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Daily transcripts
Hearing summary
4th November 1999
Today the Inquiry received feedback on the clinical case note review it
announced in August 1999.
The review looked in detail at a sample made up of 80 cases taken from
over 1,800 children and babies who received either open or closed heart surgery over a
12-year period.
The exercise has been carried out by review teams from the
Inquiry’s independent experts with a wide range of clinical, academic and managerial
experience.
The teams have looked at the adequacy of key aspects of pre-operative,
surgical and post-operative care, as well as the adequacy of care overall. A summary of
the review teams’ conclusions, which is published below, was presented to the Inquiry
Panel on 4 November 1999.
It is the first time that a sample of cases, drawn from virtually all
the paediatric cardiac activity at the Bristol Royal Infirmary and Bristol Children’s
Hospital between 1984 and 1995, has been so thoroughly reviewed.
The clinicians on the Inquiry’s Expert Group have been formed into
review teams, which consist of five members:
- paediatric cardiac surgeon;
- paediatric cardiologist;
- paediatric anaesthetist/intensivist;
- paediatric pathologist; and
- paediatric nurse or intensive care nurse.
The following representatives from the Review Teams attended the
Inquiry today to present the preliminary report findings:
Mr Leslie Hamilton, Paediatric Cardiac Surgeon, Newcastle
Upon Tyne Hospitals, Dr Eric Silove, Paediatric Cardiologist, Birmingham
Children’s Hospital,
Dr Duncan Macrae, Consultant in Paediatric Intensive Care, Great
Ormond Street Hospital,
Dr Stephen Gould, Paediatric Pathologist, John Radcliffe
Hospital, Oxford
Carol Williams, Clinical Nurse Specialist, Guy’s and St
Thomas’s NHS Trust
Professor Stephen Evans, Principle Consultant Statistician,
Quintiles
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FULL TRANSCRIPT
1 Day 71, Thursday, 4th November 1999
2 (9.50 am)
3 THE CHAIRMAN: Good morning, everyone. Good morning,
4 Mr Langstaff. Again, I tender apologies for a slightly
5 later start than we announced. Again there were some
6 minor issues, not least the train having been somewhat
7 late. Mr Langstaff?
8 MR LANGSTAFF: Sir, today we are going to hear, as indicated
9 yesterday, the results of and discussion around
10 the Clinical Case Note Review process, a review which
11 may begin to say something as to the explanation for
12 the apparent difference in statistical performance or
13 performance revealed by statistics which we heard of
14 yesterday.
15 But before the evidence of today begins, Mr Sharp
16 has an application to make which is why he, rather than
17 Ms Grey, sits immediately to my right. Such is
18 the strength and width of our expert panel, that this is
19 the convenient place from which he should do it.
20 THE CHAIRMAN: Mr Sharp?
21 MR SHARP: I have no aspirations to take over Mr Langstaff's
22 job, I can assure you.
23 APPLICATION BY MR SHARP ON BEHALF
24 OF SURGEONS' SUPPORT GROUP
25 MR SHARP: Sir, as you know, I represent the Surgeons'
0001
1 Support Group. As you know, that group represents some
2 518 families, numbering therefore something in
3 the region of 750 people.
4 Many of those, the majority of those are patients
5 or the families of patients who have undergone treatment
6 either within or without the reference period of
7 the Inquiry. It is important to remind you, although
8 I know you already know it, but perhaps the wider
9 public, that amongst my client group there are many who
10 have lost loved ones, who have lost children.
11 Sir, at the outset of this Inquiry in October of
12 last year you made a number of observations about
13 the manner in which this Inquiry should be conducted.
14 You observed that inevitably pain would be caused and
15 you could not take that pain away. You did however
16 indicate that you would do your best and the procedures
17 of the Inquiry would be such that that pain would be
18 minimised wherever possible.
19 Sir, you spoke of respect, you spoke of
20 sensitivity, you spoke of responsibility and you hoped
21 the whole matter could be conducted without rancour.
22 There are two applications I wish to make this
23 morning. The first is a request to you, sir, to
24 reiterate some of that which you said over a year ago.
25 It is inevitable, and my client group recognise this
0002
1 very much as much as anybody else would, that the issues
2 which this Inquiry has to grapple with will cause and
3 have caused distress. But the manner in which all
4 the parties to this Inquiry conduct themselves can
5 affect the level of that distress.
6 Sir, you will know that there have been events
7 which have added to that distress. One can perhaps
8 understand, but with respect one cannot condone how
9 those events have developed. I have had the opportunity
10 today of speaking both with the staff of the Inquiry,
11 with counsel to the Inquiry and with counsel and
12 the solicitor for the Heart Action Group.
13 I am delighted to say that I have had very
14 positive responses from all of those, and in particular
15 I know that those acting for the Action Group entirely
16 understand and I think endorse what I am saying.
17 But I do ask that all of those who are involved in
18 this matter should conduct themselves with that degree
19 of responsibility which you asked for at the beginning.
20 Because without that those who have important things to
21 say to this Inquiry will feel inhibited, as well as
22 being unnecessarily distressed. That is my first
23 application.
24 My second application is linked to it, and it
25 relates to the issue of the application that was made on
0003
1 behalf of the Action Group for the recall of certain
2 witnesses relating to organ and tissue retention.
3 If I may again harken back to what you said in
4 October of last year. This Inquiry is to be
5 inquisitorial and not adversarial. The terms in which
6 that application on 12th October this year was made was
7 distressing to a number of people. Sir, you will recall
8 the evidence in fact of Mrs Francombe, who is not
9 a member of our group, who said to you in the course of
10 her evidence a few days ago how, when she, as she put
11 it, heard the "screaming headlines", it caused
12 additional pain to her.
13 Some of the words that were used in that
14 application on 12th October were, perhaps I can use
15 the word, "hyperbolic" in the quotations from e-mails
16 and similar. It is our concern that the manner of that
17 application and the thinking behind that application is
18 likely to result in an adversarial approach to
19 the evidence of those witnesses who it is sought to
20 recall. We do not believe that will advance
21 the interests of this Inquiry. We do not believe that
22 it is in the spirit of this Inquiry.
23 We understand that there are issues which those
24 who make that application wish to explore. Two days ago
25 you published proposals for Phase II. Amongst those
0004
1 proposals there were proposals for seminars and you
2 sought suggestions for themes for those seminars. It is
3 our suggestion, and indeed it was going to be our
4 suggestion prior to the publication of that document,
5 that the best way of exploring the problems that
6 the Action Group wish to explore in relation to
7 retention, would be in the context of a seminar where
8 the matters can be discussed and debated, rather than in
9 any sort of adversarial approach in the forum of this
10 Inquiry.
11 So the application I make is that you reject
12 the application to recall those witnesses. Thank you
13 very much.
14 THE CHAIRMAN: Mr Sharp, thank you. I understand Mr Trusted
15 wishes to come forward. Please do, Mr Trusted.
16 APPLICATION BY MR TRUSTED ON BEHALF
17 OF THE HEART CHILDREN'S ACTION GROUP
18 MR TRUSTED: Sir, thank you. On behalf of the Bristol
19 Hospital Heart Children's Action Group can I say first
20 of all in response to the first aspect of Mr Sharp's
21 application that we entirely endorse his view and his
22 submission that this Inquiry and all associated with it
23 should behave with responsibility and without rancour.
24 We of course agree that that applies to all of
25 those who are involved and especially to those who have
0005
1 suffered the most. It is of course particularly
2 difficult for them to act with the restraint which
3 becomes them. But it is vital if your work is to be as
4 successful as we hope it will be.
5 Dealing with the second part of his application,
6 I must tell you, sir, that our application on
7 12th October stands. We invite you to consider it as
8 made by Mr Lissack and in my submission it was a proper
9 application to make.
10 Very briefly, if I may say, I cannot accept on
11 behalf of the Children's Action Group that either
12 the manner or the thinking of that application was
13 intended to provoke anything like an adversarial
14 approach.
15 It is our view that the best way of dealing with
16 that very difficult problem is the recall of
17 the witnesses. Whether or not at the end of the day you
18 accept that is of course a matter for you. But we feel
19 profoundly that the adversarial approach is not one in
20 itself which is going to help you.
21 In this particular case, however, it remains our
22 submission that the best thing is to call those
23 witnesses back to answer some further questions here.
24 Thank you, sir.
25 THE CHAIRMAN: Mr Trusted, thank you. Mr Langstaff, do you
0006
1 want to help me at all on this?
2 RESPONSE BY MR LANGSTAFF
3 MR LANGSTAFF: Sir, no, there seems to be considerable
4 agreement, as one would expect, that all those concerned
5 with the Inquiry, despite the fact that it deals with
6 matters which are inevitably distressing to many and may
7 provoke reactions quite naturally in many, that there
8 seems to be agreement that there needs to be
9 the greatest restraint.
10 Sir, that I think you can endorse and accede to
11 Mr Sharp's first application.
12 As to the second, that has to be resolved on
13 the merits of the application in the light of
14 the evidence which you have heard. I am pleased to note
15 that both counsel who have addressed you have endorsed
16 and accepted the inquisitorial rather than
17 the adversarial approach that this Inquiry has adopted.
18 THE CHAIRMAN: Yes, thank you, Mr Langstaff, that is very
19 helpful.
20 STATEMENT BY THE CHAIRMAN:
21 THE CHAIRMAN: Speaking about the second point first, we
22 received the application. We have set in train an
23 enquiry. Letters have gone out. Only when we see what
24 that has produced will we have to make a decision
25 finally as to whether the application has, as it were,
0007
1 fallen away or needs to be addressed in its specifics.
2 So I hope Mr Sharp and Mr Trusted can bear with us while
3 we wait to see how that progresses.
4 As regards the former point, yes, it is one thing
5 to say we all understand; it is another thing always to
6 be able to behave in a way which satisfies the needs and
7 demands of everyone. We will all try and let us
8 continue to try; that is all I can say.
9 Mr Langstaff?
10 MR LANGSTAFF: INTRODUCTION TO TODAY'S EVIDENCE
11 MR LANGSTAFF: Sir, let me then introduce the subject matter
12 of today. As I think is now widely known, one of
13 the consequences of this Inquiry was that every record
14 which the Bristol Royal Infirmary and Children's
15 Hospital could identify as relating to children who had
16 surgery falling within our terms of reference was passed
17 to the Inquiry.
18 You heard yesterday from Professor Stephen Evans
19 the results that all those cases, every single one of
20 them, played in producing a view of care at Bristol. As
21 I said yesterday, statistics may produce questions; they
22 cannot in themselves give a reason or explanation for
23 any apparent difference that they may show. Although
24 the statistics arising out of the Clinical Case Note
25 Review do not in themselves show a difference, because
0008
1 they are not comparing Bristol with anywhere else,
2 nonetheless they produce rates for particular surgery of
3 mortality, they produce information as we heard
4 yesterday and some of that information needs perhaps to
5 be understood.
6 For that purpose, and for the purpose of helping
7 as part but only part of the picture, the complex jigsaw
8 to which reference was made yesterday, 80 cases were
9 selected for review. You will hear the process today by
10 which that was done and you will hear not only from
11 Mr Hamilton and Dr Silove, who have given evidence to us
12 before and who sit at the main witness table, but you
13 will hear from members of the teams which reviewed those
14 notes who sit to my right. We have Dr Gould,
15 a pathologist; we have Ms Carol Williams, a senior
16 nurse; and we have Dr Duncan Macrae, whom we have met
17 before, who sits behind them. As I say, we have so many
18 experts that space at the table is limited.
19 They will in the course of today in what I hope
20 will be a contributive discussion, rather more
21 contributive in form than yesterday, give you some
22 insight into what they have picked up with the benefit
23 of their expertise as arising from the Clinical Case
24 Note Review.
25 Professor Evans will put it in a statistical
0009
1 context both at the outset in describing why it should
2 be that 80 cases have been chosen, 40 of which are cases
3 in which a child died and 40 other cases, when there is
4 no suggestion that 50 per cent of the children who
5 received surgery at Bristol died, far from it. He will
6 explain the purpose behind a selection in those numbers
7 and why -- despite its failure, as it were, to reflect
8 the overall pattern, it is nonetheless truly
9 representative in a statistical sense of the whole. He
10 will explain the extent to which you may be able to draw
11 generalised lessons from a random though stratified
12 sample of the whole.
13 In the course of today you will hear a number of
14 figures and you will form a reflection of the extent to
15 which care is in the views of our various expert Panels
16 said to be adequate or less than adequate, and if less
17 than adequate the extent to which it may have made
18 a difference to outcome and the extent to which it
19 probably did make a difference to outcome.
20 I am conscious that in yesterday's discussions
21 the focus was principally upon mortality as an outcome.
22 That is obviously much easier to measure. Despite
23 the difficulties of defining what a death is for
24 statistical purposes, it is much easier to deal with and
25 to count and to assess than morbidity. But it may be
0010
1 that at the end of today you will have had further
2 information which may help at any rate to assess
3 the degree to which children who have had treatment at
4 the Bristol Royal Infirmary have suffered from morbidity
5 and the extent to which that may relate to
6 the statistics which we heard yesterday.
7 THE CHAIRMAN: Just so that we have everything clear, you
8 may need to explain what morbidity is to the wider
9 audience as well as to myself.
10 MR LANGSTAFF: Sir, yes. The simple definition would
11 perhaps be leaving a child sicker than the child might
12 have been had treatment been fully successful. It is
13 probably easiest to think of it in terms following
14 cardiac surgery of neurological complications if, for
15 instance, there is as a consequence either of
16 the condition treated pre-operatively and its management
17 pre-operatively, perhaps delays in surgery or
18 the surgery itself or the post-operative care, if there
19 is a lack of oxygen or a shortage of oxygen that may
20 affect the brain and the central nervous system and lead
21 to neurological complications.
22 The other complications which I understand to be
23 most commonly associated with cardiac surgery are
24 respiratory and renal complications. You will probably
25 hear there are others, in particular the liver and
0011
1 the bowel. That is the broad scope of what is implied
2 by the term "morbidity".
3 Sir, it is probably best that those involved in
4 the process describe it rather than I attempt
5 inadequately from here to do so. May we begin today by
6 having all our experts, as this will be a contributive
7 session, sworn. We need not re-swear Professor Evans,
8 who remains under oath from yesterday. But because it
9 has been some time since Dr Silove and Mr Hamilton were
10 last with us, and Dr Macrae, they I think should be
11 resworn.
12 DR ERIC SILOVE (SWORN)
13 MR LESLIE HAMILTON (SWORN)
14 MS CAROL WILLIAMS (SWORN)
15 DR STEPHEN GOULD (SWORN)
16 DR DUNCAN MACRAE (SWORN)
17 MR LANGSTAFF: Ms Williams, we have not met you before.
18 Would you like to tell us a little bit about yourself,
19 your background and why it is that you are here?
20 MS WILLIAMS: I am currently the lead nurse for children's
21 critical care services at Guys and St Thomas's Trust in
22 London. I have been working in the field of children's
23 intensive care since March 1985 either as a clinical
24 nurse or as a lecturer running the children's intensive
25 care nursing course, and more recently as both
0012
1 a practicing clinical nurse and manager at Guys and
2 St Thomas's.
3 I have a degree in Nurse Education and Master in
4 Child Health Nursing which focused very much on my
5 practice setting and developing my knowledge and skills
6 in that area.
7 MR LANGSTAFF: Dr Gould?
8 DR GOULD: I am consultant paediatric pathologist at
9 the John Radcliffe Hospital in Oxford and here I suppose
10 for two reasons: the first is that I have been very
11 involved in the Confidential Enquiry into Stillbirth and
12 Death in Infancy since its inception in 1992.
13 MR LANGSTAFF: That is what we know as CESDI.
14 DR GOULD: Yes. We have built up a certain amount of
15 experience on the process of confidential Inquiry, such
16 as we are looking at today.
17 Secondly, I have also been involved in
18 the confidential enquiries themselves as a pathologist
19 contributor to panels.
20 MR LANGSTAFF: Can I begin by asking you, Dr Silove and
21 Mr Hamilton, to look, if you would please, at INQ 16-1.
22 Is this the start of your report on the Clinical Case
23 Note Review?
24 MR HAMILTON: Yes, it is.
25 DR SILOVE: Yes.
0013
1 MR LANGSTAFF: If we go to page 39, after a number of
2 tables, is that in fact the last page of that
3 preliminary report?
4 DR SILOVE: Yes, it is.
5 MR HAMILTON: Yes, it is.
6 MR LANGSTAFF: You adopt that, do you, as your report to
7 this Inquiry as a preliminary report upon the results of
8 the Clinical Case Note Review?
9 DR SILOVE: Yes, we do.
10 MR LANGSTAFF: Dr Silove, I want first of all to explore
11 the process which the review took. In order to put that
12 into its setting, the review was, was it, a process of
13 taking a careful and close look at a selected number of
14 cases from those who received cardiac surgical services
15 at Bristol between 1984 and 1995?
16 DR SILOVE: Yes, that was the way it was set about.
17 MR LANGSTAFF: For that purpose, did you divide
18 yourselves -- yourselves, I say; was it arranged that
19 there should be teams looking at each and every case?
20 DR SILOVE: Yes, we were divided into teams of clinical
21 experts; each team consisting of a paediatric
22 cardiologist, a cardiac surgeon, an intensive care nurse
23 and an anaesthetist who also served the function as
24 intensivist, and a pathologist.
25 Q. Had you all had experience of the period 1984 to 1995?
0014
1 A. I believe that everybody in the teams had had experience
2 at least during some part of that time span, not
3 necessarily all of it. Very few of us were old enough
4 to have done that.
5 Q. We are told in your report that in total you looked,
6 I say "you", the teams together looked at 100 children's
7 cases, there being five which were looked at as part of
8 a pilot project and 95, of which there were 80 cases, 15
9 being looked at twice, as part of the principal project?
10 A. That is correct.
11 Q. Roughly how many hours were spent, taking each team upon
12 each case?
13 A. We estimated that on average each case took 3 hours of
14 time of each of the clinicians, that is time involved in
15 preparation and time involved in discussion. Some
16 obviously took a shorter period of time and some took
17 a longer period of time, depending on the complexity of
18 the cases. But we thought on average it was about 3
19 hours per clinician, so that each meeting really
20 involved a total of 15 clinical hours per case.
21 Q. So a total then of 1,500 clinical hours spent?
22 A. That is correct.
23 Q. Some of the children you mentioned in your report had
24 more than one procedure which was looked at and
25 assessed?
0015
1 A. Yes. Of the 80 children, there were 80 children looked
2 at in the actual study, they had between them 100
3 procedures. So there were actually 18 children who had
4 had more than one procedure, two of those 18 had had
5 three procedures. The remainder had had two.
6 Q. You I think may not have been party to the decision as
7 to why 80 and why the 80 should have been split as it
8 was. Can I ask you, Professor Evans, to give
9 a statistical insight as to why that number and why it
10 is appropriate to choose 40 deaths and 40 other cases?
11 PROFESSOR EVANS: I think it would be helpful probably to
12 turn to INQ 16-32. This is a supplementary note that
13 gives an outline of the Inquiry's approach to selecting
14 the cases. Under title 2, I think that perhaps it is
15 worth reiterating that in the middle of the document, as
16 you can see on the screen, it is really very important
17 that cases have to be representative of all children,
18 but also selected cases must reflect concerns that led
19 to the Inquiry.
20 If we go and look at what CESDI does, that looks
21 at stillbirths and deaths in infancy, and only looks at
22 deaths. So one of the fundamental principles we had was
23 that in contrast to that we were going to look at not
24 just deaths but also for two main purposes we had those
25 who had not died, firstly, for comparison, so that we
0016
1 had some kind of comparison, because it could be if we
2 assessed the care of those who had died in isolation we
3 might not have any insight at all into really whether
4 that care had led to death or whether death was quite
5 independent of the care. So one of the things that is
6 very important is to have some comparison group.
7 The other thing is to have a group who potentially
8 at least have morbidity, that is have some illness that
9 is severe enough to be taken into account.
10 In terms of the actual number 80, very often
11 statistically we can choose a number that has specific
12 objectives that will determine that number. We do this
13 in assessing new treatment. We can say beforehand that
14 we need perhaps 80 or maybe 800 or maybe 8,000 people to
15 assess a new drug treatment. We could not do that
16 here. We were not looking for something specific to
17 say, "We want to find a particular difference."
18 Being honest, the 80 is set almost entirely for
19 practical reasons. We cannot assess an enormous
20 volume. 80 as a basic number, and in fact as you have
21 mentioned, in order to assess 80 we had to assess some
22 more. It is very important that we also checked whether
23 the assessment is consistent. It is no good assessing
24 80 if it turns out that the opinions of the clinicians
25 are so variable among themselves that their information
0017
1 is worthless. So it is important to repeat this on some
2 people, and hence that is why we took 15 repeated
3 cases.
4 So I think that the argument for the 80 is one on
5 practical grounds. It gives us a reasonable number to
6 say something, and choosing 40 who had died and 40 who
7 were alive enabled us to make comparisons. It enabled
8 us to make comparisons within each category that we
9 regarded as important. Younger children, children who
10 had had the higher risk operations were particularly
11 ones which had been the concerns that led to
12 the Inquiry.
13 MR LANGSTAFF: To what extent is it possible, as far as
14 the study design is concerned, to generalise to
15 the whole of the population from the representative
16 sample of it which the 80 cases constitute?
17 PROFESSOR EVANS: If we had chosen 80 on the basis of my or,
18 with all due respect, your whim, we would be unable to
19 generalise, the same would apply to anyone, if we had
20 gone and selected those cases we regarded as
21 interesting.
22 It is an important scientific principle that, if
23 we wish to generalise, it must be very important that
24 the cases we have selected are what we call "randomly"
25 selected. This is not devaluing. We often use the word
0018
1 "random" to mean something of unimportance. But
2 statistically and scientifically that is a highly
3 technical term which means that we have made sure that
4 every child for example who was aged under 1 year --
5 under 90 days, who was having open heart surgery and who
6 had died, all of those children in that category had an
7 equal chance of being in the survey.
8 The consequence of that is that we can turn
9 the survey results back in to the whole set of children
10 that we looked at. It will have some uncertainty
11 associated with it, but we can actually statistically
12 measure that uncertainty. By choosing a random sample
13 it ensures we can generalise the information with
14 a considerable degree of confidence.
15 MR LANGSTAFF: One of the questions which is certain to
16 arise is whether or not the sample, constituted as it is
17 from if you like only 80 cases out of some 2,000, can
18 give a fair reflection. On the page that you have in
19 front of you, towards the bottom of the screen, there is
20 a description of how the cases themselves were weighted
21 preferentially towards children of a certain age, that
22 is under 1 year at the time of the first procedure;
23 secondly, those who received higher risk procedures;
24 and, thirdly, died within 30 days of their last
25 procedure.
0019
1 Is that a valid statistical approach?
2 PROFESSOR EVANS: Yes. One of the things is that had we
3 taken what is called a simple random sample of all 1,827
4 children, then because in the whole sample there would
5 be only 13 per cent of children who had died, if we then
6 take a sample of 80 out of those 1,800, we are likely to
7 find only a very small number of children who had died.
8 Therefore the concerns of the Inquiry which were focused
9 on those who had died would be unable to be met.
10 Had we similarly taken a sample from children
11 across the whole age range, we actually have rather
12 larger numbers who were rather older. Again,
13 the concerns of the Inquiry were focused on younger
14 children.
15 Similarly, there were a large number of closed
16 operations which, as it happens, we learned yesterday
17 did not have any difference in mortality compared with
18 the rest of the country. But their mortality is really
19 quite low.
20 So, again, if we had taken a simple random sample,
21 we would have ended up with only one or two cases where
22 the focus of the Inquiry was concentrated.
23 The consequence is that that would have meant that
24 the numbers on which we were basing any review results
25 would be very small indeed.
0020
1 We have now got reasonably large numbers and this
2 is called statistically a stratified random sample. It
3 allows us to generalise, it allows us to focus our
4 concerns and is still fully representative when we make
5 adjustment for the fact that we selected the sample in
6 that way.
7 MR LANGSTAFF: So the purpose of a stratified random sample
8 is essentially a pragmatic one, is it, to target
9 the available resources in terms of time, and for that
10 matter finance, upon that material which is most likely
11 to assist in the areas of concern?
12 PROFESSOR EVANS: Exactly.
13 MR LANGSTAFF: But does this not give rise to a risk that
14 one first of all has to identify areas of concern before
15 looking at the data?
16 PROFESSOR EVANS: Yes, to a degree. One can often have some
17 idea beforehand of the factors that are likely to be of
18 great interest. In some samples, if one thinks about
19 it, the ones that the public know about, you can think
20 of samples for voting behaviour. It is very clear that
21 the interest in your sampling should be on those who are
22 likely to vote. So the way the polling organisations go
23 is they very carefully of course do not include those
24 who are under 18 in their sample because they have to
25 ensure they have those who are voting.
0021
1 They also have other subtle techniques to ensure
2 that when they do their sample they may wish to stratify
3 them by being male and female, because voting differs by
4 the different sexes. They may well wish to stratify
5 their sample by being in an urban area or a rural area.
6 So they have an idea that those things affect the voting
7 behaviour.
8 MR LANGSTAFF: This stratification is something done, as it
9 were, in advance rather than looking at the data --
10 PROFESSOR EVANS: It is done in advance. We have
11 the advantage that we knew all 1,827. In practice you
12 do not know the whole population of the country. There
13 does not exist a perfect register, whereas we had a set
14 of notes and we knew those were the only notes that we
15 could review.
16 MR LANGSTAFF: We spoke yesterday of the disadvantage of
17 looking at a study population, calling it that for
18 the purposes of statistics, retrospectively rather than
19 prospectively. One of the comments which you make,
20 Dr Silove, is that there may be problems in looking at
21 this data retrospectively in the knowledge that it is
22 Bristol data?
23 DR SILOVE: Yes, that is right. Not only the knowledge that
24 it is Bristol data but inevitably, if a child has died,
25 one has the instinct that perhaps something could have
0022
1 been done differently so that the child would not have
2 died. So one looks very much more critically at
3 the case notes of children who have died than one might
4 otherwise look.
5 MR LANGSTAFF: Does this give us a problem?
6 PROFESSOR EVANS: It certainly does. I think ideally had we
7 lived in an ideal world with infinite resources it would
8 have been very much better to have gone through
9 the notes and perhaps effectively retyped every bit of
10 the notes excluding all reference to the possible
11 outcome. The possibility of doing that even for 80
12 notes was just not possible, and I am sure Dr Silove and
13 Mr Hamilton will explain something of the volume of
14 notes that they even looked at in looking at those 80.
15 The thought of going through those notes and ensuring
16 that all reference to future outcome was deleted from
17 them would have been something that would be ideal.
18 Therefore we have to bear in mind the limitations, that
19 they knew the outcome at the time they were doing that
20 assessment. But I think that if you know that, that
21 helps.
22 MR LANGSTAFF: Dr Gould, you have had considerable
23 involvement with CESDI. CESDI obviously is looking at
24 deaths and therefore in a sense limits its inquiry to
25 deaths and itself picks a random sample which is
0023
1 stratified by the fact of death.
2 DR GOULD: Yes. The original function of CESDI was to look
3 at deaths in stillbirth and infancy. In our first sort
4 of selection of cases we looked at, it was intrapartum
5 deaths. We looked at all the intrapartum related deaths
6 in the original study. One of the features in fact when
7 one was conducting the Panels at that point everybody
8 was very aware that the baby died and this was one of
9 the problems that have already been mentioned.
10 We also did not look at live births at all, partly
11 because that was our remit. This was the sort of
12 problem that arose from that. We started to become
13 aware of, or at least we were aware of all the time, but
14 we have now started to try and take that into account.
15 So for instance our latest study we are not only looking
16 at a set of case where we are having live birth as an
17 outcome, but for instance the obstetricians in this
18 particular study were doing were having a study which
19 was following through babies obviously from when they in
20 utero through to ex-utero.
21 MR LANGSTAFF: Can I ask you to slow down a little. I see
22 that I am being thanked by the stenographer on my left.
23 DR GOULD: The obstetricians do not know the outcome. So we
24 have been able to take that another stage further
25 because we have been very conscious of the problems that
0024
1 have -- potential problems and biases that have already
2 been discussed. So we have been able to take that into
3 account. I am not putting up one study against another,
4 but I think it is just reflecting that we are all aware
5 of the potential biases and our awareness. We are in
6 agreement in that respect.
7 MR LANGSTAFF: To what extent do you think the effect that
8 at least earlier studies under CESDI knew that they were
9 dealing with deaths may have influenced the assessment
10 of care?
11 DR GOULD: I suppose if I am honest it is extremely
12 difficult to judge, particularly with some of
13 the assessments that are involved within CESDI. Some of
14 the monitoring that occurs of, say, intrapartum deaths,
15 it is very easy to look at a chart and say that is
16 clearly abnormal when you know the baby has died. What
17 you often do not know is whether a baby that lived would
18 have had exactly the same sort of monitoring
19 appearance. So it is very difficult.
20 Having said that, obviously everybody is giving
21 their opinion based on an honest opinion as to whether
22 they believe the management was appropriate or not, so
23 one can make allowance for that. But I think one has to
24 be aware that it is very possible that criticism will
25 be -- there will be a sort of over-criticism, as it
0025
1 were, of management.
2 MR LANGSTAFF: For how many years now has CESDI or something
3 along that model been in operation?
4 DR GOULD: As I said, we have constantly been modifying our
5 approach since we have started, as the lessons have
6 grown, as we have learned our lessons about
7 the process. So our new model has only really just
8 started in this last year.
9 MR LANGSTAFF: But I was asking when the first model --
10 DR GOULD: The very first one. We started about 1992, I
11 think 1993 -- 1993.
12 PROFESSOR EVANS: Can I just comment there that the fact
13 that CESDI (a) only looked at deaths and (b) may have
14 known that they were deaths is different to
15 the situation we have here. We need to make that
16 distinction. We have both deaths and those who were
17 alive in equal number. So, although there is
18 a knowledge of death, the fact that we also have some
19 who were alive enables us to make comparisons that
20 the early CESDI could not do. I think that is one of
21 the things.
22 We do not have the advantage that we have been
23 able to what I would call veil the outcome, so that
24 the assessment is made not knowing what the future is.
25 MR LANGSTAFF: Again, so that there is a background to what
0026
1 we are going to be told in a moment by Mr Hamilton and
2 Dr Silove, can you tell us what the basic CESDI model
3 for review of case notes has been since 1992?
4 DR GOULD: Yes, I think in many respects it is very similar
5 to what has already been outlined. We have had a
6 multi-disciplinary Panel group: obstetrician,
7 paediatrician, pathologist, nurse, GP, whoever be
8 involved, study case notes and generate a form, an
9 outcome form grading cases as whether they are -- in
10 fact we have used the term "suboptimal". It is
11 "adequate" here. But we have used the term whether
12 management has been suboptimal and whether that
13 suboptimal care has given rise to -- if the care had
14 been optimal, whether or not a different outcome would
15 have resulted.
16 I think one of the things I should emphasise that
17 we have also learned is that in our first start, when we
18 first started, everything was very free. Everybody was
19 just given a set of notes and said, "Go along and bring
20 your conclusions." I think what we learned was that we
21 had to structure it far more. If you did not ask
22 a Panel to comment on a particular aspect of care, it is
23 very possible for some reason that Panel may focus on
24 a different aspect of care and they might not look at
25 one particular aspect at all.
0027
1 So we have learned that we have had to be far more
2 structured. So, again, that aspect of the Panel has
3 changed as well.
4 MR LANGSTAFF: From the beginning, did the CESDI Panels go
5 about it by way of discussion between the members of
6 the Panel?
7 DR GOULD: Yes. It is very much as has happened with these
8 clinical case review note inquiries.
9 MR LANGSTAFF: Although we have not yet had a full
10 description of the process which was used here, it can
11 be read in the report and will be, if it has not already
12 been, by the Panel, but we have not as it were mentioned
13 it in detail in the chamber today. Is it nonetheless
14 your experience the way in which the Panel here went
15 about matters was informed by the CESDI experience?
16 DR GOULD: Yes, the way in which they were set up was very
17 similar to CESDI. Yes, I mean, our processes were
18 exactly the same or very similar.
19 MR LANGSTAFF: Dr Silove and Mr Hamilton, have you in
20 the past been involved yourselves in CESDI?
21 DR SILOVE: No, I have not.
22 MR HAMILTON: No.
23 MR LANGSTAFF: But you know of it?
24 DR SILOVE: Yes.
25 MR LANGSTAFF: Amongst the wider clinical community, what
0028
1 degree of respect do the findings have, do you think.
2 DR SILOVE: I think the findings are significant and are
3 respected. It was because of our knowledge of the CESDI
4 approach that we, in setting up our original pilot
5 study, adopted the principles of their approach.
6 MR LANGSTAFF: So we had here a model which was adopted for
7 a pilot. Tell us about the pilot. You were involved.
8 I think Dr Macrae was involved in the pilot in
9 particular.
10 DR SILOVE: That is right. In the pilot study we first set
11 up some forms which we later modified further. Perhaps
12 it would help if at this stage I showed the forms which
13 we used for the current study.
14 MR LANGSTAFF: Can we have INQ 20-1.
15 DR SILOVE: Thank you.
16 MR LANGSTAFF: That is rotated.
17 DR SILOVE: So this form had a cover page in which
18 the child's initials, date of birth, registration
19 numbers and diagnosis were put at the top. In the right
20 hand box at the top we looked at overall outcome. We
21 did not use the word "morbidity" we used "disability";
22 so dead, alive or disabled.
23 There was a space for additional comments in
24 middle. We also had an overall grade of care which was
25 filled in. I think if we could go on to the next page,
0029
1 please, number 2, page 2. These are the aspects of care
2 that we looked at with each case, the pre-operative
3 care. The aspects we looked at were the timing and
4 appropriateness of the initial referral. Perhaps you
5 could blow this up, do you think, this area?
6 The clinical assessment and management,
7 the accuracy and --
8 MR LANGSTAFF: Just pause for a moment, Dr Silove. I will
9 get that blown up.
10 DR SILOVE: There we go. So we are looking at the timing
11 and appropriateness of initial referral, the condition
12 on arrival. That was just to set the scene of what
13 these patients looked like when they came in. Did that
14 influence the overall management?
15 Then in Bristol itself there was the clinical
16 assessment and management, which was B. C was
17 the accuracy and completeness of diagnosis. D was
18 the appropriateness of initial treatment strategy. We
19 looked at E, the timing of planned treatment. We looked
20 at F, the immediate pre-operative management. We put in
21 these boxes a grading of 1 to 4, and I will explain that
22 in a little while.
23 If we could move over to the right side of this
24 form. Then there was a space next to the grading boxes
25 to put in comments. On the extreme right were boxes in
0030
1 which we could identify the specialty and perhaps
2 the name of the clinician who was involved with these
3 aspects of adequacy.
4 MR LANGSTAFF: Can I just ask you to stop there. You say
5 this is what you were going to do. But some of
6 the comments, the nature of the comments and
7 the identification of the specialty would have to be
8 understood by each and every team who were separate in
9 their constitution. So were there laid down protocols
10 or agreements, procedures, which each team would adopt?
11 DR SILOVE: Everybody was supposed to fill in every box,
12 but, you know, when you are dealing with doctors --
13 MR LANGSTAFF: I think what I am asking is how did they know
14 how to fill it in, even though they were doctors?
15 DR SILOVE: They knew how to fill in the boxes for
16 adequacy. If we can just focus on this little bit on
17 the very bottom. If we blow that up. These were
18 the grades for adequacy of care. Grade 4 was regarded
19 as adequate and grade 1, at the other extreme, was less
20 than adequate care in which different management would
21 reasonably be expected to have made a difference to
22 the outcome. That is an avoidable factor which probably
23 contributed to death or disability.
24 In between 1 and 4 we have grades 2 and 3. So
25 grade 2 then was less than adequate care where different
0031
1 management might have made a difference to outcome.
2 Grade 3 was less than adequate care, but different
3 management would have made no difference to outcome. So
4 these were what everyone was expected to put in
5 the boxes showing adequacy of care. The comments really
6 depended on how people felt.
7 What we really found was that if care was
8 adequate, if care for any aspect was given a grading of
9 4, then there were no comments most of the time. What
10 was there to comment on if care was adequate? If care
11 was less than adequate, there more often than not was an
12 accompanying comment.
13 If I could move on perhaps to the other aspects
14 that we looked at. If we turn to page 3, now, which is
15 surgical and post-operative care. If we could blow up
16 the left-hand side, please. That is great. It is not
17 blowing up. G was the surgical procedure, where clearly
18 the surgeon had a huge input on this Panel. H was
19 the perfusion, that is the cardiopulmonary bypass.
20 I was the anaesthetic, and here the anaesthetist had
21 a big input into the discussion. J, K and L were
22 post-operative care and assessment. All members of
23 the team had a lot to say about that.
24 We thought it was important also to grade
25 the adequacy of the post-mortems, because post-mortems
0032
1 are very important in assessing the overall management
2 in a department. They are important for audit,
3 important for learning and we felt that, if
4 the post-mortems were adequate, it would be a great
5 contribution to the progress of the department and, if
6 they were inadequate, it might highlight some problems.
7 MR LANGSTAFF: How was the post-mortem graded? Plainly, if
8 we take the same 4, 3, 2, 1 approach, you could never
9 say that the post-mortem lack of care would have made or
10 might have made a difference to outcome by definition.
11 Perhaps you would like to comment on this.
12 DR GOULD: Yes, I think there is a comment in the report,
13 but certainly we have always found in the past if we
14 have seen similar gradings when we are using the CESDI,
15 if someone did a similar sort of process, then it was
16 a nonsense. So we never actually did that type. We
17 never graded it in that sort of way. We had a different
18 post-mortem assessment form. We did not try to grade it
19 in this way.
20 What tends to happen, which I can see happened
21 here, and I see there is a comment in the report, is
22 that everybody says in this instance, "Grade 1 means
23 that it was a pretty poor show, so we will call it a
24 grade 1." I think that is what has tended to happen in
25 the grading here.
0033
1 MR LANGSTAFF: So really what we have to do is read
2 post-mortems, the assessment slightly differently from
3 the others. Would I be right in thinking that in
4 assessing the overall grade to be given that plainly
5 the poverty of a post-mortem, if it was poor, would not
6 affect the distinction between grades 4 and 3 on the one
7 hand and grades 2 and 1 on the other.
8 DR SILOVE: Yes, that is quite right. There was a flaw in
9 the design of this form by not specifying what should be
10 said about post-mortem. But clearly post-mortem did not
11 come into the assessment of overall management of
12 the patient.
13 MR LANGSTAFF: In terms of assessing adequacy, plainly no
14 protocol would have been appropriate because this is
15 where one relies on the expertise of the reviewer.
16 DR SILOVE: Yes. If I may say a few words about adequacy,
17 because it is a very difficult problem. When can one
18 say that care is less than adequate? There are no
19 published standards against which we can measure
20 adequacy. It is also difficult to remember accurately
21 what standards of care might have been expected during
22 the period 1984 to 1995.
23 We were acutely aware that in cases where a child
24 had died, as I have already said, we might be
25 over-critical of the standard of care, because in any
0034
1 case of a child dying one must always wonder whether
2 different care might have saved the life of the child.
3 If I could also just say that death can occur despite
4 adequate care, despite the best care in the world, so
5 complex are so many of the heart abnormalities of birth
6 in some of these children.
7 If a proportion of the Bristol children did
8 receive care that was less than adequate, what
9 proportion of cases would have been judged as receiving
10 less than adequate care in other centres?
11 If I could just go on a little. We are also very
12 aware how painful it will be for parents to discover
13 that their child might have received less than adequate
14 care. We will not be discussing any individual cases,
15 but we will be concentrating on the broader picture as
16 it appeared to us.
17 But let me assure everyone here that if we did
18 review the clinical records of any child, it was done
19 sensitively and respectfully. We tried to assess each
20 case with care for the child and the parents and at the
21 same time tried to avoid both prejudging any case and
22 bringing any subjective bias into play.
23 We tried to be both truthful and fair. We took
24 into account the feelings of the clinicians who had been
25 trying their best to help every child under their care,
0035
1 even though it appeared that some of their efforts might
2 have gone terribly wrong.
3 This, then, brings us to the whole review
4 process. But it was these considerations that I am sure
5 that every member of every team had in mind when
6 undertaking the review.
7 MR HAMILTON: Mr Langstaff, may I make a few comments as a
8 surgeon, because obviously there is a lot of focus on
9 the surgical contribution to the outcome of surgery.
10 I would endorse entirely what Dr Silove said.
11 When we were invited to be part of the Panel it
12 was not an easy decision because we were aware of what
13 was expected and I think every surgeon, indeed every
14 team member, accepted that responsibility when they took
15 on the role. We have not had a culture of criticism in
16 medicine. I think nurses have led the way in being much
17 more positive in that in using constructive criticism.
18 I think this is not for any reason or any feeling
19 to cover things up when things go wrong. I think it is
20 very much illustrated by the story in the New Testament
21 when the crowd were about to stone the lady caught in
22 adultery and whoever was perfect was invited to throw
23 the first stone. I think that outlines very well our
24 reluctance, if you like, to criticise. We are very
25 aware of the pain caused when we criticise colleagues.
0036
1 But, as Dr Silove says, we are also very aware of
2 the responsibility we had to the parents in undertaking
3 the role, and we wanted to make that clear.
4 MR LANGSTAFF: Ms Williams, you may want to comment. You
5 were also part of the pilot project. I missed you out
6 earlier, I am sorry.
7 MS WILLIAMS: That is right. I was one of the five people.
8 I was the nursing representative. At that point we
9 reviewed just five sets of case notes and we did take
10 great care to try to construct a tool having reviewed
11 those case notes which would help us reflect all aspects
12 of care in a very truthful way so that we could give
13 constructive comments which were more general comments,
14 not relating to picking out specific individuals but
15 relating to the general sort of standards and quality of
16 care that we could see reflected in the notes that we
17 were looking at.
18 MR LANGSTAFF: So the overall purpose, as you saw it, was to
19 look at each individual case, but to expect that
20 the picture shown would demonstrate a pattern rather
21 than be, as it were, an individual legal case for
22 compensation in respect of each child.
23 MS WILLIAMS: Yes, that is right. Perhaps what we were
24 hoping to identify were themes that came out of the case
25 note review rather than issues that related to any one
0037
1 child whose case notes we were looking at.
2 MR LANGSTAFF: So we have the figures which represent the
3 sum of the assessment of the Panel in each case and also
4 the reflection of the various themes that you have
5 spoken of and which we will come to I think later on
6 today when we can explore some of the themes that came
7 out most strongly to you from your various
8 perspectives.
9 Dr Silove, I interrupted your telling us --
10 DR SILOVE: Not really. I am sorry I digressed from
11 the actual pilot study. But I think from the pilot
12 study we learned how to construct a form and what
13 aspects we really wanted to concentrate on for setting
14 up this case review of 80 cases.
15 MR LANGSTAFF: The pilot study of five cases having been
16 done and the results assessed, the process then became
17 clear as to what should be done.
18 MS WILLIAMS: Yes. I think from looking at the teams,
19 the five of us who were on the original pilot project
20 were distributed among the other teams. There was one
21 person on each team from the pilot project. So if there
22 were issues about the tool that arose during the case
23 study review, we had some experience of how it had been
24 constructed and what we were looking for.
25 MR LANGSTAFF: What other attempts were made or have been
0038
1 made thus far in ensuring that the results, given
2 the difficulties you have mentioned of assessing
3 adequacy of care, are truly reflective of a broad
4 consensus of expert opinion?
5 DR SILOVE: I think that the great advantage of the way this
6 was set up by having teams of experts to look at
7 the results gave added strength to this whole process.
8 It did that because each expert individually could have
9 written a report and one could have looked at all five
10 reports. I do not believe that that would have given as
11 much information as the five people sharing
12 the experience together. There is something very
13 important about a team working together with the same
14 motivation and working in the same direction. There is
15 no doubt that a successful team is better than the sum
16 of the individuals in the team.
17 MR HAMILTON: I think the other thing to say is that this is
18 a model we use every week in every unit. All cases
19 coming up for surgery are discussed at a disciplinary
20 meeting with everybody make their contribution. Then at
21 the end, a consensus is reached. In some children it is
22 obvious and straightforward what needs to be done. In
23 other children there are many different options, so
24 these all need to be weighed up.
25 MR LANGSTAFF: You are speaking just a little bit rapidly.
0039
1 Can you draw breath for a moment so that the
2 stenographer can do the same?
3 MR HAMILTON: Apologies. I will try and keep an eye in
4 future. This is, as I say, a model we use regularly,
5 and if you like, it was a normal day's work in reviewing
6 cases in that sense, in looking at them clinically.
7 MR LANGSTAFF: Not only did you have the five reviewers,
8 expert reviewers each, but can you tell me
9 the importance, both from a statistical point of view
10 and from your own clinical points of view, of having
11 the 15 cases which were reviewed twice?
12 DR SILOVE: Professor Evans, I think.
13 PROFESSOR EVANS: I suspect it was at my instance that we
14 did this, but I do not know. We have not done any
15 formal statistical tests to measure the agreement. One
16 of the things that unfortunately the general public
17 perhaps do not all appreciate is that in almost anything
18 that involves a judgment, there will be disagreement.
19 If you take something really fairly objective, like an
20 X-ray and you ask two radiologists to assess that X-ray,
21 you will find that they come to disagreement.
22 Other measurement processes, if I take
23 a laboratory result I will repeat somebody's blood
24 pressure or I will repeat their haemoglobin test result
25 or their cholesterol test result and I will get
0040
1 variation in the measurement. If the variation in
2 the measurement is so large that the differences over
3 time or between people is swamped by the variation in
4 the measurements made of what purports to be the same
5 thing, then we are wasting our time.
6 It would be possible that these assessments that
7 were made were entirely idiosyncratic, that they were
8 dependent on those particular individuals that met in
9 one team, in spite of the best efforts. So we had to
10 look at a redo of the results to see if there was
11 agreement. We have done that and we will perhaps come
12 to that a little bit later. But statistically, we have
13 ways of assessing those agreements and we have not
14 attempted to do that very formally here, but we have
15 the opportunity to do that if we so wish. Having this
16 design means that we can have confidence, in all of
17 the 80 assessments that were made rather than just in
18 the 15 that were repeated, if there is agreement. If
19 there is disagreement, we find that we can have no
20 confidence in the 80 at all.
21 MR LANGSTAFF: Is it part and parcel of that that any team
22 reviewing a second case would not know that it was
23 a second review?
24 PROFESSOR EVANS: Yes. I used the word "veiled" a little
25 earlier. Sometimes people talk about "blind trials" and
0041
1 "blind assessment". I prefer the word "veiled"
2 myself. I think it was important that the teams were
3 "veiled" to this, that is, they did not know whether
4 they were doing a first assessment. So if a team
5 Ms Williams is in does one assessment and then a team
6 Dr Silove is in -- maybe you were in the same team, but
7 if you were in a different team, we can then see whether
8 there is agreement or disagreement between
9 the assessment made by those teams.
10 MR LANGSTAFF: The next and perhaps obvious question is
11 that, although looking at clinical records may form
12 the basis of many expert opinions, for instance in
13 the medical/legal field, it is necessarily looking at
14 records and having that evidence alone before
15 the reviewer, or in this case the reviewing Panel.
16 To what extent is it a problem in making
17 a judgment as to adequacy of care, that you do not have
18 the nurse, the intensivist, the cardiologist or
19 the surgeon there in front of you to say, "Actually what
20 you do not know about this case is what the notes do not
21 say but I remember, and it is [this or that or the next
22 thing]"?
23 DR SILOVE: That is a point that comes up all the time with
24 medico-legal litigation. A cardiologist, say, will be
25 asked to review a case and he will say, "We must get
0042
1 a surgeon's opinion or we must get an intensivist's
2 opinion". So you then have a process that goes on and
3 on for such a long time. This, I think, is the model
4 that could be used for --
5 MR LANGSTAFF: It is a slightly different point that I was
6 putting, I think, which is that it is all very well to
7 take all the areas of expertise that might be important
8 and look at notes, but can the notes themselves tell you
9 everything without interpretation by the surgeon or
10 the cardiologist who was there at the time?
11 DR SILOVE: I am sorry. No, that is obviously a problem.
12 Notes are not written for the purpose of analysing them
13 10 or 15 years later to see whether care was adequate.
14 They are written by clinicians for the clinical
15 management of the patient at the time. Things do not
16 get written in the notes which might be very obvious to
17 the clinicians at the time.
18 So, no, one can never really get a complete
19 picture without actually having a direct contribution
20 from the clinicians who have been directly involved with
21 the patient.
22 MS WILLIAMS: I think another issue to add is also
23 the completeness of the notes, that some of
24 the information that may have been helpful without
25 having the people involved there was not actually
0043
1 available at the time, which made it difficult to judge
2 the involvement of certain people in the team.
3 MR LANGSTAFF: Is there a difference in the information
4 which is available for certain disciplines? For
5 instance, if one is looking at the anaesthetic
6 intensivist, there may be records of blood pressure,
7 gases, heart rates, et cetera, which are all matters of
8 record. If one is looking at the surgery, it is very
9 difficult, perhaps, on paper to describe exactly what
10 the surgeon saw on opening up the chest and such like.
11 Is this a problem or is it not?
12 MR HAMILTON: Certainly, trying to judge the technical
13 performance of an operation from the operation note is
14 impossible, unless you are there to watch; why a surgeon
15 did a particular manoeuvre at a particular time unless
16 you were able to ask the surgeon. There might not be an
17 explanation.
18 I was very conscious last weekend, in fact when we
19 were trying to put this report together, of several
20 comments that had referred to delays in treatment.
21 I had particular experience that was a baby that an
22 antenatal diagnosis of a heart condition and there was
23 going to be an elective Caesarian section so that
24 the baby could be born in normal working time and be
25 cared for when all the staff were around.
0044
1 The surgery was planned for my list on Thursday.
2 The labour ward were busy so the Caesarian section was
3 delayed. The baby was born on Friday and came to us on
4 Friday evening. I could see that we could be
5 criticised, perhaps, for planning such a treatment to be
6 on a weekend when we would not necessarily have all
7 the staff around. So it was planned for Saturday
8 morning. The child was stable on a drug to maintain the
9 circulation, but on Saturday morning, about half an hour
10 before we were due to start, we had an emergency
11 admitted and we had to deal with that. Rather than
12 start the operation on Saturday evening, which again
13 would not have been ideal, we planned it for Sunday
14 morning.
15 Then on Sunday morning another emergency came
16 along which we had to weigh up and put that one off
17 until Monday, and then I did my child on Sunday.
18 The other one had to be put off until Monday and the two
19 cases who were planned for Monday then had to be
20 postponed.
21 None of that will be recorded in the notes, but
22 that is life and that is clinical practice. So I was
23 struck with how, when we were trying to draw the report
24 together, we were referring to delays in treatment and
25 you just cannot interpret that sort of thing from
0045
1 the notes.
2 MR LANGSTAFF: Despite those difficulties of interpretation,
3 which plainly have to be borne in mind by anyone
4 reviewing the results of the survey, to what extent are
5 you satisfied that you are able to give a reasonable
6 picture of the overall adequacy of care in the cases
7 that you looked at?
8 DR SILOVE: I think we can be reasonably confident but not
9 completely confident, for the very reasons that are
10 being brought out here. We did not have all of
11 the information available. We had most of
12 the information available and we did the best that we
13 could with what there was.
14 As I have said, I do not know whether we would
15 have a similar problem if we looked at the medical
16 records of another hospital. I am sure we would. But
17 whether the scale of what we found would be the same or
18 not is open to conjecture.
19 MR HAMILTON: Dr Silove referred to the lack of any obvious
20 standards to judge things against. We were very
21 conscious of that. I hope I made the point earlier that
22 we were aware of our responsibility to the parents to be
23 critical where criticism was necessary. We obviously
24 were not expecting perfection. I think in times we
25 maybe were looking for an ideal situation, idealism as
0046
1 the standard, and perhaps at times we were
2 over-critical. I think people did not shirk
3 their responsibility in critical where we felt that was
4 necessary.
5 MS WILLIAMS: I think another point that Dr Silove made
6 earlier is that another reason we can be reasonably
7 confident is that a great deal of discussion went on
8 between each team about each case. That did give us
9 a chance, perhaps where people were being excessively
10 critical, or forgetting that we were reviewing notes in
11 the late 1980s or early 1990s, that we were able to
12 explore those issues while we were exploring the notes.
13 It was a balanced view of the whole group, the final
14 decision about each aspect of care.
15 THE CHAIRMAN: This is obviously a central question, so it
16 may be helpful to hear from Dr Macrae, whom we have not
17 been able to hear from because of our seating
18 arrangements which we must I think somewhat amend for
19 the session after our break, which I suggest we take in
20 a few minutes.
21 I know that will be arranged, but it would be
22 helpful, Dr Macrae, to hear your view on that question
23 and any other general matter you may wish to offer us.
24 DR MACRAE: I think I agree with the general tenor of
25 the comments that have been made about the case note
0047
1 review process. I do think the strength of
2 the structure of the panels and the way that they worked
3 was that they represented a range of experience.
4 Dr Silove made the point that not all the members of
5 panel, myself included, were necessarily in practice at
6 the beginning of the era of the Inquiry, but
7 nevertheless, there was a balance in each of the panels,
8 as far as I am aware, covering that aspect and also
9 the different disciplines.
10 I very much go along with, certainly in the panels
11 I was involved with, there were certainly points which
12 one panel member would put very strongly, perhaps
13 a critical point, or it may even be a point saying --
14 there would be an equally strong view arguing against
15 that following review of the data and perhaps an
16 understanding of the context, particularly the time
17 period in which the events related to. It was usually
18 possible -- in fact it was always possible in the groups
19 I was involved with -- to come to a unanimous judgment
20 on the scoring of that particular issue.
21 MR LANGSTAFF: Dealing with the problem of information or
22 further information that might have illuminated
23 the discussion, the panels were told, were they, that if
24 they had not got enough information they would put an X
25 in the box?
0048
1 DR SILOVE: Yes. That was usually done if there was
2 something missing, if there were no notes written say
3 about an operation (which did not actually happen) or if
4 some of the investigations could not be found,
5 the x-rays for example, an "X" would go in the box,
6 yes.
7 MR LANGSTAFF: Taking this a little further: how often was
8 it, in the course of discussions, that members of your
9 panel said, "Actually, we cannot really answer this
10 without having more discussion. My tentative view is
11 that it is a 1, a 2, a 3 or a 4, but I really need to
12 know more about this before I can reach a judgment."
13 DR MACRAE: The panels I was involved in always came down
14 with a clear decision on whether it was a 1, a 2, a 3 or
15 a 4, but on reading the summary that Dr Silove and
16 Mr Hamilton have put together, I see that several panels
17 graded some 2/3, so clearly there was a balance of
18 opinion within those groups on whether to categorise as
19 a 2 or 3.
20 MR LANGSTAFF: That is a shade of judgment rather than
21 saying that we need to know more here before we can
22 reach a judgment?
23 DR MACRAE: I suppose what I am trying to get at was that
24 I suspect that many of those issues were issues of,
25 "I think the information is telling us this. If there
0049
1 were more, we would be able to make a clearer decision".
2 MR LANGSTAFF (to Ms Williams): Your experience?
3 MS WILLIAMS: I think, certainly from a nursing perspective,
4 it would have been helpful on occasions to have
5 the intensive care charts, the observation charts, and
6 I think from a medical perspective as well there is
7 a lot of information on those about exactly the things
8 you were talking about earlier, blood gases, blood
9 pressure, heart rate. In many cases those charts were
10 not available, which sometimes did mean that you were
11 making your best guess about situations because you had
12 not got the trends in front of you in relation to what
13 was being discussed in the notes.
14 MR LANGSTAFF: Mr Hamilton?
15 MR HAMILTON: I would not want to give the impression there
16 were lots and lots of things missing. We had very good
17 sets of medical records and the notes were all there.
18 Occasionally we found an old angiogram or echo or
19 something from the past would not be available, but we
20 did not feel that was a particularly important piece of
21 the jigsaw, if we had up-to-date things.
22 MR LANGSTAFF: Presumably the same shortcomings that we have
23 been talking about would apply to CESDI as well?
24 DR GOULD: No, the meetings and the nature of the meetings
25 were very parallel.
0050
1 MR LANGSTAFF: As we have heard, CESDI enjoys general
2 respect in the profession, despite the shortcomings,
3 which must be obvious to all.
4 DR GOULD: We would like to think so.
5 MR LANGSTAFF: Sir, on that note, may it perhaps be time for
6 our first break?
7 THE CHAIRMAN: Yes. Shall we take 10 or 15 minutes, which
8 will take us up to 11.35 am?
9 (11.20 am)
10 (A short break)
11 (11.35 am)
12 MR LANGSTAFF: I am pleased that we have been able to
13 arrange that all experts not only have a table, but have
14 room at it.
15 Professor Evans, I wonder if you would like to
16 comment upon the degree to which the figures which you
17 have seen coming out of the review demonstrate any
18 degree of lack of confidence by reason of lack of
19 information?
20 PROFESSOR EVANS: I think it is important to note that in
21 the overall --
22 THE CHAIRMAN: May I interrupt before we start? I am very
23 grateful to those who have arranged it so we can have
24 all our experts at the table. It may be slightly
25 awkward but helpful if you pass the microphone between
0051
1 you. There may be a slight delay, but that would help
2 us here.
3 PROFESSOR EVANS: I do not think we need to turn to the
4 pages of the report yet, but it is important to note
5 that the X where there was inadequate information was
6 not given for the overall aspect of care for any of the
7 80 children. The information for all those 80 was
8 adequate.
9 The sample was not replaced in any way if that was
10 so: that was a finding that the overall information was
11 adequate there.
12 For individual aspects of care, there are a small
13 proportion of values that have an X where the
14 information is missing, for example, there are a few for
15 perfusion and there are a slightly larger number for
16 post-operative cardiological care. But the number of
17 Xs, of missing data, is really quite small.
18 MR LANGSTAFF: The next issue which I wanted to explore was
19 how difficult it is, if it is, to think back into
20 1984/85 and so on, rather than think back to the
21 practices of last week.
22 MR MACRAE: Perhaps I can make a few comments on that.
23 1985 takes me back to almost my first experience of
24 paediatric cardiac practice. As a senior trainee,
25 I have been in a consultant post since 1989, so
0052
1 I suppose I have been in practice in some form
2 throughout that period. Because the early part of that
3 period was, if you like, my formative years, I think
4 I have reasonable recall about a limited area of
5 practice in the institution in which I was training,
6 which I happen to think was quite a good place.
7 What I am not able to give, which perhaps someone
8 with Dr Silove's experience is able to give, is
9 a broader view of what the whole UK picture was, and he
10 might have a much better view or the more senior members
11 of the panel may have a better view of the context of
12 the practice.
13 I now can tell you, in 1999, I have a much better
14 idea about how the practice in my hospital perhaps
15 compares to other places if I go and visit them and
16 listen and watch what they do, so I think there is an
17 element of that, but as I said earlier, I think each of
18 the panels did have a fairly broad representation, so
19 that overall, I think that the panel was able to put
20 itself in the context of the period, for instance, the
21 question, did they have this particular type of
22 investigation in 1989, and one of the panel members
23 would be able to say, "In my experience, that only
24 became available or common practice beyond 1992", or
25 something like that.
0053
1 So those types of discussions did take place.
2 MS WILLIAMS: I would support that. I think that there
3 were people with a wide-ranging experience in each of
4 the review panels, and sometimes, you know, we did need
5 reminding that we needed to go back and look, but there
6 were normally two or three people who had been in
7 clinical practice in mid to late 1980s and it was just
8 a case of really thinking about what things were like
9 then.
10 DR SILOVE: Having been pointed to as a "senior member", it
11 was actually very difficult, but one did have to think
12 back, did we have that particular technology in 1985?,
13 when did that become available? and so on. But I think
14 we all got around the problem quite well. I think we
15 were able to extrapolate back and I think we made
16 special allowances for standards of care, say in
17 intensive care units, being quite different from what
18 they are today.
19 There were all sorts of things that were
20 different, but I think we were able to take that into
21 account quite well.
22 MR LANGSTAFF: What about the point Dr Macrae was making
23 which is essentially that his experience in the 1980s,
24 although he recalls it well, was limited to one centre
25 because that is where he had it? What efforts were made
0054
1 in the design of the study to spread the experience of
2 different centres amongst the different groups?
3 DR SILOVE: We were very careful to have teams of reviewers
4 who, for the most part, each member came from
5 a different centre. We did not succeed completely on
6 that, but mostly.
7 MR LANGSTAFF: We have talked about the design and we talked
8 about the pilot study. Do you want to give us,
9 Dr Silove, an overview of the results that came out?
10 DR SILOVE: First let me say we are calling this
11 a preliminary report, and the reason we are doing that
12 is partly because the report was prepared during
13 a two-week period immediately after the last case review
14 had been done, and it really was very rushed; it was an
15 awful lot of work. If I could just say that Mr Hamilton
16 and I are very, very grateful for the skilful and
17 dedicated support we got from the Secretariat of the
18 Inquiry, in particular Una O'Brien; I think it was quite
19 outstanding support. Without that it would not have
20 been possible to complete the report.
21 I will present some data, but I think that people
22 might find some of it rather disturbing, for the reasons
23 that Professor Evans has outlined. It is very heavily
24 weighted towards babies who had open-heart operations
25 and who died. We will later see the data that Professor
0055
1 Evans prepared at midnight last night, which might give
2 us a more balanced view, but I would like to proceed
3 with the raw data as we have it.
4 If we could have INQ 16/6 on the screen, please,
5 this gives you an overall idea of what happened if we
6 could look at this graph, in all 80 children.
7 Unfortunately, the shadings of grey have not come out
8 very well on this, but at the bottom here we have
9 gradings for overall care, 1 on the left, 2, 3 and 4,
10 and the bars on the left are patients who are alive and
11 the bars on the right are patients who have died.
12 So in overall grade 1, you will see that there
13 were 11 patients who died and two who are alive.
14 When you get to grade 4 of adequacy of care, that
15 is where care was adequate, there were still a number
16 who had died and most were alive.
17 If we could just go to the bottom of that page,
18 there is a table which gives you the figures. You will
19 see that as Professor Evans indicated, 40 were selected
20 who had died and 40 who were alive, and those were an
21 overall grade score of 1, there were 11 who had died and
22 two alive; grade 2, there were 10 who had died and
23 1 alive; and so on, up to grade 4, where there were 7
24 who had died and 33 are alive.
25 If we could go on to page 8, we will see bar
0056
1 charts showing the adequacy of care, first for the 40
2 who were alive -- just seeing the same thing as I have
3 already shown you in a different way. On the left are
4 those where adequacy of care was rated the worst, and on
5 the right, where adequacy of care was rated the best.
6 If we could go lower down on that page, the patients who
7 died, you can see that there is a reasonable spread of
8 adequacy of care across -- that is adequacy of care 1,
9 2, 3 and 4, this little group of 2/3 really upset us
10 a bit. There were four patients in that group. The
11 authors of this report would have preferred the
12 reviewers to have given a definite grade of either 2 or
13 3, but that was their decision and we accept it.
14 MR LANGSTAFF: Just pausing there, I suppose to get
15 a reflective pattern, one would have to halve that box
16 and add one half of the box to the 2 column, and one
17 half to the 3 column, to get a reflective pattern?
18 DR SILOVE: Not necessarily. It is more complicated than
19 that. They might all be grade 2s, they might all be
20 grade 3s in somebody else's estimation --
21 MR HAMILTON: Having said that, when we first set out to
22 review the results we took those four cases and reviewed
23 the forms. We did not have the case notes. We felt,
24 looking at the forms, that we would have put two of them
25 into 2 and two of them into 3, as it happens, but
0057
1 recognising that they were evidence to the Inquiry,
2 I think it is interesting that these were the only four
3 of the 80 cases where the teams could not agree on
4 a final score, which I think says something itself for
5 the review process.
6 DR SILOVE: That then gives you an overall picture of the
7 overall grades of adequacy of care.
8 I would now like to focus on some of the aspects
9 of care that we looked at and if we could turn to
10 page 11, INQ 16/11, this is text, and I am just going to
11 C, D and E at the bottom here.
12 MR LANGSTAFF: Let us highlight C, D and E.
13 DR SILOVE: I really just want to highlight some of the
14 information that we got from this.
15 In the pre-operative management, I would just like
16 to focus on these three aspects for a moment. The
17 accuracy and completeness of diagnosis, in 12 instances
18 concerns were raised about the diagnosis, but in only
19 7 was a wrong or incomplete diagnosis thought to have
20 made any difference to outcome.
21 The initial treatment strategy, grades of less
22 than adequate were given for 14 procedures, and in 9 the
23 inappropriateness of initial treatment strategy was
24 thought to have affected outcome.
25 In E, the timing of planned treatment -- this came
0058
1 through in all of the reviewers' comments at various
2 times -- we were concerned about delays in the timing of
3 planned treatment. This was mentioned in relation to
4 21 procedures, although in only 6 cases were delays
5 considered to have contributed adversely to outcome.
6 So this is where, when I say "considered to have
7 adversely", I mean that they were given grades 1 or 2
8 for adequacy of care. Just to remind you, grade 1 is
9 less than adequate care in which different management
10 would reasonably be expected to have made a difference
11 to outcome, and grade 2 is where different management
12 might have made a difference to outcome.
13 MR LANGSTAFF: That is in each case, an avoidable factor: in
14 1s, probably contributed to death or disability; in 2s,
15 might have?
16 DR SILOVE: Might have, yes. If we can go on to the next
17 page, page 12, this is the surgical procedure. I will
18 see if I can highlight that for you. What has happened
19 to my highlighter?
20 THE CHAIRMAN: I may be able to help you -- you are doing
21 it, otherwise Tony at the back will quite happily do it
22 for you, provided you do not touch the screen, because
23 the mouse is mightier than the pen!
24 DR SILOVE: I think he told me that the pen was mightier
25 than the mouse!
0059
1 For the surgical procedure, it was very
2 interesting that although grades of less than 4, in
3 other words less than adequate care, were given for 21
4 procedures, in only 11 procedures, that is 11 out of 100
5 procedures -- remember, there were 100 procedures in 80
6 patients -- the reviewers did not consider that surgical
7 care affected outcome, whereas in 7 procedures, those
8 with a grade of 2 where different management might have
9 made a difference to outcome and in only 2 there were
10 patients with a grade of 1, was it considered that
11 different care would reasonably have been expected to
12 have made a difference to outcome.
13 So the actual surgical procedures did not features
14 very highly in the overall assessment of adequacy of
15 care.
16 MR LANGSTAFF: Can I just ask you about what you have said?
17 Is what you are intending to say that if one focuses
18 upon inadequacies, then surgical procedure does not
19 feature very highly?
20 DR SILOVE: We have avoided the word "inadequacies". Where
21 the care is less than adequate, yes, surgery does not
22 feature very highly.
23 MR LANGSTAFF: I am grateful for the correction.
24 The point you are making by reference to the
25 previous page was that by comparison with accuracy and
0060
1 completeness of diagnosis, appropriateness of initial
2 treatment strategy and timing of treatment, the
3 pre-operative stage had a greater reflection as being
4 less than adequate than did the surgical procedure?
5 DR SILOVE: Yes, it seems in a sense it set the scene for
6 the whole of the management of that patient thereafter.
7 The pre-operative care, assessment, diagnosis and so on,
8 did seem to set the scene for all of the care
9 afterwards.
10 There was another important aspect, though, and
11 that was, if we could go down the page, this is the
12 post-operative intensive care and assessment. If we
13 could just -- we can probably read all of this, but
14 essentially, let me highlight. The clinical case note
15 review of post-operative management was set up to be
16 subdivided between anaesthetists, surgeons and
17 paediatric cardiologists, but it was actually very
18 difficult for the reviewers to attribute primary
19 responsibility to specific members of the clinical
20 team. The reviewers had often graded medical care,
21 which was probably intensivist anaesthetist care as
22 surgical and vice versa, because of difficulties in
23 discerning the separation of the roles of these
24 respective disciplines in the Intensive Care Unit.
25 So we commented on the data as it was, but we did
0061
1 have those reservations.
2 If we look at the medical care or anaesthetic
3 aspect J, there was a grading of less than adequate care
4 following 19 procedures, including 9 instances where the
5 care was graded as 1 or 2. The surgical post-operative
6 care, that is aspect K: less than adequate in 12
7 instances, of which seven grades were 1 and 2. There
8 were many comments about the intensive care touching on
9 a range of issues which included poor control of
10 ventilation, early extubation, failure to undertake
11 echocardiography, problems with fluid balance, failure
12 to act when the blood oxygen was low post-operatively,
13 and failure to assess reasons for poor cardiac output.
14 MR LANGSTAFF: Just pause there for a moment. You are
15 reading, I think, what is at the bottom of the page.
16 DR SILOVE: Yes; if we could go over the page?
17 MR LANGSTAFF: You were speaking fairly quickly then.
18 DR SILOVE: I think the important comment that came through
19 time and again was that reviewers could find little
20 evidence of the presence of paediatric cardiologists on
21 the Intensive Care Unit at the Bristol Royal Infirmary.
22 MR LANGSTAFF: I want to pick up in a moment or two with the
23 assistance of all of you what role you would expect
24 particular disciplines to play at particular stages, so
25 this is something we will come back to, and in
0062
1 particular, pick up that comment and its relevance.
2 DR SILOVE: I think what I would like to do at this stage is
3 to get on to those patients in whom the overall grading
4 of care was 1, in other words, those patients in whom it
5 was considered that different management would
6 reasonably be expected to have made a difference to
7 outcome.
8 If we could turn the table at page 37, after that,
9 you could have [INQ 16/37].
10 This table is an eyesore, but it really shows you
11 each row indicating the gradings for aspect of care
12 which are in the columns, so each row is a patient or
13 a procedure, I should say. 1/1 means overall grade 1,
14 first patient. 1/9a for example is the 9th patient who
15 had two procedures, 9a and 9b, and so on. So this
16 table, if you look across the columns -- can this be
17 enlarged, do you think, the table?
18 MR LANGSTAFF: We may be able to enlarge sections of it
19 for you.
20 DR SILOVE: Perhaps if it was enlarged from here, the whole
21 table from left to right there.
22 THE CHAIRMAN: I wonder, while we are trying to do that,
23 Dr Silove, whether figure 6 might be even more of
24 a helpful starting point for us? That is on
25 page INQ 16/10.
0063
1 DR SILOVE: I have a better one than that. Perhaps we could
2 put up the bar chart?
3 THE CHAIRMAN: Bear with me and tolerate my eccentricity.
4 Let us look at page 10 first.
5 MR LANGSTAFF: I think what you wanted to show us,
6 Dr Silove --
7 DR SILOVE: I want to concentrate on patients who are grade
8 1 overall care, and this gives just a summary of the
9 grades of each aspect of care. It is more accurate if
10 I could show you, perhaps, INQ 19/1. This is a bar
11 graph, if you could enlarge that for us. These are the
12 aspects of care for patients who had an overall grading
13 of 1, and it is divided into -- this is pre-operation
14 (indicating). This section here is operation area.
15 G is the operation itself and I is the anaesthetic.
16 These last three are J, K and L, post-operative
17 aspects. The dark shading is those given a grading for
18 the aspect of care of 1, and the light shading, those
19 given a grading for aspect of care of 2.
20 You can see here how those with an overall grade
21 of 1 had this high preponderance of low scores in the
22 pre-operative management -- I am sorry on this vertical
23 bar on the left, it tells you the number of procedures.
24 So this shows you quite clearly that for only two
25 procedures was grading of surgical care in this group 1
0064
1 or 2. The same applied to the anaesthetic.
2 Then post-operatively, there was again
3 a scattering -- as I have indicated. This is the
4 post-operative care group. The one on the end is the
5 postmortem.
6 So post-operative care also featured quite highly
7 in this group of patients.
8 I hope that is clear. If I could perhaps move on
9 to overall grade 2, which is INQ 19/2, here, similarly,
10 we have the pre-operative period. We have the operative
11 period here, those three. G is surgery, H is perfusion
12 and I is anaesthetic. Here is the post-operative care.
13 In this group, interestingly, we found that one patient
14 had been given a grading of 1 for the surgical procedure
15 and I think it was four who had been given a grading of
16 2 for the surgical procedure.
17 Post-operative management featured again quite
18 strongly in grades of adequacy of care, but this group,
19 these 11 patients who received 13 procedures, it was
20 considered that different management might -- might --
21 have affected outcome. We are not saying that it would
22 have done.
23 I wonder if it is possible to bring up the table
24 from page 38? That is INQ 16/38. I do not have any
25 more of these bar charts. I am now going to go on to
0065
1 overall grade 2/3, and just take it as it comes.
2 If you look across --
3 MR LANGSTAFF: Can I just stop you there? If one is looking
4 at cases where the less than adequate care might have
5 made a difference, or probably made a difference, what
6 you have shown us is two bar graphs which reflect
7 slightly different pictures as to the relative
8 importance of the pre-operative, the surgical and the
9 post-operative phases.
10 What interpretation, if any, do you give to the
11 relative importance of each of those periods in terms of
12 the overall adequacy of care that the Panel has to
13 assess?
14 DR SILOVE: I think that a lot of what we showed on those
15 overall grades 1 and 2, the division into aspects could
16 have occurred by chance. Perhaps Professor Evans would
17 agree or disagree with that. In other words, I think it
18 was by chance that we had more cases in which surgical
19 care was regarded as slightly less adequate in overall
20 grade 2 than in overall grade 1.
21 I think the message that we have really got from
22 all of this is that all aspects of care contributed to
23 overall less than adequate care.
24 MR LANGSTAFF: Could I just stop you there? I am not quite
25 sure what you mean by saying that the allocation as
0066
1 between 1 and 2 may have happened by chance. Do you
2 mean the chance of having these particular 80 cases, or
3 do you mean that there is a chance that one panel will
4 have allocated to 1 rather than to 2? In what sense are
5 you using it?
6 DR SILOVE: No, I do not mean that anyone else would have
7 allocated different gradings. I mean that if you took
8 another sample of different children who might also be
9 given an overall grading of 1, say, you might find that
10 more of those patients had inadequate surgical care.
11 MR LANGSTAFF: You might find more had had adequate
12 surgical care?
13 DR SILOVE: You might.
14 MR LANGSTAFF: Can I ask Professor Evans to come in on
15 this? Is this part of the purpose of taking a sample
16 like this, in order to get a reflection of the whole
17 from the part?
18 PROFESSOR EVANS: It certainly is part of the purpose of
19 taking a sample to do that. I would be very reluctant
20 to try and draw very strong conclusions about important
21 differences in the way that one might be tempted to
22 looking at those numbers.
23 What I would wish to summarise, perhaps, is that
24 in overall grades 1 and 2, what is very clear is that
25 the surgical aspects, if you like, particularly aspect
0067
1 G as we have labelled it, surgical care on its own, is
2 not appearing to be inadequate from the way the teams
3 have assessed it, as being the major contribution to the
4 overall adequacy of care being 1 or 2. That is the key
5 thing.
6 I think that what Dr Silove said, that is, that if
7 one looks at adequacy of care 1 or 2, the reason for
8 that is something that is spread across the board. It
9 varies from individual case to individual case, but what
10 is very clear is that there are aspects across the whole
11 spectrum of care and the whole time period of care which
12 are contributing to that. It would be incorrect to talk
13 about, in my view, a statistical comparison of whether
14 surgery is greater or less than some other aspect.
15 So I do not think the sample focusing down to that
16 level has the ability with such small numbers to draw
17 the correct conclusions.
18 MR LANGSTAFF: Going back to the evidence we heard
19 yesterday, would it be a mistake, then, to attribute the
20 apparent difference in performance of Bristol compared
21 with other centres to less than adequate surgery as
22 opposed to possibly less than adequate care on the part
23 of the unit?
24 PROFESSOR EVANS: Yes, I think it would be inaccurate.
25 I think that there is, and I think somebody at least
0068
1 yesterday did warn that the idea that we were focusing
2 on surgeons or surgical care, as per surgery, as being
3 the explanation for any difference between Bristol and
4 elsewhere, would be mistaken. I think this review makes
5 that quite explicit.
6 MR LANGSTAFF: Dr Silove, you were going to go on and show
7 us briefly 3 and 4.
8 DR SILOVE: Yes. I would like to thank Professor Evans for
9 saying so eloquently what I was trying to put across.
10 I am not very used to using statistical terms.
11 Could we move the chart up so we can see table 3?
12 Here you see a different type of picture from the
13 aspects of care that you would have seen in tables of
14 overall grade 1 and overall grade 2. Those with aspects
15 of care overall grade 3, most of the way across you will
16 see aspects of care for different aspects being given
17 grades of 4 or 3, and occasionally, 2.
18 I think one has to leave it to the individual
19 teams of experts to decide from their overall
20 discussion, what overall grade they should give.
21 I am sorry to do this to you, but I wonder if we
22 could just point out one little anomaly and go back to
23 the table of overall grade 1, which is page INQ 16/37.
24 I would like to focus on case 11. In case 11
25 which I have highlighted, it was very interesting that
0069
1 the reviews gave an overall grade of 1, even though
2 there was no single aspect of care that was 1 or even
3 2. The lowest aspect of care grading that was given
4 here was 3.
5 This patient is alive and the reviewers considered
6 that because so many -- at least I am assuming, I was
7 not one of the reviewers in this case. I am assuming
8 that they considered that there were so many aspects of
9 care that were given lowish gradings that they had to
10 consider the overall aspect, the overall grade, for this
11 patient was down to 1. So it is an anomaly in all these
12 tables which is probably worth highlighting.
13 MR LANGSTAFF: There may be an explanation, might there not,
14 in the protocol which was used, which was that 3
15 describes less than adequate care? The judgment as to
16 whether the less than adequate care might have made
17 a difference, or probably made a difference, must be
18 a judgment as to the causative potency of the less than
19 adequate care?
20 What you are therefore reflecting here is, is it,
21 a picture where, generally speaking there was felt to
22 be, across a number of aspects, less than adequate care
23 and the overall judgment as to what that caused or did
24 not cause is that it probably made a difference.
25 DR SILOVE: Yes, I think that is right. That was our
0070
1 interpretation.
2 MR LANGSTAFF: I do not know whether we have amongst us
3 a member of the Panel who may recognise the markings on
4 this? (No response).
5 DR SILOVE: We are all denying it! It must have been one of
6 the other teams!
7 PROFESSOR EVANS: Can I comment, although I am obviously not
8 a clinician, there was a specific comment made by the
9 team that was listed, and as it happens, the comment
10 says that it represents clear evidence of delay in the
11 treatment strategy putting the patient at risk and that
12 was why the overall grade was given as 1 and that is
13 a specific comment made by the team.
14 Of course, as Mr Hamilton said, the reasons for
15 the delay may not be recorded in the notes, but that was
16 the comment that they made.
17 DR SILOVE: Yes, and it is interesting that the patient is
18 alive and I do not believe that patient has
19 a disability; is that correct?
20 PROFESSOR EVANS: I think you are right.
21 DR SILOVE: The patient is alive without a disability, so
22 that there is no way that different management could
23 have produced a better outcome. So the review team were
24 not sticking strictly to the protocol that had been set
25 out, but that does not matter. I think one has to
0071
1 respect their judgment that the overall care was that
2 bad that they had to downgrade it to 1.
3 MR LANGSTAFF: So they would have expected it, applying
4 intellectual rigour, to make a difference, even though,
5 as it happened, it did not?
6 DR SILOVE: I think what they were really saying was, if
7 something had gone wrong, then different management of
8 care would have produced a better outcome. But
9 fortunately, nothing went wrong in that case.
10 DR GOULD: Could I make a comment about our experience with
11 CESDI, because certainly in the early days this was
12 a problem that came up not infrequently. What tended to
13 happen was that panels felt what happened here was
14 really bad management, and therefore they wanted to
15 indicate this, they felt, by giving it as it were a high
16 grade, despite the fact that technically it made
17 a nonsense of the grading if they did not comply with
18 the grading system. We went through a phase where we
19 had to instruct chairmen, "You have to be very careful
20 about this", in the same way this anomaly has crept in
21 with the postmortem here. It happens occasionally.
22 THE CHAIRMAN: Your CESDI high grade would be a low grade in
23 our context?
24 DR GOULD: Yes, that is right, in this sort of circle. So
25 it is easy for panels to try and do that, because they
0072
1 are trying to highlight something. In fact, that is one
2 of the reasons why we did undergo a change at one phase
3 with one of our grading systems, where we separated how
4 bad we felt the care was from whether we thought the
5 care would affect management.
6 So we had actually two grades that were applied,
7 because we recognised often there seemed to be very poor
8 management, but it would not have affected outcome, so
9 somehow, what we had as a grade 3 here, one still wanted
10 to highlight that there was poor management occurring.
11 MR MACRAE: I think it is important to make the point that
12 assessment of outcome can be a technical exercise in
13 that a child may eventually be discharged from hospital
14 without any morbidity or any ongoing problems. Having
15 had a technically successful operation, his or her care
16 could still have been inadequate, given that the
17 intensive care stay may have been unduly prolonged
18 because of a level of inadequate supervision or a wrong
19 decision or a different decision.
20 So it is still possible to have a perfectly
21 acceptable outcome, but nevertheless, a child or
22 a family may have been put through something which was
23 not optimal.
24 MR LANGSTAFF: So you are saying that one might distinguish
25 between outcomes which are other than death and
0073
1 disability?
2 A. Yes, which I think is one way that you could make lots
3 of number 3s add up to an overall number 1, although
4 I was not involved in this particular assessment.
5 THE CHAIRMAN: I think Professor Evans wanted to come in on
6 something?
7 PROFESSOR EVANS: I think that it is slightly unfortunate in
8 some ways that because we are not veiled to the outcome,
9 we clearly have a measurement of adequacy that is
10 muddled up with the outcome, and because the way the
11 gradings have been written in that way, it says less
12 than adequate care would be expected to have made
13 a difference to outcome. So the assessment of adequacy
14 is muddled up with that outcome.
15 Yet, by having selected carefully children who had
16 died and children who were alive, to some degree we were
17 wanting to have some assessment of adequacy of care that
18 was to a degree independent of outcome.
19 So I do not know, but I think that the team were
20 right in using a grade 1 there, even though it did not
21 exactly conform to the rules that were written down
22 there. It met the spirit of the adequacy of care,
23 rather than the exact legalism of the term used.
24 MR LANGSTAFF: Is it perhaps dangerous, when one is trying
25 to interpret the results of a study, to know, and
0074
1 indeed, to give permission to a team, to depart from the
2 rules which they are supposed to be observing? We have
3 here a team which, it could be said, did not follow the
4 rules. Does that not invalidate the conclusion and the
5 study?
6 PROFESSOR EVANS: No, I do not think so. I think one has to
7 realise that these numbers we are giving, 1, 2, 3, 4 and
8 5, are not measurements of height. I think that these
9 are subjective measurements and the criteria used by
10 people in trying to use the measurements, you try to set
11 down the rules, and I think if you have too rigid an
12 adherence to the rule, you may equally end up confusing
13 yourself in terms of giving a picture.
14 These numbers are not to be interpreted -- I as
15 a statistician would not wish these numbers to be
16 interpreted with the rigidity with which I might
17 interpret height, weight, blood pressure; they are not
18 as reproducible in that way. But nevertheless, the
19 question is, are they reproducible?
20 While the rules have been slightly broken,
21 nevertheless, by the way we have deliberately included
22 children who were alive and those who were not alive, to
23 some degree you might as well say that anyone who was
24 alive should never have any score other than adequate.
25 I would think that would not be the sort of thing the
0075
1 Inquiry is really interested in. The Inquiry is
2 interested in adequacy of care, and I would argue that
3 the team in having some discussion there, although
4 I obviously was not present, was right in doing this.
5 I think Duncan Macrae has made exactly that point
6 that the adequacy of care being poor, the fact that it
7 did not make a difference to what we have measured as
8 outcome, and we have recorded on our bits of paper,
9 there may be some other bits of outcome there. There
10 might have, for example, have been distress to parents
11 caused through this inadequate care. I do not know.
12 I think the team should be allowed to do that, even
13 though it does not fall exactly within the apparent hard
14 and fast rule of the protocol.
15 MR LANGSTAFF: So you are saying that the difficulty about
16 applying the rules might lead to a wider margin of
17 appreciation, might it?
18 PROFESSOR EVANS: I think so. I think if you had believed
19 that the assessment of this was perfect and those
20 numbers were regarded as carved in tablets of stone,
21 then you would be mistaken. One of the things that
22 statisticians are employed to do professionally is to
23 estimate uncertainty. I think that one of the messages
24 that perhaps in some instances did not come out from
25 yesterday was the uncertainty in our apparent estimate
0076
1 of things like 34 excess deaths or a doubling. There is
2 enormous uncertainty in that, and I think that if we
3 focus on the exact numbers here and think that they have
4 a degree of certainty, that would be spurious and it
5 would be a pity if people took that kind of message
6 away; it is a rather more general message.
7 DR SILOVE: Could I just come in for a moment there? It
8 is unfortunate, I think, that our guidelines, which is
9 what they were meant to be, of writing down grades of 1,
10 2, 3 and 4, for adequacy, it is unfortunate that our
11 guidelines were written down quite in the way that they
12 were, and perhaps became rules. I do not think any of
13 the teams regarded them as rules; I think they regarded
14 them as guidelines. When all the groups of experts met
15 before the study commenced, I think it was made clear
16 that we were setting out guidelines rather than rules.
17 None of us in this room, at least, none of these
18 experts, are criticising the team that did award a grade
19 1 overall when none of the aspects of care were grade
20 3. I am just commenting on it.
21 MR HAMILTON: Can I say, I do not have a problem with this
22 at all. I do not think the team broke any rules. You
23 are assuming that measurement of outcome is being
24 alive. When we scored each individual aspect of care,
25 that was looked at as a defined thing. When we sat back
0077
1 we looked at the overall management. It may have been
2 a surrogate measurement like length of stay, extent of
3 care, management of the patients and that all came into
4 the thing. The overall score was a summation of the
5 factors plus an overall feeling, so I do not have
6 a problem with it.
7 DR SILOVE: I think it would be boring to show you a table
8 of overall grade 4. There are 40 patients in that table
9 and 4 that are scattered very liberally throughout.
10 There is just the occasional 3 and I think there is just
11 one 2 in the whole table, so I will not show you that.
12 I do not think there is much more to be said about
13 patients whose care was considered to be adequate.
14 Unless you want to ask any further questions,
15 I think it would be interesting if we could move on to
16 the second review exercise and let Professor Evans
17 perhaps tell us about his analysis of that.
18 MR LANGSTAFF: I am going to be sorry to disappoint you on
19 that, Dr Silove, because what I would like to do is to
20 get a better feel, in evidence, for the various
21 responsibilities and the components of what we see here
22 on the screen as letters.
23 A is the timing and appropriateness of the initial
24 referral, or it may be the condition on arrival. If we
25 are looking at A, then, are we looking at something
0078
1 which is outwith the control of Bristol Royal Infirmary
2 or Bristol Children's Hospital?
3 DR SILOVE: Yes. That was not under the control of Bristol
4 Children's Hospital. It was really put in there so that
5 reviewers could comment on how well the patient was at
6 initial presentation, because that, in itself, might
7 have affected the whole management of the child. If
8 that had got a very low grading, I think one could
9 probably discount some of the measures that were made in
10 Bristol.
11 In fact, there were very few low gradings for that
12 particular aspect of care.
13 MR LANGSTAFF: If we look under A on the screen, if we look
14 down to 1/13a, A is described as 2, so at the start of
15 the first procedure, the child concerned may have been
16 late or the referral may have been inappropriate, the
17 condition on arrival may have been poor. Is that what
18 that is telling us?
19 DR SILOVE: That is correct, yes.
20 MR LANGSTAFF: That may then inform the need at stages B and
21 D and E to in essence get on with it, or to in some way
22 relieve or stabilise the condition of the child before
23 moving further; that is the point, is it?
24 DR SILOVE: Yes, that is correct. I think that it tells us
25 that the clinical assessment and management after
0079
1 presentation, if that had been better, it might have
2 counterbalanced the poor condition of the baby on
3 admission, and certainly, when we get to the timing of
4 planned treatment, which got a grading of 1, that
5 certainly, if it had been better, could have
6 counterbalanced any effect that a grading of 2 would
7 have had on presentation.
8 MR LANGSTAFF: So without going back to the clinical notes,
9 case 1/13a, it looks like a case of delayed treatment?
10 DR SILOVE: Yes.
11 MR LANGSTAFF: Not picked up either as an urgent case on
12 first assessment?
13 DR SILOVE: That is correct. I do not know what the details
14 of that case were, but let me just also point out that
15 that particular case had two procedures. 13a and 13b
16 and if you look along 13b, you will see there was an
17 overall grading of 1 for aspect D, which was again the
18 appropriateness of initial treatment strategy.
19 So for both of those procedures, there was
20 a grading of aspect of care of 1 in more than one place,
21 and that clearly deserved an overall grading of 1.
22 Let me just highlight what I said before, that in
23 this group of overall grade 1, it was the pre-operative
24 management and care that got the lowest grades in the
25 sample.
0080
1 MR LANGSTAFF: Can we move on and explore column B?
2 Column B is the clinical assessment and management.
3 Whose responsibility, essentially, is that?
4 DR SILOVE: That is the cardiologist.
5 MR LANGSTAFF: So we are looking here at the
6 appropriateness and the adequacy of the cardiologists'
7 first contacts with the child?
8 DR SILOVE: Yes. I mean, it might be the cardiological or
9 junior medical staff, but they should very quickly call
10 the consultant cardiologist if they have a sick baby
11 come in. I think the consultant must take
12 responsibility for that aspect of care, the clinical
13 assessment and management.
14 MR LANGSTAFF: Was anything else, other than the
15 cardiologists' role and the scope of their role looked
16 at under column B?
17 DR SILOVE: No. I am sorry, maybe I misunderstood; could
18 you repeat the question?
19 MR LANGSTAFF: Anybody else involved, other than the
20 cardiologists?
21 A. No.
22 Q. So B is focused on cardiologists only?
23 A. That is correct, yes.
24 Q. C, the accuracy and completeness of the diagnosis: whose
25 task is that?
0081
1 A. That is again the cardiologist. He is the one who will
2 do the investigations, which would be clinical
3 examination, ECG, x-ray, echocardiogram, maybe cardiac
4 catheterisation, in order to get an accurate and
5 complete diagnosis.
6 MR LANGSTAFF: So the accuracy might be -- would that be
7 a matter of interpretation of the echo or any other
8 diagnostic tool?
9 DR SILOVE: It would be both the performance of the
10 procedure and the interpretation.
11 MR LANGSTAFF: D: the appropriateness of the initial
12 treatment strategy: what does that cover?
13 DR SILOVE: The paediatric cardiologist will have assessed
14 the baby, made a diagnosis and instituted some initial
15 treatment, so it really is primarily the paediatric
16 cardiologist. He will also, or should, communicate at
17 that early stage with the cardiac surgeon, so that the
18 two of them together can discuss the initial treatment
19 strategy, and decide on whether the patient should or
20 should not go through for an operation later on.
21 I think in a way it blended in with the next
22 aspect, which is E which is the timing of the planned
23 treatment. I think those two aspects of care are
24 probably primarily the responsibility of the paediatric
25 cardiologist, but with a great deal of input from the
0082
1 cardiac surgeon as well.
2 MR LANGSTAFF: I see Mr Hamilton is nodding vigorously.
3 MR HAMILTON: I think in an ideal world you would bring in
4 research from C at the time of diagnosis. If the
5 cardiac surgeon does not think they have been given
6 enough information, they would have a responsibility to
7 point that out. It is sometimes not possible to get all
8 the information.
9 MR LANGSTAFF: At what stage would the surgeon be involved
10 in saying to the cardiologist, "I need more information
11 here", or "Is the diagnosis complete?"
12 MR HAMILTON: That would depend on the urgency of the case.
13 If it was a case that needed urgent treatment on the
14 weekend, it would simply be that cardiologist and that
15 surgeon. In the normal run of events, if it was not
16 that urgent, it would come up at the team meeting, where
17 hopefully we would have input from the other
18 cardiologists and other surgeons in the team.
19 THE CHAIRMAN: I wonder whether I could ask Mr Hamilton,
20 when you say "bring the cardiac surgeon in" what does
21 that in practice mean? Telephone? A joint visit with
22 the patient? A conversation somewhere? How does it
23 work?
24 MR HAMILTON: It would depend really on the case. It would
25 have been an initial contact. I do not think it
0083
1 actually matters how much it is. That would vary from
2 case to case, but I think the surgeon would begin to be
3 involved there. In most cases it would simply be the
4 paediatric cardiologist and then it would come up at the
5 weekly meeting and the case conference and be presented
6 by the cardiologist.
7 MR LANGSTAFF: Tell me more about the weekly meeting and the
8 extent to which that may affect the accuracy or
9 completeness of diagnosis, or indeed the initial
10 treatment strategy.
11 The usual practice is for there to be a weekly
12 meeting to review cases which are coming up for
13 treatment?
14 MR HAMILTON: Yes, I think that would be the practice in
15 most units, and the bigger the unit the more frequent
16 the meetings they would have to have because there would
17 be more patients coming through. I think all units
18 would have a case conference where, ideally, all members
19 of staff would be present, including the anaesthetist at
20 times, depending on the planning of the patient. The
21 cardiologist would present the evidence and come to
22 their conclusion; the other cardiologist in the team may
23 say "I disagree", or "You need something further". The
24 surgeon may say, "I am not quite clear about that
25 aspect. We need some further information".
0084
1 MR LANGSTAFF: Who would you expect, in the 1980s, to be
2 present at such a clinical conference?
3 MR HAMILTON: Thinking back again, like Dr Macrae, I was
4 a Senior Registrar in the mid-1980s. In an ideal world
5 you would have the whole team. We do not work in an
6 ideal world; people are on leave --
7 MR LANGSTAFF: Who is on the team?
8 MR HAMILTON: The cardiologist and the surgeon.
9 MR LANGSTAFF: Nobody else?
10 MR HAMILTON: It would depend on the case. If it was a sick
11 baby in intensive care, then the anaesthetist would be
12 involved. The junior staff would obviously be there as
13 well for educational purposes, and for their input, and
14 the nurses may well be there. But the core would be the
15 cardiologist and the surgeon.
16 DR SILOVE: In some centres, where cardiac catheterisations
17 were done the radiologists would probably be involved as
18 well, because the radiologists, certainly in Bristol,
19 were very heavily involved with all the cardiac
20 catheterisations and angiocardiograms.
21 MR LANGSTAFF: Dr Macrae?
22 MR MACRAE: I think my experience of working in two centres
23 during the relevant time was that, really, these
24 conferences were events which very much involved
25 cardiological and cardiac surgical input. There would
0085
1 occasionally be a call for more specific input from
2 anaesthesia or intensive care, where clearly a child was
3 already established in the Intensive Care Unit, but the
4 usual practice, I think, was for the vast majority of
5 these decisions to be made by the cardiologist and
6 surgeon.
7 MR LANGSTAFF: So going back to the question of the case
8 conference, how long before anticipated surgery, again
9 assuming a non-urgent "tomorrow morning" type of case,
10 would that be likely to be held?
11 MR HAMILTON: It would usually be at the time of diagnosis,
12 the initial presentation and diagnosis, so a plan would
13 evolve at that stage.
14 MR LANGSTAFF: So you would expect, then, diagnosis actually
15 to be not so much the cardiologist on his own but
16 a shared responsibility between cardiologist and cardiac
17 surgeon?
18 MR HAMILTON: I think that may be putting too much weight on
19 the surgical involvement. I was saying it was beginning
20 to bring the surgeon in at that point.
21 DR SILOVE: I think that every case is different and we have
22 to look right across the spectrum of the way patients
23 present to the cardiologist. I must say that where we
24 are talking about less than adequate care of initial
25 treatment strategy and the timing of planned treatment,
0086
1 this sounds to me like a more urgent case. I think that
2 the more routine cases, where a paediatrician has
3 referred a patient to a cardiologist from outside,
4 a three years old, say, with a heart murmur, this is not
5 urgent, or usually non-urgent, and there is much more
6 time available to do at all of these things. The
7 patient will wait then for admission, for
8 investigation. The conference can take place a week
9 after the investigation; it is not going to do any
10 damage to the patient. The patient might not need the
11 operation for several months after the investigation.
12 That is in contrast to the sick baby who comes in
13 and needs urgent early decisions. So the involvement of
14 the surgeon at the early stage will depend on the
15 presentation of the baby, or the child.
16 MR LANGSTAFF: "F: Immediate pre-operative management
17 including nursing."
18 What do we cover there?
19 DR SILOVE: Again, this depends on whether the child is
20 admitted as a routine admission for surgery or for the
21 waiting list, in which case the child will probably be
22 admitted under the surgeons directly. The surgical
23 house officer would see the child and the surgeon would
24 see the child and there would be nurses involved. It
25 would really be very unlikely that nursing care or
0087
1 pre-operative management would be less than adequate at
2 that stage.
3 On the other hand, where you have the other end of
4 the spectrum, where you have a very sick baby who needs
5 an urgent operation, there it is a combination of
6 a number of personnel: it is the cardiologist; it might
7 be the intensivist and the nursing staff; it might be
8 the surgeon as well. But primarily, in those urgent
9 circumstances, it would be the cardiologist, nursing
10 staff and possibly intensivist.
11 MS WILLIAMS: May I add something? I think there are some
12 key aspects of nursing management that were included
13 here, and those were routine pre-operative checks made
14 for all children, whether they present as a routine case
15 or an emergency case. In the case of the notes that
16 I reviewed, and I think are reflected in the scores, the
17 nursing aspects of the care in all cases were quite
18 good: there was good documentation of routine checks and
19 documentation of pre-operative management.
20 But there are standard checks, whether you are at
21 Bristol or any other hospital, which would be
22 undertaken.
23 MR LANGSTAFF: So, as far as this stage is concerned, your
24 impression is that this was something which was done
25 well by the nurses?
0088
1 MS WILLIAMS: Yes.
2 DR SILOVE: I think there was probably only one case in the
3 whole of the 80 patients where that aspect of care was
4 given a grading of less than 4. I think. I am sorry,
5 there were 3 cases.
6 MR LANGSTAFF: If we can go on to "G", this is surgical
7 procedure. That probably speaks for itself, but is that
8 the province solely of the surgeon?
9 MR HAMILTON: I think there have been various analogies and
10 pictures painted of an operation, but no, the surgeon is
11 obviously a key figure, but there are, I suspect, about
12 10 people involved in an open-heart operation, from the
13 anaesthetist with the anaesthetic nurse when the child
14 comes to the anaesthetic room --
15 MR LANGSTAFF: But we have the anaesthetist here as
16 letter "I", do we not?
17 MR HAMILTON: Yes.
18 MR LANGSTAFF: So if we are looking at what is comprised in
19 "G" here, are we looking just at the surgeon, or not?
20 MR HAMILTON: From the reviewing point of view, yes.
21 MR LANGSTAFF: How do we go about giving a less than
22 adequate rating to a surgical procedure? What sort of
23 things are you looking for?
24 MR HAMILTON: First of all, the only evidence you have to go
25 on is the operation note. I think all the teams
0089
1 commented very favourably on the quality of the
2 operation notes, both handwritten in the notes and
3 typed, so there was good evidence to make judgments on.
4 You would look at the technical details to see how
5 the operation was carried out; it is not just the actual
6 technique of where you cut or where you sew, there is
7 all the management of the case, from the heart-lung
8 machine to how you protect the heart. In open-heart
9 surgery, by definition you are using the heart-lung
10 machine. In most cases we would have to stop the heart
11 to work inside. To do that you have to cut off its
12 blood supply. During that time it is going to be
13 ischaemic, which means it is going to be temporarily
14 damaged. We try and mediate that damage by different
15 methods and traditionally we cool the heart.
16 There are several different ways of doing that,
17 there is no right or wrong answer, but you look for
18 adequate care of the heart during the operation as well
19 as the technical aspects of what you actually do.
20 Then there are the aspects of what is done and how
21 it is done, and then particularly how the patient is
22 managed coming towards the end of the operation and how
23 they are weaned from the heart-lung machine.
24 So there are a lot of different aspects to be
25 judged.
0090
1 MR LANGSTAFF: So what extent do you take into account the
2 time it might have taken to do a particular procedure?
3 MR HAMILTON: That is something that was raised by many
4 reviewers, and it was something I know we debated in our
5 own group.
6 One of the surrogate markers, if you like, of the
7 operation and how it has gone is what we call the
8 cross-clamp time. That is the period for which the
9 heart, if you like, is cut off from the circulation and
10 has its blood supply stopped. You put a clamp across
11 the aorta, the main body artery. The longer that is on,
12 the more potential damage the heart is building up, no
13 matter how you have protected it.
14 On the one hand, in transplantation we store the
15 heart in an ice solution for up to four hours, so you
16 could argue that length of time maybe does not make that
17 much difference, but I think there would be a feeling
18 that the longer the cross-clamp time, the more potential
19 problems you are storing up for the heart function after
20 the operation.
21 Whether you can actually put a hard and fast
22 figure on how long a cross-clamp time should be allowed
23 for any individual operation is difficult because every
24 child is different and every operation is different.
25 Even a straightforward closure of a VSD could take
0091
1 anything between 30 minutes and an hour, perhaps,
2 depending on how difficult it was to get access and what
3 size it was.
4 So although it would be taken as a surrogate
5 marker, if you like, of the technique of the operation
6 or even skill, it is not the whole question. The other
7 aspect is that there are certain parts of the operation
8 you can only do with the aorta cross-clamped, there are
9 parts of the operation which are easier to do if the
10 aorta is cross-clamped, and there are some parts of the
11 operation you do not have to have the aorta
12 cross-clamped at all.
13 Surgeons will vary in how much of those different
14 phases of the operation they do with the cross-clamp
15 on. For instance, in the switch procedure you have to
16 have the cross-clamp on while you are swapping over the
17 main arteries and while you are transferring the
18 coronary arteries, the heart arteries, to the new
19 aorta. There is no way round that. But then you have
20 to reconstruct the other artery, the lung artery, and
21 that can take a while. That is easier to do if there is
22 no blood in the operative field, but it is not
23 absolutely necessary to do it with the cross-clamp on.
24 So you have to interpret the cross-clamp time with
25 what is actually being done during that period, and
0092
1 I think there are no hard and fast rules. There were
2 lots of comments in the records that perhaps this was
3 a rather long cross-clamp time.
4 MR MACRAE: Could I make a comment on that? I agree, you
5 cannot just take a cross-clamp time as a statistic,
6 meaning short is good and long is bad, because I think
7 a lot depends on what a surgeon is doing during the
8 cross-clamped period. For instance, a slow surgeon may
9 well be handling the heart far more gently and being far
10 more effective in doing a procedure than perhaps a fast
11 surgeon who gets in there, puts in lots of stitches and
12 gets out quickly: the heart may have been stretched and
13 pulled and damaged in other ways.
14 So I think it is not possible to say that a slow
15 surgeon is necessarily a bad surgeon; however, a surgeon
16 who does some work and then stops for two or three
17 minutes, thinking about what to do next, is wasting time
18 and is not being efficient.
19 So from the other side of what we sometimes called
20 the blood/brain barrier, the other side of the
21 anaesthetic screen, I like to see a surgeon who does not
22 stop and waste time, but I am not too worried about
23 someone who just works slowly and methodically.
24 MR HAMILTON: That is an excellent summary.
25 THE CHAIRMAN: How relevant could the interaction be between
0093
1 what you have just described and any difficulties or
2 inadequacies there might have been, or less than
3 adequate diagnosis, before the surgeon starts his or her
4 job?
5 MR HAMILTON: Certainly if you go into a case and you have
6 opened the heart and it is not as you expect, that
7 certainly sets you back. You have to then start from
8 first principles and go back through and try and work
9 out what is happening.
10 MR LANGSTAFF: So you may in fact have, for reasons which
11 are not of your making, the pause to stop and think that
12 Dr Macrae has been talking about?
13 MR HAMILTON: Yes. The other thing that we noticed in one
14 or two notes certainly that we reviewed was that the
15 cross-clamp time would be written down as a figure and
16 seem quite long, but when you actually explored the
17 operation note, it was two periods of cross-clamping.
18 Perhaps there had been some concern at the end of the
19 operation that things were not quite right and the
20 surgeon had gone back, after the heart had already been
21 what we call reperfused and had a second period, but in
22 the summary of the operation, that would be down as one
23 time.
24 So there was some confusion, I think, in the way
25 it was recorded. It was not always one long period of
0094
1 cross-clamping.
2 MR LANGSTAFF: So to look on any such case as being
3 a measure of less than adequate surgery to the
4 disadvantage of the surgeon would be potentially
5 misleading?
6 MR HAMILTON: Yes. If I could sound like a statistician for
7 a moment, you could use it as a marker but it has to be
8 interpreted with caution and a degree of uncertainty.
9 MR LANGSTAFF: I think you picked up the phraseology!
10 Moving away from surgical procedure, perfusion and
11 anaesthesia: what are we looking for here?
12 MR MACRAE: It suggests here that perfusion is mainly an
13 anaesthetic responsibility. I think it is a shared
14 responsibility between the perfusion technician, who is
15 usually a scientist who has been trained to look after
16 the circuitry and to understand the physiology of the
17 heart-lung machine; but also it is a shared
18 responsibility between that technician, the surgeon who
19 is doing the plumbing side of things, putting the pipes
20 in the appropriate blood vessels, and the anaesthetist
21 who has overall responsibility for the physiology of the
22 rest of the body whilst the heart is being looked at and
23 operated on by the surgeons.
24 So all three team members have a role to play in
25 the overall conduct of perfusion.
0095
1 I think the most important thing about perfusion
2 is that there is a proper structure and protocol in
3 place, which all of those three elements will bind to.
4 You asked me specifically about the role of the
5 anaesthetist, and I think that that, in particular, is
6 to help the perfusionist to interpret the blood gas
7 levels, particularly the levels of oxygen and so on, in
8 the blood during the bypass and the level of acid that
9 builds up, and help him to manage that; to help the
10 perfusionist to control blood pressure so it is not too
11 low and not too high, because we know that in both of
12 those situations that if there is a lot of blood coming
13 back because the perfusion is not good, the surgeon may
14 not be able to do the operation as quickly and as
15 efficiently as possible. So there is that aspect of
16 making the surgeon's job easier and also protecting the
17 patient.
18 So it is very much a team effort. If the surgeon
19 has not put the pipes in or has put in a tube that is
20 too small, the bypass may not be adequate. The
21 perfusionist will say, "I cannot get enough flow". The
22 anaesthetist will say that the oxygen levels are low or
23 the acid levels are high.
24 So all three must interact. It is not possible,
25 for that category, to say really perfusion equals
0096
1 perfusionist; perfusion equals all three of those
2 elements.
3 THE CHAIRMAN: Mrs Maclean has a question.
4 MRS MACLEAN: I just note on the tables there seems to be
5 a larger number of absent records for the
6 perfusionists. Do you have any comment on that?
7 MR HAMILTON: I presume most of those -- having checked most
8 of those, those are closed-heart operations where there
9 is no perfusion. We did notice one or two where there
10 were closed operations where they had given a score for
11 perfusion! I think that was inadvertent.
12 May I just mention -- it struck me when Duncan was
13 speaking -- one of the changes in the management of
14 perfusion since the mid-1980s through to now has been --
15 Duncan will probably explain better -- just how we
16 managed the pH, as we call it, the acid levels in the
17 blood on bypass, which has a bearing on, if you like,
18 cerebral damage. This is one of the things we touched
19 on earlier.
20 When we operate, we almost always cool the child,
21 because that protects the heart, helps in protecting the
22 heart, and also helps in protecting the brain and the
23 other organs, because on the heart-lung machine, it is
24 a steady state flow, it is not pulsatile, which is what
25 our body is used to, so it is not perfect.
0097
1 I think I would be right in saying, Duncan, back
2 the 1980s, I think it would have been more a pH-stat
3 management and now it is alpha-stat?
4 MR MACRAE: I think this is probably a difficult area to get
5 into because there is still, as we speak, a level of
6 uncertainty and still debate, certainly in the cardiac
7 anaesthetic journals, about whether pH-stat or
8 alpha-stat, the opposite school of thought, is the best
9 strategy. Certainly the latter, alpha-stat, is the one
10 that I think most people follow, that I am aware of,
11 now.
12 MR HAMILTON: But that would have been a change from pH-stat
13 in the 1980s?
14 MR MACRAE: I think so.
15 MR LANGSTAFF: Can you, in terms that the layman might
16 possibly understand, explain the difference between
17 alpha-stat and pH-stat?
18 MR HAMILTON: If I can try a surgical explanation first of
19 all, and Duncan can correct me, when you cool the body
20 the pH rises, so the response to that was to add carbon
21 dioxide as an acid to try and counteract that. Now we
22 think that is maybe not such a good idea. In the past
23 they would have added carbon dioxide to the circuit to
24 bring the pH down to normal, to make it more acid.
25 Yes?
0098
1 MR MACRAE: I think that is good enough for me!
2 MR LANGSTAFF: We have been through the letters which take
3 us up to the end of the operation. We are going to look
4 next at the post-operative categories. Can we look at
5 that post-lunch?
6 THE CHAIRMAN: Yes. Shall we break now for 45 minutes and
7 reconvene, therefore, at a quarter to 2?
8 (1.05 pm)
9 (Adjourned until 1.45 pm)
10 (1.45 pm)
11 MR LANGSTAFF: We may have left the operation a shade too
12 early. Professor Evans, you have, I think, a question to
13 ask?
14 PROFESSOR EVANS: I think that one of the really key things
15 when we look at different elements in the aspects of
16 care is that each one of them can be graded 1, 2, 3 or
17 4, and the really important thing is that for each of
18 the aspects, whether it involves the perfusionists or
19 the nurses or the surgeons or the cardiologists, there
20 must be essentially an equal opportunity of having a 1
21 or a 2 or a 3 as the aspect of care. If, for example,
22 surgical care was not able to be assessed without
23 a video of the operation itself, then it would tend to
24 score towards 4. It would not have the opportunity of
25 having a 1 or a 2. Essentially I would like to have
0099
1 reassurance from Mr Hamilton that the assessment of
2 surgery was able to record a 1 or a 2 on the basis of
3 the information they had.
4 MR LANGSTAFF: It is a good question, is it not? Many
5 people may ask: if you are not actually watching
6 the surgery, you cannot see where the stitches go, you
7 cannot see the exact anatomy, how on earth do you form
8 a judgment?
9 MR HAMILTON: A very good question. I mentioned earlier how
10 we looked through the operation notes in detail.
11 The other markers that we would use as to whether or not
12 the operation has been satisfactorily performed would
13 be, first of all, whether the heart works at the end of
14 the operation.
15 You do on occasions find that the heart will not
16 take over the circulation at the end of the procedure
17 and the child dies on the operating table. That is
18 obviously fairly clear that there has been something
19 intra-operative, and usually the operation. Although
20 even then it is not possible maybe to pin point it, but
21 the operation would be scored there.
22 Other markers would be post-operatively to get an
23 echo assessment. First of all if the circulation is
24 working okay, then you would have that as a marker.
25 Particularly in more recent years we would always get a
0100
1 cardiac echo in the intensive care as early after
2 the operation as possible to see whether the structural
3 part of the operation has been okay. I think you can
4 use those measures as to whether the operation has been
5 technically performed.
6 If you have an echo showing that the cardiac
7 anatomy is now back to normal, then that is a good
8 marker that the technical side of the operation has been
9 satisfactory. We had a case that we reviewed where,
10 after a switch procedure, the heart was working well,
11 the coronary arteries were in the right place, but
12 the child died of infection two weeks post-operatively
13 in intensive care. There the operation would have been
14 scored as adequate. So there are other markers apart
15 from just the operation note.
16 DR SILOVE: On the question of doing echocardiography during
17 or immediately after the operation in theatre, that is
18 something that was not widely practised until I would
19 have thought around about 1992/1993.
20 MR HAMILTON: I was not suggesting that it be done in
21 theatre, although that now would be an ideal standard to
22 aim for. It is possible to do echos in the operating
23 theatre. I am talking about in the intensive care unit.
24 MR LANGSTAFF: Do we know that that facility was available
25 in the BRI as opposed to the BCH?
0101
1 MR HAMILTON: Certainly there were some cases where it was
2 noted in the notes, although I think that was
3 a potential criticism.
4 DR SILOVE: I remember seeing in the notes, although it
5 might have been before the 1990s, I think it was
6 somewhere in the 1980s, where the radiologist had done
7 an echocardiogram in the intensive care unit.
8 MR LANGSTAFF: At the BRI?
9 DR SILOVE: At the BRI. The case which we as a panel
10 reviewed threw a lot of doubt on the validity of his
11 actual interpretation of the echo, even though we did
12 not have the echo to look at. He obviously did not know
13 what happens to babies post-operatively in the intensive
14 care unit. What he reported was out of context.
15 MR LANGSTAFF: But, coming back to the question which
16 Professor Evans was posing, in essence it is a "yes" or
17 a "no" answer: do you think you had enough information
18 from the various different aspects you have mentioned to
19 be able to grade surgery 1, 2, 3 or 4 with equal
20 facility to choose between 1 and 4?
21 MR HAMILTON: Yes.
22 MR LANGSTAFF: Can we move on to post-operative care and
23 assessment. The first of these, I, is ITU medical;
24 the second, K, is post-operative care and assessment,
25 surgical; and then L is post-operative care and
0102
1 assessment, paediatric cardiological. So the only
2 distinction between J, K and L is the identity of
3 the specialist delivering the care, is it, or is it in
4 the nature of the care which you would expect each of
5 these three different disciplines to provide?
6 DR MACRAE: It is somewhat confusing, but I will try and put
7 it in some context. I think the intention was to
8 describe medical care as being the care delivered by
9 the anaesthetist or, if there had been such a person,
10 the intensivist, a non-surgeon, non-cardiologist. That
11 would relate mainly to aspects of, really, I suppose,
12 ventilation and technical procedures such as vascular
13 access, putting in drips and lines and tubes, that sort
14 of thing.
15 Surgical care however, and things that would be
16 clearly identified -- those things would mainly be down
17 to anaesthetist to do, wearing their medical
18 post-operative care hat. The things that were clearly
19 surgical would be perhaps putting in a chest drain to
20 drain blood or fluid from around a lung or reopening
21 a patient who was bleeding on the intensive care unit.
22 Clearly that would be 90 per cent or more a surgical
23 responsibility.
24 Something like performing a cardiological
25 reassessment in a patient not doing well, perhaps an
0103
1 echocardiogram, that would be within the province of
2 the paediatric cardiologist.
3 But overall it is very difficult to tease out
4 specific elements of post-operative care and say, "That
5 was a surgical problem. The surgeon should have written
6 that or the anaesthetist should have written that or
7 noticed that," because so much of intensive care is
8 a team discipline. To an extent, it does not really
9 matter who does it as long as someone knows it is their
10 job to do it.
11 MR LANGSTAFF: Two questions: under J, K and L, since they
12 are all post-operative care and assessment divided by
13 specialty, where do we find the equipment failure;
14 the ventilator which does not work and so they have to
15 then find another one and you have lost 20 minutes which
16 may be critical? Secondly, and it is allied perhaps,
17 where do we find the nursing input?
18 DR MACRAE: I think the equipment failure probably would
19 come into intensive care medical. That is the most
20 general of those three categories. But I think the most
21 important thing is perhaps in a sense all of those three
22 categories could be combined into just one category that
23 says intensive care. The important information would
24 actually come out of the comments that go along with any
25 comment on inadequacy or less than adequate care.
0104
1 MS WILLIAMS: I think aspects of nursing care come into all
2 three categories, particularly the surgical and
3 the medical categories. I think the nurse is actually
4 very important in the intensive care because they are
5 the person by the bed of the patient 24 hours a day,
6 they are the person who is making the observations,
7 often with doctors who have more than one patient they
8 are responsible for. So it is the nurse's role to point
9 out things that are changing, express concerns to the
10 medical staff. So nursing covers all three aspects, but
11 particularly the first two.
12 MR LANGSTAFF: In terms of assessing the adequacy or
13 inadequacy so far as nursing care was concerned, were
14 you able to allocate 4, 3, 2, 1 with equal facility?
15 MS WILLIAMS: Yes, because the nursing care plans and
16 evaluation sheets were present for all patient notes.
17 So for the majority of the patients there were very full
18 nursing notes. The one thing, as I said earlier, that
19 would have been useful is having the intensive care
20 charts to go alongside that because nurses were making
21 reference to observations that were on the charts, but
22 you could not see what was happening before or after
23 that. It was perhaps the one measure of blood pressure
24 or one measure of heart rate. It was not clear from
25 the notes what the changes were sometimes.
0105
1 But I think overall it was fairly easy to assess
2 the sort of adequacy of nursing care.
3 MR LANGSTAFF: Do you want to come on this, Mr Hamilton, as
4 to the extent to which you would comment upon
5 the desirability of having a separate category for
6 post-op care and assessment surgical?
7 MR HAMILTON: As Duncan said, there are specific things
8 the surgeon would be responsible for and, in a sense,
9 major management issues like does the patient need to go
10 back to theatre. There was one case that I think we
11 reviewed where we felt the child perhaps should have
12 returned to theatre and that different management might
13 have made a difference. That would have been
14 the surgeon's decision as to whether the child should
15 have gone back to theatre.
16 The nurse, as we have said, is the key person at
17 the bedside. The next link in the chain, if you like,
18 of command or care would be the resident junior medical
19 staff. We say "junior", but it is usually someone
20 fairly senior. That person would vary from unit to
21 unit, and maybe the paediatric cardiologist, a junior
22 surgeon or an anaesthetist, and it would vary from unit
23 to unit, would also be a key link. To a certain extent
24 they would then be responsible for the next part in
25 the chain of command.
0106
1 MR LANGSTAFF: Stopping at this stage, the end of
2 the post-operative care and assessment, we will deal
3 with those portions in a moment, we have 12 aspects of
4 care thus far. Are they evenly weighted? Is there
5 a danger by dividing up pre-operative and post-operative
6 care in to rather more numerous categories that one may
7 have an over-reflection of, for instance,
8 the cardiologist's role or an under-reflection of
9 the surgeon's role throughout the process of care and
10 its adequacy or the converse?
11 MR HAMILTON: From my experience in the team, it was more
12 a feeling of whether you felt the whole pre-operative
13 care was adequate, or whether he felt the intraoperative
14 care was adequate, or whether post-operative care. If
15 you did not, it was a case of allocating the grade to
16 the most appropriate box. So I think the teams probably
17 did look on it as a sort of period of care and then try
18 and subdivide it down as we set out in the sheets.
19 Whether that is an artificial subdivision or not,
20 certainly in reviewing and bringing the report together,
21 we felt the post-operative period, as Duncan has said,
22 would have perhaps been better grouped as just
23 post-operative care, and used the comment section for
24 then making any particular points.
25 MR LANGSTAFF: Professor Evans, do you want to comment upon
0107
1 the extent to which subdivision into these groupings may
2 distort the obviousness of the findings that can be
3 drawn from them?
4 PROFESSOR EVANS: No. I think again I would want to go back
5 to what I said in relation to the grades; that is that
6 in looking at these things, the fact that we have
7 subdivided the care and we have divided the grading for
8 the level of adequacy of care into four numbers, all of
9 these things are subjective. I think if we try and
10 apply too great a precision to the numbers, if we
11 attempted to add up numbers across the different
12 aspects, then we will mislead ourselves.
13 If on the other hand we take away a general
14 impression from those numbers, I do not think we will be
15 misled. I think I have a general impression. I think
16 that there are also some areas where we can attach
17 a little more to the numbers, and we may want to come
18 back to that in re-visiting the overall adequacy of
19 care.
20 MR LANGSTAFF: Can I come back to that in a moment,
21 immediately after we have heard from Dr Gould on
22 the post-mortem issues, which is the one aspect that we
23 have not yet explored in some detail. What is involved
24 here and why do we record it as an aspect of care rather
25 than a record made after care?
0108
1 DR GOULD: I think in a way one has to ask the question:
2 what is the function of post-mortem? Obviously in one
3 sense it is to provide the cause of death and give
4 feedback to the clinicians. I think one also has to
5 regard it as a process. It is not just the examination
6 that takes place in the post-mortem room. But it is
7 a process which carries on afterwards. It will be very
8 difficult, if not impossible, for the pathologist to
9 give all the answers on his or her post-mortem report,
10 certainly without very lengthy discussions usually with
11 some of the clinicians either before or after the
12 post-mortem -- preferably before and after
13 the post-mortem itself.
14 It is a process where, particularly with cardiac
15 surgery, it is such a complex process that to actually
16 get all the answers it is going to be a two-way process
17 of discussion of what the pathological features are.
18 The clinicians will have to be asking you specific
19 questions very often so that you can try to answer them
20 from the post-mortem findings.
21 Part of the problem of assessing it from the data,
22 obviously a lot of the post-mortems were described as
23 inadequate and some were given grades 4 or grades 1
24 which I do not really know quite -- it obviously is
25 a criticism. They are obviously considered particularly
0109
1 inadequate.
2 The problem I have a little bit with that is that
3 for many review panels they would not have used the same
4 scoring. So it is actually difficult to know what
5 proportion of the post-mortems were considered
6 inadequate. From one or two of the comments clearly
7 some of the reports were too brief. There either was no
8 histology or the histology was inadequate, or in some of
9 them the post-mortem work just was not detailed enough
10 to answer the questions that the clinicians asked at
11 the review panel, for instance. They said,"Well, this
12 is not enough."
13 It is impossible to assess the extent to which
14 post-mortem discussions occurred after the post-mortem
15 examination between the pathologist and the clinician,
16 because that could have occurred and on occasions --
17 that feedback may have occurred without that being
18 recorded very well. So it may not always be on
19 the post-mortem report.
20 In the long-term it is important because if there
21 are inadequacies, particularly of things like surgical
22 techniques or misdiagnoses, very often it is at that
23 point that the post-mortem can be useful. That can be
24 fed back to the clinical team and they will be able to
25 either re-evaluate for that case or take note for
0110
1 the next case, for another case, a similar type of
2 case.
3 It is a sort of audit procedure so that it is
4 a continual education and feedback of information to
5 the clinicians so they can improve their side of things
6 for subsequent cases.
7 MR LANGSTAFF: Thank you.
8 MR HAMILTON: May I make two comments just on post-mortem
9 from the surgeon's point of view. We were struck by
10 the commendably, as we thought, high post-mortem rates
11 when a death had occurred. I think that is something
12 that is debated a lot, and many units would not have had
13 post-mortems in so many cases. I do not know if you
14 want to comment on that.
15 The other thing is from the surgeon's point of
16 view it is surprising how rare it is for a post-mortem
17 to actually turn up something obvious. If you like,
18 that is the ultimate marker. You were asking about
19 markers of the operation. It is disappointing how rare
20 it is that something does turn up that you can learn
21 from.
22 DR GOULD: I think as far as post-mortem rate, I do not know
23 our own figures specifically for this, but you are
24 right, it was a very high autopsy rate. They appeared
25 to have a relatively high autopsy rate.
0111
1 Again, in a way it is almost reassuring what you
2 say, because we always have this problem that a child
3 will sometimes die either intraoperatively or shortly
4 afterwards. One does a post-mortem and clearly there
5 are abnormalities there. At some stage one can say,
6 "This must be related to congenital heart disease,
7 ultimately." But why that child died at that particular
8 point, it is often very difficult for us as pathologists
9 to say, or indeed if one is discussing it with the
10 clinicians and going over the case with the clinicians,
11 it is very difficult sometimes to find out precisely
12 anatomically why that child died.
13 MR HAMILTON: If a patch has been put in the wrong place, or
14 something has been cut, or a stitch is in the wrong
15 place, that is obvious.
16 DR GOULD: They are rare.
17 MR HAMILTON: They are very rare.
18 DR SILOVE: I just wanted to add on this question of
19 post-mortems. Dr Gould has already said that
20 the pathologist needs to know what the clinician is
21 looking for. It was our impression, looking at
22 the cases that our group reviewed, and also reading some
23 of the comments of other reviewers when we wrote
24 the report, that there seemed to be very little evidence
25 of communication between the pathologists and
0112
1 the clinicians. That struck us as being a weak point.
2 We felt that the pathologists did not know what they
3 were supposed to be looking for and we are not really
4 sure that the clinicians had the opportunity of learning
5 from the post-mortems.
6 We do not have any evidence about that. It was
7 something that was implied or inferred from the lack of
8 information.
9 MR LANGSTAFF: Something which I think we may need to pick
10 up later, but just from that last comment: to what
11 extent was it the impression gained by the teams that
12 there was either a heartening degree of teamwork within
13 this department or the opposite?
14 DR SILOVE: Did you say you want to ask that later or --
15 MR LANGSTAFF: I want to explore it later. But if you just
16 tell me briefly now what --
17 DR SILOVE: I think that we have the appearance of poor
18 teamwork. There does not seem to have been enough
19 communication between cardiologists and surgeons,
20 pre-operatively. There does not seem to have been
21 enough immediate discussion, although it might have
22 taken place and we do not know what was said. All we
23 can go by are the medical records. So it might not have
24 been written down.
25 It seems most unlikely that a cardiologist ever
0113
1 went into the operating theatre at BRI to see a problem
2 that the surgeon had encountered. We certainly did not
3 read any evidence of that in the operating notes.
4 There was very little reference to
5 the cardiologists being apparent on the intensive care
6 unit post-operatively.
7 Clearly there was a big logistic problem in
8 the cardiologists getting to the --
9 MR LANGSTAFF: Can we go into this in greater detail later,
10 given the flyer that you have given us by that comment.
11 Can I turn now, Professor Evans --
12 PROFESSOR EVANS: Can I just raise one other point, and that
13 is a point that Ms Maclean raised about the perfusionist
14 records. I think Mr Hamilton may have inadvertently
15 misled you in suggesting that all the Xs, there were
16 four Xs, were for closed operations. That was not so.
17 They were in fact all four open operations.
18 I think that Dr Macrae may wish to comment on
19 the fact that the perfusionist records were not kept
20 within the clinical case notes. So the case notes that
21 we had available at the time of the sampling did not
22 have the perfusionist records. So there had to be
23 a hurried exercise to retrieve those records for
24 perfusion to be assessed. That was a logistical
25 problems. So those Xs I believe are likely to relate to
0114
1 the logistical problem of retrieving those records from
2 a long time ago.
3 DR MACRAE: Yes. Just two brief comments on the perfusion
4 records. One is that is absolutely correct, they appear
5 to have been kept in a separate store, a separate filing
6 system, and there were one or two bypass cases were the
7 perfusion record was not available to the review panel.
8 Having said that, the records that our panel
9 reviewed were actually of a high standard and in
10 particular I would comment on what I consider to be
11 the unusual practice for that era of having a continuous
12 record of blood pressure. The actual chart was filed.
13 That is not a standard of care even now. It tends to be
14 interval measurement every five minutes or something
15 like that it is written down. I think that point is
16 worth making.
17 Can I make an additional point perhaps to correct
18 a misperception that may have come out of Carol
19 Williams' comments on intensive care charts. Most of
20 the intensive care charts were available for the panels
21 that I took part in. So there may have been
22 a difference or perhaps a logistical problem in getting
23 intensive care charts to Ms Williams' Panel. We had not
24 a complete set of charts but a reasonably complete set.
25 MR LANGSTAFF: Thank you. Professor Evans, at this stage
0115
1 I would like to take an overview of what the review thus
2 far -- we will deal with the 15 review cases in
3 a moment -- shows us, not about the 80 cases but about
4 the whole population from which it is drawn, using
5 "population" in the sense of 1,829 cases of which this
6 study is reflective.
7 PROFESSOR EVANS: Yes. I think it is very important that
8 people realise that, when we have looked at adequacy of
9 care in these 80, we have done so in a way that is
10 weighted towards the dead cases, weighted towards
11 younger ones and weighted towards those that were at
12 higher risk of open operations.
13 This may be seen by some as suggesting that we had
14 some preconceived ideas about where problems lie. This
15 is certainly not true. The Inquiry was set up with
16 concerns in various areas. But it was not preconceived
17 that those areas would have less than adequate care. It
18 was very important that that is seen.
19 MR LANGSTAFF: You said earlier I think this morning, and it
20 is a comment which was picked up on, that the Inquiry
21 was interested in deaths and was interested in
22 the younger children. Can you explain what you meant to
23 convey by that?
24 PROFESSOR EVANS: What I mean is that, had we taken a simple
25 random sample from all 1,800 or so children, we would
0116
1 have had a very, very small number of deaths and a small
2 number of those who were younger children. Yet
3 the major reasons why the Inquiry was instituted centred
4 around concerns in those areas.
5 To me it is important that the Inquiry does not
6 have a preconceived idea that care was less than
7 adequate in those areas. But had it failed to look at
8 those, because they only form a small proportion of
9 the total, and if we only had one or two cases in those
10 areas and concluded that care was adequate for them,
11 then we would have been under criticism in the Inquiry
12 as a whole.
13 I wonder if we could look at INQ 21-1 at this
14 stage. I think that will probably help us set the whole
15 of this in context.
16 If we were to go to the original report, we would
17 see a table that is actually just for reference purposes
18 in INQ 16-6, figure 2. But it is the same as the top
19 part of that which you see on the screen now, INQ 21-1.
20 What this shows us is that in the sample of 80, 13 had
21 a grading of adequacy of 1, and 11 had a grading of
22 adequacy of 2. The total of that is 30 per cent.
23 So if you went home, as you might say, with
24 the take-home message that 30 per cent of the children
25 in Bristol had inadequate care, that would be a grave
0117
1 error.
2 If you now look at the second table there, what we
3 have done is we have reweighted the sample. This is why
4 it is very important to have taken a statistical
5 approach to this so that we can now go -- the 1,829 are
6 not, and I am really in some senses pleased it is 1,829,
7 the number there, because our original sample was
8 actually 1,827. We have not actually got 1,829. But we
9 are saying, had we sampled the 1,827, our answers would
10 have had this pattern.
11 So rather than having 30 per cent in grades 1
12 and 2, we have 9.3 per cent. We have 5.5 per cent 1,
13 and 3.8 per cent 2. So now when we look at the whole
14 pattern of care, because we had differentially sampled
15 the high risk and those who had sadly died, we need to
16 step back and say, "In the whole pattern of Bristol
17 care, our estimate from that which this clinical review
18 exercise was done suggests that 9.3 per cent had scores
19 of 1 or 2, and importantly 72 per cent, rather than 50
20 per cent, had a grade of 4 for adequacy."
21 So we need to bear that in mind. We could have
22 done all of these tables in exactly the same way. In
23 order to get a fair picture for the whole, it may be
24 reasonable to do that. But to do that for all
25 the clinicians involved, with all respect to them, if
0118
1 they got numbers of 1,829 and they knew they reviewed 80
2 cases, life would be very confusing. But I think that
3 it may be important to the Inquiry to have a later
4 report on this on the record -- obviously it is your
5 decision -- but we need to look at some of these other
6 more detailed things using this reweighting of
7 the sample.
8 MR LANGSTAFF: I think it is likely to commend itself --
9 the Panel will need to take a little while to consider
10 it -- I expect to the Panel that such a study should be
11 done, so that the right messages can be gained from this
12 material; again, so that the material is transparent.
13 The percentage then of less than adequate care
14 which might possibly have made a difference, and I use
15 the words "might possibly" because of the 2/3 position,
16 is no greater than 10.4 per cent taken overall so far as
17 this sample is concerned generalised to the whole.
18 Are confidence intervals appropriate for this sort
19 of study, given what you said about its subjective
20 nature?
21 PROFESSOR EVANS: Yes, I think in this sort of table it
22 would be reasonable to calculate confidence intervals.
23 As it happens, that is fairly complicated. But again
24 I think that is the sort of thing that should probably
25 appear in a subsequent report. But it is possible to
0119
1 calculate that.
2 I would be reluctant to do that in all the details
3 of all the tables, but it may be helpful for people to
4 see that. Our confidence intervals for that 10.4
5 per cent should not be based on 190, as you might say,
6 which is the sum of the numbers in the table there,
7 the 101, 69 and 20. It should not be based on 190; it
8 is actually based on examining 28, the 13, 11 and 4. So
9 there is a fairly complex calculation to do that, but we
10 do have the ability to do that. I have not done that
11 and I cannot give it to you instantly, but I think it is
12 reasonable to do.
13 MR LANGSTAFF: Does the point need to be made that the 101
14 cases in total where by generalising these results it
15 might be said, it is said, that the care was less than
16 adequate and it would probably have made a difference,
17 that that is simply a statistical figure and does not
18 represent 101 actual cases in respect of which any
19 parent could say, "That is my child" or "That is not my
20 child"?
21 PROFESSOR EVANS: Yes, I think that is so. I think it is
22 very important to realise that, without going back and
23 examining all 1,800 cases, we would not be able to do
24 that. But, even if we were able to, we have to
25 acknowledge the potential error in that grading of 1.
0120
1 We must not attach to it a numerical value that is more
2 certain than the process by which we arrived at it.
3 I think that we need to use this sort of thing to look
4 at the picture in the round rather than being specific.
5 So certainly that 101 is in some senses a hypothetical
6 number.
7 If we go back again, let us remember that in
8 the 1,800 or so we have about 13 per cent of deaths. In
9 our sample by design we have 50 per cent of deaths. So
10 we need to take account of that sort of imbalance. That
11 is why we have now got only 5.5 per cent there rather
12 than the 16 per cent.
13 I think that that 9.3 or the 10.4 per cent should
14 not be quoted with that kind of precision. I do not
15 like percentages saying 9.3, really; it gives it
16 a spurious precision. It is of that sort of order
17 rather than of the sort of order of magnitude of 30
18 per cent from the sample. But that is a message that is
19 a reasonable one.
20 MR LANGSTAFF: I appreciate you have not done the figures,
21 but can you give us from your appreciation of
22 the balance between pre-operative surgical -- or
23 intra-operative I should say and post-operative results,
24 roughly what sort of percentage you would expect to be
25 in each of the groups?
0121
1 PROFESSOR EVANS: I would find that difficult to do with any
2 kind of numerical attachment without being able to go
3 back to my computer, which I am afraid I failed to do in
4 this regard.
5 What is clear, and I am sure you are going to want
6 to re-visit that, is that I would reiterate what
7 Dr Silove said in my looking at this; it is clearly not
8 concentrated in surgery, the balance of the 1s and 2s is
9 across the board and it is very clear that problems that
10 occur in the early part of that can cause problems
11 later. So the pre-operative problems are ones that have
12 considerable consequences for the rest of the care for
13 the child.
14 MR LANGSTAFF: Thank you, Professor. Having reviewed with
15 the help of those tables what picture of the whole this
16 study may give us, can I go back to you, Dr Silove. You
17 are going to let us know how reliable the study may well
18 be, given the findings of the 15 review cases?
19 DR SILOVE: Yes. I think here again Professor Evans would
20 be in a better position to judge this than I would. We
21 want INQ 16-24, please. I could give you our
22 interpretation, which is written in the report, or
23 perhaps should I do that before Professor Evans -- he is
24 nodding -- talks.
25 Of the 15 cases selected for repeat review --
0122
1 I wonder if we can just push this up so that the table
2 is showing. Thank you.
3 MR LANGSTAFF: Can we perhaps highlight the table as you
4 talk?
5 PROFESSOR EVANS: The second two columns are what are
6 required to be highlighted. Can you magnify just
7 the second two columns, I think?
8 MR LANGSTAFF: If you go ahead and talk as it is done.
9 DR SILOVE: Firstly, 8 children were alive and the other
10 7 died. So it was a sort of equally balanced
11 selection. We did not choose which -- this was thrown
12 at us and we just took the cases that we were given to
13 do a second review.
14 MR LANGSTAFF: And you did not know that they were second
15 review cases?
16 DR SILOVE: We did not know they were second reviews.
17 Everybody knew in advance that some of the cases would
18 be reviewed twice, but we did not know which cases would
19 be second reviews and no team knew that they were going
20 to be doing second reviews. Some of us might have
21 guessed it with some of the cases, but we did not know.
22 In 9 of the 15 cases there was complete agreement
23 on overall scores between the teams. Actually perhaps
24 Mr Hamilton should talk about this. Do you want to talk
25 to this? I can read it or you could read it. But there
0123
1 was complete agreement on overall scores in 9 of
2 the cases.
3 MR HAMILTON: It just struck me there while you were
4 speaking that one of the impacts possibly of knowing
5 there was going to be a second review is to make
6 the teams perhaps a little more critical than they might
7 otherwise have been. We were conscious that every set
8 we did would be reviewed possibly by somebody else.
9 I do not know if that was a factor, but it was an
10 interesting sort of nuance.
11 Certainly going down the group, we wanted to split
12 them into -- those scoring 1 and 2 where different
13 management would or might have made a difference and
14 those scoring 3 or 4. As we said, there were 9 of
15 complete agreement. There were 4 cases that we looked
16 at particularly where there was a difference. There
17 were two of them scored -- there was one scoring grade
18 between them.
19 DR SILOVE: I wonder if you could give me this pointer back,
20 please? Thank you. I cannot point while this is
21 highlighted. Never mind.
22 MR HAMILTON: There were two cases scoring 3 with one team
23 and 2 with the other team, so it crossed that boundary
24 that we saw as important as to different management
25 might have made a difference. They are highlighted
0124
1 there in the report. If you want to bring up INQ 16/25.
2 MR LANGSTAFF: Just before we go to page 25, just on
3 the mathematics, would you check for a moment that it is
4 right that there are actually 9 cases rather than 8
5 where there is complete agreement?
6 THE CHAIRMAN: Maybe we do not need them highlighted, so
7 that we can use the pen here.
8 DR SILOVE: There are 8 and there is one --
9 MR HAMILTON: The 2/3 I think.
10 DR SILOVE: There was one case which was 2/3 and the second
11 review gave it 2. We thought that was reasonably fair.
12 MR LANGSTAFF: That is complete agreement.
13 DR SILOVE: Sorry, no, it is not. You are quite right.
14 There were 8, and this one was so close as to be
15 reasonable to call it ...
16 MR LANGSTAFF: In agreement rather than in complete
17 agreement?
18 DR SILOVE: Not complete, no.
19 MR HAMILTON: When we did the second review exercise and
20 pulled this part of the report together we had regraded
21 that 2/3 I think to a 2, but we then reverted back to
22 the 2/3.
23 MR LANGSTAFF: Was that with hindsight having seen what
24 the second review had done?
25 MR HAMILTON: No, it was not. It was at the time when we
0125
1 were going through the first review, so it was not.
2 That aside, there were the four cases we looked at in
3 particular. If you can bring up 16/25?
4 MR LANGSTAFF: Can we scroll down just to get the -- that is
5 it. Thank you.
6 MR HAMILTON: The details are outlined there. We wanted to
7 see why the teams might have differed in their scoring.
8 The first one outlined there, SR4, it was very unusual
9 anatomy and the teams differed merely as to whether this
10 rare diagnosis might have been dealt with differently.
11 The second case was a child who survived
12 the operation but had a disability following a stroke,
13 and both teams were of the opinion that the operation
14 should have been done earlier but whether it might have
15 made a difference was the point at issue.
16 So we felt that was not a strong disagreement. We
17 concentrated more on the other two cases where there
18 were two scoring grades of difference. That is at
19 the lower half of the page. Again, you see the details
20 there. One child was given 3 by one team and 1 by
21 the second team. This was a child who died. Again
22 a rather complex case. I suspect if the two teams had
23 been put together and discussed it they would have come
24 to agreement on this. Again it highlights
25 the difficulties in children with difficult anatomy, how
0126
1 best to manage them.
2 In the other case one team gave it a score of 2
3 and the other team scored it 4. Again, you see
4 the details there. It is a question of -- again, both
5 teams commented on the complexity and the difficulty of
6 the case. In such a situation it was not too surprising
7 to us that there should be a difference of opinion as to
8 whether different management might have made
9 a difference in outcome.
10 So overall we were quite I think impressed, having
11 been aware of the second review happening, with
12 the level of agreement among the teams.
13 MR LANGSTAFF: Is that lay approach from those actually
14 involved in doing the work, Professor Evans, something
15 which you would support statistically?
16 PROFESSOR EVANS: Yes. I think that there are statistical
17 methods of looking back, which have I not done. Again,
18 I can only apologise. All of this was done in
19 considerable rush and, although we managed to get
20 the tables, we were concentrating on the ones that were
21 of greatest clinical interest. There is no doubt that
22 statistically the agreement here is beyond chance, which
23 is what we would expect. But there is some
24 disagreement. There are ways of assessing that amount
25 of disagreement. The amount of disagreement is typical
0127
1 for that for clinical subjective judgments, but is quite
2 a reasonable agreement.
3 MR LANGSTAFF: How does it compare with what you might find
4 in a CESDI analysis?
5 DR GOULD: I have to say I looked at the tables for
6 the first time a couple of days ago, I think it was, and
7 I was very impressed with the table.
8 MR LANGSTAFF: You mean it is better than CESDI?
9 DR GOULD: I think that level of agreement without the
10 various statistics done on it, my initial impression
11 would have been yes. The fact that where there were two
12 grades apart, for instance, paragraph 6.7, both teams
13 appear to have focused on exactly the same issue. They
14 may have come to different conclusions, but they were
15 looking at the same issues. Very often with some of the
16 disagreements we had in CESDI they were because teams
17 were actually looking at different issues in the same
18 case and reaching different conclusions. So generally
19 I was very impressed with the table.
20 MR LANGSTAFF: How do we regard this indication from
21 the review as casting doubt or giving rise to a greater
22 margin of appreciation on the findings of the 80 upon
23 which you have reported and which are reported earlier
24 by Dr Silove and Mr Hamilton?
25 PROFESSOR EVANS: I think the important thing is that, as we
0128
1 were yesterday with some things, we have a necessary
2 condition but not a sufficient condition. That is that,
3 had there been major disagreement or lack of agreement
4 between the raters, that would have undermined the whole
5 of this process.
6 We have found that there is a reasonable level of
7 agreement. We can use a thing called "weighted
8 agreement" and about 75 per cent is the agreement we
9 have. We obviously want to have 100 per cent. One of
10 the difficulties of course is that a lot of the scores
11 are 4.
12 Statistically we would like to have scores that
13 were not 4 in order to be able to look for the measure
14 of agreement. But the fact that we have lots of 4s
15 means that statistically it is quite difficult to
16 measure the amount of agreement precisely. That relates
17 to the way similarly that in looking at the sample as
18 a whole we want to weight it towards the 1s and 2s, as
19 you might say.
20 We designed the sample of the resampling prior to
21 our knowing the results of this. Had I designed
22 the sample knowing what this was, I would have got
23 a redo of cases that were 1, 2, 3 and 4 equally spread
24 across there in order to get a more precise indication.
25 So statistically the agreement, the CAPA score, is
0129
1 a value of about 0.4, which is not wonderful. But that
2 is largely because having a lot of 4s in there we do not
3 have much opportunity to show disagreement in some
4 senses, just as I was asking Mr Hamilton, do we have an
5 opportunity of having those scores. In fact in this
6 redo it is not as helpful as we would like it to be had
7 we known the results before we began, as you might say.
8 But the consequence of it, the bottom line is that
9 my view is that this validates the overall exercise to
10 a considerable degree. It does not mean it is perfect,
11 but it means that we can apply some reasonable weight to
12 the conclusions.
13 DR SILOVE: Could I just add here we only compared
14 the overall grading in these two groups of cases. We
15 have not had time to look at aspects of care. I just
16 wonder whether statistically it might help to look at
17 aspects of care in these cases and compare them and
18 whether that might give you enough information.
19 PROFESSOR EVANS: I think again we then look at a large
20 number of them. Again the variability in the scores is
21 not necessarily very great. I think you would find that
22 there is no better agreement and from my quick look at
23 it there is slightly worse agreement on the individual
24 components than there is on the overall care. So there
25 is not quite as much agreement on the specific scores
0130
1 that are given there. The overall patterns are in
2 agreement.
3 MR LANGSTAFF: So we can take from this, can we, with some
4 but not by any means complete confidence, that there is
5 a pattern shown by the 80 cases which may be said to be
6 truly representative of the whole?
7 PROFESSOR EVANS: Yes. I think it would be a mistake to
8 focus too much on the precise values of the numbers of
9 1, 2, 3 and 4s in any particular aspect of care. But
10 the overall distribution of that across them is
11 a sensible thing to do.
12 MR LANGSTAFF: Moving ahead, as you will know, the Inquiry
13 has offered to anyone who is concerned at the results in
14 any particular case to ask, if they have good and proper
15 grounds for it, for that case to be further reviewed by
16 a second review panel, independent of the first.
17 If that second review panel should be invited to
18 consider a case and should produce an identical answer
19 in ignorance of course of the first, that would confirm
20 one's confidence in the first review.
21 If it produced a different result, to what extent
22 would that damage any conclusion that one might draw
23 from the first reviews generally?
24 PROFESSOR EVANS: I would like a little clarification: are
25 you meaning that if we are to do this in the future?
0131
1 MR LANGSTAFF: Yes.
2 PROFESSOR EVANS: I think one of the things is that, if
3 reviews are done for specific cases in the future, they
4 would contribute to our overall assessment of agreement
5 if they were doubly reviewed in the way that we have
6 reviewed these 15 in the same way. That would
7 contribute.
8 MR LANGSTAFF: It is my fault. I am thinking about, let us
9 suppose, the 13 cases here in which they are grade 1.
10 PROFESSOR EVANS: Yes.
11 MR LANGSTAFF: Let us suppose there are those who are
12 concerned that some cases which have been graded as
13 a grade 4 should more appropriately for reasons they may
14 know of be graded as a grade 1 and not as a grade 4. So
15 they say to the Inquiry, "You have this case wrong. You
16 do not know what we know. You should reassess these
17 cases. Can we have it looked at again by a second
18 review panel", and the Inquiry has said that that is
19 what will happen if there is good cause for it.
20 Suppose that happens, suppose that is done, how
21 does one deal with any results that may be produced?
22 PROFESSOR EVANS: I think that it is absolutely imperative
23 that one realises that one will expect to find more
24 disagreement among those cases on statistical grounds
25 than one would find from doing a random sample. We
0132
1 chose these 15 very carefully randomly, and so we can
2 draw conclusions about the repeatability of
3 the assessment.
4 But if you choose specifically cases that are at
5 an extreme and which you believe there is a mistake in
6 and you go and look at that, you will automatically and
7 I can guarantee that the amount of agreement in the 1s
8 and the 4s that you look at as a result of a request
9 will appear to be less. That would be true
10 statistically, however good the assessment was, assuming
11 it was not perfect agreement. That is a statistical
12 thing.
13 It is related to something called "regression to
14 the mean", which I will not trouble you with, but is
15 a statistical problem. So it is very important that
16 people do not apply that kind of methodology to getting
17 an overall assessment of the reliability of repeated
18 assessment. If you are to do that, I can design you
19 a better study.
20 MR LANGSTAFF: In other words, it may tell us something
21 about the individual case, but not about the overall
22 message.
23 PROFESSOR EVANS: Absolutely.
24 MR LANGSTAFF: I am going to come back to you at the end,
25 Professor Evans, in order to tell us where, if anything,
0133
1 we need to go now from what is described as
2 a preliminary review. But what we have not yet taken
3 from our experts who have been on the panels is their
4 impressions taken overall so far as Dr Silove and
5 Mr Hamilton are concerned, and from their particular
6 case series so far as our other three experts are
7 concerned, of any particular themes or messages that
8 might have emerged from the material that they have
9 seen. Can we now do that?
10 DR SILOVE: Thank you. We asked the team co-ordinators to
11 write to us and tell us what themes they felt had come
12 out of the overall review that they had undertaken. All
13 we have on that is comments, and that is in section 5 of
14 our report. I do not know whether you want to go
15 through it stage by stage?
16 MR LANGSTAFF: I think it would be more helpful perhaps to
17 the Inquiry, who can and either have or will read
18 the report, if you give us your impressions, selecting
19 the strongest messages which come out to you from what
20 has been said to you.
21 DR SILOVE: There were very strong messages in pre-operative
22 issues about delays; delays in doing cardiac
23 catheterisations, delays between the time of a cardiac
24 catheter and an operation. There were references in
25 out-patient notes by cardiologists to the waiting list
0134
1 being "very tight" was an expression that was used.
2 We gathered from that that the waiting list was
3 a problem and maybe that was the reason, but we have not
4 really elucidated just why there were such long delays
5 very often in cases which needed operations done quite
6 early and urgently. So that was the one point which was
7 highlighted to us.
8 We found it difficult to determine who took
9 medical or nursing responsibility for directing
10 the management of patients on the ITU, and particularly
11 as applied to the management of paediatric patients.
12 That was a real problem that came out of this whole
13 review.
14 We felt that on the ITU there was failure to
15 anticipate clinical problems. There was a delayed
16 response to these problems and there was a failure to
17 involve other team members. So we are really
18 criticising, if criticism is the word, the pre-operative
19 delays, some of the assessments, but in particular we
20 were very concerned about the ITU management.
21 I think that summarises our feeling about it.
22 I do not know whether Mr Hamilton would like to add any
23 more.
24 MR HAMILTON: We were very aware when we were drawing this
25 report together that we were not to be judging
0135
1 the issues at all, that is the Panel's role, but merely
2 draw the things together. We felt it was easiest to
3 reflect that by simply quoting comments from the various
4 people.
5 MR LANGSTAFF: But I cannot let you get away with that.
6 What is your impression as to the strength of comments
7 in the particular areas?
8 MR HAMILTON: I think Dr Silove has summarised those. We
9 were in agreement on that.
10 MR LANGSTAFF: What is your impression as to the degree to
11 which they may, if at all, show a failure to work as
12 a team?
13 MR HAMILTON: I think the comments that came back both in
14 the records and in the forms and from the letters that
15 the team leaders wrote back were consistent with what we
16 found in the clinical review, that there seemed to be an
17 issue right across the board of people working together,
18 of co-ordination, occasional comments on resources, but
19 it seemed to reflect a general difficulty across
20 the board.
21 MR LANGSTAFF: That is a general picture. How far did it
22 reflect what you found? You may want to comment in
23 particular from your own particular specialities.
24 MS WILLIAMS: I think from a nursing perspective I was on
25 the team that reviewed -- I was on the initial pilot
0136
1 study and then a team that reviewed another two sets of
2 10 case notes, so 25 sets altogether. I think there
3 were several issues about nursing that came out.
4 Although I did feel on the whole that the level of
5 detail in the nursing notes was very good, but there was
6 some issues particularly in relation to intensive care
7 plans, that some of the care plans that were used for
8 these children had a very adult focus. They were
9 preprinted care plans which had obviously been designed
10 for use in adult intensive care.
11 I think one of the issues that arose from that is
12 that there was very little reflection of the child as
13 a part of the family, and these were very --
14 MR LANGSTAFF: Just slow down a little.
15 MS WILLIAMS: It did not necessarily reflect the child as
16 part of the family. I think a lot of these were very
17 young children and the level of stress that parents
18 experience when children are in the intensive care unit
19 is very high, and a lot of nursing time is spent dealing
20 with that stress and explaining things to families.
21 There was no reflection of that in the care plan.
22 I think those issues would have been true in
23 the mid-to late 1980s, as they are today. I think
24 particularly for those parents of children who died, it
25 is unclear what sort of support was offered to those
0137
1 families. So that was one issue that came out.
2 I think also the issue about team work, there was
3 one case in particular that we spent a lot of time
4 discussing in relation to a child's fluid management
5 where the nurses had been recording the lack of urine
6 output over a considerable period of time, and this did
7 not seem to be picked up in the medical notes. In fact
8 renal replacements that supported the kidneys was not
9 instituted until a long time after the problem arose.
10 It was not clear where the line of responsibility
11 was for the nurses to report that to, although in
12 the notes it had been reported.
13 Another issue that came out which -- there were
14 several cases where in the nursing notes there was
15 reference to an infant having sinus tachycardia, which
16 would be a heart rate that was faster than a normal
17 heart rate for that age of child, when in fact the heart
18 rate discussed was actually normal for the infant, and
19 these were infants. I think it illustrated perhaps
20 a lack of understanding of normal physiological signs in
21 children of different age groups; not in all notes, but
22 in relation to some patients.
23 MR LANGSTAFF: Did you have a sense then that these were
24 nursing staff who had no particular paediatric
25 inclination or training?
0138
1 MS WILLIAMS: Yes. There is a comment made in the Inquiry
2 notes 16, page 23, that 0.5.10, there appeared to be
3 a lack of paediatric nursing input, I think is an
4 accurate reflection of what was felt for the group.
5 DR MACRAE: I will concentrate my comments on really
6 anaesthesia and then move on to post-operative care.
7 I think my general assessment, and again I reviewed 25
8 sets of case records, was that the technical conduct of
9 anaesthesia for the group of children was of an adequate
10 standard. That is a generalisation. There were one or
11 two specific technical issues that were picked up by
12 some of the Panels. But, overall, in terms of what was
13 done and how it was documented, I think it would stand
14 up against practice in other comparable institutions in
15 the country.
16 I found it very difficult to comment on
17 the anaesthetic input into intensive care because it is
18 not entirely clear to me, and others will have heard
19 evidence presented to the Inquiry, as to how exactly
20 the intensive care unit was structured. But it is not
21 entirely clear to me what precise role or what tasks
22 devolved to the anaesthetist in the intensive care
23 unit. It was not clear to me how the various elements
24 worked as a team, or if they did really see intensive
25 care as a team issue or whether it was just seen as
0139
1 a surgical environment to which other people were
2 invited to contribute on a sort of "we need this doing;
3 he should come and do it."
4 I was surprised, I think, again reflecting
5 Dr Silove's comments, at the lack of paediatric
6 cardiological input, and specifically the lack of or
7 what appeared to be a relative lack of echocardiological
8 examination of patients who were clearly not doing well
9 in the intensive care unit.
10 Almost the first thing that many surgeons and
11 cardiologists ask for if a child is not doing well
12 following heart surgery is to have an image of that with
13 an ultrasound probe. I would not recommend it, but
14 almost before they pick up a stethoscope they want to
15 see a picture of the inside of the heart. That often
16 provides very important information, particularly things
17 like bleeding around the heart which, if it is picked up
18 earlier, it should be easy to put right and may well be
19 a life saving manoeuvre. If you wait for the clinical
20 evidence of that, it may well be a much more urgent
21 situation and far less easy to rescue. I think I will
22 stop.
23 DR GOULD: I think pathologically I do not know that I have
24 an awful lot to add from what we said five or ten
25 minutes ago. Personally I ended up reviewing 13 cases,
0140
1 which included some of those that would have been
2 reviewed twice. In general the post-mortem report
3 quality was very variable. Some were very brief, partly
4 because they were on the relatively old coroner's
5 autopsy report forms where you have a very limited
6 space. Some were very, very detailed, and I would
7 certainly be more than happy to produce reports of that
8 quality, even start to produce reports of that quality.
9 Part of the problem I think for assessing
10 the pathology is so much the communication will often
11 occur afterwards. One knows it is often verbal, and
12 I find it very difficult to assess the extent to which
13 that verbal communication occurred because it is likely
14 not to have been recorded. I am being very cautious
15 there because I find that aspect to be very, very
16 careful -- so I need to be very cautious about. I do
17 not want to say too much more on that.
18 MR LANGSTAFF: Can I ask what may be very difficult
19 questions to answer. First of all, were the teams able
20 to form any view as to case mix and how it might have
21 compared with what you would have expected given
22 a random sample formed in the way that this was?
23 DR SILOVE: I do not think that I can really answer that.
24 We were seeing a significant number of complicated
25 cases, and that is due to the weighting that was done in
0141
1 selecting the cases. But we took that as it came,
2 really. So the case mix was weighted.
3 MR HAMILTON: Yes, I do not think we could make any
4 particular comment from the sample. But I think I have
5 to say I would see no reason that the case mix should be
6 any different from anywhere else, just on a clinical
7 feeling.
8 MR LANGSTAFF: But that is not based on the sample? That is
9 a general comment?
10 MR HAMILTON: No. We recognised it was weighted and there
11 were comments from many of the reviewers that there were
12 very complex anatomy, difficult cases. Those comments
13 did come out from time to time.
14 PROFESSOR EVANS: It would be very dangerous if
15 the clinicians were to make any strong comments on case
16 mix based on this because of the fact that the sample
17 was weighted in the way that it was. The only sort of
18 the thing that would be sensible for them to do would be
19 to say, for example, that this child had surgery much
20 earlier or much later than they should have done. That
21 sort of comment in regard to something that we were
22 effectively discussing yesterday as a possible
23 explanation for case mix affecting our assessment of
24 the Bristol situation, that they could do. But to talk
25 about case mix overall, that would be a mistake to do on
0142
1 the basis of this sample.
2 MR LANGSTAFF: Does the same apply to morbidity?
3 PROFESSOR EVANS: Yes. One of the things on the forms that
4 we have really not discussed at all was that we did have
5 an assessment of disability. To some degree at the time
6 that was designed we had expected to find a considerable
7 degree of disability. But among those 40 children who
8 were alive, who were in the sample, we did not have
9 anything in the clinically coded records database that
10 would unequivocally identify children as disabled in any
11 way or having severe morbidity, as you say. We did not
12 sample in regard to that.
13 So to some degree that was randomly selected, but
14 there were only four children who were recorded as
15 having disability, and only one of them did the team
16 believe that the disability was in a major way
17 associated with the care that was given. So to focus on
18 that one case or the three others where disability was
19 recorded would have probably detracted from the overall
20 exercise. Again, that may be something to do in
21 the second look at these data.
22 MR LANGSTAFF: In essence, are you saying that the numbers
23 are simply too small?
24 PROFESSOR EVANS: The numbers are too small. But in some
25 senses the fact that the numbers are small is in some
0143
1 senses an encouragement in terms of the estimate of any
2 effect.
3 DR SILOVE: May I just say that I do not have any data to
4 support what I am going to say, but it is certainly my
5 impression that it would be unusual to see more than
6 5 per cent of one's post-operative patients who were
7 alive with a disability, from ordinary clinical
8 practical experience.
9 MR LANGSTAFF: Perhaps the final question, unless there is
10 anything that any of you would wish to add to today's
11 symposium, is to what extent does the study, which has
12 been reported on today, inform or relate to the studies
13 which we looked at yesterday?
14 PROFESSOR EVANS: If I can summarise what we saw yesterday.
15 We saw yesterday that there was some reasonable evidence
16 from the UK Cardiac Surgeons' Register and rather
17 stronger evidence from the hospital episodes statistics
18 that Bristol in particular age groups and particularly
19 for open heart surgery and not for closed heart surgery
20 had a higher death rate than other centres; not as
21 the BBC said, double the number of deaths. The death
22 rate was higher, not the number.
23 In order to look at that, one of the things that
24 we do not have is any kind of comparison with other
25 centres. We are implicitly making a comparison by
0144
1 asking teams of experts to have some idea of what
2 the comparison would be, and we are believing their
3 expertise to be able to make some kind of comparison.
4 But that has severe limitations. If we were to go
5 and look at other hospitals, which the Panel may wish to
6 consider doing, that would gain us something. It still
7 would not gain us everything, because it could be that
8 the recording of clinical problems in the notes in
9 Bristol may in principle at least have been better such
10 that it is easier to find problems. If you do not write
11 anything down, it is very difficult to find problems.
12 In some senses the fact that there were no Xs among
13 overall care shows that the record keeping was good, and
14 it would be important to see whether that was also so
15 elsewhere.
16 I think that this very much informs the reasoning
17 behind why Bristol may have been different to other
18 centres. My judgment -- forgive me, I am only
19 a statistician -- is that the important thing here is to
20 see that, if anything, it is something more like
21 a system failure than specifically a surgical failure.
22 I think in some senses the phraseology that we used
23 yesterday and the words that were used yesterday
24 concentrated on surgery. It is obviously not my
25 position to make any judgment in that way, but I think
0145
1 that this exercise makes it clear that it is a pattern
2 over the whole of care that was a problem, and
3 particularly obviously in regard to open heart surgery,
4 and we are seeing it in regard to BRI.
5 So we see something that is consistent. That is
6 where things happened between the two hospitals
7 particularly that there were failures. We found
8 yesterday that it was in the open heart surgery and not
9 in the closed heart surgery where there was a problem of
10 excess deaths. That is consistent with that kind of
11 pattern, rather than focusing on particularly
12 the surgery. But I think that any such conclusion has
13 to be provisional in the absence of comparative
14 information.
15 MR LANGSTAFF: Finally, perhaps you could indicate where you
16 think the Inquiry might wish to take the study further
17 and what further research might usefully be done, given
18 obviously the requirements of time effectiveness, given
19 cost and time, and what we might call "deliverability".
20 PROFESSOR EVANS: I think that within a reasonable time
21 scale it would be very much better, given
22 the understanding of the anxieties of health
23 professionals involved and parents involved, to put
24 resources towards a more scientific re-examination of
25 the cases than to go through things driven by
0146
1 individuals concerned. That would be my advice, if at
2 all possible. Accepting, and I think it would be
3 perhaps a reasonable thing to do, to have some
4 discussions with those who are interested parties.
5 I think the other thing where we would gain
6 something is whether we could show across the other
7 centres, perhaps not necessarily all of them but some of
8 the other centres going through a similar exercise and
9 perhaps at the same time repeating slightly this
10 exercise, and if it were possible to have the outcome
11 veiled at the time of assessment being made, I think
12 that that would offer significant gains. The
13 consequence is that looking at adequacy would have to be
14 done in a subtly different way. But I think that
15 perhaps after a workshop involving those who have been
16 involved in the review exercise, to be able to say what
17 are the key features and to go through as CESDI has done
18 and say "We need to have some structure that focuses on
19 areas where we think we can assess things reasonably
20 reliably and set out clear guidelines, that would be
21 a possibility. But it is not cheap and you cannot do it
22 that quickly.
23 I think that it may nevertheless give us some
24 increased confidence in these results. At the moment we
25 have only focused on Bristol. If we were to extend it,
0147
1 that would give an increased confidence in the results
2 that we had yesterday.
3 MR LANGSTAFF: Sir, I think there are two issues here. We
4 heard yesterday what Dr Spiegelhalter told us at
5 the end, with which I think you agreed, as to the amount
6 of information that one might get from further national
7 studies. Here one is exploring the particular reasons
8 why Bristol performed as it did by looking at a number
9 of cases, and it was really in that respect that I was
10 asking for your advice and assistance as to how much
11 more one might do reasonably within the scope of
12 the Bristol exercise to identify what had happened.
13 Effectively, have we done enough? Have we done as much
14 as is likely to tell us the information that the Panel
15 need to consider as part of the picture, and only part
16 of the picture? Or is there more that must be done or
17 it might be desirable to do?
18 PROFESSOR EVANS: I think that though the number 80 was
19 chosen on non-statistical grounds, I do not think for
20 example doubling that number to 160 and merely repeating
21 the same exercise would give us very much gain at all.
22 I think that repeating the second review on all of
23 the cases would similarly win us very little.
24 I think that the biggest gain in information we
25 would have would undoubtedly be in doing a similar
0148
1 exercise and it would probably be best in my view if it
2 were modified slightly from these review notes, but to
3 do so both in Bristol and elsewhere.
4 I think that that would strengthen the Panel's
5 information on whether the situation in Bristol was
6 indeed, as might be said, a system failure, whether
7 there were specific areas that had difficulties or
8 whether there were surgical failures or not. I think
9 that area of the explanation of possible differences in
10 Bristol could be strengthened by this kind of exercise.
11 MR LANGSTAFF: Sir, I do not know if the Panel have any
12 questions?
13 THE CHAIRMAN: Mrs Maclean?
14 Examined by THE PANEL
15 MRS MACLEAN: I think this is a question for Professor Evans
16 primarily. We have been discussing the problem of
17 searching for a comparator. In the report we have
18 mention of CESDI and the question of comparison is
19 implicit. I think perhaps this is a question not for an
20 immediate answer, but for further consideration.
21 We have CESDI offering a level of criticism in
22 40 per cent of cases but we are aware that CESDI looks
23 at only in deaths and is using the term "suboptimal
24 care" whereas in our review we are talking about "less
25 than adequate" and we are looking more at the cases
0149
1 where children died. So it is not easy to make a direct
2 comparison, but are we able to make any sort of
3 comparison at this stage, or is this something we could
4 explore while we lack the better and stronger solutions
5 that you have been outlining to us?
6 PROFESSOR EVANS: I would wish to give that rather more
7 thought, but I think that the methodological
8 inadequacies, if I might say so, of CESDI in not having
9 comparator groups of any kind in the earlier times is
10 such that comparison with that will not be helpful.
11 The problem is that if one were to compare new
12 CESDI, if I may call it that, which is going on now,
13 that this is dealing with things in a different calendar
14 time period. So I think that the views of someone like
15 Dr Gould on the comparison would be helpful, I think
16 anything more detailed in doing that would probably win
17 us very little, because the methodologies are so
18 different and the time scales are different. I think
19 our methodology is slightly better in some respects.
20 Our methodology is not as good as new CESDI because we
21 are not veiled the outcome and we have not looked at
22 other centres.
23 DR SILOVE: I know you want to finish off, but I would like
24 to go back if I may to the question of the team.
25 I think it is a very important question. We have talked
0150
1 about it today and it does appear as if there has been
2 a systems failure, as Professor Evans calls it, or
3 a team failure, and I think that really is the crux of
4 most of what we were seeing as a problem at BRI.
5 We have heard about intensive care unit management
6 from Dr Macrae and Mr Hamilton and from Carol Williams.
7 I would just like to make the observation that somebody
8 has to be in overall charge of the patient and that all
9 members of the team have to work with that leader,
10 whoever the leader may be. It may be the surgeon, it
11 may be the intensivist, it depends on the setup in
12 the particular place. But you must have the whole team
13 working together.
14 It begins first thing in the morning every day and
15 it finishes first thing the next morning. It is not
16 scattered just for a few hours during the day. It is
17 a 24-hour job. I do not think we saw any evidence of
18 that type of approach in Bristol.
19 THE CHAIRMAN: There are no more questions from the Panel,
20 but I just have a few remarks I would like to address.
21 MR LANGSTAFF: There is one matter I think of clarification
22 which I am grateful to Miss Grey for.
23 Further questions by MR LANGSTAFF:
24 MR LANGSTAFF: Mr Hamilton, a little while ago you said
25 this, and you were talking about the agreement or
0151
1 disagreement between the cases. You were saying that it
2 struck you that one of the impacts possibly knowing that
3 there was going to be a second review is to make
4 the team perhaps a little more critical than they might
5 otherwise have been.
6 By "critical" do you mean critical of the BRI or
7 self-critical or what?
8 MR HAMILTON: I think what I was hoping to say or hoping to
9 convey was going back to our remarks at the beginning of
10 today that there were no standards that we could measure
11 things against. I wonder if, knowing there was going to
12 be a second review, we maybe set standards a little
13 higher than we might have in terms of standards to judge
14 care against. Does that make sense?
15 MR LANGSTAFF: Why should you set standards higher knowing
16 that another team is going to come along with experience
17 of the same epoch and apply what they consider to be
18 the standard that applied at the time?
19 MR HAMILTON: Maybe I should not have said that at all.
20 I think it was just a subjective feeling, that the role
21 of the reviews was to look at the adequacy of care.
22 Knowing that another team might come along and criticise
23 our judgment, if there was say a choice between scoring
24 it at 4 or a 3, you might err on the side of scoring at
25 3 rather than 4 because you would not want to be seen to
0152
1 be not taking the responsibility seriously. Does that
2 make sense?
3 MR LANGSTAFF: So you would not want to be condoning what
4 other people might regard as poor care; is that what you
5 are saying?
6 MR HAMILTON: I think we would not want to be seen to be
7 classing care as adequate that others might consider to
8 be inadequate.
9 MR LANGSTAFF: If you considered care adequate, would you
10 have said so?
11 MR HAMILTON: It goes back to the difficulty of not having
12 an absolute standard to measure it against. It depends
13 where you set the level of adequacy.
14 MR LANGSTAFF: Dr Silove, would you want to comment?
15 DR SILOVE: Mr Hamilton and I are great friends, but I do
16 not agree with him on this one. I do not think that
17 entered into our consideration at all when we looked at
18 our review cases. I think we looked at each case on its
19 own merits and we were not thinking about what other
20 teams might be doing. But I would like to hear what
21 Dr Macrae thinks and what Carol Williams thinks, and
22 Steve Gould.
23 MR LANGSTAFF: Were you over-critical, prepared to be
24 critical, uncritical?
25 MS WILLIAMS: No, I do not think we were over-critical. We
0153
1 were conscious that perhaps some of the cases we were
2 reviewing may be reviewed again. Certainly in the group
3 I was working in what we tried to get was consensus
4 about each case and that may have meant being told that
5 sometimes we were being over-critical and trying to
6 re-evaluate issues that arose from the case. But at
7 the end of each case what the chairman of our group
8 aimed to do was to get consensus about the overall score
9 that we were allocating to each case.
10 MR LANGSTAFF: But consensus which was weighted towards
11 being critical of care or weighted so that it accurately
12 reflected the best view that you had of care at
13 the time? Which was it?
14 MS WILLIAMS: So that it gave a fair reflection of what we
15 could judge based on the case notes that we had, not
16 that we were being excessively critical, that what we
17 were doing was basing our judgment on what we had in
18 the case notes.
19 DR MACRAE: I think I would go along with that. Certainly
20 in the group that I chaired we were very much looking
21 for consensus and it was usually achieved in virtually
22 all areas. I think where we were perhaps aware of
23 the possibility of second reviews would be perhaps in
24 a case where there was some debate, there was not quite
25 consensus about whether to score a 4 or a 3, and really
0154
1 for the purposes of highlighting the issue we would
2 choose to go to score it as a 3 so that there was a flag
3 or a marker to say "This is something which was not
4 completely adequate care. There was certainly some
5 dissension. Some of us thought there was a small
6 problem which we felt it was our duty to highlight". We
7 did that because perhaps another group or the wider body
8 of peers, if you like, there may have been more votes on
9 one side than the other. It was more of a flagging up
10 exercise. I do not think it happened to the same
11 extent, others may disagree with me on this, in the more
12 severe categories, that scoring 2s and 1s there was
13 complete consensus certainly in my panel on that.
14 MR LANGSTAFF: Do you think it happened then to any extent
15 in scoring 2s and the 1s?
16 DR MACRAE: We had no experience of that we reached
17 consensus on those --
18 MR LANGSTAFF: You dealt with 25 reviews?
19 DR MACRAE: Yes.
20 MR LANGSTAFF: Were you chairman of each case?
21 DR MACRAE: Yes.
22 MR HAMILTON: I am grateful for Dr Macrae for clarifying
23 what I was trying to say.
24 MR LANGSTAFF: What was your impression, Dr Gould?
25 DR GOULD: I must admit the panel meetings that I attended
0155
1 were very similar to the ones I have attended with
2 CESDI. I think everyone was looking to try and find
3 problems if they were there but being very fair in their
4 assessment of whether they were or were not.
5 You do get the feeling there were differences
6 within panels. You attend one panel and -- certainly
7 this is true of CESDI -- and you can tell that
8 personality comes into it in the sense you can tell one
9 person is being very critical. But where that tends to
10 come in, or at least my feeling of where that comes in
11 is that if you take any patient that goes through
12 a hospital system and has an inch and a half of notes,
13 the probability if you go through those notes, at some
14 point you will be able to find something you will be
15 able to criticise. Very often the differences between
16 panels will be whether one panel decides "Actually
17 overall that was okay. That is the sort of care I would
18 have expected or I might have given myself. So that is
19 okay. I will give that a grade 4". On the other hand,
20 if you are being really critical -- and this is where
21 the change might come in -- you are going through and
22 you say "Actually they did not come up to the standard
23 there. It is the sort of thing I might have done
24 because we know we all make errors at some point and we
25 do not come up to the standards we would set ourselves,
0156
1 so we will call it a grade 3."
2 So occasionally I think that is where, if you are
3 being very critical and to some extent acknowledging
4 that will be the type of problem or inadequacy, if that
5 is the right word, or less than adequacy that one would
6 make oneself in one's own practice.
7 MR LANGSTAFF: So that type of being alert to possible
8 problems, would that spill over into the grade 2s and
9 grade 1s?
10 DR GOULD: My impression, and by chance I think maybe
11 the first three or four panels I attended, the first one
12 or two there were no grade 1s or 2s. I thought this
13 exercise is becoming -- I was quite worried almost for
14 a while. But I felt certainly my observation, because
15 I was often an outsider in the sense that it was very
16 difficult for me to make a clinical assessment at all,
17 I thought the panels were extremely fair in trying to
18 make their assessment of suboptimal or inadequate care
19 which might have altered management.
20 CHAIRMAN'S THANKS TO THE EXPERT ADVISERS
21 THE CHAIRMAN: Thank you very much, Mr Langstaff. I just
22 wanted to say, as I think I ought, a few words in
23 the light of today.
24 As yesterday, so today, we must express our very
25 great thanks to our expert advisers. They, and you as
0157
1 being some of them, took on what can only be described
2 as a colossal task, the nature of which you set out this
3 morning, Mr Langstaff, at the start of the hearing --
4 the number of hours, the number of cases, the meetings.
5 It was a unique challenge which the panels and you
6 representing them rose to outstandingly well, if I may
7 make so bold. We cannot thank you and them enough.
8 Together with the leadership which Dr Silove and
9 Mr Hamilton gave in preparing the report at the end and
10 the dedication which, Dr Silove, you generously
11 acknowledged of the Inquiry secretary, Una O'Brien, who
12 has managed this process of the case review from start
13 to finish.
14 The Panel yesterday was shown a statistical
15 picture. Dr Spiegelhalter advised us that further
16 statistical analysis would not really take us much
17 further. What we needed were clinical insights. Today
18 in this analysis we have the beginnings of clinical
19 insights from you, our experts, acting according to
20 the principles set out and explained today.
21 Another piece of the jigsaw has been put in place
22 and we thank you profoundly for that. Yesterday
23 I mentioned that we had sought to dispel the mystique or
24 the mystery of statistics. Today I hope we have begun
25 to include everyone in another of our tasks, the process
0158
1 of reviewing cases.
2 Professor Evans referred to how some of this
3 information which we heard yesterday has been reported.
4 These are complex matters. I am confident that over
5 time understanding will grow. Again, thank you very
6 much indeed. Mr Langstaff?
7 MR LANGSTAFF: Sir, it remains for me only to say that this
8 is the last day that we shall meet this week. Next
9 Monday the Inquiry continues at 10.30 in the morning
10 with the evidence of Dr Stephen Pryn who is an
11 anaesthetist at the Bristol Royal Infirmary.
12 THE CHAIRMAN: Until 10.30 on Monday, good afternoon
13 everyone and thank you very much. Good afternoon,
14 Mr Langstaff.
15 (3.30 pm)
16 (Adjourned to 10.30 am on Monday, 8th November 1999)
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25
0159
1 I N D E X
2
3 Application by Mr Sharp on behalf
4 of Surgeons' Support Group ................. 1
5
6 Application by Mr Trusted on behalf
7 of the Heart Children's Action Group .... 5
8
9 Response by Mr Langstaff ......................... 7
10
11 Statement by the Chairman ........................ 7
12
13 Mr Langstaff: Introduction to today's evidence ... 8
14
15 Expert advisers (sworn) .......................... 12
16 Dr Eric Silove
17 Mr Leslie Hamilton
18 Ms Carol Williams
19 Dr Stephen Gould
20 Dr Duncan Macrae
21
22 Examined by the Panel ............................ 149
23 Further questions by Mr Langstaff ................ 151
24
25 Chairman's thanks to the expert advisers ......... 157
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Published by the Bristol Royal Infirmary Inquiry, July 2001
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