National Institute for Health and Clinical Excellence - Health Committee Contents


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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