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If tics are stimulant-related, reduce the dose of methylphenidate or dexam-
fetamine, consider changing to atomoxetine, or stop drug treatment.
12.8.4.15 Anxiety symptoms, including panic, may be precipitated by stimulants, partic-
ularly in adults with a history of coexisting anxiety. Where this is an issue,
lower doses of the stimulant and/or combined treatment with an antidepressant
used to treat anxiety can be used; switching to atomoxetine may be effective.
12.8.5 Improving adherence to drug treatment
12.8.5.1 Communication between the prescriber and the child or young person
should be improved by educating parents or carers and ensuring there are
regular three-way conversations between prescriber, parent or carer and the
child or young person. For adults with ADHD, and with their permission,
a spouse, partner, parent, close friend or carer wherever possible should be
part of these conversations. Clear instructions about how to take the drug
should be offered in picture or written format, which may include informa-
tion on dose, duration, side effects, dosage schedule, the need for supervi-
sion and how this should be done.
12.8.5.2 Healthcare professionals should consider suggesting peer-support groups
for the child or young person with ADHD and their parents or carers if
adherence to drug treatment is difficult or uncertain.
12.8.5.3 Simple drug regimens (for example, once-daily modified-release doses)
are recommended for people with ADHD.
12.8.5.4 Healthcare professionals should encourage children and young people with
ADHD to be responsible for their own health, including taking their
medication as required, and support parents and carers in this endeavour.
12.8.5.5 Healthcare professionals should advise parents or carers to provide the
child or young person with visual reminders to take medication regularly
(for example, alarms, clocks, pill boxes, or notes on calendars or fridges).
12.8.5.6 Healthcare professionals should advise children and young people and
their parents or carers that taking medication should be incorporated into
daily routines (for example, before meals or after brushing teeth).
12.8.5.7 Where necessary, healthcare professionals should help parents or carers
develop a positive attitude and approach in the management of medication,
which might include praise and positive reinforcement for the child or
young person with ADHD.
12.8.6 Duration, discontinuation and continuity of treatment in children
and young people
12.8.6.1 Following an adequate treatment response, drug treatment for ADHD should
be continued for as long as it remains clinically effective. This should be
reviewed at least annually. The review should include a comprehensive
Summary of recommendations
379
Summary of recommendations
380
assessment of clinical need, benefits and side effects, taking into account the
views of the child or young person, as well as those of parents, carers and
teachers, and how these views may differ. The effect of missed doses, planned
dose reductions and brief periods of no treatment should be taken into account
and the preferred pattern of use should also be reviewed. Coexisting condi-
tions should be reviewed, and the child or young person treated or referred if
necessary. The need for psychological and social support for the child or
young person and for the parents or other carers should be assessed.
12.8.6.2 Drug holidays are not routinely recommended; however, consideration
should be given to the parent or carer and child or young person with
ADHD working with their healthcare professional to find the best pattern
of use, which may include periods without drug treatment.
12.8.7 Duration, discontinuation and continuity of treatment of adults
12.8.7.1 Following an adequate response, drug treatment for ADHD should be
continued for as long as it is clinically effective. This should be reviewed
annually. The review should include a comprehensive assessment of clini-
cal need, benefits and side effects, taking into account the views of the
person and those of a spouse, partner, parent, close friends or carers wher-
ever possible, and how these accounts may differ. The effect of missed
doses, planned dose reductions and brief periods of no treatment should be
taken into account and the preferred pattern of use should also be reviewed.
Coexisting conditions should be reviewed, and the person treated or referred
if necessary. The need for psychological, social and occupational support
for the person and their carers should be assessed.
12.8.7.2 An individual treatment approach is important for adults, and healthcare
professionals should regularly review (at least annually) the need to adapt
patterns of use, including the effect of drug treatment on coexisting condi-
tions and mood changes.
12.9 RESEARCH RECOMMENDATIONS
12.9.1.1 Grounds for diagnosis of ADHD in adults
● What is the prevalence of inattention, impulsivity and hyperactivity/
restlessness in males and females in the adult population?
● How far do the core symptoms of inattention, impulsivity and hyper-
activity/restlessness cluster together?
● To what extent are the core symptoms comorbid with other forms of
mental disturbance?
● To what extent are the core symptoms associated with neuropsycho-
logical and social impairment? This would be best conducted as an
epidemiological survey.
● Why this is important: There is evidence that ADHD symptoms can
persist into adulthood and cause impairment, but there are no clear
conclusions about the level of ADHD symptoms in adults that
should be considered as grounds for intervention, or whether symp-
toms take a different form in adulthood. The costs to society and to the
affected people and their families make it pressing to know whether,
and how far, services should be expanded to meet the needs of
this group.
12.9.1.2 Discontinuation of drug treatment
● Are there any benefits or disadvantages to the extended/long-term
use of methylphenidate compared with its discontinuation at least
18 months after starting treatment? To what extent does continuing
drug treatment beyond 18 months alter quality of life, core ADHD
symptoms, associated symptoms including emotional lability, poten-
tial adverse effects of continued drug treatment and neuropsychologi-
cal function? This would be best conducted as a drug discontinuation
randomised controlled trial.
● Why this is important: Methylphenidate is often given for periods of
years without good evidence of whether prolonged therapy is effective
or safe. Methylphenidate is also typically discontinued in late adoles-
cence; evidence is required of the benefit of continued prescribing in
this age group.
12.9.1.3 Effectiveness of group-based parent training
● Are group-based behavioural parent-training/education methods more
effective than drug treatment in school-age children and young people
with ADHD in terms of symptoms, quality of life and cost effective-
ness? This would be best evaluated by a head-to-head randomised
controlled trial.
● Why this is important: The evidence for the effect of group-based
parent-training/education programmes is largely based on studies of
younger children. These programmes are an important part of the
management of ADHD although their cost effectiveness is not clear
for older children and adolescents.
12.9.1.4 Effectiveness of non-drug treatments for adults with ADHD
● Are non-drug treatments (including focused psychological treatments
and supportive approaches such as coaching) more effective than drug
treatment (methylphenidate) in terms of symptoms, quality of life, cost
effectiveness, drug misuse and other coexisting conditions, and the
cost of health, forensic and criminal justice services, in the treatment
of adults with ADHD? This would be best conducted as a randomised
controlled trial.
● Why this is important: Currently there is good evidence supporting the
effectiveness of methylphenidate in people with ADHD symptoms and
associated impairment. However, there is insufficient evidence on
whether non-drug treatments could have specific advantages in some
Summary of recommendations
381
important aspects of the life of a person with ADHD. Given the strong
association of ADHD in adults with substance misuse, personality
disorder and involvement in the criminal justice system, a health
economic approach would be essential.
12.9.1.5 Effect of providing training in behavioural management of ADHD for
teachers
● Does the training of teachers in the behavioural management of chil-
dren with ADHD in primary and secondary schools improve ADHD
symptoms and academic attainment, the teacher’s experience of stress
in the classroom and the impact of ADHD on other pupils when
compared with current education methods? This would be best
conducted as a randomised trial.
● Why this is important: Secondary school is typically a different envi-
ronment from primary school, particularly in terms of organisation of
the daily timetable and expectations of the increasing independence of
pupils. These factors may have an adverse impact on young people
with ADHD, but the effect of understanding and modifying this impact
has not yet been researched. The potential for teachers to take a more
active role in the behavioural management of primary and secondary
school children with ADHD shows some significant promise in at least
one trial. The benefits of examining primary and secondary education,
compared with education as usual, and examining the broader impact
on the child, the teacher and the wider classroom, would significantly
improve future versions of this guideline.
Summary of recommendations
382
13. APPENDICES
Appendix 1: Scope for the development of the clinical guideline 384
Appendix 2: Declarations of interests by GDG members 390
Appendix 3: Special advisers to the GDG 411
Appendix 4: Stakeholders and reviewers who submitted comments
in response to the consultation draft of the guideline 412
Appendix 5: Researchers contacted to request information about
unpublished or soon-to-be published studies 414
Appendix 6: Clinical questions 415
Appendix 7: Review protocols 421
Appendix 8: Search strategies for the identification of diagnostic
studies, clinical studies and reviews 440
Appendix 9: Clinical study information database 451
Appendix 10: Quality checklists for diagnostic studies, clinical
studies and reviews 453
Appendix 11: Search strategies for the identification of health
economics evidence 459
Appendix 12: Quality checklist for full economic evaluations 460
Appendix 13: Data extraction form for economic studies 462
Appendix 14: Evidence tables for economic studies 465
Appendix 15: Focus group study of children and young people’s
experience of psychostimulant medication 474
Appendix 16: ADHD Consensus Conference 499
Appendix 17: Study characteristics tables on CD ROM
Appendix 18: Clinical evidence forest plots on CD ROM
Appendix 19: GRADE evidence profiles on CD ROM
Appendices
383
Appendix 1
384
APPENDIX 1:
SCOPE FOR THE DEVELOPMENT OF THE
CLINICAL GUIDELINE
Final version
8 August 2008
GUIDELINE TITLE
Attention deficit hyperactivity disorder: diagnosis and management of ADHD in
children, young people and adults
Short title
ADHD
BACKGROUND
The National Institute for Health and Clinical Excellence (‘NICE’ or ‘the Institute’) has
commissioned the National Collaborating Centre for Mental Health to develop a clinical
guideline on attention deficit hyperactivity disorder for use in the NHS in England and
Wales. This follows referral of the topic by the Department of Health and Welsh Assembly
Government (see below). The guideline will provide recommendations for good practice
that are based on the best available evidence of clinical and cost effectiveness.
The Institute’s clinical guidelines will support the implementation of National
Service Frameworks (NSFs) in those aspects of care where a Framework has been
published. The statements in each NSF reflect the evidence that was used at the time
the Framework was prepared. The clinical guidelines and technology appraisals
published by the Institute after an NSF has been issued will have the effect of updat-
ing the Framework.
NICE clinical guidelines support the role of healthcare professionals in providing
care in partnership with patients, taking account of their individual needs and prefer-
ences, and ensuring that patients (and their carers and families, where appropriate)
can make informed decisions about their care and treatment.
CLINICAL NEED FOR THE GUIDELINE
Attention deficit hyperactivity disorder (ADHD) is a heterogeneous behavioural
syndrome and its diagnosis does not imply any specific cause. However various
genetic and environmental risk factors have been implicated in its development.
ADHD is characterised by the ‘core’ signs of inattention, hyperactivity and impul-
siveness. There are two main sets of diagnostic criteria in current use, the
International Classification of Mental and Behavioural Disorders 10th Revision
(ICD-10) and the Diagnostic and Statistical Manual of Mental Disorders fourth
edition (DSM-IV). The ICD-10 definition makes reference to hyperkinetic disorder,
primarily evidenced by high abnormal levels of hyperactivity, and a combined sub-
type in which hyperactivity, impulsivity and inattention need to be present, together
with stricter requirements for pervasiveness across situations, and exclusion of
comorbidity. The DSM-IV criteria describes ADHD more broadly to include three
subtypes: a combined subtype in which all three core signs are present; a predomi-
nantly inattentive subtype in which inattention is present but not hyperactivity or
impulsiveness; and a predominantly hyperactive–impulsive subtype in which hyper-
activity and impulsiveness are present but not inattention. Both ICD-10 and DSM-IV
require 6 months duration of symptoms. The identification of ADHD in adults, and
the diagnostic criteria that should underpin case recognition, are less clear and lead to
uncertainties in practice.
ICD-10 and DSM-IV adopt a different approach to comorbidity. In ICD-10,
secondary complications to hyperkinetic disorder include dissocial behaviour and low
self-esteem. In DSM-IV common comorbidities include: disruptive behaviour disorders,
mood disorders, anxiety disorders, learning disorders and communication disorders.
ADHD is not diagnosed if symptoms of inattention and hyperactivity occur exclu-
sively during the course of a pervasive developmental disorder or a psychotic disor-
der; but the problems may still need to be recognised and treated. It seems likely that
a similar pattern of comorbidities pertains to adults with ADHD, although definitive
research in this area is lacking.
A number of genetic and environmental risk factors for ADHD have been identi-
fied. Hereditary aspects, neuroimaging data and responses to pharmacotherapeutic
agents support the suggestion that ADHD has a biological component. However, there
is a continuing debate over the causes of ADHD.
ADHD affects children, young people and adults in different ways and to differ-
ent degrees, but the consequences of severe ADHD can be serious for both the indi-
vidual and their family and carers. Children with ADHD often have low self-esteem
and can develop additional emotional and social problems. The secondary effects of
ADHD can be damaging. For example, some children and young adults with ADHD
are at increased risk of accidental harm and many later have an increased risk of auto-
motive accidents. Moreover, affected children are often exposed to years of negative
feedback about their behaviour and may suffer educational and social disadvantage.
A sizeable proportion of children referred for hyperactivity disorders continue to have
problems into adulthood, including emotional and social problems, substance misuse,
unemployment and involvement in crime.
Estimates of the prevalence of hyperkinetic disorder/ADHD vary widely within
and between countries. Prevalence estimates for hyperkinetic disorder in children and
young people are around 1 to 2% in the UK. ADHD is estimated to affect 3 to 9% of
school-aged children and young people in the UK, and about 2% of adults worldwide
Appendix 1
385
(using DSM IV diagnostic criteria). These differences are, at least in part, explained
by differences in diagnostic criteria used in different countries.
Studies of clinic-based diagnoses suggest that ADHD is nine times more common
in males, although this gender imbalance is inflated to some extent by referral
bias; epidemiological studies suggest that prevalence is only two to four times greater
in males.
The prescribing of stimulant drugs for ADHD reflects the increased frequency of
diagnosis of this condition. In 1998 there were about 220,000 prescriptions in
England for stimulant drugs (methylphenidate and dexamfetamine) at a net cost of
about £5 million; in 2004 this number had almost doubled to 418,300 at a cost of
almost £13 million.
The use of CNS stimulants has been controversial and there are concerns about
prescribing such medication to children. Further anxieties surround the potential for
their inappropriate prescription, abuse and unauthorised trading and/or illegal selling.
THE GUIDELINE
The guideline development process is described in detail in two publications which
are available from the NICE website (see ‘Further information’ below). The guideline
development process: an overview for stakeholders, the public and the NHS describes
how organisations can become involved in the development of a guideline. Guideline
development methods: information for National Collaborating Centres and guideline
developers provides advice on the technical aspects of guideline development.
This document is the scope. It defines exactly what this guideline will (and will
not) examine, and what the guideline developers will consider. The scope is based on
the referral from the Department of Health (see below).
The areas that will be addressed by the guideline are described in the following
sections.
POPULATION
The guideline will cover:
● The treatment of children aged 3 years and older, young people and adults with a
diagnosis of ADHD and related diagnoses: hyperkinetic disorder (ICD-10) will be
considered, along with the three DSM-IV ADHD subtypes.
● The management of common comorbidities in children, young people and adults
with ADHD as far as these conditions affect the treatment of ADHD.
● The specific management of ADHD in those individuals who also have:
– a learning disability
– a defined neurological disorder.
The guideline will not cover:
● the separate management of comorbid conditions
● the management of children younger than 3 years
Appendix 1
386
HEALTHCARE SETTING
The guideline will cover the care provided by primary, community and secondary
healthcare professionals who have direct contact with, and make decisions concern-
ing, the care of children, young people and adults with ADHD.
This is an NHS guideline. It will comment on the interface with other services
such as social services, educational services, the voluntary sector and young offender
institutions, but it will not include recommendations relating to the services exclu-
sively provided by these agencies, except insofar as the care provided in those insti-
tutional settings is provided by healthcare professionals funded by the NHS.
Recommendations in the guideline will nevertheless map onto the tiered model of
CAMHS services specified in the NSF for children and utilised in the NICE guide-
line on depression in children. Some of the recommendations will be made to staff in
the education services, where this may have a positive contribution to the health of a
child with ADHD, either directly (where this is appropriate) or indirectly through
collaborative working with CAMHS professionals.
The guideline will include:
● care in general practice and NHS community care
● hospital outpatient and inpatient care
● primary/secondary interface of care
● transition from childhood services to adult services.
CLINICAL MANAGEMENT
Areas that will be covered by the guideline:
● The full range of care routinely made available by the NHS.
● Validity, specificity and reliability of existing diagnostic criteria (ICD-10 and
DSM-IV) in children, young people and adults, and to determine/specify the crite-
ria that should be used to determine the circumstances in which this guideline
should be used.
● Assessment both before and after diagnosis.
● Early identification of ADHD in children at risk, and identification of factors that
should lead to investigation into the possibility of ADHD.
● Pathways to treatment.
● Identification and management of risk.
● The appropriate use of pharmacological interventions, for example initiation and
duration of treatment, management of side effects and discontinuation. Specific
pharmacological treatments considered will include:
– methylphenidate and dexamfetamine (currently licensed for treatment of
ADHD in children and young people)
– atomoxetine (currently licensed for treatment of ADHD in children and in
adults if treatment was initiated in childhood)
– tricyclic and other antidepressants
– bupropion
Appendix 1
387
– nicotine (as skin patches)
– clonidine
– atypical antipsychotics (particularly risperidone)
– modafinil.
Note that guideline recommendations will normally fall within licensed indications;
exceptionally, and only where clearly supported by evidence, use outside a licensed
indication may be recommended. The guideline will assume that prescribers will use
a drug’s Summary of Product Characteristics to inform their decisions for individual
patients.
● All common psychological interventions currently employed in the NHS for exam-
ple, family interventions, cognitive-behavioural treatments, and parent training.
● Combined pharmacological and psychological treatments.
● Other physical treatments, including dietary elimination and supplementation.
● Treatment approaches for adults with ADHD (including longer-term outcomes
and transitions from child to adult healthcare).
● Sensitivity to different beliefs and attitudes of different races and cultures, and
issues of social exclusion.
● The role of the family or carers in the treatment and support of people with ADHD
(with consideration of choice, consent and help), and support that may be needed
by carers themselves.
Areas that will not be covered by the guideline
● Treatments not normally available in the NHS.
STATUS
Scope
This is the final scope.
The guideline will incorporate the following relevant technology appraisal guid-
ance issued by the Institute:
Methylphenidate, atomoxetine and dexamfetamine for the treatment of attention
deficit hyperactivity disorder in children and adolescents (including a review of guid-
ance no.13) NICE Technology Appraisal (Published March 2006)
Previous recommendations made in other guidelines may be updated by this
guideline, based on the most up-to-date evidence for this particular population.
GUIDELINE
The development of the guideline recommendations will begin in March 2006.
Appendix 1
388
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