TUESDAY 3RD DECEMBER 2002

DR DAVID BROWN, PROFESSOR PAUL GRIFFITHS, DR DEENAN PILLAY AND DR MARIA ZAMBON

  179. Good morning, lady and gentlemen, I am sorry to keep you waiting for a few minutes. I am very pleased that you have come along to talk about virology as part of our inquiry. First of all I would like to ask you to introduce yourselves and then, secondly, if you have any opening statement to make now is the time to make it, before we got on to the questions. If you would like to start introducing yourselves, with a brief CV, shall we say?

  (Dr Zambon) Dr Maria Zambon, virologist, head of the National Influenza Laboratory and Deputy Director of the Enteric, Respiratory and Neurological Virus Laboratory at the Public Health Laboratory Service at Colindale.
  (Dr Pillay) I am Dr Deenan Pillay, also a clinical virologist in Birmingham. I am Head of the PHLS antiviral susceptibility reference unit.
  (Dr Brown) My name is David Brown, I am a clinical virologist and for the last 15 years I have run the Enteric, Respiratory and Neurological Virus Reference Laboratory through which we deliver national reference services for a range of virus infections.
  (Professor Griffiths) I am Paul Griffiths, I am Professor of Virology at the Royal Free and University College Medical School, but I am here today as Chief Executive of the Clinical Virology Network.

  180. Are there any brief comments that any of you would wish to make? Let us move on to the questions. I will start off with the first one on how the training and day-to-day work of clinical virologists differs from that of clinical microbiologists and clinical infectious disease physicians?
  (Professor Griffiths) Obviously, the patients present with possible infectious diseases to our clinical colleagues, who may be in infectious diseases. Infectious disease consultants are a major source of the material that we process in the laboratory. They are not, of course, the only source. For example, transplant patients have big problems with virus infections, and so many of those samples come directly from the physicians who care for those patients. We then have microbiologists and virologists who are laboratory trained, who do not directly see those individual patients themselves but provide laboratory services to support the work of the clinical colleagues, working out the differential diagnoses and advising on treatments, for example. Without getting too technical, you are asking the difference between microbiologists and virologists. For many years virologists and microbiologists were able to grow their infectious agents within the lab, and so were able to provide quite a rapid service to clinicians. They, therefore, have provided the phenotype of the organism they can see. In virology it was not possible to do that, really, and it was only when we got through to molecular assays that we were able to amplify the virus and we can now provide routine, daily diagnostic services to clinicians—not just detecting virus but, also, quantifying virus; telling them about distinct strains that may be present, for example, some that are resistant to antibiotic chemotherapy, some that require different courses of therapy, as in Hepatitis C. Many of those assays require people to have worked them up in their own laboratories, so-called in-house assays rather than commercial assays. So with that difference it leads into the training of the two different groups. If you are a virologist you have to spend a lot of time learning how to make assays and how assays can give you the wrong results, because quality control and quality assurance of the assays is actually very important. You cannot see viruses directly, you have to infer their presence by the signal you get from one of these assays. In microbiology a lot of it is looking at the phenotype of a particular bacterial infection, but they have rather different techniques in the lab. There is some overlap and some sharing of techniques but, in general (I am not sure what my colleagues might think) that is the polar position between the microbiologist and the virologist. Some of the shared areas, for example, some of the routine tests which are done for ante-natal patients could be done by either microbiologists or by virologists, and in different parts of the country you will see different solutions to providing those services. The reason for that is that the assays are well-established, they are available commercially with good quality control, there is a national external quality assurance scheme that can validate the use of those assays and anybody can be trained to do those. We are talking about the cutting edge of virology here—the molecular type techniques.
  (Dr Pillay) Just to add some issues to what Professor Griffiths has mentioned. Because it has been difficult hitherto to grow some viruses, I think virology has represented the cutting edge of new developments in laboratory medicine by predominantly molecular methods. So it has led to a separation, really, between microbiologists and virologists in terms of the degree to which virologists will cooperate very closely to develop these new methods which Paul has already mentioned, and link them to clinical outcomes. In the context of antiviral therapies that have now become available, they play a much more important role in, I think, active clinical management where, previously, virology represented more retrospective diagnostics. So I think those are two areas which also separate, to some extent, virology (in terms of the ethos of the subject) and clinical microbiology.

1. From what you say, the number of diagnostic labs that can actually grow viruses is few in number and they would be more central than regional. Would that be a fair computation?
     (Dr Pillay) I do not think that is necessarily true, and clearly there are a number of viruses that can be grown: for instance respiratory viruses and enteroviruses. However, I think even for those infections there is an increased application of molecular assays to those viruses which involve monitoring treatment, and determining whether the treatment is going to be effective.
     (Dr Zambon) A few further points. It should be noted that the training of virologists is specialised compared with clinical microbiologists, with a relatively short period in common. Secondly, there are rather fewer clinical virologists—substantially fewer—than clinical microbiologists, and the consequence of that is that they are usually, but not exclusively, employed in academic centres and usually have quite a strong academic background. The consequence of that is, further, that virologists are usually also required to have quite an input into research and training, both research as the development of clinical diagnostics but, also, research into the delivery of antivirals, the appreciation of outcome measurements and training not only of their fellow clinicians but, also, laboratory staff. So, for me, the analogy between microbiologists and virologists is, in a way, the analogy between general surgeons and vascular surgeons; you have some areas in common but you also have some areas where they are specialised.
     (Dr Brown) I was going to follow up on Dr Pillay's point, which is that molecular diagnostics have been used very much for individual patient management and I think will replace tissue culture nationally for that, but we do have a need to isolate virus for public health purposes. If one thinks of the influenza vaccine, for example, we need to make isolates of the virus which will not be provided through routine diagnostic services. There is sometimes a distinction between a public health need and what is provided through clinical diagnostic services.

  182. Can I tease out these comments that you made about training and, also, on diagnostic services? How does this compartmentalising of both training and diagnostic services from clinical services (and you did not comment, I see, on the training of microbiologists and virologists as opposed to infectious disease physicians) help in surveillance, the delivery of patient care in a co-ordinated way and, also, and much more importantly, the surveillance of infectious diseases? Why is this model better that you describe?
  (Professor Griffiths) I am not sure any of us said it was better. I think we answered the question "What is it like?". The surveillance of virus infections could be dramatically improved.

  183. By changing this model?
  (Professor Griffiths) You need to start from the position of the way things are now and try to look forward and say how would you like them to evolve in the future. We would very much like to meet many of the things that are in the report Getting Ahead of the Curve. For example, having standard operating procedures throughout the UK; having standard ways of coming to a diagnosis that differentiated between diseases. To take Hepatitis B as an example, if you ask at the moment "Can you tell us how many carriers of Hepatitis B there are in the country and can you differentiate from acute cases of Hepatitis?" I think the answer is no. That is unfortunate, from the point of view of justifying the deployment of Hepatitis vaccine, for example. Things could be greatly improved. We are not saying to you "This is the ideal situation".
  (Dr Zambon) I think it might also be fair to say that surveillance of viral diseases does not only depend on clinical virologists. One of the greatest areas where there is need for improved surveillance of viral disease is in primary care, and the ability to deliver viral diagnosis in the primary care is really a serious challenge, I think, for any health system. In particular, delivery of viral diagnosis is an expensive process. In a seven-minute consultation, actually taking time to take an appropriate sample is often regarded as a time-wasting exercise because the ability to provide information to affect patient management is not available during the time of the consultation or, indeed, shortly after it. So the point I wish to make is that improvement of surveillance of viral diseases requires improvement of diagnosis in many different fields, of which clinical virology is only one.
  (Dr Pillay) Another example, I think, of why the existing model is not optimal, in terms of the separation somewhat between epidemiology and clinical virology, comes with these new techniques. For instance, the ability to quantify the amount of virus being carried in chronic carriers of Hepatitis B and Hepatitis C (which will become increasingly important) and HIV, is currently in the realm of very "clinical" rather than "epidemiological virology", but these measurements also allow the ability to assess how infectious those individuals are to others. Here is an example where with a more integrated epidemiology and clinical virology network there is the ability to assimilate that new data into a broad epidemiological framework.
  (Dr Brown) Just trying to address your point from the surveillance perspective, which is the one that I am most familiar with, clearly currently there are different approaches that are used for detecting viral infections, although I think it is fair to say that there is increasing convergence of those techniques across microbiology, and in the future I think that will be true. The reasons why we do need both areas were touched on by Dr Zambon and I might characterise it by suggesting that you would not want to let a general surgeon do paediatric cardiac surgery, as we have seen in the past. There is a wide range of infections here, we need expertise across the range. Virus infections are distinct from microbiological infection and only yesterday, for example, we have heard of the smallpox plan that has been announced. That is a virus infection, and you want somebody with an understanding and profound knowledge of the infection to contribute to the expert advice needed to the Department of Health. So there is clearly overlap but there is a need for virology as a speciality within that to help drive the field forward to educate our microbiological colleagues and to contribute expert advice for those specific infections.
  (Professor Griffiths) We would not want to give you the impression that we do not get on with our microbiology colleagues and support them. There is a proper team interaction, patient-orientated team interaction, to solve individual problems that present.

  184. I get the feeling that you get on with them when you like them.
  (Professor Griffiths) Just to follow up David's point about the medical specialists, there is another example that has been in the public domain for the last couple of years and that is the public health policy on measles, mumps and rubella vaccine being driven by a surgeon by training. I am sure you would agree that is inappropriate—as inappropriate as me, with my primary medical qualification, offering to operate on patients. I suggest public health would not be well-served by that.

  185. If virology is primarily about laboratory methods, how important is the clinical component of training in virology? Could the service be delivered by a non-clinical virologist?
  (Professor Griffiths) In some parts it is. We have shared skills with our non-medical colleagues, who lead in some of the laboratories, particularly on the research and development side. We have put it in the document we sent to you, and we put in specific examples of much more clinically orientated virology. For example, some virologists go to out-patient sessions, invited there by their infectious disease colleagues, to help out and, obviously, maintain an interest in particular infections. So different people labelled as virologists will do different things, largely depending on the need of the service at that local site.

Chairman: I think we should move on to the next question.

  186. I think question 1 leads very nicely into question 2, which is on clinical information. This Committee has received a considerable amount of evidence which points to a shortage of co-ordinated activity, both between the clinical specialists and public/environmental health officials. Do you think this is justified, and could co-ordination be addressed both within virology and between virology and other areas? You have touched on this in your answers to the first question, but if you could just expand on it it would be quite helpful.
  (Dr Brown) I would accept the premise there is a lack of co-ordination across a range of interfaces. Within virology, because it is rather a small speciality, we all know each other and the point made by your colleague earlier is probably the case, that things work despite, sometimes, rather than because of the system that is in place. In terms of how we improve that (and this would apply to infectious disease consultants, GPs and clinicians generally as well as clinical microbiologists and clinical virologists), that is quite a challenge. The first point is that we are all busy people and, therefore, you need to make that requirement seem an important part of the job, which I think it often is not perceived as at the moment. I think that laboratory medicine can play an important role in improving that communication because they are often the interface between the surveillance programmes and the clinicians, and one way that that might be improved is if laboratories took on some role in encouraging reporting and surveillance. Certainly in my own lab, for example, we have a system whereby if we identify an infection, which we are not obliged to but a clinician is, we would put a sticker on that report saying "This is a confirmed infection, you should notify this". There are a number of practical mechanisms such as that which could be introduced to try and break down some of these barriers which I think are there.

  187. Surveillance itself is a very complex area and co-ordination is particularly difficult with a small number of specialists. However, it is very important, from the patient's point of view, that there is this co-ordination. What we hear quite a lot in this Committee is that there is a lack of co-ordination and it is very important we tackle that. Would you make a comment on that?
  (Dr Pillay) I wanted to follow up the discussion. I think another problem in terms of this co-ordination within virology is that the predominant role of clinical virologists outside of the public health virology/public health arena is to provide a clinical service. That service is, as we have discussed, cutting edge in many cases but is under an enormous cost pressure in the context of pathology. Budgets are decided and contracts are negotiated in the context of a hospital Trust pathology budget. They therefore lead to major differences between the diagnostic test methods that are used across the UK even for some infections that have now, within the sexual health strategy of the UK, been put at the top: for instance Chlamydia. There are still major differences across the UK which actually make a mockery of the ability of the more clinical side of virology to link with public health because the methodologies, the payment and the resources for that are different. This may be addressed within a wider, sort of more infection type—certainly a Clinical Virology Network—which is more integrated into the public health arena.
  (Dr Zambon) The comments I would like to make are that co-ordination is, in a way, rather variable in the system. There are places where it is particularly good and there are places where it is, perhaps, not so good. If you look at the national centres for reference microbiology and national centres for epidemiology, at that level, between those two areas, the co-ordination is good. It becomes more fragmented the further away you get from the national or regional picture. The second thing is that I think the distribution of resources is important in the sense that, as Dr Pillay has just alluded to, the introduction of new techniques and technologies will affect pathology budgets but will actually deliver improvements in a clinical care arena. There is not a way of actually improving the pathology budget from a clinical budgeting perspective, so that there is a constant tension between the introduction of new techniques, at whatever level, and feeding through the information to clinicians on how that can improve care and management, and how that can improve co-ordination on ascertainment of disease. I think it would be wrong to say that co-ordination is universally poor because there are some very good examples where it works well.

  188. One of the important things about co-ordination is to be able to co-ordinate similar issues and I wonder if there are standardised operating protocols for virological diagnosis and procedures, not only for operating but for reporting too, so that co-ordination can be made effective across the whole range of diagnostics?
  (Dr Brown) The process has begun. There is now, through the Clinical Virology Network, a national process of trying to agree standard operating procedures, but I think many of us are concerned that if you want to have regionally generated data that is compatible at a national level you have to actively manage that process, and it is one of the concerns that some of us have about the proposals made by the Chief Medical Officer, because it was not clear within that how we were going to ensure that the data generated could be consolidated and that it was compatible to be used for national policy decisions. My experience is that you have to actually identify the question and actively manage the process, it will not just happen by rain falling across the whole garden.
  (Dr Zambon) One can also think of quite specific examples where the introduction of, if you like, best practice methodology will have significant cost implications for hospitals who should take that on, which might well not be agreed upon locally. So I think it is wrong to think that just having standard operating procedures and best practice methodology will invariably lead to universal improvement.

  189. If there are no further questions on that point, can we move to question 3, which is something that interests me, which is the interaction between those investigating animal viral infections and human viral infections, and the Public Health Laboratory Service and the Veterinary Laboratory Agency. Two or three issues come up. One is West Nile virus. Is there good co-ordination between the people watching out for West Nile in animals and birds and in humans, for example?
  (Dr Brown) I think there are a number of issues around this area. In terms of West Nile, I think now that we are two or three years on from the outbreak in the United States we are gradually getting to a position where we have human surveillance and there is some animal surveillance that will give us the true picture next year, perhaps. Clearly, if it was a major human pathogen I would hope that we might have picked it up by now, but it is probably a small-scale problem. The issues around this area—and there are several—are, firstly, that we tend to have a fairly good reactive response when a crisis hits us. I think that happens quite often. Luckily, there have not been major problems in the field of virology, although I acknowledge that BSE and foot-and-mouth in animals did require a reassessment of how we respond to these things. I think it is the planning and looking at where we are going in the future and trying to predict and prioritise the work that we need to do in this area which is most difficult, and I do not see a clear structure for how this is co-ordinated, and how horizon scanning and prioritisation of very different types of threats is undertaken. There is a clear gap there. There is co-ordination between the veterinary and human health services but it is not positively and actively managed in a forward-looking way; it is rather "We are working on influenza, so are the vets. Have we got common interests there?" We are not identifying where we need to be, it is rather looking at where there are fits and responding to that. There is an important area here that does need moving forward.
  (Dr Zambon) I would like to add to that that funding streams and the agency priorities are different, which makes co-ordination rather difficult in overall policy. There is not really an appropriate mechanism for joint development funding, and that is exactly where the business of horizon scanning becomes a problem because you may well be able to identify with your opposite number in the veterinary field where the field should be moving to but not exactly the mechanisms for ensuring funding. The greatest weakness, I think, as Dr Brown has alluded to, is the fact that there is not really a good mechanism for forward planning, for picking up potential things which might be a problem, seeking to justify some small amount of research or surveillance effort to take such things forward. My conclusions are that overall the liaisons are rather dependent on individuals and, as Dr Brown has indicated, good in a reactive mode but not so good in a proactive mode.

  190. What can we learn from medical virology generally, from the massive outbreak of foot-and-mouth disease or swine fever, for example? Are there lessons to be learnt in virology in general?
  (Dr Zambon) I think one mechanism is to improve institutional learning. For example, things which the PHLS have learnt about the introduction of information technologies should be available to be shared with equivalents in the veterinary agency and the Home Office and vice versa, and there are not good mechanisms for sharing institutional learning on the introduction of new techniques and new technologies and new approaches to surveillance. I think that is one lesson that could be learnt. Secondly, clearly vets must be working on diagnosis of foot-and-mouth, which may also be appropriate in trying to test for cases of human foot-and-mouth, for example. There is not ever a sharing of that information until there is a crisis. That is not necessarily a good situation to be in. I think it is the business of sharing information.
  (Dr Brown) Could I add two quick points to that? One of the key issues in handling the foot-and-mouth crisis was the ability to find the surge response that was needed to do the testing. I think there is a generic issue there that applies across the range for new infectious challenges, be they in animal health or in human health. I think, also, the need for some contingency planning for how we could respond to these things being in place in advance enables one to get a much more rapid and effective response.

  191. This is really addressed to Professor Griffiths. Thank you for explaining the difference between virologists and microbiologists because that helps me to understand the question. In the written evidence from the Clinical Virology Network, of which you are the Chairman, you express concerns about the integration of virology into the Pathology Modernisation exercise and the HPA. I wonder whether you could elaborate on this and describe how you would see an integrated virology service working?
  (Professor Griffiths) The Clinical Virology Network was set up by the virologists ourselves to act as a series of specialised laboratories to roll out best practice across the UK. Basically, if you had a relative with any given virus infection, there is someone in the UK who can make the diagnosis for you and advise you on the prognosis and the potential treatment, but there is no one laboratory that provides all of those services nationwide. We think we should try to roll out that best practice so that wherever you live you have access to those diagnostic services. So the network is professionally led, we are unanimous in wanting to achieve that objective and aim to pool our resources to do so. Before I get on to the criticism, we very much approve of and support the objectives set out in Getting Ahead of the Curve; specifically, to have standard operating procedures, the use of modern diagnostic methods, the reasons for reporting for the whole of the UK and having disease policies for managing conditions throughout the whole of the UK. Our criticism is that at the moment the focus has been very much on what you might call the bureaucratic side, or related to the transfer, perhaps, of the PHLS to the HPA and there is not very much coming through on the professional side that will make a real change at the sharp end of clinical practice. I think you are also picking up a letter that I wrote on behalf of the Network to Dr Mary O'Mahony back in September when it was announced which laboratories would be designated HPA laboratories. To precis the letter, it basically said what is the point (I work in London) in designating a laboratory in North London when the current concern is to do with smallpox where if we have a case, which would be considered atypical chickenpox (as I am sure would be the initial case), we would make the diagnosis rapidly using electron microscopy, we would rapidly be able to phone to my colleagues up at Colindale, who would confirm the diagnosis, and we would take all of the appropriate steps? None of this would involve the laboratory that had been designated for North London. Therefore, what is the point in designating one? We see no reason for having a parallel system to set up as a Health Protection Agency series of labs; we think that if extra resources are to come through to cope with bio-terrorist problems they should be used to improve the infrastructure generally for infectious diseases. So that for most of the time—let us hope for all of the time—the resources will be used to improve the diagnosis and treatment of individual virus infections and if there was a bio-terrorist release then, of course, people would stop what they were doing and deal with that particular issue. That is our criticism. In short, there should be a HPA function in all of the specialist laboratories rather than having designated HPA laboratories which alone are thought to cope with that problem. We do not see that working.

  192. In that way, are you satisfied that there would be sufficient quality assurance and sufficient incentives to use new techniques and this sort of thing?
  (Professor Griffiths) Yes. I think the way we would like to manage it is to have a service level agreement with the HPA and say "These are the things that need to be achieved". We will deliver (depending on what resources are available) as many of these things as we can agree on and roll them out throughout the UK, including the standard operating procedures and including reporting back to a CDSC. It is crying out for all the laboratories to be linked electronically to the CDSC to report things instantaneously, and all the laboratories are not connected electronically at the moment.

Lord Patel: I would like to enlarge on this but today there might not be enough time to do so. All that you have just said is not in the written evidence that you have supplied and it would be very helpful if you were able to put a detailed paper in as evidence.

Chairman: Are there any more comments on this question? If not, can we move on to Lord Rea?

  193. This is really a question divided into two parts. It concerns the area we have already touched on, which is the relationship between practitioners, clinicians, and laboratory workers. We have heard from many of our witnesses that most clinicians under-report largely because they feel too removed from the surveillance activity. What role do you believe virologists can play to ensure that other clinicians and nurses feel that they are part of that surveillance process? The second half of the question—and I speak particularly as a former general practitioner—is; do you feel that GPs have a sufficient understanding of viral infection and its treatment and have adequate access to virological information and advice? I could say one or two things from my experience but I would rather hear from you.
  (Dr Zambon) I think it is important to recognise that public health activities—and that would include reporting of infections—take time. As we have already heard, most clinical virologists are in service jobs and, indeed, most infectious disease specialists are in service jobs. So I think I would argue that it is not so much a failure to see the point of reporting as a failure in being able to find the time to do the thing where you do not see the immediate outcome in your immediate environment. I think it is true to say that virologists, perhaps, could play a bigger role but I think it is also important to recognise that there are limited numbers of virologists and their ability to interact with a multitude of different people is also resource limited. To try to pick up on points about GPs, I think the question of virological diagnosis in primary care is one which is grossly under-developed and under-recognised, largely through lack of availability of appropriate, easy and cheap tests to be used in primary care, but I think it is also not necessarily a good reflection on the way that public health has been structured when we do not find it easy to develop the burden of illness data based on important syndromic disease. For example, it is considered that 20 per cent of all consultations in general practice are due to respiratory viral infections, yet we actually have very little diagnostic information underlying that. We could also have some data on the burden of illness due to enteric virus infections in primary care. We know that there is an enormous burden of illness out there with very little evidence underpinning it in the way of notifications of tests or tests being done. On the one hand it is fair to criticise and say there is little reporting but, on the other hand, the systems are not necessarily geared to allow diagnosis and then capture of information.

  194. The problem, seen from a practitioner's point of view, is that the result that you get, which may be, as you say, many days later, is often after the patient has got better. However, even if you did get it a bit earlier it would not necessarily help you in the treatment of that case, although of course it would be important to differentiate it from other diagnoses.
  (Dr Zambon) Indeed. It may not be essential to have such information coming from every single GP in the country but it is clearly important to set up surveillance systems perhaps involving sentinel GPs to deliver at least a snapshot of disease in the community. We had some excellent examples with the Royal College of General Practitioners in particular on influenza surveillance, but it is important to note that the surveillance structure is fragile and is largely funded on the goodwill of participants; it is not well-funded and I think there is not a good succession planning.

  195. Should the sentinel practice system be strengthened, do you think, and how is it working at the moment?
  (Dr Zambon) I personally believe it should be substantially strengthened, not only to look at respiratory syndrome disease but, also, many other diseases including enteric syndrome diseases. I believe the Food Standards Agency has used the model which has been developed on surveillance in primary care to address the question of enteric viral infections and the overall burden of disease. So I think there are many gains to be had from strengthening surveillance in primary care with a good network of GPs so that we have a snapshot of disease in the community.
  (Dr Brown) I would entirely agree with that and as somebody developing the enteric primary care surveillance that is something that we are trying to put in place. There are some constraints to that, and I think one central issue is the question of where surveillance lies between patient management and research. At the moment surveillance tends to be captured by ethical committees as requiring informed consent for each patient investigation. In general practice, essentially, that means that you cannot have it. I think there is a generic issue on surveillance around that very point.
  (Dr Pillay) Just to follow up on your personal view of GPs' perception of virology, I do think that the relationship between reporting, seeing the national benefit, and the individual clinician is, to some extent, based on an understanding of how useful virology can actually be. I would argue that (I agree with Dr Zambon) there are cost limits to the extent to which diagnoses can be undertaken in primary care, and it may be seen that it is of no use in the acute management situation. However, of course, the net effect of an active diagnosis of the viral cause of respiratory illness is in reducing, perhaps, the amount of antibiotics that are prescribed, which have huge other consequences in primary care and the spread of antibiotic resistance. I think an economic case can be made for more active diagnoses which then feed into surveillance, but of course I come back to my previous point that the diagnostic budget is negotiated locally with PCTs which makes it very difficult to push those arguments as a basis for virology funding.

  196. I am a little concerned at your mention of patient confidentiality being a problem here. Could you amplify on this because, in fact, practices or hospital clinicians that send in samples, are not aware, I think, at the moment, that they might actually be contravening any kind of ethics on this?
  (Dr Brown) The point I was seeking to make—and it does apply, I think, most precisely to primary care—is that if you have a case in front of you of a child with diarrhoea, do you do an investigation for the direct patient management? In most cases, I think, the situation is that you would not. However, if we are to have an understanding of the burden of disease due to different enteric pathogens in the community, clearly we need—because they all present in the same way with diarrhoea and vomiting—to do a laboratory test to confirm the cause. Can that be covered by normal patient management (you would not do it for the individual patient management) or do you have to get informed consent from each of those patients from whom you are requesting a clinical sample that the information will then be used for surveillance? I think there is an issue there, because clearly in general practice it is impractical to do proper informed consent for each investigation of diarrhoea.

  197. Also, the patient does not know whether the sample is being taken to aid the doctor in diagnosis and treatment or whether it is going to be used mainly for the purposes of surveillance. Surely, the data can be anonymised, to an extent?
  (Dr Brown) One might hope so but I think the ethical committees may take a different view.

  198. The description of samples coming in and diagnosis depends very much on the diagnostic acumen of the individual person in primary care. I just wondered, following on from what Dr Zambon was saying, whether you see a knowledge and training deficit within the current training systems available to GP trainees and, also, on-going postgraduate education—whether actually there is a huge educational gap in terms of recognition and accurate diagnosis so that they can start to ask even for the right test? I have a concern that if the wrong sample is sent and sent to the wrong laboratory we will never get anywhere near, however good your laboratory services are.
  (Dr Brown) I would suspect that is true but I have lived in a national reference centre for 15 years so perhaps I should ask my colleague, who is a little closer to the coalface, to answer that.
  (Dr Pillay) I would agree there is a big variety in the ability to send appropriate samples and test the appropriate samples.
  (Dr Zambon) Just to make the comment that one of the benefits and hidden spin-offs of sentinel schemes is that the GPs that are involved do, if you will, undergo a learning process, learning about results from these samples. Eventually, there develops intuitive knowledge which accumulates from realising the kinds of person who are likely to give positive samples. I do not quite know how to explain it, but it is part of the diagnostic acumen. There is a learning curve in it, which can be very beneficial, and those sentinel GPs can often—and do often—end up with an important educational role within their own practices and for local practices. I do see encouragement of sample taking as being beneficial on the learning side, but I think it has to be tempered with resources. I think you cannot say that for everything you will have to investigate.

Baroness Finlay of Llandaff: Some of that educational acumen has dropped out of some of the GP training schemes around the country and certainly does not necessarily feature in the MRCGP exam, so it may have fallen from the high profile in the minds of trainees, who are our future practitioners.

1. I would like to ask whether you feel the infection control nurses have a part to play, both in the community and within the clinical field? If so, do we set maximums?
     (Dr Pillay) They certainly do have a very important role to play, and in my experience good infection control systems within hospitals are, to some extent, a function of close working relationships between the laboratories as well as the clinicians. So they provide that ideal interface and understanding as well about the importance, in some cases, of making a diagnosis and, in other cases, the fact that it is more for surveillance than diagnosis. I would agree with you.