Paper 18.07 Bowel Screening Wales Network Multidisciplinary Team and National Referral Centre for Complex Polyps Author: Hayley Heard, Head of Programme Bowel Screening Wales Date: 10 May 2012 Version: 0b Purpose and Summary of Document: This document describes the need for a Network Multidisciplinary Team and National Referral Centre for treatment of complex colorectal polyps in Wales. It summarises the findings of a recent pilot and recommends the way forward for consideration by Public Health Wales Trust Board. Sponsoring Executive Director: Professor Hilary Fielder Who will present: Professor Hilary Fielder Documents attached: None Date of Board meeting: 24 May 2012 Committee/Groups that have received or considered this paper: None Please state if the paper is for: Discussion Yes Decision Yes Information Contents 1 PURPOSE ................................................................................ 3 2 INTRODUCTION ...................................................................... 3 3 BACKGROUND ......................................................................... 4 3.1 Benign polyps in Bowel Screening Wales .................................. 4 3.2 Risks and benefits of alternative approaches ............................ 5 3.3 BSW Network MDT and National Referral Centre ....................... 5 4 RECOMMENDATION(S) ........................................................... 6 5 TIMING ................................................................................... 7 6 FINANCIAL IMPLICATIONS ..................................................... 7 6.1 Costs .................................................................................. 7 6.2 Source of funds .................................................................... 8 7 BOARD MEMBERS ARE ASKED TO: ........................................... 9 8 NEXT STEPS ............................................................................ 9 9 APPENDIX 1 .......................................................................... 10 SCREENING DIVISION BUSINESS CASE TEMPLATE ..................... 10 DEVELOPMENT OF AN ALL WALES COMPLEX POLYPECTOMY TREATMENT SERVICE............................................................ 10 10 REFERENCES ......................................................................... 16 1 Purpose This document summarises the requirement, development and outcome of the pilot Bowel Screening Wales network multidisciplinary team and national referral centre pilot for treatment of complex polyps and includes recommendations for the way forward. Public Health Wales Trust Board are asked to consider the document and to approve continuation of this service in order for participants of the bowel screening programme to access equitable care. 2 Introduction Bowel Screening Wales (BSW) is responsible for the care of participants prior to a diagnosis of cancer. Most participants can be managed within the normal screening pathway, but a few have complex benign colorectal polyps which have historically been dealt with in different ways across Wales. Complex polyps can be removed endoscopically or by surgery. Endoscopic removal is usually preferable as it is associated with less risk to the patient (Association for Coloproctology 2011; Massimo et al 2004, Moss et al 2011) and is more cost effective (Swan et al 2009), but is dependent on clinical skill. There are currently few colonoscopists in Wales who are able to undertake complex colonoscopic procedures and this has resulted in significant variation in referral rates for surgery and the evolution of an inequitable service. BSW have recently conducted a pilot to establish a network multidisciplinary team (NMDT) and a national referral centre (NRC) for treatment of complex polyps. The pilot has resulted in participants being Public Health Wales Trust Board Meeting 24-5-12 offered the choice of endoscopic removal of their lesion at the national centre in Cardiff or local surgery following expert opinion from the NMDT. Thirteen meetings of the NMDT were held over the course of the 6 month pilot and 44 participants discussed. Twelve participants were referred back to their local assessment centre for colonoscopy with advice from the expert panel and 9 people were referred for surgery at their local centre as their lesion was not removable endoscopically. Fourteen participants were referred for treatment to the NRC and 7 await further investigations. Two people are awaiting a local clinician decision prior to a management plan being agreed. Of the cases referred to the NRC for treatment there have been no adverse events and excision has been completed when checked at 3 months in 100% of cases. 3 Background 3.1 Benign polyps in Bowel Screening Wales Since the beginning of the bowel screening programme in Wales polyp detection rates have been higher than expected at around 60% and many complex lesions have been detected. The aim of polypectomy is to remove a lesion in its entirety in a safe, timely and cost-effective manner. Methods of removal include laparoscopic surgery, open surgery or endoscopic therapeutic techniques such as Endoscopic Mucosal Resection (EMR) or Endoscopic Submucosal Dissection (ESD), but it may not always be immediately apparent which option is best. Although usually preferable, endoscopic removal of complex lesions is often technically challenging and carries an increased risk of incomplete excision, recurrence and complications if not undertaken by appropriately skilled endoscopists. Complete removal of lesions is more likely when EMR is undertaken by an experienced colonoscopist (Srinivas et al 2009). The Date: 11.5.12 Version:0a Page: 4 of 16 Public Health Wales Trust Board Meeting 24-5-12 BSW assessment process for screening colonoscopists does not currently assess therapeutic skill and some colonoscopists are more experienced than others in removing complex lesions. Prior to the pilot Health Boards without appropriate expertise for endoscopic removal of lesions could only offer participants surgery. This potentially exposed them to unnecessary risk and resulted in an inequitable service for participants of the bowel screening programme in Wales. 3.2 Risks and benefits of alternative approaches As with all surgical interventions, there is a mortality rate associated with colorectal surgery there have been instances where participants of the English bowel cancer screening programme have died as a result of undergoing surgical procedures to remove benign colorectal polyps. Recent mortality data reveals a 30 day mortality for major colorectal surgery of 3.4% in England and 4.0% in Wales (Association for Coloproctology 2011). Mortality from colonoscopy is extremely rare at around 1 in 10,000 cases. Colorectal surgery is expensive and involves a lengthy recovery period for what is largely benign disease. Participants undergoing surgery usually have part of their bowel removed and a permanent stoma may be required. Procedures undertaken endoscopically do not involve removal of bowel or formation of stoma and are usually undertaken on a day case basis. 3.3 BSW Network MDT and National Referral Centre The BSW Network MDT and NRC was established as a pilot in October 2011 to address issues of safety, patient choice and equity. Referrals were taken from Screening Colonoscopists and local MDT’s according to specific, agreed criteria. The pilot focused on developing an equitable, participant Date: 11.5.12 Version:0a Page: 5 of 16 Public Health Wales Trust Board Meeting 24-5-12 focused service aiming to reduce waste, harm and variation of practice. Formal evaluation is ongoing, but preliminary findings suggest that it has been successful and confirmed that this approach is feasible within an NHS programme rather than a purely research setting. The pilot has created a mechanism for expert opinion on complex polyps found during screening colonoscopy. It enabled discussion of options and technical feasibility for removal of complex lesions at MDT level. Information is then given to participants in order for them to make an informed decision on management. Wales is leading the way in management of complex polyps in the UK as other bowel screening programmes in the country have recently started planning their approach to this issue. It is likely that other programmes will use the findings of the Welsh pilot to inform their developments. The bowel screening programme in Wales is well placed to undertaken such innovative developments as the QA process is now robust and population size manageable while significant enough to generate meaningful data. 4 Recommendation(s) The continued delivery of a safe, sustainable and high quality screening programme means that patients identified by the programme as requiring further intervention should be referred to and dealt with by a service that has the best possible outcomes, is cost effective to deliver and makes the most efficient use of NHS resources. Screening programmes must do more good than harm at a population level. Ensuring optimum care and management for participants identified with complex polyps is an important mechanism to reduce unnecessary harm. Date: 11.5.12 Version:0a Page: 6 of 16 Public Health Wales Trust Board Meeting 24-5-12 Continuation of the network MDT and NRC is recommended in order for participants of the bowel screening programme to access high quality, safe and equitable care. Continuation of the service will also provide the opportunity to train additional Screening Colonoscopists to undertake complex procedures, who could then offer the procedures more locally in the future. It is recommended that the service should be further developed to disperse expertise throughout Wales. This can be achieved by Expert Advisors undertaking complex procedures in other units in Wales while training the local Screening Colonoscopists. This would future proof the service and enable development of enhanced skills for colonoscopists which would in turn also benefit the symptomatic service. Continuous evaluation will report outcomes annually and include comparison of completion rates, mortality reduction and costs. Service delivery will be monitored in line with SLA arrangements and reported through established lines of communication to the Trust, to Health Boards and to the Welsh Government. 5 Timing The pilot has been extended and a decision on the way forward is requested as soon as possible in order to establish a smooth transition into service model. 6 Financial Implications 6.1 Costs Health Boards have not, so far asked Bowel Screening Wales to pay for surgical procedures, although these participants remain the responsibility of the screening programme and it is likely that this cost will need to be covered by BSW in future. A precedent exists where Breast Test Wales Date: 11.5.12 Version:0a Page: 7 of 16 Public Health Wales Trust Board Meeting 24-5-12 (BTW) pays for the cost of participants open surgical biopsy when required. The average HRG cost for major colorectal surgery is £7,448 per procedure compared to £3,000 for an endoscopic procedure. Had the 14 cases referred to the NRC undergone local surgery the cost to NHS Wales, and potentially BSW in the future would have been £104,272. This relates only to the procedure cost and additional resources for hospital stay, pathology and follow up procedures need to be factored in. NRC cases have cost BSW £42,000 which represents total clinical expenditure. Based on experience during the pilot and taking into consideration the expansion of eligible age range (undertaken in December 2011) it is anticipated that the NMDT will refer an average of one case per week and approximately 45 per annum to the NRC for treatment. Please see business case for further details (appendix 1) Total costs for the NMDT and NRC are £160k per annum. The Network MDT established for the pilot comprised of 8 expert advisors including surgeons, colonoscopists, pathologists and radiologists. Each advisor was paid a nominal half session per week to attend NMDT meetings and advise on management of participants. 6.2 Source of funds The service can be funded from efficiency savings with within existing Screening Division funding. No additional funding is required to provide this service for the age range currently invited. A business case has been presented to the Public Health Wales Executive Team. 6.3 Sustainability The pilot has established that around 45 people per year will require referral to the national centre for complex polypectomy. Bowel Screening Wales is currently inviting all people aged 60-74 for bowel screening Date: 11.5.12 Version:0a Page: 8 of 16 Public Health Wales Trust Board Meeting 24-5-12 every two years, and invites around 300,000 people per year. Thus the rate of referral for complex polypectomy is around 1: 6,700 invitations. The Screening Division is currently in discussion with Welsh Government regarding options for expanding the age range invited for bowel screening. The cost of providing complex polypectomy would be included in any plan for programme expansion. 7 Board Members are asked to: Approve continuation of service for the network MDT and National Referral Centre for treatment of complex polyps on a permanent basis within the remit of Bowel Screening Wales. 8 Next Steps Continuation of NMDT and NRC. Further development of patient information, standards, QA processes and pathways based on evaluation of the pilot phase. Date: 11.5.12 Version:0a Page: 9 of 16 Public Health Wales 9 Trust Board Meeting 24-5-12 Appendix 1 SCREENING DIVISION BUSINESS CASE TEMPLATE Development of an all Wales Complex Polypectomy Treatment Service Authors: Rhys Blake; Hayley Heard Date: 11th April 2012 Version: 1.0 Purpose and Summary of Document: To set out service development in the bowel screening programme to ensure a high quality, safe and sustainable service for the treatment of complex polyps discovered within the screening programme. Financial Framework approved by Financial Manager: Signature of Financial Manager: Name of senior sponsor: Dr Rosemary Fox / Dr Hilary Fielder Signature of senior sponsor: Approved by Director: Signature: Date: 11.5.12 Version:0a Page: 10 of 16 Public Health Wales Trust Board Meeting 24-5-12 Executive Summary: Bowel Screening Wales (BSW) is responsible for the care of bowel screening participants prior to a diagnosis of cancer. Most participants can be managed within the normal screening pathway, ie home faecal occult blood testing followed by colonoscopy and polypectomy where required. A few participants have large complex polyps. These polyps are within the remit of the programme to manage as they are mostly benign but may develop into cancers if not removed. These complex polyps can be removed either by open surgery or endoscopically. Endoscopic removal is preferable as it is associated with less risk to the participant. Endoscopic removal of complex polyps is available at only one of the Health Boards in Wales The Health Boards without appropriate expertise for endoscopic removal of lesions currently offer these participants surgery. This potentially exposes them to unnecessary risk and results in an inequitable service for participants of the bowel screening programme in Wales. Bowel Screening Wales is currently piloting a national service for complex polypectomy. The pilot is being evaluated and results are expected in May 2012. This case makes the request for £160,000 recurring in order to offer endoscopic management as an alternative to open surgery to BSW participants. The programme will refer participants to Cardiff and Vale University Health Board for endoscopic intervention. Referral will be managed by an all Wales MDT consisting of surgeons, colonoscopists, pathologists and radiologists. The MDT will receive cases identified as having large polyps and assess for suitability of referral assessed against agreed criteria to ensure equity of access. Need: Define the need Current arrangements see screening participants identified with these particular types of polyps referred for colo-rectal surgery. There is a mortality rate associated with open colorectal surgery. NBOCAP Audit data 2010 published: Post-operative mortality Mortality within the first 30 days after major surgery was 4.0 per cent for patients with colon cancer, 3.7 per cent for patients with rectosigmoid cancer, and 2.7 per cent for patients with rectal cancer. In England, 3.4 per cent of the patients undergoing major surgery died within 30 days of surgery. This figure was 4.0 per cent in Wales Colorectal surgery is expensive and involves a long recovery time for what is largely benign disease. Participants undergoing surgery usually have a large part of their bowel removed and a permanent stoma may be required. Procedures Date: 11.5.12 Version:0a Page: 11 of 16 Public Health Wales Trust Board Meeting 24-5-12 undertaken endoscopically do not involved removal of bowel or formation of stoma. (Health Boards have not, so far asked Bowel Screening Wales to pay for surgical procedures, although the participants are the responsibility of BSW, and a precedent exists where Breast Test Wales (BTW) pays for the cost of open surgical biopsy in BTW participants where required) Strategic context Local / context The continued delivery of a safe, sustainable and high quality screening programme means that patients identified by the programme as requiring further intervention should be referred to and dealt with by a service that has the best possible outcomes, is cost effective to deliver and makes the most efficient use of scarce NHS resources. Screening programmes must do more good than harm at a population level and ensuring best practice for participants identified with a polyp is an important method to reducing unnecessary harm. To ensure equity across Wales . participants must be given the choice of endoscopic removal of their lesion at a national centre or local surgery Referred for open colo-rectal surgery with associated risks service and outcomes in Health Boards without appropriate expertise. Complex polypectomy is only currently available in Cardiff and Vale University Health Board. Dr Rosemary Fox & Dr Hilary Fielder Case sponsor Options: List of options Option 1: Do nothing Option 2: Introduce complex polypectomy service Selection criteria Clinical Outcomes Equity of access Workforce development Impact on treatment services (surgery) Cost: Option 1 ‘Do nothing’: No improvement to clinical outcomes. Date: 11.5.12 Version:0a As the programme Page: 12 of 16 Public Health Wales Trust Board Meeting 24-5-12 continues it can reasonably expect to detect increasing numbers of complex / difficult cases not always picked up symptomatically. This option would result in an inequitable provision of services within the national bowel screening programme: participants living in the Cardiff & Vale Health board area would be able to access endoscopic resection while those in other areas would require open surgery. There would be no opportunity for development colonoscopic expertise to more colonoscopists. of Local surgical services would continue to be referred patients who could be offered minimally invasive treatment elsewhere, and who would take up operating theatre and surgical capacity. Although Health Boards have not to date charged Public Health Wales for open surgery for these participants, there is a risk that in future open surgery costs for these procedures are billed to the programme. The HRG spread of costs for these ranges between £5,000 and £10,000. The cost for a procedure to be done endoscopically is in the order of £3,000 Option 2: ‘Introduce complex polypectomy service’: This would ensure all participants receive an equitable and high quality service, with optimal clinical outcomes (Increased numbers seen as day case procedures. Lower risk of colostomy and other associated risks from open surgery) The provision of the service would provide the opportunity for training additional colonoscopists in these procedures, who could then offer the procedures locally. Would reduce pressure on theatre capacity Undertaking endoscopic removal of complex polyps costs £2,950. Based on experience during the pilot the programme will see an average of one case per week and approximately 45 per annum. Expert MDT panel is established as part of the process panel. A nominal half session a week payment is made to 8 expert advisers which include surgeons, colonoscopists, pathologists and radiologists. Preferred Option Date: 11.5.12 To introduce all Wales polypectomy service Version:0a Page: 13 of 16 Public Health Wales Trust Board Meeting 24-5-12 Cost benefit Recurring revenue There are currently 4 screening slots on a standard list for costs colonoscopy. Undertaking endoscopic removal of complex polyps takes up 4 screening slots and costs £2,950. Based on experience during the pilot the programme will see an average of one case per week and approximately 45 per annum. Expert MDT panel is established as part of the process panel. A nominal half session a week payment is made to 8 expert advisers which include surgeons, colonoscopists, pathologists and radiologists. There is a risk that open surgery costs for these procedures are billed to the programme. The HRG spread of costs for these ranges between £5,000 and £10,000. The cost for a procedure to be done endoscopically is in the order of £3,000 Non-recurring revenue costs N/A Capital costs £100,000* *provided by Cardiff and Vale discretionary capital* Expenditure profile £160k per annum. (assumes continuation of pilot plus formalisation of service in 12/13) Source of funds The funding of this service development is dependant on the release of costs elsewhere within screening: As a result of ongoing reconfiguration the following changes to LTA’s are to be reinvested to fund this development Colposcopy Benchmarking exercise: Benefits Date: 11.5.12 £308,000. Reduction in mortality and morbidity from open colorectal surgery Improved patient outcomes and quality of life Equity of access across Wales to services Reduced pressure on theatre and critical care/recover beds. Usually day case, or one night inpatient procedure Potential saving if Health bards were to charge for open surgery Ability to spread good practice throughout Wales by using the service as a training setting. Version:0a Page: 14 of 16 Public Health Wales Evaluation Trust Board Meeting 24-5-12 Continuous evaluation will report outcomes annually to include comparison of completion rates, mortality reduction and cost and length of stay amongst criteria to be monitored and evaluated. Service delivery in terms of waiting times, results and case numbers will form part of the evaluation of delivery via existing LTA arrangements. These will be reported through existing established lines of communication through the Trust, to Health Boards, Welsh Government and the public as part of the continuous programme statistical reporting process. Implementation Implementation leads: Mrs Hayley Heard, Programme Lead Dr Sunil Dolwani, QA colonoscopist, Bowel Screening Wales Plan Risk analysis Date: 11.5.12 If case is not approved there will be inequitable provision of treatment for screened participants, exposing significant numbers to unnecessary risk Open surgery is more costly than removal endoscopically and if screening covered these costs then this would be financial risk for programme cost.. Version:0a Page: 15 of 16 Public Health Wales 10 Trust Board Meeting 24-5-12 References Massimo Conio, Alessandro Repici, Jean-Francois Demarquay, Sabrina Blanchi, Remy Dumas, Rosangela Filiberti: EMR of large colorectal polyps. Gastrointestinal Endoscopy 2004 Volume 60:No2 Moss A, Bourke MJ, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Chen RY, Byth K: Endoscopic mucosal resection outcomes and prediction of submucosal cancer from advanced colonic mucosal neoplasia. Gastroenterology 2011 Association for Coloproctology of Great Britain and Ireland, The Royal College of Surgeons of England & The NHS Information Centre for Health and Social Care (2011) The National Bowel Cancer Audit Annual Report 2011; www.ic.nhs.uk/bowelreports Srinivas R.P, Yasuo K, Takuji G, Daphne A, Yutaka S, Mainor RA: Metaanalysis resection. and Systematic World Journal review of of colorectal Gastroenterology endoscopic 2009 mucosal September 14, 15(34):4273-4277 Swan MP, Bourke MJ, Alexander S, Moss A, Williams SJ: Large refractory colonic polyps: Is it time to change our practice? A prospective study of the clinical and economic impact of a tertiary referral colonic mucosal resection and polypectomy service (with videos). Gastrointestinal Endoscopy 2009;70:1128-1136. Date: 11.5.12 Version:0a Page: 16 of 16