SCREENING FOR BOWEL CANCER USING FLEXIBLE SIGMOIDOSCOPY REVIEW APPRAISAL CRITERIA FOR THE UK NATIONAL SCREENING COMMITTEE

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1 SCREENING FOR BOWEL CANCER USING FLEXIBLE SIGMOIDOSCOPY REVIEW APPRAISAL CRITERIA FOR THE UK NATIONAL SCREENING COMMITTEE The Condition 1. The condition should be an important health problem Colorectal cancer is the third most frequently diagnosed cancer worldwide, accounting for more than 1 million cases and 600,000 deaths every year 1. In England in 2007, 30,727 people were diagnosed with colorectal cancer and 12,841 people died from it. 5- year survival rates for colorectal cancer are 50.9% in men and 52.6% in women. Survival is strongly related to stage at diagnosis, with survival rates of 90% for localised cases The epidemiology and natural history of the condition, including development from latent to declared disease, should be adequately understood and there should be a detectable risk factor, disease marker, latent period or early symptomatic stage Most colorectal cancer arise from adenomas, predominantly symptomless growths that develop in 20-30% of the population 3 4. Two-thirds of colorectal cancers and adenomas are located in the rectum and sigmoid colon, which can be examined by flexible sigmoidoscopy (FS) All the cost-effective primary prevention interventions should have been implemented as far as practicable Although some high risk factors for colorectal cancer are known (obesity, alcohol consumption), until now there has been no proven intervention for primary prevention of colorectal cancer. The Department of Health in England is working to increase the awareness of the signs and symptoms of colorectal cancer through the National Awareness and Early Diagnosis Initiative. 4. If the carriers of a mutation are identified as a result of screening the natural history of people with this status should be understood, including the psychological implications 1 WHO. Cancer, fact sheet 297. Geneva: World Health Organisation, Cancer Research UK. By stage at diagnosis. London: Cancer Research UK, Lieberman et al, Use of colonoscopy to screen asymptomatic adults for colorectal cancer. N Engl J Med 2000; 343; Schoenfeld et al, Colonoscopic screening of average-risk women for colorectal neoplasia. N Engl J Med 2005; 352: Atkin et al, Prevention of colorectal cancer by once-only sigmoidoscopy. Lancet 1993; 341:

2 The Test 5. There should be a simple, safe, precise and validated screening test FS has been shown to be a well accepted, safe and quick method for population screening for colorectal cancer The distribution of test values in the target population should be known and a suitable cut-off level defined and agreed 7. The test should be acceptable to the population In the context of a clinical trial with dedicated trial staff, FS is a well tolerated procedure. There are high levels of satisfaction with service provision and positive attitudes towards the programme 8. A demonstration project on FS screening in North West London has shown that uptake of FS screening delivered as a population-based programme was over 50% among the eligible population in a socioeconomically and ethically diverse area of London 9. Acceptance of the FOBt programme in London is around 40%, and in the two PCTs involved in the FS project FOBt uptake is 39% and 48%. Despite FS requiring bowel preparation, a visit to the hospital, and a more invasive test than FOBt screening, uptake rates for the two tests are surprisingly similar 10. This suggests that barriers to CRC screening are likely to lie not in the specifics of the test but in the public s lack of awareness of the high incidence of colorectal cancer or the potential value of screening There should be an agreed policy on the further diagnostic investigation of individuals with a positive test result and on the choices available to those individuals There is very clear policy on the further diagnostic investigation of individuals with a positive FS result. Participants in the trial underwent flexible sigmoidoscopy with polypectomy for small polyps and referral for colonoscopy if they had polyps meeting any 6 UK Flexible Sigmoidoscopy Trial Investigators. Single flexible sigmoidoscopy screening to prevent colorectal cancer: baseline findings of a UK multi-centre randomised trial. Lancet 2002; 359: Wardle et al. Psychological impact of colorectal cancer screening. Health psychology 2003; 22: Taylor et al. Acceptability of flexible sigmoidoscopy screening in older adults in the UK. J Med Screening 2000; 7: Robb et al Flexible sigmoidoscopy screening for colorectal cancer: uptake in a populationbased pilot programme J Med Screen 2010: 17: Wardle and Atkin, Colorectal cancer prevention through screening: population acceptance of flexible sigmoidoscopy J Med Screen 2010; 17: Robb et al, Demographic and psychosocial factors associated with perceived risk for colorectal cancer. Cancer Epidemiol Biomarkers Prev 2004; 13:

3 of the following high-risk criteria: 1cm or larger; three or more adenomas; tubulovillous or villous histology; severe dysplasia or malignant disease; or 20 or more hyperplastic polyps above the distal rectum. 9. If the test is for mutations the criteria used to select the subset of mutations to be covered by screening, if all possible mutations are not being tested, should be clearly set out The Treatment 10. There should be an effective treatment or intervention for patients identified through early detection, with evidence of early treatment leading to better outcomes than late treatment If bowel cancer is detected through FS or subsequent colonoscopy, the care of the patient is handed over to the relevant multidisciplinary team (MDT), who follow guidance from the National Institute for Health and Clinical (NICE), Guidance on Cancer Services: Improving Outcomes in Colorectal Cancers, manual Update (May 2004). Following consultation by the MDT and discussion with the patient, an individual programme of treatment and care will be agreed. The NICE guidance states that around 8 in 10 people who have bowel cancer detected will have surgery to remove the cancer. The proportion of patients who would be suitable for surgery would be expected to be considerably higher in a screened population. After surgery, over 50% of people will live for more than five years. Pre- or post-operative chemotherapy or radiotherapy may be offered to patients to clear protocols, depending on the stage of the cancer. Patients who are diagnosed at an early stage have a much better prognosis than those who present with more extensive disease. Over 93% of patients diagnosed with Dukes A (the earliest stage of disease) survived five years compared with 7% of patients with Dukes D (advanced disease) There should be agreed evidence based policies covering which individuals should be offered treatment and the appropriate treatment to be offered The NICE Improving Outcomes Guidance states that the management of all patients with colorectal cancer should be the responsibility of colorectal cancer MDTs. The MDT should be responsible for planning care in a seemless way so each patient receives prompt and appropriate care throughout the treatment process. 12 National Cancer Intelligence Network Colorectal Cancer Survival by Stage. NCIN Data Briefing. June

4 12. Clinical management of the condition and patient outcomes should be optimised in all health care providers prior to participation in a screening programme Cancer Peer Review, undertaken by the National Cancer Action Team, assesses MDTs against measures developed from the NICE Improving Outcomes Guidance. Prior to their inclusion in a national FS screening programme, NHS Cancer Screening Programmes would assess peer review results before accepting teams into the programme. The National Cancer Intelligence Network is monitoring case mix-adjusted 30 day mortality following colorectal cancer surgery at all NHS Trusts in England. Results are likely to be published soon. The Screening Programme 13. There should be evidence from high quality Randomised Controlled Trials that the screening programme is effective in reducing mortality or morbidity. Where screening is aimed solely at providing information to allow the person being screened to make an informed choice (eg. Down s syndrome, cystic fibrosis carrier screening), there must be evidence from high quality trials that the test accurately measures risk. The information that is provided about the test and its outcome must be of value and readily understood by the individual being screened 14. The results of a randomised controlled study of FS screening were published in The Lancet in May 2010, showing that men and women aged 55 to 64 attending a one-off FS screening test for bowel cancer can reduce their mortality from the disease by 43% (31% on a population basis) and reduce their incidence of bowel cancer by 33% (23% on a population basis) 13. The study found that that FS is a safe and practical test and, when offered only once between ages 55 and 64 years, confers a substantial and long lasting benefit. A very similar trial has been conducted in Italy, but the results have not yet been published. A verbal update will be given to the NSC meeting in November. 15. There should be evidence that the complete screening programme (test, diagnostic procedures, treatment/ intervention) is clinically, socially and ethically acceptable to health professionals and the public The results of the study by Atkin et al and publications relating to the demonstration project in Harrow and Brent have clearly shown that the complete screening programme is clinically, socially and ethically acceptable to health professionals and the public. 16. The benefit from the screening programme should outweigh the physical and psychological harm (caused by the test, diagnostic procedures and treatment) 13 Atkin et al, Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial, The Lancet, Volume 375, Issue 9726, Pages , 8 May

5 A programme that can reduce mortality from bowel cancer 43% (31% on a population basis) and incidence of bowel cancer by 33% (23% on a population basis) has benefits considered by the Bowel Screening Advisory Committee in England to outweigh the physical and psychological harm 1415, and is more effective than the current FOBt based bowel screening programme and indeed the breast screening programme. 17. The opportunity cost of the screening programme (including testing, diagnosis and treatment, administration, training and quality assurance) should be economically balanced in relation to expenditure on medical care as a whole (ie. value for money). Assessment against this criteria should have regard to evidence from cost benefit and/or cost effectiveness analyses and have regard to the effective use of available resource Economic analyses suggest that a once-only flexible sigmoidoscopy screen at age 55 or 60 years would be cost saving, largely because of the avoided costs of treatment resulting from the reduction in incidence The costs of the FS programme have been estimated based on the feasibility study in North West London, the current costs of cancer screening programmes, current tariff prices and workload estimates based on equivalence to the FS trial. 18. All other options for managing the condition should have been considered (eg. improving treatment, providing other services), to ensure that no more cost effective intervention could be introduced or current interventions increased within the resources available Although survival rates for colorectal cancer are improving (eg fiveyear relative survival for male colon cancer rose from 22% in the early 1970s to 50% in the mid 2000s for females it rose from 23% to 51% 18 ), half of patients still die from thneir disease in the first five years. National action to increase survival, such as the existing FOBt screening programme, the National Awareness and Early Diagnosis Initiative (NAEDI), and nutrition programmes (eg 5-aday), may have an impact on survival rates from colorectal cancer, but none will have the impact of a population based FS screening programme. FOBt for people aged 50 to 59 would be an alternative to FS, as is being done in Scotland, but FS is the only screening method which has been shown to reduce incidence. There are also no direct comparisons between FOBt and FS. 14 UK Flexible Sigmoidoscopy Trial Investigators. Single flexible sigmoidoscopy screening to prevent colorectal cancer: baseline findings of a UK multi-centre randomised trial. Lancet 2002; 359: Wardle et al. Psychological impact of colorectal cancer screening. Health psychology 2003; 22: Loeve et al, Endoscopic colorectal cancer screening: a cost-saving analysis J Natl Cancer Inst 2000; 92: Tappenden et al, Option appraisal of population-based colorectal cancer screening programmes in England. Gut 2007; 56; Cancer Research UK. CancerStats: Survival England and Wales,

6 19. There should be a plan for managing and monitoring the screening programme and an agreed set of quality assurance standards The UK countries have extensive experience of piloting and rolling out national cancer screening programmes, most recently the FOBt bowel screening programme. Co-ordinating teams are in place in each of the four countries to take forward such work, assessing services on capacity and quality criteria, developing IT systems, and develioping quality assurance standards before implementation. Quality assurance standards and an infrastructure already exist for all aspects of the FOBt programme, including the colonoscopy element, and these will be amended to reflect FS screening based on the experience of the trial. 20. Adequate staffing and facilities for testing, diagnosis, treatment and programme management should be available prior to the commencement of the screening programme Funding to pilot the FS programme, devlopment of an IT system and an endoscopy training programme has been secured in England as part of the Spending Review. Adequately trained nurse practitioners can undertake FS as competently as can gastroenterologists 1920, and public acceptance of nurse endoscopy is high In addition, there have been discussions with the British Society for Gastroenterology (BSG) regarding the current surfeit of gastroenterology trainees who would have the requisite expertise for the commencement of the programme. Several sites have already volunteered to become pilot FS programmes and have indicated that they can meet the demand. 21. Evidence-based information, explaining the consequences of testing, investigation and treatment, should be made available to potential participants to assist them in making an informed choice. The UK countries have extensive experience of producing evidence based information to support informed choice in cancer screening programmes, and will base new FS materials on those used successfully in the trial and demonstration project. 22. Public pressure for widening the eligibility criteria for reducing the screening interval, and for increasing the sensitivity of the testing process, should be anticipated. Decisions about these parameters should be scientifically justifiable to the public As the FS programme will be a once only screening intervention, we will not need to consider the screening interval. The age of 19 Pinsky et al, Variability in flexible sigmoidoscopy performance among examiners in a screening trial. Clin Gastroenterol Hepatol 2005: 3: Schoenfeld et al, Accuracy of polyp detection by gastroenterologists and nurse endoscopists during flexible sigmoidoscopy: a randomised trial. Gastroenterology 1999; 117: 312_18 21 Brotherstone et al, Uptake of population-based flexible sigmoidoscopy for colorectal cancer: a nurse-led feasibility study. J Med Screening 2007; 14: Schoenfeld et al, Effectiveness and patient satisfaction with screening flexible sigmoidoscopy performed by registered nurses. Gastrintest Endosc 1999; 49:

7 screening and sensitivity of the testing process will be scientifically justifiable to the public based on the FS trial and accompanying publications. It is proposed that initially the programme will invite men and women at age 55 for FS screening. The trial showed no significant difference in efficacy due to age so far. However, it is understood the researchers are continuing to work on the issue and should new evidence become available, this policy will be reviewed. It is also proposed that the programme proceed on the asumption that those invited for FS at 55 will be offered FOBt screening at 60 in the current programme. This will also be kept under review. The programme is working with the FS researchers to examine the FOBt results of those who participated in the trial. 23. If screening is for a mutation the programme should be acceptable to people identified as carriers and to other family members ACTION: In light of the new evidence on the clinical and cost-effectiveness of one-off flexible sigmoidoscopy for men and women aged 55 to 64, the UK NSC is asked to consider whether this new approach should now be recommended as a national screening programme for people in their 50s in those administrations not currently screening people in this age range or as an alternative to FOBT in those administrations which are already undertaking screening in this age group. Pilots should be undertaken to inform the development of new flexible sigmoidoscopy services. 7