513481

2013
CRE28610.1177/0269215513513481Clinical RehabilitationDrummond and Wade

CLINICAL
Editorial REHABILITATION

Clinical Rehabilitation
National Institute for Health 2014, Vol. 28(6) 523­–529
© The Author(s) 2013

and Care Excellence stroke Reprints and permissions:

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DOI: 10.1177/0269215513513481
rehabilitation guidance – is it cre.sagepub.com

useful, usable, and based on best

evidence?

Avril Drummond1 and Derick T Wade2

Abstract
In the UK, the National Institute for Health and Care Excellence (NICE) is responsible for producing
clinical guidance based on sound evidence. In 2013 they produced guidance on Stroke Rehabilitation
and this editorial outlines why this is not a useful guide for clinicians or commissioners. Primarily this is
because NICE used inappropriate methods; the methods used are appropriate for evaluating drugs, but
are inappropriate when applied to any complex intervention. Moreover, the actual recommendations are
written in clinically unhelpful language.
Future rehabilitation guidance should include ensuring that the team responsible for the guidance are all
familiar with and understand the biospsychosocial model of illness and the nature of the rehabilitation
process (which is not synonymous with therapy), setting a relevant and appropriate scope for a guideline,
agreeing to use all evidence relevant to a particular question, and using a more appropriate way to
evaluate evidence while recognising that rehabilitation is a complex intervention.

Keywords
Stroke, rehabilitation, guideline
Received: 22 October 2013; accepted: 28 October 2013

Introduction
The National Institute for Health and Care
Excellence (NICE) recently published Stroke
Rehabilitation guidelines1 and the key recommen-
dations have been summarised elsewhere.2 In the
UK, NICE provides national guidance to improve
health and social care, and consequently these
guidelines are significant because they demonstrate
that NICE recognises stroke rehabilitation as an
important area of practice where improving access
and quality of care is essential. Its guidance is also
used internationally.
NICE generally aims to produce guidance based
on the best evidence available, which will be both
clinically useful and usable. This editorial considers
1University of Nottingham, Nottingham, UK
2Nuffield Orthopaedic Centre, Oxford, UK
Corresponding author:
Avril Drummond, University of Nottingham, A Floor, South
Block, Queen’s Medical Centre (QMC), Nottingham NG7
2HA, UK.
Email: avril.drummond@nottingham.ac.uk
524 Clinical Rehabilitation 28(6)
the guidance on stroke rehabilitation against these
criteria, used by NICE itself. While we welcome the
commitment of NICE to this topic, there are several
issues that need to be addressed and highlighted; it
is vital that we learn lessons for developing future
rehabilitation guidelines for stroke and for other
conditions.
From the onset of this editorial, we need to
declare that Professor Avril Drummond was origi-
nally a member of the Stroke Rehabilitation
Guideline Development Group (GDG), but resigned
in 2012 because of growing unease with the meth-
odology and process. We should also declare that
both the journal editor, Professor Derick Wade and
Professor Avril Drummond are long-standing mem-
bers of the Inter-Collegiate Stroke Working Party
(ICSWP), which has been responsible for four edi-
tions of the National Clinical Guideline on Stroke,
including the most recent.3
Scope
The first issue of concern must be the limited scope
of the document and the rationale for the list of top-
ics selected. It is disappointing that NICE did not
attempt to produce a comprehensive set of guide-
lines, as they did for Multiple Sclerosis and
Parkinson’s Disease. Even if time and resources
precluded this, we would still expect NICE to
address the more important issues in stroke rehabili-
tation and to present a clear rationale for the choice
of areas selected; neither is evident.
The scope seems to jump from overarching top-
ics, such as intensity of rehabilitation and goal set-
ting, to very specific interventions, such as treadmill
training and provision of foot orthoses; there is no
attempt to link these together within a coherent
framework and the actual questions posed are odd.
Although the overall guideline title suggests the
focus of the document is on long-term aspects of
rehabilitation, this is not explicitly tackled or
reflected in the choice of topics selected.
If one were to choose the most pressing clinical
questions in stroke rehabilitation in the UK, they
would not be these. So while, for example, ‘return
to work’ is a key aspect of rehabilitation and a
worthwhile area for research, the actual number of
patients for whom this is relevant is small, as only a
quarter of people are of working age when they
have their stroke.4 Consequently, it seems irrational
to include this topic at the expense of more critical
problems, such as which patients should have early
supported discharge? And how soon should some-
one start to mobilise after their stroke?
Group membership
There were difficulties in the composition of the
Guideline Development Group. Most notably there
was no stroke physician on the committee and the
Stroke Association – the largest charity representing
patients with stroke and their carers in the UK – did
not have formal representation. In addition, although
there were representatives from both clinical and
academic backgrounds, in several instances there
was only one person to represent a professional
body. The links between members and their profes-
sional bodies were not clearly articulated.
By comparison, members of the Inter-Collegiate
Stroke Working Party3 directly represent and have
clear contact with their professional groups. With
hindsight, it was unrealistic of NICE to expect such
a small group to provide comprehensive and mean-
ingful representation across the stroke rehabilitation
pathway. Consequently, there was a lack of external
validity for the group. Also, unlike other NICE
committees, the Chair of the group did not have a
separate Clinical Advisor, and so a huge workload
was placed on one individual who had to be respon-
sible for leading the group and ensuring good clini-
cal input.
Evaluating the evidence
The system used to identify and evaluate evidence
used by NICE may be appropriate for evaluating a
unique simple intervention, such as a drug, but it
was completely inappropriate for this guideline.
Almost all rehabilitation interventions are complex,
being delivered by a person to a patient and involv-
ing several processes, such as teaching (by the per-
son), learning (by the patient), giving practical and
emotional support, optimising the environment, and
supporting family members.
Drummond and Wade 525
The target of many rehabilitation interventions,
such as controlling increased tone or improving
walking, is one that is not unique to a particular dis-
ease, such as stroke. Therefore, it is irrational to
ignore evidence derived from people with the same
basic deficit (e.g. altered control of gait owing to
cerebral damage) but with a different disorder (e.g.
traumatic brain injury). Indeed, the term stroke
already includes sub-arachnoid haemorrhage, where
the damage and secondary problems are much
closer to traumatic brain injury and hypoxic brain
injury than they are to the other 95% of stroke
patients.
In practice the criteria set for selecting evidence
were unsuitable and the virtual exclusion of
Cochrane systematic reviews meant that many key
reviews were not examined and their evidence was
not used. NICE used the GRADE (Grading of
Recommendations Assessment, Development and
Evaluation5) appraisal tool in order to judge the
quality of the trials. The NICE reviewers did not
modify their approach despite requests to do so.
Consequently, many trials, regarded by the stroke
community as being of high quality, were labelled
as low or moderate quality.
The methods used demonstrated the lack of
understanding of rehabilitation by those responsible
for selecting relevant evidence. Issues such as blind-
ing certainly need and receive careful consideration
in the context of rehabilitation, where there are
pragmatic difficulties in blinding patients and thera-
pists to treatment allocation. Although it was
acknowledged that double blinding in rehabilitation
trials was not possible, no further account of blind-
ing was taken within the appraisal system.
The review process also confused the absence of
evidence with evidence of absence. Many trials
were penalised for issues that were outside the con-
trol of the trialists – most notably house reporting
styles for particular journals. Older studies in par-
ticular may lack details on randomization and
recruitment – but this does not necessarily mean
these issues were not addressed or were not of high
quality – just that they were not reported.
Distinctions need to be drawn between the actual
methodology employed and reporting restrictions.
Indeed, this is a further reason for using Cochrane
systematic reviews. Cochrane reviewers often con-
tact trialists to establish missing details, such as
facts about blinding procedures or random alloca-
tion – and this is then often documented in the
review.
Relevant evidence was not considered from
other related fields. The guideline restricted itself to
studies exclusively on patients with stroke.
Clinically this is unsound as, for many rehabilita-
tion interventions, there is no rational reason to
exclude studies on patients with other diseases that
have the same problem. For example, there is a
solid body of literature in the dementia field, which
has direct relevance to many of the cognitive prob-
lems experienced by patients with a stroke; this
would have been an important area to search for
related research, but was largely ignored.
This inflexible approach is also irrational.
Consider another example: stroke is a major cause
of cognitive loss and dementia, and therefore
excluding studies on treating people with cognitive
losses owing to dementia (which often was proba-
bly related to stroke) is illogical. Second, stroke
itself results in a wide and heterogeneous range of
problems and includes subarachnoid haemorrhage,
which usually leads to a specific different range of
problems. Thus the argument that restricting
searches to people with a disease diagnosis of stroke
when considering treatment of a particular impair-
ment, such as amnesia, is unsound.
The reality is that research into many aspects of
stroke rehabilitation and related fields is extensive
and of high quality. This can be seen in the ICSWP
stroke guidelines published six months earlier than
the NICE guidelines.3 By disregarding or down-
grading the rehabilitation trial evidence and the evi-
dence syntheses from Cochrane systematic reviews,
NICE has not only wasted the funding invested in
conducting this research, but also diluted the
strength of the recommendations that could be
made.
In summary, the approach used to select and to
evaluate the relevant evidence was completely
flawed, ignoring much important and relevant evi-
dence, and using an approach that is designed spe-
cifically for evaluating drugs and other ‘simple’
interventions. This has resulted in much of the
526 Clinical Rehabilitation 28(6)
evidence cited in the guidelines being labelled as low
quality and thus leaves an impression that there is a
lack of evidence concerning stroke rehabilitation.
Our main concern is that if NICE insists on using
this incorrect method of appraising evidence, there
will be serious consequences. The main one is that
clinical staff and commissioners who use NICE
guideline will be using biased, incomplete, and mis-
leading evidence. At the same time, research funded
by the NHS to improve stroke care may be wasted
or researchers may start using inappropriate trial
designs simply to satisfy NICE and any other simi-
lar organisations who follow their example.
Delphi methodology
NICE decided to include the findings of a modified
Delphi consensus survey in order to address ‘areas
with little or no evidence’.2 However, as we have
already pointed out, NICE ignored good evidence in
some of these areas.
The scientific methodology used in the Delphi con-
sensus was in itself questionable, although NICE
describe this as a ‘robust process’.1 Many of the ques-
tions posed were inappropriate (e.g. who is the most
important member of the multi-disciplinary team
(MDT)) and clinically unhelpful (e.g. questions on the
value of organised care – presumably as opposed to
providing haphazard, uncoordinated, and disorganised
care); there were problems both with the topics covered
and in the ambiguous nature of some questions (e.g.
questions on shoulder pain were not explicit as to
whether experts were to consider therapy interventions
only or therapy in combination with analgesic pain
relief); questions about whether patients were ‘mem-
bers’ of the MDT or later ‘involved’ with the MDT (and
is this pedantic terminology actually important?).
Labelling the Delphi ‘modified’ does not exclude it
from usual scientific rigor.
Furthermore, the expert sample used in the Delphi
Consensus survey was not balanced in terms of pro-
fessional background or areas of expertise. The fact
that such a large number of physiotherapists contrib-
uted, in comparison to the small number of psychol-
ogists, meant that there was a real possibility of bias
towards ‘physical’ issues. NICE concluded there
were no systematic differences in physiotherapists’
responses compared with those of other professions.
However, it is unclear how this conclusion was
reached given the very low representation of some
professions for comparison purposes. There was no
information given about the number of nurses who
contributed to this survey. Nurses are crucial to
effective rehabilitation in hospital, but these guide-
lines give the overall impression that the nursing role
in rehabilitation is peripheral.
It was, in any case, fundamentally wrong to include
this Delphi consensus in the guidelines when other
important evidence had been omitted. For example:1
People with disability after stroke should receive
rehabilitation in a dedicated stroke inpatient unit and
subsequently from a specialist stroke team within the
community. [Based on modified Delphi consensus
statements]
There is robust evidence from stroke unit trials6 and
from early supported discharge research7 to support
such a recommendation without needing to cite con-
sensus. Indeed, to suggest that stroke unit efficacy is
based on expert consensus rather than on high-qual-
ity evidence is scientifically incorrect. This is also
true for other statements based on consensus, which
seem to have ignored evidence. There is a paradox
that, on one hand, high-quality rehabilitation trials
and Cochrane systematic reviews were judged poor
quality or not included in the guidelines and, on the
other, a Delphi survey based on a weak design was
used to generate recommendations.
Recommendations – style and
content
The guidelines provide little actual guidance to
stroke rehabilitation teams or to patients and their
carers. Many of the recommendations are too impre-
cise to be helpful. For example:1
Provide occupational therapy for people after stroke
who are likely to benefit, to address difficulties with
personal activities of daily living.
This does not define to whom the treatment should be
given, or by whom. Which patients ‘are likely to
Drummond and Wade 527
benefit’? What ‘difficulties with personal activities
of daily living’: walking, using stairs, continence? Is
occupational therapy only given by occupational
therapists? any occupational therapists? or by any
member of the MDT? Indeed, what is included within
the scope of ‘personal activities of daily living’?
It is usual in guidelines to provide statements
that take the general form of ‘patients with this clin-
ical problem should have this intervention’ – and
then to qualify this further if needed with any
defined considerations. The statement concerning
cognitive functioning is another example of unhelp-
ful ‘guidance’:
Use interventions for memory and cognitive functions
after stroke that focus on the relevant functional tasks,
taking into account the underlying impairment.
Interventions can include…
No clinically useful definition of which patients
should be included is provided and the term ‘mem-
ory and cognitive functions’ in itself makes little
sense as memory is a cognitive skill. Providing
lists of what ‘can’ be used is of little value, as the
purpose of a guideline is to advise on which treat-
ments should be used. Compare this with the
ICSWP3 guidance:
Any patient found to have a memory impairment
causing difficulties in rehabilitation or undertaking
activities should:
– be assessed medically to check that there is not
another treatable cause or contributing factor (e.g.
delirium, hypothyroidism)…
Here the recommendation is clear and the action
needed explicit.
Similarly, the ‘guidance’ on other areas is too
general to be helpful; the use of the word ‘consider’
that appears several times is particularly unhelpful,
for example:
Consider strength training for people with muscle
weakness after stroke.
Consider constraint-induced movement therapy for
people with stroke who have movement of 20 degrees
of wrist extension and 10 degrees of finger extension.
Be aware of potential adverse events (such as falls,
low mood and fatigue).
Does consideration itself lead to benefit (the literal
interpretation of this instruction)?! And being less
literal, if we identify these people, do we give them
this treatment or not? And what actually does ‘be
aware of’ mean? Can we avoid these events? Are
these events acceptable?
A long list of the 120 recommendations is pro-
vided at the beginning of the document.1 However,
it is unclear whether these are all equal or whether
some are more important than others. For example,
should any priority be given to managing people
with swallowing problems (recommendation 60),
over teaching someone how to look after a splint
(recommendation 89)? Is offering early supported
discharge (ESD) (recommendation 8), as important
as encouraging people to participate in physical
exercise (recommendation 81)? In the ICSWP
guidelines,3 a list of key recommendations are
listed, so there is an attempt to identify some recom-
mendations as more weighty than others.
Finally, there is no sense of how the research rec-
ommendations were generated. It is not clear how
the four areas selected were prioritised, although
NICE report these were identified as (i) important to
patients, (ii) a national priority, (iii) having potential
for impact on the NHS, and (iv) ethical/technical
feasibility. It is doubtful, although the four topics
are worthy of further research, that these are the
burning research questions facing stroke rehabilita-
tion clinicians or stroke survivors in the UK today.
Consider the example of electrical stimulation. The
research recommendation is:
What is the clinical and cost effectiveness of electrical
stimulation (ES) as an adjunct to rehabilitation to
improve hand and arm function in people after stroke,
from early rehabilitation through to use in the
community?’
Aside from the facts that (a) this is an ill-conceived
question and (b) there is already much evidence
suggesting little benefit,8,9 how many therapists or
patients want/need to know the answer? There are
many more important questions, such as providing
528 Clinical Rehabilitation 28(6)
treatment ‘late’ after stroke, e.g. after six months,
providing treatment in nursing homes and use of
unqualified staff. NICE seems to have ignored the
top priorities relating to life after stroke, identified
through consultation with patients and carers, by
other groups such as The Stroke Association,10 and
The James Lind Alliance.11
The Stroke Rehabilitation Guidelines are signifi-
cant because of the status afforded by NICE.
Unfortunately this has been a missed opportunity to
improve the delivery of stroke rehabilitation in the
UK and it is unlikely that these guidelines will do
much to promote real improvements into this area.
Conclusions
There are some fundamental lessons to be learnt
from this process, which extend beyond stroke reha-
bilitation. It is vital that these issues are considered
in all future guidelines that concern rehabilitation.
In any new guidance concerning rehabilitation, it
is vital that the review team, and specifically the
systematic reviewers, are familiar with the biopsy-
chosocial model of illness, which is the framework
used in all rehabilitation research,12,13 and that the
review team are all fully aware of the rehabilitation
process,13,14 especially recognising that rehabilita-
tion is not synonymous with therapy.
Given this basis, three major factors must be
considered carefully.
• Scope of the guideline, which must be
comprehensive:
• if resources are limited, selection should be
based on a scientifically sound assessment
of the frequency and importance of the clin-
ical problems and not on personal opinions
of a small number of people.
• Scope of the evidence that will be considered,
which must include all evidence relevant to any
particular question:
• Systematic searching must be adapted to the
specific question and must not be driven by
primary disease diagnosis.
• Evaluation of the evidence, which must recog-
nise that rehabilitation involves:
• complex interventions delivered usually by
people to patients;
• a likelihood of influencing several outcomes
at different levels;
• major problems or actual impossibility in
blinding patients and treating therapists.
We hope that NICE will return to following the
guidance given above, as they have in earlier guid-
ance15 and that when the stroke rehabilitation guide-
lines are revised, these issues will be addressed.
Conflict of interest
The author declares that there is no conflict of interest.
Funding
This research received no specific grant from any funding
agency in the public, commercial, or not-for-profit
sectors.
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