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We would like to voice our concerns about some of the recommendations in the guidelines recently published by the British Society of Gastroenterology and Association of Coloproctology for screening and surveillance for asymptomatic colorectal cancer in patients with inflammatory bowel disease (Gut 2002;51 (suppl V):v10–12).
(1) In the present medicolegal environment, failure to comply with guidelines which carry the imprimatur of respected national bodies will require vigorous defence should mishap occur. We do not believe the evidence is strong enough to justify the recommendation that every patient with extensive colitis of duration greater than 8–10 years should undergo regular colonoscopy. Firstly, it must be determined at each hospital whether it is possible and considered sufficiently cost effective to offer such a service within the constraint of local resources available. Secondly, if regular colonoscopy can be offered, then each patient should decide whether or not to accept regular colonoscopy after full discussion of its possible advantages and limitations.
(2) The success of colonoscopic surveillance programmes is disputed. Although some centres (including our own) have been protagonists for this approach, others have argued that it is not only labour intensive but also ineffective. Before imposing global national guidelines we should have firm evidence of a scheme’s efficacy or, failing this, we should have multicentre consensus. The guidelines, as published, appear to be the sincerely held opinions of a single consultant team based on their own research and assessment of the literature, followed by approval of a committee, but no indication is given of widespread consultation.
(3) The recommendations for patients with extensive colitis of a colonoscopy every third year during the second decade of disease, every second year during the third decade, and annual colonoscopies thereafter are complex. The evidence for an increasing risk of cancer in the second, third, and succeeding decades of disease duration is controversial, and is not borne out by the unstratified figures for patients with total colitis based on 26 reported studies in the meta-analysis reported by the authors of the guidelines, although an increase was observed in stratified data1. The strategy suggested therefore is not based on firm data, and in particular published data after the third decade are few due to the small numbers involved.
(4) We have concerns about the benefits during routine colonoscopic examinations of taking two to four random biopsy specimens every 10 cm. This approach is time consuming for both the colonoscopist and the pathology department, and adds a considerable financial burden to the programme (which is not included in Eaden and Mayberry’s cost analysis). In theory, the risk of a false negative examination is reduced as more biopsies are taken but in practice the additional yield is very low indeed. During a recent study at St Mark’s Hospital, almost 3000 random surveillance biopsies from such patients yielded no dysplasia (unpublished data).
(5) Considering the disputed efficacy of current colonoscopic surveillance programmes for patients with extensive ulcerative colitis, it is inappropriate at present to extend this by default to patients with left sided colitis or (by implication) those with Crohn’s disease.
We would like to thank Dr Forbes et al for their response to the guidelines published by the British Society of Gastroenterology (BSG) and the Association of Coloproctology of Great Britain and Ireland on screening and surveillance for asymptomatic colorectal cancer in patients with inflammatory bowel disease (Gut 2002;51(suppl V):v10–12). They raise a number of points which will be answered in turn.
(1) There are medicolegal implications of failing to comply with recommendations from a respected body but a guideline is precisely that—a guideline. They are not etched in stone and may need to be amended at future dates to continue to reflect best practice. The case of Wilsher v Essex Area Health Authority1 demonstrates that all clinicians now need to practice to the highest standards. However, the courts (Early v Newham Health Authority) will consider local guidelines.2 This will be of particular consequence to units that are unable to deliver standards that have been identified nationally, provided the local practice has been formulated into a local guideline. There is a wealth of data supporting the increased cancer risk in patients with ulcerative colitis and although evidence of the effectiveness of surveillance as practised in many centres is uncertain, such an approach is widespread. The purpose of guidelines is to identify good practice and to achieve a uniform approach throughout the country. The alternatives are to abandon surveillance or to offer haphazard and unstructured (and so ineffective) service. The anticipated cost of surveillance for both colitics and Crohn’s patients is estimated to be £9600 per annum. Hopefully, all centres will be able to meet this cost but we realise funds may not be available initially which is one of the reasons for suggesting the guidelines are audited in five years. It is clearly stated in the guidelines that a discussion should take place between the doctor and patient informing them of their individual risk so that the patient can make an informed decision before embarking on a surveillance programme. Gone are the days of a paternalistic attitude, as patients should now accept some responsibility for their illness.3
(2) Forbes et al raise the point that before any guidelines are imposed there should be firm evidence of a scheme’s efficacy. There are no randomised studies comparing different surveillance protocols or for that matter even surveillance versus no surveillance. As Forbes et al are well aware, it will never be possible to provide grade A recommendations on this issue and the best we can do is to assess surveillance programmes retrospectively. Data are accumulating that surveillance participants have reduced morbidity and mortality, as outlined in the guidelines, and one of the signatories to your letter has stated that surveillance improves survival.4 One notable review of surveillance programmes from the Leeds group did not show any benefit from surveillance but the group had very stringent criteria.5 They felt inclusion of dysplasia alone as a measure of success was of debatable value. Therefore, they limited their audit to those eventually found to have cancer. They also decided to exclude patients in whom cancer was found at an initial colonoscopy undertaken at least 12 years after the onset of symptoms. We feel that finding dysplasia is the very aim of surveillance and just because it is found on the first colonoscopy in a surveillance programme it should not be deemed a failure of surveillance.
As much consultation as possible was obtained before the guidelines were published. A national audit of the surveillance practices of gastroenterologists in the UK was conducted which revealed that although 94% of gastroenterologists performed surveillance, there was wide variation in practice.6 This alone suggests there would be little chance of a consensus opinion across the UK. Once the guidelines had been formulated, the Clinical Services and Standards Committee comprising approximately 40 individuals reviewed them. They then went through the usual guidelines process after being seen by the Clinical Services Committee and were examined by the IBD section of the BSG. After this they were posted on the BSG website for six weeks to attract comments from other members of the society. The guidelines then went back to the Clinical Services Committee after amendments were made on the basis of comments from the wide range of consultees. Finally, the guidelines were passed to the Executive Committee of the BSG for a further review and signing off. Thus the guidelines were fully evaluated before they were accepted and published. They are not simply the opinions of two consultant gastroenterologists.
(3) We appreciate that increasing the colonoscopy frequency with increasing duration of disease is more complicated than 1–2 yearly surveillance. However, we are sure that it is not too difficult to calculate and it actually reduces the number of colonoscopies being performed initially, so this must be regarded as a substantial improvement on the present routine practice of some gastroenterologists.
The meta-analysis does show an increasing cancer risk in the second and third decades of disease and is not controversial in the least.7 The whole point of stratified data was to see if the cancer incidence did increase by decade of disease. It is only stratified data that can be used in this way. Such data will give the most accurate estimate as it is only these data that included studies which reported cancer incidence stratified by decade and duration of patient follow up (19 studies). The decade specific incidence rates correspond to a cumulative risk of 1.6% (95% confidence interval (CI) 1.2–2%) by 10 years, 8.3% (95% CI 4.8–11.7%) by 20 years, and 18.4% (95% CI 15.3–21.5%) by 30 years.
The 26 studies Forbes et al refer to also included studies which reported cancer incidence where only duration of patient follow up was reported—that is, the incidence rates were not broken down for each decade. Even when these unstratified data were examined the cancer incidence still increased by decade of disease! The unstratified cumulative probabilities give a risk of 4.4% (95% CI 2.0–6.8%) at 10 years, 8.6% (95% CI 4.0–13.3%) at 20 years, and 12.7% (95% CI 6.0–19.3%) at 30 years.
Therefore, the strategy suggested is based on firm data. Of course the numbers of patients by the third decade are few but this is the nature of the beast. The use of a meta-analysis of cancer risk in ulcerative colitis overcomes the inadequacies of any reliance on smaller studies from single specialist centres.
(4) We accept that the cost of biopsies was not included in the cost analysis. There are numerous articles debating the number of biopsies which should be taken during a surveillance colonoscopy. Yes it is time consuming but we all know that to stand any chance of detecting dysplasia, the more biopsies taken the better. What is the point in surveillance at all if it is not conducted to the best standard? It would be interesting to know from the unpublished St Mark’s data how many biopsies were taken per colonoscopy. If for example only 10 biopsies were being taken at each examination, we would expect the chance of detecting dysplasia to be low.
(5) As patients with Crohn’s colitis have been shown to have the same cancer risk as patients with extensive ulcerative colitis, it would be doing them a disservice to exclude them from a surveillance programme.8,9 Left sided colitis also carries an intermediate risk for colorectal cancer and as such our guidelines reflects this. Indeed, one of the signatories to the Forbes et al letter has himself advocated a similar approach after discussion with the patient.4
The guidelines were formulated on the best evidence available at present. Surveillance was being conducted in an extremely disorganised fashion in the UK, which is not acceptable in the current climate of clinical governance. The BSG has properly encouraged a national approach to cancer surveillance in a range of colonic diseases. The principles, which underlie such an approach, are that of best practice throughout the country. The law no longer relies on the Bolam principle; rather we are now expected to practice to the best standards.1 If we are to offer long term care to patients with inflammatory bowel disease we must discuss with them the nature of surveillance and its inadequacies. If patients then choose to have surveillance we are obligated to provide a service which reaches the highest standards—standards similar to those in other screening services.