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Daily transcripts
Hearing summary
25th 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 Society’s 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 Association’s 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 centre’s 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.
|
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
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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
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Published by the Bristol Royal Infirmary Inquiry, July 2001
© Crown Copyright 2001