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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 page, can we enlarge the 8 beginning of the third report? 9 "The third report in 1985 perpetuated the 10 separation of surgical care for patients under one year 11 of age and patients over one year of age." 12 That is a reference to the division in 13 supra-regional services between the younger and older 14 ones. 15 "The report referred to the recently endorsed and 16 established nine supra-regional centres", so the six had 17 grown to nine? 18 A. Yes. 19 Q. "The report suggests there should be no more than nine 20 centres. In choosing this figure, the authors of the 21 report obviously followed the Black Committee 22 recommendations, which were partly based on a desire to 23 improve standards, but were also designed to limit the 24 spread of specialty and cut costs." 25 You spoke about talking to economists in Scotland 0084 1 about the proposed development of one centre rather than 2 more than one? 3 A. Yes. 4 Q. What are the health/economic considerations that apply 5 in Scotland as to whether big is better? 6 A. I think almost neutral, if -- I am quoting a little bit 7 from memory, because I had not anticipated that 8 question, but I think in terms of the argument for one 9 rather than two, costs would not impact significantly on 10 the debate, currently. 11 Q. Can we go down to the next part of this paragraph? If 12 we scroll down, please: 13 "Supra-regional centres were said to require 14 a minimum of two surgeons to maintain 24 hour year round 15 cover and between two and four paediatric 16 cardiologists. The reality of paediatric cardiological 17 practice at the moment is a little different from the 18 conclusions in the third report. The number of 19 consultant paediatric cardiologists has indeed increased 20 in the supra-regional centres [we saw that from 21 Dr Swanton's evidence] but few supra-regional centres 22 have two full-time paediatric cardiac surgeons." 23 The way that is expressed conveys, to someone like 24 me, perhaps a note of regret? 25 A. Yes, I think that is so. I think there had been 0085 1 optimism from earlier reports, by the time this report 2 was written, that most of the larger centres at least 3 would have two individuals committed almost entirely, if 4 not quite entirely, to the practice of paediatric 5 cardiac surgery. 6 Q. What is the purpose of having two specialist paediatric 7 cardiac surgeons? 8 A. Obviously the purpose of having two is to provide, as 9 far as is practical and feasible, 24-hour cover, 10 365 days of the year. From time to time, there will be 11 emergency procedures which will require the surgeons, or 12 two surgeons, to have almost equal skills. 13 In many centres in the 1980s there might well have 14 been, for example, a lead paediatric cardiac surgeon and 15 another cardiac surgeon supporting or backing up. 16 Whilst he or she might well have been able to do almost 17 the whole range of procedures, it is perhaps not to the 18 same level of competence as the lead individual. 19 So the concept here was to have two individuals of 20 approximately the same standard and level of competence. 21 Q. And full-time? The importance of that? 22 A. Full-time, recognising the belief (rather than the 23 evidence) that if committed to doing only paediatric 24 cardiac surgery procedures, competence would be improved 25 and would be greater. 0086 1 Q. So one comes back to the same issue, as it were, of size 2 or numbers of operations? 3 A. Yes. 4 Q. May I ask, since 1979, when that belief appears to have 5 informed the unpublished report by Gray and others, up 6 until now, has that belief changed at all? 7 A. I think, and you may well find this in the course of the 8 Inquiry, many will give different viewpoints. I am sure 9 there will be cardiac surgeons who argue that competence 10 in fact is improved by doing the whole range of cardiac 11 surgical work, paediatric and adult, so that any 12 unforeseen circumstance can be coped with competently. 13 I think there has been an increasing perception 14 that the work will be better done by those who are 15 committed entirely to paediatric cardiac surgery, but 16 there are going to be different viewpoints on this. 17 Obviously I am not disguising that, because I am sure it 18 is not capable of being disguised. 19 Q. I think you are saying that, if anything, the view has 20 increased in acceptance? 21 A. Yes; particularly, obviously, those who are primarily 22 involved in the care of children with congenital heart 23 disease, and there has been a decline in number of 24 individuals who are practising, for example, 25 substantially in adult cardiac surgery and with only 0087 1 a lesser part of their work committed to paediatric 2 cardiac surgery. 3 Q. If it has increased in acceptance -- and there is no 4 empirical evidence for it -- presumably you would have 5 to say it is based on people's perceptions of their 6 experience? 7 A. Yes. 8 Q. In general, that would be the perceptions of the cardiac 9 surgeons themselves and those most intimately connected 10 with surgery and its outcome? 11 A. Yes. 12 Q. If we can look for a moment, then, at the numbers, so 13 far as we have them, of operations that were apparently 14 conducted in different centres in the 1980s, I would 15 invite your comments against the background of what you 16 have said. Give me one moment, if you please. May 17 I please have UBHT 278/487? 18 We are looking at a report on paediatric cardiac 19 services, the supra-regional services, which was drawn 20 from the cardiothoracic register. May I say at once, 21 and in particular for the wider audience that may be 22 looking at these remarks on screen, that this Inquiry is 23 investigating to verify numbers and to derive what 24 numbers it can from the original data as best it can, 25 and it is accepted that some of the figures may have 0088 1 certain question marks over them. 2 Looking at the figures as indicative 3 representations (at any rate) of what may have been the 4 case, if we look at the numbers there for the various 5 centres, Newcastle, Leeds and so on, one can see the 6 nine supra-regional centres that there were in England 7 and Wales. 8 Bristol, in the open heart operation numbers, is 9 considerably less than any other of the supra-regional 10 centres over those three years, and for that matter, is 11 small in the number of closed heart operations -- again, 12 it has to be emphasised, on the under-1s. 13 A. Yes. 14 Q. Would it have been difficult, with those numbers, to 15 produce, in Bristol, for the under-1s, as good a set of 16 results, probably, as it would have been in one of the 17 other centres, given surgical teams of equal skill and 18 competence? 19 A. My belief is that it would have been, particularly in 20 the 1980s. You said "surgical teams"? We are not 21 talking just of the surgeon but of the team and all the 22 other professionals. I believe it would be unlikely 23 that they could have produced as good results as larger 24 centres. 25 But you have, yourself, indicated that some of 0089 1 these numbers and figures are not accurate. I think it 2 is probably beyond my competence to point out today that 3 it was at least one centre there whose figures I think 4 are grossly inaccurate. 5 Q. That is why I was at pains to emphasise that the figures 6 are being checked. The purpose of the question is 7 really -- it is an indicative question. It cannot be 8 based and is not based, upon these figures as being the 9 last word in numbers? 10 A. No, and you accept that mine is a personal opinion on 11 that, and I qualify it also by saying that we know from 12 more recent audits in the UK that some small centres, 13 allowing for the fact that we understand their case mix 14 properly, have achieved results that are comparable to 15 larger centres, including in the infant and neonatal age 16 group. Again, you know, I underline or re-emphasise my 17 earlier point, and the difficulty in trying to interpret 18 many of these figures, even currently, let alone from 19 the 1980s. 20 Q. What I think I can ask you, and it follows from what you 21 have been saying, is that although individual centres 22 may be able to produce results as good as elsewhere, let 23 us accept that, that there are inevitably difficulties 24 with small numbers in producing as good a result? 25 A. Yes. I believe that to be so. 0090 1 Q. And that is one of the reasons why supra-regional 2 centres, as you understand it, were designated in the 3 first place? 4 A. Very much so. It was one of the philosophies that 5 underpinned the development. 6 Q. I think you are saying to us it was recognised and 7 progressively recognised, throughout the 1980s and 8 certainly the 1990s, that part of the reason for that is 9 that one needed to have specialist teams who were 10 specialist, because of the operations which they did, 11 and could only be specialist if they had that number of 12 operations to do in the first place? 13 A. Yes, and indeed, as you know, and referred to earlier, 14 the cardiothoracic surgeon's register did indicate that 15 outcomes for neonatal cardiac surgery, even though we 16 have reservations about some of the numbers, were better 17 in those centres doing larger numbers. 18 Q. In terms of going back from looking at those figures to 19 what you yourself say in 47/10 -- let us go back to that 20 for a moment, the bottom of the passage, please. It is 21 the identification of the critical mass that you have in 22 mind? 23 A. Yes. 24 Q. This is a threshold requirement or observation, I think 25 you are making? 0091 1 A. Yes. 2 Q. It has to be so big before it is going to be reasonable, 3 and the optimum is nonetheless the over 300 -- 4 A. Probably. 5 Q. -- that the American research has suggested, but query 6 the case mix on that? 7 A. Yes. 8 Q. What sort of level is the critical mass? 9 A. It is certainly unlikely that in 1999 a centre could 10 perform, say, less than 200 or 250 cases, and we say 11 that not just in terms of the critical mass of numbers, 12 but the resource that is going to be required, because 13 proportionately that resource is much greater in terms 14 of personnel for 100 cases than it is for 250 cases: 15 providing for example round-the-clock intensive care 16 cover, 24 hours a day at junior level, will require 17 almost the same number of staff for 50 cases a year as 18 it will for 200 cases per year. 19 Q. Again, just so there can be no misunderstanding about 20 it, that is open and closed operations? 21 A. That is open and closed operations, yes. 22 Q. And it is open and closed operations in children? 23 A. Open and closed operations in children, but the surgeons 24 performing those operations may also have work in 25 congenital heart disease in older adolescent and adult, 0092 1 and although this is spelt out, I think that is 2 a philosophy that many would support and encourage very 3 strongly. 4 Q. If we go overleaf to the top of page 11, you make the 5 point -- I will read you into it. You say on the 6 previous page: 7 "Regardless of the size of the centre, success 8 nonetheless should be judged not on the numbers of cases 9 operated but on the outcomes." 10 That, I think, is perhaps self-evident? 11 A. Yes. 12 Q. "The need, therefore, is to have a strong professionally 13 regulated review system in place for the assessment of 14 any centre undertaking paediatric cardiac surgery." 15 You comment on what is going to happen in fact in 16 the future. I am not going to ask you about that, 17 because we can see that for ourselves. It is what 18 follows next I want to ask you about. 19 "There is general acceptance that for the 20 post-operative care of children with paediatric cardiac 21 surgery, there is a need to have experienced trained 22 middle grade intensive care staff on site 24 hours 23 a day, as well as members of the surgical team." 24 "Middle grade" means what sort of grade? 25 A. That, in this context, would usually mean an individual 0093 1 in their late 20s, early 30s, who had done general 2 professional training in paediatrics or anaesthesia, and 3 was spending a selected portion of his further training, 4 his higher professional training, within anaesthesia or 5 paediatrics, specifically in intensive care. Of course, 6 as you referred to earlier, paediatric intensive care is 7 now recognised as a separate specialty, and there are 8 separate training programmes in paediatric intensive 9 care. 10 So when we speak about an experienced, trained, 11 middle grade intensive care member of staff, it would be 12 somebody who would have certainly broad experience in 13 anaesthesia/paediatric anaesthesia, or paediatrics, but 14 had not completed all formal training in paediatric 15 intensive care. 16 Q. You are looking at someone on the doctor's side of 17 things? 18 A. In this particular context I was looking at some on the 19 medical side, yes. 20 Q. You say there is general acceptance of that. General 21 acceptance by whom? 22 A. I think now by the profession. I think now virtually 23 every major centre in the UK doing paediatric cardiac 24 surgery will have at least one, more usually two or 25 three, consultant paediatric intensivists, and with 0094 1 a junior staff training programme. 2 Where they do not have that, there is acceptance 3 that they need to have it and they are rapidly trying to 4 put it in place. 5 Q. And finally, just to finish this point, you deal in the 6 very last sentence that we see on the screen with the 7 difficulties the smaller centres have in providing the 8 quality of round-the-clock care and smaller centres, 9 that again fits with your 200, 250 threshold? 10 A. Yes. 11 Q. Let me turn away from the question of size to the issue 12 of standards. 13 You tell us, 47/5, the top of the page in 14 italics: 15 "There is at present a vacuum in relation to the 16 enforcement of standards. The Royal College are 17 primarily concerned with training and neither the 18 Department of Health nor purchasers/commissioners for 19 services have set clearly defined standards by which 20 centres can be judged." 21 A. Yes. 22 Q. So the vacuum is between becoming qualified, is it, in 23 terms of the medical staff, and the actual practice of 24 their medicine in-post? 25 A. I think we were trying to indicate there, in that 0095 1 statement in italics, that there is no mechanism for 2 making sure that in any one centre proper outcomes, 3 proper quality of care in cardiac surgery, is being 4 delivered. 5 I think the thrust of your question to me just 6 now, unless I have misunderstood it, perhaps related 7 more to training, and saying that colleges are concerned 8 with training, are concerned through continued medical 9 education in maintaining standards, educational 10 standards, but here I think we were talking of trying to 11 refer more broadly to the standards set in the 12 accreditation, the recognition of quality of outcomes in 13 centres doing paediatric cardiac surgery. 14 Q. I think we are at one. It must be my inability to put 15 the question clearly. I was suggesting there was indeed 16 a difference between educational standards on the one 17 hand and performance standards on the other. If you 18 like, "outcomes" is a surrogate for "performance 19 standards"? 20 A. Yes. 21 Q. So how would one, as the BPCA put it -- enforcing 22 training standards is easy enough, you pass your exam or 23 assessment or you do not, but performance standards, how 24 do you go about that? 25 A. North of the border, since the early 1980s, through the 0096 1 National Services Division, cardiac surgery has been 2 contracted on a national basis in the Children's 3 Hospital in Edinburgh and Glasgow. Progressively, and 4 in an evolutionary way, the National Services Division 5 have attempted to set down certain standards in terms of 6 nurse staffing, intensive care staffing, 24 hour 7 availability of staff. They have attempted to define 8 how rigorously audit is performed, and, for example, in 9 the unit in Edinburgh, there has to be, or should be -- 10 I cannot claim it has always been consistently 11 achieved -- but there should be, in terms of performance 12 standards, an audit held once a month and the results of 13 that audit submitted as part of an annual report to the 14 Scottish Office via the National Services Division. 15 That has progressively become tight and tighter in 16 terms of performance or standards setting. It is not 17 yet a perfect model, but I think it is a model that 18 could be developed and extended. 19 Q. So putting a practicality to that description, what 20 happens if, let us say, it shows Glasgow's results are 21 half as good as Edinburgh. What happens to Glasgow? 22 A. The reality is, at present, nothing. That, of course, 23 is not so, I would emphasise in the context of this 24 Inquiry. 25 Q. It is a purely hypothetical question, I have to say. 0097 1 A. It is a very pertinent question, because I have said 2 that performance standards, performance setting, has 3 been evolving, but I think has not evolved far enough. 4 The nub of it is, when is somebody going to grasp that 5 issue, that is, you put in place a set of standards, but 6 if they are not achieved, who is going to say to the 7 centre, "Look, your performance is not adequate, what 8 steps are going to be taken? When can we return to see 9 that the steps you have set in place have been 10 successful in improving performance?" 11 Q. What do you suggest? 12 A. I think, as you know in our final conclusion we 13 suggested a role, perhaps too ambitious a role, for the 14 British Paediatric Association, but I think we could 15 help very substantially, since we are an 16 interdisciplinary group, a professional body, and 17 I think through the aegis, perhaps of a larger body like 18 the British Cardiac Society, then we could set in place 19 a series of teams who would regularly inspect, perhaps 20 at two, three or four yearly intervals, centres to make 21 sure standards were being achieved, and obviously to 22 define those standards. Whether that report is sent to 23 the Cardiac Society or a body like the General Medical 24 Council or the Department itself, I think is very much 25 still an area for debate. But that there is a vacuum 0098 1 there and that as far as, to my knowledge, there is no 2 other group coming in with a recommendation to fill that 3 vacuum, then I think the BPCA's proposals at least merit 4 inspection and further consideration. 5 Q. In examining the problem, and again taking the purely 6 hypothetical case I have given you, the first step will 7 be in identifying the practical level of the eventual 8 outcome, but the second will be identifying some 9 shortcomings in standards which might have and probably 10 did contribute to the difference in outcome? 11 A. Yes. 12 Q. Because without it, any remedial measures would be 13 senseless, would they not? 14 A. That is so. It is perhaps a model in the Mid-west 15 America Cardiac Surgical Register in Minnesota. Again, 16 I would not pretend to understand or know the complete 17 workings of their register, but basically, as I do 18 understand it, where an individual centre or individual 19 surgeon's performance falls out with a defined mean, 20 then that triggers an action centrally by the auditing 21 body and they, in conjunction with the centre, may send 22 in senior individuals to look at performance. 23 I think we could use that in the UK context; that 24 is, if a centre was clearly performing outwith defined 25 standards, then that would be a trigger for a team of 0099 1 senior experienced individuals, nursing, medical, 2 surgical or whatever other professional advice would be 3 required, to go in fairly quickly to analyse the 4 situation jointly with the centre. 5 One has to recognise that of course even in highly 6 experienced hands, many surgical procedures will be 7 associated from time to time with a clustering of poor 8 results. We are not dealing with very large numbers in 9 paediatric cardiac surgery. Even a very large centre 10 will be doing no more than 500 to 600 procedures per 11 year, compared perhaps with 2,000 or 3,000 coronary 12 artery bypass surgical procedures. There will be 13 a clustering effect in the results from time to time and 14 even an excellent surgeon may have a run of apparently 15 poor results, but at least if there was a mechanism for 16 identifying that fairly quickly to the individual 17 surgeon, so that at least those results could be 18 discussed with colleagues, to see if there is any 19 organisation or systems failure operating that might 20 have contributed to those poor results, then I think 21 there will be improved confidence in the results as 22 presented perhaps annually by that particular individual 23 surgeon or individual centre. 24 Q. Does this investigation necessarily imply that there has 25 to be some idea of not only standards of outcome, but 0100 1 standards of system? 2 A. Yes. It does. 3 Q. So it requires the fairly careful setting in a number of 4 different disciplines, a number of different areas, of 5 optimum standards? 6 A. Yes. That is why I think we suggest that perhaps each 7 centre, each accredited or recognised centre for 8 paediatric cardiac surgery, would be inspected every 9 three, four, five years, to make sure all its systems 10 were in place and operating appropriately. 11 Q. Those standards would have to be based upon 12 a supposition, at any rate, that adherence to the 13 standard would be more likely to secure a proper result 14 or good outcome than falling below the standard? 15 A. Yes. 16 Q. Which itself, that supposition ought to be based on 17 empirical evidence, ought it not? 18 A. Yes, it should be. 19 Q. And there is not any? 20 A. That is the difficulty. 21 THE CHAIRMAN: Mr Langstaff, may I just interrupt for 22 a moment? We would normally be taking a break at 23 12.30. Are you intending to go on for very much longer 24 than perhaps a quarter of an hour or 10 minutes? 25 MR LANGSTAFF: I was thinking about that on my feet, before 0101 1 you asked the question. I think perhaps it would be 2 sensible to take a break now, and prevail upon 3 Dr Godman, if he would not mind, to come back after that 4 break. 5 THE CHAIRMAN: Shall we say 20 minutes, then, and then we 6 can go on, and also the take the third witness 7 thereafter, or maybe we should discuss whether we should 8 take a further break. Perhaps we should discuss it 9 outside. Thank you. We will break for 20 minutes. 10 (12.35 pm) 11 (A short break). 12 (1.00 pm) 13 MR LANGSTAFF: Can I take you, Dr Godman, to page 3 of your 14 witness statement? At the bottom of the page, the last 15 sentence, perhaps because the typist has missed 16 something in translation, has caused a certain amount of 17 controversy amongst the Royal Colleges, as you know, 18 because you have read their comments on your evidence. 19 The Royal College of Surgeons, Anaesthetists, 20 Radiologists and the Royal College of Paediatricians and 21 Child Health, all comment they did not devolve 22 responsibility for continuing medical education in 23 paediatric cardiology to the BPCA. 24 I think there may well be a misunderstanding as to 25 what you had intended to convey? 0102 1 A. Obviously, there are typographical errors as well as 2 perhaps errors in drafting, for which one accepts 3 responsibility. What one intended to convey was 4 approval for continued medical education in paediatric 5 cardiology is devolved to the Council of the British 6 Paediatric Cardiac Association and to a specific 7 individual. That responsibility has been recognised and 8 accepted by the Royal Colleges of Physicians, whom the 9 BPCA in terms of continued medical training relates. 10 The reference was specifically to paediatric cardiology, 11 not to areas such as radiology, surgery or anaesthesia. 12 Q. Can I turn for a moment to the question of training and 13 how that interrelates with standards. 14 You, for your part, I think acknowledge that 15 training can only go so far in first qualification, and 16 there is a need for continuing medical education? 17 A. Yes. 18 Q. One of the aspects of training or continuing medical 19 education is in the evolution of new techniques of 20 surgery. You deal with -- let us look at it -- the 21 question of the "learning curve" as it has been called. 22 It is the very bottom of page 9 and the very top of 23 page 10 of your witness statement. Perhaps we could 24 have that on the screen and have the split screen, 25 perhaps. That is the bottom of page 9. Can we put that 0103 1 on the left, and 10, please. It is rather small 2 writing, but I hope you can see what is on the left 3 there. You are picking up here the theme we were 4 discussing before the break of how the standards might 5 be enforced. You say: 6 "A similar approach [the monitors approach]" in 7 effect, I suppose, a system of peer review ... 8 A. Yes, it is. 9 Q. "Could be adopted to monitor outcomes from new 10 techniques". 11 Is there, as the BPCA sees it, an impact here upon 12 clinical freedom? 13 A. I think I need to be a little careful in answering that 14 question, because it is currently being debated within 15 the Association. We are looking very actively at the 16 whole process of how we monitor, assess, audit, for 17 example what is done with many of the new interventional 18 procedures in paediatric cardiology, that is, procedures 19 which may replace cardiac surgery, the use of catheter 20 balloons to stretch valves, the use of devices to 21 occlude holes within the heart without the need for 22 cardiac surgery. Devices are inserted through a small 23 incision in the groin and introduced via catheter 24 techniques. 25 I know there is an anxiety on the part of some 0104 1 members that, when our discussions and report is 2 produced, there may be a recommendation that individual 3 clinical freedom is curtailed, but I think there is also 4 a recognition within the Association and particularly on 5 the part of paediatric cardiologists and cardiac 6 surgeons of the wider context in which this has to be 7 looked at. I think it will be accepted that there has 8 to be some curtailment of individual freedom to 9 practice, if we are going to have both better outcomes 10 and that we are going to satisfy the wider profession as 11 well as parents and the public that we are auditing our 12 work and assessing our work appropriately. 13 Q. So in short in the wider public interest, you think that 14 your Association will probably recommend that there be 15 some limits placed on clinical freedom? 16 A. Yes. We should use the word "probably" rather than 17 "certainly" at this stage. 18 Q. Because there is obviously a difference of view? 19 A. Yes. 20 Q. Am I right in thinking that those views which were most 21 stridently in favour of clinical autonomy, clinical 22 freedom, were diminishing in volume from 1980 onwards? 23 A. Yes, I think progressively so. 24 Q. Can I go back to the matter I was first asking you 25 about, the question of size, the bigger is better, and 0105 1 you will appreciate that in England and Wales the basis 2 for the supra-regional services for the neonates and 3 infants was the perception that bigger was better and 4 services needed to be centralised, in the public 5 interest. 6 It appears that in 1993/94 the recognition was 7 that so many other centres were performing paediatric 8 cardiac surgery; that although it would still be optimum 9 to have a few centres, supra-regional designation, 10 special funding, could no longer be supported. 11 Essentially, as I understand it, clinical freedom 12 being preserved at the expense of the public benefit, is 13 one way of putting it? 14 A. Yes, but I think that is the wrong way of putting it, 15 because I do not think that was the driving force behind 16 the decision. As you know, in terms of the 17 supra-regional centres, essentially all that was being 18 counted was numbers, outcomes, quality of what was being 19 delivered was not being assessed. Yes, the number of 20 centres had grown and that was thought at the time by 21 many to be undesirable, but in terms of any constraints 22 on that growth, the profession was not in a position to 23 limit that increase in the number of centres. It also, 24 of course, coincided with the introduction of the 25 purchaser/provider relationship and the internal market. 0106 1 Q. This is where my question is leading. Having accepted, 2 in at least the context in which my questions began 3 after the break, that there may well need to be some 4 limits placed on clinical freedom, would that extend, as 5 the Association will probably, possibly, see it, to an 6 acceptance that surgery of certain types is best 7 restricted and should be restricted to a few centres, if 8 that is felt to be in the public interest, and that 9 therefore there should be no freedom to practice that 10 surgery elsewhere? 11 A. Yes. I think it could very well be, and I say that 12 because in essence that has already been practised, for 13 example in a lesion known as the hypoplastic left heart 14 syndrome, where the left side of the heart is 15 under-developed and survival is not possible without 16 surgery. Those procedures have concentrated at present 17 in only a few centres in the United Kingdom. 18 Q. I have asked you about page 9. On page 10 it is 19 recognised by your Association it is not acceptable to 20 have learning curves for established procedures. You 21 are drawing the contrast at the bottom of page 9 between 22 monitoring outcomes for new techniques and having 23 learning curves for established procedures? 24 A. Yes. 25 Q. When does a procedure become established? 0107 1 A. Again, some difficulty in answering that question, but 2 let us take, for the purposes of this Inquiry, something 3 like the arterial switch procedure. It was clearly an 4 established procedure throughout the world by 1990. It 5 had been increasingly performed in most centres in the 6 United Kingdom throughout the 1980s. So it was an 7 established procedure. 8 If one looks for an analogy in the 1990s, then 9 perhaps the hypoplastic left heart syndrome is a good 10 analogy. It is now an established procedure, not 11 perhaps as widely applied in most centres as the 12 arterial switch procedure was progressively throughout 13 the 1980s, but that is because some lessons have been 14 learned from the introduction of the arterial switch 15 procedure. 16 I am perhaps not answering your question directly 17 in terms of giving you a definition of "established". 18 Q. You are saying it all depends, are you not? 19 A. I am indicating what practice might be, and I think 20 I have attempted to give an example from the 1980s and 21 an example from the 1990s. 22 Q. The way, very often, a new procedure may burst on the 23 world may be that some surgeon who has performed 24 a procedure for the first time will publish it? 25 A. Yes. 0108 1 Q. And there may be conferences at which you present his 2 result, the results of a series. Is there perhaps 3 naturally a temptation, in the rest of the world, to 4 wish to follow suit? 5 A. Yes, there is. Of course, in the past that is how 6 innovation has been progressively introduced. 7 I listened earlier this morning to some of the evidence 8 that was produced on the ethics of the arterial switch 9 procedure in the early 1980s and late 1970s, and I think 10 many of the arguments and points raised in that ethical 11 debate obviously hold true for any new technique that is 12 introduced. 13 But I am afraid, I am no better at answering the 14 questions raised by Elliott Shinebourne in relation to 15 the arterial switch than others were in the 1980s. 16 I think it needs to be debated and talked out 17 professionally and in a wider setting. 18 Q. Your evidence is if you were to do the new procedure, 19 begging that question, then you do it by, as 20 I understand it, shared responsibility or -- 21 A. At the very least, yes. 22 Q. Or a form of hands-on apprenticeship? 23 A. Yes. 24 Q. So this would envisage not simply the cardiac surgeon 25 experienced in other forms of surgery standing and 0109 1 watching, or possibly being the first assistant at an 2 operation, but doing the operation under the eye and 3 tutorage of -- 4 A. -- mentored by the individual who has introduced it and 5 has at least substantial if not unique experience with 6 it. 7 Q. How often, or how many such operations would one need to 8 do? Again, does it all depend upon the nature of the 9 operation? 10 A. I think very much it would do, and I have to say, 11 obviously, my surgical colleagues would be better placed 12 perhaps to give illustrative examples. 13 Q. One could take it from the province of cardiology in 14 using a new technique, for instance using a catheter? 15 A. Yes, one could give an example there. In the last two 16 and a half/three years in the United Kingdom there has 17 been the progressive introduction of a new device, an 18 occlusion device to close a hole in the partition 19 between the two upper chambers of the heart, the atrial 20 septal defect. The practice there has been that 21 a centre has to do a minimum of six procedures with an 22 experienced investigator or clinician who has done the 23 procedure and a substantial number of cases. He needs 24 to be present for 6 procedures. 25 Q. So my next question was going to be, did you know 0110 1 anywhere where it had been done. Obviously you have 2 just answered that, at least in respect of one 3 technique. 4 A. Yes. 5 Q. But so far as surgery itself is concerned, as opposed to 6 the cardiologist's province, do you know of anywhere 7 that the hands-on apprenticeship, as I have termed it, 8 has been successfully achieved? 9 A. I know a number of centres where increasingly, for 10 example, where there are two paediatric cardiac surgeons 11 in the centre, they are working together, particularly 12 on more complicated cases, so they are not working in 13 isolation, you have two assisting each other with the 14 procedure. If one is a relatively new appointment, his 15 senior colleague may at least help him in a significant 16 number of cases, for example, in his first six or nine 17 months in a post. 18 Q. When you are talking about the learning curve here, you 19 are talking about somebody visiting from one centre to 20 another centre? 21 A. Yes. 22 Q. That has funding implications? 23 A. Yes, it does. 24 Q. So the position of the BPCA would be that this is 25 necessary in the protection of the patient, and 0111 1 necessary to divert a surgeon from his operating list in 2 Birmingham, so that he can go to -- again, purely 3 hypothetical -- Newcastle? 4 A. Or Edinburgh. 5 Q. And work there for a week, two weeks, hands-on, before 6 he comes back to Birmingham? 7 A. No, in practice it would not be a week or two weeks. We 8 are talking about individual procedures. We are talking 9 about small numbers in congenital heart surgery, so if 10 we were talking about a particularly complex lesion 11 a visiting surgeon was asked to come to help with or 12 introduce, that might be a series of visits, four, five 13 or six in the course of a year, rather than coming and 14 spending a week or two weeks. It is more probable it 15 would be a visit for a day. 16 Q. If it is to be a learning curve, that has to be done 17 before the surgeon actually operates himself for the 18 first time? 19 A. Yes. 20 Q. That would mean your four or five visits would have to 21 be sufficiently narrowly spaced so that -- 22 A. Ideally, yes. 23 Q. We have spoken about training, learning curves, and just 24 before the short break that we had, I was asking you 25 about the need to monitor outcomes before one could 0112 1 essentially control performance, or continually regulate 2 performance. 3 You make a number of points in your statement, 4 historically, about the way in which data has actually 5 been gathered. You say this, on page 9, at the very 6 beginning of the paragraph, the main paragraph on the 7 page: 8 "There is an obvious need to strengthen the 9 quality of data submitted to any register on congenital 10 heart surgery." 11 You go on, I think, to deal with the model in 12 Minnesota, but am I right in thinking that the model in 13 Minnesota deals really with the analysis of data which 14 has been submitted? 15 A. Yes, but individual centres are obviously asked if the 16 quality of analysis is going to be sufficiently good and 17 rigorous that their data is submitted in a particular 18 form. 19 Q. To deal with the submission of data so far as you 20 understand it to have been in this country, data was 21 submitted to what, the Society of Cardiothoracic 22 Surgeons? 23 A. Yes. 24 Q. From the 70s onwards? 25 A. From '77/78, if my recollection is correct. 0113 1 Q. What is your understanding as to the reliability of the 2 data as submitted, not as analysed, but as submitted? 3 A. I think there is anxiety about some of the data. We 4 know that numbers are not necessarily accurate. We are 5 not always certain as to how the data has been compiled; 6 the level of seniority with which the data may have been 7 inspected before it is submitted to the Cardiothoracic 8 Surgical Register, but again, in terms of that specific 9 question I think one or other of my surgical colleagues 10 may be better to answer. 11 Q. It is really your comment, page 5, which simply says 12 this: 13 "Lack of resource has severely limited the 14 accurate collection and in particular validation of 15 data." 16 A. Yes. 17 Q. What lack of resources do you identify as having been 18 present in the 1980s and 90s? 19 A. If we take the latter, the validation of data, the 20 validation of data could really only be achieved by 21 in-site inspection and that has not taken place. That 22 is again within the wider frameworking issue we have 23 identified within the wider framework of accreditation 24 of centres and would be an important part of it. 25 Q. So the data purely relies, as it were, upon trust of the 0114 1 data given by the analyst to the collector? 2 A. Absolutely. 3 Q. So far as the lack of resource limiting the actual 4 collection, what lack of resource are we talking about 5 there? 6 A. In some centres it may be limited secretarial support. 7 That has improved, one would have to say, throughout the 8 1980s and indeed in the 1990s many centres will have 9 a specific Audit Secretary who will collect the data and 10 get it in a form suitable for presentation to the 11 register. 12 So it is not all entirely black. Things have 13 improved. But I think in terms of the type of data that 14 is submitted, we have no idea, really, for the most 15 part, of risk stratification for an individual patient, 16 an individual baby who is operated on at three months 17 with a hole in the heart may in fact be doing reasonably 18 well, it may be a fairly elective operation, the baby 19 may come in good condition to surgical procedure. In 20 contrast, another baby who on paper appears to have an 21 identical lesion may have appeared for operation already 22 on a ventilator, supported massively with a number of 23 drugs, and again, intuitive belief is that the outcome 24 for the latter patient is unlikely to be as good as for 25 the former patient. 0115 1 Q. So the first issue is, whatever data was actually 2 required or requested, whether that was an accurately 3 collected? 4 A. Yes, that is one issue. 5 Q. That depends upon the secretary, her time, whether she 6 goes to look at the surgeon's log or whatever the data 7 source is? 8 A. Yes, an individual committed to audit. 9 Q. Or whether someone comes and tells him or her what the 10 figures are and if so, what the motivation is for that 11 person? 12 A. Yes. 13 Q. That is the collection process. 14 A. Yes. 15 Q. Secondly, you are saying whatever data is collected, 16 there was not enough detail in it to make any sensible 17 analysis further down the road? 18 A. Or to make an adequate analysis further down the road. 19 Q. Because of the need to identify, as you put it, the risk 20 stratification and therefore to see whether particular 21 results were comparable, given that it is a small 22 series? 23 A. Exactly. 24 Q. Thirdly, no validation, we have established that. 25 Fourthly, the question about the resources devoted to 0116 1 the analysis of the data at the collection point. 2 Going back to the first, the secretary who goes 3 and gets the data or has it given to him or her, 4 I imagine that anecdotally, within the field of the 5 Society, the general Society of Cardiologists, there 6 must be observations about how accurate that has been 7 done from time to time? 8 A. Yes. 9 Q. What is the anecdotal view? 10 A. The anecdotal view is that from time to time it has been 11 done poorly or inadequately. 12 Q. Your suggestions from the BPCA would involve, of 13 necessity, again the commitment of resources to a proper 14 and adequate system, a detailed system, of data 15 collection? 16 A. Yes. 17 Q. Which would have to be policed? 18 A. Yes, and funded. 19 Q. Finally, can I turn to the issue of informed consent, 20 which you deal with at 47/11. 21 You begin by saying: 22 "It is now widely recognised and accepted that 23 patients and families need to be given more information 24 before coming to a decision ..." 25 By whom is it more widely recognised and accepted? 0117 1 A. I think in this context, I was specifically thinking, or 2 we were specifically thinking of the medical profession 3 itself, but I think it is also recognised, obviously, 4 that parents, patients, families, also wish to have more 5 information. 6 Q. The next sentence: 7 "For cardiac surgery, this information should 8 include unit or individual surgeon's experience with 9 a particular operation, including the risks/morbidity 10 and not just the mortality." 11 A. Yes. 12 Q. We have just been looking at the learning curve. You 13 are suggesting, are you, that if there is a patient 14 about to undergo what is for them dramatically serious 15 surgery, or a parent whose child is about to undergo 16 dramatically serious surgery on the heart, as they see 17 it that the surgeon should say, "Well, I have never 18 actually done one of these operations before, so 19 I cannot tell you what the risks in my hands are, but it 20 is a risky procedure and generally speaking 25 per cent 21 of patients will die." 22 Is that the sort of thing which should be said? 23 A. It may need to be said, or explained in a context from 24 time to time. One of the difficulties is whether that 25 risk is expressed descriptively or numerically. There 0118 1 has recently been a study from the United States looking 2 at cardiac surgical consent and looking at how patients 3 wish information to be given to them. The majority of 4 patients wish the risk to be expressed to them in 5 descriptive terms rather than in numerical terms, but 6 when they were asked to define what "probable" and 7 "possible" meant, there was enormous variation in terms 8 of understanding and acceptance of what "possible" 9 meant. "Possible" risk might vary something from 3 or 10 4 per cent to 80 per cent, and similar variations with 11 the term "probable". 12 The difficulties are enormous in terms of what we 13 mean by "informed consent". I have earlier indicated 14 I am not an ethicist, and some here will clearly 15 recognise the difficulties of this ongoing debate of 16 what we mean by "informed consent". 17 Certainly, we accept that it has to be extended, 18 and I think in that extension we have to recognise that 19 probably does impose a requirement on an individual unit 20 at least and probably a surgeon also to discuss their 21 individual results. 22 Q. How does one cope with the difficulties from the 23 patient's perspective of being told that the surgeon has 24 not done this particular procedure before, or has only 25 done one or two of them? 0119 1 A. I switch now perhaps to personal observations, rather 2 than observations on behalf of the BPCA. I think if 3 a surgeon has done only a limited number of procedures, 4 but that procedure is an uncommon or rare one and he 5 knows that few surgeons anywhere will have large 6 numbers, or sufficient numbers to be analysed in 7 statistical terms, then it is reasonable for him to say, 8 "My experience is very limited with this procedure, but 9 most other surgeons also have very limited experience". 10 The discussion or the consent procedure then of 11 course may extend somewhat wider. The patient then 12 asks, "Is there anywhere that this particular procedure 13 is performed more frequently with better results?" If 14 one said yes, there is centre X in a continent 15 elsewhere, then it may not be practical to suggest that 16 all patients with that condition travel to that other 17 continent. There may be greater difficulties, however, 18 if one other centre in the UK has somewhat greater 19 experience than others with a particular procedure, and 20 that knowledge is widely disseminated or made available. 21 Are we then to recommend that only one centre 22 carry out particular, or perhaps two or three centres 23 carry out particular procedures? I do not know the 24 answer to that yet. 25 Q. I was going to ask you what your answer was. 0120 1 A. No, I do not know it. I think the debate has just 2 started, but for sure, it is not a simple debate. 3 Q. What would the general view be as to the position that 4 was proposed by Mr McLean to Dr Swanton earlier today, 5 where you have a fairly established risk in one 6 operation, the Sennings or Mustard procedure for dealing 7 with transposition of the great arteries and along comes 8 the arterial switch, a new procedure, which the surgeon 9 may not have done before, although he may have done lots 10 of Mustards or Sennings. Is he to say, "I have never 11 done one of these before so I cannot tell you the risks 12 in my hands, but I can tell you if you had this other 13 procedure the baby would live to 25, 27, 30, might need 14 another operation on the way, might not live any longer, 15 but will probably have a good chance of surviving 16 surgery". What should be said? 17 A. I think that depends on the nature of this "new", in 18 inverted commas, procedure that the surgeon may be 19 doing. If in type it is very similar to other 20 procedures he has done, he can explain that clearly to 21 the family, that in essence the technique or methods of 22 surgical operation he will be using will be based on 23 many other similar operations. 24 But if it really is an operation that requires the 25 application of an entirely new technique or method, then 0121 1 what we are proposing is that he should not operate for 2 the first time single-handedly. That is exactly the 3 kind of situation in which he will invite a colleague 4 from elsewhere to come and assist him with the first 5 three, four, five, six cases. That should become the 6 accepted norm of practice, rather than a surgeon 7 returning from an international conference, having heard 8 somebody in centre X report on a new procedure, and 9 saying "Look, I am going to try that when I get back 10 home" as opposed to the modification of an established 11 procedure. 12 Q. You have implied in your report that views have changed 13 on the question of informed consent over the period this 14 Inquiry is concerned with. Just to take your last 15 example of the surgeon returning home from the 16 international conference, and again, really asking for 17 your anecdotal experience of this, anecdotally, is that 18 what it is thought happened with perhaps a number of 19 procedures during the 1980s and perhaps early 1990s? 20 A. I would not put it as boldly or as crudely as that, 21 obviously, but if we take the arterial switch procedure, 22 it was recognised as promising better results in the 23 long-term. We had a number of surgeons who felt they 24 were technically competent with well-established 25 procedures in paediatric cardiac surgery, therefore, why 0122 1 should they not be competent with that procedure, 2 whereas it was recognised fairly soon there were some 3 technical pitfalls that had to be worked through by the 4 leaders in the field before the operation, the new 5 technique, became established as an acceptable 6 alternative to the Mustard and Senning procedures. 7 But yes, I think it will be acknowledged by the 8 medical community, there were surgeons who attempted 9 worldwide the arterial switch operation who probably 10 would have benefited from wider exposure to colleagues 11 who had already taken on board the procedure as an 12 established part of their surgical armamentarium. 13 Q. I accept the question was crude and stark, but I suspect 14 that what you said in your elegant reply could be 15 crudely and starkly be summarised as "Yes"? 16 A. Yes. 17 Q. That is all I am going to ask you, Dr Godman. Thank you 18 very much from my perspective for coming to give the 19 evidence you have. There are undoubtedly going to be 20 some questions from the Panel. 21 Examined by THE PANEL: 22 MRS HOWARD: There are two questions I would like to ask. 23 Can I refer you to your statement, 47/6. 24 You refer at the top of that statement to the role 25 of the Liaison Cardiac Nurse. 0123 1 A. Yes. 2 Q. You go on to say, or you reply that this is an extremely 3 important role. Could you explain to me the views of 4 the Association in respect of the roles and 5 responsibilities of that person and also the 6 qualifications and skills you would expect that person 7 to have? 8 A. The individual would usually have come from a background 9 of involvement in either paediatric cardiology or 10 paediatric cardiac post-operative care. I think there 11 are one or two individuals that may have come generally 12 from the background of general paediatrics, but they 13 would be individuals familiar with handling not only 14 children but obviously the families, so an important 15 part of the role is the preparation of the individual 16 child and the family for surgery or for the 17 cardiocatheter procedure, for the totality of the care 18 whilst the child was in hospital. 19 The individual's role may not be confined to 20 looking at the family within hospital. He or she may 21 look at the family in the home, in the general practice 22 setting, before the child comes into hospital, and will 23 follow through post-operatively as well. 24 They will have a number of remits, but one in 25 which we hope their role will be extended is picking up 0124 1 the kind of information the cardiologist and cardiac 2 surgeon fail to do so, often in the setting of 3 relatively short interviews, even though they may be an 4 hour or an half, fairly short in the context of an 5 individual child being prepared for a major life event. 6 Q. In the situation where unfortunately the child succumbs, 7 particularly if this has been during the operation 8 itself, where do you see the role of somebody such as 9 the Cardiac Liaison Nurse in that very difficult time of 10 breaking that news? 11 A. Obviously, for example, the time of day in which if 12 a child dies after surgery, it may define the role in 13 some ways in terms of the immediate setting, but the 14 Cardiology Liaison Nurse will play a key part in 15 supporting the family, with usually the cardiologist, 16 perhaps, rather than the surgeon in the hours -- not 17 immediately after surgery, but, say, 12, 18, 24 hours 18 after, and I believe that in most centres that 19 Cardiology Liaison Nurse will sit in when the news is 20 transmitted to the parents that their child has been 21 lost, to play an important role in setting up the 22 follow-up meetings with the family and liaising with the 23 cardiologist and the surgeon in terms of helping with 24 counselling of the family after the loss of the child. 25 Q. Just one other question. You referred very early on in 0125 1 your statements to the responsibilities for quality that 2 would emanate from the Board of the hospital. Do you 3 have any particular comments with regard to particular 4 directors on the Board whom you might see as having an 5 essential role in relation to both the setting and 6 monitoring of standards? 7 A. I am not quite sure I have understood the thrust of the 8 question. Do you mean that there should be a particular 9 non-executive director or executive director with total 10 responsibility. 11 Q. I am particularly interested in your view of the 12 executive members of the Board. 13 A. Yes, I think there should be an executive member of the 14 board with specific duties for quality setting. I know 15 that on many Boards that will often be the Director of 16 Nursing, but not exclusively the Director of Nursing, 17 but I think, equally important, there should be 18 a non-executive director with a remit very much for 19 helping to monitor, or indeed, chairing the quality 20 standards setting committee. 21 MRS HOWARD: Thank you very much. 22 PROFESSOR JARMAN: Three questions, Dr Godman. You very 23 honestly said you just do not know whether the results 24 should be published or not and also the difficulties 25 between "probable" and "possible" etc, and risk? 0126 1 A. If I could correct that, committed to the publishing of 2 the results. Not quite sure of the form in which they 3 are published, and do believe strongly that whatever 4 form that is, we need to extend the debate with the 5 public at large on what that information is actually 6 telling them and meaning. 7 Q. So you are committed to the publishing of them? 8 A. Yes. 9 Q. And there is this problem "probable" and "possible". 10 We have heard in the Inquiry often people are given 11 figures, 20 per cent, 30 per cent and so on. Do you 12 think it would be useful if patients were given 13 a written number, and then also the "probable" or 14 "possible" discussions? We both know that patients do 15 not understand everything during the consultation. They 16 could take that away with them and cogitate over it 17 after this? 18 A. Yes, personally, I would support that. 19 Q. The second question is that you say at the end of your 20 statement you think the BPCA might assume a regulator 21 function and question the outcome performance and so on? 22 A. Yes. 23 Q. Later on you discuss the difficulties of measuring 24 outcome and performance, which we all know about. My 25 impression as a GP is that patients are very interested 0127 1 in low death rates. I just wonder whether you see there 2 might be a role for the patient working with their GP in 3 looking at outcome, perhaps in the new structure of 4 primary care groups. 5 Would you see any role for the patients working 6 via their GPs and BCPs and looking at outcome? 7 A. I have to confess, it is not an approach I have 8 considered, or we have considered, I think because we 9 thought already the exercise was likely to be 10 extraordinarily difficult. I would turn it round on the 11 question and say "Yes, one would be interested. What is 12 it that is being proposed?" 13 Q. I suppose what I am proposing is that patients would be 14 very interested to know what the figures were, but may 15 not be able to interpret them themselves easily so that 16 they could get help via their GPs and working within the 17 primary care group to collect evidence? 18 A. Yes, I certainly would be supportive of that approach. 19 Q. Thank you very much. The third question is the one 20 I asked Dr Swanton: whether BPCA did discuss what were 21 suggested to be problems at Bristol at all in any of 22 their meetings? 23 A. No, we did not. 24 Q. Do you think it might have been useful, that you might 25 have expected to have discussed it? 0128 1 A. I think it would have been useful. I think we might 2 well have laboured under considerable difficulties in 3 getting accurate information on data. 4 PROFESSOR JARMAN: Thank you very much. 5 THE CHAIRMAN: Thank you. I have no questions. 6 Dr Godman, unless Mr Langstaff has, thank you very 7 much indeed for coming and sharing your knowledge and 8 wisdom with us today. I am sorry we kept you over the 9 lunch break, as it were, the short lunch break as it 10 was. We are very grateful to you. If in the coming 11 period of time you wish to submit anything else to us, 12 we would of course be happy to receive it. 13 THE WITNESS: Thank you very much. 14 (The witness withdrew) 15 MR MACLEAN: Sir, could I call Dr Jane Ratcliffe, please? 16 Dr Ratcliffe, as you know, we take the oath. 17 Would you stand up, please, to take the oath. 18 DR JANE RATCLIFFE (Sworn): 19 Examined by MR MACLEAN: 20 Q. Do sit down, Dr Ratcliffe. Could you give us first of 21 all your full name and professional address, please? 22 A. I am Dr Jane Margaret Ratcliffe. 23 Q. Could you move closer to the microphone? 24 A. I am a consultant in paediatric intensive care at the 25 Royal Children's Hospital, Alderhay, and I hold the 0129 1 qualifications of Bachelor of Medicine and Surgery. 2 I am a Fellow of the Royal College of Physicians and 3 a Fellow of the Royal College of Paediatrics and Child 4 Health. 5 Q. I think you are currently the Chairman of the 6 Intercollegiate Committee for Training in Paediatric 7 Intensive Care Medicine and were, until very recently, 8 the Honorary Secretary of the Paediatric Intensive Care 9 Society, which post you held between 1991 and 1998? 10 A. That is correct. I have actually just taken over the 11 Chairmanship of the Intercollegiate Committee from 12 Professor Hatch. 13 THE CHAIRMAN: May I interrupt, could you come forward just 14 a little. It is I not you, it is just that I do not 15 hear too well. 16 MR MACLEAN: Could I have on the screen WIT 60, page 1. 17 Dr Ratcliffe, is that the first page of 18 a statement you have submitted to the Inquiry? 19 A. Yes, it is. 20 Q. If we move on, please, to page 8, that is your 21 signature, is it not? 22 A. Yes, it is. 23 Q. That is the end of that same and formal written 24 statement that you have submitted to the Inquiry? 25 A. Yes, it is. 0130 1 Q. The Panel will have read your statement, and we can 2 assume that they are familiar with the content of it. 3 The Paediatric Intensive Care Society was established in 4 1987? 5 A. Yes, that is correct. 6 Q. And it has a wide-ranging membership, involving which 7 disciplines? 8 A. It involves people who have any input into paediatric 9 intensive care, so paediatric anaesthetists, 10 paediatricians, paediatric intensivists, surgeons, both 11 general paediatric surgeons and specifically 12 cardiothoracic surgeons, cardiologists, paediatric 13 cardiologists. That is the main bulk of the medical 14 membership, including trainees in the specialities. The 15 other group are nurses mainly working in paediatric 16 intensive care, some working in neonatal intensive care 17 and some in mainly general intensive care. 18 Then professions allied to medicine, such as 19 pharmacists and physiotherapists are also members. 20 Q. You would describe yourself, I think, now, as being 21 a consultant paediatric intensivist? 22 A. Yes. 23 Q. And I think we are going to see in the next few minutes, 24 that the concept of a paediatric intensivist as 25 a specialist consultant is one that has developed really 0131 1 over the last ten years for the first time, has it not? 2 A. Yes, in this country, although there are models abroad. 3 Q. We see from the first page of your statement you 4 yourself worked at the Hospital for Sick Children in 5 Toronto as a Paediatric Intensive Care Unit fellow? 6 A. Yes. 7 Q. That was before you took up your post here in 1991? 8 A. Yes. 9 Q. The Paediatric Intensive Care Society was formed in the 10 wake of a report from a Working Party of what was then 11 the British Paediatric Association, which was set up in 12 1985, the Working Party, in 1985? 13 A. Yes. 14 Q. The report was published in 1987. 15 Could I have RCPCH 1/1, please? That is the 1987 16 report, is it not, in front of you? 17 A. Yes. 18 Q. If we just have a look at this briefly, if we go, 19 please, to page 2, the bottom of the page, that last 20 paragraph: 21 "Terms of reference: the Working Party was 22 established by the Council of the British Paediatric 23 Association [in March 1985] to consider intensive care 24 for older children in the UK. Its terms of reference 25 were to 'investigate and report on the facilities, 0132 1 organisation and staffing, (including training) for 2 intensive care of infants outside the neonatal period 3 and older children and to make recommendations to the 4 Association'." 5 A. Yes. 6 Q. So the first thing we see there is that in 1985 there 7 was a distinction being drawn between one type of child 8 and another by age: older children were being looked at 9 separately from the very young? 10 A. Yes. I think the distinction is more between neonatal 11 intensive care, which was a well-established area of 12 specialisation, and children who fell outwith that, but 13 these children could also be neonatal, i.e. within the 14 first month of life, but in general, they were not the 15 pre-term infants that formed the bulk of neonatal 16 intensive care. They may be infants who had never been 17 in a neonatal intensive care or special care unit who 18 came back into hospital with other conditions. 19 Q. Because most neonates cared for in an Intensive Care 20 Unit, or perhaps a Special Care Baby Unit, would be 21 obviously within the first 28 days of life cared for in 22 a maternity hospital, in a Special Care Baby Unit or an 23 Intensive Care Unit at the maternity hospital? 24 A. Yes. 25 Q. But obviously children might for example be taken home 0133 1 and only a few days later or a week or so later it is 2 detected there is a congenital heart defect? 3 A. Yes. 4 Q. Then you would find yourselves not in the Special Care 5 Baby Unit or the ITU item but in the children's hospital 6 or the adult hospital, and then we would have to be 7 looking at the intensive care facilities there? 8 A. Yes. 9 Q. If we go to page 3, and turn it round, under the heading 10 "introduction", the first paragraph, the Panel can see 11 that for themselves, I will not read it out. That is 12 the paragraph that makes the point we have just made, is 13 it not? 14 A. Yes. 15 Q. If we scan down that page to the paragraph under the 16 heading "Questionnaire", this Working Party did not 17 consider units providing care for a single specialty, 18 such as neurosurgery, cardiology and burns. Those were 19 excluded? 20 A. Yes. 21 Q. I want to try and separate out all the cross-cutting 22 specialities here. We have one distinction between 23 adults and children? 24 A. Yes. 25 Q. Another distinction is between the specialty, 0134 1 neurosurgery or cardiology, for example, and general 2 surgery or general medicine, or another specialty? 3 A. Yes. 4 Q. Are you able to comment on which of those two is the 5 most fundamental for the care of children with 6 paediatric cardiac problems? Is it important that they 7 are cared for in a centre which is a cardiac centre, 8 first and foremost, or is it important that they are 9 cared for in a centre which is a paediatric centre first 10 and foremost, or is it a mixture of both? 11 A. I think in terms of the paediatric cardiac spectrum, it 12 is very different from the adult cardiac spectrum of 13 illness. 14 Q. Why? 15 A. It is in the main congenital heart disease, structural 16 heart defects. It is not diseases of degeneration. 17 These are children with often complex other problems, in 18 addition to that, so I would say the ideal is a cardiac 19 centre which is a paediatric cardiac centre which has 20 the input not just of paediatric cardiologists, cardiac 21 thoracic surgeons and around the surgical period people 22 with specific training in management of the 23 peri-operative period for children, paediatric intensive 24 care consultants, but it is also the additional input of 25 the specialities, the paediatric support specialities in 0135 1 terms of, for instance, renal respiratory and sometimes 2 genetic support, counselling support, I think, is the 3 trained nurses -- it is the appropriately trained nurses 4 who are trained both in the management of paediatric 5 cardiological problems and paediatrics, and the 6 environment which is focused on the child and is 7 child-friendly. 8 Q. Would it be fair to say that whereas there might be, in 9 the view of your Association, scope for a single 10 specialty cardiac centre dealing with adults, which is 11 populated by cardiac surgeons and cardiologists, and so 12 on, but as a separate centre, that might be as it were 13 okay for adults, but because of the congenital heart 14 conditions that children will suffer from, that type of 15 approach of having a separate cardiac centre away from 16 the general run of paediatric expertise would be much 17 less appropriate in the case of children than adults. 18 That is a very long question. 19 A. Yes. I think it is not the ideal configuration, 20 although there have been several centres that have 21 developed like this, and, you know, shown themselves to 22 be providing an excellent service. I think the way to 23 look at it is, if you were configuring it from a blank 24 sheet, I would want to configure it within a paediatric 25 setting, but with all the key figures who can make the 0136 1 specific specialty, you know, of the highest excellence. 2 Q. Can we move to page 4, then, of the 1987 report, at the 3 bottom of the right-hand column and just blow that up. 4 This was a Working Party set up in 1985, so right at the 5 beginning of the Inquiry's period. It says: 6 "At least one consultant should bear 7 administrative responsibility for the unit. Consultant 8 cover for the purposes of advice and consultation on the 9 care of individual patients should always be available 10 so a consultant should be on call for the unit at all 11 times ..." 12 In 1985/86/87, who was responsible ultimately for 13 the clinical care of a child in an Intensive Care Unit? 14 Was it the surgeon or someone else? 15 A. I think it would depend on the individual staff who 16 would say, "I am in charge". I think it is a difficult 17 one. 18 Q. What was your impression of the position at that time? 19 A. In terms of the general intensive care unit side of 20 things, it seemed to be a sort of joint -- the position 21 was of a joint care between the person who was running 22 the intensive care, the consultant in charge, and the 23 consultant from this specialty admitting the child 24 there. 25 In specific cardiac terms, I think the surgeon 0137 1 feels that that is their patient, progressing through 2 the unit, or the cardiologist, but I think that it is -- 3 it was clear that within a unit, within an intensive 4 care unit, that person was not always as available, 5 because they were probably doing more surgery or 6 whatever, that there should be a shared person who was 7 spending their time working on the intensive care. 8 Q. I am sorry to interrupt you. It is the first sentence 9 of that paragraph. It is the words "administrative 10 responsibility", which suggest that there was some other 11 responsibility, perhaps clinical responsibility, which 12 lies elsewhere than with this one consultant; is that 13 right, or am I reading too much into that? 14 A. I was not involved in the preparation of this document, 15 as you probably appreciate, and we have since amended 16 that slightly, but in terms of for a Paediatric 17 Intensive Care Unit, not particularly one with 18 a specialist one, it is that somebody should lead the 19 clinical team, i.e. somebody is head of that department, 20 leading the way it works, but on a day-to-day or an 21 individual basis, the actual consultant supervising the 22 care will vary. 23 Q. Would it be fair to say that in the mid-1980s, so far as 24 you are aware, most cardiac surgeons would have taken 25 the view that the patient was their patient in the 0138 1 theatre and afterwards in the Intensive Care Unit and 2 that they were responsibility for the clinical care of 3 that patient until they were discharged from hospital? 4 A. I think that was a view that I -- I certainly -- and 5 I was a trainee at that time -- saw that as happening, 6 yes. 7 Q. That was a prevalent view? 8 A. Yes, certainly in this country. 9 Q. Can I just have the same document, please, at page 7? 10 The bottom of the left-hand column, the penultimate 11 paragraph, please. 12 At this stage, the last sentence: 13 "It was suggested [by the Working Party] that 14 where possible the provision of paediatric intensive 15 care should be organised so that units have a minimum of 16 five beds." 17 Was that indicative of the general position at 18 that stage, or was that an aspiration? 19 A. I think it was an aspiration for a lot of units. 20 I think there were a lot of very small units at the 21 time, but it was felt that to have the full panoply of 22 support, five beds would be an absolute minimum. 23 I think the number of beds has increased in subsequent 24 views, but -- 25 Q. We will see that. I am interested at the moment in the 0139 1 late 1980s. 2 A. Yes. I think that five beds would -- you really would 3 not call it a true Paediatric Intensive Care Unit, then, 4 with fewer than those. 5 Q. Can we have the next paragraph, please. The Working 6 Party had conducted a survey? 7 A. Yes. 8 Q. That showed at that time a third of children requiring 9 care were admitted to general intensive care units; that 10 means adult intensive care units essentially. 11 A. Yes. 12 Q. "About half of those GICUs taking children admitted 12 13 or less [I think that should be 'fewer'] children per 14 year (thus accounting for 16 per cent of children 15 admitted to GICUs)"? 16 A. Yes. 17 Q. So the pattern in the late 1980s was that a good number 18 of children were admitted to general ICUs in 19 non-specialties -- because we remember we are not 20 dealing here with neurosurgery or cardiothoracic 21 surgery. 22 A final reference to this document, please, 23 page 8, just above the heading "Parents". This is in 24 the context of a discussion of nursing. 25 "Following the creation of such courses [dealing 0140 1 with nursing training] it would then be hoped that an 2 increasing number of nurses in PICUs should have 3 a qualification in paediatric intensive care nursing and 4 that it should be possible in the identified GICUs to 5 ensure that at least one nurse per shift has paediatric 6 intensive care training." 7 It is fair to say, is it not, that that position 8 in 1987 is very far removed from the position which your 9 organisation would adopt now as being best practice? 10 A. Yes. 11 Q. And that especially in respect of paediatric intensive 12 care nursing, there has been an exponential shift in the 13 expectations of what is required in terms of nursing 14 sick children? 15 A. Yes. 16 Q. Let us go, then, to another document, WIT 60/11, please: 17 this is one of the documents you refer to in your 18 statement, the Paediatric Intensive Care Society's own 19 standards from 1992. Could we go, please, to page 13? 20 That tells us who prepared the document. The 21 Panel can see that. 22 Would you go, then, to page 15? 23 We see there a definition of "intensive care" and 24 the definition of "intensive care unit". For the 25 Panel's note, the footnote references can be found at 0141 1 page 24 of the same bundle. We need not go there. 2 Those are generally accepted definitions and were 3 in 1992. There was nothing controversial there, was 4 there? 5 A. I do not think so, no. 6 Q. Under the heading, just scrolling down slightly, 7 "Paediatric intensive care." 8 "There are only a small number of paediatric 9 intensive care units in the United Kingdom. Many 10 critically ill children undergo treatment in general 11 intensive care units which cater predominantly for 12 adults. In these units, children may be nursed in an 13 open-plan area alongside adults undergoing intensive 14 care. An alternative adopted by some hospitals is to 15 manage critically ill children in part of a general 16 paediatric ward", so not in an intensive care setting at 17 all. "Both these arrangements have a number of 18 disadvantages" and they are set out. 19 It is fair to say those disadvantages have been 20 again highlighted time and time again since 1992? 21 A. Yes. 22 Q. Over the page, page 16, please. The top of the page: 23 "Although it has been suggested that there should 24 be a minimum of one general paediatric intensive care 25 bed per 40,000 of the child population, this may be an 0142 1 under-estimate. Because intensive care is expensive in 2 terms of manpower and resources, it is essential to 3 centralise paediatric intensive care facilities so that 4 they may be used in the most efficient and 5 cost-effective way". 6 How did the Paediatric Intensive Care Society 7 envisage that that centralisation process would come 8 about? 9 A. They hoped that there would be a general recommendation 10 coming from them and from the multi-disciplinary working 11 party convened by the British Paediatric Association 12 which reported in 1993, that this would be a stimulus to 13 change, to report on the fragmented way it was 14 happening. 15 Q. It is one thing to report in a fragmented way of things 16 being done and saying "This is a bad show, we need to 17 centralise". It is another to actually centralise? 18 A. That is right. 19 Q. What was the mechanism for bringing this suggestion and 20 recommendation to bear fruit? 21 A. From the perspective of the Paediatric Intensive Care 22 Society, actually producing standards of practice was 23 felt to be a way of illustrating what should be achieved 24 and for individual units to actually look at where they 25 stood. 0143 1 An independent organisation of interested 2 professionals has no clout in things. Therefore, the 3 other route was the British Paediatric Association, 4 which was -- 5 Q. Now the Royal College of Paediatrics and Child Health? 6 A. Yes. It was felt that the recommendations from very 7 concerned professionals, plus the information contained 8 and the details, would -- 9 Q. Would somehow permeate through? 10 A. Somehow permeate through, that perhaps there would be 11 leadership via the Department of Health that would 12 ensure that change took place. 13 Q. Let us pause there and go to the bottom of the same 14 page. Under the heading "Regional organisation", we 15 have to remember this was 1992, so at the beginning of 16 a period of fundamental change in the Health Service? 17 A. Yes. 18 Q. "We consider that paediatric intensive care should be 19 provided on a regional basis. There needs to be a clear 20 strategy for the provision of paediatric intensive care 21 facilities with one or more paediatric intensive care 22 units per region, to be based at a children's hospital 23 or major paediatric centre." 24 We see from the foot of the page that those were 25 to be additional to the supra-regional paediatric 0144 1 subspecialty units which then just about still existed 2 for cardiothoracic surgery. 3 That seems to suggest that the role, the key role 4 in setting up this process of having paediatric 5 intensive care units was to be carried out at a regional 6 level by the Regional Health Authority at that time? 7 A. Yes. 8 Q. Is that right? 9 A. Yes. 10 Q. And regional health authorities disappeared shortly 11 thereafter, but we now have a system of the National 12 Health Executive with its eight areas, do we not? 13 A. Yes. 14 Q. So is it fair to say that to the extent that paediatric 15 intensive care is to be developed on a regional basis or 16 an area basis, that the key organisation to deliver that 17 structure would now be the areas of the National Health 18 Service? 19 A. Yes, it would be. 20 Q. What is the mechanism for them doing that in the context 21 of a system which has purchasers and providers operating 22 across the country with, as it were, the freedom to buy 23 services in theory from wherever they like? 24 A. I think that would go in a very unhelpful way, to put it 25 mildly, to the thrust of grouping the services and 0145 1 getting this sort of procedure. I think it would be 2 actually a difficult process. It would be made more 3 difficult by the situation with Trusts and the 4 organisation, and there was less of a regional thrust, 5 although there were these eight Health Authorities, 6 I think there was a lot of Trusts trying to develop as 7 much as they could within the political climate of that 8 time. 9 Q. It is usual for a National Health Service Trust to want 10 to accumulate specialities which are high profile, will 11 attract high profile and good staff and which will then 12 attract, presumably, finance from purchasers? 13 A. Yes. 14 Q. That is fair comment, is it not? 15 A. Yes. 16 Q. Just looking at that page, just before we leave it, on 17 minimum size and number of admissions, the Society was 18 suggesting, it was suggested, recommended in fact, that 19 a paediatric intensive care unit should have at least 20 four beds and admit the minimum of 150 patients per 21 year? 22 A. Yes. 23 Q. I think it is fair to say that subsequently when the 24 National Health Centre for Reviews and Dissemination got 25 a hold of a later document, they criticised the way in 0146 1 which the suggested numbers had been arrived at by the 2 Society? 3 A. Yes. 4 Q. How was that number of at least four arrived at? What 5 is it based on? 6 A. I think it was based on the knowledge of certain 7 paediatric intensive care units being of that size, but 8 the views of the members of the Society, you know, at 9 that time, that this would be an absolute minimum to be 10 able to be given the name of Paediatric Intensive Care 11 Unit at that time -- 12 Q. What is the view now? 13 A. That Paediatric Intensive Care Units has been 14 considerably bigger than that. 15 Q. How big? 16 A. I think we would say at least 8 beds. 17 Q. Why has it increased by 100 per cent since 1992? 18 A. In order to actually run a paediatric intensive care 19 transport service, and to have the staff and the 20 expertise maintained, you need a significant and ongoing 21 through-put of patients, and you need the staff to be 22 able to transfer the patients, resuscitate and transfer 23 them and bring them into the unit, and you cannot do 24 that in a centre without the medical and nursing 25 resources to be able to do that. 0147 1 So it is the infrastructure and the perceptions of 2 what infrastructure you need that have really changed 3 and have dictated the increase in numbers. 4 Q. Let us go on, then, to page 17, please. The middle of 5 the page, under the heading "Consultant medical staff", 6 similar to the passage we saw in the 1987 report. In 7 the middle paragraph there: 8 "Most British paediatric intensive care units 9 adopt a multi-disciplinary approach to patient 10 management. Although the unit medical staff will 11 supervise and oversee many aspects of treatment, the 12 patients will normally remain under the overall charge 13 of the hospital consultant under whom they were 14 admitted". 15 A. Yes. 16 Q. That would be for a child admitted for a repair of 17 a congenital heart defect to the cardiac surgeon? 18 A. Yes. 19 Q. So he or she is in charge overall? 20 A. Yes. 21 Q. Then we go on: "The consultant in administrative charge 22 [the same word again] of intensive care, should 23 therefore be responsible for establishing lines of 24 communication with all staff who have involvement with 25 the care of patients on the unit". 0148 1 No doubt a very unfair characterisation, but one 2 view of that paragraph is that the consultant in 3 administrative charge is essentially a communications 4 person making sure that the right people are talking to 5 the right other people? 6 A. Yes. 7 Q. But it is the surgeon who is in overall charge of the 8 patient whilst they are in the paediatric intensive care 9 unit? 10 A. I would think many units were run on that basis. 11 Q. That seemed to be the norm? 12 A. That seemed to be at the time, although I think read in 13 that way it does not actually give credence, or it does 14 not give any support to the consultant who may be 15 managing the patient on an hour-by-hour basis, really. 16 They are co-ordinating for the specialist areas relating 17 to the cardiac surgery or the cardiological input, for 18 instance, an echocardiogram, or the cardiac surgeon's 19 input into whatever aspect of the care. But they are 20 themselves doing a lot of the actual care and management 21 as well. 22 Q. I understand that, but we hear a lot about 23 multidisciplinary treatment, and so on, and take that on 24 board, but it is important, is it not, for the parent of 25 a child, or for an adult patient, to know who is in 0149 1 charge of their care? 2 A. Yes. 3 Q. "Who is caring for me while I am here?" 4 A. Yes. 5 Q. And what this tells us is that in 1992 they were being 6 cared for, overall, by the consulting surgeon, so they 7 would be looking, would they not, to the surgeon, would 8 be expecting the surgeon to come round and look after 9 them to see how they were and taking a role in directing 10 the clinical care they were given; is that right? 11 A. Yes, they would on paper, but in fact on an individual 12 PICU basis, they would be looked after by the staff, who 13 would actually introduce themselves and say, "I am 14 actually looking after you while you are here". 15 Q. So in fact what you are saying is, in fact they are 16 looked after by the people in the Intensive Care Unit, 17 actually, the others decide the drug doses, the other 18 care in the Intensive Care Unit, but to the extent that 19 the patient or the parent still considered them to be 20 under the care of Mr X who had done the operation the 21 day before, there would be scope, would there not, for 22 the parent to misunderstand the role of the surgeon 23 after the patient had left surgery? 24 A. Yes. I think they may expect the surgeon to manage the 25 post-operative care when it is going to be managed by 0150 1 the medical staff, cardio -- we are talking specifically 2 about cardiac surgery, the cardiologist, and the 3 consultant in intensive care, whoever that may be, but 4 also, I think the crucial person who will help the 5 understanding of the process is the bedside nurse 6 actually managing the nursing care and giving the 7 prescribed clinical care and ongoing support. 8 Q. Let us look at nursing. At page 18 of the document, the 9 foot of the page, please: 10 "In 1992 the recommendation was that there should 11 be a senior nurse with several years experience in 12 paediatric intensive care in charge of the nursing care 13 in the unit. 14 A. Yes. 15 Q. Every senior member of staff should be an experienced 16 paediatric intensive care nurse." 17 That is a long way away from the 1987 report, 18 which said that children could be cared for in a general 19 intensive care unit, provided there was one nurse per 20 shift who had some paediatric specialist training. That 21 has been moved a long way in that five year period? 22 A. Yes. 23 Q. Staffing levels: "A minimum of one trained nurse to one 24 patient is usually required throughout the entire 24 25 hour period." 0151 1 Over the page, page 19, the different levels of 2 dependency category are set out? 3 A. Yes. 4 Q. These are the dependency categories that are recognised 5 today, are they not? 6 A. Very generally. 7 Q. There was a development at one stage of a level 4? 8 A. Level 4 is for very specialised services, but in general 9 these are the three that are accepted. But it is 10 a guideline only. Individual children may need 11 a different care. It was a guideline to determine the 12 nursing ratio per child, not to be prescriptive about 13 it. 14 Q. It is a guidance? 15 A. Yes. 16 Q. At the foot of the page, the nursing establishment, the 17 key ratio, the recommendation was that it was 6.4 WTE 18 [whole time equivalence] to 1, so 6.4 nurses had to be, 19 as it were, employed in a unit for every patient, in 20 order to give the appropriate amount of care, taking 21 account of shifts, and so on? 22 A. Yes. 23 Q. That again is a ratio that is still the recommendation 24 in this country, is it not? 25 A. Yes, that has been endorsed by the Paediatric Intensive 0152 1 Care Society and has generally been accepted by the 2 majority. I would not say universally accepted. 3 I think there are people who practice in neonatal 4 intensive care who say that the ratios do not need to be 5 as high as this. But I think the view is that this is 6 the minimum ratio. 7 Q. Could I then go, please, having set that ratio out, to 8 page 20, towards the foot of the page? 9 "Size and location ... the Paediatric Intensive 10 Care Unit should be situated close to other essential 11 services and departments". 12 A. Yes. 13 Q. "The accident and emergency department, the x-ray 14 department, the operating theatres and the 15 laboratories." 16 A. Yes. 17 Q. That is still obviously conventional wisdom? 18 A. Yes. 19 Q. Page 21, please, towards the bottom of the page: 20 "Facilities for parents". We have been hearing 21 evidence for the last few days and one of the points 22 that has come back again and again has been the concern 23 that parents have for the facilities provided for them 24 while their child is in hospital. 25 A. Yes. 0153 1 Q. We see there what is said. The language is in terms of 2 "should". Facilities "should include" the matters we 3 see listed. To what extent does that paragraph 4 represent the position at the time this report was 5 written, or was that, again, an aspiration to improve 6 upon the general position? 7 A. I think the position was in some units, but in others, 8 it was an aspiration. Certainly, many did not come up 9 to those standards. 10 Q. Then page 22, please. Data collection and audit. 11 "In order to assess the performance of an 12 Intensive Care Unit, it is necessary to collect 13 information and undertake audit." 14 I do not think anyone is quibbling with that 15 sentence. 16 "This should include details of the unit workload, 17 collection of patient data and analysis of morbidity and 18 mortality ... There should be regular audit meetings so 19 that all staff can be made aware of any adverse 20 occurrence or alteration in the standard and quality of 21 care. Audit and data collection will be facilitated by 22 the development of information technology systems." 23 Again, the same question: to what extent is that 24 aspiration, as of 1992? 25 A. I think it was an aspiration, there were some units who 0154 1 were collecting data. I do not think that the data 2 collected had a great reproducibility between different 3 units. They were not all collecting the same data. It 4 depended partly on the enthusiasm of individual doctors 5 within units and -- 6 Q. So there was a patchwork of different levels of audit 7 going on across different intensive care units across 8 the country, with no sensible co-ordination or guidance? 9 A. Not in paediatric intensive care, no. 10 Q. And this pre-dates something called the Intensive Care 11 National Audit and Research Centre which has been set up 12 since, which has been designed to address those 13 difficulties? 14 A. It has been set up with an adult basis, but there is not 15 as yet a paediatric arm to that, although data is 16 collected using that, and there will, we hope, be 17 a paediatric -- the data that is collected for adults, 18 some of it is helpful in children, but overall in 19 paediatric intensive care with lower mortality and the 20 different types of morbidity, it needs to be a different 21 process. 22 Q. I will just deal with this point very briefly. If we 23 move to page 42, please, this is an update to the 24 Standards document in 1996. I think you were part of 25 the production of this update in standards. We see in 0155 1 the second paragraph: 2 "The Paediatric Intensive Care Society [this is 3 1986, so after the Inquiry's terms of reference will 4 have finished] is developing a common data set in 5 conjunction with the Intensive Care National Audit and 6 Research Centre which is intended to be used by all 7 units providing paediatric intensive care in the United 8 Kingdom. It is hoped that the introduction of the 9 common data set will help stimulate units to implement 10 the recommendations contained in this document ..." 11 So there we see, by 1996, that the suggestion, the 12 recommendation in the paragraph we were looking at at 13 page 22 in 1992 about data collection and audit, 14 remained an aspiration by 1996? 15 A. Yes. 16 MR MACLEAN: Chairman, I am conscious of the hour. I am 17 conscious you have been sitting now since 9.30 this 18 morning, and we are coming towards what should be the 19 end of the hearing day. Dr Ratcliffe, obviously, is not 20 finished in oral evidence. I have been going as quickly 21 as I can. But we would not be doing her evidence 22 justice were we to try to collapse it into the next 10 23 minutes. 24 In those circumstances, obviously, we are in your 25 hands, but I do not see us concluding Dr Ratcliffe's 0156 1 evidence in the next short period before I anticipate 2 the Panel would like to break. 3 THE CHAIRMAN: I am very grateful, Mr Maclean. If 4 Dr Ratcliffe is prepared to bear with us, and others are 5 able to carry on, I think let us say that we can go on 6 until 3 o'clock, at the outside. 7 If you think that will not really be of any great 8 benefit to anyone, then we shall stop now. 9 MR MACLEAN: I think, Chairman, we should go to 3 o'clock 10 and see where we are. I am conscious also of the fact 11 that this is a topic, paediatric intensive care, that we 12 will be looking at on Monday again. Dr Ratcliffe has 13 submitted to me today a new important document which you 14 may have a copy of a little bit of, and it may be that 15 in the light of that we would invite Dr Ratcliffe to 16 make a supplementary written statement, which we would 17 consider then, having concluded the oral evidence 18 today. I think we should press on. 19 THE CHAIRMAN: The Panel, as I say, is prepared to go on for 20 half an hour. If Dr Ratcliffe and you and the 21 stenographers are prepared to do that, and then we will 22 stop then, out of a pure reflection of our own 23 efficiency, but let us go until then. 24 MR MACLEAN: The next important event was that a report was 25 published by a Working Party on Paediatric Intensive 0157 1 Care convened by the British Paediatric Association 2 called "The Care of Critically Ill Children". That was 3 published in 1993, was it not? 4 A. Yes. 5 Q. You were a member of the Working Party which drew up 6 that report? 7 A. Yes. 8 Q. The terms of reference for that document we see at 9 WIT 60/63. The Panel will see the terms of reference. 10 Can we then go to page 68? These were the 11 limitations on the position as at 1993, as the Working 12 Party saw it. One of them, (v), was that: 13 "Children's wards may be located at some distance 14 from other departments in the hospital and in the event 15 of an acute emergency immediate availability of 16 anaesthetic and other appropriate help cannot always be 17 guaranteed. 18 "(iii) Appropriate management of critically ill 19 children cannot be extrapolated from knowledge of the 20 care of acutely ill adults or of less acutely ill 21 children." 22 We have heard already this morning it is the view 23 of some at least that the practice of a paediatric 24 cardiac surgeon is a very different job from the 25 practice of an adult cardiac surgeon. They are two 0158 1 different types of work entirely. Would it be fair to 2 say that the Working Party was of a view that paediatric 3 intensive care as opposed to adult intensive care were 4 similarly different jobs? 5 A. Yes. 6 Q. That is really the key point, that organisations like 7 the Paediatric Intensive Care Society have been pushing 8 over the last 10 years with some success? 9 A. Yes. 10 Q. If we pick up page 67, we have the levels of dependency 11 set out. We saw those already. It is the same levels 12 of dependency. With that in mind, can I go to page 184 13 of the same -- it is a different document, WIT 60/184. 14 If we blow up the table, and paragraph 68, this shows 15 that most children needing intensive care at level 2 or 16 above are very young. The age profile we see set out, 17 and we see the bar chart: 18 "The age distribution of critically ill children 19 raises questions about the appropriateness of providing 20 paediatric intensive care on a general (adult) intensive 21 care unit." 22 We see from the bar chart that the majority of 23 children admitted to paediatric intensive care units are 24 less than one year old? 25 A. Yes. 0159 1 Q. So that merely emphasises, does it not, that not only 2 are children's intensive care units different from adult 3 intensive care units, but they are dealing with the very 4 youngest of children? 5 A. Yes. 6 Q. So that passage is, as it were, grist to the mill of the 7 Working Party report at page 68 that we have just looked 8 at? 9 A. Yes. 10 Q. Page 99, please. We are still in the 1993 Working Party 11 report again. Towards the bottom half of the page: 12 "Adult intensive care units". The last sentence: 13 "The lack of staff with paediatric qualifications 14 was recognised by several units". 15 I should say, there was a survey carried out by 16 the Working Party, was there not. 17 "The lack of staff with paediatric qualifications 18 was recognised by several units as an unsafe practice, 19 particularly when very young children need nursing. The 20 results of the main survey confirm that a shortage of 21 registered sick children's nurses in adult intensive 22 care units is widespread." 23 A. Yes. 24 Q. "Unsafe" is a strong word to use. In what way was it 25 unsafe? 0160 1 A. In several ways. From the medical aspects, having good 2 paediatric airway skills and knowing how to manage 3 critically ill children who are often very small and who 4 have very different physiology from adult patients, and 5 nurses recognising the same sort of issues, you know, 6 knowing about paediatric intensive care in children who 7 are critically ill and very unstable, is something that 8 you cannot just extrapolate from adult practice, and you 9 need a throughput of continued experience to recognise 10 potential problems before they have evolved into more 11 major problems. For instance, recognising that an 12 endotracheal tube is block by secretions and avoiding 13 action, that is just one example of something that is 14 something that can occur very easily because of the size 15 and the area of these tubes, which would be much less of 16 a problem, much less of an issue with an adult-sized 17 patient. 18 Q. Let us look at the bottom of the page, the last 19 paragraph we have there. The last sentence: 20 "A split site hospital with paediatricians and the 21 adult intensive care unit on separate sites also 22 reported problems with medical cover." 23 We know that through the majority, indeed, all of 24 the Inquiry's period, the arrangement for cardiac 25 surgery for children in Bristol, was that the surgery 0161 1 was carried out at the Bristol Royal Infirmary, which 2 was in essence an adult hospital. 3 A. Yes. 4 Q. That the cardiologists were at the Bristol Children's 5 Hospital, which was, not surprisingly, a children's 6 hospital and that after surgery, the patients were taken 7 into the Intensive Care Unit at the Bristol Royal 8 Infirmary, which catered for adults and children and 9 that the children might then have been returned later to 10 the Intensive Care Unit at the Children's Hospital, but 11 not necessarily. 12 A. Yes. 13 Q. So we have the cardiologist on the one side and the 14 surgeons on another. 15 How common, or, by contrast, unique, was that 16 arrangement through the 1980s and early 1990s, as far as 17 you are aware? 18 A. I cannot think of another unit where the cardiologist 19 and cardiothoracic work were in a different site. I can 20 think of several units, that there were separate 21 cardiothoracic sites, but they were together, in effect, 22 so I am not able to think of one. 23 Q. So there might be a site where the cardiothoracic people 24 were all together, but the surgeons and the 25 cardiologists would be together in that place. But as 0162 1 far as you were aware at Bristol, the Bristol setup was 2 unique in not having the cardiologists in the same 3 building as the cardiac surgeons? 4 A. Yes. 5 Q. How worrying would that structure have been if you had 6 been working in such a place? 7 A. I find it very worrying, because you need somebody to 8 consult very rapidly. I know that the geography of the 9 Royal Infirmary and the Bristol Children's Hospital is 10 not across town, but even so, I think I would find it 11 very difficult in working practice to try and work and 12 do justice to both sides. 13 Q. In the context of some hospitals being, for example, 14 concerned that the Intensive Care Unit was not on the 15 same floor of the building as the theatre and the need 16 to care for the very sick patient in the lift going up 17 one floor, then any type of journey outside of one 18 building to go to another building would be much more of 19 a concern than moving even within one building, 20 obviously? 21 A. Very much so, and also the concept of moving children 22 from one hospital to another following surgery at some 23 stage in their post-operative management, when they may 24 be in an unstable state without it being a necessary 25 thing. I am not talking about children who are 0163 1 critically ill being transferred between hospitals, but 2 in a post-operative state, to have to move a child in 3 this circumstance would be not one we would think was 4 good practice. 5 Q. You were a member of this Working Party, as we have 6 discussed? 7 A. Yes. 8 Q. Do you remember if the split site hospital referred to 9 at the bottom of the page was Bristol? 10 A. I do not remember at all. I do not have any 11 recollection as to which hospital it was. 12 Q. If we just go back one page to page 98, please, this is 13 a table showing the regional distribution of paediatric 14 intensive care beds in both 1991 and 1993. 15 Halfway down the page, we have South Western, the 16 region we are in currently. 17 A. Yes. 18 Q. There were seven intensive care beds in a single unit in 19 1991, the same number in 1993, and we see in the note at 20 the foot of the table, please, if we can scroll down, 21 the relevant footnote is the third one: 22 "In 1992, 61/267 admissions to the paediatric 23 intensive care unit in Bristol" -- that would be at the 24 Children's Hospital? 25 A. Yes. 0164 1 Q. "23 per cent, were from outside the South Western 2 region, predominantly from ... Wessex and Wales. The 3 effective number of PICU beds available for the region 4 is therefore 5.4 (i.e. 77 per cent of 7) which equates 5 to 1 bed for every 124,000 children? 6 A. Yes. 7 Q. This working party recommended, did it not, that the 8 ratio should be one bed for every 48,000 children. We 9 see that at page 75. 10 A. Yes. 11 Q. So the Working Party was taking the trouble to draw 12 attention in the footnote to the fact that the South 13 Western region was more badly off than the bald figure 14 in the table would suggest? 15 A. Yes. 16 Q. Because of the influence of the infill from Wessex and 17 from Wales? 18 A. Yes. 19 Q. And that is because, presumably, the Working Party 20 considered that South Western was, indeed, badly served 21 by paediatric intensive care beds? 22 A. Yes. 23 Q. It is right, is it not, that this Working Party report 24 in 1993 was received rather lukewarmly by the National 25 Health Service as a whole when it received it, by the 0165 1 organisation I mentioned, the NHS centre for reviews and 2 dissemination; is that right? 3 A. Yes. 4 Q. What was the reaction to the Working Party report? 5 A. In essence, it said it was not based on the Health 6 Service's research and it was a document that was -- 7 I think you could read the statement, that it is not 8 based on rigorous scientific Health Service research and 9 therefore, although it has good ideas, it cannot be used 10 as a template for changing the service. 11 Q. Tell me if this is unfair: would it be a fair 12 characterisation to say that the reaction was that the 13 Working Party report was a wish list? 14 A. Yes. I think they actually wrote that in the document, 15 that it was. 16 Q. And then something happened, did it not, to lead to the 17 setting up of a further Working Party looking at 18 paediatric intensive care? 19 A. Yes. There was the tragedy of a child in the North West 20 who could not get access to paediatric intensive care, 21 and ended up going to three separate units, and this 22 triggered an Inquiry into the death of Nicholas Geldhard 23 and the subsequent report to the Secretary of State 24 triggered the national coordinating group which 25 published the document "A Framework for the Future". 0166 1 Q. Pausing there, what had happened, therefore, was that 2 a child had ended up out of region by the time he 3 arrived at a hospital which did have an intensive care 4 bed which would have cared for him; he unfortunately 5 died? 6 A. I think that is slightly -- in terms of being actually 7 correct, they had no facilities to scan the child at the 8 local hospital. They moved the child for a scan. They 9 had not been able to find a paediatric intensive care 10 bed. They moved the child for a scan. They knew the 11 child was irretrievable, even at that hospital, which 12 was an adult neurosurgical hospital and general 13 hospital, and therefore moved the child across region to 14 a paediatric intensive care unit, outside the region. 15 Q. That led in the end, as you have said, to the national 16 co-ordinating group on the provision of paediatric 17 intensive care, and you were a member of that group? 18 A. Yes. 19 Q. Can we have page 150, please, WIT 60/150? That is the 20 report, is it not? 21 A. Yes. 22 Q. The action plan, the framework for the future? 23 A. Yes. 24 Q. And that was published in July 1997? 25 A. Yes. 0167 1 Q. Outside of the Inquiry's period. The terms of reference 2 are at page 158, if we could just have that, please, the 3 bottom of the page, paragraph 3. Those are the terms of 4 reference. They carried on, I think, over the page. 5 This report was to be read in conjunction with a sister 6 report published by the Chief Nursing Officer's Task 7 Force which looked at the nurse staffing and training 8 issues for paediatric intensive care? 9 A. Yes. 10 Q. I do not want to go into much of this report, because it 11 is outside our period, but it does bring us up to date. 12 Page 160. I think we might here, if I have 13 understood your evidence, have really captured the 14 essence of what you are telling us in paragraph 9: 15 "Children are not adults scaled down in size. 16 Their relative immaturity in all respects, 17 physiological, anatomical, functional, developmental and 18 psychological, creates greater vulnerability to 19 a variety of adverse influences and they should be 20 looked after by specifically trained staff familiar with 21 the changes characteristic of each stage of 22 development ..." 23 A. Yes. 24 Q. Is that really, in a paragraph, the rest of the 25 paragraph continues, the essence of what you are telling 0168 1 the Panel? 2 A. Yes. 3 Q. And it is right, is it not, that this action plan, in 4 essence, takes up the theme of the 1993 Working Party 5 report that we have looked at? 6 A. Yes. 7 Q. Which had initially been received in that lukewarm 8 fashion you described? 9 A. Yes. 10 Q. And this report, the action plan, does not itself cover 11 neonatal intensive care. That was still seen as being 12 separate? 13 A. Yes. 14 Q. If we go to page 165, please, that is the geographical 15 spread of paediatric intensive care. It is slightly 16 misleading, is it not, for our purposes, because there 17 is a paediatric intensive care unit in Cardiff, so that 18 Wales is not shown on this map, but there is one in 19 Cardiff. 20 A. It is actually really at that stage a paediatric cardiac 21 one, but not a general one. It was a small unit, the 22 General seemed to be managed on a general Intensive Care 23 Unit. 24 Q. To capture the essence of what is suggested by this 25 action plan, which comes from the National Health 0169 1 Executive, finally, could we have page 189, please? 2 This approach divides hospitals into four 3 different categories: there is the district general 4 hospital, the large lead centre, the major acute general 5 hospital and the specialist unit. The Panel can see how 6 that is described. There is a helpful diagram at page 7 190 which shows how it is going to work. 8 This action plan is being implemented? 9 A. Yes. 10 Q. Would it be right that the Paediatric Intensive Care 11 Society was happy and content with the content of this 12 action plan, to the extent that it picked up the themes 13 of the Working Party report from 1993? 14 A. Yes. I think that that is true to say. 15 Q. But that is because -- 16 A. But also to say that the Paediatric Intensive Care 17 Standards document was taken as a major source of 18 reference and input into this document described. 19 Q. I rather skated over the 1996 version of the standards. 20 A. Yes. 21 MR MACLEAN: Does the Panel have any questions for 22 Dr Ratcliffe? 23 Examined by THE PANEL: 24 PROFESSOR JARMAN: I just wanted to ask the questions 25 I asked the cardiologists today, whether your Society 0170 1 had discussed what happened at Bristol at all? 2 A. It has discussed it in an informal way, but not in 3 a detailed way. 4 Q. Did it discuss it at the time when there was all the 5 publicity and so on? 6 A. Within the Council, it was discussed, it was not 7 discussed in a way that one would formalise it and say 8 what was happening, but, you know, it was felt that some 9 of what we had been saying for many, many years was 10 borne out by what seemed to have happened in Bristol. 11 PROFESSOR JARMAN: Thank you very much. 12 MR MACLEAN: Dr Ratcliffe, I am conscious that there are one 13 or two important areas that we have not covered. If 14 I may mention one, that is the issue of training. I did 15 mention at the very beginning that although you are here 16 today wearing your hat, as it were, as the recent 17 Honorary Secretary of the Paediatric Intensive Care 18 Society, you are also currently the Chairman of the 19 Intercollegiate Committee for Training in Paediatric 20 Intensive Care Medicine? 21 A. Yes. 22 Q. Training is an issue which the Inquiry recognises as 23 being important and we intend to spend some time dealing 24 with that later this year. 25 A. Yes. 0171 1 Q. It may well be that we will want to hear from you, 2 certainly in writing, dealing specifically with 3 training, wearing that hat, later on. 4 I hope you feel that we are not skating over 5 that. We recognise that it is important. 6 If there is anything else arising out of today's 7 evidence, areas that we have covered, that you feel 8 I have not covered in sufficient depth, then by all 9 means set it out in writing and submit it to us and the 10 Panel will of course read that. 11 Unless there is anything else you would wish to 12 add at this stage, that is all I have to ask you for 13 now, thank you very much. 14 THE CHAIRMAN: Dr Ratcliffe, is there anything you would 15 like to add? 16 DR RATCLIFFE: I think the contents of this document, 17 really, are quite pertinent to the NHS Centre for 18 Reviews Dissemination. The structure and the report's 19 commission, because they give a view both in Australia 20 where they have a very centralised service and the view 21 from Leeds, but there is broad support from the thrust 22 of the Multidisciplinary Working Party document, but 23 looking from a slightly different perspective. 24 THE CHAIRMAN: You are referring to the document produced by 25 the University of York which has been made available to 0172 1 us. 2 DR RATCLIFFE: Yes. 3 THE CHAIRMAN: Thank you very much. 4 MR MACLEAN: We will scan that document into the database 5 and the Panel will have all of that document provided to 6 us. 7 THE CHAIRMAN: It must be made available generally. 8 Dr Ratcliffe, your evidence is and has been of 9 great assistance to us. I was therefore particularly 10 grateful, when Mr Maclean drew our attention to the 11 time, that he emphasised the fact that it was clear we 12 must give your evidence the value it deserved, the care 13 it deserved and I hope you feel we have done so. I echo 14 what he said about it. If after today you think there 15 are other things he did not ask, or that we have failed 16 to ask you that you would like to remind us of, please 17 do so. 18 I also echo the fact that we are clearly not, 19 today, taking on the issue of training, but it is on our 20 agenda, and it is clear that we will have to come back 21 to you for some advice probably in writing, but maybe in 22 another form. 23 For today, may I again say thank you very much for 24 coming and talking to us. 25 If you would like to sit there for just a second, 0173 1 we will all leave together. 2 MR LANGSTAFF: Sir, that is it for today and this week. On 3 Monday we intend and hope to hear from Doctors Lawler 4 and Jones. 5 THE CHAIRMAN: I am grateful to you, Mr Langstaff, so we 6 meet again on Monday at 10.30. 7 MR LANGSTAFF: At 10.30. 8 (2.55 pm) 9 (Adjourned until Monday, 29th March, 1999 at 10.30 am) 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 0174 1 2 I N D E X 3 4 5 DR ROBERT HOWARD SWANTON (Sworn)...................... 1 6 Examined by MR MACLEAN................................ 1 7 Examined by THE PANEL................................ 51 8 9 DR MICHAEL GODMAN (Sworn)............................ 57 10 Examined by MR LANGSTAFF............................. 57 11 Examined by THE PANEL............................... 123 12 13 DR JANE RATCLIFFE (Sworn)........................... 129 14 Examined by MR MACLEAN.............................. 129 15 Examined by THE PANEL............................... 170 16