the screening, but were later
excluded if this was the only outcome assessed.
Studies that only examined tests of psychological
function (e.g. the continuous performance test),
measures of depression and/or anxiety or measures
of coexistent problems (including poor peer
relationships, and conduct/oppositional disorderrelated
outcomes) were not included in the review.
However, if the trial examined these outcomes in
addition to one or more of the four presented
above, it was noted in data extraction tables.
Studies that presented all results in figures without
presenting actual numbers, or only significance
values for comparisons, were excluded from the
review.
Publication
Studies that met the inclusion criteria above, but
were only published as abstracts or as conference
presentations, were not included in the review
unless a full paper could be obtained that related
to the abstract (a list of these excluded
publications is presented in Appendix 3).
As there was no language restriction in the search
strategy, trials reported in any language were
considered for inclusion in the review. However,
time limitations resulted in the exclusion of two
papers written in Mandarin (see Appendix 3).
Inclusion and exclusion criteria
for systematic reviews: clinical
effectiveness
To be included, systematic reviews with adverse
events data had to:
● provide evidence of a search for primary
literature
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