Evidence submitted by the Improving Surgical
Outcomes Group (ISOG) (NICE 75)
1. INTRODUCTION
1.1 The ISOG is an independent medical group
comprising surgeons, anaesthetists, critical care consultants
and others involved in operative management and care. The group
is concerned with improving patient outcomes and modernising care
for patients undergoing major surgery. [86]
2. EXECUTIVE
SUMMARY
2.1 Overwhelming scientific evidence shows
that haemodynamic optimisation (maximising the flow of blood from
the heart) of patients undergoing moderate and major risk surgery
reduces the number and severity of post-operative complications.
As a consequence, as patients feel better and need less post-operative
care, they can be discharged sooner.
2.2 The clinical benefit therefore translates
into economic benefit as the cost of the patient's hospital stay
is reduced. In 2004 it was shown that the benefits shown in the
clinical studies, of better patient outcomes at less cost, could
be delivered in the NHS at Trust level.
2.3 In February 2005, NICE decided that
they did not believe that this procedure falls within its remit
and stated that this was because oesophageal Doppler monitoring
is considered standard clinical practice with risks and benefits
that are sufficiently well-known.
2.4 Despite the fact that NICE decided that
oesophageal Doppler monitoring was considered to be "standard
clinical practice" the reality is that two years later, up
to 90% of all NHS patients are still being denied the monitoring
system.
2.5 Despite the fact that NICE made this
decision two years ago, there has been no widespread implementation
of haemodynamic optimisation in the NHS and as a consequence,
ISOG has had to produce an implementation document to drive this
treatment forward. The reasons why the NHS has been slow to implement
the treatment is multi-factoral but the main reason has clearly
been lack of funding.
2.6 This submission will examine only the
term of reference concerning the consequences of the NICE decision
that oesophageal Doppler monitoring constitutes "standard
clinical practice".
3. TERM OF
REFERENCE: THE
IMPLEMENTATION OF
NICE GUIDANCE
3.1 ISOG welcomes the confirmation by NICE
that improving patients' post-operative prospects with haemodynamic
monitoring during surgery should indeed be standard practice for
patients undergoing surgery but we bitterly regret that this just
isn't being implemented in many UK hospitals at the moment. NICE
may think this is a standard practice but the figures show that
this is in actual fact far from the case.
3.2 Over 90% of patients undergoing surgery
are not benefiting from a technology that is totally in line with
Department of Health policy to implement the modernisation of
care and improve surgical outcomes for patients. The NHS Confederation
has also been urging Trusts to make the new NHS a reality by using
new practices and technologies that can save lives, time and money.
3.3 Oesophageal Doppler monitoring involves
the measurement of blood flow velocity in the descending thoracic
aorta using a flexible ultrasound probe.
3.4 The economic benefits of the introduction
and use of haemodynamic optimisation are enormous and arise because
the technique not only saves lives but also saves money. Government
initiatives like "spend to save" however, need to be
more proactive to allow the faster introduction of procedures,
approved by NICE, that are proven to benefit patients and save
money for the NHS.
3.5 The clinical studies suggest typical
reductions in length of stay for haemodynamically optimised moderate
and major risk surgical patients of around four days and audits
of the real world impact have reported reductions of up to three
days per patient. Even if these reductions were only in the lowest
cost wards in UK hospitals at around £200 per day, this saving
still equates to £600 to £800 per patient. It costs
£50 to £60 to optimise each patient.
3.6 Based on the body of clinical evidence
which has accumulated, mostly from UK hospitals, over the last
10 years, there are about 1,000,000 NHS patients a year who would
derive a clear clinical benefit from haemodynamic optimisation.
If lengths of hospital stay for these patients were only reduced
by two days each, the UK NHS would free up nearly 5,500 beds—the
equivalent of 11 hospitals of 500 beds each. The saving would
be, at the lowest estimate, £350 million a year rising to
over £1 billion. This would represent a magnitude of cost-saving
that could allow huge reductions in the deficit of an average
NHS Trust
3.7 The resources freed up by haemodynamic
optimisation would be redeployed to enable the other two step
ISOG recommendations at minimal additional cost.
3.8 The benefits of haemodynamic optimisation
are now well accepted by the majority of UK anaesthetists and
those involved in intensive care. However, we estimate that no
more than 40,000 NHS patients were monitored with appropriate
equipment to allow doctors to haemodynamically optimise them in
2004.
3.9 At the rates of technology adoption
typical in the NHS it will be many years until the remaining 960,000
patients receive the treatment evidence based medicine and basic
economic sense demand they receive today. As a result, thousands
of patients will continue to die unnecessarily each year, many
more will carry on suffering the pain and misery of avoidable
post-surgical complications and NHS hospitals will continue to
spend hundreds of millions of pounds treating compromised patients
who need not have been so ill in the first place.
3.10 Examples demonstrating better use of
surgical/anaesthetic resources include improving surgical outcomes
by intra-operative haemodynamic optimisation and other techniques.
3.11 These interventions reduce both the
number and severity of post-operative complications.
3.12 A study conducted at York District
Hospital on the use of improved intraoperative care involving
haemodynamic optimisation and other interventions, combined with
the planned transfer of patients to ICU, resulted in a reduction
of the mortality rate to 3% compared with 18% in the control group.
3.13 The study also demonstrated a reduction
in the patients' length of hospital stay—in terms of total
bed days as well as ICU bed days—without increasing costs.
3.14 A Department of Health funded study
at Worthing Hospital assessing "goal directed" fluid
administration during bowel surgery (using oesophageal Doppler
probes) showed a significant reduction in post-operative morbidity,
faster return of gut motility and shorter length of stay.
3.15 Recent work from St Georges Hospital
using goal directed fluid therapy in high risk surgical patients
in intensive care after surgery reduced post-operative infections
by 50% and cut length of stay by almost 40%.
3.16 Improvements in pre-operative assessment
and preparation, peri-operative care and post-operative support
have provided an important reduction in the mortality rate as
well as decreasing the number and severity of complications suffered
by patients following surgery, which has in turn provided savings
in terms of ICU/HDU bed days per patient.
3.17 In addition to reducing the mortality
rate, the study conducted at York demonstrated that haemodynamic
optimisation reduced the number of ICU or HDU bed days used by
40% compared with routine care (median 3.3 days vs 5.5 days),
and total bed days per patient were reduced by 41% (median 13
days vs 22 days).
3.18 The capital and running costs for providing
improved pre-operative, peri-operative and post-operative support
are marginal in comparison with the potential savings.
3.19 Pre-operative surgical risk assessment
of patients undergoing major surgery can be measured by use of
Cardio-pulmonary exercise testing (CPX), which is cheaper and
more effective at predicting individualised pre-operative risk
than many of the tests that are currently conducted to assess
surgical risk (such as resting echocardiography) which are poor
at predicting actual risk.
3.20 Consistent implementation across the
NHS of existing treatments known to be effective at preventing
post-operative complications (such as measures to prevent the
formation of deep vein thrombosis) would also reduce unnecessary
post-operative morbidity. Evidence on this particular issue has
recently been given to the Health Select Committee.
3.21 For haemodynamic optimisation, the
potential savings in terms of reduced hospital stays have been
estimated for an average NHS trust to be in the order of over
£2 million, based on reduction in stays of 22-31% and taking
into account capital outlay of £60,000 and running costs
of £150,000.
3.22 Overall, the package of improvements
described would be cost effective. In addition, the introduction
and use of haemodynamic optimisation into the NHS could realise
savings for the NHS in the region of £1 billion which would
have an enormous impact on the current and potential deficits
in the NHS.
3.23. Due to the delay in implementing haemodynamic
optimisation within the NHS, ISOG had now produced a second document
intended to assist Trusts with its introduction. Lack of funding
is clearly a major issue for some Trusts and this is severely
hampering a technology that will substantially help patients and
ultimately save Trusts money.
3.24 NICE has an important role to play
in the introduction of such technologies and it is regrettable
that despite a positive outcome from NICE, no real advance has
been made in the last two years to introduce this technology into
the NHS, despite enormous support from the medical profession.
Simple, straightforward steps can be taken to allow this to happen
which will benefit patients, Trusts and the NHS.
3.25 The ISOG would be prepared to offer
oral evidence if requested to do so by the Committee.
4. RECOMMENDATION
4.1 Government initiatives like "spend
to save" need to be more proactive to allow the faster introduction
of procedures that are proven to save money for the NHS.
4.2 A better system of disseminating information
to Trusts is essential to make sure that all stakeholders are
aware of NICE Guidance.
4.3 A streamlined system is needed to help
facilitate the introduction of NICE appraised devices into the
NHS.
4.4 The Government should consider mechanisms
whereby the Interventional Procedures arm of NICE can attract
compulsory funding in the same way as drugs positively appraised
under NICE's Technology Appraisals arm.
Improving Social Outcomes Group
March 2007
86 The members of the group responsible for this submission
are as follows: Professor Monty Mythen; Portex Professor of Anaesthesia
and Critical Care, University College London; Head of The Portex
Anaesthesia, Intensive Care and Respiratory Unit, Institute of
Child Health, UCL; and Council Member of the Intensive Care Society
of Great Britain & Ireland; Professor David Bennett; Professor
of Intensive Care Medicine, St George's Hospital, London; Mr Eddie
Chaloner; Consultant Vascular Surgeon: University Hospital, Lewisham. Back
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