Annex A > Chapter 17 - Communication Between Healthcare Professionals and Patients > Calculating risks and informing parents about them
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Calculating risks and informing parents about them
The approach of the clinicians in Bristol
Mr Dhasmana
`The national data, as received from the UK Cardiac Surgical Register (UKCSR) certainly influenced me in my discussions with parents. I believed that this data was an average for all centres in the country, some of which were lesser volume units like ourselves and may have been new to the procedure, and therefore should be achievable. As the data from the individual units were not available, this was the best guide I could have, during the early part of my career in mid to late eighties, when I had [a] smaller number of cases, where figures could not be predicted with any confidence. But the register was not helpful in ... operation[s] like Arterial Switch, as the UKCSR categorises paediatric patients according to the pathology and not the type of operations. The Arterial Switch was performed in different group of patients and similarly the patients with Transposition of Great Arteries were treated by more than one technique in the country. Therefore the true mortality figures of the Arterial Switch procedures for a particular group of patients could not be known from the register.' [93]
74 Mr Dhasmana said he used the data relating to the BRI as a basis for discussion with parents for most procedures, with the exception of Arterial Switches, which only he carried out. [94]
`I did take account of my record after 1990 when I had enough patients on my list to speak with any confidence on most of procedures. But this did not help me with Arterial Switches, which was started late (1988 in older children and the neonatal programme in 1992). In addition I was operating on average on 2 - 4 patients per year, not enough to speak with any confidence on my own figures, except in the group of older children, where I developed enough experience by the end of 1992, to quote with confidence my own figure.' [95]
76 Mr Dhasmana told the Inquiry that he did not inform parents of the figures relating to his success or failure figures in a particular procedure unless he was asked:
`A. The first few patients I always quoted 50:50 may or may not make it. I even quoted 60 per cent, but my record is very good in Truncus after 1989; I had done 6, 7 or 8 without any deaths. I think in 1993/94 when I was talking to a parent about truncus, I would be giving a risk of about 30 per cent.
`Q. From that last answer, it appears you modify your assessment of risk given your own personal experience?
`A. That is right. If you have a series you will quote with confidence, you can quote. If you have no series, you have nothing else to fall back on except published literature, which you believe in.
`Q. I want to contrast the fact that your good experience causes you to reduce an estimate of risk made to a parent, as in, you say, your Truncus Arteriosus after 1989, but your bad experience, as in the neonatal Switch, did not cause you to increase your risk estimate to a parent, rather it made you go back to published literature and rely on the general medical risk in any particular centre.
`Why take a different approach depending on whether your results were good or bad?
`A. It was not a different approach. I find it difficult to explain nowadays with whatever information we have in the post-1995 era, what we should be talking to parents and what we should not be. I do believe that one has to put [in context], especially as a surgeon, in the era you were talking to parents, and what was happening. I did not think I was doing anything different than what was being done elsewhere. If any of those parents would really have asked me what was happening before, I would definitely have told them that had happened.
`Q. That relies on them asking you. You are the expert?
`A. Well, I am afraid at that time, that is what the practice was, and I was just following the practice.
`Q. You did not have to follow anyone else's practice; you had your own relationships with parents, did you not?
`A. Well, you do not develop a relationship on the first day you are seeing them, really, do you?
`Q. What, if anything, prevented you from saying, for instance, "Well, the risk in this operation is 25 per cent but what you ought to know is that the last five such cases that I have dealt with have been entirely successful." That is one way of putting it, if that has been the case. One would have no problem with that, if 25 per cent reflected a general risk.
`The converse: "The risk is 25 per cent but what you need to know is that sadly, for I think particular reasons, but sadly the last five I have operated on have all died." Did you ever think of putting it that way?
`A. Not at that time, no. I did not tell them my successes or failures, unless I was asked about it.
`Q. Do you think you ought to have told them, rather than wait to be asked?
`A. Now, I think what has happened after 1995, I think, yes, we should be now doing that, but thinking always changes with the passage of time. We have become wiser now.' [96]
`My quotations for mortality figures changed over years keeping in pace with improvement nationally. To quote an example, in Tetralogy of Fallot a figure of 15% mentioned over mid to late eighties changed to under 10% after the year 1992-93. Similarly in cases of Complete AV canal, quotes for the mortality figures came down from 25-30% in late 80s to 20% in 90s.' [97]
78 As regards referral to another centre, particularly when the proposed surgical procedure was new, Mr Dhasmana stated that he followed what he understood to be the standard practice prevalent amongst his colleagues, together with knowledge from his training. He stated that his practice was to inform parents when new procedures or modifications to existing procedures were being proposed. [98]
`In 1988 when I started the Arterial Switch programme, the parents of the first patient were informed and asked whether they would like to take their child to another centre like Birmingham ... Similarly in 1992 when I started the neonatal Switch programme, the parents were informed that this was a new operation in the neonatal period and that I had performed this procedure in older children.' [99]
79 Mr Dhasmana further stated:
`I was not aware of any obligation that I should have quoted any comparative figure from other centres to parents during the preoperative discussion. During my training I had not witnessed this in any of the centres ... I was aware that in most cardiac operations I was within UK figures or catching up ... For Arterial switches no comparative data was available from other UK centres except from Birmingham until 1992 ...' [100]
`... I would have provided some information to parents if asked.' [101]
80 He referred in his written evidence to the Inquiry to a meeting with parents of a baby with Truncus who did ask about comparative information. He stated that he could only give figures from the UKCSR:
`I mentioned centres like GOS [Great Ormond Street Hospital] and Birmingham without any real data, as no figures were available from these or any other centres in the country.' [102]
81 As regards informing parents, during pre-operative discussions, about the current record relating to mortality and outcome in the Unit, Mr Dhasmana told the Inquiry:
`I used to tell them, in a way, that we were not doing this type of thing before; now we have started doing it. But I do not think I have really mentioned, except for the first few cases in the beginning, that this is what has happened in the past and I am not - you know, this is my results, no, not that way.' [103]
82 Discussing guidance on informed consent and on quoting risks, Mr Dhasmana said:
`There was no guidance at that time, and I did not know we were supposed to be saying that, because I had worked in a number of places and I heard nobody saying those things.' [104]
Mr Wisheart
83 Mr Wisheart described his approach in his written evidence to the Inquiry:
`My training, reading and personal views led me to explain to parents in detail what was involved in an operation and what estimate of risks were attached, and I devoted a substantial amount of time to this part of my work. This was the case throughout my time in Bristol from 1975 and initially I understood that my practices in this respect, were new in Bristol.' [105]
84 Mr Wisheart stated that he understood:
`... that the first written advice from the GMC on consent was published in 1999. Their booklet "Good Medical Practice" published in October, 1995, contained general advice only. The Senate of Surgery of Great Britain and Ireland gave advice on consent in October, 1997 in "The Surgeon's Duty of Care".
`I believe that there was a booklet prepared by the Medical Protection Society on the subject of Consent, but it was only sent out on request or in relation to a relevant enquiry.' [106]
85 Mr Wisheart stated that as regards informing patients of the risks involved in surgery:
`During the period 1984-1995 I provided information on the risks associated with surgery in the following manner, in outline:
- `I provided an explanation of the abnormality that was present in the heart.
- `I explained what would be the consequences of that abnormality if left untreated.
- `I indicated what treatment was available for this abnormality.
- `I indicated what I believed was the treatment of choice, and gave that as my advice. I would have indicated what I hoped would be achieved by following that course and whether there were any major predictable limitation. I would then have given them an indication of what risk of mortality was associated with this advised operation. I would normally do this by saying either:
`(i) that the risk of this operation is X%, by which I mean that if 100 children had the operation 100-X would come through but X might die at or following the operation.
`(ii) I might simply say that if 100 children had this operation I would expect so many to come through (quoting a number) but that the remainder (quoting the residual number) would not come through, or would die at, or following the operation.
`Occasionally, I would have discussed alternative methods of treatment.
`Save for coarctation surgery ... it was not part of my routine to indicate the risk of surviving with a permanent complication or injury, which for practical purposes means a central nervous system injury. It is my belief that such explanations were not generally given until recent years ...
- `This explanation, in nearly all cases was given by myself and in many cases would have been in the presence of a nurse, a counsellor or a junior doctor.
- `I always invited parents to ask questions and discuss the issues.
`For completeness, consent for cardiac catheterisation was obtained by the cardiologist and consent for general anaesthesia by the anaesthetist.' [107]
86 Mr Wisheart told the Inquiry that he took account of data relating to his own practice, in so far as they were relevant to the patient whom he was treating at the time. [108] In his written evidence to the Inquiry he stated:
`The risk involved in a procedure, is the risk in the here and now; that is to say in this Institution, by this surgeon, in the present era. It is not sufficient to quote the results of another surgeon or an eminent centre elsewhere, such as the Mayo Clinic. There will normally be figures for the Institution and for the surgeon which can be the basis of information provided to the patient or to the patient's parents. However, the difficulty is that for many operations, the numbers involved in the Institution's own experience will be so small as to make those figures unreliable, or unhelpful. Reference must then be made to larger registers and other sources of information.
`It is also important to note that the risk given for any given child is not just the risk for a set procedure, taken from some list or document, it is the risk of that procedure taking account of all the relevant details and circumstances of that child. Thus for example;
`1) If the child has additional abnormalities, or
`2) If the child's condition is unstable at the time of the operation, or
`3) If the operation is of an emergency nature,
`any of these factors will add to the risk of the operation. Therefore the risk to be given has to be tailored to the needs and the circumstances of the individual child.
`Finally it would be quite wrong to depict a surgeon as a doctor who simply carries out procedures, the results of which can be measured, or that the understanding between a surgeon and his patient is simply that the surgeon will carry out a tightly defined procedure.' [109]
87 Mr Wisheart told the Inquiry further:
`The indication of the level of risk that I would give to parents about a particular child would be based on the information I had about that child and would be tailored for that individual child. So in this context if the child under consideration to the best of our knowledge had an AVSD with either nothing more or only something that would have changed things relatively marginally, then that would have been quite different from a situation where a child had an atrioventricular Septal Defect and let us say I knew that the child had left ventricular outflow tract obstruction or if I knew the child had severe but not inoperable pulmonary vascular disease. So you cannot just say AVSD, press a button and get a number. The individual child has his own characteristics or her own characteristics and one therefore does one's best to tailor what one says to those individual characteristics because I think it would clearly be inappropriate to ignore those differences that I have just indicated to you if you knew them.
`So when I looked back on my experience, I think you said at this point I have operated on 13 patients in this particular series from 1990, [110] and that would be correct, so I can say to you that just 9 of those 13 were free of a significant abnormality. Therefore if the child in front of me now appears to be free of any significant additional abnormality or risk factor, then the immediate relevance of the previous 13 patients has to be carefully considered, and it is not just a matter of transferring the number or whatever it may be from that experience to this child.' [111]
88 Mr Wisheart stated in his written evidence to the Inquiry that information on the child's condition was:
`... the essential and the fundamentally most important information in assessing the risk of that child having any particular procedure. The risk can be predicted to be influenced by such factors as -
`ii. The child's condition at the time of the operation; eg. is he or she ventilator dependent?
`iii. Is it an emergency operation?
`iv. The presence of Pulmonary Vascular Disease, which has not achieved a level of severity that would contra-indicate the operation altogether.
`v. In the early part of the era mainly young age and low weight would have been considered important incremental risk factors.
`This group of factors, without doubt influences the risk. Some factors will do so to a marginal extent and others to a highly significant extent. The difficulty is that there is no general accepted basis for assessing in a precise or quantitative manner, the degree to which any of these factors would increase the risk. It is only possible therefore to do so in a qualitative or, even possibly, an arbitrary manner. Once a risk factor is identified then one can begin the work of attempting to neutralise or minimise the effect of a risk factor and thus reducing the risk of the operation.
`It was my practice always to consider factors such as these when making an estimate of the risk, even though there was no basis for doing so in a precise manner.' [112]
89 Mr Wisheart stated that, as a consequence, the BRI's and his own personal record were the basis for any quotation of risks to parents:
`These should be taken together as they are the real foundation for advice to parents about the risks of any particular procedure. In 1999 it might be thought that such data would have been constantly updated and freely available to surgeons throughout the period under review by the Inquiry. However, this should probably not always be assumed to be correct. I depended on my own log and on the material in the annual statistical summaries. In my experience the main limitation of local data was that for many of the procedures, the numbers locally may be very small. Indeed these numbers may be too small to be considered in isolation.' [113]
90 Asked by Leading Counsel to the Inquiry about the extent to which risk stratification could affect the way he described the degree of risk to a parent, Mr Wisheart replied:
`... risk stratification are the factors that may exist within each of those categories altering the risk above or below the figure given and that is the core of the problem in all of this issue.
`Because I can describe the presence of the abnormalities, I can give a qualitative indication of their severity but I cannot put a figure on it and therefore I cannot do a calculation and say "In this group of patients the risk is half normal, double normal, treble normal", I cannot do that. All I can say is that the effect of all of these observed additional factors put together seems to be important and may double or whatever the risk. But there is no basis for being precise about it. That really is the central difficulty. Otherwise I think one would be able to communicate it much more clearly.' [114]
91 Referring to the figures and the quoting of risks at other centres, Mr Wisheart stated:
- `In general, this information about individual centres was not known, therefore it would not have been possible to refer to risks at other institutions.
- `There may have been some procedures, for which there may have been information (although not necessarily precise information) about higher or lower risks at some other institutions.
- `I am not aware of any professional or ethics guidance or requirement to refer to risks at other institutions during the period under review by the Inquiry.' [115]
92 Mr Wisheart described the use of national and international data and published papers. As for national data, he stated:
`Throughout the period 1984-1995 there has been national data in the form of the United Kingdom Cardiac Surgical Register (UKCSR). It has strengths and weaknesses, which have been outlined elsewhere in the evidence provided to this Inquiry. For the surgery of any condition, it provides an aggregated figure for the whole country or a national average. It does not provide the range of results from the Institutions or surgeons across the country, nor does it provide risk-stratified data. Nevertheless, where the unit's or my own surgical figures for the procedure in question are very small, I would also consider and give appropriate weight to the reported experience across the UK.' [116]
93 Regarding international data, Mr Wisheart stated:
`During the period 1984-1995 data from registers in other countries or from international registers was very limited. The only data which I can recall came from two groupings of surgeons in North America, namely the Congenital Heart Surgeons of North America and the Paediatric Cardiac Care Consortium. The information they made available up to 1995 was very limited. The latter group has published the results of their work for 1984-1995.' [117]
94 As for published papers, Mr Wisheart stated:
`Often these papers came from centres of excellence and usually only papers are published which give the best results. They are therefore not representative, and are of limited use, and do not often contribute to the assessment of the risk in a particular operation. Over the years I can only remember a very few occasions when I relied on reports in published papers, to make an estimate of the risks of an operation.' [118]
95 Commenting on the views of other members of the team, inclusive of specialist nurses and family support services, Mr Wisheart stated:
`In general the opinion being expressed to the parents by me as a surgeon, was indeed the opinion which had previously been reached by the team. That is to say the cardiologists, the radiologists, the surgeon and any others who may have been in attendance at the clinical meeting. In the case of an emergency operation, generally it is the opinion of the cardiologist on call and myself as the surgeon on call, who will have conferred together. The advice being offered is virtually never the unilateral advice of the surgeon.' [119]
`I always sought to make my estimate of risk as accurate as possible, but also sought to avoid optimism. I believe that my estimates of risk were adequate in that they were as precise and accurate as possible.
`However, I wish to make two points:-
`i) The accuracy, precision or statistical reliability of any figure given to a patient or a patient's family, will always be questionable. Such a figure is at best an approximation and its validity would virtually always be open to debate. The importance of this consideration is underlined by the very large number of different procedures which are carried out in paediatric cardiac surgery, each type of procedure being carried out in very small numbers.
`ii) For the patient or parent such a statement is always inadequate, because in the event for that patient, the risk will either be zero per cent or 100 per cent.' [120]
97 Mr Wisheart described where and when discussions with the parents took place:
`For elective operations I believe that the explanation should be given at a reasonable time interval before the operations so that the parents would have time to absorb and come to terms with, whatever has been said in the explanation. They also would have an opportunity on mature reflection, to think of any other questions that they might wish to ask. I usually met with the child and the family in the outpatient clinic. In a minority of instances, usually where the decision was a difficult one, more than one consultation would be needed to reach a conclusion.
`It would be my practice to see the parents again on the ward when the patient is admitted for surgery. On that occasion I would offer to repeat the explanation or to answer any questions which they would ask.
`Inevitably in the course of complex medical treatment, such as paediatric cardiac surgery, unforeseen findings may be encountered. It is not practical to obtain further consent from the parents during the course of the operation. In these circumstances the surgeon has no alternative but to take whatever action he believes protects the best interest of the patient.' [121]
98 As regards the use of written information or leaflets to inform parents, Mr Wisheart stated:
`These were rarely used in my practice beyond occasionally using a pre-existing diagram to explain the abnormality in the heart.' [122]
99 Mr Wisheart stated further that:
- `I am not aware of any guidance as to how one should quote for risk, in the sense of the process of ... making the best estimation of risk. I believe I did understand how to quote for risk, in the sense of how to talk with a patient or parents.
- `In quoting for risk I took into account the procedure being advised, the detailed circumstances of the patient, the experience of the surgeon and the institution, and where appropriate, the national or internationally available data.' [123]
100 In his written evidence to the Inquiry, Mr Wisheart described his practice relating to the discussion of morbidity:
`From the early 80s the risk of paraplegia following Coarctation surgery in children was something which I explicitly stated to parents. This risk was of the order of 1 in 200 to 1 in 300. Indication of the risk undoubtedly caused distress and anxiety until the operation was over.' [124]
`It was not part of my routine to mention the possibility of Central Nervous System injury as a risk of other operations.
- `If I were asked about this, I would have responded by indicating that there was a risk, but that it was very small.
- `My view was that the risk of surviving with severe neurological damage was very small.
`In the latter part of the period there was discussion in the field of cardiac surgery generally, including paediatric cardiac surgery, about the need to indicate the possibility of Central Nervous System Injury. I do not believe that it ever became common practice in the UK to do so during or before 1995.' [125]
102 Mr Wisheart stated further that:
`Recoverable complications would only be discussed if I was asked about them.' [126]
103 Mr Wisheart described his practice relating to discussing with parents the likelihood of future surgery or continuing care being needed:
`Where the risk of future surgery was predictable I told the parents about it in the discussion. For example, I would say that:
`a) A patient having a palliative procedure would normally require a corrective procedure later.
`b) If Coarctation surgery was carried out very early in life (the first 3 months), then the possibility of a recurrence of the Coarctation was greater than if carried out later. This might lead to the need for further surgery (or in the latter part of the period under review, to the need for non-surgical intervention).
`c) The use of any prosthetic or bio-prosthetic material (other than a simple patch), early in life, meant that as the child grew that prosthesis or bio-prosthesis would be inadequate in size and therefore would need to be surgically replaced.
`d) In some operations, of which Atrio-Ventricular Septal Defect (AVSD) corrections are an example, the surgery was complex and the risks of needing some later surgical treatment were greater than after most other procedures. Following AVSD correction further repair or replacement of the mitral valve might be needed or a permanent pacemaker might be required in the event of complete heart-block.
`e) The likelihood of protracted drug regimes being needed was relatively uncommon, but might be predictable as a possibility in a small number of cases. I doubt that this would have been routinely discussed before surgery.' [127]
104 As regards any discussion with parents as to alternative methods of treatment, Mr Wisheart stated:
- `Sometimes there would be a choice between correction or initial palliation and part of our advice would be to indicate which was more appropriate for the child. The advice would be determined by consideration of the details of the abnormality and the operations involved.
- `Sometimes it would be agreed that an operation was needed but that there would be no urgency as to this procedure and therefore there could be a discussion about its timing.
- `The view would have been held with increasing conviction throughout the period under review, that usually, and for most conditions, anatomical correction relatively early in life gave the best chances for future length and quality of life. Therefore alternatives to anatomical correction were in principle undesirable.
- `With increasing importance as time progressed through the period under review, for some abnormalities there was a choice between surgical and non-surgical intervention. Usually these two options would have been discussed by the cardiologists, surgeons and radiologists at the clinical meeting and if the patient was referred for surgery, it was because the clinicians had agreed that surgery offered the better prospect for the patient. If non-surgical intervention were mentioned in that discussion, it would usually have been indicated that we regarded it as a less favourable course of action.
- `If at a clinical meeting the clinicians had decided that non-surgical intervention was the course of choice, then the cardiologists would have explained that to the parents and the patient would not have been referred to the surgeon.' [128]
105 As regards non-intervention, Mr Wisheart stated:
- `If the conclusion reached at the clinical meeting by the clinicians was that surgical intervention was not appropriate, then that patient or that patient's parents would not normally see the surgeon. The advice would have been conveyed to them by the cardiologist.
- `The possibility of non-intervention is referred to in the discussion with every patient, when the outcome of the condition if it is left untreated is discussed.
- `If the decision to advise surgery was genuinely borderline (ie there was a fine balance between the risks and benefits), and the patient was referred to the surgeon, then the real option would have been discussed. This was an uncommon situation and the patients would have been in two groups:
`a) those with a trivial abnormality, in whom the prospects of a long and fit life untreated were good, but the prospects following surgery would have been better in our opinion. Such benefits are relatively marginal and a long way into the future. The two options would have been discussed and surgery could only be considered if its risks were very low. The patient or the patient's parents then decide.
`b) Those in whom the condition was extremely complex, and a proposal to operate may have been on the borderlines of what was possible. Again that would have been discussed, with a rehearsal of the main factors on either side of the decisions.' [129]
Dr Martin
106 Dr Robin Martin discussed reference to data from other centres, its uses when referring to other centres and the relevant considerations for referring to Bristol, in the following exchange:
`Q. ... if you had said to the parent, who perhaps is the best judge of the child's interests "You may stay here in Bristol where it is good and it is local and where we have only done three operations of this sort on children at this age and they have all died, or we can, if you wish, send you to Birmingham where there is a risk, we cannot deny the risk but there appears on what we know about the figures to be a better chance of survival"; how do you suppose a parent would react from your experience to a choice put in those terms?
`A. That predisposes I had that information. As I have already said, I did not have information from other units. The only crude data I would have would be that from the Surgeons' Registry, the Society of Cardiothoracic Surgeons' Registry which gave very broad data for different groups, but it was not operation specific. We had really no comparable data to be sure about based on that. So whether I should refer patients to another hospital because Joe Bloggs had said their results when I met him at a meeting were good, I do not think that is a basis for making the referral. I would really have liked to see more data than that.
`Q. I think you jumped the question.
`Q. You have answered the question which I had not yet asked, which is: why did you not? The question I was asking: suppose the parent were presented with the option in something like those terms, what would you, from your experience, expect the parent to do? We will come in a moment to whether you could have put it in those terms because you may not have had the information. Suppose you had put it in those terms to a parent, what would the parent do you think have said?
`A. It is very hypothetical. As I already said, that presumes you have the knowledge to put it in those terms.
`Q. If you had the knowledge to put it in those terms and you said it, what would you expect most parents would say to you?
`A. I think if you put it in those terms without any riders, I would expect probably the parents to say "I will go to a different centre", most likely.
`Q. You suspect that because, if those terms are appropriate on that hypothesis, I appreciate, there is really no answer, is there, to the suggestion that the child is probably better cared for in a centre which has an apparently better track record and has a much greater experience of the operation?
`A. That predisposes you know that information.
`Q. But on that hypothesis, that must be right, must it not?
`A. If you tell me so. I think it is very difficult to judge, but there are many reasons why you might favour a referral to your own centre, which is the sort of line you are taking. There is the geographical ideas we have already discussed. The patients you are talking about may be only a relatively small proportion of your overall work so you build up a working relationship with your surgical colleagues. You certainly come to rely on their experience and expertise and listen to their advice. Any patient that is being assessed for surgery, it is not something I am saying this is what has to be done, it is something you discuss as a group and - I am not sure whether you have seen yet, but the joint conference data notes that would be done for most patients mean that opinions are canvassed from different areas, so my cardiological colleagues, my surgical colleagues all would have input into that decision-making process.
`So deciding what treatment is right for that particular patient is a complex one; it is a complex interaction between many individuals of a team.
`Q. As part of that answer you have said to me that the building up of a relationship with the surgeon in your centre is a matter of importance?
`A. You inevitably build up a working relationship with colleagues and to an important degree you do listen to other people's advice, you know, within your unit. So building up a relationship per se is not the "be all and end all", but it is an important part of how cardiologists, cardiac surgeons work, they work as a team.
`Q. Do you think it would prejudice the relationship of any cardiologist at Bristol with the surgeons at Bristol to have said "In this case we are going to refer this child to another surgeon for an operation which can be done here, but we think it can be done better there"?
`A. It is very difficult to say. I think you would have to ask other colleagues, you know, particularly the surgical colleagues, whether they would have done.
`I think there would have been a danger it could do so.' [130]
Dr Joffe
107 Dr Hyam Joffe discussed the role of the cardiologists, in informing parents, particularly as regards new procedures, in the following exchange:
`Q. You said a moment ago that once the decision [to operate] had been taken, that the cardiologists - I forget your phrase -
`Q. - fully, I think, was the impression you were giving?
`Q. Does that mean that the cardiologists, in talking to parents about the operation, gave perhaps a more enthusiastic description of the operation and what it might achieve than they individually would have given had the decision as it were been theirs alone and had they not been part of the collective that decided to conduct the Arterial Switch?
`A. I do not believe so. I think, with any new procedure, one has to be as open as possible, with parents. I do not believe actually we mentioned to anybody that this operation had never been done in this unit before, but the view would certainly have been given that this is a new operation, generally; that the results are not quite as good or not as good as the results of immediate post-operative surgery using the Senning procedure, but that the belief is, among the cardiac fraternity, paediatric, around the world and in this country, that the long-term benefits would be better. So, of the two operations available, we would recommend the Arterial Switch.
`Q. Why was it, do you think, that it was not mentioned by anyone that this was the first or the second such operation being done in the unit?
`A. I think at the time I do not believe that any unit would have taken a different approach, personally.
`Q. That is not quite the same - that is not quite an answer.
`A. I was going to come on to say that either one started a new procedure or one did not. I believe that it is a very difficult question to deal with, but I do not believe we would have necessarily started that operation if the advice had been given to parents in such a way that they knew we had no experience at all in neonates and would most likely not have wanted to do the operation.
`At the same time, we would have told them that the surgeons had a fair amount of experience with the non-neonatal Switch, and that in that procedure the surgeon doing the operation has been achieving results that are more or less equivalent to those in other units in the country. And that that same surgeon would be tackling the neonatal Switch.
`Q. So what you are saying in effect is that if you told the parents the whole truth, the whole facts about the operation, they probably would have said "No, I will not have the operation", and to avoid that as a result, you did not volunteer all the facts?
`A. Not all the facts, no, but I think we would have indicated, certainly, that this was a new operation and that if asked, I think we would have informed the parents that in fact, at that point for case number 1, we had not done one previously. There always has to be a case number 1.
`Q. How many parents, in your experience, say to you, "Doctor, this is the operation you are recommending; tell me, have you ever done one before?"
`A. I agree with you entirely, today that is exactly what I would say, that we have not done one before. In the current climate of 1992, which was more defensive, that was the view of, I believe, most of my colleagues around the country and that was the one we followed. I think it is inappropriate today, in retrospect, I would agree with you.' [131]
108 As regards informing parents generally, Dr Joffe told the Inquiry:
`... I think the understanding of the lay public (and that includes parents as well as other patients) has evolved, has changed, has opened up, has become more desirous of knowing the full facts and I believe now (and I am using my usual kind of non-direct approach, if you like) [it is] probably best to give the full facts but put them in perspective as far as one can and somehow retain the sense of hope in the patient.
`But I still believe there is an element of judgement and selectivity involved and that there are some patients or parents ... where I think I might have been a little tardy about telling them absolutely everything in a stark fashion because of my judgement, not that they would not want their child to be operated upon, but because it might - destroy is too strong a word, but might be too tough for them to cope with at that time.
`I would rather, under those circumstances, perhaps break up the information into what I believed at the time they would cope with, with a view to seeing them again once or twice before an operation and try and convey additional risks thereafter; it is a very difficult subject. I believe it comes with experience of being with people and unfortunately I have had to be part of the process, not only of informing people of the total picture but also of being present at bereavement situations and inevitably there will be a difference of opinion about how that should be handled. But I think one does one's best in one's own perception of the requirement.' [132]
109 Asked by the Chairman whether seeking to retain `some sense of hope' [133] in the patient was misleading or unhelpful, Dr Joffe replied:
`It is a balance. I think the primary or the overriding risks I think should be stated and I do not think that under any circumstances one should shy away from that.
`By that I mean that if an operation has a risk of 1 in 3 or 1 in 4, and quite frankly at that time I do not think there is a difference in a parent's mind about what 33 mortality rate is versus 35 mortality rate, it is a real mortality rate, their child could die is the point and I think that is as far as one needs to go, frankly, at that stage but one cannot hold back on that, that is reality.
`But in terms of some of the less common complications, I believe that can be introduced in a gentler way in the case of cerebral haemorrhage or as Dr Houston mentioned, renal failure and other sorts of complications that would be far rarer.' [134]
110 Dr Joffe was asked about training in communication skills, in the following exchange:
`Q. Did you have any training in communication skills?
`Q. You have picked up the skills that you have by practice?
`A. Yes, correct.' [135]
Dr Jordan
111 Dr Stephen Jordan discussed the issue of giving estimates of the risks involved in an operation to parents, in the following exchange:
`A. ... from my own point of view I find this whole business of emphasis on giving parents an exact figure for the mortality for an operation rather strange and it did not seem to relate to the real world in which I worked at the time. It may well be the situation in 1999 is entirely different, but I was much more prone to use terms like "This is a major operation, there are going to be considerable risks, but on the other hand ... " and you know, describe what the advantages are.
`In other words it was not my practice unasked to say to the parents "I am going to tell you what the statistics are with regard to the chance of your child surviving this operation".
`Q. In terms of statistics from other centres, I think we have already discussed this a couple of times, there was not any reliable published comparative data showing the comparison between Bristol or any other centre and other individual centres?
`A. The statistics on this occasion would consist of what either we heard formally at meetings of people presenting results or what was discussed over coffee at the same sort of meetings with clinicians there.
`Q. There might be papers published by centres who were anxious to broadcast to the relevant professional community?
`A. Papers usually are sort of given as presentations first. You would probably hear of it more quickly by going to something like a British Cardiac meeting or surgeons going to one of the Cardiac Surgical meetings.
`Q. Typically centres would be more anxious to write papers and give lectures and presentations on their successes as opposed to their failures?
`A. That is true, yes.' [136]
112 The issue of informing the parents before a neonatal Switch procedure was discussed by Dr Jordan in the following exchange:
`A. My best recollection of what I said in effect was that, rather similar to starting off what I would have said about a normal neonatal Arterial Switch operation, the severity of the condition and obviously it is important that the parents realise once you are starting to talk about an operation with important risks that you are also talking about an operation on a child who otherwise is not going to survive. That is the first thing that is said.
`The second thing is to say that there are actually two ways of dealing with this condition. We will be discussing with the surgeon, this is if I had not already discussed it with the surgeon, that "There is one operation which can be left for some time and in our hands has very good immediate results, but the operation which would actually correct the condition is a much more major operation and it would have to be done fairly soon while your baby is still very small."
`Q. What would be said about the relative risks of mortality in that Arterial Switch procedure?
`A. As I have said before, I was not one to write figures on a piece of paper, I know the surgeons did on occasions, but I would have used terms like "major risk"and so on.
`Again, had I been pushed I would have said at that time "I think that the risks of doing a neonatal Arterial Switch operation in our hospital with this surgeon with his previous experience in a relatively uncomplicated transposition are going to be similar to the risks that would have occurred in the older patients with the more complicated form of anatomy".' [137]
Dr Masey
`It has always been my practice to see patients prior to surgery, as far as is possible. Consequently I would visit a child having cardiac surgery the evening before surgery and discuss with the parents, and child if old enough, the anaesthetic plan. I would give them the opportunity to ask questions although I was not involved in obtaining consent for surgery.' [138]
Dr Pryn
114 As regards discussing risks associated with surgery with parents, Dr Pryn stated:
`I always visited the patients on the afternoon or evening prior to surgery. I attempted to coincide my visit with the child's parents or guardians, although this was not always possible. I did not see it as my role, nor did I have the experience, to re-assess the patient's cardiac condition, with a view to determining whether the proposed operation was still indicated, nor whether this was the optimum time for the surgical intervention. This I assumed to be performed by the cardiac surgeons in conjunction with the paediatric cardiologists ... I developed an anaesthetic care plan in my mind and explained to the parents the basics of my plan for pre-operative starvation, pre-medication, anaesthetic induction, invasive monitoring and intensive care. I always invited questions from parents or guardians. I did not specifically cover issues of operative risk, although if asked directly I covered it in general terms and referred the parents to their surgical consultant for further discussion. The approach I have always taken to pre-operative visits is encompassed by the standards subsequently published by the Royal College of Anaesthetists (RCA Guidance for Purchasers 1994). There were no information booklets on anaesthesia for parents, similar to that produced by AAGBI (Anaesthesia and Anaesthetists - Information for Patients and their Relatives), available within the BRI. Consequently no literature was provided for the parents concerning anaesthesia.' [139]
115 Dr Pryn stated in his written evidence to the Inquiry that he would explain operative risks to parents in `general terms'. He discussed this further in the following exchange:
`A. I would say: "Your child is extremely unwell. His is a high-risk procedure. You are aware of that", or "Your child is relatively well at the moment. We do lots of these procedures. It is relatively low risk", that sort of general terms, but I would not put figures on it.
`Q. What about risks associated with anaesthetics? Is there any necessity to explain any of those?
`A. I thought that that was all incorporated within the overall surgical risk, because the risk associated with an anaesthetic is relatively small in most patients compared with the operative risk.
`Q. So there was no need to treat that separately at further length?
`A. I did not feel at the time.
`A. I did not feel so, so I did not.
`Q. Presumably one of the reasons why you might refer a patient, or parent rather, back to the surgeon for further surgical discussion of risk would be if you picked up the fact that they did not appear to be adequately informed about the dangers of the operation that lay ahead.
`A. That is true, but Mr Wisheart and Mr Dhasmana were extremely conscientious of documenting in the notes, in their clinic appointment that they had spoken to the parents about risk, and they often would write down the risk that they quoted to the parents. So I knew pretty much what had been told to the parents already.
`Q. And, knowing what had been told to the parents, were there any occasions when you felt concerned about the adequacy of that explanation that had been apparently offered by the surgeons?
`Q. What about parents' perception of the advice that had been given to them? Were there times when, having looked at the notes, you thought an adequate, proper, reasonable explanation of risk had been given, but it did not appear to have filtered through on to the consciousness of the parents?
`A. I cannot remember any instances when I thought that the parents were not adequately prepared for a very risky procedure.
`Q. So overall this was an area that did not cause either concern or a need to refer back patients or parents to the surgeons for further discussion?
`A. Not often, no, and, in fact, the night before surgery is not a good time to have detailed discussions of risks anyway, so I probably did not court those discussions.' [140]
116 Dr Pryn expanded on the incorporation of any risk from anaesthesia into the risks of surgery in the following exchange:
`A. I assumed that when parents are told about the risk of the procedure, that risk incorporates all the risks: anaesthesia, surgery, intensive care.
`Q. Is that integration of risk a normal assumption for you, or do [you] separate the risk in any other situation, and therefore discuss with parents risk of anaesthesia as a separate issue?
`A. I think it is normal to group them together. I think the one time you would not group it would be, say, for a cardiac catheter study, where the risk of the procedure is relatively small, the main risk is that of anaesthesia, but for a complex surgical operation, the main risk will be surgery.' [141]
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Footnotes
[93] WIT 0084 0119 - 0120 Mr Dhasmana. See Chapter 3 for an explanation of clinical terms
[94] WIT 0084 0120 Mr Dhasmana
[95] WIT 0084 0121 Mr Dhasmana
[96] T87 p.90-2 Mr Dhasmana. See Chapter 3 for an explanation of clinical terms
[97] WIT 0084 0123 Mr Dhasmana. See Chapter 3 for an explanation of clinical terms
[98] WIT 0084 0122 Mr Dhasmana
[99] WIT 0084 0122 Mr Dhasmana
[100] WIT 0084 0122 Mr Dhasmana
[101] WIT 0084 0123 Mr Dhasmana
[102] WIT 0084 0123 Mr Dhasmana
[105] WIT 0120 0368 Mr Wisheart
[106] WIT 0120 0368 Mr Wisheart
[107] WIT 0120 0357 - 0358 Mr Wisheart. See Chapter 3 for an explanation of clinical terms
[109] WIT 0120 0360 - 0361 Mr Wisheart
[110] AVSD series. See Chapter 3 for an explanation of clinical terms
[112] WIT 0120 0363 - 0364 Mr Wisheart. See Chapter 3 for an explanation of clinical terms
[113] WIT 0120 0362 - 0363 Mr Wisheart
[114] T92 p.109-110 Mr Wisheart
[115] WIT 0120 0367 Mr Wisheart
[116] WIT 0120 0361 Mr Wisheart
[117] WIT 0120 0362 Mr Wisheart
[118] WIT 0120 0362 Mr Wisheart
[119] WIT 0120 0364 Mr Wisheart
[120] WIT 0120 0370 - 0371 Mr Wisheart
[121] WIT 0120 0359 Mr Wisheart
[122] WIT 0120 0365 Mr Wisheart
[123] WIT 0120 0369 Mr Wisheart
[124] WIT 0120 0373 Mr Wisheart. See Chapter 3 for an explanation of clinical terms
[125] WIT 0120 0373 Mr Wisheart (emphasis in original)
[126] WIT 0120 0375 Mr Wisheart
[127] WIT 0120 0374 Mr Wisheart. See Chapter 3 for an explanation of clinical terms
[128] WIT 0120 0375 - 0376 Mr Wisheart
[129] WIT 0120 0376 - 0377 Mr Wisheart
[131] T90 p.135-7 Dr Joffe. See Chapter 3 for an explanation of clinical terms
[137] T79 p.181-2 Dr Jordan. See Chapter 3 for an explanation of clinical terms
[138] WIT 0270 0005 Dr Masey
[139] WIT 0341 0016 - 0017 Dr Pryn