Examination of Witnesses (Questions 580
- 599)
THURSDAY 18 OCTOBER 2007
DR BEVERLEY
HUNE, PROFESSOR
ROGER ATKINS
AND DR
ANITA THOMAS
Q580 Chairman: We are not having
a hearing on VTE as opposed to the issue of NICE, but I understand
what you say. You will be pleased to know that that is now on
the record. Professor Atkins?
Professor Atkins: Sticking to
the critique of the NICE process, the first point to make is that
the guidance was prepared under the heading of cardiothoracic
surgery. I was asked by the president of the British Orthopaedic
Association to take on the lead role for NICE in about September
of last year. The orthopaedic community did not know that a VTE
guidance document involving us was being produced. I scanned the
NICE website at great length and that document did not appear
as a musculoskeletal document. I discovered it only by accident,
and with some surprise, when I deliberately opened it to see what
NICE was recommending for cardiothoracic surgery. In generating
the document NICE gave the role of looking at guideline development
to the National Collaborating Centre for Acute Care. NCCAC barely
had any orthopaedic input and the only person who sat on the NCCAC's
guidance development group was an orthopaedic surgeon with no
specific knowledge of venous thromboprophylaxis. According to
him, he was not asked to comment on thromboprophylaxis in orthopaedic
surgery. When we received the draft document at the turn of 2006
the BOA, specialist societies and the group I chair wrote a 17-page
document of commentary, including the latest evidence, and received
no reply. We emailed the chairman of NCCAC on a number of occasions
and received no reply. When the final document came out in April
we immediately started to approach NICE to say that it had simply
got it wrong. It took until June before we could have a first
meeting. At the beginning of that meeting the impression I gained
from NICE was that it simply did not believe that orthopaedic
surgeons collectively had any interest in this area or that they
could possibly have come up with a scientific critique of its
methodology. Having surmounted that barrier, with the realisation
that we were able to critique its scientific methodology, in which
there were very significant flaws, it took us until October to
have another meeting with NICE to find a way forward to resolve
the issue. It does not seem to have a mechanism to review its
guidance once it has been published to address the very real concerns
of clinicians. That is the critique of its process. Against that
background, we thoroughly agree with most of what is in that document.
Patients should be assessed for VTE. One should do everything
in one's power to stop them getting venous thromboembolism. We
have been doing this for the past half-century. I can go through
the critique of its scientific methodology, but I am not sure
that is what you want to hear because it is highly complex. In
outline that is our critique of NICE's process.
Q581 Dr Taylor: I should like to
concentrate first on the NICE process. Here we have a practising
orthopaedic surgeon, a practising physician and a practising haematologist
all of whom agree that the process is not exactly superb as described
by Professor Devlin in the previous session. Dr Hunt, in your
written evidence you go as far as to say that the way in which
NICE formulates its recommendations can lead to flawed, capricious
decisions. Professor Atkins, you have significant concerns about
the scientific basis. The orthopaedic community was not adequately
consulted, and there does not appear to be a robust mechanism
by which your concerns can be transmitted. It appears that all
of you condemn the lack of expert advice that is provided to NICE.
Is that a fair summary?
Dr Hunt: This is not new. I read
the Health Committee's 2002 report on NICE. I quote: "Medical
consultants have said they find it staggering that treatments
are being appraised by clinicians who have no working understanding
of the clinical areas they are investigating." That really
says it in a nutshell. We have very good clinicians reviewing
evidence, as they are trained to do, but do not understand the
data and nuances of all the different studies, so they will not
be able to weigh up whether this is a good study or that is a
bad study. Therefore, we end up with different results from others
who review data. The American College of Chest Physicians who
produce the gold standard guidelines in the area use 87 international
experts in venous thromboembolism to come up with its guidelines.
Q582 Dr Taylor: You say that the
thrombosis experts in this country are a tight-knit group; they
all know one another. Therefore, you know that none of them was
involved at all?
Dr Hunt: No, they were not.
Dr Thomas: I have not commented
on NICE's process outside what I have said about the problem with
the handling strategy agreed between NICE and the Department of
Health. I do not have any knowledge of the NICE process and have
not been as involved as others.
Professor Atkins: I agree entirely
with Dr Hunt. There are major orthopaedic experts in venous thromboembolism
and they were not involved. Perhaps I may quote your previous
report concerning obstetricians: "An essential element in
the widespread acceptance of these guidelines within the obstetric
community was that they were introduced and supported by obstetricians
themselves." The orthopaedic experts who have dedicated 20
to 30 years of their lives to getting rid of this scourge from
orthopaedic surgery without producing unacceptable complications
were simply not involved.
Q583 Dr Taylor: Therefore, one of
our strongest recommendations to NICE must be that it employs
experts?
Professor Atkins: Yes. The timescale
for this is right this minute. Just three days ago I was sent
a NICE email about the next guideline development group on VTE.
Once again, in its remit it has orthopaedic and trauma in-patients;
it has not put an orthopaedic experts on its guideline development
group. There is nobody there to represent orthopaedic surgery.
Dr Thomas: Just to illustrate,
when I rambled earlier I should have explained one of the issues
I would be concerned about in looking at NICE process. During
the consultation responses the Department of Health said that
it was concerned that NICE did not appear to be taking the opportunity
potentially to save lives. NICE appeared not to hear that. Although
the process of consultation is, I am told, very broad, wide-ranging,
complex and intensive, whether or not the responses are acted
upon or listened to I do not know, but in respect of VTE the Department's
response was not acted upon.
Q584 Dr Taylor: I take you back to
what you said earlier about the change of remit. Can you go through
that again to make sure we absolutely understand it? At the beginning
it was to be just guidelines on high risk patients who were undergoing
orthopaedic and general surgery?
Dr Thomas: Yes.
Q585 Dr Taylor: What has it been
changed to?
Dr Thomas: It has changed to all
in-patients undergoing surgery.
Q586 Dr Taylor: What change does
that make in effect?
Dr Thomas: In effect it includes
the low and intermediate risk groups which were the subject of
an analysis of the convergence of existing evidence in our report.
Q587 Dr Taylor: Dr Hunt, I think
you made the point that your relatively small charity is spending
a lot of money making representations?
Dr Hunt: If one has a group of
people who are not experts producing guidelines one of the considerations
is that one is allowed to consult after the draft stage. At Lifeblood
we spent a huge amount of time going through the guidelines and
pointing out all the faults. I know this was done by a large number
of people. It would be much more sensible to have experts on the
committee in the first place so we do not have to do this large
critique. We are a small charity and we must deal with the whole
of the United Kingdom. Human bodies work the same whether they
are in Northern Ireland, Scotland, England or Wales. Why can we
not have the same guidelines for every region? NICE covers only
England and Wales; SIGN covers Scotland; and Northern Ireland
usually follows the NICE guidelines. Why cannot NICE cover the
whole UK?
Q588 Dr Taylor: How are we to convince
NICE? I think I am right that in talking to us it has said it
does not want experts because it believes that they can be biased.
Dr Hunt: I think it is very concerned
that experts can be tainted because the average expert has dealings
with pharmaceutical companies. It can be argued that one cannot
be expert unless one has dealings with pharmaceutical companies.
One sits on a drug advisory board when they are developing a new
drug and they will be asking for one's opinion about it and presenting
it. One can start to see the flaws in the drug. When one goes
out to do a lecture one can say that a new drug is coming along
and give a balanced view. In a way, there is a necessity to have
some links with the pharmaceutical companies. Clearly, there must
be a personal pecuniary limit on how much money anybody can make
from that type of consultation. Therefore, I suggested in what
I wrote that there should be a limit so people could not earn
more than a certain amount, and they should not have grants from
pharmaceutical companies, if so there is much more danger of bias.
If we allow experts to declare in a conflict of interest statement
where their interests lie it is clear how they might be biased.
Q589 Dr Taylor: Effectively, we have
international guidelines, the expert panel and NICE all saying
rather different things?
Dr Hunt: Yes.
Q590 Dr Taylor: How do practising
clinicians cope with that?
Dr Hunt: When NICE was set up
in 1998 there was a document called A First Class Service
which said that the aim was to produce clear, credible guidelines
and end confusion by providing a single national focus. We are
not doing that at the moment in this particular field. People
are muddling along and are confused. They have too many guidelines
coming at them saying different things and so there is inertia.
The real worry is that we are not getting any thromboprophylaxis.
Dr Thomas: What must be avoided
at all costs is the situation we saw in which the Chief Medical
Officer wrote to all doctors in the UK with guidance and within
a week, because of a last-minute change of title, NICE appeared
to contradict the CMO. Clinicians have always enjoyed an abundance
of guidance. There is a point in time when that is brought together.
My colleague Dr Hunt as a clinical expert has already referred
to her role in the NICE guidelines development group which is
considering all patients. One can just hope to gain some measure
of reassurance from an understanding that NICE will take account
of all current and any other upcoming international guidance as
well as the guidance in the letter of the Chief Medical Officer
and the report of the independent group. Perhaps NICE will get
it right next time.
Professor Atkins: From the orthopaedic
point or view the answer is slightly complex. First, although
the guidelines of the American College of Chest Physicians are
excellent for many things they are incorrect as regards orthopaedic
major surgery. That is the universal opinion. That is not just
the opinion of the British Orthopaedic Association but the opinion
of the Canadian, Australian, South African and New Zealand orthopaedic
associations. All the heads of the European orthopaedic associations
agree that ACCP has it wrong. The reasons for that are quite simple
and, if you wish, I can illustrate them. As a result of that and
with the agreement of the international presidents of the orthopaedic
associations the American Academy of Orthopaedic Surgeons commissioned
a further set of guidelines which were prepared in a robust process
that deliberately included both independent epidemiologists and
orthopaedic VTE experts to produce what I suppose we would all
call a gold standard document that is now available. Reference
to that document will now be made by orthopaedic surgeons because
it has it right. That document's final conclusion is that chemical
prophylaxis does not improve death rates following major orthopaedic
surgery. That is the sum of evidence. I do not want to go into
that any further, but the way forward is the use of the national
joint registries to register each of these major operations and
inquire what the risk of death and complication is and improve
year on year outcomes with respect to death from both VTE and
other problems. I think that is the way forward.
Q591 Dr Taylor: This shows an absolute
failure of NICE. Obviously, there is a disagreement between the
orthopaedic people on one side and the thrombosis experts on the
other, and this is just what NICE should have resolved?
Dr Hunt: I do not think there
is a difference between us. One of the problems with the NICE
process is that one looks only at randomised controlled studies,
as do a lot of the other international guidelines. Professor Atkins
is talking about a data set where a lot of the information does
not come from randomised controlled studies. Orthopaedic surgeons
have access to data that is not in the other guidelines, and it
would be very good if NICE could widen its scope and include that
type of data. It brings me to the other point that it is very
fond of using something called mixed meta-analysis. That is a
technique whereby one lumps together a whole load of studies and
analyses them. One does not have enough patients in each group;
one needs 10,000 and so one puts them together. In the VTE guidelines
it tends to lump together stockings and pneumatic compression—that
is, balloons squeezing legs. A purist would say that that is not
really very good and one should not be lumping them together but
analysing them separately because they are different techniques.
If an expert was on the panel he would say that.
Dr Thomas: The world moves on.
There continue to be advances in our understanding of what is
and what is not effective. Indeed, there are new agents coming
along within months to years which can be taken orally. Again,
the guidance will have to be revisited in the light of developments.
It is important to acknowledge that the target is a moving one.
Professor Atkins: There is no
disagreement amongst us. There are inevitably differences in emphasis.
I am focused totally on orthopaedic surgery and would not dream
of passing a comment on any other area.
Q592 Dr Taylor: We can take it you
are all agreed that risk assessment should be mandatory?
Professor Atkins: Yes.
Dr Thomas: Yes.
Dr Hunt: Yes.
Q593 Dr Taylor: Is there any evidence
that PCTs are trying to force this through, or that anybody seeks
to push it?
Dr Thomas: As part of the Government's
implementation strategy for VTE we are working with exemplar centres,
as I believe Dr Taylor is aware. Through those centres we see
examples of good practice. We do not yet, but hope to soon, have
a commissioning PCT interested in becoming an exemplar centre,
but I cannot say any more at this point because we are in the
early stages of discussion.
Q594 Charlotte Atkins: Dr Hunt, you
spoke about experts possibly having a conflict of interest and
you came up with a formula that might overcome that issue. Do
you think that if instead of having experts on the panel as full
members they acted as expert advisers that would overcome the
problem, or not?
Dr Hunt: It depends on how they
are used and the quality of the chairman. The other issue is:
how does one define an expert? It is a very loose term, is it
not? It needs to have a tool whereby it defines an expert as maybe
someone who has produced more than 20 clinical papers and maybe
has an active research group and is lecturing in that particular
area. Because the NICE process takes probably two and a half years
it is more sensible for the experts to be members of the guidelines
development group rather than maybe just attending one of the
sessions. They can have a more ongoing discussion within the group
about how to analyse the data.
Q595 Charlotte Atkins: For instance,
this Committee has advisers who stay with it for the whole period
of an inquiry and they advise it and give it the value of their
expertise. What I suggest is that to overcome any possible conflict
of interest experts, however they are defined, can simply be professional
advisers to the committee.
Dr Hunt: What you describe is
an excellent idea. I had not thought of it in that way. You have
someone there for most of the process but he or she is not a member
of the committee but sits in. It sounds a very logical way forward.
Q596 Charlotte Atkins: Dr Hunt, you
referred to problems with randomised controlled trials. Do you
believe that NICE has got it completely wrong and it must adopt
a less biased approach to the way it conducts its appraisals?
Dr Hunt: It does not have it completely
wrong. I very much admire NICE and I am part of the process. I
have signed up to the process, but it just needs tweaking round
the edges. It needs to look more widely perhaps at the data out
there. Certainly, for thromboprophylaxis there is quite a lot
of data that is not available from randomised controlled trials
and it is just put to one side in the analysis. Maybe it should
consider looking at it.
Q597 Charlotte Atkins: Professor
Atkins, what is your view?
Professor Atkins: One of the difficulties
of not having orthopaedic surgeons directly on the panel is that
the RCTs are not level one evidence in the sense that what we
are interested in doing is improving our patient outcomes. The
endpoint is: do the patients survive or die? The RCTs look at
a surrogate of a surrogate. The evidence that that surrogate is
applicable in orthopaedic surgery today, as opposed to 25 years
ago, is not there. Therefore, the RCTs may be worthless. One must
have broader and much more informed view of the science out there
and one can get it only by having folk who are truly expert. That
means that not only are they researching the area but doing the
work on the ground. Year on year we change our surgical technique
to improve patient outcome, so data adduced 10 years ago is today
almost worthless.
Q598 Charlotte Atkins: Do you believe
that NICE is not providing the right balance between technology
appraisals, procedure and clinical guidance? Do you think that
it is just not getting it right, or is there some way that they
can make progress?
Professor Atkins: If we broaden
it slightly, in this case NCC delegated to NCCAC the process of
guideline development. My view is that NCCAC's process is badly
flawed and NICE does not appear to have had sufficient oversight
of what NCCAC was doing. If one broadens it out to technology
appraisal, NICE needs more expert advice from the orthopaedic
community. The statistics of orthopaedic surgery are incredibly
arcane. If one looks through the NICE technology appraisals, many
of which are very good, there are some really bad statistical
howlers which it would have got round had it had proper orthopaedic
expert advice. If one puts the orthopaedic experts on the committees
the orthopaedic community will take ownership of the guideline
and implement it. To me, that is why it is essential to have the
experts there. I just do not believe that the business about a
conflict of interest is a real issue.
Q599 Charlotte Atkins: So, they should
be full members of the committee rather than advisers to it?
Professor Atkins: Definitely,
yes.
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