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Hearing summary13th December 1999 The Bristol Royal Infirmary Inquiry this week will hear evidence which covers concerns raised about paediatric cardiac surgery at the Bristol Royal Infirmary between 1984 and 1995 and any failure to take action promptly. Mr James Wisheart, retired Medical Director, United Bristol Healthcare NHS Trust, UBHT, will give evidence on Monday, Tuesday and Wednesday. Mr Wisheart began his evidence this morning by giving his opinion, at the time of his retirement, of his professional career by discussing his view of his own surgical competence. He focussed on the recording of his results in his Surgeons Log throughout his consultant career. He commented on results he performed to repair atrial ventricular septal defects in children and discussed his decision to cease performing operations in September 1994. He then told the Inquiry about the affect on audit following the publication of criticism of the Bristol paediatric cardiac service in the magazine, Private Eye. Mr Wisheart next explained his role in the presentation of the 1995 report reviewing paediatric cardiac surgery at the BRI prepared by Dr Stewart Hunter, consultant cardiologist and Prof Marc de Leval, consultant paediatric cardiac surgeon. He went on to describe a visit made to Bristol by medical officers from the Welsh Office in 1986. He commented on concerns raised by them and the response made by the Bristol paediatric clinicians to the Welsh Office and to BBC Wales. He then spoke about the reduction in the ages of babies undergoing complex surgery across the country in the late 1980s and 1990s and discussed the case mix of patients referred to Bristol. He concluded by discussing the meeting held to decide whether to proceed with the arterial switch operation in Bristol on Joshua Loveday in January 1995. Mr Wishearts evidence continues tomorrow. |
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FULL TRANSCRIPT
1 Day 92, Monday, 13th December 1999 2 (10.35 am) 3 THE CHAIRMAN: Good morning, everyone. Good morning, 4 Mr Langstaff. 5 MR LANGSTAFF: Good morning, sir. Sir, today we have the 6 return of Mr Wisheart. 7 THE CHAIRMAN: Good morning, Mr Wisheart. 8 MR WISHEART: Good morning, sir. 9 MR LANGSTAFF: Mr Wisheart, could you stand, please, to take 10 the oath? 11 MR JAMES WISHEART (SWORN): 12 Examined by MR LANGSTAFF: 13 Q. Mr Wisheart, this is the second time you have been with 14 us. You know our procedures by now. Let me just run 15 through with you and identify the statements you have 16 given from Issue B through to the end of Issue N. 17 The statement on Issue B, which we have looked at 18 already in evidence, begins, does it, at WIT 120/1. Can 19 we have that on the screen? Does that go through to 20 120/90 and your signature at the bottom? 21 A. Yes, thank you. 22 Q. On Issue C, WIT 120/283, and can we go through, please, 23 to page 304: again, your signature. 24 Issue D on referrals begins at 112 and goes 25 through to 120: again, your signature? 0001 1 A. Thank you. 2 Q. Issue E, pre-operative management, beginning at page 121 3 and going through to page 152. 4 Issue F, 153 to 177, management of surgery. 5 Issue G, intraoperative care, 178 through to 224? 6 A. Post-operative care, it is. 7 Q. I am sorry and I am grateful. Issue H, the split site, 8 page 91 to 111, and you make the point in bold, towards 9 the bottom of that page, that all of the changes, that 10 is the appointment of a dedicated paediatric cardiac 11 surgeon, and the remedying of the split site were 12 proposed and decided upon before the allegations in 13 respect of paediatric cardiac surgery became public? 14 A. Yes. 15 Q. The point you would make is that this was the unit, if 16 I use the vernacular, "sorting itself out", without 17 there being the outside pressure upon it to do so? 18 A. Yes. This was the unit making what it thought was best 19 plans for the future, at that time, with the assistance 20 of the Trust, of course, as a whole. 21 Q. Issue I, the treatment of parents begins at page 225 and 22 goes through to page 240. 23 Issue J, postmortems and inquests, 241 to 254. 24 We have a supplementary one-page statement on the 25 retention of tissue at page 264. 0002 1 Issue K, training and retraining, 305 to 352, and 2 in that statement, in particular, you deal with what is 3 called the "learning curve" and I think you say that as 4 you see it, some degree of learning curve, however best 5 one tries, is inevitable. 6 A. I said that, amongst other things, yes. 7 Q. Issue L, dealing with informed consent, page 353 to 377. 8 Issue M, 378 to 410. 9 Issue N, dealing with concerns, 411 going through 10 to 457. 11 In addition, and I do not propose to take you 12 through the list one by one because we will be here some 13 time, you have commented on a number of other statements 14 of those who have, both in writing and orally, submitted 15 to the Inquiry, and I think there are still some which 16 you intend to respond to in the near future? 17 A. That is correct. 18 Q. All those pages of evidence, which are in excess of 19 500 pages, you would wish the Inquiry to take as your 20 evidence to it, would you? 21 A. Yes, I would, please. 22 Q. And you will understand, having been here already, that 23 the Panel have read every word that you have written and 24 that the purpose of my questioning will be to select 25 certain aspects of the matters to which you depose, and 0003 1 ask you further questions about it and around it. 2 A. Thank you. 3 Q. By way of introductory questions, let me ask you this: 4 when you retired were you at that stage proud of your 5 surgical skills? 6 A. When I retired in 1998, I was, of course, very 7 disappointed at the manner in which my professional 8 career had finished. I felt that my surgical skills had 9 achieved a great deal, but clearly, some aspects of 10 those skills were then under criticism. So that is the 11 position I was in. So certainly I think "proud" would 12 not be the term I would use. 13 Q. Some of your skills, you say, have been under 14 criticism. That tells us little of your view of those 15 skills at that time. What was it, your own personal 16 view of your own personal performance as a surgeon? 17 A. I think my own view was that I had done my best but on 18 what appeared to be the figures and judgments at that 19 time, there was at least a question mark at whether my 20 skills had been what I would have hoped they would be. 21 At that time I do not think there was an answer to all 22 those questions, so I was in doubt and everybody was in 23 doubt. 24 Q. If I had asked you the same question in, let us suppose, 25 1980, a few years after you first became a consultant, 0004 1 what do you think you would have said to me then? 2 A. I would have felt that I was a competent surgeon who was 3 carrying forward cardiac surgery in Bristol. 4 Q. And if I had asked you the same question in 1990, what 5 then? 6 A. I think the answer would have been largely the same. 7 I would of course have been conscious of changes, 8 I would have been conscious of eager young men pursuing 9 me and so forth and so on, but I think I would have 10 still felt I was offering a competent service and the 11 questions that arose later had not significantly arisen 12 at that time. 13 Q. The second question by way of introduction, and I hope 14 to draw the threads together in a moment: you have, 15 throughout this Inquiry, shown a considerable interest 16 in what one might describe as the "figures", if one 17 calls them statistics that may dignify them, but the 18 figures. 19 A. Yes. 20 Q. That is a comment from me. Is it one that you would 21 accept? 22 A. I would. 23 Q. Have you always had an interest in "the figures" 24 relating to the surgical work? 25 A. Yes, I have. 0005 1 Q. You kept your log almost from the beginning if not from 2 the beginning of your work as a consultant, did you not? 3 A. From the beginning, and all the way through. 4 Q. And you personally made returns to the Cardiac Surgical 5 Register, or ensured that those returns were accurate? 6 A. I made them to the best of my ability from 1977 through 7 to 1992, and then I handed that over to Mr Dhasmana. 8 Q. On one occasion that we have heard some evidence about, 9 in January 1994, when there was a meeting in level 7 of 10 the cardiologists, cardiac surgeons, the anaesthetists 11 and others, for the presentation of results when 12 Mr Dhasmana was not himself there, you were able, 13 I think, to give the meeting the results of cardiac 14 surgery, if I say "from the top of your head", I do not 15 mean to say they were invented, because you had 16 memorised them, or you knew them? 17 A. I must say, I do not think it was quite as great a feat 18 as one or two have suggested because in preparation for 19 that meeting, Mr Dhasmana and I had worked together in 20 the preparation of the figures. You will remember that 21 he was the one who was going to make the presentation, 22 so he was the one who had concentrated, so to speak, but 23 we had worked together and that is why I was familiar 24 with the figures, and able to make whatever presentation 25 I was able to make on that occasion. 0006 1 Q. So would it be fair to say that you tended to carry 2 a number of the figures in your head? 3 A. Yes, it would be fair to say that -- not all of them. 4 Q. In March 1997, there was a report, was there, into the 5 performance of the surgeons within the unit in respect 6 of adult cardiac surgery? 7 A. Yes, there was. 8 Q. May we have a look on the screen at UBHT 53/59? The 9 assessors, if we scroll down, Professor Treasure and 10 Professor Taylor, assisted by Professor Black. 11 Can we go to page 66? The second bullet point as 12 they found it: 13 "The performance of one consultant surgeon 14 (identifiable only by the code 1231) appeared to be 15 significantly poorer than the other UBHT consultant 16 cardiac surgeons." 17 Can we go down to the bottom of the page? The 18 second bullet point from the bottom tends to repeat the 19 same point, but it notes that there is more complete 20 data and more detailed analyses that have been performed 21 in order to establish that. 22 The purpose of this question is not to embarrass 23 you but to lay the groundwork for what will follow in 24 respect of paediatric cardiac surgery. Was that surgeon 25 you? 0007 1 A. That was me, yes. 2 Q. Can we go to page 71? The second recommendation: 3 " ... in absolute terms, the assessors consider 4 that [the] operative mortality figures are too high. 5 The data indicate a particular problem in the area of 6 coronary surgery." 7 You accepted their recommendation? 8 A. I accepted their recommendation. 9 Q. The adult surgical report had, had it, approached the 10 analysis of one surgeon in respect of another by looking 11 at risk stratification? 12 A. To an extent. 13 Q. So the results which it purported to show were results 14 which, as far as possible, gave a level playing-field 15 for comparison. 16 A. Yes, they did that, in a number of -- well, they did 17 it -- in the actual report they used what one might call 18 a conventional method of risk stratification and they 19 used it to a limited degree. 20 Q. When did you, if you did, first realise that your 21 personal performance by this period of time, despite 22 attempting to do your best, was not in line with the 23 other adult surgical performances of your colleagues? 24 A. In the preceding November, when the provisional results 25 that you referred to a moment ago were drawn to our 0008 1 attention, and that is when I stopped operating. 2 Q. But before then, despite your interest in and to an 3 extent the retention of some of the figures relating to 4 cardiac surgery, you had had no idea? 5 A. I was surprised, that is correct, but it is not only 6 because of my own personal views. The period we are 7 referring to here is 1997 and over a period of 8 approximately two and a half years, just a little less 9 than that, questions had been asked, that is, prior to 10 Professors Treasure, Taylor and Black holding their 11 investigation. 12 At each point when those questions were asked, the 13 figures of all the surgeons and my figures were examined 14 by a whole range of different people who I can tell you 15 about if you wish to know, but the point I wish to make 16 is that it was not only my own assessment of the figures 17 that had given me a measure of confidence up until that 18 time; it was the advice that I had received from leading 19 people, both inside and outside the specialty, both 20 inside and outside the hospital, so the figures had been 21 shared, as we knew them, fully and openly, and the 22 judgment of those to whom I had looked for advice during 23 that two and a half year period was entirely 24 supportive. So that is why I was surprised, not just my 25 own judgment. 0009 1 Q. Do you, in retrospect, regret not knowing earlier of the 2 apparent disparity between yourself and your colleagues? 3 A. Very much so. That is why I sought the advice of 4 a range of people other than myself and outside the 5 immediate group of cardiac surgeons in Bristol, because 6 I would have wished to have known. If that were the 7 case, then I would have wished to have known as early as 8 possible. 9 Q. Because if you had had an indication of this earlier, 10 as I suspect any responsible surgeon would have done, 11 you would have stopped operating then, rather than 12 later? 13 A. I believe I would, and when it was first drawn to my 14 attention, that is the decision that I made. 15 Q. May we have a look at WIT 87/25? This is a transcript 16 from a handwritten note of Professor Farndon's in 17 relation to a meeting which you and he had together on 18 17th November 1994. 19 Can we look at the first full paragraph: 20 "In fact subject to acceptability of performance 21 figures first broached by James. Degrees of uncertainty 22 on part of JW [obviously you, James Wisheart] re who is 23 ?stirring?/examining/questioning figures of performance. 24 "I think it is you being reported as being aware 25 that Steve Bolsin questions paediatric cardiac surgical 0010 1 performance. But who questions the adults? I say SB 2 [Steve Bolsin] did not question the adults." 3 He reports that three people identified, "Sheila 4 Willatts, Chris Monk and Professor Prys Roberts speak to 5 me about the situation", and "adult performance figures 6 are questioned by Gianni." 7 Again, concentrating for a moment on the adults, 8 your response was: 9 "The figures for the adults have been examined, 10 especially in detail in 1992 and 1993. If stratified as 11 for risk category, little difference between 12 consultants... Some have not wanted analysis according 13 to risk strategy ..." 14 A. Yes. 15 Q. So that was as you saw it at the time. 16 A. That is how I saw it at the time, yes. 17 Q. Implicit in that question is an acceptance by you, of 18 course, that this was actually said at the meeting, and 19 it is Professor Farndon's notes, so feel free to 20 disagree, if you do. 21 A. I would have to say that I do not have a precise 22 personal recollection, but if Professor Farndon has 23 written it, I would be very inclined to accept it. 24 There may be some nuances that I would wish to discuss 25 in this note, if they arise, but basically, I would 0011 1 agree with his note. I would accept his note. 2 Q. At the bottom of the screen, now the second bottom 3 paragraph: 4 "JW says that adverse results must in part be due 5 to (1) weighted patient population re adverse factors, 6 and (2) natural history of AO and valves is that they 7 will, by now, be ready for revisional surgery - query 8 difficult results." 9 So you were, according to the note, explaining the 10 apparent poor results, or adverse results, by two 11 reasons: one was what one might call the case mix and 12 the other was, I think, the fact that the surgery was 13 the second time round, a revision. 14 Have I got it right? 15 A. Essentially, I think that is right. There is case mix 16 and a variety of factors contributing to risk 17 stratification. 18 Q. So in November 1994, there is a conversation between 19 yourself and the Professor of Surgery at which it is 20 recognised that the results may be adverse. Your 21 response at the time is, "Well, if you look at the case 22 mix and the fact that these are second time round 23 operations, in fact the results are entirely 24 acceptable". 25 Again, I am paraphrasing, but is it a reasonable 0012 1 paraphrase? 2 A. Yes, that is the view that I took at that time. 3 Q. Your view, contrary to what was subsequently to emerge 4 from the study performed by Professor Treasure and 5 others, was that the case mix, as between yourself and 6 fellow consultants, made the difference? 7 A. Yes. 8 Q. Can I turn from adult surgery to paediatric surgery? 9 One of the matters I want to explore with you is whether 10 there is a parallel in your approach. 11 First of all, a general question: did you, as 12 a surgeon, always try to do your best surgically for 13 your patient? 14 A. I believe I did. 15 Q. Do you believe that you put considerable effort in terms 16 of time, interest and dedication into that task? 17 A. Yes, I did. 18 Q. Is it the fact that until the report by Messrs Hunter 19 and de Leval in respect of paediatric surgery, you had 20 not thought to question whether your personal results as 21 a paediatric cardiac surgeon, despite doing and trying 22 your best, were not perhaps good enough? 23 A. I am sorry, the question is -- I apologise. 24 Q. Did you ever think, before 1995, putting it slightly 25 differently, that your personal results in paediatric 0013 1 cardiac surgery, or part of it, may not have been good 2 enough, despite trying your best? 3 A. I am not sure what you mean exactly by "good enough", 4 but I questioned my results repeatedly throughout the 5 period under review and before that, myself and with my 6 colleagues. 7 Q. You gave up operating, did you, on the arterial switch? 8 A. Yes, 1988 or 1989, yes. 9 Q. You had performed four operations, had you, and 10 participated in a fifth? 11 A. Yes. 12 Q. And participation was operating with Mr Dhasmana? 13 A. Correct. 14 Q. Why did you personally give up operating on the arterial 15 switch series? 16 A. There are two reasons. The first is that it is 17 a technically complex operation; and the second one was 18 that before we started, I think I had imagined there 19 were going to be quite a number, but once we started, it 20 became clear that the numbers of these operations were 21 going to be quite limited and therefore the conclusion 22 I came to was that in view of the complexity of the 23 operation, it would be appropriate for that work to be 24 concentrated in the hands of one surgeon rather than 25 diluted into the hands of two. It seemed appropriate 0014 1 that the younger surgeon would be the one to carry that 2 forward. 3 Q. Why was age a factor? 4 A. I think that paediatric cardiac surgery has been and 5 still is a rapidly changing and developing specialty, in 6 which the younger men are constantly carrying it 7 forward, if I may put it that way, and clearly the 8 younger man is -- that is his role. That is what you 9 are looking for him to do. That is what you expect of 10 him. 11 Q. The corollary might be thought to be that the older, 12 more experienced surgeon may be too old. Is that what 13 you are saying? 14 A. I think the corollary is turning a little bit on its 15 head what I said. I think that it is a fact, and it has 16 been observed and many people have referred to it in 17 a variety of ways, like it being a "young man's game". 18 The question is, is the old man too old? I did not 19 think that was the issue, but I felt that it was right 20 that it should be concentrated in one surgeon's hands, 21 and given the choice, it seemed right that it should be 22 in Mr Dhasmana's hands. That is a positive decision. 23 Q. You both operated on the AVSD series? 24 A. Yes. 25 Q. Did you give up? 0015 1 A. Doing AVSDs? 2 Q. Yes. 3 A. Complete AVSD? 4 Q. Yes. 5 A. In the latter part of 1994 I did. 6 Q. When precisely? 7 A. I can tell you when I did the last operation, or I can 8 tell you when I made the decision not to do any more. 9 Q. It is the decision. 10 A. The decision? That would have been at the end of 11 September or early October of that year. 12 Q. Why? 13 A. The reason is that over the previous five years I had 14 operated on a number of children with complete AVSD. 15 The results in numerical terms were disappointing. 16 I believed that there were factors of reasons relating 17 to this which, unless you wish me to, I will not talk 18 about now. But I had that information and I believed it 19 to be true and proper information. However, the weight 20 upon me of these deaths and the anxiety and emotional 21 investment, if you like, or drain associated with it, 22 weighed very heavily, and although I still did feel that 23 these additional considerations made at least a very 24 major contribution as a cause of death in these 25 children, I still felt that the weight of this was very 0016 1 heavy upon me. 2 On some date in the middle of that month -- 3 a rather important event had taken place, namely, that 4 Mr Pawade was appointed and at that point we expected 5 him to take up his duties quite early in 1995 -- I said 6 to myself, "Really, I should not, there is no need for 7 me to do any more of these. Mr Dhasmana can cope with 8 whatever needs to be done in the next few months and 9 when Mr Pawade comes, I will be withdrawing from 10 paediatric cardiac surgery". Therefore, I made that 11 decision at that time. 12 Q. So was it the emotional load, trying to do your best as 13 a surgeon for children suffering with that condition, 14 but seeing that your best was not in those cases always 15 good enough, that made you give up? 16 A. Essentially, that is correct. I mean, obviously there 17 was a question in my mind as to whether these reasons 18 that I have referred to, which contributed as causes of 19 death, to a major extent, was my judgment about that 20 correct? Looking back at that now, the one thing that 21 I can clearly say that I regret is that earlier that 22 year I did not sit down with my colleagues and draw 23 their attention to this issue and seek their advice as 24 to whether my views and opinions on the matter were 25 appropriate or not, and to see what their advice was. 0017 1 Q. You refer to that at WIT 120/298. It is the top of the 2 page where you discuss it. 3 "It was, therefore, relatively late in the series 4 of 15 patients when the full weight of these 5 disappointing results came clearly into focus. At that 6 stage I did know the results of the work I was doing. 7 I also knew in retrospect that there was a very 8 unusually high proportion of additional risk factors in 9 my series of patients and I was reassured by that." 10 Do we then perhaps see, in that sentence, the 11 explanation you had been giving yourself? 12 A. Yes. 13 Q. Knowing the figures as you did, because you had the 14 particular interest in figures that you had, you looked 15 for an explanation as to why it was that in your hands 16 the results were not as good as you might have hoped? 17 A. If any child died in anybody's hands, in the team, we 18 always looked to try to find a reason. That was part of 19 our regular activities. I mean, we always questioned 20 any death. 21 Q. Tell me if this is right or wrong, but it must be very 22 rare that there is not some reason, however inevitable 23 the reason may make the death? 24 A. I think it is not rare. I think it is not always 25 possible to identify the cause, the reason, the factor 0018 1 that really made the difference in a particular case. 2 Sometimes you can and sometimes you cannot. 3 Q. If you look down at the part we have on the page, 4 without needing to move it on the screen, the final 5 patient in the series that you operated on had 6 additional factors that, in your view, made the child 7 inoperable, and yet you stopped after that? 8 A. Yes. 9 Q. If the child was truly inoperable, then no surgeon, 10 however skilled, could have saved the child's life. 11 That must follow. 12 A. Yes. 13 Q. Was there, then, at the back of your mind, coming to the 14 conclusion that you did after that to cease such 15 operations, a lingering suspicion that perhaps the child 16 was not as inoperable as logic told you the child was? 17 A. No. There was no lingering suspicion of any sort about 18 that patient. I do not need to go into details, but 19 that patient had two very major factors, one of which 20 was a major factor and one of which on its own would 21 have made it inoperable and the two together meant that 22 that child was, as I say, effectively inoperable. But 23 I must hasten to point out that we did not have that 24 information before the operation, otherwise I would 25 never have embarked upon it. I accept the paradox you 0019 1 are pointing out, but I think it just underlines the 2 fact -- I mean, it is in a sense nearly irrational, but 3 the weight of these results weighs on one and it did not 4 seem necessary for me to embark on that particular 5 operation again, whatever the reasons were. 6 Q. Can we look at 120/410? With regard you say to the 7 series of complete VSDs in the 1990s, "there had been 8 audit activities and in particular the details of each 9 patient who died were reviewed by the team at clinical 10 pathological conferences. It would have been prudent 11 and sensible, however, had the series as a whole also 12 been reviewed by the time, so they could have reached 13 a view on what steps, if any, should have been taken." 14 So you are saying there very much what you said 15 a moment or two ago in evidence, that your regret, 16 I think you put it as, is that you did not say to your 17 colleagues, "Let us have a look at these operations", 18 and not one by one but as a series. 19 The point is, is it, that as a series you may 20 realise a pattern which is not apparent if you look at 21 the individual case on a one by one basis? 22 A. Yes. That is right, and so -- well, whatever number of 23 patients it would have been at that point, 12 or 13 or 24 whatever, those patients could have been looked at as 25 a group, mine alone, not Mr Dhasmana's. They might have 0020 1 been compared with Mr Dhasmana's, but, yes, to 2 concentrate on that. 3 The real issue is that I think what I am saying 4 here is that in fact I relied upon my own judgment and 5 I can give an account of my own judgment if that is 6 needed, but given the figures in retrospect, it would 7 have been right and proper for me to seek the advice of 8 my colleagues so I was not relying entirely on my own 9 judgment, because each one of us, in making a judgment 10 in a situation like this, might be influenced by factors 11 or considerations that another person who is not so 12 involved might not be. 13 So that is why I think it would have been the 14 right thing for me to do. 15 Q. If you, as someone involved, look at a case or series of 16 cases on a one by one basis, there may seem to be, in 17 each case where there is a sad and tragic outcome, 18 a reason, a particular reason, why that was 19 a particularly difficult operation or the diagnosis that 20 you had had, as in the last of the cases, was one which 21 you had not fully appreciated until the child was on the 22 operating table, and so on, particular factors in 23 particular cases that make them particularly difficult. 24 But if you look at it as a series, of course, you 25 cannot take the personal explanations quite so easily, 0021 1 can you, because you have to look at it as a comparative 2 series where the numbers will tend to iron out the 3 differences? 4 A. I am not quite sure, again, of the question, 5 I apologise, but, yes, one would expect that, in a group 6 of patients, factors of this sort would, as you say, be 7 ironed out across the group, and one always expects that 8 in any group of patients there will be a number of 9 patients who have some extra features. 10 What is extraordinary about this group is the 11 concentration of extra features and these are extra 12 features that are objective; they are not a matter of my 13 opinion. Indeed, often the features were not even 14 identified by me, so these are objective features. I am 15 not trying to say that across my work as a whole there 16 was any special systematic difficulty. All I am saying 17 is that it is a matter of objective fact that these 18 additional features were present in this particular 19 group of patients to quite an extraordinary degree, and 20 all the various experts who have commented on this group 21 of patients from whatever standpoint or point of view, 22 none have disputed these facts. 23 Q. Can we look at page 74 of your statement? Can we scroll 24 down? This is dealing with the raising of concerns. 25 You set out here, the third paragraph down on the page, 0022 1 I think, the theoretical approach that should be taken: 2 "Assuming that the concern had been raised clearly 3 and without ambiguity, the response must be in 4 principle, and would have been in practice, both open 5 and clear. This is so regardless of how or through whom 6 the concern has been raised ..." 7 If we go overleaf: 8 "Security Action: 9 "Taking seriously a concern", that is the next 10 step; you say every concern must be taken seriously, if 11 you take it seriously there must be action. "In the 12 first instance that action will be an investigation of 13 the allegation, either internal or external, and what 14 further action, if any, would flow from that 15 investigation will depend on its findings." 16 Can we go back to page 74? In principle, it does 17 not matter who raises the concern. It may well be, may 18 it, the surgeon himself who raises a concern about his 19 or her own work? 20 A. Absolutely. 21 Q. If so, that would require the sort of internal or 22 external investigation and the possibility of action to 23 which you referred. 24 A. Yes. 25 Q. You are saying to us, are you, that thinking back on it, 0023 1 it is a matter of regret that you did not raise your own 2 concerns about your own series of AVSDs at a time when 3 others might then say, "Well, do these need to be taken 4 seriously, shall we have an internal or external 5 investigation, and see where it leads?" 6 A. Or whatever, yes. 7 Q. Because if it had done, then do you think that possibly 8 you might have stopped operating on the AVSDs earlier 9 than you did? 10 A. It is possible, but I mean, I cannot predict what the 11 view of the team or any other people would have been. 12 I did not know. The issues were real issues and the 13 answer to it was not clear. My ability to do the 14 operation as a surgical manoeuvre had been shown earlier 15 in the series, and in the later part of the series where 16 these disappointing results were concentrated, the 17 actual surgical technique and the actual operation 18 itself did not appear to be the issue. 19 So these are real issues and I cannot predict 20 conclusion the committee or group reviewing it would 21 have come to. 22 Q. You regret as well, in your statements, not having 23 pursued Dr Bolsin in early 1994, when you appreciated 24 that he was said to have concerns but had not discovered 25 what those concerns were. 0024 1 A. Well, I had discovered that he was expressing the 2 viewpoint. I am not sure if you are using the word 3 "concern" in the manner defined by this Inquiry. If 4 you are, then I did not know that. I knew that he was 5 expressing criticisms to other people, for a variety of 6 reasons, and I did ask him to tell me what those 7 concerns were in April 1994. 8 Q. But you say in your statement -- I assume it is right -- 9 that you regretted not pursuing him? 10 A. After that. 11 Q. And you give us the reason why you did not? 12 A. Yes. I allowed myself to be deflected. 13 Q. Can I just analyse with you what would perhaps or 14 probably have happened had you pursued those issues with 15 him? Assuming that Dr Bolsin had shared with you his 16 criticisms, shown you the data which he had collected, 17 you might, in early 1994, have been in possession of 18 figures relating to three operations, VSD, tetralogy of 19 Fallot and the AVSD series, and you might also have 20 known of his concerns in relation to the arterial 21 switch. 22 A. His audit in early 1994 I do not think contained any 23 data on the arterial switch. I think that came later. 24 Q. That is why I said "concerns" as to the arterial 25 switch. 0025 1 A. Okay, I am sorry. 2 Q. The response to those would, do you expect, have been 3 something of the internal or external inquiry to which 4 you refer in the passages from your statement that 5 I have just shown? 6 A. Yes, I believe it would. I think that if he had shared 7 his information or his viewpoints with us openly, then 8 I would have, we would have, responded in the way I did 9 in January 1995, when Professor Angelini came to me. We 10 would have been able to sit down with his information, 11 with his viewpoints, we would have been able to examine 12 it and see how much we agreed with, what we did not 13 agree with, and on what was agreed, if there were areas 14 where improvement was needed, then we would have had to 15 address it. If there were areas where there were bigger 16 issues and questions as to whether a procedure should 17 continue, then we would have certainly had to address 18 that. I am in no doubt we would have done that. 19 Q. And because one of the operations was the AVSD, it would 20 almost certainly have provided a review, albeit in 1994, 21 of the AVSD series which might have persuaded you, had 22 it taken place then, to cease operating earlier than you 23 did? 24 A. That is a possibility. 25 Q. It is very difficult for the hypothetical question: is 0026 1 it more than a possibility? Do you think it is 2 a probability, from what you now know? 3 A. I do not think I can say it is a probability. I think 4 I have to stick with the "possibility", but the answer 5 is, I do not know. The answer is, I do not know. 6 Q. You describe what one should in principle do in respect 7 of concerns. Can we look at the Private Eye for 1992? 8 SLD 2/3, first. The passage in the bottom left column: 9 "Recently the unit failed to provide a paediatric 10 cardiac surgery nurse for post-operative care because it 11 was assumed that the baby would not survive the 12 operation, although Liverpool surgeons had successfully 13 operated on 160 babies with Fallot's tetralogy. The 14 Bristol mortality rate is between 20 and 30 per cent." 15 It is talking about what it called the "perilous" 16 state of the paediatric cardiac surgical unit. 17 Can I go forward to SLD 2/5? Again, the bottom 18 left: 19 "In America the mortality rate for arterial switch 20 is now 0 per cent, nearer to home in Birmingham, 3 per 21 cent. In Bristol, despite the fact the operation has 22 been performed since 1988, it is 30 per cent. Sadly, 23 consultant cardiologists continue to refer patients to 24 their surgeons to support the local unit. As a recently 25 retired and very eminent cardiac surgeon in Southampton 0027 1 says, 'Everyone knows about Bristol'." 2 These were concerns, were they not, even within 3 the definition used by the Inquiry, expressed through 4 the media in a satirical magazine. 5 The response from the unit, you tell us, was to 6 put a block upon the holding of audit meetings in the 7 way in which they have been held previously. Why was 8 that the response rather than the open examination, the 9 internal or external review, that you mentioned at pages 10 74 and 75 of your statement? 11 A. First of all, I will answer the question, why was that 12 the response? 13 Q. Why was that the response? 14 A. I do not agree it was the response. It was one 15 consequence, what you describe, but there were other 16 responses, in relation to the first article that you 17 have shown, not the one that is on the screen at the 18 moment, which was about Fallot's tetralogy -- 19 Q. Let us go back to SLD 2/3. 20 A. -- a number of things happened. I discussed it with 21 Dr Roylance. I got out the figures for the last number 22 of years for Fallot's tetralogy, and we reviewed those, 23 and saw they were significantly different from the 24 figures reported in Private Eye. 25 We also received an enquiry from the Department of 0028 1 Health that I think you know about and we shared with 2 them -- we shared with them information which, prior to 3 that, I had shown to a particular parent, and that 4 information included our overall results, the results of 5 Fallot's tetralogy, and as it happened, the results of 6 the particular operation for which those parents and 7 their child, the operation for which that child was 8 waiting. So I think it is not correct to say that the 9 response of the unit was simply to be inhibited about 10 some of its audit activities. It is true that some of 11 them were inhibited and that is, I would point out, the 12 response to the second of the two excerpts you showed us 13 specifically, and the reason for that is that the 14 information provided in that second article somewhat 15 distortedly was reported in Private Eye. 16 Q. The letter that you mention, writing back to the 17 Department of Health because of a parent's concerns, 18 having read the Private Eye article, we can pick up at 19 JDW 3/157. 20 If we go down to the bottom of the page, you say 21 that each item raised in Private Eye on 8th May was 22 fully discussed. In particular, "The results of 23 paediatric cardiac surgery in Bristol for children in 24 general in the late 1980s, the Fallot's tetralogy in 25 particular was discussed in detail ... able to inform 0029 1 the parents of the outcomes in Bristol in relation to 2 the outcomes in the United Kingdom as a whole." 3 The second paragraph on the next page: 4 "Copies of the figures which we put before the 5 [parents] are enclosed for your interest. From them you 6 will see that our overall results are extremely close to 7 the UK results. That our results for Fallot's ... 8 appear to be less good ... chiefly because of an excess 9 number of deaths occurring in the treatment of this 10 condition in 1990. There are other conditions in which 11 our results are better than those for the country as 12 a whole." 13 We will come back to the use of the words 14 "extremely close" to the UK results. Do you, however, 15 let me ask you at this stage, think that was an accurate 16 way for Dr Roylance, in a letter which as we understand 17 it you had dictated for him, or given him the 18 information for, do you think that is an accurate way of 19 putting the relationship between the Bristol results and 20 the UK results? 21 A. I did think so, otherwise I would not have said it. If 22 I might just add, I mean, we did not just offer those 23 words, we actually offered the figures with the UK 24 figures, which I had forgotten about, so the reader is 25 in fact able to judge for themselves. 0030 1 Q. And the explanation so far as Fallot's is concerned is 2 because there has been, if I can describe it as a "blip" 3 I do not mean to be offensive particularly to any of the 4 children treated, but there is an explanation given 5 which is consistent with the overall performance in 6 Fallot's tetralogy being as good as the national 7 average, even although the statistical results and 8 figures would appear to suggest the opposite? 9 A. In 1990 and in 1991, our results with Fallot's tetralogy 10 were disappointing. It so happens that whatever figures 11 reached Private Eye happened -- I mean, it is no more 12 than that -- they happened to focus on that particular 13 time. What that audit did not take account of was what 14 had happened in the preceding years, and indeed, nor did 15 that person take account of what happened in the 16 succeeding years either, as they passed, but to simply 17 state that what happened in 1990 was representative of 18 our work in Fallot's tetralogy was not, on its own, 19 correct. 20 Q. So what you are addressing here was the allegation in 21 respect of 1990 alone, and saying you have to put that 22 into context? 23 A. Yes. 24 Q. And although that is disappointing, if one takes an 25 overall picture, it is rather different. Is that the 0031 1 point you are making? 2 A. Yes. I do not remember at the moment the figures, 3 although I have them here, the figures for 1990, but 4 I absolutely acknowledge and it was a source of serious 5 discussion amongst us that that happened, but it was not 6 representative of a longer period. 7 Q. I am going to come back to the way in which the unit 8 dealt with figures and outcomes, and will explore with 9 you the suggestion that adverse or unhappy results may 10 tend to be explained by a mixture of reasons, case mix, 11 whatever, rather than being treated as the basis for 12 a detailed and thorough investigation. That is going to 13 be a suggestion which I shall come back to and on which 14 I would welcome your response. It is not a case, 15 I hasten to add, it is telling you what the proposition 16 is so that it may be denied, agreed with, or whatever. 17 I must make it plain that I put it to test the evidence 18 and not because there is any form of conclusion by us or 19 by the Panel or by the Inquiry. 20 I tell you that so you can see the purpose of some 21 of the questions I shall be asking and the light in 22 which I hope you will feel able to answer the specific 23 points that I put. 24 Let me first, and the last matter that I want to 25 deal with before the break, can we look at UBHT 52/266? 0032 1 This is part of a report produced by Messrs Hunter 2 and de Leval in 1995, following the operation on Joshua 3 Loveday. It was, I think, commissioned by Dr Roylance 4 and yourself? 5 A. By the Trust. Dr Roylance. 6 Q. If we scroll down, please, and look at the last three 7 paragraphs, consultant 1 has a mortality of 0 per cent 8 for ventricular septal defects, 13.5 per cent for 9 tetralogy of Fallot, 87 per cent for AV canals. 10 Consultant 2 has a mortality of 0 per cent for 11 ventricular septal defects, 0 per cent for tetralogy of 12 Fallot and 8.6 per cent for AV canals. 13 The last sentence of the page: 14 "There is little doubt that consultant 2 would 15 certainly compare very favourably with the best UK 16 institutions. Consultant 1 would be amongst the high 17 risk surgeons." 18 Can we put that on a split screen with 19 UBHT 61/384? There, if we look at the report as it 20 finally was: 21 "For the results of open-heart surgery from 22 January 1992 to January 1995, we have extracted the 23 results of tetralogy of Fallot, VSD and AV canal 24 repaired by Mr Dhasmana, who currently does the majority 25 of those operations, to compare them with the 1990/92 0033 1 results produced by Dr Bolsin. There was 0 per cent 2 mortality for VSD, 0 per cent for tetralogy of Fallot 3 and 8.6 per cent for AV canals. 4 "The current results for individual units in the 5 UK are not available to us. There is little doubt, 6 however, that the above results compare very favourably 7 with the best UK institutions." 8 Can we just highlight that passage, or perhaps cut 9 it out? 10 In the original, on the right, became what we see 11 in the final report on the left. Consultant number 1 12 has been cut out of the picture in the drafting, has he 13 not? 14 A. In the second account, so it would appear. 15 Q. Yes. Can we look at UBHT 52/269? If we scroll down, 16 this was data which was produced and attached to, 17 I think, the original report? 18 A. Correct. 19 Q. When the original report came in, is it the case that 20 a decision was made that three persons would review the 21 original report and make comments upon it? 22 A. I now know that to be the case. I did not know that at 23 the time. 24 Q. Because you were one of the persons who was supposed to 25 have the responsibility of looking at and commenting on 0034 1 the report. There is a memo to that effect. 2 A. Prior to Dr Roylance going on holiday? 3 Q. Yes. 4 A. A few days after the report came in, Dr Roylance being 5 on holiday, Mr McKinlay, who was the Chairman of the 6 Trust, asked me not to have any further dealings with 7 it, and, certainly until Dr Roylance returned, I did 8 not. That is why I did not know that the three or four 9 people, whom I now know, did in fact look at it and 10 write a document, which of course I have since seen. 11 But I did not know about that at the time. 12 Q. Who was it, then, who responded to Messrs Hunter and 13 de Leval and suggested that if they did that, the 14 passages adverse to consultant number 1 should be cut 15 out? 16 A. I do not know that anybody ever made such a suggestion. 17 What was drawn to the attention of Mr de Leval, after 18 Dr Roylance returned from holiday, was that the report 19 which had been written for him was going to be made 20 public, and whatever changes were made were in essence 21 the responsibility of Mr de Leval. 22 Q. This is just for the sake of clarity; you may have 23 answered it: did you have any input yourself in the 24 changes that were made? 25 A. Only in the sense that I believe that I was asked by 0035 1 Dr Roylance to convey what I have just said to 2 Mr de Leval, and I believe I did so. But I may say that 3 I have great difficulty recollecting this conversation. 4 Do you wish me to tell you what I recollect? 5 Q. Yes, please. 6 A. You will recall -- why do I not try to do it 7 chronologically, and put it in its context, if I may? 8 You will recall that Mr McKinlay had, in a sense, 9 put me on the touchline as far as this matter was 10 concerned, which was entirely appropriate. The question 11 of putting the report into the public arena surfaced 12 immediately prior, I believe, to Dr Roylance's return. 13 He determined, in his own mind, some way to deal with 14 this. He asked me to inform Mr de Leval that the report 15 would be put in the public arena, and I believe that 16 I did so. 17 I do not recollect the details. I am certain that 18 I did not suggest to him what changes should be made; 19 I am absolutely certain of that. 20 I believe that, after an interval -- and I do not 21 remember how long it would be but we could probably work 22 it out if we tried to do so -- Mr de Leval had a further 23 conversation with me in which I believe he informed me 24 of the proposed changes that he was going to make. I do 25 not believe that I made any particular comment on that, 0036 1 because I would have considered it quite inappropriate 2 to do so. So that is my recollection. 3 In addition to that, what I do remember is that 4 Mr de Leval was extremely upset when he was informed 5 that the report would be placed in the public arena, 6 because he had not written it with that in mind. 7 Q. Do you have any idea why the report should have been 8 amended in the particular respect that I have just drawn 9 attention to? 10 A. I have no idea why it should have been done in that 11 particular way. 12 Q. As far as you personally were concerned, difficult 13 though it may have been, you would have been prepared 14 for those conclusions to go in the public document? 15 A. If that was Mr de Leval's considered view and -- if that 16 is his view, that would be what would have to go in the 17 public document. 18 Q. One of the conclusions one may perhaps reach is that 19 there were others within the unit or the Trust who felt 20 that you needed to be protected in a way which you 21 yourself did not necessarily desire. 22 A. I would have wanted Mr de Leval to say in the report 23 whatever he thought was correct and appropriate, and 24 whatever that was, then we would have had to deal with. 25 MR LANGSTAFF: I have overstepped a little our usual hour 0037 1 and a quarter, so may we take a break? 2 THE CHAIRMAN: Yes, thank you, Mr Langstaff. Until 12.10, 3 then. 4 (11.53 am) 5 (A short break) 6 (12.20 pm) 7 MR LANGSTAFF: Mr Wisheart, there are some matters of detail 8 that you want to put right, I think? 9 A. Thank you very much. I think I may have misled you in 10 an answer earlier on, and I would wish to correct that, 11 please. 12 I think the reference is WIT 120/336. 13 Q. Let us have that on the screen. 14 A. You put to me that I had said that the learning curve 15 was inevitable and I agreed. But I immediately realised 16 that in fact that was not correct because that is not 17 what I had said in my statement and I apologise. 18 Q. It was my paraphrasing of it and it was therefore my 19 fault for putting to you my understanding of what may 20 have been taken from your statement. Tell us what the 21 case is. 22 A. If we scroll to the bottom of this page, the 23 question: "(A) Is it inevitable?" What I had actually 24 said is "It is probably not inevitable, and in principle 25 it is possible that a learning curve might not happen, 0038 1 but I believe that it will usually be present and 2 measurable." 3 Of course there are a lot of queries, questions 4 that arise out of the word "measurable" because it 5 depends on what you are looking at and observing as to 6 whether you can see something that is actually changing 7 with experience: 8 "My own experience in cardiac surgery is that the 9 learning curve is a real phenomenon." 10 That is really what I wanted to say, thank you. 11 Q. Before we pass from that, that I think is a consequence 12 of my putting to you a question to which I had assumed 13 the answer and thereby inviting you wrongly to agree 14 with me and I am sorry. 15 THE CHAIRMAN: More to the point as well, nothing is ever 16 set in stone; you always have an opportunity to put 17 something in if you feel you have not expressed yourself 18 as you would have wished to have done so. That 19 opportunity exists and should be taken advantage of by 20 all. Eventually we will stop, but do not let us be 21 nervous immediately that this is our last word. 22 A. There is one actually one other sentence which is not 23 a sentence at all and it may have left people 24 wondering. It is at page 29 when I made an -- I spoke 25 an incredibly long sentence, but the bit I am concerned 0039 1 with is at lines 20 to 22. It is in the transcript of 2 what I said. 3 Q. We cannot get the transcript back, I am afraid. 4 A. It is quite simple. What I said was, the words I used 5 were, what was in the second article in Private Eye 6 "came from Private Eye". What I meant to say was that 7 what was in the second article in Private Eye came from 8 an audit meeting within the Trust and I cannot imagine 9 why I said what is written down, but I apologise for 10 that and I have nothing more at this stage. 11 MR LANGSTAFF: I do not think that would have misled 12 anyone. Thank you very much for pointing it out. 13 Can I then begin this section by again asking you 14 a general question? Do you accept the decision of the 15 General Medical Council in your case? 16 A. The answer is that had it been possible to appeal 17 against that verdict I would have done so, but I was 18 advised that in as much as the verdict -- 19 Q. You need not tell us what you were advised unless you 20 wish to do so? 21 A. Not in particular, but I was advised simply that an 22 appeal would not have been successful and therefore 23 I did not proceed with that. 24 Q. Again it is not the purpose of these questions to 25 embarrass you, but I will come back to what it is that 0040 1 you may think -- it may be implicit from what you tell 2 us, was wrong or right in the conclusions that the GMC 3 reached. 4 But let me ask you a second introductory question 5 to the matters I want to raise in this session. You 6 told the General Medical Council that you had "wrestled 7 in your mind", those are the words they use to describe 8 your evidence, with the results that you were achieving 9 in the complete AVSD series. Was that a true and fair 10 reflection of what you were saying? 11 A. Yes, I said that and it is another way of saying to you 12 that I had been thinking about it myself, as I say in 13 retrospect I would have wished I had taken other steps, 14 but, yes. 15 Q. You knew Mr Dhasmana did the same operation? 16 A. Yes. 17 Q. And that his results were, on paper, on the face of it 18 better than yours? 19 A. Yes, I knew that. 20 Q. That the cardiologists on the whole were referring AVSD 21 cases to him rather than to you? 22 A. Yes. 23 Q. And the explanation for your comparative success or lack 24 of it relied heavily upon case mix? 25 A. That would depend on what one means by the words either 0041 1 "case mix" or "risk stratification", yes. 2 Q. You would point out I think in your defence that 3 of 3 the 15 cases that you dealt with in the series in the 4 1990s involved the left ventricular outflow tract 5 obstruction and there was evidence before the General 6 Medical Council that the accepted incidence of such 7 a condition was about 2 per cent? 8 A. That is what I understand to be the case. 9 Q. So you had had the misfortune of having 10 times 10 20 per cent, 3 out of 15 what one might have expected? 11 A. Yes. 12 Q. Therefore you point to there being justification for 13 your approach saying "I had the more difficult cases as 14 it happened to deal with"? 15 A. As it happened, yes. 16 Q. Can I with those few introductory questions go to 17 UBHT 61/271? This is a letter from Dr Doyle to 18 Professor Angelini. Can we scroll down? 21st July 19 1994. 20 "Dear Gianni, It was a great pleasure to meet you 21 on Tuesday. From my point of view, the meeting was 22 extremely helpful, I was very grateful ... 23 "It is with some regret that I have to write to 24 you on an entirely different matter. It has recently 25 been brought to my attention that there are concerns 0042 1 about the mortality rates for paediatric, especially 2 neonatal and infant, cardiac surgery performed at the 3 BRI. I further understand that some sort of audit has 4 been carried out which confirms a greater than expected 5 mortality rate for certain procedures [in the plural]. 6 "As I am sure you will agree, this is a matter for 7 very great concern. If the position proves to be as 8 reported to me, the excess deaths are in themselves 9 a tragedy. If the problem has been recognised and 10 adequate remedial steps have not been taken it becomes 11 an unacceptable tragedy..." 12 This was a letter from Dr Doyle to 13 Professor Angelini, is it a letter which you ever saw in 14 1994? 15 A. Not in 1994. 16 Q. When did you first see it? 17 A. When the GMC provided papers to me. 18 Q. UBHT 61/273. This is Professor Angelini's reply to that 19 letter to Dr Doyle. It is dated 19th August. 20 "I appreciate your frankness and concern about 21 some of our paediatric cardiac surgery work. I have to 22 admit that indeed there have been audits carried out 23 which have shown a greater mortality than perhaps could 24 be expected in a particular surgical procedure" in the 25 singular, although the letter from Dr Doyle had been in 0043 1 the plural. 2 "This has been a matter of concern for us all and 3 we have tried very hard in the last few months to 4 implement changes aimed at improving our results ...." 5 And it goes on to deal with the cardiac surgeon 6 and the unification of children's cardiac surgery at the 7 Children's Hospital. 8 Can I ask you: did you see this letter at the 9 time? 10 A. I saw this letter early in September of that year. 11 Q. Go back up to the top. That is how it comes to you, is 12 it, that this is Dr Roylance writing to you saying, "Can 13 I have your comments?" because what he told us was that 14 when a particular matter arose in respect of paediatric 15 cardiac surgery he would pass the letter over to you or 16 ask you to draft a response to a letter which he had 17 received. You did that and it went out in his name, was 18 the general pattern that he told us? 19 A. That happened from time to time. He often altered them. 20 Q. We looked at a case where he had done just that. 21 A. Yes. 22 Q. We will come to that particular letter later. You 23 replied to him at 276. 4th September: 24 "This letter rightly emphasises that the problem 25 is with one procedure only ..." 0044 1 What procedure did you think that was? 2 A. I was referring to the neonatal switch operation. 3 Q. "The rest of the work is entirely acceptable or 4 better." 5 How many weeks after this letter was it that you 6 gave up operating the AVSD? 7 A. Perhaps a month. 8 Q. So this was written at a time towards the end of the 9 period that you had been wrestling in your conscience 10 with whether you should go on doing the AVSD or not; the 11 answer must be "Yes" to that? 12 A. Sorry, yes. 13 Q. And at a time when you appreciated that your own results 14 were poor. How many of the last 8 AVSDs that you had 15 operated on at this stage had been unsuccessful? 16 A. 7. 17 Q. Why is it that you did not mention in that letter that 18 there was a further problem with the AVSDs? 19 A. I believe I should have done so. Shall I answer your 20 question? 21 Q. Please. 22 A. I mean I have asked myself this question because what 23 I have written here is not sufficient, I should have 24 said more. I can think of two reasons why I did so. 25 One is not very good and one may be marginally better. 0045 1 I think that I too readily accepted the fact that 2 Professor Angelini's letter had referred to a particular 3 operation and ran with that and I think I should not 4 have done so, I should have resisted that. 5 I think the other reason was, you said a moment 6 ago about my wrestling with my conscience. I do not 7 know that "conscience" is quite the right word. I was 8 wrestling with what these figures meant. It was in fact 9 still my view that the additional factors were the major 10 contribution to the cause of death in those children and 11 in a sense the final patient that we have already 12 referred to who was inoperable or virtually inoperable, 13 although the weight of the results led me to the 14 decision to stop that particular patient did not weaken 15 the proposition that the additional factors were the 16 major contributor to death. 17 I think that is the other thing that was in my 18 mind. Having said that, let me say categorically that 19 in line with what I said about seeking a team review, 20 I should have shared this problem with Dr Roylance, at 21 least shared what I was thinking about with him. 22 Q. It follows from what you accept that this letter, the 23 first point certainly is, it is frankly misleading, is 24 it not? 25 A. It depends on what view you take of the AVSDs, whether 0046 1 it is frankly misleading, but the fact that it was 2 something I was thinking about is something that 3 I should have shared with him. 4 Q. If we look at point number 3: "It might be useful for 5 you to write indicating the limited nature of the 6 problem." It is the same point really, is it not? 7 A. Yes. 8 Q. It compounds the failure to address point number 1 in 9 words which, on more mature reflection you would have 10 used? 11 A. Yes. 12 Q. Can we put it that way? 13 A. Yes, indeed. 14 Q. The AVSDs had been recognised, had they not, for quite 15 some time as a possible problem? Let me take you back 16 to UBHT 61/127. 19th March 1990. Perhaps we ought to 17 go back to 126 to show you the start of it. It is an 18 audit meeting for open heart surgery in 1989. Looking 19 at the results, and a particular series are looked at, 20 VSD, Sennings and one thing which needs to be said, your 21 Senning results, and they were your operation 22 principally, were they not, were actually very good 23 indeed? 24 A. That is correct. 25 Q. TAPVD. Then we go over AVSD, other operations and 0047 1 future direction. These operations were selected 2 because they were the major complex operations, were 3 they? 4 A. I am sorry, could I ask you to let me see the beginning 5 of it again, please? 6 Q. Of course. 7 A. Yes, this was an audit meeting considering all the open 8 heart surgery undertaken in children under 1 year of 9 age. So that is the context in which these subgroups, 10 if you like, came up. 11 Q. Do you want to go back to page 127? 12 A. Yes, please. 13 Q. The AVSD: "7 patients were operated on, 6 with complete 14 detects, 1 with a partial defect. There were 4 15 survivors and 3 deaths." 16 In numerical terms not a happy percentage, 17 I suspect, and we see, do we, the explanations given for 18 the particular deaths, post-operative pulmonary vascular 19 problems and one child with left ventricular hypoplasia 20 where the AV valve was small. 21 When it says 2 deaths and then 1, does that make 22 up the 3 or is that the one there one of the two with 23 post-operative pulmonary vascular problems; can you 24 remember? 25 A. It looks as if it is 2 plus 1 equals 3, yes. 0048 1 Q. It is not entirely clear from the text, you see. 2 A. It is not entirely I agree. 3 Q. It could be one of the two; it could be two plus one. 4 A. I agree. 5 Q. It may be it is unfair to ask you to think as it were on 6 your feet. So if you have a further thought about that 7 perhaps you would let us know in due course? 8 A. I may or may not be able to help you, but I will 9 certainly look and see. 10 Q. If we move forward from here -- 11 A. I would like to point out, these of course were not all 12 my patients. 13 Q. No, these are the unit's patients. But the letter which 14 you were responding to which began this train of 15 questions, your handwritten letter to Dr Roylance about 16 the problem operations, if I can call it that, was 17 talking on behalf of the unit, it was not saying "This 18 is my problem"? 19 A. But the problem in 1994 was my problem, not the unit's 20 problem. 21 Q. It was also the unit's problem, was it not? 22 A. In as much as I was part of the unit, but Mr Dhasmana's 23 results, they themselves were perfectly acceptable in 24 this area. In fact I only operated on one infant in 25 1988 and 1989 with AVSD. 0049 1 Q. If we move forward to 61/146. We picked up 1990. This 2 is now July 1991. The minutes you will recall are the 3 minutes which may be disputed to an extent because they 4 were penned by Dr Bolsin and he has told us there was 5 some controversy about to whether he ought ever to 6 minute again. 7 He notes on the first page that the part of the 8 function of the meeting was to review what he records as 9 having been regarded as "difficult operations, e.g. 10 Tetralogy of Fallot, AVSD, et cetera". 11 Is it right that part of the function of that 12 meeting in July 1991 was to review what were thought to 13 be difficult operations such as AVSD? 14 A. I am sure that is correct. 15 Q. If we go on in that minute to page 150, AVSD: 16 "Mr Wisheart said that, in view of the Melbourne, 17 and recent Great Ormond Street experience, these 18 patients should be operated on at a younger age. This 19 proposal was accepted by the meeting. Mr Dhasmana 20 reviewed cases ... but it was a difficult operation." 21 If we scroll on down. 22 So although no mortality figures are there looked 23 at, the feeling at the meeting appears to be this is an 24 operation which is difficult, it is not easy, and there 25 is an appreciation of the need to try various changes in 0050 1 pre-operative, operative, post-operative management in 2 order to see if the unit's results can improve. That is 3 the flavour of it, have I got it right? 4 A. That is correct, yes. 5 Q. If we then go from there to 161. We have looked at 6 1990, 1991 and now 1992. Can we look at 1992. This is 7 where the meeting looked at paediatric cardiac surgical 8 mortality for 1991 with comparison to previous years. 9 Can we scroll down? 10 There AVSD, the last three years mortality for 11 infants, that is under 1s, I think, AVSD, 4 out of 20 12 equals 20 per cent. That is said to be good results. 13 Was it? 14 A. The 20 per cent for infants with AVSD -- we are talking 15 about 1991 -- would certainly be close to what was the 16 figure in the UK register in the years 1990/1991. I do 17 not remember exactly what it was. 18 Q. Still I think -- 19 A. Marginally above, but close, but close. 20 Q. So the unit as a whole has got closer to the UK figures 21 but still above. 22 Can I pick up in passing what is said to be there 23 "Poor results in TAPVD". You appreciate that the 24 document we looked at earlier in respect of TAPVD showed 25 poor results in 1990? 0051 1 A. Yes. 2 Q. Is it right at least at this stage that was a difficult 3 problematic operation? 4 A. Yes, we recognised that and we reviewed it in detail at 5 a subsequent meeting. Could I just please go back? 6 Q. Yes, please. 7 A. You suggested the 20 per cent was less good than the 8 figure in the UK register. I mean I would say to you 9 that I think it would be very difficult to say it is 10 different. 11 Q. Different in what sense? 12 A. In a statistically meaningful sense. 13 Q. This is always one of the problems, is it not, in 14 looking at numbers because if you do one operation of 15 a difficult kind and the child survives, you have 16 100 per cent success rate but you cannot say that the 17 next such operation will be 100 per cent successful. 18 Equally if the converse occurred you would have a 19 100 per cent failure rate and you would not be able to 20 say your next operation was certain to lead to mortality 21 because it is a function of numbers, is it not, and you 22 would not have statistical significance from either 23 result, would you? 24 A. No, but there are 20 operations here. 25 Q. Within a range there is going to be no statistical 0052 1 difference? 2 A. Yes. 3 Q. What happens if year after year after year, taking the 4 results of the unit overall, let us suppose, the Bristol 5 figures although in any one individual year would be 6 within the chances indicated by the national figures, if 7 year after year after year as a point figure they are 8 higher, what conclusion would one eventually draw? 9 A. Well, the statistical methodology will allow you to 10 explore that and as the numbers get bigger, the 11 confidence limits will become narrower and therefore the 12 possibility of showing a difference will increase so 13 that the method will allow you to deal with that. 14 Q. And it makes, does it, the layman's point: that although 15 in one year because of small numbers, a difference let 16 us suppose of 30 per cent mortality in Bristol compared 17 to 20 per cent in the UK as a whole may be entirely due 18 to chance and -- 19 A. Absolutely. 20 Q. If it happens year after year after year, let us 21 suppose? 22 A. Yes. 23 Q. Then as each year succeeds each other year, it is less 24 and less likely to be a chance variation, there must be 25 something institutional, systematic -- 0053 1 A. That possibility certainly exists. 2 Q. Anyway, focusing back on the AVSD, can we now have 3 a look at WIT 115/26? 4 THE CHAIRMAN: Mr Langstaff, just interrupting you for 5 a moment, in your question to Mr Wisheart you say "as 6 each year succeeds another year it is less and less 7 likely to be chance variation, there must be something 8 institutional". There may be, but at least an 9 explanation is called for, that is about as far as we 10 can go; is that not the case? 11 MR LANGSTAFF: Yes, I am happy with that and the question 12 was overstated. 13 This is your document, your response to what 14 Professor Vann Jones said. Can we go to page 27 at 15 (b). You describe here Professor Dieppe coming to see 16 you in November 1993. You were describing I think that 17 he was bringing to you concerns that he had heard in 18 a general, lay sense expressed by others? 19 A. No, he was specifically reporting the conversation he 20 had had with Dr Bolsin. 21 Q. It may be the same thing. In any event he is reporting 22 a conversation about paediatric cardiac surgery? 23 A. Yes. 24 Q. Your response was, as we see at (b), was it, to draw his 25 attention to two operations, the neonatal switch and 0054 1 then your own series of AVSD? 2 A. Yes, I first of all showed him tables with all the 3 results and then I drew his attention to those two 4 operations. 5 Q. You chose those two operations; why? 6 A. Because those were the two series, the figures for which 7 if you like raised a question and if this was actually 8 in November, and I think it is an estimate of the time, 9 but assuming that is correct, then of course the 10 neonatal switches had stopped just the previous month. 11 So that was very much in the forefront of consciousness. 12 Q. That is why I put this in November 1993 because we know 13 they stopped in October. 14 A. In October, yes, but -- I am just explaining why I drew 15 his attention to neonatal switches. I mean, as I have 16 said, it was at this stage (very broadly speaking) in my 17 AVSD series that the fact that the numbers involved 18 raised a question was coming more clearly into focus and 19 so I shared that with him and I said to him obviously 20 what I thought were the reasons for that, how I thought 21 at that time, so I explained that to him. 22 Q. If anyone had approached you, as Professor Dieppe did, 23 at the end of 1993 and said "Do we have any problems in 24 paediatric cardiac surgery?", you would have said "Yes, 25 we have solved one because the neonatal arterial switch, 0055 1 we are no longer doing" and the second is "I have had an 2 unfortunate run of cases in AVSD and I am worried about 3 that, that may be a problem". That is the way you would 4 have responded, is it? 5 A. The figures raised the question, if you like an apparent 6 problem and I am sure I would have indicated to him my 7 understanding of that problem which would then have been 8 up for him to either accept or question further. 9 Q. Insofar as the AVSDs were concerned the problem got no 10 easier or better during 1994, did it? 11 A. That is correct. I operated on the fourteenth and 12 fifteenth patients in the series. 13 Q. Can we have a look at UBHT 54/4? Can we see what that 14 is. That is your statement made long after the 15 operation on Joshua Loveday on 3rd June 1996. You are 16 making your statement in defence of your position in 17 answering criticisms that had been made of you. Can we 18 go to the bottom of page 5? You say that since you came 19 to Bristol in 1975 your personal practice had been 20 conspicuous and time and care was taken to explain to 21 parents the nature of the problem, the proposed 22 operative treatment, the potential risks benefits, the 23 risk always expressed as a precise number. Can we go 24 over the page? 25 "For me the allegations specifically relate to the 0056 1 six AV septal defects operated in the years 1992 to 2 1994. With the benefit of hindsight and the knowledge 3 of outcome in this group, I am asked the question, did 4 I inform the parents appropriately?" And you deal with 5 the question of how on earth one assesses risks and you 6 come, at the bottom of that paragraph to say: 7 "Do I say the risk is 10 to 15 per cent because 8 that is the overall result in our group? No, I said the 9 risk was 20 to 25 per cent. I will gladly rebut 10 allegations about consent in detail and in any forum." 11 Let me understand the process of interpretation 12 that goes on in your mind addressing the next operation 13 in a series. You have told us you are conscious of your 14 own figures. You are worried for a period of 1993 15 undoubtedly, 1994 certainly in respect of AVSDs and you 16 may have had concerns before. When you come to look at 17 the risk for the next operation, how much do you take 18 account of your own series and the success you have been 19 achieving? 20 A. I take account of my own series in as much as they 21 relate to the patient who is now under consideration. 22 Q. If one takes, let us suppose, the AVSD series as it was 23 when Professor Dieppe came to speak to you, 13 of the 24 15. Within that 15 there were quite a number variations 25 on the theme of AVSD, were there? 0057 1 A. There were indeed. 2 Q. But nonetheless all having the same common description 3 applied to them? 4 A. Yes, but that did not make them similar necessarily. 5 Q. So when one comes to the fourteenth, you did not give 6 the fourteenth a risk simply numerically derived from 7 the experience of the previous 13? 8 A. I would have regarded that as misleading. 9 Q. To what extent did you make adjustments up or down in 10 the percentage chances that you would quote to a parent 11 in response to your perception of the condition of the 12 particular child? 13 A. The indication of the level of risk that I would give to 14 parents about a particular child would be based on the 15 information I had about that child and would be tailored 16 for that individual child. So in this context if the 17 child under consideration to the best of our knowledge 18 had an AVSD with either nothing more or only something 19 that would have changed things relatively marginally, 20 then that would have been quite different from 21 a situation where a child had an atrioventricular septal 22 defect and let us say I knew that the child had left 23 ventricular outflow tract obstruction or if I knew the 24 child had severe but not inoperable pulmonary vascular 25 disease. So you cannot just say AVSD, press a button 0058 1 and get a number. The individual child has his own 2 characteristics or her own characteristics and one 3 therefore does one's best to tailor what one says to 4 those individual characteristics because I think it 5 would clearly be inappropriate to ignore those 6 differences that I have just indicated to you if you 7 knew them. 8 So when I looked back on my experience, I think 9 you said at this point I have operated on 13 patients in 10 this particular series from 1990, and that would be 11 correct, so I can say to you that just 9 of those 13 12 were free of a significant abnormality. Therefore if 13 the child in front of me now appears to be free of any 14 significant additional abnormality or risk factor, then 15 the immediate relevance of the previous 13 patients has 16 to be carefully considered, and it is not just a matter 17 of transferring the number or whatever it may be from 18 that experience to this child. 19 I hope I have made myself clear because it is 20 a terribly -- it is fundamentally important to me, this 21 particular point. 22 Q. You have. Let me try and get a perspective on it, again 23 moving from the individual case where there are always 24 going to be individual reasons and justifications for 25 particular risk quotations. Let me ask you this: over 0059 1 the whole of the series of 15 cases, what was the 2 highest risk of mortality that you ever quoted? 3 A. I think 50 per cent and I think that is the notes in the 4 earlier cases. But in order to quote the high risk you 5 have to have the information about the child and so 6 I would wish to point out that in most of these cases we 7 did not have the information at the time. So looking 8 back over the cases, I had the information, but for the 9 child in front of me at that moment I did not have the 10 information so I was acting on the best information that 11 I had. 12 Q. But in the knowledge that the information you had might 13 be incomplete in the way that it had been incomplete in 14 other cases? 15 A. That is theoretically correct, but I mean I must, if 16 I may, point out two things: that in this particular 17 series of mine there was an extraordinary preponderance 18 of these factors. Remember we are talking here of 2 or 19 3 patients a year and there was no such systematic 20 problem across the generality of my work, that is 21 paediatric work, nor indeed was there such a systematic 22 problem across AVSDs which were undertaken by 23 Mr Dhasmana or myself. I mean it is just the way it 24 happened. 25 So you are absolutely right to say that in my 0060 1 series those additional problems were present and were 2 recognised at a late or very late stage, but it is not 3 true that it was in the generality of the work and 4 therefore having had a series of unexpected findings, 5 I mean actually your mind set was the opposite because 6 you thought "I have had more than my share of unexpected 7 findings and therefore it is less likely that in this 8 very series the next patient or the next two patients 9 are going to reveal the same thing"; that is actually 10 very unlikely. 11 Q. To anyone used, as I expect you are to scientific 12 statistics, it is a bit like saying "because the coin 13 has come down heads nine times in a row, the chances 14 must be much greater of it coming down tails the next 15 time you toss it", and of course they are not, are they? 16 A. I take your point and I think you are correct to make 17 it, but I would still point out that the chances of 18 LVOTO are 1 in 50, not 1 in -- 19 Q. 5? 20 A. -- 5, thank you. So it is still a low possibility. You 21 are quite right to correct me, thank you, but it is 22 still a low possibility and you do not expect it to keep 23 coming up. 24 Q. Can you help me with this, just two questions which 25 I would like you to answer in respect of this series: if 0061 1 the highest risk you ever quoted was 50 per cent, what 2 (if you had averaged out the risks that you had quoted 3 across the series of 15) roughly do you think the figure 4 would be? 5 A. This question is the figure I quoted. 6 Q. The figure you actually quoted? 7 A. To the patient, yes. Well it ranged from -- the 50 8 I remember was in a patient in whom we recognised an 9 additional problem and it was also early in the series 10 when my view of, if you like, the baseline risk was 11 a little higher and you will be aware that my initial 12 experience in this series was actually quite favourable 13 and I probably lowered the risk marginally because of 14 that, but only marginally. 15 So I think the average, if you are asking me the 16 average risk, it would probably have been around or just 17 below 30 per cent, but that is an estimate. 18 Q. It is an estimate which I am happy to work with, around 19 or just below 30 per cent. If one looks at the results 20 across the 15, what -- again you probably have the 21 figure off pat -- is the percentage so far as the actual 22 results are concerned? 23 A. Just over 60. 24 Q. As it happens you had over a series of 15 cases quoted 25 half the risks -- looking forward to the operation -- 0062 1 than the event showed to be, if I use the word 2 justified, I mean it in this context: why do you think 3 the results turned out to be twice as bad as you doing 4 your best had anticipated? 5 A. Because additional risk factors of one sort or another 6 were present which had not been identified at the time 7 I quoted the risk. 8 Q. Is the problem the existence of the factor or the 9 failure to identify the factor or both? 10 A. In theory it has to be the failure to identify the 11 factor, whether it was possible or not to identify the 12 factor is another question. I mean the factor was 13 present; it had not been identified; I did not know it 14 -- in most cases, not in absolutely every case, but in 15 most cases -- so that is where we were, that is the 16 position. 17 Q. One of the results of the analysis thus far of the cases 18 in the Clinical Case Note Review for the Inquiry has 19 suggested that much of the criticism or the 20 inappropriate care may have taken place pre-operatively 21 rather than during the course of the surgery itself. 22 There have been told to us in summary a reflection of 23 a failure to identify by the cardiologist, surgeon or 24 both prior to operation the true nature of the anatomy 25 so that the surgeon on the table is surprised by it. 0063 1 How far do you think that report to us is an accurate 2 reflection of the problems that there were at least so 3 far -- let us start where we are -- as you and your AVSD 4 series are concerned? 5 A. We are speaking now of complete or incomplete diagnosis 6 as a question? 7 Q. Yes. 8 A. As far as my AVSD series was concerned, it was the major 9 factor, it was very important. As far as -- well, you 10 did not ask me that, but I was going to say as far as 11 other areas of work is concerned, there was no such 12 systematic happening, it was just the way it happened, 13 it was not across the board. I mean occasionally 14 elsewhere, but not, not like this. 15 Q. Let me ask you a few more questions before we come to 16 our lunch break. Can I ask you to look at UBHT 150/13? 17 This is a letter from Professor Farndon to Dr Black. It 18 is dated 24th July 1996. Page 14. In the second 19 paragraph he is talking about the way in which the Trust 20 and colleagues within the Trust -- this is four lines 21 down -- have behaved at times towards you and 22 Mr Dhasmana and describes that as "despicable", 23 "prisoners in a dock or a soldier in a court martial do 24 not stand alone and have no representation." 25 He talks about providing moral support "will not 0064 1 and cannot be a party to accusations without fact", and 2 then says this: 3 "Mingled into that difficult area are the things 4 that you comment upon, which are the structure of each 5 person's makeup and personality. One example of which 6 might be some inability of James to always see the 7 problem being directed at him. Another example would be 8 Janardan's reticence and totally implicit belief in the 9 Trust and his colleagues without ... having been totally 10 destroyed." 11 The comment there is made from what in the course 12 of this letter appears to be, if I can describe it as 13 a friendly source; do you recognise that as in any way 14 an accurate description of yourself or not? 15 A. That is quite a difficult one. I think it is always 16 easier for others to make this comment about one than 17 for oneself. I would like to have thought that I was 18 able to understand problems that were being put to me. 19 I guess it is for others to judge whether I did or I did 20 not, but I believe I was open to what other people were 21 saying to me and I always regarded myself as a bit of an 22 easy person to influence. In fact if somebody wanted to 23 put a case to me, I found myself being sympathetic to 24 what was being said. I find it difficult to comment on 25 this. 0065 1 Q. I am not going to ask you more about that. We have been 2 through the AVSD series, we have been through your 3 calculation of risks, the risks as you express them to 4 parents and as it turned out approximately double, if 5 one takes a broad average, those that you were quoting. 6 The problem being, in part or largely, that of 7 undetected abnormalities, difficulties with the anatomy, 8 coming to surgery, wrestling with it in your mind and 9 you making the comment as I thought you might in 10 response to what Professor Farndon had to say, but one 11 of the features that the unit would seek to pride itself 12 on was its openness and honesty in discussing problems; 13 why is it that having recognised that the AVSD series 14 was difficult for you personally, that the difficulties 15 may not be with yourself but might be with others in 16 failing to give you the right information as a surgeon, 17 why was it that you did not use your influence in the 18 unit and call for a general investigation, study, 19 examination of the results and simply, unilaterally as 20 it were, gave up? 21 A. In answering your question: I first of all took the 22 view, based on my own experience -- I am repeating 23 myself and I apologise -- that across the board of the 24 work, across the whole spectrum of the work there was 25 not a major problem of incomplete diagnosis. This was 0066 1 something that occurred occasionally, but across the 2 spectrum it was not a systematic, major problem. 3 It so happened -- and that is life -- that in this 4 particular series there was a concentration of such 5 problems. Each individual problem had been, of course, 6 drawn to the attention of whichever cardiologist at the 7 time it came to light and we were discussing and 8 reviewing that patient. 9 So that the problems had been brought to their 10 attention, people did know and I have every reason to 11 believe that -- I do not mean this to sound patronising 12 in any way -- the cardiologists were making their very 13 best efforts to make and deliver as complete diagnosis 14 as possible, I did not doubt that. So I did not do what 15 you suggest, if I understand you correctly by suggesting 16 a sort of wholesale inquiry -- 17 Q. I am not suggesting, I am asking why not? 18 A. Sorry -- 19 Q. The suggestion may be implicit in the question, but the 20 question is: why not? 21 A. Those are the reasons: because the individual cases were 22 drawn to their attention and I did not believe there was 23 a systematic problem across the whole spectrum of the 24 work, it just so happened there was a concentration here 25 and that is what the facts appear to suggest. 0067 1 Q. One of the difficulties I suspect is, is it, that if one 2 atomises a number of operations so that one focuses upon 3 each individual operation as a separate problem, one 4 never gets a perspective of the whole? 5 A. I agree, you need to do it both ways and that is why 6 I regret we did not do the second part of that. 7 Q. I suppose the layman might describe it as not being able 8 to see the wood for the trees? 9 A. I think you have to do both. 10 MR LANGSTAFF: I am going to turn to another matter which is 11 along the same lines. It will take me probably quarter 12 of an hour to deal with it. I am in your hands, sir, it 13 is just after 1.15 and I think it is an appropriate 14 moment for a lunch break. 15 THE CHAIRMAN: We will take lunch until 2.00. 16 (1.20 pm) 17 (Adjourned until 2.00 pm) 18 (2.00 pm) 19 MR LANGSTAFF: Mr Wisheart, in 1986 the unit was visited, 20 was it, by a group of clinicians and others from the 21 Welsh Office? 22 A. Yes. I recall it was. 23 Q. Were you the paediatric cardiac surgeon who showed them 24 around? 25 A. With others. 0068 1 Q. Can we look, please, at Welsh Office 1/266? This is 2 part of the report which Dr Jennifer Lloyd made to the 3 Welsh Office as a result of the visit that she had had. 4 She has described how she was taken around by Bristol 5 staff, and then said this: 6 "We did however raise the question of outcome with 7 Bristol staff." 8 Could I stop there? There had been expressions at 9 about this time, had there not, in Wales, of some 10 concern about the outcomes at Bristol? 11 A. I think that came later. I may be wrong, but I think 12 that came later. 13 Q. Certainly the article or the BBC TV programme was later? 14 A. I was not aware of anything prior to that. 15 Q. Talking about the Bristol staff: 16 "They put to us the accepted point that outcome is 17 influenced greatly by case mix." 18 Do you recollect this discussion? 19 A. Not in detail. Well, I do not really recollect it at 20 all, to be honest. 21 Q. What appears to come from the document is that the 22 results, one might suppose from reading through the 23 paragraph, were presented to the Welsh Office staff, 24 frankly, as not being of the best, but the explanation 25 it would appear was given that outcome, that is, not of 0069 1 the best, is influenced greatly by case mix; that is, 2 "We have more difficult cases and therefore this 3 explains the results". 4 That is what one might take, I think, from the 5 paragraph. By all means, read it through to yourself 6 and tell me if you think that is a fair reading of what 7 one may take from those words? 8 A. I think one could read the second sentence, "They put to 9 us the accepted point ..." as a stand-alone principle 10 statement. I do not think it necessarily has to relate 11 to anything in particular. But as I say, I am not 12 recalling this, please be quite clear, so I am just 13 interpreting what I see before me. In its position 14 prior to the description of the other accounts of 15 outcomes, that, I think, is a possibility. So then, as 16 I say, clearly we stated outcomes for a range of 17 procedures and made some comments about them and there 18 we are. 19 Q. It is not actually clear whether you gave figures or 20 whether you gave a verbal explanation of that which the 21 figures showed. Perhaps it does not matter. 22 A. I accept it is not clear from this, but it would 23 normally be my style to provide figures rather than just 24 make assertions. 25 Q. So if one were, then, to have a look at the figures that 0070 1 there might have been for 1986, if we go to UBHT 55/8, 2 the best I can do from the documents we have, 1984 to 3 1986, the Bristol figures, the UK 1984 comparison: 4 "Open-heart surgery over 1 year, 7.9 compared to 5 the UK 6.9. Under 1 year 26.5 compared to the UK 21.8". 6 Not there broken down by individual operations but 7 a summary total, which would suggest that Bristol is 8 lagging behind, but not far, the rest of the UK, on the 9 right figures, would it not? 10 A. Not necessarily. 11 Q. 7.9 is not as good as 6.9, on the face of it? 12 A. Because I do not think there is any difference, and 13 I mean, what has been put together here is a wide range 14 of patients and operations. So what is the true meaning 15 of 7.9 and 6.9 is not revealed on this table, nor is the 16 true meaning of 26.5 and 21.8. 17 Q. If you are explaining figures such as those to the 18 sceptic who says 26.5 may be a difference of 5 19 percentage points, roughly, compared to 21.8, but that 20 is a quarter as much again, a ratio of approximately 21 4 to 5 between the two figures, how would you say, 22 "Well, this is not actually necessarily different at 23 all"? 24 A. Because in saying what you have said, you are making the 25 assumption that you are comparing like with like and so 0071 1 the question is, is that assumption valid or not? It 2 may be or it may not be. 3 Q. In order to compare like with like, you would have to 4 know what? 5 A. I think there are steps, if you like, but the least that 6 you would need to know to proceed further, I mean, you 7 could, if you like, approach this in a slightly 8 different way of thinking. You could say to yourself, 9 "This looks like a difference; is it or is it not?" So 10 how would you find out? 11 The first step in finding out would have to be 12 what actual operations were carried out on the one hand 13 in Bristol, 49 patients and on the other hand in the 14 United Kingdom for 131 patients, because you know -- by 15 which I mean one knows -- that within each of those 16 groups there will be a mixture of high risk patients -- 17 I am speaking now relatively -- and low risk patients. 18 So the important thing is: are those proportions 19 similar or are they not? 20 Q. Is that a description, in other words, of case mix? 21 A. Yes. 22 Q. So if one were to go back to Welsh Office 1/266, the 23 sentence "They put to us the accepted point that outcome 24 is influenced greatly by case mix", you are quite right, 25 it could be an expression of philosophical principle 0072 1 standing on its own as it were, but in the context of 2 a report such as this, reporting a visit coming as it 3 does before a discussion about the results, the 4 likelihood is that the author, who I say has not given 5 evidence to us, it needs to be said, the likelihood is 6 that the author has it in mind that this is in the 7 relation of explaining the Bristol results. 8 What you have just told me is that looking at the 9 figures for 1984 to 1986, comparing them with the UK for 10 1984, you would say that you have to compare like with 11 like and the results may very well be a consequence of 12 case mix. 13 A. It could even be that the Bristol results were better 14 than the UK. You cannot say from those figures. 15 Q. The paragraph goes on " ... quite openly quoting 16 outcomes for some of the commoner procedures they have 17 to undertake. They see a gradual improvement in these 18 as expertise grows and specialist equipment becomes 19 available." 20 The "gradual improvement... as expertise grows" 21 looks as though it is an explanation for a degree of 22 under-performance by Bristol relative to the rest of the 23 UK. Is it, do you think? 24 A. I think it could equally be a positive statement, that 25 as experience, expertise in the volume of work 0073 1 undertaken grows, then it is likely that results will 2 improve. I do not think it has to be seen as an 3 explanation for something that may or may not be 4 inadequate. I think everybody will agree -- 5 Q. "Inadequate" is not the word I actually used. 6 A. I am sorry, it was a loose term. 7 Q. Can we just examine that point in relation to DOH 4/28? 8 Turn it sideways. At this stage, the end of 1986, 9 a build-up in numbers of open-heart operations -- 10 I think you and I may have discussed this table before, 11 but not very many open-heart operations under 1 year of 12 age, on any showing. 13 A. Correct. 14 Q. And if one goes to the point that was being made about 15 expertise increasing as results improving expertise 16 increase, one might very well have a reflection of the 17 idea that low numbers, which one hoped would increase, 18 would lead to an improvement in results? 19 A. One certainly could. 20 Q. And it would have been appreciated, I expect, that in 21 terms of throughput of cases in this age group, most 22 other centres in the United Kingdom would be doing 23 a larger number. 24 A. I think that may be so and there certainly were centres 25 doing a larger number. Most of the tables from the DOH 0074 1 show that we were smallest, but they also show that 2 there were a group of centres doing a relatively small 3 number. I think the historic setting of what we were 4 talking about is very important, because surgery in the 5 under 1s was something that had been at a very low level 6 through the 1970s and was beginning to grow, so, okay, 7 some folks were a year or two ahead of other folks, and 8 quite a number of folks were not doing very much, and in 9 the early to mid-1980s, we were in that latter group, 10 and hoping to develop the work as others were doing. 11 Q. Indeed, and as others had done, because I suspect if you 12 had in mind the larger unit where there may have been 13 a throughput of 50 or 60 cases per year instead of the 14 4, 11, 14, 24 that we have seen for the years 1983 to 15 1986, it must follow that if increased experience 16 improves results, you would expect the larger units 17 actually to have better results. 18 A. Yes. I mean, I do not disagree with that thesis in 19 principle, but in fact everybody was on the move. You 20 suggested that the larger units had done something. 21 They were moving. They were just at a further point 22 along the road. But everybody was changing. If you 23 look at the register over the years, you will see the 24 very dramatic evidence for that in the total numbers of 25 open operations in the under 1 age group. Everybody was 0075 1 moving at this stage. 2 Q. I think the point I was simply making or asking you to 3 comment on was whether it is not the case that if 4 everyone was on the move, it is a necessary consequence 5 of an acceptance of the principle that experience of 6 a greater number of operations leads to better results, 7 that they would get to the good result position quicker 8 because they would have a greater throughput and more 9 experience. 10 A. Possibly, but then clearly those who are not as far 11 along the road as they are at that particular point 12 aspire to get up level with them, so these are not fixed 13 positions. It is not a fixed situation at all; it is 14 a situation in which everything is changing and people 15 are changing their techniques and practice, and those 16 who are behind are seeking to achieve the standards of 17 those who are presently in front of them, but to achieve 18 those standards. That, I think, was everyone's goal at 19 that time. 20 Q. Can I go back in the light of that discussion to 21 WO 1/266? I appreciate you have no specific memory of 22 the conversation. What I am trying to do is to 23 understand the ideas, the arguments, the thoughts, at 24 the time. 25 "For most of the more commonly occurring 0076 1 conditions, their figures compare well with other 2 centres. They acknowledge, however, that surgeons in 3 different centres develop special expertise in rarer 4 conditions and that outcomes may therefore vary greatly 5 for these between centres." 6 Is this a way of saying, "Well, for those 7 conditions which we do a number of and therefore have 8 developed an expertise in, our results are quite 9 reasonable; that for the rarer conditions, they are not 10 so good simply by virtue of the fact that these are 11 rarer conditions and we have not yet built up the 12 necessary expertise, even though we hope to do so"? 13 A. Yes, it could mean that. I do not entirely recognise 14 myself in this sentence here, if I may say so, but it 15 could mean that which you suggest. Of course, that is 16 a correct reflection of the position we were at. There 17 were some operations with which we had a limited 18 experience at that time. 19 Q. Did it follow that at this stage, the end of 1986, if 20 anyone had asked you outright at the time, "Are Bristol 21 good at [a rare complex operation]?", the answer would 22 be "Well, we are learning, we are getting there, but we 23 are not actually as good as some places who have more 24 experience of this condition than we do"? 25 A. I cannot think of a for instance, but I think it would 0077 1 have varied from operation to operation. 2 Q. So true of some but not others? 3 A. Yes. 4 Q. The throughput that there was in Bristol remained 5 relatively low, did it, even though in absolute numbers 6 it increased, as we saw at DOH 4/28, up to 40 by the 7 early 1990s? 8 A. Yes. It increased up to 50 by 1993/94. 9 Q. That is as high as it ever got, I think? 10 A. That is correct. You are now referring simply to the 11 work on the under 1s? 12 Q. Yes. 13 A. That was relatively low, yes. 14 Q. Part of the reason for the increase in the under 1s was 15 a general desire to do work at an earlier age? 16 A. Yes. It was not an arbitrary desire; it was a wish to 17 do so because it was thought to be in the patient's 18 interest. 19 Q. But a consequence of that general desire in the 20 patient's interest? 21 A. Yes. 22 Q. And no doubt also in the development of surgical 23 techniques and improvements in equipment that enabled it 24 to be done? 25 A. Yes. The two go hand in hand, because you can only 0078 1 advise it when you can do it and do it, as I say, in the 2 patient's interest. 3 Q. So far as case mix is concerned, we were told in almost 4 the first question and answer that he gave by Dr Joffe 5 that the case mix, as he saw it at Bristol, was, he 6 thought, no different from that anywhere else in the UK, 7 in general terms, with the exception of Down's syndrome, 8 which I will want to deal with separately in a moment. 9 Is that a proposition that you accept or reject? 10 A. I do not entirely agree with it. I would be happy to 11 offer you the evidence, although it does not come 12 chronologically until a year after this. 13 Q. Tell me. 14 A. It would be helpful if I could refer to a document. 15 Q. Yes, please. 16 A. I might need a prompt from somebody as to what its 17 number is. I think it is UBHT 167/32. 18 Q. Let us try that. You are right. 19 A. Shall I take you through it? I think the introduction, 20 if I may, is that if one is doing a relatively small 21 proportion of operations in the first year of life, as 22 we were at this time, I mean, not only number-wise but 23 percentage-wise -- I am now talking about 24 a hypothesis -- then it seemed likely that there would 25 be a preponderance of emergency and unavoidable cases 0079 1 whereas the ones that were elective and probably had 2 lower risks were ones we were not doing and if that was 3 so, that might bear on the overall results. 4 With that in mind, I took all the Bristol figures 5 for the four years 1984 to 1987 and I took the UK 6 figures that were most recently available to me and 7 rather than just take all the under 1s in each group and 8 compare the overall numbers -- which were approximately 9 the 21 and 27, I think, for this whole period, I think 10 if we scroll down we would see that, actually, just 11 a little bit. So 21.4 for the UK and 27 for Bristol. 12 So I actually took the categories of operation that were 13 carried out in Bristol -- 14 Q. Could I just ask you to stop there to ask you two 15 questions? First, when did you do this? 16 A. In 1988, I believe. 17 Q. And the second question: did you carry out this 18 examination in response to a concern that the Bristol 19 figures might be so regularly higher than the United 20 Kingdom figures that they needed some investigation 21 because some explanation was called for? 22 A. I am not conscious of that. I mean, my recollection is 23 that I did it out of my own curiosity. 24 Q. To find an explanation for what? What made you curious? 25 A. One always looks at numbers and wonders why they are the 0080 1 way they are. I have explained to you that there was 2 a proposition that was generally held amongst us but 3 which had not been explored, so I thought it would be 4 interesting to explore it. 5 Q. So you were exploring a reason which others, and 6 yourself, had suggested? 7 A. Yes. 8 Q. I am sorry, I stopped you -- 9 A. It is more a commentary on the work than an explanation 10 for a perceived problem, I think. 11 Q. I was curious to know why it was thought that the 12 commentary was one which it was sensible to undertake. 13 A. It is part and parcel of trying to understand why people 14 have died. You have to look into it. You cannot just 15 stop at the numbers, you have to ask why. There are all 16 sorts of whys that need to be investigated, and this is 17 one of them. 18 So I took the categories of operation that we 19 actually did in Bristol and for each of those, I took 20 the reported mortality in the UK. So if we take the 21 first one, we had operated on 7 patients with aortic 22 stenosis. The mortality in the UK was 23.3 and so 23 I said to myself that if the mortality in Bristol with 24 7 cases had been 23.3, then 1.63 deaths would have 25 occurred. You will forgive the decimal point, but it is 0081 1 the only way you can do it. 2 Q. You are dealing with the concept and not the actual 3 people? 4 A. Yes. 5 Q. Can I ask you one question about that? Did you have the 6 number of cases for the United Kingdom when you started 7 this comparison? 8 A. Yes, I would have had. 9 Q. Were you comparing the position as it would have been in 10 Bristol as against the whole of the UK including 11 Bristol? 12 A. Yes. 13 Q. Or the whole -- I was going to say, not the whole of the 14 UK excluding Bristol? 15 A. No, I did not subtract the Bristol numbers; I just took 16 the whole numbers as they were. 17 Q. It may not make a very great deal of difference to the 18 figures, but you would have to subtract the Bristol 19 figures from the UK figures to get a comparison of 20 Bristol against the others, would you not? 21 A. I do understand that, yes. Yes. 22 Q. I am sorry, again, I stopped you. 23 A. If we go down to ventricular septal defects, where there 24 were 15, then the UK mortality is 12.4 and if that 25 mortality were applied to Bristol patients, we would get 0082 1 1.86 deaths, and so forth. 2 To cut through to the bottom line, if one adds the 3 calculated or expected deaths in Bristol based on a UK 4 mortality, the total is 19.24. The actual number of 5 deaths that occurred in those patients in Bristol was 6 20. So while this is simple, perhaps even naive 7 statistics, it is very simple, nevertheless, this did 8 seem to indicate to me that case for case, the overall 9 results, therefore, were very similar. 10 Q. How does one allow for the miscellaneous category, what 11 it may contain? 12 A. They contain -- I think there is an asterisk there. 13 Q. Can we scroll down and see what the asterisk relates to? 14 A. No, that does not help us. I think to be honest, 15 I would need notice of that. I cannot remember exactly 16 what I did. I may have taken the categories from the 17 register which related to the operations in our 18 miscellaneous experience, or I may have taken everything 19 else and I cannot answer that question at this minute, 20 I am sorry. 21 Q. The overall conclusion then that you drew from this was 22 that the difference in overall figures in Bristol 23 compared to the UK was because Bristol was doing 24 a higher number within the period 1984 to 1987 of those 25 cases which carried the greater risk of mortality. 0083 1 A. Yes. 2 Q. And if one allowed for that in the way that you have 3 done here, the results were so close as to be almost 4 indistinguishable? 5 A. Yes. I am not sure that "allow" is the right word 6 because it suggests a concession, and I do not think it 7 is a concession; I think it is a statement of reality, 8 if I may. 9 Q. If you take the interpretation of the figures in the 10 light of that information, may be a better way of 11 putting it, perhaps, but that is the point you are 12 making? 13 A. Yes, in a simple amateur way. 14 Q. So having done that exercise for the years 1984 to 1987, 15 where there is a relatively small number of cases, did 16 you replicate it for later years? 17 A. I do not believe I did at the time. 18 Q. If we come back to the question which sparked your 19 showing us the document, it was whether you accepted or 20 rejected that which Dr Joffe told us. 21 A. That is right. 22 Q. And your indication was, I think, that you accepted it 23 to an extent, but not entirely, or you differed from it 24 a bit. How would you put it? 25 A. That is correct, I differ from him to a degree, and 0084 1 I think at that time -- I cannot remember the figures, 2 although there is a table somewhere with them on it, but 3 the percentage of work we did in the first year of life 4 at this time was smaller than the rest of the UK. By 5 1990 and later, the percentages were much closer 6 together. I think it is sufficient to say that, 7 I think, to make a point, and therefore I would not have 8 expected these sort of differences to be a major factor 9 necessarily through the 1990s. 10 I think at this stage they were, and it was simply 11 a reflection of fact that we did a smaller proportion of 12 work in the first year of life. 13 Q. So at what stage, again, roughly -- you do have the 14 table set out in your statement, I think, of the 15 proportion of operations? 16 A. Somewhere. I think it is in d