Effects of ‘Bristol’ on surgical practice in the United Kingdom

Abstract

In 1995 a child died following an arterial switch operation for complex transposition of the great arteries. There had been general concern regarding the outcomes for the arterial switch procedure in the unit in Bristol. A review, prompted by parents whose children had died, showed that 29 children had died and four others suffered from cerebral damage postoperatively. The General Medical Council (GMC) considered the conduct of three doctors from the unit. This hearing culminated in the suspension and subsequent removal from the Medical Register of the senior Cardiac Surgeon and the Chief Executive of the hospital. The second Cardiac Surgeon was banned from practising in the field of paediatric cardiac surgery for three years (his results in adult cardiac surgical practice were not called into question). Following this the Government set up a public Inquiry to investigate the causes behind the deaths. This Inquiry, which took three years, made recommendations that have affected the way all doctors in the UK practice.

1. The Inquiry

The Bristol Royal Infirmary Inquiry ran from October 1998 to July 2001 [1,2]. The Inquiry took evidence from 577 witnesses of which 238 were parents of children treated at the centre. They reviewed approximately 900,000 pages of evidence including 1800 sets of case notes. The taking of oral evidence took 96 days.

The Inquiry carried out the Clinical Casenote Review (CCNR). In an effort to define the standards of care expected for children with cardiac disease, the medical records of 80 children treated in Bristol during the period of the Inquiry were selected ‘blindly’, but structured to reflect the range of ages and complexity seen in congenital heart disease practice. These records were then reviewed by multispecialty team picked from other units around the UK. Standards of care were defined and the Bristol cases scored against the defined standards. The Inquiry team concluded that while the majority of children received satisfactory care, deficiencies in care were related to issues across the management and clinical spectrum rather than specifically related to the surgery.

The second part of the Inquiry consisted of 7 seminars with 180 papers presented on the events in Bristol and their consequences. It is estimated that the Inquiry cost in the region of £14,000,000 and resulted in a 529-page report. There were 198 recommendations covering such areas as informing and supporting patients, audit, regulations of health care professionals, management, training and setting and monitoring of standards with particular reference to children but also applying to adult patients. Of the 198 recommendations, most related to the wider NHS – only 31 related specifically to children and only 7 to paediatric cardiac surgery.

2. Effects on practice

The recommendations that most closely affected the practice of clinicians were those concerned with com-munication, competence, performance appraisal and regulation.

All doctors should undergo regular appraisal and revalidation of their right to practice. The GMC was to develop this system. The current proposals are for annual appraisal with revalidation every five years based on the appraisals. A licence to practice will be issued on successful completion of these stages.

Further bodies have been set up to oversee the profession (Table 1). The National Clinical Assessment Authority has the responsibility to investigate any concern about the practice of an individual Consultant. It will co-operate with the Medical and Surgical Royal Colleges and advise on remedial steps to be taken.

The Inquiry expressed the strong opinion that training should be based on achieving competency rather than on a fixed term training programme. (At present the programme for cardiothoracic surgical trainees is 6 years.) A competency (rather than time based) curriculum relating to the nine surgical specialties has recently been published by the Joint Committee for Higher Surgical Training (www.jchst.org).

New standards of information for patients were set and the taking of consent for procedures has been improved so that the risks and benefits quoted to the patients or their parents must now be detailed and be relevant to both the patient and the practice of the surgical team.

Results of procedures done by a particular surgeon should be available when the patient is considering surgery. The Government has taken this recommendation a step further in that it promised to publish data on individual (adult) cardiac surgeons’ mortality starting with coronary artery bypass surgery in 2004. This information has recently been published in the Annual Database Report from the Society of Cardiothoracic Surgeons of Great Britain and Ireland [3].

In its response to the Inquiry's findings the Government accepted all the recommendations, but recognised the difficulties in achieving a no-blame culture within the NHS. It indicated that this would be necessary to allow the openness between the public and the profession that was at the root of the Inquiry's recommendations.

These recommendations have altered the way doctors practise and their relationship with their patients. More difficult has been the result of the highly emotive and in some cases aggressive publicity campaign surrounding the events in Bristol and the subsequent Inquiry.

Paediatric cardiac surgeons were, of course, particularly affected and their relationships with patients and parents were severely damaged in some cases.

3. Adult cardiac surgery

The Government's desire to see results published has put considerable pressure on surgeons to ensure that their mortality is kept as low as possible. Unfortunately, in some cases there is a perception that the best way to achieve this is to avoid high-risk cases, paradoxically often those patients who might most benefit from surgery. This was also seen when a similar exercise was carried out in New York State and Pennsylvania. Further concern was expressed over the accuracy of the data upon which these releases were based [4,5],. The issue of publication of surgeon specific results has caused intense debate both within the profession and between the SCTS and Department of Health. The crux of the debate centres on the question of why results are being published — are these to ensure patients’ safety (a key concern for the individual Surgeon) or is it to allow the patient to choose their Surgeon [6,7].

4. Paediatric cardiac surgery

Performance monitoring in paediatric cardiac surgery is even more complex – internationally accepted definitions of diagnoses and procedures have only recently been agreed. For any given procedure there will be patient specific and procedure related factors which will affect the outcome. The Bristol Inquiry highlighted the need for a method to address case mix in surgery for congenital heart defects and prompted an international collaboration (Aristotle Complexity Score) [8].

The need for accurate data on outcomes was emphasised by the Inquiry and the Department of Health established a national database to which all units submit results. Data quality is monitored by an external validation team.

Following on from the Inquiry, the Department of Health set up a national review to determine the best way to provide services for patients with congenital heart disease in the future – the Paediatric and Congenital Cardiac Services Review. www.advisorybodies.doh.gov.uk/childcardiac/reviewnov02.pdf.

The Review Group had representatives from all the different specialties involved in the care of children and from each of the 12 units currently providing children's cardiac surgery in the UK. It recommended that some paediatric cardiac surgical units be amalgamated so that each surgeon should have a minimum defined workload, each unit should carry out a minimum of 300 surgical procedures and there should be a minimum of three surgeons in each unit. This recommendation was not too dissimilar from that produced by the EACTS Congenital Heart Surgery Committee www.eacts.org/doc/6865.

This figure of 300 was chosen pragmatically as there is some evidence in the literature to suggest that outcome is related to unit volume, but this is not robust. At present only two units in the UK have more than two surgeons and only four units carry out more than 300 cases. It was felt strongly by the Review Group that it would not be possible to sustain the service in the future with two surgeons – changes in surgical training mean that the contribution from trainees, particularly in post operative intensive care, will diminish and the European Working Time Directive will have a significant impact both on Consultants and trainees.

Thus it was felt that units needed to be bigger – as the workload for congenital heart disease is fixed (and possible reducing in the future), larger units meant fewer units. The Review Group recognised the political sensitivity of this. The Government has accepted all the recommendations but the one aimed at closing centres performing less than 300 procedures a year.

While the political sensitivities are recognised, the British Paediatric Cardiac Association continues to press the Department of Health to accept the need for reconfiguration of services (with a reduction in the overall number of surgical units) – having less than three surgeons in each unit is not sustainable for the future. However, there is little point in having three surgeons if they have insufficient work to maintain their skills and so if units are to have more Surgeons, they must have a larger workload.

It also raises the question of performance monitoring – if numbers in a unit are small then the confidence limits around any statistical estimate of mortality will be wide thus reducing the value of any comparison. This has been highlighted recently in a public debate about the outcomes in one of the smaller units [9].

While the outcome of Bristol has undoubtedly led to an increase in pressure on individual surgeons with particular concern over the release of mortality data, there does not appear to have been a significant reduction in trainees wishing to practise paediatric cardiac surgery. Surprisingly perhaps there are still many trainees who wish to take on this challenging speciality in the UK.

References

Author notes