As we go to press, the
count on NICE technology appraisals reaches the high seventies and the
guidelines explosion has begun. Over 20 clinical practice guidelines have now
been published, 20 more will be produced over the next 12 months and there are
also about another 40 other guidelines in simultaneous development. NICE says
that this is the 'largest guideline development programme of any healthcare
system in the world'. It is not surprising therefore that the output of NICE
this year is expected to be almost double that of 2003! But this mountain of
guidance will surely place a huge and significant burden on the
NHS.....
When NICE was set up way back in 1999, Chairman Prof. Sir Mike
Rawlins said that NICE was not in the implementation business and it was not
seen as part of NICE's role. Nevertheless, the Institute clearly has had a deep
interest in the implementation of its guidance. So it was of great interest
then that a significant theme of last December's annual NICE conference was
this key issue around implementation. NICE currently has no 'formal'
responsibility for this area but as evidence builds of lack of wholesale
implementation, watch out this year as NICE appears set to get more
involved.....
Certainly 2004 will mark a year of renewed focus on the
implementation of NICE guidance and the Institute is now working closely with
both Government and the NHS in order to identify best practice in
implementation. The Institute reported back at the January Board meeting on the
findings from its consultative workshops on implementing guidance that took
place last November and the Institute is now developing a new implementation
strategy, due out mid-April. This is likely to focus on a 'whole systems'
approach locally. NICE will also take on board the findings from Prof. Trevor
Sheldon's study (University of York) on the impact of NICE guidance. This
two-year study looked at patterns and trends using a number of 'tracer' pieces
of guidance for prescribing across both secondary and primary care.
At
the NICE conference, Prof. Rawlins was clear as to the ways by which
implementation could be made more successful. He said that the topics for
appraisal and guidelines must be relevant to clinical practice; that the
processes involved in developing NICE guidance should be robust and command
broad confidence; that the guidance must be clear and unambiguous; that the
guidance must be implementable and that it must be appropriately disseminated
to those who need it and in a manner which is accessible at the time they need
it. On topic selection, he was not sure that this was optimal as yet and that
NICE had not really managed to engage the wider NHS in proposing topics nor had
the NHS been forthcoming in suggesting topics for disinvestment.... On clarity,
he said that this was an 'awkward' area in that on the one hand guidance must
be comprehensive and yet on the other hand it must be accessible during the
hurly-burly of surgeries, clinics and ward rounds. Probably, he said, they had
so far erred on the side of comprehensiveness so new simpler formats are now
being produced. On 'implementability', he said that this very much depended on
the availability of appropriate financial and human resources, as well as the
necessary infrastructure. And on dissemination, NICE is to change the way it
disseminates guidance to meet the needs of each key audience. Said Prof.
Rawlins, "Only if our guidance is implemented - and makes a real difference to
patients - can we really claim to be successful. We will be doing everything we
can to support the NHS in this key task, by producing answers that matter, in
concise and accessible formats with practical advice on impact and
implementation". He also said that NICE needs to know why its guidance might
not be being adopted into routine clinical care as well as whether the uptake
of its guidance was having any real effect on health....
And closing
the NICE Conference, Lord Warner, Parliamentary Under Secretary of State for
Health, and the minister responsible for NICE, had a lot to say about
implementation. He said, "We now need to examine how effective we have been at
implementing NICE guidance. For instance, have we been realistic about the
speed at which NICE guidance can be implemented? Have we got the processes
right whereby the NHS receives 'implementation-ready' guidance from NICE? Do we
understand enough about what health bodies and clinicians do with the guidance
when it arrives at the local level? How clear are the accountabilities for
ensuring that action is taken on NICE guidance. Where does NICE guidance fit
into national standards for the NHS to be produced under the Health and Social
Care Act?" Lord Warner was also clearly concerned that the three-year funding
notification wasn't working re the PCT planning and budgeting process,
suggesting that some PCTs were not allocating enough local budgets for NICE
implementation.
So what is the government planing to do? Well note
particularly the following from Lord Warner: "We see a key role for the
Commission for Healthcare Audit and Inspection to monitor the implementation of
NICE guidance during the course of its reviews of NHS bodies and as part of
seeing how bodies are meeting national standards. The Health and Social Care
Act 2003 places CHAI under a duty to take the statement of standards, to be
published in the New Year, into account when exercising its review and
investigation functions...I am confident that CHAI will want to concern itself
with the uptake and implementation of NICE guidance.....Ultimately this
performance review process will reveal the places where NICE implementation is
slow, with all the consequences that flow from falling below national
standards.".... Well that seems pretty clear then - it is now up to Professor
Sir Ian Kennedy, CHAI Chair, to fix it...... More teeth are-obviously-a-coming
and non-implementation seems set to become an individual P45 performance
indicator for Chief Executives and a loosing stars indicator for organisations.
Watch out too as the Modernisation Agency gets more involved with stuff around
'compliance with evidence-based protocols.'....
Please note that CHIA
will be for England only (unlike CHI) and that Wales will now have its own
Healthcare Inspectorate and a Health Care Standards Board. And note too that in
Scotland the Scottish Medicines Consortium's advice is to be made binding and
that NHS Quality Improvement Scotland (NHSQIS) is set to 'absorb' SIGN this
year....
So implementation has now finally been recognised as a key key
challenge for both NICE and the NHS. Do please note then you avid 'NICE
watchers' out there, all the documents due out shortly around implementation.
But really there is nothing new here in all of this - the 'Hill of Resistance'
model as regards the implementation of evidence-based medicine was produced by
the DoH at least a decade ago. This is outlined in the accompanying diagram. As
one can see, the barriers recognised at that time, as regards the uptake and
the implementation of EBM, remain much the same as for the implementation of
evidence based NICE guidance now!...
And finally, Lord Warner also said
at the NICE conference, "In addition to the various pieces of work described,
we also need to play into the discussion information on uptake from
pharmaceutical companies...."..... Now this is an interesting one and a
recognition perhaps at last that the Industry has some of the best data around
on medicines uptake. I do wish that NICE would also think about 'formally'
allowing companies to promote its guidance... Maybe Sir Ian can fix that
too?.....
Article first pulished in PharmaTimes March 2004
