Memorandum by the National Institute for
Health and Clinical Excellence (PS 57)
1.1 Patient safety is important to NICE
and is an integral part of the guidance issued to the NHS. In
addition, at the request of the Department of Health, NICE has
issued guidance on the reduction of risk of transmission of Creutzfeldt-Jakob
disease (CJD) via interventional procedures. Working with the
NPSA, again at the request of the Department of Health, NICE has
issued guidance on strategies to prevent ventilator-acquired pneumonia
and guidance on medicines reconciliation on admission. This Memorandum
provides insight, gained from NICE's experience, into the Health
Select Committee's questions as to what the NHS should do next
regarding patient safety. A number of suggestions for future development
2.1 NICE is responsible for providing national
guidance on the promotion of good health and the prevention and
treatment of ill health, in three areas:
on the use of new and existing medicines, treatments and procedures,
including interventional procedures used in the NHS.
on the appropriate treatment and care of people with specific
diseases and conditions within the NHS.
Public healthguidance on the
promotion of good health and the prevention of ill health for
those working in the NHS, local authorities and the wider public
and voluntary sector.
2.2 The Institute and its remit have grown
rapidly since its establishment in 1999 and it is now the primary
source of clinical standards, based on clinical and cost effectiveness,
in England, Wales and Northern Ireland. The applicability of NICE
guidance in the UK, as a whole, is summarised in Table 1.
Table 1: Applicability of NICE guidance
in the UK
|Country ||Technology appraisals
||Clinical guidelines ||Interventional procedures
||Public health guidance |
| England ||Yes ||Yes
||Yes ||Yes |
|Wales ||Yes ||Yes
||Yes ||No |
||No ||Yes ||No
|N Ireland ||Yes
2.3 Established in April 1999 to set clinical standards
as part of a comprehensive quality framework for the NHS, NICE's
role has since been extended. The public health white paper Choosing
Health, published in November 2004, confirmed the Institute's
new role in providing the NHS and the wider community with guidance
on effective public health practice. NICE merged with the Health
Development Agency in April 2005 and by the end of 2006 systems
to deliver public health interventions and programme guidance
were fully established and beginning to provide guidance in a
wide range of areas, including physical activity, smoking cessation,
sexually transmitted infection and drug misuse.
2.4 Patient safety is important to NICE and is an integral
part of the guidance that it issues. In November 2006, NICE issued
its first patient safety guidance on "patient safety and
reduction of risk of transmission of Creutzfeldt-Jakob disease
(CJD) via interventional procedures".
This guidance was developed following a specific request from
the Chief Medical Officers of England, Scotland, Wales and Northern
2.5 Safety First, a review of the organisational arrangements
for patient safety in the NHS, made a number of recommendations
about the future of patient safety, including the establishment
of a Patient Safety Forum, which includes NICE in its membership.
In February 2007, the Institute co-signed the Patient Safety Charter
alongside the National Patient Safety Agency (NPSA), the Healthcare
Commission and other national bodies to emphasise organisational
commitment to improving patient safety.
2.6 One of the key recommendations of Safety First was
that "a pilot should be established to examine the option
of the National Institute for Health and Clinical Excellence (NICE)
developing technical patient safety solutions". As a result,
NICE and the NPSA were asked to develop and evaluate a pilot project
for the production of a technical solution to address specific
patient safety issues, which would form guidance for the NHS.
They were also asked to take advantage of international experience,
such as that of the WHO World Alliance for Patient Safety, so
that duplication of effort would be minimised.
2.7 The pilot began in April 2007.
Two topics were chosen, evaluating a total of seven potential
patient safety solutions (PSS). NICE and the NPSA issued joint
safety guidance to the NHS on three potential solutions for errors
in medicines reconciliation on admission of adults to hospital
in December 2007; and on four potential solutions for the prevention
of ventilator-associated pneumonia in adults in August 2008.The
evaluation was completed in February 2008.
2.8 NICE's Citizens' Council, a representative group
of 30 members of the general public, considered patient safety
issues in June 2007. Its findings are presented in Section 5 and
the full report can be found in on our website.
3. THE NICE/NPSA PATIENT
3.1 For the purposes of the pilot study, a technical
PSS was defined as "a cost-effective intervention to prevent
or mitigate patient harm stemming from processes of healthcare
based on the best available evidence". The terminology is
derived from the WHO's definition of a safety solution as "any
system design or intervention that has demonstrated the ability
to prevent or mitigate patient harm stemming from the processes
3.2 Patient safety solutions can vary greatly in their
complexity, function and application and can assist with patient
monitoring, treatment management and service delivery. However,
safety solutions may introduce new risks and increase existing
risks as well as eliminating and reducing other risks.
3.3 The WHO Collaborating Centre for Patient Safety Solutions
states that the basic purpose of the solutions is to guide the
re-design of care processes to prevent inevitable human errors
from actually reaching patients.
An individual solution will present the problem, the strength
of evidence supporting the solution, potential barriers to adoption,
risks of unintended consequences created by the solution, patient
and family roles in the solution, and references and other resources.
Solutions need to be practical, deliverable, and minimise risk
without themselves introducing risk, and they need to take into
account the mobility of the workforce.
3.4 The pilot's methodology and process were designed
to meet the Institute's core principles of guidance development:
a comprehensive evidence base; independent advisory committees;
clinical and patient expert input; transparent process and decision
making; genuine consultation; effective dissemination and implementation;
and regular review.
3.5 For each of the pilot topics, the Institute applied
its methods of assessing clinical and cost-effectiveness within
a project-specific frame work.
The methodology chosen was intended to complement the existing
Root Cause Analysis and Risk Assessment methodology used by the
NPSA. Elements of existing processes were used, with shortened
intervals to ensure that the guidance could be produced within
a six months timeframe.
4. WHAT THE
NHS SHOULD DO
4.1 A flexible system is required
4.1.1 Patient safety comprises a range of errors and
system failures associated with the delivery of patient care.
This can include situations such as mistakes and delays in diagnosis,
medication and treatment errors, problems with equipment, infections
acquired in hospitals and accidents such as slips and falls. Each
event is unique although there may be similarities in the patterns
and sources of risk. As a consequence, there are a range of potential
PSS types and complexities.
4.1.2 We believe that mechanisms for evaluating potential
PSS need to be adaptable enough to examine each different type
using the most appropriate method and process. In some circumstances,
for example the prevention of ventilator-associated pneumonia,
a guideline approach might be most appropriate. This would allow
a large number of PSS to be evaluated simultaneously and permit
consensus-based methodology to supplement health technology assessment
(HTA) methodology to enable recommendations about entire pathways
of care, even in the absence of robust evidence. In other circumstances,
a focused intervention-based approach would be more appropriate,
for example directly comparing kinetic beds with manual rotation
of the patient in order to prevent ventilator-associated pneumonia.
4.2 Determination of best practice
4.2.1 The NHS is potentially a rich source of information
on measures to improve patient safety. However, many locally developed
measures may never be published and the literature is therefore
unlikely to reflect current NHS practice. We suggest that for
each patient safety issue a survey of current practice could identify
potential solutions and inform the development of new solutions.
4.2.2 In addition to potential PSS identified through
incident reporting, there are a number of PSS that have already
been developed, including those launched by the WHO patient safety
solution initiative. The possibility of adapting existing PSS
has been raised, and we suggest that an approach similar to ADAPTE,
which has been developed for guidelines, could be developed. Further
methodological exploration is required.
4.3 Evidence base for measures to improve patient safety
4.3.1 A key finding from NICE's pilot was that the published
evidence base for most of the seven PSS examined was extremely
poor. The paucity of the evidence base is related to both the
quality and quantity of the research that had been undertaken.
Much of the research that had been undertaken used non-randomised
controlled trial (RCT) methodology that is inherently at greater
risk of bias and requires appropriate critical appraisal and interpretation.
It is likely that much research undertaken by the NHS is never
published. Further development of the infrastructure is required
to raise awareness about methodology and also encourage research
to be undertaken and disseminated.
4.3.2 It was also extremely difficult to identify the
relevant literature. It is unclear whether patient safety research
is adequately represented in the medical literature databases
that are commonly searched. For example Medline and Embase. In
addition, it is unclear to what extent existing MESH
headings adequately catalogue patient safety issues. If the studies
are not catalogued properly then they cannot be identified.
4.3.3 The grey literature (conference proceedings, research
reports and theses) could be another potentially rich source of
evidence. However there has been no research to investigate the
extent to which patient safety issues are addressed in the grey
literature. The validity of such grey literature will however
need to be rigorously evaluated because it has not been through
the publication process, which affords a degree of quality assurance.
4.3.4 We therefore recommend further exploration of methods
to overcome the inadequacies in the evidence-base summarised in
this section and including, for example, formal consensus methodology
4.4 Involving patients and the public
4.4.1 One of NICE's core principles of guidance development
is that a genuine consultation is undertaken. In order to ensure
this a common process has been developed that identifies the relevant
stakeholders. The stakeholders are then asked for their views
on the question being asked, the evaluation exercise being undertaken,
and the proposed guidance.
4.4.2 NICE's experience was that it was difficult to
engage with stakeholders during the pilot projects. The relevant
stakeholder group differs slightly from those that are used to
working with NICE and there was therefore a lack of awareness
about the Institute and its guidance.
4.4.3 In particular it is crucial that patients and groups
representing patients are fully engaged, as they hold vital perspectives
on the patient safety issues and can therefore have a key role
in being part of the solution. NICE routinely consults with a
wide range of patient experts, primarily through patient-support
groups and umbrella organisations that are condition-specific.
We suggest, however, that a different approach is required when
identifying individuals who have had first-hand experience of
the patient safety issue.
4.5 What should be measured and assessed?the role
of clinical and cost-effectiveness
4.5.1 The existing Technology Appraisals-based methodology
that was used in the pilot is well suited to assessment of the
clinical and cost-effectiveness of existing PSS that are underpinned
by an evidence base. The methodology is however not suitable for
the development of new solutions to address a patient safety issue.
4.5.2 For each patient safety issue there are likely
to be a number of potential solutions. Careful consideration needs
to be given to whether alternative PSS are directly compared or
considered in isolation. In addition to the issues with the evidence-base
already identified, it is unlikely that direct comparisons of
PSS will have been undertaken.
4.5.3 As highlighted in the pilot the cost-effectiveness
of PSS can be evaluated. However, in many circumstances there
will be a lack of appropriate evidence, which is likely to increase
the uncertainty surrounding the results. For PSS that require
service reconfiguration the evaluations are likely to be complex.
It is unlikely that stakeholders will develop alternative economic
models for evaluation due to lack of ownership of many PSS. In
addition, formal modelling may not be needed in some circumstances.
4.5.4 Current cost effectiveness evaluation methodology
could be used to explore the cost effectiveness of PSS in general,
but such evaluations are likely to be complex. Furthermore there
is likely to be considerable uncertainty surrounding the results
due to the lack of appropriate evidence. This is particularly
the case for PSS systems involving multiple parameters and service
reconfiguration. In some circumstances it will be evident that
other considerations would become paramount, for example availability
of relevant human expertise. A decision whether to appraise cost-effectiveness
would need to be made on a case by case basis.
4.5.5 Establishing cost-effectiveness using cost-utility
methodology would allow interventions for patient safety to be
evaluated on the same basis as other health technologies. For
PSS that cover a range of diseases or the complete management
of a condition, multiple models would be required to determine
cost-effectiveness. There has to be sufficient flexibility in
the system to accommodate this range. There has been very little
research into applying HTA methodology to patient safety issues.
We suggest that further methodological development is required
including a review of the existing literature.
4.6 What data should be published?Cost of implementation
of patient safety solutions
4.6.1 To assist the NHS with financial planning NICE
develops costing tools to help organizations estimate the costs
and savings associated with implementing our guidance.
4.6.2 Estimating the national cost or saving associated
with implementation can be challenging and subject to a degree
of uncertainty, particularly if limited data are available and
significant variation in current practice exists across service
4.6.3 In the pilot project, the lack of good quality
national data concerning baseline practice for medicines reconciliation
on admission to hospital was overcome by collecting a random sample
and extrapolating the results to estimate wider practice. This
pragmatic solution allows an estimate to be made where no published
data are available.
4.6.4 At a local level direct cost of provision of some
PSS should be easier to estimate, depending on information being
available on local circumstances. Estimating costs such as staff
training and potential changes to number and grade of staff are
relatively straight forward; estimating the effect of consequences,
such as bed days avoided through safer practices preventing adverse
events, is subject to greater uncertainty.
5. CITIZENS COUNCIL
5.1 NICE's Citizens Council brings the views of the public
to NICE decision-making about guidance on the promotion of good
health and the prevention and treatment of ill health. A group
of 30 people drawn from all walks of life, the Citizens Council
tackles challenging questions about valuessuch as fairness
and need. The Citizens Council met from June 7- 9 2007 at the
NICE headquarters in London. The Citizens Council was asked to
consider the following questions
Does the Citizens Council accept that it is appropriate
when developing "patient safety solutions" that NICE
takes the costs, as well as the benefits, into account?
If the answer to question 1 is "yes,"
what principles of cost- effectiveness should apply?
If the answer to question 1 is "no,"
what criteria should NICE apply in deciding whether or not it
should recommend a particular safety solution to the NHS?
5.2 At the three-day meeting the Council heard evidence
on the extent of medical error in the NHS, on the case for and
against taking cost-effectiveness into account when designing
new measures, and how this could be done in practice. The Council
heard from patients' representatives, doctors, nurses, health
managers and economists. Three case studies were also considered
in which risk reduction was needed or had been attempted, and
the Council performed exercises intended to place them in the
position of those whose task it is to make and justify decisions
on what should be done. The Council questioned the experts and
discussed the issues among themselves, collectively and in small
sub-groups. To monitor changes in the responses to NICE's basic
questions, tracking questionnaires were completed by Council members
at the beginning and end of the meeting, and twice during its
5.3 After three days of presentations from experts and
debate, the Citizens Council concluded that it was appropriate
for NICE to take costs as well as benefits into account when developing
guidelines on the improvement of safety.
5.4 The Council highlighted the fact that the economic
methodology used by NICE in its other guidance programmes might
not lend itself well to making decisions on cost-effectiveness
in the area of patient safety. In particular, the fact that the
perspective used by NICE does not include certain costs including
litigation, cost to carers and those left behind following a death.
5.5 The Council also pointed out some of the methodological
weaknesses of the outcome measure used by NICE- the quality-adjusted
life year (QALY). Given however that the QALY continues to be
widely used in work of this kind and that currently there is no
other adequate cost-effectiveness tool, the majority of the Council
felt it would not be helpful to NICE simply to dismiss QALYs out
5.6 So, with this absence of a suitable alternative,
the Council suggested that if NICE is to use QALYs in assessing
safety solutions, it should do so with a degree of flexibility
greater than is normally the case when setting limits (the threshold)
on how much the NHS should pay for each additional QALY equivalent
gained as a result of an intervention. The Council recognised
that departing from a single standard limit could create problems
of its ownnot least in consistency, However it also noted
that NICE does on occasion move outside its own self-imposed limits
when particular circumstances seem to justify such action.
5.7 With respect to the circumstances that might be relevant
when making decisions on the cost of equipment or practices intended
to avoid error, the Council envisaged a sliding threshold limit.
Factors that might contribute to the case for moving a threshold
the severity to an individual of any likely injury
or harm resulting from the error;
the wider cost to society of coping with the aftermath
of the errorcost to those left caring or bereaved, cost
the extent to which the error is unique to the
medical environment (falls can happen anywhere; only in operating
theatres do people have the wrong kidney removed); and
the possibility that failure to address the safety
issue in question could have a severely damaging effect on public
confidence in the NHS.
5.8 We suggest that further consideration of economic methodology
in the assessment of PSS should take account of the issues raised
by NICE's Citizens Council.
With advice on implementation in Scotland from NHS Quality Improvement
In Northern Ireland, from the DHSSPNI. Back
Department of Health. Safety First: a report for patients, clinicians
and healthcare managers. London 2006. Back
and http://www.nice.org.uk/media/DCC/95/EvaluationOfPatientSafetyPilotResultsOfStakeholderSurvey.pdf Back
Medical Subject Headings (MESH) are a standardised set of subject
terms and an associated thesaurus that is used to catalogue medical
research. It is maintained by the United States National Library
of Medicine. Back