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Hearing summary25th MARCH 1999 The second block of evidence, which began today, will look at the national scene - including evidence from the Department of Health, witnesses from the Supra-Regional services, Royal Colleges and professional organisations. Dr Howard Swanton, President of the British Cardiac Society (BCS), gave evidence to the Inquiry today. He outlined the Societys function and its role regarding the production and enforcement of guidelines and staffing surveys, stating that guidelines are published in the journal Heart. He also described the voluntary peer review system, which was started in 1996 and includes 165 cardiac centres (incl. six paediatric cardiac centres). He emphasised that the guidelines and peer review scheme are produced and run by cardiologists in adult cardiac medicine and not cardiac surgery. He went on to tell the Inquiry that the BCS has been extensively involved since 1995 with the Central Cardiac Audit Database and has been involved with the National Confidential Enquiry into Post-operative Deaths. Dr Swanton told the Inquiry that the BCS is not directly involved with surgical training issues. In his evidence to the Inquiry, Dr Michael Godman, President of the British Paediatric Cardiac Association (BPCA) raised many issues. He commented on the "vacuum in relation to the enforcement of standards relating to paediatric cardiac services". With regards to monitoring, he said that during the period of supra regional centres only the number of surgical operations, not the outcomes, were monitored centrally. He stated that the Associations view was that the analysis of surgical outcomes should be assessed on the basis of organisational performance and the identification of system failures rather than focus only on the surgeon. He said that there was a need for a framework in which continuous appraisal of a centres performance in surgical and medical care can be made and went on to suggest a system of peer review to undertake this task. He stressed the need for high quality data collection and went on to discuss the need for the establishment of the register of experts to teach new procedures to surgeons and physicians. He stated the importance of experienced trained middle grade ITU staff being available 24 hours a day and discussed at length the value of informed consent.
Dr Jane Ratcliffe, former Honorary Secretary of the Paediatric Intensive Care Society (PICS) came to give evidence to the Inquiry today. She described a series of reviews of Paediatric Intensive Care, which had taken place across the country during the 1980s and 90s. She noted that all of these reviews had observed deficiencies in the facilities provided and had made recommendations, which had not been acted upon at the time. She raised several issues including the view that the preferred configuration for paediatric intensive care should be in a paediatric setting rather than a cardiac setting and that a split site between cardiac surgery and cardiology was not ideal. PICS recommended that a Paediatric Intensive Care Unit (PICU) should be situated close to other essential services and departments: A&E, X-ray, operating theatres, and laboratories. She highlighted the changing emphasis placed on the importance of specialist trained nursing for paediatric intensive care over the period and discussed issues relating to the number of intensive care beds available for babies and children. Dr Ratcliffe went on to comment on the need for appropriate facilities to be provided for families wishing to stay with their children whilst being cared for in a PICU.
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FULL TRANSCRIPT
1 Day 7, 25th March, 1999 2 (9.35 am) 3 MR MACLEAN: Chairman, good morning. Could I call 4 Dr Swanton, please? 5 Dr Swanton, could I ask you just to stand to take 6 the oath, please? 7 DR ROBERT HOWARD SWANTON (Sworn): 8 Examined by MR MACLEAN: 9 Q. Do sit down, Dr Swanton. Could I ask you to tell us 10 first of all your full name and your professional 11 address, please? 12 A. I am Robert Howard Swanton. I work at the Middlesex 13 Hospital, Mortimer Street, London W1. 14 Q. You are, I think, a consultant cardiologist? 15 A. That is correct. 16 Q. You have been for a period of how long? 17 A. 20 years. 18 Q. You have worked at that Middlesex Hospital for all of 19 that period? 20 A. All of that time. 21 Q. I think currently you are the President of the British 22 Cardiac Society and your term of office runs from 23 October 1998 until the year 2001? 24 A. That is correct. I had to take on an extra year at 25 short notice following the death of one of my 0001 1 colleagues. 2 Q. Dr Swanton, if you look at the screen in front of you, 3 if we could have document witness 66/1, please, if we 4 just scroll down that page, that is the first page of 5 a statement that you have made to this Inquiry, is it 6 not? 7 A. Yes, it is. 8 Q. If we could just scroll through, please, to page 66/5, 9 that is your signature, is it not? 10 A. It is, yes. 11 Q. You have made a five-page statement to this Inquiry, and 12 you have submitted some other helpful documents we will 13 come to in a moment. 14 A. Indeed. 15 Q. The British Cardiac Society has as its main object, does 16 it not, the advancement of knowledge of diseases of the 17 heart and circulation for the benefit of the public? 18 A. That is correct. 19 Q. The officers of the Society comprise the President, the 20 President-Elect and Honorary Treasurer, Secretary and 21 Assistant Secretary? 22 A. Correct. 23 Q. Whilst you are the President of the Society now, you 24 have previously served a term as the Secretary of the 25 Society? 0002 1 A. I have. 2 Q. You have set out briefly in your statement that the 3 Society first met in 1937. We need not go back as far 4 as that, but there are cardiologists and cardiac 5 surgeons on the Council of the Society? 6 A. That is correct. We always have one surgeon on the 7 Council, so that when his term of office expires, the 8 electorate are requested to nominate a surgeon, or more 9 than one, and then the votes are cast and a surgeon is 10 elected. So there is always one surgeon on the Council, 11 yes. 12 Q. It would be fair to say that the Cardiac Society was 13 predominantly an organisation of cardiologists? 14 A. It is. 15 Q. The surgeons having their own organisation, the Society 16 of Cardiothoracic Surgeons? 17 A. That is right, yes. 18 Q. It happens at the moment Professor Angelini from the 19 University of Bristol sits on the Council of the 20 Society? 21 A. He sits on the Council by virtue of his role as part of 22 the Society of Cardiovascular Research. The elected 23 surgeon is actually Mr Jim Munroe from Southampton, so 24 we have two surgeons on the Council at the moment. 25 Q. There are nine affiliated groups to the Society. Page 2 0003 1 of your witness statement, WIT 66/2, please. You set 2 out those nine groups there at the top of the page? 3 A. Yes. 4 Q. We see that many of these societies we will be hearing 5 from, indeed Dr Godman, as you may know, will be here 6 later this morning. He is from the British Paediatric 7 Cardiac Association. These organisations are, within 8 their own fields, largely autonomous of the Cardiac 9 Society, are they not? 10 A. They report to the Council of the British Cardiac 11 Society. The President of each of them sits on 12 a Council which meets twice a year, so they are 13 autonomous to a certain extent, but nonetheless, linking 14 through the Council of the Cardiac Society. 15 Q. So would it be fair to describe the British Cardiac 16 Society as the umbrella organisation of these 17 nine affiliates? 18 A. Yes. 19 Q. The British Paediatric Cardiac Association was founded 20 in 1991, Dr Godman I think will tell us. Was there any 21 body of the Society before 1991 which was specifically 22 concerned with paediatric cardiac medicine or surgery? 23 A. Not to my knowledge. Not a specific group. It was all 24 under the umbrella of the British Cardiac Society as 25 a whole. 0004 1 Q. Was that because paediatric cardiology and cardiac 2 surgery was not seen as a separate branch of cardiology? 3 A. I think 20 years ago, a lot of adult cardiologists were 4 treating children. Certainly, when I started at the 5 Middlesex Hospital 20 years ago, we had a paediatrician 6 with an interest in cardiology and I was treating 7 paediatric patients with him, so it was not unusual in 8 those days for adult cardiologists to treat children. 9 As time went on, it became clear that was inappropriate 10 and gradually a group of paediatric cardiologists 11 developed, but there were still small numbers. I think 12 part of the problem was there were small numbers of 13 paediatric cardiologists. 14 Q. Would it be right to say now it would be unusual, 15 perhaps highly unusual, for a cardiologist to treat both 16 adult and paediatric patients? 17 A. It would be unusual, yes. There is a grey area when the 18 child reaches adolescence and a new specialty is 19 developing, Grown-up Congenital Heart Disease, GUCHD for 20 short, in which both adult cardiologists and paediatric 21 cardiologists obviously have an interest with the 22 interface. 23 Q. So we can discover how many different branches of 24 cardiology function there now are, 20 years ago, in the 25 late 1970s, there were simply cardiologists who treated 0005 1 adults and children? 2 A. There were. There were some paediatric cardiologists, 3 but there were some adult cardiologists treating 4 children as well. 5 Q. But nowadays, we have first of all a distinction between 6 adult cardiologists and paediatric cardiologists? 7 A. Yes. 8 Q. There is an interface at the adolescent level, the 9 Grown-up -- 10 A. -- Congenital Heart Disease Group, yes. 11 Q. Within paediatric cardiology, there is a division, is 12 there not, between very young children, the neonates and 13 infants, those under one year of age, and older 14 children, adolescents? 15 A. Yes. They do subdivide, but you will have to ask 16 Dr Godman more about that than myself. 17 Q. As it happens, your own practice, as you have already 18 suggested has moved away from treating children, and you 19 would now see yourself as exclusively an adult 20 cardiologist? 21 A. Absolutely, yes. 22 Q. Dr Godman will tell us that one of the first acts of the 23 British Paediatric Cardiac Association was to establish 24 a Working Party on the future of paediatric cardiology. 25 In fact, a Working Party was established, I think, in 0006 1 1988. 2 If we go to document BPCA 1/1, this is a report of 3 the Joint Working Party of the British Cardiac Society, 4 your society. If we look at the first paragraph on the 5 left-hand side: 6 "The committee was formed as the result of 7 a perceived crisis in consultant staffing in paediatric 8 cardiology in the United Kingdom ... The situation 9 which confronted the profession in 1987 and 1988 was 10 very worrying. Two newly constituted consultant posts 11 in paediatric cardiology and two existing posts were 12 unfilled because there were no suitably trained 13 applicants." 14 We see the Working Party was set up. 15 Are you able to help us with why it was that 16 a particular crisis should have emerged in 1987 and 17 1988? 18 A. I cannot tell you very much about it. I was aware there 19 was a shortage of Senior Registrars in paediatric 20 cardiology at that time. The paper goes on to point out 21 that they will not be able to fill further consultant 22 posts and suggests making proleptic appointments to 23 allow continuing training in the consultant grade. 24 Why that shortage of Senior Registrars occurred, 25 I do not know. I think it was obviously manpower 0007 1 planning problems. We were dealing at that time with 2 a very small specialty in its own right, anyway, and 3 I think manpower planning obviously was a big problem at 4 that stage. 5 Q. It is a phenomenon that is true equally of cardiac 6 surgery as cardiology, that there is a small number of 7 surgeons, paediatric cardiac surgeons and paediatric 8 cardiologists, but the resource from which the 9 consultant pool is drawn will be the Senior Registrar 10 level, so obviously, tomorrow's consultants will be 11 drawn from today's Senior Registrars? 12 A. Specialist Registrars now, but yes. 13 Q. I think Mr Langstaff will probably go into this report 14 in a little more detail with Dr Godman. I do not want 15 to dwell on it now. Can I turn to the journal which is 16 published by the British Cardiac Society? It is now 17 called Heart, is it not? 18 A. It is. 19 Q. It used to be known as the British Heart Journal? 20 A. Correct. 21 Q. That has been published ever since January 1939. It is 22 published how often? 23 A. It is published every month. 24 Q. That will go to every member of the British Cardiac 25 Society? 0008 1 A. It will. 2 Q. Which is in effect every cardiologist and every cardiac 3 surgeon in Britain? 4 A. It should be. I do not have proof that every surgeon is 5 a member of the British Cardiac Society, but we have 934 6 members, so it certainly includes every cardiologist, 7 yes. 8 Q. Would it be fair to describe Heart as being the major 9 published public forum for debate amongst the specialist 10 cardiac community? 11 A. Yes, it is our only journal. We used to have 12 Cardiovascular Research, which we sold two years ago. 13 It is our forum journal. 14 Q. What is the editorial arrangement for that journal? 15 Is an editor elected or appointed? 16 A. Yes. The editor is appointed for five years, which is 17 renewable for a period within agreement. The editorship 18 is actually just changing this month, the previous 19 editor having done seven years. He then chooses his own 20 board of assistants which will include a European member 21 and possibly an international member from the States 22 also, and will include a cardiac surgeon. 23 Q. So the editor is appointed by whom, for that period? 24 A. The editor is appointed by Joint Committee. I did not 25 make it completely clear: Heart, the journal, is owned 0009 1 jointly by the BMA and by the British Cardiac Society, 2 50:50, so the election of the editor is a joint 3 appointment by the BMA and by the British Cardiac 4 Society together. 5 Q. You refer in your statement, if we can just go to 6 WIT 66/2, please, the foot of the page: 7 "Standard setting 8 "Over the years the BCS has produced a series of 9 guidelines and staffing surveys, a list of which is 10 enclosed for your records. These started in 1985 and 11 have continued on a regular basis until the present 12 day." 13 You have helpfully provided that list. If we go 14 to WIT 66/6, there is a list at pages 6, 7, 8 and 9. 15 So the Panel understands how this information has been 16 obtained, you have drawn attention here to 40 separate 17 publications, each of them published in the British 18 Heart Journal, or later Heart, as it became, and I think 19 the Inquiry has requested copies of some but not all 20 those documents. You have provided the ones we have 21 asked for? 22 A. Yes. 23 Q. We see that when the British Cardiac Society wants to 24 lay down some guidelines or some principles or give some 25 instruction to the cardiac community, it will do so 0010 1 through the forum of the British Heart Journal, or 2 Heart? 3 A. Yes. I mean, before it reaches Heart, it may well have 4 been discussed, obviously in Council, and has to be 5 passed by the Council of Cardiac Surgery, the 6 guidelines, and they may well have been discussed at one 7 of the meetings of the British Cardiac Society. There 8 is always a bit of a delay before they appear in Heart, 9 but that is where they end up, yes. 10 Q. As you know, the Inquiry's terms of reference cover the 11 years 1984 to 1995. What I do not want to do is to go 12 through all the papers you have submitted, because the 13 Panel will read those. What I do want to do is just to 14 highlight some of the important developments in 15 cardiology and cardiac surgery from the Society's point 16 of view during the Inquiry's terms of reference. 17 Can we therefore turn to BCS 1/1, please? Just 18 blow that up a little. The Panel will be aware that 19 this is one of the reports which Dr Godman will be 20 dealing with, because it is one of the reports on which 21 the 1992 Joint Working Party report is based. 22 We see there that this is a Royal College of 23 Physicians of London, Royal College of Surgeons of 24 England and Joint Cardiology Committee third report. 25 This would therefore give us a useful overview of the 0011 1 position in adult and paediatric cardiology at the 2 beginning of the Inquiry's terms of reference, because 3 this is published in 1985. 4 If we just look at the first page, if you scan 5 down the summary, we see that the conclusions were as 6 follows: 7 "Cardiology was continuing to change rapidly ..." 8 In the fourth line: 9 "(2) The burden of heart disease in Britain shows 10 some decline recently, but this falls short of that 11 which has occurred in other countries. The vital role 12 of the initial assessment of patients to ensure the 13 efficient use of limited resources falls upon physicians 14 and paediatricians in district general hospitals." 15 We will come back to that in a moment. 16 "Each district general hospital should have at 17 least one physician practising general medicine but 18 having a special expertise and training in cardiology." 19 Pausing there, what is being contemplated is that 20 each district general hospital would have not 21 a specialist cardiologist, far less a specialist adult 22 or paediatric cardiologist, but would have at least one 23 doctor who had a special expertise and training in 24 cardiology. 25 Would that be typical of the pattern in 1985, in 0012 1 district general hospitals? 2 A. It would be the desirable pattern. Certainly, 3 several district general hospitals in those days had 4 no cardiologist under any circumstances. By 5 'cardiologist', we mean a person who spends more than 6 40 per cent of his time looking after cardiac patients, 7 but some DGHs would not have had anybody. Certainly 8 there were some districts, at least 22 in those days, 9 who had no cardiologist at all. 10 Q. We see the other conclusions in the summary. Number 7, 11 towards the foot of the page: 12 "Supra-regional centres for the cardiac problems 13 of infants under the age of one year have been 14 identified and should receive supra-regional funding. 15 Their staffing and equipment should be appropriate to 16 the exceptional demands of this work. If such a centre 17 is sited within an existing cardiac centre, the staff 18 will be additional to those needed for the adult work. 19 Facilities for older children should continue to be 20 provided as at present at all cardiac centres." 21 So those under one year old were treated 22 specially, as supra-regional services, while all other 23 children from one year and above were to be treated at 24 all cardiac centres? 25 A. Yes. 0013 1 Q. You mentioned there, Dr Swanton, the definition of 2 'cardiologist'. We get that on the next page of this 3 document, page 2, the foot of the left-hand column: 4 "A cardiologist is a physician who has received 5 formal training in cardiology, spends a major part of 6 his time practising the specialty, but may also have 7 responsibilities in general medicine." 8 That would be an accepted definition of 9 "cardiologist" at that time? 10 A. Yes, I think so. 11 Q. If we look at the next page, page 3, to pick up the 12 theme of what was happening at the district general 13 hospital, in the left-hand column: 14 "Requirements for a cardiac department in 15 a district general hospital." 16 About halfway down the left column: 17 "A recent survey has shown that of the 215 health 18 districts in England and Wales, only 152 had a member of 19 staff with special expertise in cardiology, though since 20 then the number has increased slightly. This leaves 21 12 million of the population without a cardiologist or 22 physician with cardiological training in their own 23 district ..." 24 We see in the right-hand column: 25 "Staffing: 0014 1 "The Committee recommends, therefore, that each 2 district general hospital should have at least one 3 physician with special training in cardiology; larger 4 hospitals might have two." 5 That is what was suggested in 1985 as being the 6 appropriate benchmark figure for cardiologists in 7 district general hospitals? 8 A. Right. 9 Q. Page 5, the same document, the right-hand column, 10 dealing with paediatric cardiology and cardiac surgery: 11 "In children, cardiological and cardiac surgical 12 needs are best separated into those of infants (under 13 one year), many of whom are seriously ill or 14 emergencies, and those of older children." 15 So there is a two-fold categorisation of children. 16 "The special requirements of the former were 17 recognised in the second report [Dr Godman will deal 18 with that] which follows the establishment of 19 supra-regional centres to deal with the predictable 20 demands in this field. The recommendations received 21 support elsewhere ..." 22 In the next paragraph we see named there the 23 nine supra-regional centres, Birmingham, Bristol, 24 Brompton, GOS and so on. 25 Towards the bottom of the page: 0015 1 "General paediatricians have a vital role, being 2 the first to evaluate virtually all infants and children 3 with heart disease. Paediatric cardiologists, 4 therefore, must maintain the closest liaison with them, 5 both clinically and in an educational capacity. Senior 6 Registrars in paediatrics should be given experience of 7 infant cardiology in a supra-regional centre and of 8 general paediatric cardiology, either there or in 9 a regional cardiac centre. Particular attention should 10 be paid to the dissemination of expertise in 11 cross-sectional echocardiography, both to paediatricians 12 in training, and those already established, since this 13 should lead to earlier and more accurate diagnosis and 14 referral." 15 Dr Swanton, can you just help us with, in 1985, 16 what the diagnostic tools would be for the cardiologist 17 in general, and in particular, the paediatric 18 cardiologist, and perhaps comment on the, I think then 19 developing, role of the echocardiograph? 20 A. The basic tools are still the same today. The ECG and 21 chest x-rays are still fundamentally important, but the 22 echocardiogram was, then, and has become, the most 23 important diagnostic tool available to us. 24 Q. So it was then in 1985? 25 A. It was being used then, yes. The definition and the 0016 1 quality of the images was nothing like as good as it is 2 now; colour flow doppler did not exist, it was basically 3 straightforward imaging, but it was a great deal better 4 than ten years before that, when it did not exist. The 5 quality of the images now are sensational and manage to 6 avoid a lot of needless cardiac catheterisation. 7 Cardiac catheterisation was being performed then and is 8 now, but for different reasons. I am sure Dr Godman 9 will be able to fill you in. Certainly echocardiography 10 has eliminated the need for a lot of cardiac catheter 11 procedures. 12 Q. Let us turn briefly to staffing issues. Can I have 13 document BCS 1/17, please? 14 I think what happened was that every two years, at 15 this stage, the British Heart Journal would publish 16 a survey of staffing of cardiologists throughout the 17 UK. We see this is the 5th Biennial Survey, 1988. 18 If we go to the next page, page 18, please, we see 19 from the summary, four lines down: 20 "The United Kingdom with Ireland has fewer 21 cardiologists than all other European countries with 22 reliable figures." 23 Is that something to do with the level of training 24 required for cardiologists in the UK and Ireland? 25 A. No, I mean, the whole of these surveys was driven by 0017 1 Douglas Chamberlain (the first author on all of them) to 2 simply improve the number of cardiologists in this 3 country. I think at the beginning of the 1980s there 4 were only 200 cardiologists in the country. We now have 5 just over 600 -- 603. So in the space of 19 years the 6 number has tripled. 7 Q. If we look at the next page, page 19, the top of the 8 page, there is a table. The number of cardiologists in 9 England and Wales between 1980 and 1988 is charted 10 there, so this covers the first part of our period. 11 We see it is divided into adult and paediatric; 12 cardiology only; or those having a major interest in 13 cardiology. So it appears by 1980 the division between 14 adult and paediatric cardiologists that you suggested 15 was not well known more than 20 years ago was becoming 16 a well-established division? 17 A. Yes, but as you will see, in very small numbers. 18 Q. And in 1988, paediatric cardiologists, there were 33 of 19 those in England and Wales, which was exactly the same 20 number as there had been two years before, albeit that 21 two of those first 33 were major interests rather than 22 pure cardiologist specialists. 23 At the bottom of that page there is another table 24 which divides those cardiologists by region in 1988. We 25 see, about halfway down the table, "South Western", the 0018 1 population 3,205,500, which would be covering this area 2 of the country. Cardiology only: adults, 5; 3 paediatric 2; major interest adult cardiologists, 6; no 4 major interest paediatric cardiologists. So for the 5 south western region in 1988, there were two paediatric 6 cardiologists. 7 A. Yes. 8 Q. At the very bottom, Wales, there were 5 adult 9 cardiologists and no paediatric cardiologists; another 10 8 adult major interest cardiologists, but none at all in 11 the whole of Wales describing themselves as paediatric 12 cardiologists. 13 If we look at the text of the paper, just above 14 that table on the right-hand side: 15 "The total number of cardiologists within the 16 region shows wide disparities that do not appropriately 17 reflect the differences in population. For example, the 18 South Western region has 1 cardiologist for every 19 246,500 people, whereas North West Thames has one 20 cardiologist for every 140,500." 21 What would be the factors which would drive the 22 number of cardiologists that there would be in an area 23 in the late 1980s? This is before Trusts, before the 24 purchaser/provider split? 25 A. This was a question that caused a lot of consternation, 0019 1 I remember, in the early days of the British Cardiac 2 Society. The reason was that district general hospitals 3 were not appointing cardiologists, and then somebody 4 would retire, for instance, and instead of 5 a cardiologist being appointed, a diabetologist or 6 a gastroenterologist was felt to be more necessary. It 7 was a local DGH (District General Hospital) issue, but 8 it was widespread. None of us were ever able to 9 establish the real reasons behind it, whether there was 10 prejudice against the formation of cardiologists, but 11 there were definitely occasions in which a cardiologist 12 was needed and then some other specialty was appointed 13 in their place, with the funding. 14 Q. That would be the decision of the general manager, would 15 it, in the late 1980s? 16 A. Well, a group decision, with the physicians who existed 17 in the DGH at the time, together with the management, 18 yes. 19 Q. So the different consultants in the different 20 specialities would get together with the general 21 manager, and essentially would have to thrash out -- 22 A. -- what their greatest need was at the time, as they saw 23 it. 24 Q. Once they had made that decision at the district general 25 hospital level, would there be any scrutiny higher up in 0020 1 the Health Service chain to see whether, as a region or 2 a country as a whole, an appropriate overall pattern was 3 being established? 4 A. Certainly the figures were being observed, as you can 5 see, but I do not think there was anything anybody else 6 could do about it. The fact was in those days the 7 general physicians with gastroenterology or gastric 8 medicine or diabetic interest were the people who looked 9 after coronary care patients. Essentially that is what 10 we were generally dealing with. Patients coming into 11 the coronary care units were (and still are in some 12 units) being managed by non-cardiologists. 13 Q. That is different today, is it? 14 A. Certainly. The feeling was they could manage it 15 perfectly well. That was the philosophy. In a sense 16 cardiologists were not felt to be necessary, perhaps, in 17 those particular units. They had a Coronary Care Unit 18 which was working well and they had been looking after 19 coronary care patients for a long time and would 20 continue to do so. 21 Q. If we look at document BCS 1/38, please, this is the 22 next by biennial staffing survey, 1989. I do not want 23 to go into this in great detail, but in the left-hand 24 column we see the number of cardiologists had increased 25 over the two years from 1988 to 1990 by 32, of which 0021 1 23 work only in the specialty and nine as general 2 physicians. The rate of increase in numbers over the 3 past decade has been reasonably consistent, with an 4 average of approximately 4.4 per cent per year. 5 So there is a pattern of not spectacular but 6 steady rise in the number of cardiologists going on 7 through the 1980s, which is accelerated, I think, in the 8 early part of the 1990s? 9 A. Yes. I do have a graph right up to the present day, and 10 it is pretty linear: between about 5 and 7 per cent 11 annual increase. It has just drooped this last year, 12 but by and large it has been between a 5 and 7 per cent 13 increase per year. 14 Q. If we go to page 39, at the foot of the page, there is 15 a table that the Panel might see as being helpful: 16 cardiologists divided into adult and paediatric 17 cardiologists. We see the increase in purely paediatric 18 cardiologists. There is an increase of 105 per cent 19 during the 1980s, from 19 to 39, so that would be 20 indicative, would it not, of the developing recognition 21 of paediatric cardiology as a separate specialty from 22 adult cardiology? 23 A. Absolutely, yes. 24 Q. Again, there is a similar graph on the next page, 25 page 40. 0022 1 Then, at the foot of that page, if we show one 2 more table, this is similar to the one we saw two years 3 before. Again, if we look at South Western, South 4 Western's population is 3.2 million odd. It has a total 5 of 14 cardiologists, up one from two years before. 6 If we look at the other regions with comparable 7 populations, for example, Northern and North West 8 Thames, the Panel can read the table for themselves, but 9 we see that South Western, for whatever reason, has 10 a smaller number of cardiologists than other regions of 11 comparable population? 12 A. Yes. The geographical inequalities were well known, and 13 still exist in certain areas of the country. That is 14 one of the many things the National Health Service 15 framework is going to have to deal with. 16 Q. There are other similar reports. I will not weary the 17 Panel with too many of those, but for the record, the 18 1991 staffing record is at page 51; the 1992 staffing 19 survey at page 89. 20 May I go, then, to the question of the 21 cardiologist in the district general hospital. 22 May I have BCS 1/103, please? We have moved ahead 23 to a publication in the British Heart Journal in 1994. 24 There was a Working Group set up by the BCS dealing with 25 cardiology in the district general hospital. 0023 1 If we look on 103 in the left-hand column, please, 2 about halfway down: 3 "The role of the district hospital 4 cardiologist ..." 5 The second paragraph: 6 "Coronary artery surgery...", as opposed to 7 congenital heart disease that the Inquiry is most 8 concerned with. We see in that paragraph, the last 9 sentence: 10 "It is now the policy of the British Cardiac 11 Society to encourage properly trained district hospital 12 cardiologists to participate in the invasive 13 investigation of their patients." 14 That means, essentially, catheterisation? 15 A. Yes. 16 Q. And the foot of that column: 17 "The role in elective care has developed from that 18 of the provision of a basic screening service for 19 patients suitable for intervention to that of provision 20 of highly technological diagnostic skills and therapy." 21 So the cardiologist at district hospital level is 22 moving from assessing the situation with the patient and 23 then handing the patient on to someone else, to 24 actually, as it were, doing it himself? 25 A. Yes. This is a gradual process. The vast majority of 0024 1 district general hospitals do not have cardiac 2 catheterisation laboratories, but gradually we are 3 seeing an increase in the number of DGHs that have 4 catheter laboratories, and one of the recommendations in 5 this report was that every district general hospital 6 which possessed a catheter laboratory should have two 7 full-time consultant cardiologists on the staff, not the 8 one as was recommended in the 1985 report. 9 Q. I think if we look at the right-hand column of that same 10 page, please, in the top half, paragraph 2.5, the end of 11 the paragraph: 12 "There were still 44 districts in the United 13 Kingdom [this is 1994] that do not provide the services 14 of a physician with a special interest in cardiology, 15 and there are 34 larger districts that do not have two 16 cardiologists, despite the recommendations made in the 17 Fourth Report of the Joint Cardiology Committee of the 18 Royal College." 19 That is the recommendation you have just referred 20 to? 21 A. Yes. 22 Q. Over the page, page 104, paragraph 2.10. By this stage 23 something called 'Calman' had happened. 24 2.10 says: 25 "It is anticipated that cardiology trainees 0025 1 post-Calman will be required to spend at least 20 per 2 cent of their training period in district hospitals. 3 This will have a considerable impact on the time that 4 district hospital cardiologists will have to commit to 5 teaching. Future requirement for consultants will be 6 long overdue mandatory continuing medical education, or 7 CME. Another development in recent years has been the 8 development of courses in cardiac care for nurses, and 9 many of these are now run in district hospitals. It is 10 vital that protected time for all these important 11 activities is available. The commitment to such 12 activities necessarily removes the consultant 13 cardiologist from direct patient contact, and is an 14 important factor in the recommendations ..." 15 What was the difference that was coming about with 16 the Calman report suggestion that 20 per cent of 17 training should be in district hospitals? What is the 18 rationale for that? 19 A. The problem is that more than half of the Calman 20 Specialist Registrars are going to be dual accredited, 21 that is, they have to be trained in general medicine and 22 in cardiology in the 6 years they are spending as 23 Specialist Registrars. Slightly less than half will be 24 accredited in just cardiology, i.e. not requiring 25 general medical expertise at this time. 0026 1 The Registrars that are seeking dual accreditation 2 in general medicine and cardiology will need to spend at 3 least a year in the district general hospital doing 4 general medical take. The exact training programme, 5 even now, is still being debated by the Royal College of 6 Physicians and the British Cardiac Society, and still 7 changes are occurring. 8 Q. What does the British Cardiac Society think the pattern 9 ought to be? 10 A. Well, we, as cardiologists, feel that the training for 11 general medicine should occur in the first part of the 12 six-year programme, and certainly in the first two 13 years, but then the last three years at any rate, we 14 feel, the British Cardiac Society, should be devoted 15 purely to cardiology, because it is such a huge 16 subject. The College of Physicians feel that the final 17 year, or at least some of the time in the final two 18 years, should be spent doing general medical take, which 19 is tending to take the Specialist Registrar back to the 20 DGH to get his on-take experience. That is causing 21 considerable difficulties. 22 So even now, two years on, we still have not quite 23 got the training sorted out for these dual accreditation 24 Specialist Registrars. Generally it is working out 25 reasonably well in most centres, but the nub of the 0027 1 facts are that in the first year, or possibly first two 2 years, much of the Specialist Registrar's training will 3 be in the DGH, where he will get his or her on-take 4 experience, plus his early cardiology training, which 5 may include catheterisation at the DGH. If it does not, 6 then it is possible he could spend a day a week perhaps 7 in the tertiary centre learning cardiac catheter skills 8 from the DGH. 9 Q. As well as the catheterisation techniques that would be 10 learned, there have been developments which this paper 11 highlights in echocardiography as well. If we look at 12 the foot the middle column, the very bottom, 3.6: 13 "The provision of cross-sectional echocardiology 14 combined with doppler facilities and colour-flow imaging 15 should now be regarded as the norm within district 16 hospitals." 17 So that is 1994? 18 A. Yes, absolutely. 19 Q. And then, further down, there is a reference to: 20 "...new techniques such as transoesophageal 21 echocardiography, which are likely to spread to district 22 hospitals as cardiologists trained in the procedure are 23 appointed to such posts." 24 Can you explain to me what benefit 25 transoesophageal echocardiography brings? 0028 1 A. The standard transthoracic echocardiogram just involves 2 a probe on the front of the chest, and inevitably the 3 structures at the front of the heart are better 4 visualised than the structures at the back. To get at 5 structures at the back of the heart, particularly the 6 left atrium and the mitral valve, and also in patients 7 who have had valve replacements, where acoustic shadows 8 are cast by the metal struts of the valves, we can get 9 much better imaging by sliding a probe down the 10 oesophagus, much in the form of an endoscopy, and 11 looking at the back of the heart with this technique. 12 Q. When did this technique come on the scene? 13 A. I would think at least 5 years ago, and is now being 14 used in a lot of district general hospitals, many, many 15 consultant cardiologists are having to learn the 16 technique themselves, and then train their Specialist 17 Registrars subsequently. It is becoming an absolutely 18 fundamental part of echocardiography, and all Specialist 19 Registrars will be trained in it. 20 Q. Can I move ahead to BCS 210/3, please. Just to recap 21 before we come to this latest document, the changes that 22 we have seen up to 1994 can be summarised as follows, 23 could they: that the district general hospital 24 cardiologist has been increasingly engaged in advanced 25 techniques which were previously the province of the 0029 1 regional centre? 2 A. Correct. 3 Q. Therefore, it is important that the district hospital 4 cardiologist has a greater degree of expertise, not just 5 at the screening stage but at the invasive procedure 6 stage, than would have been necessary 15 years ago when 7 the district general hospital was simply a screening 8 operation? 9 A. Yes. I mean, 15 or 20 years ago, it would probably have 10 been impossible to have obtained a consultant cardiology 11 post with very little if any cardiac catheter 12 experience, but that would simply not be the case now 13 and all appointments would be expected to have done 14 quite a lot of cardiac catheterisation, even if they 15 were not going to do it in their DGH post. 16 Q. I think this is after the end of the Inquiry's period, 17 but it brings this little topic up to date: 203 is 18 a recent publication from the Society's journal, Heart, 19 November 1997, another Working Group of the Royal 20 College and the British Cardiac Society. We see the 21 conclusions of the Working Group in the left-hand 22 column, the sixth of which is: 23 "Some centres will be linked with paediatric 24 cardiology and paediatric cardiac surgical units ... 25 "The provision of cardiac and cardiac surgical 0030 1 services continues to fall short of the target set in 2 1994, with long waiting lists for elective and urgent 3 cases and difficulties in transfer of patients for 4 emergency treatment existing in many parts of the 5 country." 6 Then 2.3, picking up the subject I have been 7 dealing with: 8 "The recent expansion in number of the district 9 general hospital cardiologists in the separation 10 purchasers and providers have resulted in changes in the 11 relation of the regional centres with their surrounding 12 districts." 13 This is the result of the purchaser/provider 14 split. 15 "Increasingly, DGH physicians are catheterising 16 their own patients, either within their nearest centre 17 or in catheterisation laboratories in their own 18 hospitals, which are sometimes shared with adjacent 19 districts. 20 "Patients are then referred for surgical 21 treatment, often without the involvement of the 22 cardiologist in the centre. The development of DGH 23 cardiac catheterisation laboratories has been driven by 24 the shortfall in existing facilities, the convenience 25 for patients of not having to travel long distances for 0031 1 investigation, the training of cardiologists based in 2 the centre, which places strong emphasis on invasive 3 investigation ... and by the potential for Trusts to 4 generate income." 5 This pattern of the district general hospital 6 cardiologist doing the catheterisation treatment and 7 then perhaps referring direct to the surgeon at 8 a centre, and as it were, cutting out the cardiologist 9 at the centre: is that something that is a concern of 10 the British Cardiac Society? 11 A. There are concerns which have been expressed. The first 12 is that a patient, as you say, may arrive in the 13 tertiary centre having been referred from the DGH and 14 the physicians and cardiologists in the tertiary centre 15 basically do not know the patient. So what most centres 16 now do is make sure that they come in under a consultant 17 cardiologist in the tertiary centre, who then takes 18 over, as it were, the care for the duration of the time 19 with the relevant surgeon. Often other medical 20 procedures, such as permanent pacing, et cetera, are 21 required after surgery, so they do need a consultant 22 cardiologist as well, as part of their care. That is 23 becoming the normal role. 24 The second thing that is happening is that the 25 shift of routine investigation from the tertiary centre 0032 1 out to the periphery has changed completely the sort of 2 work which is now being done in the tertiary centre. 3 Whereas ten years ago a lot of the work would have been 4 routine investigation, very little routine investigation 5 now occurs in the tertiary centre, which now devotes its 6 time much more to interventional procedures such as 7 angioplasty, valvulopasty, and so on. 8 Q. So the tertiary centres become super specialist? 9 A. It is becoming super specialist, yes, it is. A lot of 10 the early routine catheter training which the Specialist 11 Registrar needs has to be done in the DGH. 12 Q. Can I have BCS 1/78, please? This document, as we see, 13 is a discussion of the role of catheterisation 14 laboratories in district general hospitals in the 15 context of the development of the internal market. We 16 do not know, I have not been able to find out when this 17 paper was written, but we know that it was published in 18 1994. 19 If we go to page 80, please, and just blow up the 20 top two-thirds of that page, can I ask you to have 21 a look at that section under the heading "Contracting 22 arrangements" and tell me whether or not the problems 23 highlighted there have resolved or got worse, or what 24 has happened since. 25 A. The whole purchasing system is changing as we speak now, 0033 1 and I think the comments being made here really no 2 longer are as relevant. Certainly, when the DGH started 3 to take over the routine investigation work, great holes 4 appeared in the funding for the tertiary centre, because 5 suddenly a lot of its work was being removed and 6 performed in the district general hospital. One 7 hospital in Scotland told me one third of its budget had 8 suddenly disappeared as soon as the peripheral DGH 9 started work, so there were in the early days 10 considerable fund movements. But I think things have 11 settled down a bit in the sense that the tertiary centre 12 is now taking over more interventional work, which is 13 obviously per case more expensive, so that the actual 14 end result in funding has not altered very much. 15 Q. Let us look at another document, BCS 1/67. This is 16 evidence from the Society of which you are the President 17 currently, the British Cardiac Society, to something 18 called the Cardiac Specialty Review. That was, I think, 19 concerned with the review of London health service 20 provision generally. We see from the foot of this page 21 that the evidence is dated 6th April 1993. 22 The passage I want to go to is the next page, 23 page 68. We see paragraph 2.1: 24 "The Cardiac Specialty Review has the task of 25 recommending how cardiac services in and around London 0034 1 may be organised and configured in a way which provides 2 London with high quality and accessible cardiac care 3 avoiding unwarranted duplication, providing a stronger 4 service and an academic base for the future. 5 "2.2: In considering the task and its advice, the 6 British Cardiac Society Working Party was heavily 7 influenced by the fourth report of a Joint Cardiology 8 Committee of the Royal College of Physicians of London 9 and the Royal College of Surgeons of England [which we 10 will see with Dr Godman]. 11 "This report was agreed by the Councils of the 12 two bodies, thus indicating wide professional support. 13 Beyond this, the Working Party has made certain 14 assumptions, discussed in the paragraphs that follow. 15 "(i) Over time, regions outside London would move 16 progressively towards self sufficiency with cardiac 17 services other than those which were highly specialised 18 or dealt with conditions of low frequency. This 19 situation does not, of course, prevail today with some 20 well-known current substantial inflows, e.g. from the 21 South Western and Oxford regions, and from South Wales." 22 Help us, if you can, with the nature of those well 23 known substantial inflows from the South West and from 24 South Wales? 25 A. I cannot tell you a huge amount, because I was not one 0035 1 of the centres that was taking these patients, but 2 certainly, the Royal Brompton Hospital had a substantial 3 flow of patients from the South West of England, from 4 Devon and Cornwall, and also from South Wales. 5 Q. And they would be going for cardiac surgery? 6 A. They would be going for both investigation for cardiac 7 catheterisation and subsequently cardiac surgery, 8 because in those days there was no catheter laboratory 9 in Devon or Cornwall, to my knowledge. 10 Q. But there would have been one in Bristol, for example? 11 A. There would have been. Obviously some of the patients 12 were going to Bristol and some were coming to London and 13 some were going to Southampton. 14 Q. Was the pattern that certain areas, as it were, sent 15 their people to Bristol and other areas sent their 16 people to London, or was the pattern rather that each 17 area would send some to Bristol and some to London? 18 A. I think it was more dependent probably on personal 19 relationships between cardiologists, that these flows 20 were originally established. I do not know how they 21 were originally established, but I know that 22 cardiologists from London would go down to the South 23 West and occasionally do clinics and so on there. So 24 links were established and close interpersonal 25 relationships were established which I think influenced 0036 1 the direction and flow of patients. 2 Q. So there was a substantial inflow of patients coming 3 from the furthest South West of England, as it were 4 driving past Bristol and going to London to be treated, 5 perhaps having been seen in an outreach clinic by 6 a cardiologist from a London hospital? 7 A. I think that is true. I have no figures, but certainly 8 I was aware of the fact that patients were coming up 9 from Cornwall to the Brompton, yes. 10 Q. Adult patients, children or both? 11 A. I only know about adults; I do not know about children. 12 Q. Are you able to help us with when this flow of patients 13 might have started? Is it a phenomenon that had been 14 well-known for a long time by 1993? 15 A. Yes. It was well-established by 1993. It was 16 established by cardiologists at Brompton who have now 17 long since retired, so it was in the 1980s. 18 Q. This evidence to the Cardiac Specialty Review deals 19 briefly with paediatric cardiac surgery at page 76. 20 At the foot of the page: 21 "The working party was grateful to Dr Hunter and 22 the British Paediatric Cardiac Association [Dr Godman's 23 association as it now is]. Their recommendations were 24 supported by both the working group and the plenary 25 meeting." 0037 1 Over the page, 77, the British Cardiac Society 2 made the suggestions we see set out at 6.2, and that 3 rationalisation was necessary. That is the last one. 4 Then down the page, please: 5 "6.4: Against this background, the conclusion of 6 the BPCA, and our own, is that rationalisation should 7 take place to produce two comprehensive paediatric 8 cardiac units for London." 9 Can you help us with what the mechanisation would 10 be for who is going to ensure there would be only two 11 paediatric cardiac units in London? 12 A. I think that is a very difficult question to answer. 13 There is no legislation which says "You will now close 14 your paediatric unit" and, as you know, at the time this 15 report was written, there was a unit at Guys, a unit at 16 Great Ormond Street and a unit at Brompton, all of them 17 thriving, and really, only recently, as a result of 18 mergers of hospitals and medical schools, has the 19 situation been rationalised, or is being rationalised 20 slowly, although those three paediatric units still 21 exist. Indeed, there was a certain amount of paediatric 22 activity also going on at the Hammersmith hospital, too 23 small a unit in many people's eyes to continue. 24 Q. In making this recommendation, how did the Society 25 envisage that the rationalisation would take place? 0038 1 A. Essentially enlarging the two units which I think they 2 felt should "take over", in inverted commas, and 3 I suppose, reducing the patient flows to the third unit, 4 but they had no way of legislating to prevent physicians 5 and paediatricians on the periphery referring patients 6 to any one of those three units. 7 Q. Those patients who have been referred to these units 8 would be referred by the cardiologists in a particular 9 General Hospital and would be funded by a particular 10 Health Authority, which by this time was purchasing the 11 care provided by a particular Trust. Is there any 12 mechanism for saying to a cardiologist in a district 13 general hospital, or perhaps at management level to 14 the purchaser, "We want you to send your work now to 15 Mr X, hospital Y"? 16 A. Yes. Indeed, that happens. Occasionally now we have 17 the message "This has not been funded here. This work 18 will be done locally or at a district trust". Indeed, 19 that happens. At the time this report was written, I do 20 not think it was. 21 Q. I just want to deal briefly, it may be we are moving 22 away from your own patch. If I am, do tell me. 23 So the Panel has the principles in mind at this 24 stage, we will be hearing evidence in due course from 25 experts in all of these specialities, but it is accepted 0039 1 wisdom, is it not, that paediatric cardiology has now 2 been recognised as being a quite different specialty 3 from adult cardiology? 4 A. Absolutely, yes. 5 Q. And that the links with other branches of paediatric 6 medicine are very important? 7 A. Yes. 8 Q. Does the British Cardiac Society have a view as to the 9 structure within which paediatric cardiac services are 10 best delivered at the end of the 20th century? What 11 kind of structures would they be? 12 A. I think the feeling is that a paediatric cardiac unit 13 should be part of a larger more general paediatric unit, 14 because of the need for ancillary paediatric services. 15 One of the concerns we have is of a dedicated single 16 site paediatric cardiac unit in the absence of general 17 paediatrics, for instance, much in the same way of 18 isolated adult cardiac surgery in a unit without general 19 medical facilities. 20 The fact is that in London the feeling is that we 21 are gradually devolving to two large units, as specified 22 in this 1993 report. It is taking time to get there, 23 but it is, I think, going to happen. Both of those, 24 certainly the Great Ormond Street one, is in obviously 25 a unit which has a large number of general 0040 1 paediatricians in general paediatrics available. 2 Q. I want to deal with a couple more issues, and then 3 I will be through. Dealing first of all with the 4 collection of data and audit, if we go to BCS 1/60, 5 please, the British Cardiovascular Intervention Society 6 is one of the affiliates to the British Cardiac Society, 7 as we saw earlier. This is a paper from 1992, the 8 British Heart Journal, volume 68. It is reviewing 9 cardiac interventional procedure in the United Kingdom 10 during 1990. 11 If we move to page 61, in the right-hand column: 12 "Paediatric interventional procedures, table 11: 13 "The total number of procedures increased by 14 26 per cent since 1989. The range of procedures widened 15 to include... dilatation of subaortic stenosis and 16 closure of ventricular septal defects. The paediatric 17 interventional procedures had a low mortality and 18 morbidity, with the exception of balloon dilatation of 19 the aortic valve. Comments on the 1990 survey of 20 procedures. Many cardiac units still had difficulty in 21 providing complete data. There was no improvement since 22 the 1989 audit." 23 Why should those difficulties have been present in 24 1990, about providing data? What is the key to 25 understanding that? 0041 1 A. I do not know. The fact is that the audit from the 2 British Cardiovascular Intervention Society has been 3 going every year since 1988, so 11 years, so all the 4 units have had plenty of time to get their databases 5 together. 6 I think one of the problems is that a large amount 7 of data has to be put into the computer and perhaps 8 personnel are just not available to do it. I mean, 9 there is no other reason. The software required is not 10 expensive or difficult and the amount of patient flows 11 are not huge, so theoretically the doctor should be able 12 to feed the data in. 13 Q. It would be the doctor who would feed it in? 14 A. The doctor would feed in the data after each individual 15 procedure. The British Cardiovascular Intervention 16 Society is demanding more information about each patient 17 and it is becoming a more and more daunting prospect at 18 the end of a procedure to fill all the data in, but it 19 is possible and very much easier now than when this 20 paper was written. 21 Q. Why? 22 A. I think people are gradually realising that audit is 23 a fundamental requirement of medical practice. When 24 this paper was written, it was perhaps seen as less 25 fundamental. Now we have 58 centres in the country 0042 1 doing angioplasty, and I think the returns are very much 2 tighter and harder than they were in these days. 3 Q. At the moment there is something called the Central 4 Cardiac Audit Database which has been highlighted? 5 A. Yes. 6 Q. If we go to BCS 2/19, please, the left-hand side -- just 7 blow that left-hand side up, please -- the Central 8 Cardiac Audit Database was being piloted in six 9 centres. The pilot phase was due to complete this very 10 month in 1999. Are you able to help with what has 11 happened to that? 12 A. It has been delayed by about six months. One of the six 13 centres was having a bit of a problem with its software 14 and had to delay its data input, so the three-year 15 project has been extended by another six months. 16 Essentially, the idea, when it was piloted three years 17 ago, was to see if it was possible to collect data on 18 all cardiac activity in a unit, centralise it with total 19 security, encrypted security, for the use of 20 establishing norms, standards and outcomes. 21 Q. Is it possible to do so? 22 A. Well, I think it is possible, but it will require 23 a large amount of money and personnel. There is a huge 24 amount of data already collected from the six centres. 25 I am not really an expert in the actual data collection, 0043 1 but the hope was that the CCAD would roll out to all 2 cardiac units in the country. We are waiting to hear 3 from the Department of Health whether a grant is going 4 to be available to allow that to happen. It will be 5 a very expensive undertaking, because at least two 6 personnel are probably required for each unit, just to 7 feed in all the data. We are talking about angioplasty, 8 pacing, catheters, all cardiac surgery, anaesthetic 9 problems, and all congenital and paediatric cardiac 10 disease. 11 It is a huge amount of data, but it is possible, 12 if the money is available to fund the personnel, yes. 13 Q. We touched at the beginning on the fact that the British 14 Cardiac Society involves both cardiologists and cardiac 15 surgeons, although surgeons have their own organisation 16 as well. 17 In some of the publications in the British Heart 18 Journal, the topic of learning curves and developments 19 of new techniques is touched upon. Can I show you 20 BCS 3/17, please? This is a paper from 1984, volume 52 21 of the British Heart Journal, by Dr Shinebourne, who was 22 then and I think is now a cardiologist at the Brompton 23 Hospital in London? 24 A. Correct. 25 Q. And a paediatric cardiologist at that? 0044 1 A. Correct. 2 Q. I do not want to get into the details of this article, 3 but it touches on the question of consent and new 4 operations. If we go to page 19, please, I should say 5 that we have seen from page 17 that this was published 6 as an editorial, so this would have been an article 7 commissioned by the then editor of the British Heart 8 Journal? 9 A. Yes. It would have been an invited article, yes. 10 Q. We see at the foot of 599, the left-hand column, 11 Dr Shinebourne said this: 12 "It is salutary to compare the extensive debate of 13 the ethics of implanting an artificial heart in an adult 14 with the lack of debate of the ethical issues involved 15 in introducing the arterial switch procedure in children 16 with transposition of the great arteries, since use of 17 the arterial switch operation in children presents 18 a similar ethical dilemma. Intra-atrial repair of 19 complete transposition of the great arteries by either 20 the Mustard or Senning techniques has been widely used 21 for more than ten years." 22 This was 1984. 23 "By the mid-1970s, hospital mortality for 24 correction of simple transposition of the great arteries 25 by the Mustard technique was reported as being less than 0045 1 10 per cent in several large series, even when the 2 operation was performed in the first year of life. 3 Similar results were reported for the Senning's 4 procedure. In contrast, when a ventricular septal 5 defect was additionally present, mortality for 6 intra-atrial repair, plus closure of the ventricular 7 septal defect, was higher, between 25 and 30 per cent." 8 Then he explains the development of the switch 9 operation. 10 Picking it up in the middle of the right-hand 11 column: 12 "An editorial in the British Medical Journal at 13 the time, while praising the surgical expertise shown in 14 the arterial switch, commented on neither the ethical 15 implications of the procedure nor the selection of 16 patients. In many cardiac surgical units, this 17 operation was then tried and small groups of patients, 18 both with and without ventricular septal defect, with 19 considerable mortality. At the same time, the concept 20 of correction of simple transposition of the great 21 arteries in two stages was introduced. In the first 22 stage, the pulmonary artery is banded to repair the left 23 ventricle to sustain the systemic circulation before 24 anatomical repair in the second stage. New surgical 25 procedures must be developed and used, as they are 0046 1 believed to offer a greater benefit to the patient than 2 previous techniques. In the individual child, however, 3 the decision of which procedure to follow is difficult, 4 as even in the best hands, the hospital mortality for 5 arterial switch operations is still higher than for an 6 inter-atrial repair." 7 So in 1984 a new technique had been developed 8 which was showing a higher mortality than the existing 9 technique, the Mustard or the Sennings. 10 Then, picking it up at the foot of the page, 11 Dr Shinebourne said this: 12 "The prospect of improved long-term survival 13 (through the arterial switch) will possibly correct 14 remains hypothetical, as even a successful initial 15 outcome from anatomical repair does not preclude late 16 complications, some of which have been reported. The 17 ethical justification for having introduced the 18 two-stage procedure for simple transposition of the 19 great arteries in 1977 remains debatable, as does that 20 for a recent study of patients operated on between 21 December 1980 and July 1982, in which the cumulative 22 mortality was 52 per cent in the 25 patients in whom 23 successive parts of the two-stage procedure, pulmonary 24 artery banding followed by arterial switch, had been 25 attempted. As the surgical unit concerned includes 0047 1 experienced surgeons, mortality from inter-atrial repair 2 alone would reasonably have been expected to be less. 3 "The last two sentences of the related abstract 4 are quoted below, in which the authors concluded, 'that 5 both stages of the procedure have high mortality and 6 morbidity, especially when banding is performed on very 7 cyanotic infants or older patients. Thus, we abandoned 8 this way to prepare the left ventricle. Since July 1982 9 a new protocol with neonatal banding and early switch is 10 in process, with encouraging results.' It might be 11 asked whether a hospital ethics committee or an 12 institutional review board would have agreed to this new 13 procedure ..." 14 Then the next paragraph, four lines down: 15 "Much of the development of cardiac surgery has 16 been associated with a high early mortality, which was 17 rightly or wrongly accepted when there was no 18 alternative. Now, when there are alternatives, one must 19 question the extent to which new operations should be so 20 freely attempted. To take the specific instance of 21 surgery for complete transposition of the great 22 arteries, on a ratio of risk to benefit, it could be 23 argued that, at least until the technical problems had 24 been solved, only patients with transposition and a 25 ventricular septal defect should have been considered 0048 1 for the switch procedure." 2 The conclusion was this: 3 "Patients in modern cardiac units could now be 4 argued to be more at risk from therapeutic research, 5 such as innovative surgery, than they are from 6 non-therapeutic research. To protect both the patient 7 and the pioneering surgeon, I suggest that new 8 operations should be subject to the same ethical review 9 as other research procedures. Would this encroach on 10 clinical freedom?" 11 There is a quote from the British Medical Journal 12 and we see the quote. 13 That is in 1984 discussing a particular operation, 14 the move to arterial switch. Does the British Cardiac 15 Society have a view as to whether or not the suggestion 16 that is made by Dr Shinebourne (that new operations 17 should be subject to the same ethical review as other 18 research procedures) should or should not be the 19 position today? 20 A. The British Cardiac Society has not discussed this 21 particular issue, i.e. new operations. Generally 22 speaking, being largely a "medical" society of 23 cardiologists -- 24 Q. But there are surgeons? 25 A. There are surgeons who have meetings, in the British 0049 1 Cardiac Society meeting, and obviously will discuss new 2 operations. The fact is, as it says, new operations 3 always have a higher mortality initially. Why is a new 4 operation necessary? The operation I am referring to, 5 the Mustard and Senning procedure, does have problems in 6 later life, so it is not a perfect operation. If it was 7 a perfect operation, they would not need any other form 8 of surgery. But clearly, there needs to be some 9 discussion as a group of surgeons as to a possible new 10 operation -- there are no animal models to, as it were, 11 test the operation out -- and then it needs to be put in 12 front of an ethical committee, as Dr Shinebourne 13 suggests. 14 Q. There is obviously a difference between the development 15 of the new technique where previously there was no 16 technique at all, where the surgeon or the cardiologist 17 would say, "Until the development of this technique, 18 there was nothing we could do, but now we can try this", 19 on the one hand, and on the other hand, the development 20 of a new technique where there is an existing technique, 21 where it is thought that the new technique might provide 22 better and longer life, but at least initially with 23 a higher mortality. 24 At the moment, as I understand it, there is no 25 formal structure in which debate would take place as to 0050 1 when and in what respects the new technique would be 2 developed in that second example; is that right? 3 A. Well, not quite right. Every hospital has its ethical 4 committee with lay members on the board, and certainly, 5 if you were planning, for instance, to try a new drug or 6 a drug trial on the medical side, you would submit the 7 protocol to the ethical committee. 8 Q. So the surgeon who wanted to do a new operation would 9 submit the proposal to the committee? 10 A. That would be appropriate, yes. 11 MR MACLEAN: Dr Swanton, thank you very much. Does the 12 Panel have any questions for Dr Swanton? 13 MRS MACLEAN: Yes. 14 Examined by THE PANEL: 15 MRS MACLEAN: Dr Swanton, I am not sure whether you may be 16 able to help me with this point or not, but I am 17 interested in the low representation of cardiologists in 18 the South West area, in the surveys that we have 19 discussed this morning. 20 I wonder if you have any views on or any ideas 21 where we could investigate why there should be such 22 a low proportion of cardiologists in the South West? 23 A. It is certainly nothing to do with a terrible place to 24 live, it is a most wonderful place to live, so it has 25 nothing to do with the environment. 0051 1 I think part of the problem was the shortage of 2 large hospitals in this part of the country. I mean, 3 I do not know the area terribly well, but as it stands 4 at the moment, in Cornwall there is one large unit in 5 Truro and then, coming more in this direction, we have 6 Plymouth. There are just those two units. Until 7 recently, Plymouth did not have cardiac surgery and this 8 city was the only centre for cardiac surgery in the 9 whole of the South West of the country. 10 The population is certainly big enough to justify 11 it, but for some reason the development did not occur. 12 Whether that was a local issue amongst the physicians, 13 I just do not know, but it is still a problem, as I said 14 earlier, in other parts of the country at the moment. 15 There are big geographical holes in cardiac service 16 provision in the country. I do not want you to feel 17 that the South West is alone by any means. There are 18 huge black holes still. 19 MRS MACLEAN: Thank you very much. 20 MRS HOWARD: Dr Swanton, just two questions. Given the 21 comments that have been made this morning about lack of 22 resource in respect of cardiologists, do you have any 23 view on the development or the philosophy of peripheral 24 clinics, particularly in respect of specialists from 25 a tertiary centre feeding district hospitals? 0052 1 A. You mean specialists going out from tertiary centres 2 to -- no, indeed we support that, and in fact it is 3 happening. We send a surgeon out to one of our 4 referring centres every month, to do a sort of joint 5 clinic, and it is very much appreciated by both units. 6 It ensures very good communication and patients like to 7 see their surgeons after the operation, and it works 8 very well. It is time-consuming. It takes essentially 9 a whole day out of the surgeon's or cardiologist's week 10 by the time you have got down there and back again, but 11 it is very valuable. 12 I think in time, it will become less important as 13 more of the DGHs have established two cardiologists 14 per hospital. A lot of these cardiologists are single 15 cardiologists in a hospital managing a whole unit on 16 their own with no support. They are the people who need 17 the outreach support from London or the big cities. 18 Q. The point round the tracheoesophageal echocardiograph: 19 is that a technique used for infants or other children? 20 A. Yes. Obviously there are different sized probes, but it 21 can be done for all age groups as an outpatient 22 procedure under minimal sedation. In children it can be 23 done under general anaesthetic, and it can be done in 24 theatres during surgery. It has a widespread 25 application for all age groups. 0053 1 Q. Was that the situation from the beginning of the 2 introduction of that procedure, or is that something 3 that has happened more recently? 4 A. You mean the infants and children? I do not know. 5 I think you have to ask Dr Godman. I think the adult 6 came on first, following from the endoscope, and then I 7 think they miniaturised them, but you would have to ask 8 Dr Godman that. 9 MRS HOWARD: Thank you very much. 10 PROFESSOR JARMAN: Three questions. The first is 11 a double-barrelled one. In one of the earlier papers we 12 had, BCS 1/51, of the papers you gave us, it mentions 13 that the number of Senior Registrars and 14 lecturers -- Specialist Registrars now, I suppose -- 15 would be inadequate to provide a full period of training 16 from most who advanced to consultant status, and the 17 situation will worsen from 1995 onwards. 18 A. That is the paediatric report. 19 Q. Yes, the 7th survey of Staffing in Cardiology in the 20 United Kingdom in 1991. This was in relation to your 21 comment that earlier on that gastroenterologists would 22 manage people that came in. 23 The question is, do you think there is still 24 a problem? 25 Secondly, people coming into casualty now with 0054 1 cardiac problems, say acute chest pain: would they be 2 likely to get a cardiologist? 3 A. Increasingly so. The problem is getting less as the 4 number of cardiologists in the country increases, and 5 more and more papers appear which show that outcome data 6 show that your prognosis is better if you are looked 7 after by a cardiologist rather than a gastroenterologist 8 if you come in with a heart attack. It is pretty 9 self-evident, but it has to be proven. 10 Q. So you think the situation is improving? 11 A. It is improving, and more and more of these patients are 12 being looked after by cardiologists, yes. 13 Q. We had a reference earlier on in one of the papers you 14 sent us, BCS 3/9, about this CUSUM technique, for people 15 to work out their position in terms of how they are 16 doing. 17 A. Yes, the paper that Mark De Laval had written. I do not 18 know enough about the statistics of the actual 19 technique, but it gives you a way of determining case by 20 case whether you are actually exceeding the standards, 21 going over the line, as it were. 22 Q. Are people beginning to adopt that? 23 A. I think so. I think Mark is a unique man. I went to 24 his presentation five years ago. It was absolutely 25 stunning. He is a very unusual man, and surgeon and a 0055 1 statistician at the same time. But it is becoming more 2 of an accepted technique, yes. 3 Q. The third question is, I just wonder whether any of the 4 aorta problems at the Bristol Royal Infirmary which we 5 are dealing with came up at all at the British Cardiac 6 Society, or whether there are any publications? 7 A. No, not a thing. 8 Q. Do you think it might have been something you would have 9 discussed, or not? 10 A. If it had been discussed, it certainly was not discussed 11 in the open forum. I do not think I have any 12 recollection of even a whisper of it being discussed in 13 open forum at any meeting of the British Cardiac 14 Society, no. 15 Q. Do you think it might have been something that could 16 have been discussed, or not? 17 A. Yes, it is something which might have been brought up in 18 one of the surgical forums, certainly. 19 PROFESSOR JARMAN: Thank you very much. 20 THE CHAIRMAN: I have no questions. 21 MR MACLEAN: In that case, thank you very much, Dr Swanton. 22 I wonder, Chairman, if that might be a convenient time 23 to have a short break. 24 THE CHAIRMAN: Yes. First, may I echo on behalf of the 25 Panel our thanks to you. We are very grateful to you 0056 1 for having come to talk to us. Yes, we will reconvene 2 at 11.15, thank you. 3 (11.00 am) 4 (A short break) 5 (11.15 am) 6 MR LANGSTAFF: Sir, our next witness is Dr Michael Godman, 7 who is the President of the British Paediatric Cardiac 8 Association. 9 Dr Godman, you know that our procedures are that 10 we stand for the oath. 11 DR MICHAEL GODMAN (Sworn): 12 Examined by MR LANGSTAFF: 13 Q. Dr Godman, you are Michael James Godman? 14 A. That is so. 15 Q. Your professional address, please? 16 A. The Royal Hospital for Sick Children, Edinburgh, and the 17 Royal Infirmary, Edinburgh. 18 Q. You are currently President of the British Paediatric 19 Cardiac Association? 20 A. I am. 21 Q. You have been that since 1997? 22 A. That is so. 23 Q. If we can have on the screen, please, witness 47/1, this 24 is the start, I think, of a formal statement which you 25 have made on behalf of the BPCA to this Inquiry, and if 0057 1 we can have on the screen, please, the bottom of 47/13, 2 you sign it on behalf of the association at the end? 3 A. Yes. 4 Q. We are going to take your statement as read, but what 5 I want to do is to ask you a number of issues that arise 6 from it and explore one or two that you raise in it. 7 You are quite happy, I think, in the statement 8 generally to set out the stall of the BPCA on a number 9 of issues? 10 A. Yes, we are. 11 Q. And you end with a plea for a greater role for the BPCA 12 in the future, in terms of a regulatory function? 13 A. Yes. Perhaps with others rather than in isolation, 14 because as you appreciate, we are a small organisation, 15 representing not just paediatric cardiologists but also 16 paediatric cardiac surgeons, nurses and technical staff. 17 Q. You make the point, throughout, I think, your statement, 18 that the BPCA is a multi-disciplinary body, so you have, 19 amongst your membership, cardiologists, paediatric 20 cardiac surgeons, and paediatric nurses? 21 A. That is so, as well as technical staff and pathologists 22 and others that work in fields related to paediatric 23 cardiology. 24 Q. It was the others I was going to ask you about. 25 Anaesthetists? 0058 1 A. Yes. It will not be comprehensive and we would not 2 claim that all those involved in paediatric cardiac 3 anaesthesia are members of the BPCA, but we encourage 4 them to be and we believe increasingly they are being 5 associated with the work of the Association. 6 Q. And intensivists? 7 A. I put them very much in the same category. 8 Q. By "technicians", do you include perfusionists? 9 A. Yes, and the physiological measurement technicians who 10 help with the cardiocatheter procedures, 11 echocardiographers. 12 Q. You tell us that the Association came into being in 13 1991. Was there any forerunner to it? 14 A. Yes, there was, but it was a fairly informal association 15 of those who worked primarily, although not always 16 exclusively, in paediatric cardiology. From the 17 mid-1970s a group of those who worked regularly in 18 paediatric cardiology met on a regular basis and 19 encouraged all those others, for example, those within 20 the compass of the present BPCA, to attend an annual 21 meeting where problems relating to medical paediatric 22 cardiology and paediatric cardiac surgery would be 23 discussed. 24 Q. The reason I assume that must be the case is if one 25 looks at BPCA 1/1, if we can have that on the screen, 0059 1 you refer in your statement to the Joint Working Party 2 as being one of the first tasks that the BPCA had to 3 undertake? 4 A. Yes. 5 Q. Yet we see that in the top left-hand corner, under 6 "introduction", a little bit further down, the Working 7 Party was actually set up in 1988? 8 A. Yes. 9 Q. So plainly it was set up with the blessing or the 10 contribution of the forerunners of your present 11 Association? 12 A. Yes. We would like at least to suggest, at the 13 initiative and impetus of those who were involved in 14 that forerunner organisation. 15 Q. What was the main impetus in changing what had been 16 a loose association of those interested in the area to 17 the rather more formal Association that you now 18 represent? 19 A. I think we were increasingly aware, throughout the 20 1980s, that we were a small body, a small number of 21 specialists; that in terms of making our professional 22 voice heard, particularly in terms of the pattern of 23 interdisciplinary working which we thought was the 24 foundation or should be the foundation of modern 25 paediatric cardiac surgical practice, that could only be 0060 1 achieved through probably two avenues: one formerly 2 constituting ourselves and then allying or affiliating 3 ourselves to a much larger organisation, ie the British 4 Cardiac Society, where at least there might be strength 5 in numbers. As a small group, we were inevitably always 6 going to be disadvantaged because of our numbers. 7 Q. So you were more than an interest group? 8 A. Very much more, yes. 9 Q. You draw particular reference in your statement to the 10 Constitution of the Association, which we see at 47/14, 11 please. I want to focus on article 2, "Purpose". You 12 say that the philosophy of the Constitution anticipated 13 many of the changes which are now almost taken as 14 commonplace? 15 A. Yes. 16 Q. So can I just explore that with you for a moment? You 17 are recognising that there have obviously been 18 significant changes in the treatment of paediatric heart 19 problems from 1991 to date? 20 A. Yes, indeed. 21 Q. And you are, I think, claiming in making that comment 22 that your association in 1991 anticipated what is now 23 commonplace and what, therefore, by implication was not 24 then? 25 A. That is true. 0061 1 Q. What is it about the purpose -- because I think that is 2 where the philosophy is expressed, is it not, in the 3 purpose of the Constitution? 4 A. Yes. 5 Q. If we just look at section 1, what is it about the 6 purpose that was new or was -- 7 A. I do not have anything on my screen. I am at 8 a disadvantage compared with others. 9 THE CHAIRMAN: That is my fault and I apologise. 10 MR LANGSTAFF: Let me explain why that is. We have gone to 11 considerable lengths when parents have been giving 12 evidence to make sure nothing emerges on the public 13 domain on the screen which is not checked for 14 confidentiality. The system is in place. It does not 15 apply in the same way to evidence of people who 16 represent Associations such as yourself. 17 You now see what I am looking at? 18 A. Yes. 19 Q. Thank you for telling me it was not there. The 20 purposes, then, of the organisation, what is it about 21 those purposes that was new or a breath of fresh air in 22 1991 that had not been happening? 23 A. If I focus perhaps on the rather bland last line, 24 "promote communication and co-operation between these 25 workers"; "these workers" are those involved in the 0062 1 study and care of children, so we are talking about 2 a large group of people, some of whom have been 3 identified, the intensivists, anaesthetists, surgeons, 4 physicians and the technology staff. In the 70s and 5 80s, these would have come from a variety of different 6 backgrounds and in many centres, certainly, their 7 principal work would not be concerned with paediatric 8 cardiology or paediatric cardiac surgery; there might 9 for example be an anaesthetist whose majority sessions 10 were in anaesthesia, adult surgery. That might involve 11 intensive care units. 12 It is now accepted that the United Kingdom was 13 under-resourced in terms of paediatric care in the 14 1980s. That was not a problem not recognised by the 15 profession, it was very clearly recognised by the 16 profession, not least by groups like paediatric 17 cardiologists. We compared and performed poorly with 18 the patterns that were being identified and the 19 resources being provided for paediatric intensive care 20 in North America and in Australia, and indeed it was not 21 until the early 1990s that paediatric intensive care, 22 that it was identified as requiring very substantial 23 additional national resources. 24 So it was against that kind of background that we 25 thought all professionals involved in the care of 0063 1 children with heart disorders needed to collaborate in 2 a professional organisation with a professional forum, 3 to represent the patients and to represent the 4 professional viewpoint. 5 Q. So what you are anticipating, really, was the greater 6 degree of collaboration between the various disciplines 7 that the 1990s has seen? 8 A. Yes. We believe that is what our philosophy was founded 9 on, and would like to believe that we were anticipating 10 a number of these changes. 11 Q. You therefore believed it was necessary to have an 12 organisation to create collaboration? 13 A. Yes. 14 Q. And that in turn suggests that there had been an absence 15 of such collaboration until the movement grew perhaps in 16 the late 1980s? 17 A. Inadequate collaboration, yes. 18 Q. You make the point against that background that your 19 Association would wish to see the outcome of surgery or, 20 if I can call it, a hospital episode -- you understand 21 the bland phraseology -- as a result of teamwork? 22 A. Yes. 23 Q. Beyond, in fact, as I understand what you say, the team 24 itself, if we just have a look at the way you put it, it 25 is 47/8. It is in italics: 0064 1 "The Association believes strongly that the 2 analysis of surgical outcomes needs to be assessed on 3 the basis of organisational performance and 4 identification of system failures rather than focus only 5 on the surgeon as a determinant of outcome." 6 There, beyond what you have just said to me, the 7 team approach, which I think is inherent in your 8 Association, you are mentioning organisational 9 performance and system failures. 10 Are you saying here that the result of surgery 11 does not depend simply on the surgeon's knife? I am 12 putting it colloquially. 13 A. Yes. 14 Q. It goes beyond the surgeon, him or herself, to 15 presumably the team before and after, and the context in 16 which they are placed? 17 A. Very much so. 18 Q. Who do you see as being part of that chain, that team? 19 A. At the local level, that chain, I think very much has 20 been the hospital or the Trust; its executive management 21 team; its board in terms of establishing standards of 22 care, monitoring the standards of care, the quality of 23 care, implicit in that the quality of outcomes, and all 24 the away down to individual departments, individual 25 divisions within the hospital, within cardiac surgery, 0065 1 cardiology, anaesthesia, intensive care. But they have 2 all to be working to a commonly accepted and completely 3 well-recognised system that has been established by the 4 Hospital Board and the Hospital Trust in terms of 5 quality. 6 Q. So you are putting the responsibility for quality on the 7 Hospital Trust and the Board? 8 A. The final responsibility, yes, but implicit in that, if 9 it is well done, obviously, is that feeds all the way 10 through and down to the nurse in the Intensive Care 11 Unit, the middle grade junior doctor in the 12 cardiac-cath' laboratory and the technician or 13 radiographer in the x-ray laboratory. 14 Q. Putting flesh on that for a layman to understand, what 15 you are saying in effect is, is it, that if the child is 16 not identified early enough suffering from, let us 17 suppose, congenital heart disease, that may then 18 prejudice the ultimate outcome of any surgery that is 19 later attempted? 20 A. We could take that as an example, or if you want to, as 21 a more practical example, one might say that the Trust, 22 the executive management team, have the responsibility 23 of resourcing adequately at every level what is required 24 to produce an optimal outcome. Again, in practical 25 terms that might be a simple piece of equipment. It may 0066 1 mean monitoring carefully that that equipment is 2 repaired, upgraded, timeously. It may mean that 3 a particular member of staff, if he or she retires, is 4 replaced at the appropriate time. All of that will feed 5 into the quality of care and outcome. 6 Q. If one was looking, for instance, just following that 7 last example, at intensive care, we have heard evidence 8 already that in the Bristol Royal Infirmary there may 9 have been a limited number, if indeed there was more 10 than one, of bear cub ventilators. Is that the sort of 11 provision of equipment that you have in mind? 12 A. That could well be. 13 Q. So it is management set against the financial background 14 producing the ultimate outcome through the chain that 15 you have described? 16 A. Yes. Some might say, set within the financial 17 background rather than necessarily against it. 18 Q. Can I, with that background, just ask you about what you 19 say in a number of places about the question of whether 20 heart surgery on children should be centralised, 21 restricted to a number of larger centres, or more 22 dispersed. 23 What you say is at 47/10. It is under point 6, 24 the bottom of the page: 25 "The Association believes that very careful 0067 1 consideration would be required before reverting to the 2 philosophy of designated large supra-regional centres. 3 There is no doubt that certain minimal requirements 4 should be fulfilled in terms of human and other 5 resources before any centre is accredited." 6 You ask, if we just go back, I think, to one of 7 the BCS documents, can we have BCS 1/76, please. 8 This is 1993. It is the British Cardiac Society 9 evidence to the Cardiac Specialty Review. We looked at 10 it this morning with Dr Swanton. Here, in paragraph 6, 11 the bottom of the page, the Working Party was looking at 12 paediatric cardiac surgery. 13 "Most grateful for the assistance of Dr Hunt and 14 the BPCA. Their recommendations were supported by the 15 Working Group and the plenary meetings." 16 If we can turn over, you are looking for -- 17 admittedly in relation to London -- "centres providing 18 an adequate level of clinical activity, unnecessary 19 duplication of services ... and [in the London context] 20 rationalisation." 21 The "adequate level of clinical activity" is 22 something I think you emphasise in your present 23 evidence, so, returning from that for a moment, I take 24 it that the Association still supports those points? 25 A. Which ones, because we have looked at two separate 0068 1 documents. 2 Q. The ones made in 1/76 and 1/77. 3 A. Yes. I may qualify them later, as we develop this 4 theme. 5 Q. May we go back to your evidence at 47/10, please? 6 You go on, in that evidence, to say: 7 "No doubt certain minimal requirements should be 8 fulfilled in terms of human and other resources before 9 any centre is accredited. These would to a considerable 10 degree determine the critical mass required to provide 11 specialised services for paediatric cardiac surgery." 12 Is what you are saying that you cannot do the job 13 properly if you are too small? 14 A. Yes, that is so. That, I think, would be accepted as 15 a given, particularly in 1999. 16 Q. Does it then imply that the bigger the better? 17 A. It might appear so. That is part of our difficulty. 18 That is why we chose the sentence "Very careful 19 consideration would be required before reverting to the 20 philosophy of designated large supra-regional centres." 21 Q. You obviously have a membership drawn not only from 22 larger centres but smaller centres. Is this determined 23 "sitting on the fence", if I may call it that. Is that 24 in any sense a reflection of the width of your 25 membership? 0069 1 A. Absolutely not. Perhaps I could now qualify it just 2 a little. North of the border, in Scotland, through 3 1997/98, an exercise has been taking place on which the 4 Scottish Office has been reviewing with all 5 professionals in Scotland whether there should be one 6 centre for children's cardiac surgery or two in 7 Scotland. We know a similar debate has gone on around 8 many of the regions in England and Wales. 9 One of the things that was brought home most 10 forcefully and what has been a detailed exercise in 11 Scotland over a 15/18 months period, is the lack of 12 evidence to support the perhaps inherent belief that 13 larger is going to be better and the health economists 14 in particular have taken us quite properly to task for 15 the starting assumption that one centre would 16 necessarily be better than two, because in fact the 17 evidence is fairly thin. There is some evidence from 18 the Cardiothoracic Surgical Register in the 1980s, for 19 example, that the results for infant and neonatal 20 cardiac surgery, with the perhaps exception of one 21 centre in the UK, were clearly better in the larger 22 centres. So there was one piece of evidence that 23 supported the concept that big was better. 24 Then you start to look for the other evidence, as 25 opposed to belief that bigger is likely to be better. 0070 1 One study from the United States in 1992 suggests that 2 once you achieve more than 300 children's open heart 3 surgical procedures per year, your results are 4 strikingly better. But some good results are obtained 5 from some centres performing between 1 and 200 6 operations a year. A criticism of that study is that we 7 do not know what the case mix for all these centres 8 was. Was there a possibility that some of the centres 9 are achieving apparently very good results, equal to the 10 larger centres, but only doing 1 to 200 operations 11 a year? Were they sending out their more difficult 12 cases? Was their case mix not representative? 13 With the exception of those two studies, that is 14 the one I have quoted from the United States and the 15 evidence from the Cardiothoracic Surgical Register of 16 infant and neonatal outcomes, in fact we are struggling 17 to find hard evidence as opposed to belief that bigger 18 is going to be better, when we base it purely on the 19 number of cases operated per year. We believe that 20 there will be other compelling reasons why small units 21 will fall by the wayside. 22 Q. Leave aside what will happen. Just looking at the 23 question of is bigger better, what you are saying is, 24 that is the intuitive feeling? 25 A. Yes. 0071 1 Q. There is some but limited evidence to that effect? 2 A. That is so. 3 Q. Of the evidence, that tends to relate to neonatal 4 cardiac surgery in the 1980s, the source of that being 5 the cardiothoracic register. There is some evidence 6 from America, and others, nothing. 7 A. Very little. 8 Q. Just looking at that question of intuitive belief, you 9 were emphasising in your evidence a few minutes ago the 10 development that there had been in paediatric intensive 11 care during the 1990s. Is it now accepted that 12 paediatric intensive care is a specialty? 13 A. Yes, it is. 14 Q. In its own right? 15 A. Yes, it is. 16 Q. And that to mix adult and paediatric cases in one 17 Intensive Care Unit is inadvisable? 18 A. That is so. 19 Q. And undesirable? 20 A. Yes. 21 Q. Is there any evidence for that? 22 A. I do not know. I would be going beyond the limits of my 23 competence to state that was clearly so. 24 Q. In so far as arguing a case for it, you would rely on 25 the intuitive, would you? 0072 1 A. Not entirely, but perhaps substantially, because in fact 2 the practice where paediatric and adult Intensive Care 3 Units were mixed was commonly that a paediatric patient, 4 particularly if resources were stretched or limited, 5 might well be looked after, or the care shared, with, 6 for example, a nurse whose primary expertise was not 7 paediatric. 8 So, to that extent, you may say intuitive, or 9 entirely practical, a pragmatic observation, but the 10 care is likely to be of a higher quality when given by 11 a nurse trained in paediatric intensive care procedures. 12 Q. One of the consequences of size, presumably, is the 13 likelihood that a larger centre will have a paediatric 14 Intensive Care Unit, so-called, a proper unit as opposed 15 to a mix of adult and paediatric cases in the same 16 unit? 17 You are nodding. It all goes on the Internet at 18 the end of the day, and people can see you agree with 19 that? 20 A. I agree with you. 21 Q. Can we come back to the question of what critical mass 22 you have seen in your evidence is needed to provide 23 specialised services for paediatric cardiac surgery? 24 A. We believe that it is not likely to provide it in 25 a centre that was doing less than 250 to 300 surgical 0073 1 procedures per year, but I think you will sense that 2 that I have some reservations in blandly stating that 3 figure. I have earlier stated that evidence is not 4 particularly strong to reinforce that belief. 5 Q. Can I just press you a little on the figure of 250 to 6 300? Is that a mix of open and closed heart procedures? 7 A. That would be a mix of open and closed, and I think we 8 might attempt to justify that position, or we have 9 attempted to justify that position professionally in 10 Scotland, where it is likely that one centre would be 11 doing about 280 to 300 cases per year, in other words, 12 not quite reaching the 300 mark, because that would make 13 best use of all the multi-professional resources that 14 are required to deliver the quality of care necessary to 15 produce good outcomes for paediatric cardiac surgery. 16 We believe that we can identify some of the 17 factors responsible, but we are aware that throughout 18 the 1980s, and throughout the 1990s, there has, over all 19 the UK as in other countries, been a continuing fall in 20 the mortality from paediatric cardiac surgery, and we 21 believe that broadly speaking, it is the result of 22 better delivery of the multi-professional resource or 23 the multi-professional team around the paediatric 24 cardiac surgical patient. 25 Q. I do not want to confuse in my question the optimum, 0074 1 given the present standards, and the improvement in 2 standards which has plainly taken place across the 3 board, whether units are large or small. I would like 4 to focus on whether bigger is better, whatever the 5 changes overall in standards may be. 6 Implicit in that question to you, I want your 7 comment on it, is whether the change in standards has 8 been uniform across the smaller and the larger centres, 9 whichever, so that the benefits or disadvantages of size 10 remain the same across the time 1985/95? 11 A. The benefits have been achieved and are measurable 12 I think in all units, small and large, in the sense that 13 in all mortality has fallen. How one then interprets 14 the statistics which show that perhaps small centre A 15 has a mortality of 7 per cent compared with big 16 centre B that has a mortality of 6 per cent, and say, 17 "Well, we are in the same ball-park as a big centre", 18 is much more difficult, because we have inadequate 19 information on the case-mix and the risk stratification 20 within individual centres. 21 So we may not be comparing -- in fact, we know for 22 sure that we cannot adequately at present even compare 23 like with like. 24 Q. I would like to trace through with you, if I may, the 25 thinking on the "big is better" issue, so far as one 0075 1 can, through various reports. If you would have on the 2 screen, please, BPCA 1/2 -- we had better go back to the 3 previous page, which is 1/1, confusingly, just to see 4 what we are looking at, it is a report which you 5 recognise. This is the Working Party report? 6 A. Yes, indeed so. 7 Q. Of which you were a member? 8 A. Yes. 9 Q. We can see that, if we scroll down the left-hand side, 10 your name appears as the fourth name down. 11 If we can go back to page 4, having identified the 12 report, underneath the capitals on the left-hand column, 13 can we enlarge the first passage there, thank you, 14 including the heading, please? You refer to an 15 unpublished report. I will come to that in a moment, 16 because you have been kind enough to supply us with 17 a copy. You refer back to 1979, and note that that 18 report, in summary, "was concerned because there were 19 too many small units that lacked the facilities 20 essential for ... children with congenital heart 21 disease." 22 Pausing there, that was presumably an intuitive 23 view? 24 A. Yes. 25 Q. Because there was no evidence at that stage to back it 0076 1 up. 2 "It emphasised that all staff should have 3 paediatric training and particular expertise in handling 4 the new-born. Improvements in ancillary services 5 including specialist physiotherapy, social work and 6 parental accommodation were identified and recommended. 7 Other improvements in invasive and non-invasive 8 investigational services and provision of dedicated 9 surgical theatres were identified and recommended." 10 Dedicated surgical theatres: dedicated to the 11 paediatric case? 12 A. Yes. 13 Q. Digressing just for a moment while we are on the point, 14 is there then an advantage, as you see it, in having an 15 operating theatre which deals with nothing else other 16 than the paediatric case? 17 A. No. That does not have to be particularly the case, 18 provided that the theatre has the resources in terms of 19 appropriate ventilators, appropriate staffing, that is, 20 theatre staff familiar with handling children, obviously 21 in this context particularly children with cardiac 22 surgical problems, rather than saying, "Look, that 23 theatre can only be exclusively used for paediatric 24 cardiac surgery and nothing else". In most modern 25 theatre complexes, a sufficient flexibility to enable 0077 1 a variety of disciplines often to use the one resource. 2 Q. Then the report says this: 3 "This Working Party strongly advised that 4 paediatric cardiology was better practised in a large 5 children's hospital, or in a children's department of 6 sufficient size in a General Hospital with the 7 corresponding regional cardiac unit adjacent to the 8 children's unit. 9 "Most of the centres in England and Wales 10 fulfilled one or other of these criteria." 11 You then go on to talk about the recommendation in 12 respect of London and that there should be four large 13 centres outside it to provide services for Bristol and 14 Cardiff, Liverpool and Manchester, Leeds, Sheffield and 15 Birmingham." 16 So that is what was anticipated in the 1979 17 report? 18 A. Not anticipated, it was recommended. 19 Q. You say this: 20 "Much of the philosophical content of the British 21 Paediatric Association report is still important and 22 appropriate." 23 A. Yes. 24 Q. Would that comment remain true not only in 1992, when 25 this report was produced, but today? 0078 1 A. Yes. I believe so. 2 Q. So throughout the period with which this Inquiry is 3 concerned, there has been a strong conviction that 4 paediatric cardiology is better practised in a large 5 Children's Hospital than a small one? 6 A. Yes. 7 Q. You go on, in your survey of previous reports, to look 8 at the second and third report, the bottom of the page. 9 If we can go to the top of the right-hand column, can we 10 enlarge the first half page of that column? 11 Your report was looking back at the second report: 12 "The report argued strongly for specialisation in 13 paediatric cardiac surgery with its increasing emphasis 14 on correction in infancy. The skills needed should be 15 concentrated in a few centres and supported by a central 16 fund." 17 Just stopping there, one of the features 18 throughout the 1980s and 1990s has been, has it, the 19 increasing number of operations performed on the very 20 young? 21 A. That is so. 22 Q. If one thinks of one very obvious example, the arterial 23 switch operation appears to be best performed on those 24 under three months of age. Again, you are nodding? 25 A. Yes, that is so. 0079 1 Q. That would be an example of a development which tends to 2 call for earlier correction later? 3 A. Yes. 4 Q. Is it the view of the Association, as it was, it 5 appears, the view of the Joint Cardiology Committee of 6 the physicians and surgeons in 1980, that really one 7 cannot simply transfer adult skills in cardiac surgery 8 into dealing with the very small and the very young? 9 A. Very much so. 10 Q. It goes on, about the 1980 report's recommendations: 11 "The 1980 report recommended that the needs of 12 older paediatric cardiac surgical patients should be met 13 within the same unit. Each unit was to have two 14 consultant cardiothoracic surgeons and two or three 15 consultant paediatric cardiologists." 16 So at this stage it was recognised that the 17 cardiothoracic surgeon would do both adult and 18 paediatric work? 19 A. Yes. That was certainly the acceptable philosophy in 20 the early 1980s. 21 Q. What was recognised as the optimum in the early 1980s? 22 A. I think it was recognised that some of the very best 23 results throughout the world had been obtained from 24 individuals who had devoted themselves entirely 25 surgically to the management of congenital heart 0080 1 disease. By "congenital heart disease", I do not mean 2 confined only to the infant and paediatric group, but to 3 later adolescents and adult life. But, nonetheless, 4 there were certainly outstanding surgeons performing 5 across the whole range of cardiac surgery who were 6 producing excellent work in valve surgery, coronary 7 artery surgery, as well as in congenital heart disease. 8 Q. The report goes on, again looking at the 1980 report: 9 "Recognition as a supra-regional centre was to be 10 based not just on workload and geographical location, 11 but also on the quality of the work done." 12 A. Yes. That was the recommendation. 13 Q. So that recommendation implied a view, obviously, 14 authoritatively put forward in 1980, that there would 15 need to be some system of reviewing the quality of work, 16 as well as the quantity of work? 17 A. Yes. 18 Q. Going back, if one can, to the early 1980s, how in the 19 early 1980s in this area of work was it proposed that 20 that should be done? 21 A. I think in truth, that was somewhat ducked. 22 Recommendations, and I think this will come through in 23 a number of areas and a number of reports, 24 recommendations were made, but without perhaps always 25 a clear understanding on the part of those who were 0081 1 making the recommendations on how they could be 2 implemented or not. 3 I think recurrently throughout the 1980s, a number 4 of bodies reported, made specific recommendations, but 5 these were not followed through and there was 6 insufficient recognition of how in fact they could be 7 acted upon. 8 I have to qualify that also by saying that in 9 a number of areas, and for example, I will return to 10 paediatric intensive care, very strong recommendations 11 were made, and a very strong push was made at a number 12 of levels, both locally, regionally and nationally, but 13 the voice was not sufficiently heard or taken on board. 14 Q. So although the recommendation was made, as we know, in 15 1980, so far as quality of work was concerned, I think 16 the upshot of your evidence is that in practice it did 17 not feature particularly as a factor in recognition or 18 for that matter continued recognition of the centre as 19 a supra-regional centre? 20 A. I think there was an implicit belief on the part of many 21 that those units performing good quality or high quality 22 work would be recognised and would be known. 23 Q. Did the converse apply: because they were doing the 24 work, they were therefore high quality? 25 A. No, that did not apply. As you know, there was no 0082 1 mechanism, really, for assessing whether or not high 2 quality work was being done, except from time to time 3 professionally by word of mouth, but it was accepted 4 that surgeon X was producing results for surgical 5 procedure, perhaps across the whole range of surgical 6 procedure for congenital heart disease. That word of 7 mouth might be a little stronger in terms of 8 professional presentations, professional meetings and 9 publications. The unit would establish a reputation for 10 good quality work. 11 Q. If I can go on in the reading of what was said in 1992, 12 looking back to the 1980 report: 13 "To date [a reference to 1992, again, you are 14 agreeing, to get it on the transcript, as it were]? 15 A. I agree. 16 Q. "To date no real audit of surgical results is available 17 and surgical needs are still based purely on the number 18 of patients undergoing operation." 19 A. Yes. 20 Q. So that is really a reflection of what you have been 21 saying: although it was recognised there needed to be 22 some quality control or assurance or however one puts 23 it, in practice, so far as supra-regional designation 24 was concerned, or continued supra-regional designation 25 was concerned, there was none? 0083 1 A. That was my understanding. I am from north of the 2 border, I was not intimately involved in the working of 3 the supra-regional funding, but my understanding based 4 on discussions with others who were is that essentially 5 it was about numbers and not about outcomes. 6 Q. If we look at what is said about the third report, the 7 next paragraph, scroll down the