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Rapid Responses: Rapid Responses published:
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The Wisheart affair : paediatric cardiological services in Bristol, 1990-5
- Robyn Cain (5 November 1998)
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A television company responds
- James Garrett (23 November 1998)
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The Wisheart affair by Peter Dunn
- Wendy Savage (24 November 1998)
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The Bristol cardiac disaster
- Stephen N Bolsin (1 December 1998)
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Editor's response to Stephen Bolsin
- Richard Smith (1 December 1998)
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A patient's perspective
- James Stewart (1 December 1998)
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The Bristol case and concerns about the GMC
- Richard Colman (11 December 1998)
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Audit or be damned?
- Peter West (16 December 1998)
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Bristol - What went wrong and how can we move forward?
- Maria Shortis, Elisabeth Winkler (22 December 1998)
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Re: The Wisheart Affair: reply to Dr. Bolsin
- Peter M Dunn (23 December 1998)
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Bristol Inquiry Web Site
- John McLorinan (5 February 1999)
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Developments in Cardiac Surgical Audit
- Bruce E Keogh (20 April 1999)
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Robyn Cain
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Dunn's article highlighting many concerns following the Wisheart affair comes as a breath of fresh air whilst the questions raised will not make the work of the Kennedy inquiry any easier. The media inspired hype proved a disservice to the profession and may well have clouded the judgement of the Professional Conduct Committee of the GMC. So far the previously vociferous media have ignored Dunn's article and it would seem that they do not wish to challenge their earlier often erroneous comments with the facts. It is to be hoped that there will be a cardiac surgeon on the Kennedy committee of enquiry because if not the problems beset by the GMC Professional Conduct Committee will be compounded. Robyn Cain Honorary Consultant Paediatrician 1) Dunn P. The Wisheart affair: paediatric cardiological services in Bristol, 1990-5. BMJ 1998;317:1144-5.(24 Oct) Royal United Hospital Combe Park Bath BA1 3NG |
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James Garrett, Head of Current Affairs HTV West
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I would be grateful for the opportunity to reply to the allegations made by Professor Peter Dunn about media reporting of the Bristol heart surgery tragedy. It was my programme for Channel 4's current affairs series, Dispatches, in March 1996 which prompted the General Medical Council to investigate what, it subsequently became clear, was the medical scandal of the century. Since then I and my colleagues at HTV have continued to report on this most important of subjects. I am, presumably, one of those whom Professor Dunn pronounces guilty of "using a sustained stream of biased, misleading and often inaccurate information." It is towards people like me, according to the Professor, that bereaved parents should direct the grief and anger they understandably feel over the loss of their children, rather than the surgeons who operated on them and who have since been found guilty of serious professional misconduct. Ah yes, 'Shoot the messenger!' - the age-old response of those who dislike the message. The Dispatches programme was researched painstakingly over a period of months to ensure the accuracy of the appalling story it told. Had it been "misleading" or "inaccurate" it would have surely atrracted a writ for defamation from one or more of the three doctors who were named. As your readers will know, doctors who believed they had been libelled enjoyed, until recently, free access to the expensive world of the libel courts through their medical insurance subscriptions. However, no writ followed the original programme or any of the four documentaries and dozens of shorter reports which HTV has produced since. Professor Dunn complains that the views of the three doctors have received inadequate attention in the media. I have personally written many letters to Messrs. Wisheart, Dhasmana and Roylance, seeking to report their views. Not once has any of them taken up our offer, which remains open. Their refusal to contribute notwithstanding, HTV did report the defence they made at the GMC. Interviews with lay supporters - which we have also broadcast - are, ultimately, no substitute for the doctors' own words. While it is for the GMC to defend its disciplinary practices, I would point out that only one of the three doctors found guilty of serious professional misconduct, Dr Roylance, has exercised his right to appeal to the Privy Council. If Mr Wisheart or Mr Dhasmana had genuine reason to feel he had been treated "unfairly" by his peers, as Professor Dunn suggests, surely he would have followed suit? In revealing and reporting this serious lapse by the medical profession, HTV and its colleagues have illuminated an area of life which has been dark for far too long. Professor Dunn should look closer to home for people to blame if the public does not like what we showed them and demands reform. Yours sincerely, James Garrett, Head of Current Affairs, HTV West |
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Wendy Savage
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I have felt honoured to have been elected by my peers to the General Medical Council and to have contributed to the formulation of 'Good Medical Practice'. This was a positive step towards improving services for patients and clarifying the responsibilities of doctors. In this document the Standards Committee, (under the chairmanship of Donald Irvine and later Michael O'Donnell) tried to frame the advice to doctors in a positive rather than a negative way, in contrast to the style of the old Blue Book, on which the disciplinary procedures were based. Whilst I personally questioned the necessity for the introduction of a new category of 'performance procedures', (on the grounds that one could consider poor performance as professional misconduct if not due to illhealth as has been done in the Bristol case), this was adopted as GMC policy, and was seen as remedial rather than punitive. Whilst Sir Robert Kilpatrick conceived the idea of the performance procedures, Sir Donald Irvine, when he was elected as President has been closely involved in their development. I admired his humane approach and enunciation of clear principles underlying this new venture. It was therefore with surprise and growing uneasiness that I watched the events of the Bristol case unfold. Peter Dunn's article asks a number of searching and relevant questions which the GMC as a body cannot answer as an appeal has gone to the Privy Council, but as a member not involved in the case I feel impelled to respond. The silence that has greeted Professor Dunn's article is probably related to the diffidence that doctors feel about making a judgement without all the evidence before them. We are trained to look at the facts, weigh the evidence and reach a conclusion about how best to treat a patient. We know that in many aspects of our work there is not enough scientific evidence on which to make a proper judgement, and we do our best. Dealing with uncertainty is part of our every day experience and sharing that uncertainty is often difficult as patients may not understand how limited our knowledge is. Sometimes they may want the doctor to appear to be confident and prefer to trust in his or her judgement. Just as doctors disagree, so do lawyers, but surely in a case as sensitive and difficult as this, if the defence lawyers accused him of bias, as stated in the article. it would have been prudent for the President to step down as Chair of the PCC. It is very difficult to comment on a judgement of the PCC when one has not sat through 68 days of detailed evidence, but the issues did not appear from the material that I read to be clearcut and I found it hard to understand how the committee could be absolutely sure that the doctors were guilty of SPM. Making medical decisions is not simple, people are different and cases are seldom black or white, with right and wrong answers. Doctors often disagree about the best method of management. Is Sir Donald sending the right message to the public in this complex and difficult area? As a member of the GMC it seemed wrong to criticise so I did nothing at the time but my conscience troubled me. So many people whom I did not know supported me when I was the victim of an injustice, so why was I silent? Peter Dunn was one of my expert paediatric witnesses during the inquiry into my competence under HM 61/112 in 1986, and I respect his integrity and his judgement. Professor Dunn's paper sets out clearly several new issues that concern me greatly and have led me to respond. With hindsight I think that the GMC made a grave error in arranging the case against Dr Roylance at the same time as the two cardiac surgeons. How could he be guilty of anything until the facts had been proved one way or the other about their conduct? Was this lack of thought of the impression given and a decision made for administrative convenience? The President is an intelligent man, so such an oversight seems unlikely. Had the decision already been made that they were guilty? If so how could that be when all the complex evidence had not been heard? The perception amongst a number of people, medical and lay, is that these three doctors were made scapegoats as a way of satisfying government that we were capable of regulating ourselves as a profession, and satisfying the'public' as evidenced by the less responsible media. If this perception is correct then a grave miscarriage of justice has occurred, and incalculable damage done to self-regulation, the medical profession and to the parents whose children were patients in Bristol. There are problems with the process in the GMC's conduct procedures and some of these are being addressed by the President and the Registrar. The adversarial nature of these proceedings and the tendency of the medical defence organisations to defend the doctor by bringing in irrelevant material which lengthens the process, combined with the standard of proof which is that of a criminal court not a civil court, (ie you must be sure and not decide on the balance of probabilities), that the doctor is guilty, frequently lead to decisions which leave no-one satisfied. I believe in self-regulation, in professional integrity and providing a good service to patients. However, our credibility will be undermined if we lose our scientific objectivity and sacrifice our dedicated and hardworking colleagues to satisfy ill-founded fears of some members of the public and the short-term aims of politicians. Yours Wendy Savage MSc FRCOG Senior Lecturer in Obstetrics and Gynaecology, Academic Department of Obstetics and Gynaecology, St Bartholomews and the Royal London School of Medicine and Dentistry, Queen Mary and Westfield College. Honoarary Professor, Deaprtment of Social science, Middlesex University. Wendy Savage, Senior Lecturer in Obsetetrics and Gynaecology, St Bartholomew's and the Royal London School of Medicine and Dentistry, Queen Mary Westfiled College, London E1 4DG Honorary Professor, Department of Social Science, Middlesex University. Please reply if using snail mail to my home address: 19, Vincent Terrace, London N1 8HN, England Home telephone 0171-837-7635 with fax-link NHS office, Grocers Attic, 3rd Floor, Royal London Hospital, Whitechapel Rd, E1 Telephone 0171-377-7000x2138 fax 377-7160 P/T Sec Eileen Bergh(M,Tu&Th 7-2) Bleep 1477 via switchboard or aircall if out of district. Academic Office 48-53 Bartholmew Close EC1 Telephone 0171-601-8260 Fax 0171-600-1439 Sec Helen Cagnoni Wednesday 10-6 |
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Stephen N Bolsin
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I wish to express my disappointment and concern at the publication of Peter Dunn's article.[1] The article raises several important points, which need to be addressed, and I feel that my knowledge and position in Bristol at the time give me some authority to comment. The "many senior colleagues" referred to in the article are exhibiting exactly the same behaviour patterns that allowed the Bristol cardiac disaster to occur in the first place. These are lack of insight, failure of critical appraisal, and muddled thinking. In the first half of the article Dunn presents the case that there was not a problem but then asks, "Why wasn't the responsibility of the hospital administration recognised?" This leaves unanswered the question "responsibility for what?" For allowing a problem not to develop? Was there or was there not a problem? I and others believe that there was a serious problem. If, as Dunn suggests, his three colleagues were treated unjustly, why did they not make use of the GMC's appeals mechanism and appeal not just against the sentences but also against the verdict of the disciplinary committee? Dunn asks, "Why were the surgeons judged only on a small selected fraction (4%) of their paediatric surgical workload during 1990-5?" I find his answer less satisfactory than the alternative explanation that the United Bristol Healthcare Trust only provided to the GMC's disciplinary committee the details of the operations that it had requested at such short notice that the GMC was unable to deal with anything other than the operations for atrioventricular canal and arterial switch. Even in these limited cases the excess mortality for these two operations was sufficient for the disciplinary committee to reach its verdict. However, we now learn that there were other operations with equally bad records for mortality. On 27 October, BBC television's Newsnight disclosed that in Mr Wisheart's series of operations for truncus arteriosis repair in patients under 1 year of age, nine out of 12 patients died. One of the survivors is Ian Stewart, who suffered massive permanent brain damage. The programme also reported that, in the series of operations for total anomalous pulmonary venous drainage, Wisheart also has an unenviable record. Thus Dunn's suggestion that 96% of the paediatric cardiac surgical work for this period was acceptable is open to question. In this context it may be important to note that an independent inquiry, commissioned by the United Bristol Healthcare Trust, into the adult cardiac surgical work of Mr Wisheart concluded that his risk adjusted mortality for adult cardiac surgery was four times that of his colleagues in Bristol.[2] The inevitable conclusion is that the record for the paediatric operations used by the GMC inquiry was not the isolated imperfections that Dunn is suggesting in his article but may more truly represent a level of achievement in clinical activity that required urgent review and improvement. Institutional considerations I agree that the failure of two cardiologists and one anaesthetist to give evidence to the disciplinary hearing gave the impression of guilt and that they should have been urged to give evidence to the GMC inquiry. Their attendance at the public inquiry will be compulsory and informative. The audit that Dr A Black and I carried out was never secret. The perception of secrecy was attributable to the lack of effective communication between the directorates of anaesthesia and surgery and may also be attributable to Mr Wisheart's failure to recall some important meetings with myself, Professor John Farndon (at which contemporaneous notes were made), and Professor Gianni Angelini, where concerns about performance were expressed. The director of anaesthetics had always been used as the vehicle for channelling concerns expressed by the cardiac anaesthetists to the cardiac surgeons; it had been agreed as early as 1991, by a meeting of all cardiac anaesthetists, that I should "keep my head down," as my audit activities were already attracting adverse criticism from the department of cardiac surgery. A proper audit of work was never conducted despite Dunn's assertion, and this is evidenced by the alteration of the unit's arterial switch data at the meeting on the night before the fatal operation on Joshua Loveday. Had a complete and full audit been undertaken before this, the correction of data at the last minute would not have occurred. Also, the miserable record for these operations would have been revealed at an early stage and possible lifesaving action taken. Mr Wisheart was asked on several occasions to provide a full audit of the unit's activity but this was tragically never forthcoming; the reason for this omission has never been made clear. I agree that all members of the paediatric cardiological team agreed that the operation should go ahead. My argument was not medicopolitical but that there was an institutional problem in Bristol, which meant that the safety of the child could not be guaranteed if the arterial switch operation was undertaken in Bristol. When the question was put—"Should this operation go ahead in Bristol tomorrow?"—I was the sole dissenter, and I requested that my dissent from the view be minuted as I was sure that the child's life was being jeopardised. The lack of insight shown by Mr Wisheart in comprehending the implications of his adult cardiac surgery (commented on by Treasure[2]) has, as reported by BBC1's Panorama in July, now extended to the unit's prior performance of paediatric cardiac surgery and beyond the three doctors involved. While I can understand the natural psychological defence mechanisms of denial and rationalisation exhibited by the three doctors, I am not convinced that this is justifiable in senior colleagues or warrants publication in the BMJ. I believe that the propagation of the emotional and biased views expressed in Dunn's article does not reflect well on medical staff in Bristol or on the wider medical community in the United Kingdom. The publication of such a one sided article in the BMJ is reminiscent of the time when, under legal threat from the United Bristol Healthcare Trust, the journal was prevented from publishing any letters or articles that had not been approved by the senior management of Bristol Royal Infirmary. This allowed the publication of a letter by Joffe, which glossed over many of the important criticisms that were being made at that time,[3] but prevented the publication of a considered response from Dr Black and myself. I would like the editor to confirm to his readers that the threat of legal action by the United Bristol Healthcare Trust has now been lifted from the BMJ. Stephen N Bolsin Director Department of Perioperative Medicine, PO Box 281, Geelong, Victoria 3220, Australia 1 Dunn P. The Wisheart affair: paediatric cardiological services in Bristol 1990-5. BMJ 1998;317:1144-5. 2 Treasure T, Taylor K, Black I. A report into adult cardiac surgery at the Bristol Royal Infirmary. Bristol: United Bristol Healthcare Trust, 1996. 3 Joffe HS. Hospital banned from doing neonatal heart operations. BMJ 1995;310:1195. |
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Richard Smith
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The BMJ came under no legal pressure to publish the paper by Peter Dunn. We published it because we believe that all voices should be heard in this important debate, and the voice of senior figures from Bristol is heard more often in corridors than in public. Dr Bolsin strikes a sensitive nerve when he asks about legal pressure. We consult our libel lawyer several times a week, and often papers are suppressed or emasculated. The Columbia Journalism Review, the world's leading scholarly publication on journalism, says that Britain has an unfree press.[1] I agree and have written about this at length and with passion, quoting John Milton that "if it comes to prohibiting, there is not ought more likely to be prohibited than truth itself."[2] [3] Britain has a thicket of libel, confidentiality, and copyright laws that stop free speech. The newspaper owner Cecil King wrote presciently that because of fear of libel |P`inefficient hospitals are not named, doubtful share flotations pass without comment, and some fraudulent individuals go unexposed until it is too late and someone has been hurt." He said that before Robert Maxwell famously used the libel laws to silence the press over his misdemeanours and before the BMJ had to pay out £107 000 on a libel case that we won.[4] The BMJ did receive a lawyer's letter in response to the news piece we published in 1995 on neonatal heart operations in Bristol, and we published a correction.[5] It said that |P`there was no instruction from the Department of Health to suspend neonatal heart operations" and that |P`it was incorrect to say that one surgeon had been transferred to another post and the other had been sent for further training." The public inquiry will no doubt clarify these statements. In addition, we did at one stage (and sadly I have to operate from memory, not records) have a paper on what was happening with various neonatal cardiac operations in Bristol submitted to us for possible publication. We began by getting a detailed review on the data, recognising that if we were going to publish them there would be considerable legal problems. Before we got to that stage, however, the authors withdrew the paper. Richard Smith Editor BMJ 1 Brendon P. Amendment envy: a report on the mother country's unfree press. Columbia Journalism Review 1991;Nov-Dec:68-71. 2 Smith R. An unfree NHS and medical press in an unfree society. BMJ 1994;309:1644-5. 3 Craft N, Sheard S, Smith R. The rise of Stalinism in the NHS. BMJ 1994;309:1640-5. 4 Dyer C. BMJ faces £107,000 bill over libel case. BMJ 1996;313:897. 5 Dyer O. Hospital banned from doing neonatal heart operations. BMJ 1995;310:960. (Correction. BMJ 1995;310:1288.) |
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James Stewart
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In Professor Peter M Dunn's article concerning the General Medical Council's inquiry into cardiac surgery at the Bristol Royal Infirmary, the general complaint was that the GMC was harsh and unjust and was driven by inaccurate press reporting.[1] Nothing could be further from the truth. The press is so concerned about being sued for libel, especially where eminent members of the medical profession are involved and the potential compensation is enormous (certainly far in excess of what a child's life is considered by the law to be worth) that unless the facts are thoroughly verified, the newspapers will not print a story. My personal experience of these events gives the patient's perspective. Professor Dunn correctly notes that many of the charges considered by the inquiry were dropped. They were indeed. However, Professor Dunn's assumption that they were dropped because the doctors were innocent of the charges is incorrect. Let me explain why I say this by briefly giving the example of the charge in respect of my son. The following charge—charge 9(c)— was laid: "You (Mr Wisheart) gave the parents of Ian Stewart information about the risks of mortality and of brain damage in such a way that: i) Did not accurately reflect your own experience as a surgeon." This charge was dropped by the GMC. It was dropped not because the evidence produced showed that we had not been misled but because Mr Wisheart's actual mortality results for truncus arteriosus were never produced. This vital evidence was never even requested by the GMC. Ms Lander's statement on day 16 of the hearing confirms this astounding fact.[2] Furthermore, Mr WJ Brawn, the expert witness for the prosecution, subsequently confirmed in writing to us that: "I have not seen the results of surgery for truncus arteriosus performed by Mr Wisheart and therefore I do not know what his own mortality rate is for that procedure." When my wife, Bronwen Stewart, was called to give evidence she attempted to present the mortality figures but was told by the prosecutor that they were "irrelevant and inadmissible" as evidence. We subsequently wrote to the GMC many times, saying that if this evidence was not adduced then the charge in respect of our son must inevitably fail. The evidence was never produced and, inevitably, the charge failed. BBC Newsnight, on 27 October 1998, revealed that before operating on Ian, Mr Wisheart had performed 11 truncus arteriosus operations with nine "early" deaths. Statistically, reconstructing the methodology used at the GMC, this results in an "optimistic" rate for Mr Wisheart greater than the "pessimistic" rate derived from the figures for 1991 in the Society of Cardiac and Thoracic Surgeons' voluntary audit (the United Kingdom Cardiac Surgical Register); both estimates are based on 95% confidence intervals. The GMC accepted that 1991 is the year in which the figures from this register would have been available to Mr Wisheart when our son was considered for surgery in 1993. These 1991 figures give a mortality of 25%. Excluding Mr Wisheart's results reduces this percentage substantially. Mortality in the United States and Australia was significantly lower than in the United Kingdom. The University of California, for instance, had no early deaths in 22 operations between 1986 and 1990 for the condition that Ian had. Mr Brawn himself, interestingly, is a coauthor of a paper revealing that between mid-1979 and December 1983, 23 patients with truncus arteriosus were operated on in Melbourne.[3] Three patients died; two of these were babies under 1 month and severely acidotic. This result was obtained a full decade before Ian underwent surgery. In utter frustration, I interrupted the GMC proceedings on 29 May 1998, asking why the evidence in respect of my son's charges had not been produced. The only reply I received then, or since, was to be physically removed by the police. The only people allowed rights and representation at the GMC were the doctors charged and the GMC itself. My son was accorded no rights, nor was he allowed representation. The High Court in London confirmed this when we took the GMC to judicial review before the start of its inquiry. I believe that the GMC deliberately perverted the course of justice, yet there is nothing I can do about it. The doctors charged can at least appeal to the privy council. No such option is available to the victims. Perhaps if I was wealthy, rather than a former chartered accountant whose career and livelihood have been destroyed by what Mr Wisheart did to my son, I might be able to afford the costs involved in appealing to the Court of Human Rights. Given my circumstances, the price of justice is beyond my reach. The Bristol Royal Infirmary scandal, together with its subsequent handling by the GMC, has clearly shown that self regulation has failed the patient at every stage. I have come to thoroughly detest the medical establishment. My son suffered severe brain damage, which left him screaming in agony for over a year, and all that the GMC did was to add further insult to the injury suffered. This story is just one of many such stories that I and the other parents at this disgraceful GMC hearing could tell. In the true interests of patient protection, the sooner the GMC and the whole failed edifice of self-regulation is replaced, the better. Like Professor Dunn, I too hope that the public inquiry will examine the full record of these surgeons, both the adult and the paediatric cases. I, too, hope that the two cardiologists—namely Dr Joffe and Dr Jordan, together with Dr Monk, the key anaesthetist—who were not called by the GMC will give evidence at the public inquiry. The GMC should be asked to explain why they were not subpoenaed as witnesses. Like Professor Dunn, I and the other parents involved consider that there are numerous questions concerning the conduct of the GMC inquiry that require an explanation. The following are but a few. Why was morbidity and brain damage, despite the charges, never examined? Why were the surgeons' log books never fully analysed and examined, and why were they not requested before the start of the inquiry? Why was Joshua Loveday's the final operation considered by the GMC? Indeed, on the very day that Mr Ash Pawade, the new paediatric cardiac surgeon, began work, Mr Wisheart performed his final operation on a child. The child died of severe brain damage. Why was a 1988 study that was carried out for the Department of Health and Social Security, which clearly proves that the Bristol Royal Infirmary was significantly worse than any other paediatric centre in the United Kingdom,[5] not presented as evidence? Why did nothing happen in 1992 when, as was reported by the television programme Dispatches in March 1996 and again in July 1998 by Panorama, Sir Terence English informed the Department of Health that he considered that the Bristol Royal Infirmary should be dedesignated? Why wasn't Sir Terence summoned as a witness? Why in 1995 was Mr Wisheart awarded an A merit award, whereas Dr Stephen Bolsin felt forced to leave the country? Why did the Society of Thoracic and Cardiovascular Surgeons, to whom annual returns are made, not act? Did the Bristol Royal Infirmary act against the patients' interests by operating purely so that the substantial supraregional funding would continue? The lack of funding mentioned by Professor Dunn was proved at the GMC not to have been an issue. I hope the public inquiry will address these and numerous other issues. James Stewart Former chartered accountant Blue Haze, Hillside Road, Sidmouth, Devon EX10 8JD 1 Dunn, PM. The Wisheart affair: paediatric cardiological services in Bristol, 1990-5. BMJ 1998;317:1144-5. 2 General Medical Committee. Transcript of the professional conduct committee hearing. London: GMC, 1998. 3 Sharma AK, Brawn WJ, Mee RB. Truncus arteriosus. Surgical approach. J Thorac Cardiovasc Surg 1985;90:45-9. |
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Richard Colman, Elected member of the GMC 156 Fulford Road, York, YO10 4DA, 01904-620091
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I, like Wendy Savage am concerned about the way and the direction that the GMC (General Medical Council) is being led. For the last 18 months there has been an accelerating attempt to bring about fundamental changes in the GMC and its regulation of the Medical profession. In my view there has been an indecent haste in pushing through the President’s wishes using slick management, spurious argument and the threat of the heavy hand of government. The Bristol case has been a convenient instrument with which to quell discontent within the Council but I like others feel things have gone too far. Mistakes are now being made. The patronage of influential positions is made to influence the preferred outcomes. As a principle the Professional Conduct Committee is being asked (by the selective use of legal argument) to take a hard line in punishing doctors to satisfy the baying hounds of the press. Justice is seen as expendable if it improves public relations. Revalidation linked to registration was put to the public before the GMC had even seriously considered it. Members were expected to pass the principle before any consideration had been given to detail. Before next years elections we members need to slow down and rebuild the trust that is being recklessly squandered. If this requires a period of cool reflection then so be it. Richard Coleman, Elected Member of the GMC |
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Peter West, Senior Consultant National Economic Research Associates
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Sir, In following the debate on the Bristol case I am struck by a common feature of the NHS in the late 20th Century, the failure to achieve regular, systematic, open and high quality audit of care. To all those in the NHS who say they do not have the time or that it is all too difficulty, I say only this. How can you bear not to know? How can you go on doing what you do, often taking lives in your hands, without knowing, without checking regularly and systematically, that you are achieving the outcomes you strive for? As those of us who have been involved in studies reviewing case notes know too well, the quality of routinely available information after the event is poor, frequently handwritten and often brutal and short. There is no defence for the failure to collect systematic electronic information on patients. But my own experience of trying this in a range of academic research projects is that the data is not available. To find out who had a heart operation five years' ago in most UK hospitals is to seek a group of needles, the patient records, in a hay stack, the archives of the records department. This lack of good data on outcomes was probably indefensible in the days before computers. Now, it is surely much worse than that. |
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Maria Shortis, Two mothers of Bristol cardiac patients n/a, Elisabeth Winkler
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We are two mothers of children who underwent cardiac surgery in Bristol - one who died in 1987 and one, operated on last July, who made a full recovery. In different ways we have been close to the Bristol tragedy and we are left with several concerns. Doctors can make mistakes - this is not the issue. The issue is how mistakes are dealt with. A problem which is addressed can be rectified - but if it is downplayed or covered up, improvement is blocked. Why was there so much resistance to acknowledging the problem? It was not through lack of information. The problems in Bristol's cardiac unit were known about at different levels for a long time. According to Panorama, Plymouth cardiologists had asked for a different surgical referral centre since as early as 1983. In 1992 Private Eye reported that jokes had been doing the rounds since 1988 when the Bristol's children's heart unit was dubbed the Killing Fields and the Departure Lounge (1). Bristol's reputation was not only the subject of gossip. In 1989 Sir Terence English, then President of the Royal College of Surgeons, commissioned a review of all 9 supra regional paediatric cardiac units in the country. The findings of the review identified Bristol, along with Leeds and Newcastle, as substandard. In 1992 it recommended that Bristol be dedesignated i.e. that it should no longer continue to receive funding from the Department of Health (3). How did the UBHT respond to these findings? The senior surgeon Mr. Wisheart was Medical Director and Chairman of the Hospital Medical Committee (1990-95) - in other words both judge and defendant. Could this over-powerful position have compromised any response to news of his substandard surgical performance? Even if Mr. Wisheart was in denial about his failings, was there no one in authority to bring them to his attention? In July 1992 the Royal College of Surgeons made its findings known to the Supra Regional Services Advisory Group at the Department of Health (4). Despite having information about Bristol's substandard performance, the Department continued to fund Bristol to carry out complex surgery for a further 20 months until March 31st 1994 (5). One of the surprising facts to emerge from the Bristol case is the discovery that health trusts are accountable to no one. The clearest example of this is when Dr. Bolsin and Professor Angelini tried to stop a non-emergency heart operation in January 1995, not even a telephone call from the Department of Health could stop the fatal operation going ahead (6). It is of great concern that those with the highest responsibility of care have no one to answer to but themselves. The questions remain: who makes decisions and to whom are the decision-makers accountable? The GMC took us no nearer to examining the wider picture. Although the GMC can strike off doctors, it cannot examine the systemic failure which led to the doctors being found guilty. According to Professor Rudolph Klein, Professor of Social Policy at the University of Bath, "the GMC cannot put institutions on trial. Nor can it conduct a wide-ranging inquiry, reviewing all the available evidence." (7) The GMC was restricted in other areas of its investigation. Several times during the inquiry, the solicitors acting for the GMC stated that it had no power to bring charges against doctors' competence, either clinical or technical - in other words, doctors have clinical freedom without clinical accountability. The GMC's remit was so restricted that it could only examine 4% of the surgeons' paediatric surgical workload during 1990-95 (8). Until all the data is made available the picture will remain unclear. "The GMC availed themselves to assess the culprits. However, it was, alas, left to the parents to uncover the debacle. If it had been left to the GMC," writes Dr. William Pickering, "the grim events at Bristol would have been continuing yet. So far as the identification throughout the country as far as substandard clinical practice is concerned, the GMC is irrelevant." (9) The fact that we need a Public Inquiry to get to grips with what went wrong at Bristol demonstrates the limitations of self-regulation. Certainly self-regulation failed many of the adult (10) and paediatric patients under Mr Wisheart's Directorate. What is the way forward? Although the Royal College of Surgeons are urging the implementation of league tables for coronary bypass graft in adults with risk adjusted figures, we suggest that this audit system is inadequate and open to abuse. Another model exists which we believe goes much further in ensuring patient safety and clinical accountability. We need to look no further than to present day practice in Bristol for the answer. 1) The data is collected prospectively: i.e. a person (not a surgeon) is employed to collect the data and feed it into the computer. 2) The data collected covers a range of operations not only coronary bypass graft. 3) The data gives a clear and informative picture of the surgeons' competence. 4) The data is open to public scrutiny. However there are fewer than 5 cardiac centres where this type of audit is being followed. Why? One argument is that it is too expensive to implement. But compare the cost of 40k per year (for both adult and paediatric cardiac units) compared to the 40k paid every year for 10 years for Mr. Wisheart's merit award. If every unit were to follow a similar code of practice, one could believe that doctors were responsibly self-regulating their practice and striving for clinical excellence. Otherwise we are left with the feeling that the Royal Colleges are more concerned with preserving the status-quo than looking for a workable solution. Do we need another Bristol tragedy before it is realised how dangerous the status-quo can be? We would like to acknowledge our gratitude to Dr. Stephen Bolsin, now Director of peri-operative medicine at the Geelong Hospital, Australia who risked his reputation and career to stop further unnecessary deaths. References 1. Private Eye 793, May 1992 2. Sir Terence English, former president of the Royal College of Surgeons' Dispatches Channel 4 TV, 27 March 1996. 3. Letter to Dawn Primarolo MP from Baroness Cumberlege, April 22nd 1997 4. bid 5. Dispatches, Channel 4, March 27th 1996. 6. The Independent, May 30th 1998 7. Professor Dunn "The Wisheart Affair" BMJ vol. 317, October 24th 1998 8. A Medical Inspectorate, discussion paper by Dr. W.G. Pickering for the Centre for Policy Studies, July 2nd 1998. 9. Adult Cardiac Review 1997. Treasure/Taylor. Please address any correspondence to Maria Shortis Constructive Dialogue for Clinical Accountability e-mail 101636.1720@compuserve.com |
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Peter M Dunn, Emeritus Professor of Perinatal Medicine & Child Health University of Bristol
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This response to Dr. Bolsin(1) should be read in conjunction with a letter soon to appear in the BMJ. Let me explain my interest in this affair. While I did not know any of the defendants socially, James Wisheart had for many years operated on most of the infants in my care with severe cardiac malformations. I came to appreciate that he was a quite exceptionally able, honest, hardworking and caring doctor totally committed to the interests of his patients. When the so-called Bristol "scandal" broke in 1995 I was appalled at the sustained assault by the news media against him and his colleagues. So I started to study the affair, first on my own and then, during the last year, with a group of senior colleagues in Bristol. I shared with the cardiac surgeons the problem of developing a high tech service (mine was neonatal intensive care) against a background of serious under-funding. The trouble was that we were all under-funded and efforts to obtain a larger share of the common budget meant that someone else would lose out. In the early days the neonatal mortality was much higher than it need have been with adequate staffing and facilities, a problem that was widespread in the UK(2). I constantly drew the attention of colleagues, managers and politicians to this problem with little positive effect. Meanwhile, like the paediatric cardiac surgeons, we did our best in the existing suboptimal circumstances. Following the death of Baby Loveday on January 12th, 1995 and the unilateral approach of Bolsin to the Department of Health, the Chief Executive Dr. Roylance invited Mr. Marc de Leval and Dr Stewart Hunter, independent and distinguished experts in paediatric cardiac surgery and cardiology, to report on the Bristol service. They were provided with the information they had requested, namely a complete set of data on all the operations on infants and children between 1992 and January 1995. They had also been given in February by Bolsin a copy of his secret audit for 1990- 1992. In January 1996 de Leval wrote a commentary on the Trust Report on Paediatric Cardiac Surgery for the period 1990 - 1995(3). He stated that the earlier report with Dr. Hunter should be disregarded because it had been written on the basis of data, some of which proved to be incomplete and inaccurate. He was referring to the audit by Bolsin whose data had also been leaked to the television and newspapers in March/April 1995. The Bristol paediatric surgeons and cardiologists had seen Bolsin's report for the first time in May 1995. This secret audit included erroneous data indicating that there had been 6 deaths among the surgeon's 46 patients with ventricular septal defects (13.0%), whereas in fact there had only been 1 among 42 (2.4%), a difference of over 500%(4). Although Bolsin admitted this huge error in a letter to Dr. Roylance in October 1995, the fact did not become public until the GMC Inquiry 2 years later. Meanwhile this damaging mis-information remained in the public arena. de Leval's commentary(3) revealed that the overall mortality for open heart surgery for children over the age of 1 year in Bristol (1992-95) was 4.4% against 3.6% for the UK, a difference he considered unlikely to be statistically significant. The mortality for infants under 1 year was higher than average for the UK, the outcome for atrio-ventricular septal defects and Switch operations being particularly disappointing. He concluded his report by stating: "I believe that the Bristol performance over the last three years in terms of mortality matches with the average UK results published by the UK Cardiac Surgical Register, including open- heart surgery in infancy, with the exception of the AVSD and Switch procedures". de Leval continued: "I also believe that the (Bristol) Trust and those at the sharp end of the system have taken positive steps to improve these results. This included (1) positive steps to attempt to improve the early poor results of the arterial Switch operation; (2) the appointment of a full-time paediatric cardiac surgeon which has now been implemented; (3) the decision taken by one surgeon to relinquish his paediatric cardiac surgical activities as soon as the new appointment was made; this has taken place; (4) the creation of a dedicated paediatric cardiac unit with dedicated theatres, intensive care unit, nurses, physicians and surgeons; and (5) the review and reinforcement of comprehensive clinical audit procedures".(3) The changes commended by de Leval had in fact been proposed previously to the Trust by the paediatric cardiological surgeons and physicians as long ago as 1989 in an effort to improve the service, but had not been implemented because of lack of funds. Repeated attempts to achieve these objectives were finally successful in mid-1994,. when the Trust decided to appoint a new surgeon and move the paediatric cardiac surgery to purpose-built facilities in the Children's Hospital. Wisheart indicated that he would withdraw from paediatric surgery when the new surgeon was appointed; this was all before the controversy ever entered the public arena. Since then de Leval's optimistic forecast has been amply fulfilled with the mortality for paediatric open heart surgery in Bristol as low or lower than any in the UK. The GMC's verdict, following more than three years of adverse media publicity, appeared to confirm the widely held view that the Bristol surgeons were alone responsible for the excess mortality among 4% of their operations(4). But how can such a conclusion be reached without careful consideration of the reasons for the deaths? It is notoriously difficult to make statistical judgments on small numbers of cases, especially if not taking risk stratification into account. Several of the children were considered in retrospect to have had little or no chance of survival. The opinions given by the experts to the GMC were divided. The charge of incompetence against the surgeons was dropped and indeed their technical excellence recorded. The environment in which these unforgiving operations were undertaken was less than ideal through no fault of the surgeons. Other members of the clinical team may have contributed to the disappointing outcome. Given that there was no paediatric cardiac surgeon on the GMC's professional conduct committee, how could the members of the committee be sure, as they had to be in law, that the surgeons were wholly to blame? How could they be sufficiently sure to make the fine judgement that the surgeons should have stopped operating two or three cases earlier than they did? The public is rightly proud of the NHS, but, encouraged at times by politicians, doctors and the media, its expectations are sometimes unrealistic. In spite of serious under-funding there has been a steady improvement in the service from the chaotic beginnings of 50 years ago. However, there is still much to do. Almost all the doctors, nurses and other health care workers with whom I have worked, have done their very best for their patients, often in difficult circumstances. This is especially true of the Bristol doctors who, I believe, have been treated by Bolsin and others in a most unjust way. Peter M. Dunn Emeritus Professor of Perinatal Medicine and Child Health University of Bristol Southmead Hospital Bristol BS10 5NB E.Mail: P.M.Dunn@bristol.ac.uk 1. Bolsin, SN. The Wisheart affair: responses to Dunn. The Bristol cardiac disaster. BMJ 1998; 317: 1579 - 1580. 2. House of Commons Social Services Committee. Session 1979 - 80; Second report: perinatal and neonatal mortality (Short, R. Chairman), London: Her Majesty's Stationary Office; 1980. 3. de Leval, MR. Paediatric cardiac surgery in Bristol, 1990 - 1995. Independent commentary to the United Bristol Healthcare Trust, January, 1996. 4. General Medical Council professional conduct committee. Transcripts of the case of James Wisheart, Janardan Dhasmana and John Roylance. October 1997- June 1998. |
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John McLorinan, Secretary Bristol Surgeons Support Group
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To Richard Smith, Editor, British Medical Journal It is all very well for the Press Officer, Richard Green, to boast about the high-wiz technology being set up for the Bristol Royal Infirmary Public Inquiry (2nd January)(Ref 1). However, someone, a real person, has to keep it up to date and available.(Ref 2) Had Richard Green visited his own WEB site on February 4th he would have found several items not updated for weeks; and not a bleep about the appointment of Professor Sir Brian Jarman to the Inquiry panel, which had been announced in the press 2 weeks earlier (Bristol Evening Post 26th January) (Ref 3,4) We have no criticism of Sir Brian personally, but we are in no doubt that a great opportunity has been missed in not appointing someone with experience in the subject being investigated – someone like Nick Barnes (Ref 5) , for instance. If the Public Inquiry is to have any credibility, it must be able to draw on hands-on experience in the conditions that prevailed at the time under examination. In the absence of that experience on the Panel to the Inquiry, there must now be among the Inquiry’s Panel of Experts cardiac surgeons, paediatricians, and cardiologists at the very least. Signed on behalf of The Bristol Surgeons Support Group REFs: 1. Green Richard, BMJ 1999, 318 : 60 2. No Fax or E-mail services available Friday – Sunday 23rd-25th October 1998. This was the weekend prior to the Preliminary Hearing opening in Bristol when last applications for costs were to be lodged. Explanation "lines down". 3. 14th – 18th January Internet WEB site: Who’s Who page BLANK.. NO names available. Replaced 19th January – Not updated since. 4. Internet WEB site: News Releases Page – not updated since 18th January.: The appointment of Sir Brian Jarman was made on 25th January and issued via a News Release. Still not on WEB site. 5. Barnes.N., BMJ 1998; 317: 1577 - 1579 |
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Bruce E Keogh, Secretary, Society of Cardiothoracic Surgeons of Great Britain & Ireland University Hospital Birmingham
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The cardiac surgical community has been greatly saddened by the events in Bristol and the
suffering of bereaved families. We welcome the comments from Shortis and Winkler
1 and would
like to indicate that that we are endeavouring to address some of their concerns.
Congenital cardiac surgery represents 10% of cardiac surgery in the UK. Its complexity and small numbers make individual surgical audit difficult. However, the Society of Cardiothoracic Surgeons of Great Britain & Ireland have defined repair of aortic coarctation and ventriculoseptal defect as surgeon specific marker operations for congenital cardiac surgery. Throughout the UK in 1997-8 there were a total of 238 operations for simple coarctation performed by 27 surgeons with only one death. Similarly, there were 302 operations performed by a slightly different group of 27 surgeons for isolated VSD with only two deaths. The list has been extended to seven marker operations for the year 1998-9. Similarly isolated, first time coronary artery bypass surgery was defined as a surgeon specific marker operation for adult surgery. Last year 171 surgeons performed an average of 139 isolated, first time coronary operations with an operative mortality of 2.3% (95%CL 2.04 - 2.63%). All NHS units have returned annual activity and mortality data to the society on a large number of procedure since 1977. 2 Last year was the first time that all surgeons in the UK returned individual activity and mortality data on specific marker operations. Although not risk-stratified this data provides an effective alarm mechanism, which, in the absence of risk-stratification, is likely to be over sensitive. In order to identify potential problems early we have limited the timescale for submission of data to three months after the end of the financial year. This allows time for all deaths to be captured, and for internal validation of data before submission. The results are screened by the Standards of Care Committee of the Society and mechanisms have been put in place to independently review the surgical activity of apparent outliers. Bristol should be congratulated on the publication of their comprehensive risk-stratified data. This is based on the dataset recommended by the Society of Cardiothoracic Surgeons and adopted by over half of the 35 units performing adult cardiac surgery in the UK, not just the five units as Mrs Shortis has been advised. Our Society strongly encourages all units to collect this data, in order to facilitate effective risk stratification, and we anticipate that next year the number of units collecting and submitting comprehensive data will have risen to over 80%. We agree that this does not need to be a very costly exercise although expense is inevitably incurred both locally for collection of data and centrally for downloading, merging and validation of data. At the trust level there is an initial outlay for dedicated software capable of performing the necessary analyses and employment of a dedicated individual to ensure the data is complete and accurate. Surprisingly, some trusts remain recalcitrant over this relatively small investment which leaves them ignorant of a complex corporate product and therefore highly vulnerable at several levels. Where outcomes are open to public scrutiny, data validation is a vital component of any meaningful clinical audit. To be effective this necessitates independent and external review which our Society is currently exploring - but this costs money which small specialty groups do not have. The Society of Cardiothoarcic Surgeons will be releasing its 1998 Adult Cardiac Surgical Database report as a public document in May 1999 which will outline in greater detail the progress and problems in cardiac surgical audit.
Bruce E Keogh Society of Cardiothoracic Surgeons of Great Britain and
Ireland, c/o Concorde Services, London W12 9RT |
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