Bowel Screening RESOURCE FOR PROVIDERS WORKING WITHIN THE
BowelScreening RESOURCE FOR PROVIDERS WORKING WITHIN THE BOWELSCREENING PILOT BowelScreening: Resource for providers working within the BowelScreening Pilot Published in March 2012 by Waitemata District Health Board Private Bag 93503, Takapuna, North Shore City 0740 ISBN 978-0-473-20766-3 (print/paperback) ISBN 978-0-473-20767-0 (online/PDF) This document is available electronically on the BowelScreening Waitemata website: www.bowelscreeningwaitemata.co.nz Hard copies are available from the Information Centre on 0800 924 432 or by emailing info@bowelscreeningwaitemata.co.nz The information in this resource may be changed from time to time. The updated version will be available on the BowelScreening website www.bowelscreeningwaitemata.co.nz BowelScreening RESOURCE FOR PROVIDERS WORKING WITHIN THE BOWELSCREENING PILOT 2 » CONTENTS LIST OF TABLES................................................................................................................4 LIST OF DIAGRAMS...........................................................................................................4 PART ONE: BACKGROUND INFORMATION................................................................... 5 Introduction....................................................................................................................................................... 6 Key BSP messages...........................................................................................................................................7 Important BSP contacts..............................................................................................................................10 BSP resources and documents.................................................................................................................10 Abbreviations and acronyms...................................................................................................................... 11 PART TWO: THE BOWEL SCREENING PATHWAY.......................................................12 Background to the BowelScreening pilot............................................................................................. 13 The screening pathway................................................................................................................................14 The role of Primary Health Organisations and General Practice Teams................................... 18 The role of the Coordination Centre......................................................................................................20 The BSP Register............................................................................................................................................ 21 Exclusion criteria........................................................................................................................................... 22 Increased risk.................................................................................................................................................. 22 Identification, pre-invitation, invitation and participation............................................................. 23 Identification....................................................................................................................................................... 24 Pre-invitation...................................................................................................................................................... 24 Invitation and participation......................................................................................................................... 24 Follow-up......................................................................................................................................................... 25 iFOBT test results..........................................................................................................................................26 Positive results................................................................................................................................................... 27 Negative results................................................................................................................................................30 Unclear results...................................................................................................................................................30 Diagnostic testing.......................................................................................................................................... 31 Pre-assessment.................................................................................................................................................. 31 Colonoscopy.......................................................................................................................................................33 Alternative investigations.............................................................................................................................36 Surveillance.........................................................................................................................................................38 Treatment.........................................................................................................................................................39 PART THREE: SUPPORT SERVICES FOR THE BOWELSCREENING PILOT............ 40 Aims of the BowelScreening pilot...........................................................................................................41 Objectives of the BowelScreening pilot................................................................................................41 Community engagement...........................................................................................................................42 The immunochemical faecal occult blood test (iFOBT)................................................................43 Faecal occult blood tests.............................................................................................................................43 Immunochemical faecal occult blood test description..................................................................44 The test kit.......................................................................................................................................................45 Monitoring, evaluation, and audit...........................................................................................................46 3 PART FOUR: IWI/MĀORI AND PACIFIC PROVIDERS.................................................47 Iwi/Māori providers......................................................................................................................................48 Pacific providers............................................................................................................................................48 PART FIVE: MINISTRY OF HEALTH INFORMATION....................................................49 Informed consent..........................................................................................................................................50 Code of Health and Disability Services Consumers’ Rights.......................................................... 51 Health Information Privacy Code............................................................................................................. 51 Whānau Ora.....................................................................................................................................................41 PART SIX: BACKGROUND INFORMATION ABOUT BOWEL CANCER AND BOWEL CANCER SCREENING.............................................................52 Bowel cancer in New Zealand.................................................................................................................. 53 About bowel cancer..................................................................................................................................... 53 About bowel cancer screening................................................................................................................ 53 Organised screening for bowel cancer................................................................................................. 55 Bowel screening and Māori.......................................................................................................................56 He Korowai Oranga (Māori Health Strategy)......................................................................................56 Te Pae Māhutonga........................................................................................................................................... 57 Treatment outcomes for Māori..................................................................................................................59 PART SEVEN: REFERENCES AND FURTHER INFORMATION................................... 61 Further reading..............................................................................................................................................62 Glossary............................................................................................................................................................63 Bibliography....................................................................................................................................................66 APPENDICES....................................................................................................................68 Appendix 1: Pre-invitation letter..............................................................................................................69 Appendix 2: Invitation letter.....................................................................................................................70 Appendix 3: Consent form......................................................................................................................... 71 Appendix 4: BowelScreening Test Kit Instructions.......................................................................... 72 Appendix 5: Negative result letter......................................................................................................... 73 Appendix 6: Postive result letter............................................................................................................. 74 Appendix 7: Participant information booklet ‘All About BowelScreening’......................................... 75 Appendix 8: Participant information leaflet ‘BowelScreening – Your Quick Reference Guide’.76 Appendix 9: Participant information leaflet ‘BowelScreening – All Clear’............................................ 77 Appendix 10: Participant information leaflet ‘BowelScreening – Further Investigation’...............78 Appendix 11: People at increased risk of bowel cancer.................................................................. 79 People identified as at increased risk through screening............................................................ 80 Symptoms suggestive of bowel cancer................................................................................................. 81 Appendix 12: NZ Familial Gastrointestinal Cancer Registry......................................................... 83 Who to refer to the NZFGCR?...................................................................................................................83 What does the NZFGCR do?......................................................................................................................83 NZFGCR contact information....................................................................................................................84 4 » LIST OF TABLES TABLE 1 Key messages TABLE 2 Key contacts within the BSP 10 TABLE 3 Resources and documents within the BSP 10 TABLE 4 Screening pathway responsibilities and requirements 15 TABLE 5 Key input from PHOs and GPTs 18 TABLE 6 Contact details for Coordination Centre 20 TABLE 7 Follow-up triggers and actions 25 TABLE 8 Notifying results to participants 26 TABLE 9 Roles and responsibilities for conducting pre-assessment 32 TABLE 10 Roles and responsibilities for colonoscopy procedures 35 TABLE 11 Roles and responsibilities for alternative investigations 36 TABLE 12 Roles and responsibilities for surveillance 38 TABLE 13 Roles and responsibilities for referral for treatment 39 TABLE 14 Objectives of the BSP 41 TABLE 15 Guidance on effective bowel screening for Māori 58 7 » LIST OF DIAGRAMS DIAGRAM 1 Stakeholder relationship diagram DIAGRAM 2 Screening pathway 14 DIAGRAM 3 Identification, pre-invitation, invitation and participation 23 DIAGRAM 4 Management of kit by lab 27 DIAGRAM 5 Management of positive result 29 DIAGRAM 6 Colonoscopy investigation 34 DIAGRAM 7 Alternative investigation 37 6 » COLOUR KEY Ministry of Health GPTs, GPs, and PHOs Endoscopy unit General public Participants WDHB LabPLUS Coordination Centre ADHB PART ONE: BACKGROUND INFORMATION 6 » INTRODUCTION This document provides health practitioners with information about the Waitemata District Health Board (WDHB) BowelScreening pilot (BSP). The BSP model of screening has been designed to closely integrate with primary care. Primary Health Organisations (PHOs) and General Practice Teams (GPTs) have been involved in the scoping and planning of the BSP and have key roles in the pilot. This document outlines those roles. » STAKEHOLDER RELATIONSHIPS GPTs and PHOS LabPLUS Participants/ Coordination Centre Endocscopy unit patients Community/ general public 7 » KEY BSP MESSAGES TABLE 1: KEY MESSAGES TOPIC KEY MESSAGE REFERENCE PHO AND GPT ENDORSEMENT PHOs and GPTs have been involved in the development of the BSP and endorsed the screening model, which is closely integrated with primary care Page 18 SERVICES The BSP is a four-year population-based screening programme which offers screening to the eligible population (137,000 people, projected to rise by 3 percent every year) every two years Page 13 CATCHMENT Participants in the BSP must reside in the WDHB area (Rodney, Albany, North Shore, Waitakere, and parts of the Whau ward). However, they may attend any GP practice in any area Page 13 PAYMENT Participation in the BSP is free. GPs are remunerated for contacting their patients to advise of a positive iFOBT result, discussing the implications of the positive result, and referral to colonoscopy. This consultation may be undertaken in person or by telephone, as appropriate Page 18 COORDINATION CENTRE The BSP Coordination Centre has overall responsibility for the programme Page 20 BSP REGISTER A population register has been created for the BSP (the BSP Register). The details on the register are taken from the NHI and PHO enrolment databases, and individuals who self-register Page 21 AGE RANGE • The age range for the BSP is 50–74 years Page 13 • Most people in the eligible population will be invited to participate in two screening rounds within the four-year period • A ll eligible people who turn 74 in 2012 will be invited for screening in 2012 • P eople who will turn 75 during 2012 will not receive an invitation and will need to contact the BowelScreening programme on 0800 924 432 if they wish to complete a bowel screening test before their 75th birthday. People are no longer eligible to take part in the programme once they turn 75 8 TOPIC KEY MESSAGE REFERENCE PARTICIPATION • articipation in the BSP is by invitation only. The P Coordination Centre invites eligible people to participate in the BSP according to their birth date Pages 20, 25 • eople who accept the invitation to participate in P the BSP will be recalled for screening in two years if they are still eligible • Ps do not need to invite their patients to G participate in the BSP. Invitations are sent by the Coordination Centre • ligible people are sent a pre-invitation letter E advising them about the BSP PRE-INVITATION • INVITATION Page 24 Appendix 1 he pre-invitation letter includes information T about screening and a booklet to assist people to make an informed decision about participating in screening Four weeks after the pre-invitation letter, an invitation letter is sent to eligible people. The invitation letter includes: Page 24 Appendix 2 Appendix 3 -a leaflet to assist people to make an informed decision about participating in screening -an immunochemical faecal occult blood test (iFOBT) kit -a consent form -a Freepost envelope to send their sample to LabPLUS SAMPLES TESTING • articipants in the BSP take a single sample at P home, using the iFOBT kit that is posted out to them by the Coordination Centre • articipants post the sample to the laboratory for P testing, using the Freepost envelope provided The testing laboratory for the BSP is LabPLUS at Auckland DHB Pages 45, 46 Appendix 4 Page 26 9 TOPIC KEY MESSAGE REFERENCE RESULTS • Page 26 The laboratory sends results to: – BSP Register (at the Coordination Centre) – participants’ GPs PEOPLE WHO SHOULD NOT PARTICIPATE IN THE BSP • GPs are responsible for notifying participants of positive results • GPs must advise participants of positive results and refer participants for colonoscopy within 10 working days • articipants are advised of negative results by P letter from the Coordination Centre • People with symptoms of bowel cancer should not participate in the BSP, but should see their GP as soon as possible. Common signs and symptoms of bowel cancer may include: – a change in a person’s normal pattern of going to the toilet that continues for several weeks, such as diarrhea, constipation or feeling that the bowel doesn’t empty completely – blood in the bowel • People should not participate in the BSP if they: – have had a colonoscopy within the last five years – are on a bowel polyp or bowel cancer surveillance programme – have had or are currently being treated for bowel cancer – have had their large bowel removed – are currently being treated for ulcerative colitis or Crohn’s Disease – are currently awaiting bowel investigations by their doctor Appendix 11 10 » IMPORTANT BSP CONTACTS TABLE 2: KEY CONTACTS WITHIN THE BSP CONTACT DETAILS Information line 0800 924 432 Website www.bowelscreeningwaitemata.co.nz Email address info@bowelscreeningwaitemata.co.nz Coordination Centre PO Box 33190 Takapuna Auckland 0740 BSP Endoscopy Unit at Waitakere Hospital 09 837 8892 x 6892 » BSP RESOURCES AND DOCUMENTS TABLE 3: RESOURCES AND DOCUMENTS WITHIN THE BSP RESOURCE FOR AVAILABLE FROM Posters General public Coordination Centre Website Health professionals www.bowelscreeningwaitemata.co.nz General public Participant information booklet ‘All About BowelScreening’ Participants Participant information leaflet ‘BowelScreening – Your Quick Reference Guide’ Participants Participant information leaflet ‘BowelScreening – All Clear’ Participants Participant information leaflet ‘BowelScreening – Further Investigation’ Participants Participant information ‘BowelScreening Test Kit Instructions’ Participants Website GPTs www.bowelscreeningwaitemata.co.nz Provider resource GPTs and specialists Coordination Centre Education sessions GPTs Coordination Centre Quality and Procedures Manual BowelScreening pilot providers Under development Coordination Centre Wickliffe (email: moh@wickliffe.co.nz) Coordination Centre Wickliffe (email: moh@wickliffe.co.nz) Coordination Centre Wickliffe (email: moh@wickliffe.co.nz) Coordination Centre Wickliffe (email: moh@wickliffe.co.nz) Coordination Centre Wickliffe (email: moh@wickliffe.co.nz) 11 » ABBREVIATIONS AND ACRONYMS BSP BowelScreening Pilot CRC Colorectal Cancer CRCSAG Colorectal Cancer Screening Advisory Group CTC Computerised Tomographic Colonography DCBE Double Contrast Barium Enema DHB District Health Board FOBT Faecal Occult Blood Test iFOBT Immunochemical Faecal Occult Blood Test gFOBT Guaiac Faecal Occult Blood Test FS Flexible Sigmoidoscopy GP General Practitioner GPT General Practice Team IBD Inflammatory Bowel Disease MDM Multi-Disciplinary Meeting NHI National Health Index NHS National Health System NMDS National Minimum Dataset NSU National Screening Unit NPV Negative Predictive Value NZCR New Zealand Cancer Registry NZFGCR New Zealand Familial Gastrointestinal Cancer Registry NZHTA New Zealand Health Technology Assessment OECD Organisation for Economic Cooperation and Development PHO Primary Health Organisation PN Practice Nurse PPV Positive Predictive Value RCT Randomised Controlled Trial PART TWO: THE BOWEL SCREENING PATHWAY 13 » BACKGROUND TO THE BOWELSCREENING PILOT Waitemata District Health Board (WDHB) has been funded by the Ministry of Health (the Ministry) to plan and implement a four-year bowel screening pilot. The BowelScreening pilot (BSP) is a population-based screening programme that offers screening for bowel cancer to all eligible people between 50-74 years of age who reside in the WDHB area and are eligible for publicly funded healthcare. The overarching goal of the BSP is to determine whether an organised bowel screening programme can be introduced in New Zealand in a way that is effective, safe, acceptable to the participants, equitable and economically efficient. This is the first time that a population register has been used to invite people to participate in a cancer screening programme in New Zealand. The BSP will run from 2011 to 2015, with services commencing in October 2011. The BSP project will ensure that: • screening is offered to all eligible people domiciled in the Waitemata DHB area who are aged between 50-74 years • all eligible people have access to written information to assist them to make an informed decision about participating in screening, before they consent to screening • the results from screening are made available to all people screened in a timely manner • every person with a positive screening test result is given appropriate information and referred to colonoscopy pre-assessment and diagnostic services • diagnostic services are accessible and of high quality • robust data collection and quality monitoring systems are developed • health professionals involved in screening and diagnostic services have attained the required professional qualifications • all providers of screening services have access to written information and education opportunities about screening. Fundamental to the success of the BSP is the design of systems and processes that work for all of the eligible population, including traditionally under-screened populations. 14 » THE SCREENING PATHWAY NHI database extract PHO enrolment database BSP Register (of eligible population) Pre-invitation letter and information booklet sent to eligible person Opt off 4 WEEKS Invitation letter, test kit, and consent form sent to eligible person Opt off Sample posted to laboratory POSITIVE 10 DAYS Result to BSP Register and patient’s GP NEGATIVE Coordination Centre sends letter and information to participant GPT/ Senior Endoscopy Nurse referral to colonoscopy Recall for screening in two years 50 DAYS Surveillance Colonoscopy Treatment Recall for screening in five years 15 TABLE 4: SCREENING PATHWAY RESPONSIBILITIES AND REQUIREMENTS BSP PATHWAY RESPONSIBILITY REQUIREMENTS Identification PHOs in the WDHB district Provision of data extract to the BSP Register in the Coordination Centre The Ministry Pre-invitation letter Coordination Centre, with GP endorsement Sending of pre-invitation letters and booklets about screening to eligible people Invitation to participate in screening Coordination Centre Sending of invitation letters to eligible people with: –– a leaflet to assist people to make an informed decision about participating in screening –– an immunochemical faecal occult blood test (iFOBT) kit –– a consent form –– a Freepost envelope to send their sample to LabPLUS Testing samples LabPLUS Receipt and testing of samples Notification of results to GPs and the Coordination Centre LabPLUS Electronic messaging of results to the Coordination Centre, and to GPs (except where participant does not consent to this on the BSP consent form) Notification of positive results to participants GPs Contact with patient and referral to colonoscopy within 10 working days Endoscopy Unit (Senior Endoscopy Nurse) Personal contact with participant who does not have a GP or who for any other reason has not been contactable by GP for preassessment for colonoscopy Coordination Centre Notifying participants of negative results by letter Notification of negative results to participants 16 BSP PATHWAY RESPONSIBILITY REQUIREMENTS Endoscopy services Endoscopy Unit • Provision of colonoscopy preassessment and colonoscopy • Assessment of family history with referral to New Zealand Familial Gastrointestinal Cancer Registry (NZFGCR) where appropriate (Appendix 12) • Entering colonoscopy preassessment and appointment details into the BSP information system • Standardised reporting for colonoscopy outcomes and collection of colonoscopy performance data • Provision of histopathology for samples taken at colonoscopy • Standardised reporting of histopathology results into WDHB systems • Entering colonoscopy outcomes into BSP information system • Advising histology results and recommended actions to GP and patient Colonoscopy histopathology LabPLUS Endoscopy Unit CT colonography Endoscopy Unit • Referral for CTC for participants deemed unfit for colonoscopy or from failed colonoscopy • Entering outcomes into BSP information system • Advising CTC results and recommended actions to GP and patient Treatment Waitakere or North Shore Hospital Provision of CTC WDHB Provision of surgery ADHB Radiation/chemotherapy oncology through standard practice Endoscopy Unit Manual collection and entry into BSP information system of data from treatment, by the Senior Endoscopy Nurse 17 BSP PATHWAY RESPONSIBILITY REQUIREMENTS Surgery histopathology WDHB laboratory Provision of histopathology for patients undergoing surgical resection Endoscopy Unit • Collecting outcomes and entering into the BSP information system • Advising histology results and recommended actions/actions taken to GP and patient Colonoscopy surveillance within 12 months Colonoscopy surveillance from 12 months onwards Endoscopy Unit Letter to GP and patient advising that patient is on surveillance colonoscopy waiting list WDHB Endoscopy Service Scheduling surveillance colonoscopy with one year Endoscopy Unit Letter to GP and patient advising referral of patient for colonoscopy at appropriate time GP Refer to WDHB Endoscopy Service at appropriate time (note: this is the symptomatic service, not the BSP endoscopy unit) The screening pathway ends when a participant is returned to routine screening, or referred for surveillance, surgery or oncology treatment. However, treatment data is collected for BSP monitoring and evaluation purposes. 18 » THE ROLE OF PRIMARY HEALTH ORGANISATIONS AND GENERAL PRACTICE TEAMS Waitemata District Health Board PHOs and GPTs have a fundamental role in the BSP. PHOs and GPTs have been involved in planning for the BSP since the scoping phase, and have endorsed the current screening model, which closely integrates primary care. TABLE 5: KEY INPUT FROM PHOS AND GPTS KEY INPUT FROM PHOs AND GPTs FOR THE BSP PHOs • Provide eligible participant registers to the Coordination Centre, through a quarterly data extract from PHO registers, to: –– enhance the BSP Register –– enable GPs to be informed of their patients’ screening results • Support activities to inform and educate GPTs on bowel cancer, increased risk groups (see Appendix 11) and the BSP • Coordinate processes for invoicing and payment of GPs for positive results management GPTs • Provide information and advice about bowel cancer symptoms to patients • Endorse the BSP to eligible people • Advise eligible people that the programme has been endorsed by their practice • Encourage their patients to contact the Coordination Centre to check that their details are recorded correctly on the BSP Register • Support communications and community engagement activities (for example, by having posters and leaflets in GP surgeries) • Assist the Coordination Centre to identify people who do not meet the eligibility criteria for the BSP • Provide advice about the BSP to their patients who have not sent in a sample • Inform their patients of positive results: –– Appropriate care of patients and established best practice for continuity of care involves GPs advising their patients of positive screening test results. This may also enhance the likelihood of the patient undertaking further diagnostic investigation and treatment if clinically indicated. GPs should inform patients of positive results within 10 working days of receipt of the result 19 KEY INPUT FROM PHOs AND GPTs FOR THE BSP GPTs • Refer patients for a screening colonoscopy: –– For patients with positive results, GPs make a referral to the Endoscopy Unit for a screening colonoscopy and provide additional clinical information where relevant. The Endoscopy Unit contacts the patient to undertake pre-assessment, confirm an appointment time for colonoscopy and provide bowel preparation guidance and materials • Encourage patients with positive results to remain within the public system: –– It is preferable that non-symptomatic patients with positive results are seen in the public sector, to minimise the extent to which the efficacy of the screening programme may be compromised. However, even with the encouragement of GPs and specialists to use the BSP colonoscopy service, some patients will choose the private sector • In addition to the above, refer patients to NZFGCR in the case of an increased risk of developing bowel cancer for familial reasons 20 » THE ROLE OF THE COORDINATION CENTRE Overall management and coordination of the BSP is undertaken by the Coordination Centre. TABLE 6: CONTACT DETAILS FOR COORDINATION CENTRE ROLE Programme manager Information line (for the public and GPs) CONTACT (09) 484 0205 0800 924 432 The overarching role of the Coordination Centre is to ensure that participants proceed safely along the screening pathway in a timely manner. To achieve this, the Coordination Centre is responsible for ensuring that the eligible population is: • informed about the existence of the pilot and the risks and benefits of participating • included on the BSP Register, and has their status changed to ‘ineligible’ if they become ineligible and ‘withdrawn’ if they opt off • provided with information about how to opt off • sent iFOBT kits and consent forms • followed up with a reminder letter if they do not respond to the invitation to participate in the BSP • provided with active follow-up if they are in priority segments of the population • informed promptly and sensitively of the results of their iFOBT (for positive results, this function will usually be provided by GPs, but the Coordination Centre has ultimate responsibility for ensuring it happens) • provided with timely diagnostic investigation, treatment or surveillance as necessary. 21 The Coordination Centre: • is responsible for updating participant details on the BSP Register and managing queries from the public • liaises with PHOs, GPTs, communications and community engagement partners, Māori/Iwi providers, Pacific providers, LabPLUS, the BSP Endoscopy Unit, the provider arm of the DHB and the NZFGCR • interfaces with the Ministry and the evaluation team appointed by the Ministry, and monitors the performance of BSP service providers. » THE BSP REGISTER A population register has been created for the BSP to allow the Coordination Centre to contact the eligible population and invite them to participate in screening. The BSP Register is populated from three different sources: • the National Health Index (NHI) database • PHO enrolment registers • those who self-register (if they have not been identified through the NHI or PHO registers). The BSP Register is intended to contain demographic details of the complete eligible population (people aged 50 to 74 years of age) in the pilot region. Primary identification is via the NHI, with supplementary information obtained from PHO registers. Individuals who fit the eligibility criteria, but have not been identified in the BSP Register, may self-register by contacting the Coordination Centre. Information from the Cancer Registry is used to try to ensure people with a registered bowel cancer are not invited to participate. 22 » EXCLUSION CRITERIA Inclusion and exclusion criteria have been developed for participation in the BSP and are set out in the paper “Bowel Cancer Programme: Inclusion/Exclusion Criteria”.1 The paper sets out the policy and rationale for inclusion and exclusion, and options and possible pathways for those who are excluded. People who turn 75 during the life of the pilot will no longer be eligible and, if they are not in a current screening episode, will be exited from the pilot whether or not they have completed two rounds. People with symptoms or signs suggestive of bowel cancer should consult their GP, whether or not they are eligible to participate in the BSP. » INCREASED RISK The BSP eligible screening population is people at “average” risk of bowel cancer. People who otherwise meet the criteria for inclusion in the BSP, but are at increased risk are excluded from the BSP (Appendix 11). They require access to specialist services for assessment, diagnostic testing and ongoing surveillance, including referral to the NZFGCR in the case of an increased risk of developing bowel cancer for familial reasons (Appendix 12). 1 Ministry of Health. 2009. Bowel Cancer Programme: Inclusion/Exclusion Criteria 23 » IDENTIFICATION, PRE-INVITATION, INVITATION AND PARTICIPATION BSP Register (of eligible population) Pre-invitation letter and information booklet sent to eligible person Opt off 4 WEEKS Invitation letter, test kit, and consent form sent to eligible person Priority population: NO Sample sent to laboratory within 2 weeks? Opt off General population: Sample sent to laboratory within 4 weeks? NO Reminder letter sent YES Active follow-up Sample sent to laboratory? YES YES Sample tested at laboratory and result provided to Coordination Centre and GPT NO YES Sample sent to laboratory within 4 weeks of reminder? NO Recall for screening in two years 24 IDENTIFICATION Identification of the eligible population is undertaken using the BSP Register. PRE-INVITATION Initial contact with the eligible population is through a pre-invitation letter sent by the Coordination Centre. An example of the pre-invitation letter is included as Appendix 1. The letter has a generic endorsement by prospective participants’ GPs and has BSP branding and the WDHB logo. For people not registered with a GP, the letter is endorsed by the Coordination Centre. The letter: • advises people about the BSP, and that they are eligible to participate • includes primary care endorsement of the pilot • dvises people that they will receive an invitation and an iFOBT kit a from the BSP unless they notify the Coordination Centre that they do not wish to participate • includes a comprehensive booklet (‘All About BowelScreening’) to assist people to make an informed decision about participating in the BSP • ncourages people to discuss bowel screening with their GPT e (for example, if they have concerns or questions). Pre-invitation letters are being used in the BSP because they have been shown to increase participation in bowel screening internationally. INVITATION AND PARTICIPATION Four weeks after the pre-invitation letter, an invitation to participate in the BSP is sent to the eligible population by the Coordination Centre. An example of the invitation letter is included as Appendix 2. People may opt off at this stage by advising the Coordination Centre or their GP. 25 The invitation letter includes: • a leaflet (‘BowelScreening – Your Quick Reference Guide’) to assist people to make an informed decision about participating in screening • an iFOBT kit • a consent form • a Freepost envelope to send their sample to LabPLUS. People who take a sample and send it to LabPLUS are choosing to participate in the BSP. People take their own sample at home and post it in the Freepost envelope supplied, via New Zealand Post to LabPLUS. They must include their consent form. An example of the consent form is included as Appendix 3. LabPLUS sends the results electronically to the BSP Register and electronically to the participant’s GP via HL7 messaging on Healthlink. If a sample is not received by LabPLUS within four weeks and the person has not opted off, the Coordination Centre sends the prospective participant a reminder letter advising that a replacement kit may be requested (if they have, for example, spoiled or mislaid their kit). Priority populations (Māori, Pacific and Asian people) who have not returned their test kit within two weeks are followed up via telephone and community outreach services. » FOLLOW-UP Active follow-up is a process designed to ensure fair access to the BSP for all eligible people in the pilot region. Follow-up is triggered when eligible people do not return a sample within two or four weeks of being sent an invitation letter. TABLE 7: FOLLOW-UP TRIGGERS AND ACTIONS FOLLOW-UP TRIGGER FOLLOW-UP An eligible person in a priority population has not sent in a sample or opted off two weeks after an invitation was sent Māori, Pacific and Asian community and support workers contact people via phone calls and/or home visits An eligible person has not sent in a sample or opted off four weeks after an invitation was sent A reminder letter from the Coordination Centre 26 » IFOBT TEST RESULTS LabPLUS tests iFOBT samples within three working days of receipt and sends all results electronically to the BSP Register and participants’ GPs. TABLE 8: NOTIFYING RESULTS TO PARTICIPANTS BSP PATHWAY RESPONSIBILITY REQUIREMENTS Notification of all results to BSP Register and GPs LabPLUS Electronic notification of all results to GPs and BSP Register within three days of receipt (includes positive, negative and spoilt kit results) Notification of positive results to participants with an identified GP GPs or Practice Nurses • Notification of positive results to participants as soon as possible, and always within 10 working days of receiving the result from LabPLUS • Advising participants that they will be contacted by the Endoscopy Unit for a colonoscopy pre-assessment Notification of positive results to participants with no identified GP Endoscopy Unit • Follow up of participants who have not been able to be contacted by their GP or Practice Nurse • Notification of positive results to participants without a named GP Notification of negative results to participants Coordination Centre • Notification of negative results (by letter) to participants. If the participant has a named GP the GP will already have been notified electronically by the laboratory • Sending of replacement kits to participants whose samples were unable to be tested 27 » MANAGEMENT OF KIT BY LAB Sample tested by laboratory Positive Negative Spoilt or technical fail Result to BSP Register and patient’s GP Result to BSP Register and patient’s GP Letter and replacement kit sent GPT/Senior Endoscopy Nurse referral to colonoscopy Letter sent to participant GPT notified Recall for screening in two years Opt off or participate Colonoscopy pre-assessment POSITIVE RESULTS GPs must contact their patient within 10 working days of receiving a positive result from LabPLUS, to: • inform their patient of the result • discuss the implications of the result • provide counselling and advice • refer their patient to the Endoscopy Unit for a screening colonoscopy. PATIENTS SHOULD BE REFERRED TO ‘BOWEL SCREENING WAITEMATA’ AND THE REFERRAL FAXED TO THE NORTH SHORE HOSPITAL REFERRAL CENTRE ON 09 486 8348. 28 Recognising the key role of GPs in providing ongoing health care for their enrolled population, GP involvement at this stage in the screening pathway is expected to lead to better colonoscopy attendance and lower anxiety for participants with positive results. Participants with a positive result and no GP named on their consent form are contacted by the Senior Endoscopy Nurse within 15 working days of a positive result. All participants who are referred to the Endoscopy Unit are contacted for a colonoscopy pre-assessment by the Senior Endoscopy Nurse within 15 working days of a positive result. After the pre-assessment, participants are sent: • confirmation of the positive result • confirmation of the colonoscopy date • a pamphlet which explains positive test results • information on the colonoscopy procedure • information on bowel preparation • bowel preparation tablets and sachets. If a GPT is unable to contact a participant with a positive iFOBT within 10 days, responsibility for active follow up transfers to the Senior Endoscopy Nurse, who attempts to contact the participant by phone and, if appropriate, makes a referral to Community Support Workers, who may make a home visit. If all attempts at contact are unsuccessful, the Senior Endoscopy Nurse sends the participant a letter outlining the positive result and encouraging him/her to contact their GP or the Coordination Centre. If no contact is made, the participant is placed on the iFOBT recall system, and remains on the BSP Register. The recall date for an iFOBT will be two years from the date of invitation if the participant does not proceed with colonoscopy or other diagnostic procedure. The participant will be referred for a colonoscopy if they contact their GP or the Coordination Centre at any time during the BSP. Where a participant with a positive result declines a diagnostic procedure, the Senior Endoscopy Nurse advises the participant’s GP. The participant may contact the Coordination Centre within six months if they change their mind. If the participant chooses to return for a colonoscopy after the six month period, it is at the discretion of the BSP Clinical Director, in consultation with the participant’s GP. 29 » MANAGEMENT OF POSITIVE RESULT GPT/Senior Endoscopy Nurse informs patient of positive result Endoscopy Unit contacts participant Unable to contact Contact successful Active follow-up Follow-up unsuccessful Notify GP Telephone pre-assessment Recall for screening in two years NO Endoscopist pre-assessment YES Appointment information and bowel screening prep sent to participant YES Fit for colonoscopy NO Colonoscopy Alternative investigation 30 NEGATIVE RESULTS Participants with negative results are notified in writing by the Coordination Centre within 15 working days of the result being received on the BSP Register, and advised they will be recalled to screening in two years, if still eligible. Participants will also receive the ‘BowelScreening – All Clear’ leaflet. UNCLEAR RESULTS The Coordination Centre sends new iFOBT kits to people whose samples are unable to be processed (“spoilt” results). GPs receive the “spoilt” result from LabPLus. 31 » DIAGNOSTIC TESTING PRE-ASSESSMENT All participants with positive results are referred for a colonoscopy preassessment to assess health fitness for the procedure and to provide them with full information about colonoscopy, including the possible risks and outcomes. The pre-assessment is conducted by a senior endoscopy nurse. Pre-assessment will include assessment of a participant’s family history of bowel cancer, with referral to the NZFGCR where appropriate. Pre-assessment may be undertaken either by telephone or face-to-face, depending on the participant’s preference and clinical condition. If the participant requires a pre-assessment outpatient consultation the nurse will arrange this with the participant and the Lead Colonoscopist. Nurse-led colonoscopy pre-assessment ensures support for the participant and liaison between the colonoscopy service and the Coordination Centre. Participants deemed fit for colonoscopy are offered an appointment for the procedure during pre-assessment. Colonoscopy must be completed within 55 working days of the positive result. Participants deemed not fit for colonoscopy (and those who have a failed colonoscopy) are referred for an alternative diagnostic investigation, Computerised Tomographic Colonography (CTC). Participants assessed as high-risk for colonoscopy require certain precautions to be taken to minimise risk during the procedure. High-risk individuals include those: • receiving warfarin medication • with insulin-dependent diabetes mellitus • with prosthetic heart valves • undergoing peritoneal dialysis • receiving immunosuppressing medication • with previous history of endocarditiis. Participants may also be deemed high risk for colonoscopy due to significant co-morbid disease. In this situation, the Endoscopy Unit coordinates a multi-disciplinary discussion and facilitates a decision on appropriate management, and keeps the person’s GP involved in this process. 2 NHS Rapid Response Report, available at www.npsa.nhs.uk/rrr 32 Participants assessed as fit and who consent to colonoscopy are given: • an appointment • bowel preparation instructions • culturally acceptable information about the procedure • culturally appropriate support to attend, if required • information on links to local support services. There are potential risks associated with bowel preparation. Death and harm from electrolyte abnormalities, dehydration and serious gastrointestinal problems have been reported following the inappropriate use of oral bowel cleansing solutions (Picolax®, Citramag® , Fleet Phospho-Soda®, Klean Prep®, Moviprep®) prior to surgery and/or investigative procedures. Frail and debilitated elderly patients and those with contraindications are particularly at risk from these treatments. It is therefore critical that clinical experts who routinely assess patients for colonoscopy provide a dedicated pre-assessment service. TABLE 9: ROLES AND RESPONSIBILITIES FOR CONDUCTING PRE-ASSESSMENT BSP PATHWAY RESPONSIBILITY REQUIREMENTS Arrange colonoscopy pre-assessment Endoscopy Unit (Senior Endoscopy Nurse) • Carrying out a colonoscopy pre-assessment • Scheduling a date for colonoscopy • Informing participants about bowel preparation Ensure participants with positive results have undergone a colonoscopy preassessment within 15 working days of iFOBT testing Coordination Centre Ensuring all participants with a positive result have undergone a colonoscopy pre-assessment and have a scheduled colonoscopy appointment in the BSP Register Ensure exchange of patient clinical information for colonoscopy preassessment GPs and Practice Nurses Developing a process to enable GPs and Practice Nurses to inform the Senior Endoscopy Nurse of their patient’s relevant clinical information when referring to colonoscopy 33 COLONOSCOPY Colonoscopy for the BSP is provided by a dedicated Screening Colonoscopy Unit at Waitakere Hospital in West Auckland. The unit has the capacity to deliver 2500 colonoscopies a year. Participants with ‘normal’ colonoscopies do not need to undergo another iFOBT screening episode for five years and are referred back to their GP. If screening is extended beyond the four years of the pilot, these people will be re-invited to participate when they become eligible again. Participants diagnosed with bowel cancer or high-risk polyps are referred for treatment or enter the surveillance programme run by the WDHB. Participants’ GPs are notified and these participants are considered to have exited the screening programme. Participants diagnosed with cancer or other bowel disease requiring ongoing surveillance have their care handed over to the gastroenterology service by the Coordination Centre, and are exited from the BSP. 34 » COLONOSCOPY INVESTIGATION Colonoscopy appointment Appointment NO attended? Active follow-up YES Colonoscopy Notify GPT Result Recall for screening in two years No abnormality detected Repeat colonoscopy Failed Colonoscopy Abnormality detected Notify GPT Increased risk Cancer Other Recall for screening in five years Refer as per NZGG surveillance Refer to MDT Refer, advise, and treat YES Inadequate bowel preparation? NO Alternative investigation Notify GP 35 TABLE 10: ROLES AND RESPONSIBILITIES FOR COLONOSCOPY PROCEDURES BSP PATHWAY RESPONSIBILITY REQUIREMENTS Preparation for colonoscopy Endoscopy Unit (Senior Endoscopy Nurse) • Scheduling of appointment for colonoscopy at pre-assessment • Ensuring information and bowel preparation material is sent to participant • Linking participant with culturally appropriate support to colonoscopy services as required • Assessing a participant’s family history of bowel cancer with referral to the NZFGCR, if appropriate Endoscopy Unit (Administrator) • Reminder letter and/or telephone call within one week of procedure • Follow-up support about colonoscopy requirements Colonoscopy outcomes Endoscopy Unit (Senior Endoscopy Nurse) • Collection of outcomes from colonoscopy via a standardised reporting format which includes polyp and biopsy information • Collection of performance data, using dedicated software, internally audited and reviewed at BSP quality monitoring meetings • Documentation of colonoscopy outcomes in the BSP information system Colonoscopy histopathology Colonoscopy histopathology results management Endoscopy Unit (Senior Endoscopy Nurse) Sending samples to LabPLUS by courier each working day LabPLUS Reporting histopathology results, using a standardised reporting template, directly into Concerto Endoscopy Unit (Endoscopist) Conveying results and recommended next steps to participant and GP 36 ALTERNATIVE INVESTIGATIONS Participants assessed as unfit for colonoscopy, or with an incomplete colonoscopy, are offered a Computerised Tomographic Colonography (CTC) investigation. The Medical Imaging Department at Waitakere Hospital retains emergency appointment slots each day, and these may be available for screening participants. If a slot is not available the participant is either kept overnight (depending on bed availability) or offered an appointment at Waitakere Hospital or North Shore Hospital the following day. TABLE 11: ROLES AND RESPONSIBILITIES FOR ALTERNATIVE INVESTIGATIONS BSP PATHWAY RESPONSIBILITY REQUIREMENTS CTC Endoscopy Unit (Administrator) Securing appointment for CTC as per standard procedures Medical Imaging Department, Waitakere or North Shore Hospital Provision of CTC within the timeframes and quality requirements of the BSP Quality Standards Endoscopy Unit (Senior Endoscopy Nurse) Entering procedure date and outcomes into the BSP Register CTC outcomes 37 » ALTERNATIVE INVESTIGATION CT Colonography YES Attended radiology appointment? NO Active follow-up Further investigation required? NO GPT notified YES Recall for screening in two years Abnormality detected Increased risk Cancer Other Refer as per NZGG surveillance Refer to MDT Refer, advise, and treat Notify GP 38 SURVEILLANCE Participants requiring ongoing surveillance are exited from the BSP, referred to a surveillance programme, and not recalled for subsequent screening. Surveillance is defined by the New Zealand Guidelines Group guidelines ‘Surveillance and Management of Groups at Increased Risk of Colorectal Cancer’.3 Participants falling within these guidelines are referred to WDHB’s Gastroenterology Unit. This unit operates according to the guidelines and has approximately 1250 patients on a regular surveillance programme. Patients requiring surveillance colonoscopy within one year are placed on the Endoscopy Unit waiting list. Those requiring surveillance colonoscopy over longer timeframes are discharged to their GP with a request to re-refer at the appropriate time. If a participant is considered to be at potentially high risk of developing bowel cancer, on the basis of their family history, they should be referred to the NZFGCR (Appendix 12). TABLE 12: ROLES AND RESPONSIBILITIES FOR SURVEILLANCE BSP PATHWAY RESPONSIBILITY REQUIREMENTS Refer for surveillance Endoscopist • Advising participants they have been referred for surveillance • Notifying participants’ GPs of surveillance management requirements 3 Endoscopy Unit Entering information about surveillance requirements into the BSP Register and removing from screening pathway Refer for surveillance colonoscopy GP Referring patient for surveillance colonoscopy within recommended timeframe Monitoring of surveillance WDHB Auditing of BSP participants who have been referred to surveillance if participants receive a surveillance colonoscopy within the guidelines (Surveillance and Management of Groups at Increased Risk of Colorectal Cancer, 2004) New Zealand Guidelines Group. Surveillance and Management of Groups at Increased Risk of Colorectal Cancer. Ministry of Health. 2004. 39 » TREATMENT Participants diagnosed with cancer are referred to a colorectal MultiDisciplinary Meeting (MDM). Referrals are made using a standardised, regional bowel cancer MDM form. An MDM form is used as both a referral form and a record of the decisions made at the meeting. It captures information in a standardised way to: • enable efficient presentation of bowel cancer patients in MDM • enable rapid referral after MDM by using the MDM form instead of dictating a referral letter • collect data from the MDM forms for real-time performance measurement. MDMs are held weekly at North Shore Hospital and include surgeons, a radiologist, a pathologist, a medical oncologist and a radiation oncologist. MDMs provide recommendations for culturally appropriate and coordinated care, advice and support. Outcomes of MDMs are communicated to the participant and their GP, and are documented in the medical records. All patients who require chemotherapy and/or radiation therapy are managed by the Auckland Regional Cancer and Blood Service at Auckland District Health Board (ADHB). ADHB is the regional provider of oncology services for the WDHB population. Participants diagnosed with cancer are not recalled for screening. TABLE 13: ROLES AND RESPONSIBILITIES FOR REFERRAL FOR TREATMENT BSP PATHWAY RESPONSIBILITY REQUIREMENTS Referral for treatment Endoscopist Referral of participants diagnosed with bowel cancer to MDM and treatment services Collection of treatment data Senior Endoscopy Nurse Entering of outcomes from treatment into the BSP Register PART THREE: SUPPORT SERVICES FOR THE BOWELSCREENING PILOT 41 » AIMS OF THE BOWELSCREENING PILOT The BSP’s key aims are to assess whether a national bowel screening programme in New Zealand: • is likely to achieve the mortality reduction from bowel cancer seen in international randomised controlled trials • can be delivered in a manner that: –– is safe and acceptable –– eliminates (or does not increase) inequalities between Māori and non-Māori –– is cost-effective. » OBJECTIVES OF THE BOWELSCREENING PILOT TABLE 14: OBJECTIVES OF THE BSP OBJECTIVE DESCRIPTION Programme design To pilot: • the use of a population register (the BSP Register), in conjunction with primary health care, to invite a target population for screening • a Coordination Centre and associated information system to manage a screening pathway Screening effectiveness To assess the early indicators of the effectiveness of bowel screening The iFOBT experience To assess the performance and acceptability of the chosen iFOBT in the New Zealand context Participation and coverage To determine the level of participation and coverage for the eligible and invited populations Quality To pilot the agreed quality standards and monitoring requirements along the screening pathway and assess the implications for a national programme; and in particular the acceptability and safety of the standards and screening to providers and for different population groups 42 OBJECTIVE DESCRIPTION Service delivery and workforce capacity To monitor effects and implications for a national bowel screening programme, including resource implications of screening activities, on: • primary care • community health services • laboratory services • secondary and tertiary services Fair access for all New Zealanders To determine whether a bowel screening programme can be delivered in a way that provides fair access to all New Zealanders, and in particular, to evaluate the processes designed to eliminate inequalities in planning and implementation, including the ability of the pilot site to identify factors which eliminate or reduce inequalities Cost-effectiveness To determine costs of all services along the screening pathway to assess the cost-effectiveness of a bowel screening programme, and to compare this to other preventative programmes in New Zealand and bowel screening programmes internationally Acceptability to the target population To pilot the provision of information and support to the target population to facilitate informed participation, and evaluate the knowledge, attitudes, and satisfaction of groups of participants (defined by sex, age, ethnicity, socioeconomic status and rurality) in the screening pilot, including identifying factors associated with nonparticipation Acceptability to providers To evaluate knowledge, attitudes, and acceptability to health professionals and health care providers based on community, primary care, and hospital settings » COMMUNITY ENGAGEMENT GP and PHO endorsement of the BSP are complemented by community engagement to raise awareness of bowel cancer and the benefits of screening. Community engagement is focused primarily on priority population groups. Engagement processes include: 43 • advertising in community newspapers • posters in GP surgeries and other locations appropriate to the eligible age group • targeted engagement with community groups and spokespeople, kaumatua, and Pacific elders • availability of a website and information line • public relations, including community ‘influencers’. The Coordination Centre health promotion team includes a Māori support position, and Pacific and Asian providers are contracted to provide information and support to their populations. International bowel screening programmes have found participation for ethnic minority groups, people from lower socio-economic groups and men is lower than other screened groups. Māori and Pacific peoples have higher mortality from bowel cancer due to late diagnosis. Evidence indicates that community engagement will assist in the success of the BSP, particularly for population groups that have been under-screened by other screening programmes. Māori and Pacific peoples are priority populations that are likely to need extra support to ensure that all New Zealanders have fair access to the screening pilot. As monitoring and evaluation of the pilot progresses, the priority populations may change to reflect any emerging patterns in participation. » THE IMMUNOCHEMICAL FAECAL OCCULT BLOOD TEST (IFOBT) FAECAL OCCULT BLOOD TESTS Faecal occult blood tests are tests for microscopic amounts of blood or breakdown products of blood in or on the stool, with the presence of blood being used as an indicator of neoplasia (especially cancer and larger polyps).4 These tests require the collection of faecal material which is then tested for blood. 4 Young GP, St John DJ, Winawer SJ, Rozen P. 2002. Choice of faecal occult blood tests for colorectal cancer screening: recommendations based on performance characteristics in population studies: a WHO (World Health Organisation) and OMED (World Organisation for Digestive Endoscopy) report. Am J Gastroenterol. 97(10):2499-507, Kerr J, Broadstock M, Day P, Hogan S. 2005. Effectiveness and Cost-effectiveness of Population Screening for Colorectal Cancer. New Zealand Health Technology Report Volume 8, Number 1. Christchurch: New Zealand Health Technology Assessment, Australian Government Department of Health and Ageing. 2005. Bowel Cancer Screening Pilot Monitoring and Evaluation Steering Committee. Australia’s Bowel Cancer Screening Pilot and Beyond. Final Evaluation Report. Canberra: Department of Health and Ageing, Commonwealth of Australia. 44 There is a normal loss of blood in the stool5 up to 1–2 ml per day.6 Cancers and larger polyps bleed intermittently with about two-thirds of cancers bleeding in the course of a week.7 Two main types of faecal occult blood tests are currently in use: • guaiac based tests (gFOBT) • immunochemical based tests (iFOBT). An iFOBT has been chosen for use in the BSP due to its improved test characteristics compared to guaiac testing. Immunochemical tests are analytically and clinically more sensitive, their measurement can be automated, and the programme can adjust the positivity threshold to ensure optimum cancer detection and a sustainable diagnostic service. IMMUNOCHEMICAL FAECAL OCCULT BLOOD TEST DESCRIPTION Immunochemical faecal occult blood tests use antibodies to detect partial sequences of antigenic sites usually on the globin portion of the haemoglobin molecule. The antibodies do not react to non-human globins or with plant peroxidises (as with guaiac based tests) thus eliminating the need for dietary restrictions.8 Because globin is degraded in the upper gastrointestinal tract, the test is not sensitive to upper gastrointestinal bleeding (also an issue with guaiac based tests).9 5 Dybdahl JH, Daae LN, Larsen S, et al. 1984. Occult Faecal blood loss determined by a 51Cr method and chemical tests in patients referred for colonoscopy. Gastroenterol. 19(2):245-54, Robertson JD, Maughan RJ, Davidson RJ. 1987. Fecal blood loss in response to exercise. Br Med J (Clin Res Ed) 295(6593):3035, Bird HA, Hill J, Haw WM et al. 1985. A comparison of Fecal blood loss caused by Tenoxicam and piroxicam in normal healthy male volunteers. Curr Med Res Opin. 9(8):524-8. 6 Crooke M. 2005. Faecal Occult Blood Tests. A presentation to the Colorectal Cancer Screening Advisory Group, Dybdahl JH, Daae LN, Larsen S, et al. 1984. Occult Faecal blood loss determined by a 51Cr method and chemical tests in patients referred for colonoscopy. Gastroenterol. 19(2):24554, Young GP, Macrae FA, St John DJB. 1996. Clinical methods for early detection: Basis, use and evaluation. In: Young GP, Rozen P, Levin B (eds). Prevention and early detection of colorectal cancer. London: Saunders 241-70. 7 Kerr J, Broadstock M, Day P, Hogan S. 2005. Effectiveness and Cost-effectiveness of Population Screening for Colorectal Cancer. New Zealand Health Technology Report Volume 8, Number 1. Christchurch: New Zealand Health Technology Assessment. 8 Ouyang DL, Chen JJ, Getzenberg RH, et al. 2005. Noninvasive testing for colorectal cancer: A review. Am J Gastroenterology 100:1393-1403. 9 Rockey DC, Auslander A, Greenberg PD. 1999. Detection of upper gastrointestinal blood with fecal occult blood tests. Am J Gastroenterol 94:344-50, Nakama H, Kamijo N, Fattah AS, Zhang B. 1998. Immunologic detection of fecal occult blood from upper digestive tract diseases. Hepatogastroenterology 45(21):752-4, Nakama H, Kamijo N, Fujimori K, et al. 1996. Diagnostic accuracy of immunochemical faecal occult blood test for gastric cancer. J Med Screen. 3(3):113-4, McDonald CA, Burford Y, Yuen AC, et al. 1984. Immunochemical detection of fecal occult blood. Aust N Z J Med. 14(2):105-10. 45 Sample collection varies for different types of immunochemical tests. The OC-Sensor test used for the BSP involves participants collecting a small sample of bowel motion by scraping the tip of a collection stick across the bowel motion a few times. The iFOBT is the simplest primary screening test for bowel cancer. Because no dietary or therapeutic restrictions are required (unlike gFOBT), participation rates are higher compared with gFOBT (by 13 percent in one study).10 There are no direct known safety issues with iFOBT. However, there are concerns relating to hygiene at the time of sampling and test transportation. » THE TEST KIT A single sample immunochemical faecal occult blood test (iFOBT) made by Eiken has been selected by the Ministry of Health for use in the BSP. The test, known as OC-Sensor, is an iFOBT widely used in screening programmes internationally. It is currently used in bowel screening programmes in Italy, Spain, Japan, Taiwan, Korea, Australia and the United States, and extensive work around its use is underway in France and the Netherlands. A growing number of screening programmes using the older and less accurate gFOBT are considering moving to this test. The OC-Sensor test was selected because it best met criteria identified for use and success in New Zealand. Criteria included: • extensive use in international screening trials and programmes • an extensive body of evidence supporting the test • the ability to automatically analyse the samples, reducing the chance of error • the ability to modify the positivity threshold, to identify more possible cancers • that test samples will be sufficiently stable for the New Zealand climate • value for money. As the test requires collection of only one faecal sample, it was also considered more likely to be acceptable to the population than tests requiring multiple samples. 10 Young GP, St John DJ, Winawer SJ, Rozen P. 2002. Choice of faecal occult blood tests for colorectal cancer screening: recommendations based on performance characteristics in population studies: a WHO (World Health Organisation) and OMED (World Organisation for Digestive Endoscopy) report. Am J Gastroenterol. 97(10):2499-507, Cole SR, Young GP. 2001. Participation in faecal occult blood test-based screening for colorectal cancer is reduced by dietary restriction. Med J Aust 175:195-8 46 To collect a sample, participants scrape the tip of a collection stick across their bowel motion a few times. They then replace the stick in the sample tube, seal it in a ziplock bag and post it in the Freepost envelope provided to LabPLUS for testing. » MONITORING, EVALUATION, AND AUDIT Waitemata District Health Board has entered into a contract with the Ministry to plan and implement the BSP. The Ministry and WDHB have developed and agreed a service delivery model. The Ministry has written a comprehensive set of draft quality and operating standards, as well as draft monitoring indicators. WDHB is required to report against these indicators and provide screening services to the required standards. The Ministry has contracted with providers of evaluation services who will report regularly on the status of the pilot against a wide range of evaluation areas. The Coordination Centre is responsible for coordinating and monitoring all components of the BSP screening pathway, and ensuring that each participant receives high-quality services in accordance with the required timeframes. WDHB is responsible for ensuring that resources are available to meet demand for colonoscopy within the required timeframe, without adversely affecting the waiting time for symptomatic procedures. WDHB is also responsible for ensuring that LabPLUS delivers sample analysis, histology and reporting services to the standards set by the Ministry. Monitoring and quality oversight is provided by the Ministry and the BSP Quality Group in the first instance. However, governance, quality and monitoring arrangements may change as the pilot progresses. PART FOUR: IWI/MĀORI AND PACIFIC PROVIDERS 48 » IWI/MĀORI PROVIDERS Māori and Pacific interests are represented in the governance structures of the BSP and Māori and Pacific provider groups are represented through working groups to ensure that delivery of the BSP achieves high coverage rates in these priority populations. Four Māori- and Pacific-focused providers serve more than a quarter of the total Māori and Pacific eligible registered population. Their involvement in and commitment to the BSP is fundamental to its success. Their role is the same as that of other general practices. In addition, the BSP has close linkages with these providers in the active follow-up of Māori and Pacific non-responding participants, coordinated by a Māori care coordinator employed by the Coordination Centre and Pacific care coordinators via contracts with Pacific providers. WDHB Iwi/Māori partners also play an important role in the community engagement processes. All community engagement, except for posters and newspaper articles, targets high-priority population groups, with the aim of reducing inequalities. » PACIFIC PROVIDERS Waitemata District Health Board’s two providers serving a predominantly Pacific population, West Fono Health Trust and Pasifika Integrated Family Medical, have over a quarter of the total eligible enrolled Pacific population in the district. They have a key role in achieving high uptake in this priority population group. PART FIVE: MINISTRY OF HEALTH INFORMATION 50 » INFORMED CONSENT An important part of informed consent is the aspect of being ‘informed’ or receiving information. The information that participants in the BSP will need is outlined below. 1. Entering the screening pathway –– That they are consenting to participate in the bowel screening pathway and what that pathway entails –– Options, risks and benefits of participating –– Information about bowel cancer, its signs and symptoms and what to do if these are present –– Implications for family or whānau members 2.iFOBT –– Information about iFOBT, including its efficacy and how to take a sample –– What happens to their sample after testing –– Any secondary uses of the sample (e.g. quality control), and that the sample will only be used for its intended purpose –– Third party access (if relevant) 3. Other points along the screening pathway –– That written consent will be obtained for services along the screening pathway according to each service’s standard practice (e.g. consent to colonoscopy) 4. Opting off the programme –– Enough information to enable an informed decision –– Advice that opting off will prevent them from receiving future invitations or reminders, but that they can return to the programme at any time 5. Participating in a pilot study –– Advice on the purpose of the study –– The type of information being collected –– How the information will be used –– What their management needs are once the pilot has ceased 51 » CODE OF HEALTH AND DISABILITY SERVICES CONSUMERS’ RIGHTS The Code of Health and Disability Services Consumers’ Rights provides that New Zealand health care consumers have a legal right to appropriate information to enable them to give informed consent. Information about the Code can be obtained from the Health and Disability Commissioner’s website at www.hdc.org.nz. » HEALTH INFORMATION PRIVACY CODE The Health Information Privacy Code 1994 (HIPC) sets specific rules for agencies in the health sector to better ensure the protection of individual privacy. It applies to health information collected, used, held and disclosed by health agencies. For the health sector, the HIPC takes the place of the information privacy principles in the Privacy Act 1993. The HIPC can be viewed on the Privacy Commissioner’s website at www.privacy.org.nz. » WHĀNAU ORA Whānau Ora is about: • facilitating positive and adaptive relationships within whānau • recognising the interconnectedness of health, education, housing, justice, welfare, employment, and lifestyle as elements of whānau wellbeing • ensuring Māori families are supported to achieve their maximum health and wellbeing. The Whānau Ora tool is available on the Ministry of Health website at www.moh.govt.nz. PART SIX: BACKGROUND INFORMATION ABOUT BOWEL CANCER AND BOWEL CANCER SCREENING 53 » BOWEL CANCER IN NEW ZEALAND Bowel cancer was the second most common cancer in New Zealand and the second highest cause of cancer death in 2008. That year, 2801 people were diagnosed with bowel cancer, and 1280 people died from the disease. New Zealand’s death rate from bowel cancer is one of the highest in the developed world, with the third highest mortality rate in the OECD for women and the sixth highest for men. By 2016, the number of new cases of bowel cancer diagnosed each year is projected to increase by 15 percent for men and 19 percent for women to 3302 (for all ages). » ABOUT BOWEL CANCER Bowel cancer usually develops within a pre-existing adenomatous polyp, typically over many years. The extent of spread of a cancer is known as its stage. There are various staging systems.11 Most are modifications of the Dukes’ Staging System: stage A is cancer confined to the bowel wall; in stage B it penetrates through the bowel wall; and in stage C cancer has invaded the regional lymph nodes. Stage D has been added to identify patients with cancer that has spread to other organs. The primary aim of screening for bowel cancer is to detect the cancer before symptoms develop. Screening also provides an opportunity to identify colorectal polyps that are likely to progress to cancer (thereby preventing development of the disease). » ABOUT BOWEL CANCER SCREENING Although bowel cancer may occur at any age, 90 percent of cases are in individuals over 50 years of age. Overseas screening programmes usually screen men and women between the age of 50 and 74 years. International evidence shows that a bowel screening programme may significantly reduce mortality from bowel cancer, and there is some evidence that suggests it could reduce the incidence of bowel cancer through the detection of pre-cancerous lesions. In recent years, population-based bowel screening programmes have been introduced in many countries and others have begun large scale pilots to determine the feasibility of such a programme in their country. Bowel 11 Fielding LP, Arsenault PA, Chapuis PH, et al. 1991. Clinicopathological staging for colorectal cancer: an International Documentation System (IDS) and an International Comprehensive Anatomical Terminology (ICAT). J Gastroenterol Hepatol 6(4):325–44. 54 screening programmes are either running or being piloted in Australia, the United Kingdom, Korea, Japan, Israel and most countries in the European Union. There is a strong association between the stage (extent) of bowel cancer at diagnosis and eventual survival. Those with localised disease have a 90 percent chance of a five-year survival. Those with distant spread (metastases) have only a 10 percent five-year survival rate. There is evidence to suggest that a higher percentage of detected cancers are found at a more advanced stage (greater spread of cancer) in New Zealand than in several countries where there are national or regional screening programmes, including Australia and the United Kingdom. Modelling in Ireland has concluded that a screening programme based on a biennial immunochemical faecal occult blood test (iFOBT) for people aged 55-74 could provide a lifetime reduction in the incidence of (15 percent) and mortality from (36 percent) bowel cancer.12 In New Zealand, a Ministerial Taskforce provided expert advice and recommendations to the Minister of Health and the Ministry on a programme to improve bowel cancer outcomes for all New Zealanders. The Taskforce provided strategic guidance on the direction and approach for establishing each component of the programme including: • development and implementation of the steps required to provide a bowel cancer screening programme in New Zealand • delivery of surveillance to groups with increased risk • improvement of treatment and diagnostic services for all people with bowel cancer • development and implementation of an evaluation framework for the programme • monitoring progress with implementation • providing other advice on bowel cancer as requested. Overseas data suggests that up to 8 percent of people who are screened will have traces of blood in their sample. Of these, between 30 and 40 percent will have polyps and about one in ten of them will have cancer. The BowelScreening pilot will determine whether this is the situation in New Zealand. International evidence suggests that bowel screening programmes can save lives through early diagnosis and treatment. A 2008 Cochrane review 13 suggests that the mortality rate from bowel cancer might be 12 http://www.hiqa.ie/media/pdfs/HTA_Outline_Summary_colorectal.pdf 13 Hewitson P, Glasziou P, Watson E, Towler B, Irwig L. 2008. Cochrane systematic review of colorectal cancer screening using the fecal occult blood test (hemoccult): an update. 2008 Jun;103(6):1541-9. Epub 2008 May 13. Department of Primary Health Care, University of Oxford, Oxford, United Kingdom. 55 reduced by between 14 and 16 percent (or likely to avoid approximately 1 in 6 colorectal cancer deaths) by use of a guaiac faecal occult blood test (gFOBT). New Zealand is using a newer immunochemical faecal occult blood test (iFOBT) which emerging evidence suggests may save more lives. The bowel screening pilot will provide data so we can determine how many lives could be saved in New Zealand. A Māori Equity Advisory Group (MEAG) provided the Ministry with advice and recommendations on reducing inequalities in treatment and outcomes for all people. » ORGANISED SCREENING FOR BOWEL CANCER An organised approach to screening on a national basis has been proven to be more successful at reducing incidence and mortality for certain diseases than opportunistic screening. The key difference between opportunistic screening and organised population-based screening is that opportunistic screening does not necessarily include the following essential components of an effective screening programme: • coordination of all elements of the service • a screening register • an invitation and recall system • a multidisciplinary team approach to screening • close linkages with diagnostic and treatment services • specific operational policies, quality standards and ongoing monitoring and quality assurance processes. A reduction in mortality at a population level depends upon high levels of participation and quality screening and follow-up services. Organised screening is a complex process that has the potential to both benefit and harm those who participate in the screening process. An organised population-based screening programme for the early detection of cancer differs from most health services in a number of respects. If screening is to be offered there needs to be clear evidence that the benefit to participants will outweigh the harm, and therefore clinical and operational procedures need to be of the highest quality. The screening process aims to identify early stage disease in ‘well people’ with no signs of disease. The boundaries of the population to participate in an organised screening programme are identified by general risk factors such as age and gender, by specified exclusion criteria, and international evidence from randomised controlled trials. 56 An organised bowel screening programme has the potential to reduce bowel cancer incidence and mortality by routinely screening a defined population at regular intervals. Bowel cancer screening fulfils several criteria of diseases that are amenable to population-based screening programmes. Bowel cancer is a slow-growing tumour with a long preclinical phase. Significant adenoma (>10mm) become bowel cancers at a rate of roughly 1 percent per year and if left in situ, have a cumulative risk of about 24 percent to become malignant at 20 years. The slow development process from adenoma to cancer makes bowel cancer a good example of where a screening intervention with a non-symptomatic population can save lives. » BOWEL SCREENING AND MĀORI Although Māori are not a population with elevated risk of bowel cancer, prevalence has increased over time, and Māori are at risk of not accessing services at equitable rates. To ensure Māori gain the maximum benefit from the BSP, two key documents/frameworks have been used as guidance: the Māori Health Strategy, together with its implementation plan, and Te Pae Māhutonga – the framework for health promotion/public health. HE KOROWAI ORANGA (MĀORI HEALTH STRATEGY) The Māori Health Strategy and Implementation Plan14 identify the broad approach to Māori health for the health system. The following kaupapa are given: 14 • affirming Māori processes – the strategy strongly supports Māori holistic models and wellness approaches to health and disability. It will also tautoko, or support, Māori in their desire to improve their own health. He Korowai Oranga seeks to support Māori-led initiatives to improve the health of whānau, hapū and iwi. The strategy recognises that the desire of Māori to have control over their future direction is a strong motivation for Māori to seek their own solutions and to manage their own services • improving Māori outcomes – achieving this will mean a gradual reorientation of the way that Māori health and disability services are planned, funded and delivered in New Zealand. Government, District Health Boards (DHBs) and the health and disability sector will continue to have a responsibility to deliver improved health services for Māori, which will improve Māori outcomes. King A and Turia T. 2002. He Korowai Oranga Maori Health Strategy. Wellington: Ministry of Health, Minister of Health. 2002. Whakatātaka - Māori Health Action Plan 2002-2005. Wellington: Ministry of Health. 57 Four pathways for action are identified: 1. development of whānau, hapū, iwi and Māori communities 2. Māori participation in the health and disability sector 3. effective health and disability services 4. working across sectors. While all of these pathways are important, pathways 2 and 3 are of particular relevance for the BSP. TE PAE MĀHUTONGA For effective implementation of a screening programme, Te Pae Māhutonga framework provides a useful approach. Te Pae Māhutonga is the name for the constellation of stars popularly referred to as the Southern Cross. Te Pae Māhutonga has long been used as a navigational aid and is closely associated with the discovery of Aotearoa and then New Zealand. The constellation has four central stars arranged in the form of a cross, and there are two stars arranged in a straight line which point towards the cross. They are known as the two pointers. Because it is an icon of New Zealand, and because Te Pae Māhutonga has served as a guide for successive generations, it can also be used as a symbolic map for bringing together the significant components of health promotion, as they apply to Māori health, but also as they might apply to other New Zealanders. The four central stars can be used to represent the four key tasks of health promotion and might be named to reflect particular goals of health promotion: Mauriora, Waiora, Toiora and Te Oranga. The two pointers are Ngā Manukura and Te Mana Whakahaere. 58 TABLE 15: GUIDANCE ON EFFECTIVE BOWEL SCREENING FOR MĀORI DIRECTIONS QUESTIONS IMPLICATIONS FOR BOWEL SCREENING PROGRAMME Ngā Manukura – Leadership Whose agenda are you working to? Do Māori have differential outcomes for colorectal cancer? What are the groups and organisations who will be allies? Māori medical practitioners Mauriora – cultural identity Te reo Māori resources Advertising, promotional and information resources in te reo Māori Waiora – physical environment Somewhat less relevant for a screening programme Responsible use of resources Toiora – healthy lifestyles Harm minimisation Both the screening programme and its target need to result in reduced harm as measured in Māori terms Targeted By Māori for Māori provision of services Culturally relevant Use of a Hauora model, such as that represented by Te Whare Tapa Wha Te Oranga – participation in society Participation in the screening programme Resources and incentives to ensure participation Te Mana Whakahaere – autonomy Control Highly visible Māori leadership Sensible, Māori-centric measures of outcome Development of measures of participation, acceptability and outcome Māori nurses Māori community health workers 59 Therefore, an effective bowel screening programme for Māori includes: • adoption of a Hauora model to represent health • building alliances with relevant Māori health organisations (such as the Māori Medical Practitioners Association, Māori Nurses Organisation, and Māori Development Organisations) • mechanisms (including prioritisation, resources and performance incentives) to ensure Māori participation in the planning and provision of the BSP • use of te reo Māori in information, health promotion and other materials relating to the BSP • development and use of measures of success for the BSP in Māori terms, as complementary measures. TREATMENT OUTCOMES FOR MĀORI Whether treatment of bowel cancer detected through the BSP will lead to improved outcomes for Māori is a question that needs further analysis. A recent paper, Ethnicity and management of colon cancer in New Zealand: Do indigenous patients get a worse deal?15 concluded that Māori New Zealanders with colon cancer were less likely to receive adjuvant chemotherapy and experienced a lower quality of care compared with non-Maori patients. The authors concluded that attention to health system factors is needed to ensure equal access and quality of cancer treatment for indigenous and ethnic minority populations. Inequitable outcomes are indicated in a recent chartbook of Māori and non-Māori cancer statistics,16 which analyses differences in cancer incidence, mortality, stage at diagnosis and survival in Aotearoa/New Zealand, using national cancer registrations and mortality data for the six-year period 1996–2001 (inclusive). Bowel cancer was more common among non-Māori than Māori, but mortality rates were similar for both populations. Māori males had a lower likelihood of being diagnosed with bowel cancer than non-Māori females, but a higher risk of death from bowel cancer. Stage at diagnosis was unknown for a higher proportion of Māori bowel cancer registrations (16 percent) compared with non-Māori (10 percent). Around 40 percent were diagnosed at a regional stage of disease spread. Māori were significantly less likely than non-Māori to be diagnosed at a localised stage. The likelihood of Māori being diagnosed when the disease had spread (distant stage) were two-thirds more than for non-Māori. 15 http://onlinelibrary.wiley.com/doi/10.1002/cncr.25127/full 16 Robson, B., G. Purdie, and D. Cormack, Unequal Impact: Māori and Non- Māori Cancer Statistics 19962001. 2006, Ministry of Health: Wellington. 60 Once diagnosed with bowel cancer, Māori were two-thirds more likely than non-Māori to die from their cancer. Half the survival disparity can be attributed to differences in stage at diagnosis. The higher risk of death was significant among those diagnosed at a localised or regional stage, and among those whose stage at diagnosis was not recorded. In summary, non-Māori had higher rates of bowel cancer but, once diagnosed, were less likely than Māori to die from their cancer. NonMāori were more likely than Māori to be diagnosed at an earlier stage of disease spread, but significant survival disparities exist among those diagnosed at a localised and regional stage. Bowel cancer is an important cancer for both Māori and non-Māori. The reasons for disparate outcomes should be investigated, including differential access to diagnostic and staging services, and treatment pathways. PART SEVEN: REFERENCES AND FURTHER INFORMATION 62 » FURTHER READING • Department of Public Health (Caroline Shaw, Ruth Cunningham, Diana Sarfati). March 2008. Next Steps Towards a Feasibility Study for Colorectal Cancer Screening in New Zealand: Report for the Ministry of Health. Wellington: University of Otago. • Ministry of Health (Colorectal Cancer Screening Advisory Group). November 2006. Reviewing population screening for colorectal cancer in New Zealand: Report of the Colorectal Cancer Screening Advisory Group. Ministry of Health (available on the Ministry of Health website: www.moh.govt.nz). • Ministry of Health. 2009. Suspected Cancer in Primary Care: Guidelines for investigation, referral and reducing ethnic disparities. (Available on the Ministry of Health website: www.moh.govt.nz. Hard copies can be ordered by emailing moh@wickliffe.co.nz or calling 04 496 2277.) • New Zealand Guidelines Group. 2009. Surveillance and Management of Groups at Increased Risk of Colorectal Cancer. (Hard copies can be ordered through the New Zealand Guidelines Group website www.nzgg.org.nz/practice-tools/bowel-cancer) • New Zealand Guidelines Group. 2011. Management of Early Colorectal Cancer. (Hard copies can be ordered through the New Zealand Guidelines Group website www.nzgg.org.nz/practice-tools/ bowel-cancer) WEBSITES: • http://www.cancerscreening.nhs.uk/bowel/ • http://www.bowelscreening.scot.nhs.uk/ 63 » GLOSSARY Adenoma – a non-cancerous growth in the lining of the bowel that can progress to cancer. Colonoscopy – a procedure which uses a flexible fibre-optic endoscope to directly examine the bowel for polyps or cancer. It requires bowel preparation in the form of diet restriction and laxatives in the preceding days. Cancer detection rate – the proportion of people screened in which cancers are detected. Double contrast barium enema – an X-ray examination using barium sulphate and air to outline the contour of the large bowel. Ethnicity – Statistics New Zealand describes ethnicity as “… the ethnic group or groups that people identify with or feel they belong to. Ethnicity is a measure of cultural affiliation, as opposed to race, ancestry, nationality or citizenship. Ethnicity is self perceived and people can belong to more than one ethnic group.” Faecal occult blood test – a type of test that involves taking a sample or samples of faecal matter and testing it for occult (unseen) blood or blood products which may indicate the presence of pathology in the bowel. This can be used as a screening test for colorectal cancer. The two main types of faecal occult blood tests are guaiac and immunochemical. False negative – a normal (negative) test result in a person who has the target condition. This is important in quantifying the number of cancers that will be missed by the screening test. False positive – an abnormal (positive) result in a person who does not have the target condition. First degree relative – the parents, brothers, sisters or children of an individual. Flexible sigmoidoscopy – a flexible fibre-optic endoscope used to directly examine the lower bowel for polyps or cancer. Incidence – the number of new cases of a disease in a given population during a given period of time. Incidence is usually expressed per 100,000 people per year. Inequalities in health – differences in health status between groups that are unnecessary, avoidable and unjust. 64 Interval cancer – a cancer that is diagnosed after a normal screening test result was given and before the next scheduled screening examination (or during some defined period after the screening test). Interval cancers include a spectrum of cancers, from those which did not exist or were undetectable at the previous round of screening to those that were detectable but missed. National Cancer Register – a population-based register of all primary malignant diseases diagnosed in New Zealand, excluding squamous cell and basal skin cancers. Negative Predictive Value – the proportion of individuals with a normal (negative) test result who do not have the target condition. Opportunistic screening – screening initiated through practitioner offer or patient request with no coordinated system of follow-up. Organised screening – screening where all people eligible for screening are systematically identified and offered screening, and centralised systems are used for follow-up and quality monitoring. Perforation – a complication of colonoscopy where a small hole is accidentally made in the bowel wall. Population register – a database holding selected information about each member of the resident population in a defined geographical area. Positive Predictive Value – the proportion of individuals with an abnormal (positive) test result who have the target condition. Prevalence – the number of cases of a specified disease in a given population at a designated point in time. Randomised controlled trial – an epidemiological experiment in which subjects are randomly assigned into groups to receive or not receive an experimental preventive or therapeutic treatment, intervention, procedure or manoeuvre. Randomised controlled trial evidence of benefit of screening is one of the criteria used to assess potential screening programmes. Second-degree relative – the aunts, uncles, grandparents, grandchildren, nieces, nephews, or half-siblings of an individual. Screening pathway – the sequence of steps involved in a screening programme, which includes the promotion of the programme, the identification and invitation of eligible participants, the screening test itself, and appropriate diagnostic investigations and treatment for those testing positive. (It is important to note that the offer of a screening test in isolation is not a screening programme.) 65 Sensitivity – the proportion of individuals who have a target condition who receive an abnormal (positive) test result. A screening test that is more sensitive will pick up a greater proportion of those with the target condition. However, it is possible that a more sensitive test may worsen the trade-off between benefits and harms if the test picks up more cases of inconsequential disease. Socioeconomic position – the social and economic factors that influence what position(s) individuals and groups hold within the structure of society (e.g. someone’s social class, income or relative deprivation). Specificity – the proportion of individuals who are free of the target condition who are correctly identified by the screening test as being free of the condition. If a new screening test is more specific (results in fewer false positives) then the potential harm of screening may be reduced. Surveillance – monitoring individuals known to have a disease or to be at increased risk of a disease. Test positivity rate – the proportion of people being tested who return a positive result. 66 » BIBLIOGRAPHY • Australian Government Department of Health and Ageing. 2005. Bowel Cancer Screening Pilot Monitoring and Evaluation Steering Committee. Australia’s Bowel Cancer Screening Pilot and Beyond. Final Evaluation Report. Canberra: Department of Health and Ageing, Commonwealth of Australia. • Bird HA, Hill J, Haw WM et al. 1985. A comparison of fecal blood loss caused by tenoxicam and piroxicam in normal healthy male volunteers. Curr Med Res Opin. 9(8):524-8. • Cole SR, Young GP. 2001. Participation in faecal occult blood test-based screening for colorectal cancer is reduced by dietary restriction. Med J Aust 175:195-8. • Crooke M. 2005. Faecal Occult Blood Tests. A presentation to the Colorectal Cancer Screening Advisory Group. • Dybdahl JH, Daae LN, Larsen S, et al. 1984. Occult faecal blood loss determined by a 51Cr method and chemical tests in patients referred for colonoscopy. Gastroenterol. 19(2):245-54. • Fielding LP, Arsenault PA, Chapuis PH, et al. 1991. Clinicopathological staging for colorectal cancer: an International Documentation System (IDS) and an International Comprehensive Anatomical Terminology (ICAT). J Gastroenterol Hepatol 6(4):325–44. • Hewitson P, Glasziou P, Watson E, Towler B, Irwig L. 2008. Cochrane systematic review of colorectal cancer screening using the fecal occult blood test (hemoccult): an update. 2008 Jun;103(6):1541-9. Epub 2008 May 13. Department of Primary Health Care, University of Oxford, Oxford, United Kingdom. • Kerr J, Broadstock M, Day P, Hogan S. 2005. Effectiveness and Cost-effectiveness of Population Screening for Colorectal Cancer. New Zealand Health Technology Report Volume 8, Number 1. Christchurch: New Zealand Health Technology Assessment. • McDonald CA, Burford Y, Yuen AC, et al. 1984. Immunochemical detection of fecal occult blood. Aust N Z J Med. 14(2):105-10. • Minister of Health. 2002. Whakatātaka - Māori Health Action Plan 2002-2005. Wellington: Ministry of Health. • Minister of Health and Associate Minister of Health. 2002. He Korowai Oranga: Māori Health Strategy. Wellington: Ministry of Health. • Ministry of Health. 2009. Bowel Cancer Programme: Inclusion/Exclusion Criteria. • Nakama H, Kamijo N, Fattah AS, Zhang B. 1998. Immunologic detection of fecal occult blood from upper digestive tract diseases. Hepatogastroenterology 45(21):752-4. 67 • Nakama H, Kamijo N, Fujimori K, et al. 1997. Relationship between fecal sampling times and sensitivity and specificity of immunochemical fecal occult blood tests for colorectal cancer: a comparative study. Dis Colon Rectum 40(7):781-4. • New Zealand Guidelines Group. 2004. Surveillance and Management of Groups at Increased Risk of Colorectal Cancer. Ministry of Health. • NHS Rapid Response Report, available at www.npsa.nhs.uk/rrr • Ouyang DL, Chen JJ, Getzenberg RH, et al. 2005. Noninvasive testing for colorectal cancer: A review. Am J Gastroenterology 100:1393-1403. • Robertson JD, Maughan RJ, Davidson RJ. 1987. Fecal blood loss in response to exercise. Br Med J (Clin Res Ed) 295(6593):303-5. • Robson, B., G. Purdie, and D. Cormack, Unequal Impact: Māori and Non- Māori Cancer Statistics 1996-2001. 2006, Ministry of Health: Wellington. • Rockey DC, Auslander A, Greenberg PD. 1999. Detection of upper gastrointestinal blood with fecal occult blood tests. Am J Gastroenterol 94:344-50. • Young GP, Macrae FA, St John DJB. 1996. Clinical methods for early detection: Basis, use and evaluation. In: Young GP, Rozen P, Levin B (eds). Prevention and early detection of colorectal cancer. London: Saunders 241-70. • Young GP, St John DJ, Winawer SJ, Rozen P. 2002. Choice of faecal occult blood tests for colorectal cancer screening: recommendations based on performance characteristics in population studies: a WHO (World Health Organisation) and OMED (World Organisation for Digestive Endoscopy) report. Am J Gastroenterol. 97(10):2499-507. APPENDICES 69 » APPENDIX 1: PRE-INVITATION LETTER <Person NHI> <Date> <Person Title><Person Name (First name, Family Name)> <Person Address – all address lines> Dear <Person Title> <Participant Family Name> Free bowel screening programme You are invited to take part in the free BowelScreening programme. The programme is being offered to all men and women aged 50 to 74 who live in the Waitemata District Health Board area and who are eligible for publicly funded healthcare. Your doctor, at <GP facility>, supports bowel screening. The aim of the programme is to detect bowel cancers at an early stage, when they can be more successfully treated. Bowel cancer can develop with few, if any, warning signs. Enclosed is a booklet that will help you decide if bowel screening is right for you. Next step In about four weeks time, you will be sent a free test kit, with detailed instructions on how to use it. The test is simple to do by yourself at home. If you choose to take part in the screening programme, just complete the test and return the kit to us. You will receive your results within three weeks. If you don’t want to take part in the programme, please phone us on 0800 924 432. Screening may not be right for everyone. Please call us now on 0800 924 432 if you: • have had a colonoscopy within the last five years • are on a bowel polyp or bowel cancer surveillance programme • have had or are currently being treated for bowel cancer • have had your large bowel removed • are currently being treated for ulcerative colitis or Crohn’s Disease • are currently awaiting bowel investigations arranged by your doctor. More information If you would like further information or assistance, please visit the BowelScreening website www. BowelScreeningWaitemata.co.nz, call the BowelScreening programme on 0800 924 432 or talk to your doctor. Yours sincerely Moira McLeod Programme Manager BowelScreening Programme 70 » APPENDIX 2: INVITATION LETTER <Person’s NHI> <Date> <Person Title><Person Name (First Name, Family Name) <Preferred Mailing Address> <Person Address – all address lines> Dear <Person Title> <Person Family Name> Free bowel screening programme You recently received a letter inviting you to complete a bowel screening test as part of the BowelScreening programme. The programme is being offered to all men and women aged 50 to 74 who live in the Waitemata District Health Board area and who are eligible for publicly funded healthcare. Your doctor, at <GP facility>, supports bowel screening. Enclosed is your free bowel screening test kit and a booklet that may help you decide if bowel screening is right for you. Doing the test will take just a few minutes of your time. Please follow the test kit instructions carefully. If you do not follow the instructions completely you may need to repeat the test. There is a checklist on the back page of the test kit instruction leaflet that will help you check you have completed all the steps. Results of the test You will receive your results within three weeks. Your doctor or a nurse may contact you to discuss the result. If you have not heard anything after this time, please call us on 0800 924 432. Screening may not be right for everyone Please call us on 0800 924 432 BEFORE doing the test if you: • have had a colonoscopy within the last five years • are on a bowel polyp or bowel cancer surveillance programme • have had or are currently being treated for bowel cancer • have had your large bowel removed • are currently being treated for ulcerative colitis or Crohn’s Disease • are currently awaiting bowel investigations arranged by your doctor. If you would like further information or assistance, please visit the BowelScreening website www. BowelScreeningWaitemata.co.nz, call the BowelScreening programme on 0800 924 432 or talk to your doctor. Yours sincerely Moira McLeod Programme Manager BowelScreening Programme PLEASE COMPLETE AND SIGN THE CONSENT FORM ON THE BACK OF THIS LETTER 71 » APPENDIX 3: CONSENT FORM BowelScreening Programme Consent Form Attach 1D Barcode Here Removable Barcodes for Samples Surname First Name Middle Name NHI Number Gender Date of Birth Attach 2D Barcode Here Phone Number Participant Residential Address Participant Postal Address GP/Dr Name GP/Dr Practice name GP/Dr Street Address Lab Use Only: [ IFOB ] Participant must complete all sections below Write date sample collected: If you do not wish your GP to receive your test results please mark here: Which ethnic group do you belong to? Tick the boxes that apply NZ European Niuean Maori Chinese Samoan Indian Cook Island Maori Other (Specify) Changes to current details if applicable: Surname First Name Gender Date of Birth Phone: Work Residential Address Home Mobile Postal Address GP/Dr Name GP/Dr Address or Practice Name Tongan It’s important you are fully informed about all aspects of bowel screening before you decide to take part in the BowelScreening programme, and do the bowel screening test. By completing and returning this form and the test to the laboratory you: • agree to participate in the BowelScreening programme • have read, or had explained to you, information about the BowelScreening programme • understand that if blood is found in the sample provided, you will be advised to undertake further diagnostic investigation • understand that the test will not detect all bowel cancers (studies show that FOBTs detect 70-80% of cancers) and it is important to always watch for any symptoms of bowel cancer that may develop • agree that your GP/Primary healthcare provider will be notified of your test result unless you have indicated in the tick box above that you do not want this to happen • agree that information collected about you is used for the purposes of monitoring and evaluation of the bowel screening pilot. More information on bowel screening and how we use your information is included in the booklet “All About BowelScreening”. You can download a copy from www.bowelscreeningwaitemata.co.nz or phone us on 0800 924 432 and we will post one to you. You may withdraw or suspend your participation in the programme at any time by contacting the BowelScreening programme Coordination Centre on the above free phone number. Signed 72 » APPENDIX 4: BOWELSCREENING TEST KIT INSTRUCTIONS Step 3 – Post the sample tube • As soon as the sample has been collected, put the sample tube into the zip-lock bag. Make sure the bag is completely closed. Finished? Have you: checked the consent form to ensure your details are correct? included your contact phone numbers on the consent form? included the date the sample was taken on the consent form? signed the consent form? placed the barcode on the sample tube? • Place both the zip-lock bag with sample tube, and the completed consent form, into the Freepost envelope and seal it. collected your bowel motion sample, placed it into the tube, and made sure the tube is clicked shut? washed and dried your hands? placed the sample tube in the zip-lock bag and sealed it? put the consent form and the completed sample tube into the Freepost envelope provided? sealed the envelope and posted it? • Keep the sample in a cool place until you post it. • Don’t leave it in a warm place or in direct sunlight, as your sample could spoil. • Post the Freepost envelope as soon as possible. • Avoid posting on Friday, Saturday or Sunday. Any questions? If you have any questions call the BowelScreening programme on 0800 924 432. Local Waitemata DHB trained staff will be there to help you, and your call will be confidential. Test Kit Instructions You can also visit www.BowelScreeningWaitemata.co.nz or talk to your doctor. September 2011 HP5402 Test kit instructions Before you start The bowel screening test is used to detect tiny traces of blood in your bowel motions. This may be an early warning that something is wrong with your bowel. Please complete this test as soon as possible. • You don’t need to change your diet or medication before doing the test. To do the bowel screening test you need to collect a small sample from your bowel motion. Step 2 – Collect the sample • Wait until you feel a bowel motion coming on. • Try to do the test early in the week and post it straight away. Then the sample will reach us in good condition. • For best results, try to urinate and flush the toilet before you do your bowel motion. This will stop the sample collection sheet from getting too wet and sinking. • You can do the test at any time of day. • To prevent any postal delays, it’s best not to send on a Friday, Saturday or Sunday. • Then place some toilet paper on the surface of the water in the toilet bowl. The test is quick, clean and simple for you to do at home. • Store the kit away from sunlight and heat. If you need any help or have any questions, call the BowelScreening programme on 0800 924 432. Don’t do the test: • Place the sample collection sheet on top of the toilet paper. In the kit you should have: • if blood is present in your urine or visible in the toilet bowl after a bowel motion. If this happens, talk to your doctor. • during your period, or within three days either side of it • Do the bowel motion on the sample collection sheet in the toilet bowl. Doing the test 1 Consent form with barcode label 2 Step 1 – Consent form Sample collection sheet (to put in toilet bowl) • Complete the consent form. • Sign and date the consent form, being careful to include the date the sample was taken. • Make sure your phone numbers are added to the consent form. • Remove the barcode label from the consent form and stick it along the flat side of the sample tube, below the printed serial number. You don’t need to write anything on the sample tube. 3 Sample tube 4 Zip-lock bag for sample tube If anything is missing from your test kit please call us on 0800 924 432. 5 Freepost envelope • Collect the sample immediately - before the sample collection sheet sinks. • To collect the sample, twist the lid off the sample tube. The lid has a small collection stick attached. • Scrape the tip of the collection stick over the surface of the bowel motion a few times to ensure the tip of the stick is covered. Only a very small amount of sample is required. • Take extra care when putting the collection stick back into the sample tube. Push to click shut and do not remove the lid again. • Flush the toilet with your bowel motion and the sample collection sheet in it. • Wash and dry your hands thoroughly. 73 » APPENDIX 5: NEGATIVE RESULT LETTER <Date> <Person NHI> <Person Title> <Person Name (First Name, Family Name> <Person Address – all addresses lines > Dear <Person Title> <Person Family Name> Your bowel screening test result Thank you for completing the bowel screening test sent to you recently as part of the free BowelScreening programme. Your test result was normal. This means that you do not need any further tests or treatment at this time. However no test is 100 percent accurate and it is important you watch for any bowel symptoms that may develop. Please read the enclosed leaflet for further information. Talk to your doctor if you notice blood in your bowel motions or a change in your normal pattern of going to the toilet that continues for several weeks (such as diarrhoea, constipation, or a feeling that your bowel often doesn’t empty completely). You will be invited to complete another bowel screening test in two years if you still live in the Waitemata District Health Board area, and are still within the eligible age range of 50 to 74. Regular bowel screening can detect bowel cancers at an early stage, when they can be more successfully treated. If you need more information, go to the BowelScreening website www.bowelscreeningwaitemata.co.nz, call 0800 924 432 or talk to your doctor. Yours sincerely Mike Hulme-Moir Clinical Director BowelScreening Programme 74 » APPENDIX 6: POSITIVE RESULT LETTER <Date> <Person NHI> <Person Title><Person Name (First Name, Family Name) <Preferred Mailing Address> <Person Address – all address lines> Dear <Person Title> <Person Family Name> Your bowel screening test result Thank you for completing the bowel screening test sent to you recently as part of the BowelScreening programme. By now you will have been contacted about your test result and will know that some blood was present in the sample you provided. This doesn’t mean that you have bowel cancer. There could be a number of reasons why blood was found and most are not related to cancer. The next step is to have another test to find the cause of the blood. A nurse from the BowelScreening programme will organise this for you and will provide you with detailed information about the test that is right for you, what it involves and what you need to do next. The information in the enclosed leaflet may also be useful. If you need more information, go to the BowelScreening website www.bowelscreeningwaitemata.co.nz, call 0800 924 432 or talk to your doctor. Yours sincerely Mike Hulme-Moir Clinical Director BowelScreening Programme 75 » APPENDIX 7: PARTICIPANT INFORMATION BOOKLET ‘ALL ABOUT BOWELSCREENING’ 2 3 4 » What is the FREE BowelScreening programme? » Why is bowel screening important? Bowel screening can help save lives by detecting bowel cancer at an early stage, when it can be treated more successfully. This is important, as there may be no warning signs that bowel cancer is developing. BowelScreening is a free programme to check people for early signs of bowel cancer. BowelScreening is being offered to everyone aged 50 to 74 living in the Waitemata District Health Board (DHB) area who is eligible for publicly funded healthcare. It is a four-year programme to test whether bowel screening should be introduced throughout New Zealand. The booklet explains how the screening test can help detect bowel cancer at an early stage when it can be more successfully treated, and provides information about the potential risks and benefits of screening. For more information on the BowelScreening programme, please visit: www.BowelScreeningWaitemata.co.nz Or call the programme on 0800 924 432 BowelScreening It is important you have all the information you need to make a decision about whether the test is right for you. If you need more information, you can call the BowelScreening programme on 0800 924 432, go to the BowelScreening website www.BowelScreeningWaitemata.co.nz, or talk to your doctor. All About bowelScreening Or speak to your doctor. The cells can turn into a polyp, which may then turn into cancer over a number of years. It can take a long time before the cancer grows and spreads to other parts of the body. Bowel screening provides an opportunity to find bowel cancer and treat it early. Bowel screening can also detect polyps (growths). These are not cancers, but they may develop into cancers over time. Polyps can be easily removed, reducing the risk of bowel cancer developing. Everyone eligible to take part in the programme will automatically be sent an invitation letter, a consent form and a free bowel screening test kit, with detailed instructions on how to use it. This booklet tells you about bowel screening. It may help you decide whether to take part in the free BowelScreening programme and take a bowel screening test. 5 » What is the bowel? The bowel is part of our food digestive system. It is divided into the small bowel and the large bowel, and connects the stomach to the anus (bottom) where waste material (called a bowel motion or faeces) is passed out of the body. The function of the large bowel is to finish digesting food by absorbing water and salt. The large bowel is where cancer most commonly develops. If you don’t want to take part in the bowel screening programme, and don’t want to receive a test kit, please contact us now on 0800 924 432 and let us know. If you complete the test kit and return it to us with the consent form, your sample will be tested – even if you have not signed the consent form. » What is bowel cancer? If you have any bowel cancer symptoms (see page 6) talk to your doctor. Don’t wait for your test kit to arrive. Bowel cancer is also called colon, rectal or colorectal cancer. Bowel cancer is a malignant growth that develops inside the bowel. A malignant growth occurs when normal cells on the inside wall of the bowel become abnormal and grow out of control. » How common is bowel cancer? New Zealand has one of the highest bowel cancer rates in the world. Bowel cancer is the second highest cause of cancer death in New Zealand. More than 2800 people are diagnosed with bowel cancer every year and more than 1200 die from the disease. September 2011 HP5401 6 7 8 9 You should talk to your doctor before deciding whether to do the bowel screening test if: » What are the symptoms of bowel cancer? Common signs and symptoms of bowel cancer may include: » » a change in your normal pattern of going to the toilet that continues for several weeks (such as diarrhoea, constipation, or feeling that your bowel doesn’t empty completely) blood in your bowel motion. Although these symptoms are usually caused by other conditions it’s important to get them checked by your doctor. » Who should do the bowel screening test? Bowel screening is for people who have no obvious signs or symptoms of bowel cancer. If you have any symptoms of bowel cancer, you should talk to your doctor BEFORE deciding whether to take part in the BowelScreening programme. » Who shouldn’t do the screening test? have had a colonoscopy within the last five years » are on a bowel polyp or bowel cancer surveillance programme » have had or are currently being treated for bowel cancer » have had your large bowel removed » are currently being treated for ulcerative colitis or Crohn’s Disease » are currently awaiting bowel investigations arranged by your doctor. 12 The most common test used to check your bowel is a colonoscopy. A colonoscopy involves a specially trained doctor putting a thin tube into your anus to see if there are any problems with your bowel. The tube has a very small camera on the end. If the doctor sees any polyps in your bowel, they will usually remove them and send them to the laboratory for testing. Removing polyps is generally painless. The colonoscopy takes about 30 minutes and is usually done as a day-patient procedure at the hospital. You will be given medication that makes you very sleepy and helps to minimise any discomfort. If you need a colonoscopy, you will need to prepare your bowel the day before by drinking a special preparation that will give you diarrhoea. This ensures you have a clear bowel, so the doctor can see any problems. Good bowel preparation is very important because it gives the doctor the best chance of finding any problems, especially small polyps. » Are there any risks from a colonoscopy? Colonoscopy is considered a safe procedure with few risks and is generally straightforward for most people. However, as with most medical procedures, there is a risk of complications. There is a very small risk that colonoscopy will cause serious bleeding, or damage or tears to your bowel and you may need an operation to fix it. Colonoscopy can detect 95 out of 100 cancers and polyps. » Do I need to pay for the colonoscopy, other tests or treatment? The screening test and any follow-up tests or treatments organised through the BowelScreening programme are free. » What if I am diagnosed with bowel cancer? If you are diagnosed with bowel cancer, you will be referred for treatment to the hospital. The main treatment for bowel cancer is surgery. In some cases, chemotherapy or radiotherapy may be recommended. » How successfully can bowel cancer be treated? People who are diagnosed with bowel cancer and receive treatment when it is at an early stage have a 90 percent chance of long term survival. If there is a delay in diagnosis and treatment, and the cancer is more advanced, it is harder to cure. Bowel screening can detect cancer early, when it can be more successfully treated. » you or a close family member have been diagnosed with bowel cancer at a young age (under 55 years) » there is concern that you and your family may have a genetic bowel cancer syndrome » there is a known genetic bowel cancer syndrome in your family » you have had extensive inflammatory bowel disease such as ulcerative colitis for more than 10 years. Bowel cancer is more common as you get older, particularly from the age of 50. Bowel cancer affects more men than women. A diet relatively high in red meat and animal fats, and low in fruit, vegetables and fibre, may contribute to the development of bowel cancer. Lack of exercise is also a risk factor for bowel cancer. 13 » What further tests might I need? you have a history of a number of family members over two or three generations being affected with bowel cancer » Who is most at risk of bowel cancer? Screening is not appropriate for everyone. You should not be part of a bowel screening programme if you: » » No screening test is 100% accurate. There is a chance that cancer can be missed if there was no bleeding from it when you did the bowel screening test. That’s why it’s important to have a screening test every two years. Bowel cancer may also start to slowly develop in the two years between screening tests. It’s important to talk to your doctor if you notice any signs or symptoms of bowel cancer (see page 6) at any time between screening tests. The bowel screening test is an immunochemical faecal occult blood test (iFOBT). It can detect tiny traces of blood in your bowel motions. This may be an early warning that something is wrong with your bowel. If there is blood in your bowel motion it doesn’t mean you have bowel cancer, but you should have a further test to find the cause of the blood. » What does the test involve? The test is free and is quick, clean and simple to do by yourself at home. You will be sent a free test kit, with detailed instructions on how to use it. The test kit contains everything you need. To do the test, you will need to collect a small sample from your bowel motion. This is easy to do if you follow the instructions in the kit. » Who can access my information? Your doctor will be told that you are taking part in the BowelScreening programme, but will only be told the results of your tests if you agree to it. The information on your consent form and your screening results will be used by the BowelScreening programme to provide you with any necessary follow-up, including inviting you to take part in the programme again in two years. If you tell us you don’t want to take part in the programme, we will keep a record of your details to make sure that you are not invited in the future. Information about any further assessment or treatment for bowel cancer that you may need will be collected by Waitemata DHB. This information will be held securely by Waitemata DHB and the Ministry of Health and only authorised people will have access to your information. This will include people who are evaluating the programme. Personal information and data are collected, stored, accessed and destroyed to a standard that complies with the Health Information Privacy Code 1994. » If I am not satisfied with the service I have received, how do I make a complaint about the programme? The Code of Health and Disability Services Consumers’ Rights allows you to make a complaint in a way that is appropriate for you. If you want to make a complaint about this programme or the service you have received, you can phone the BowelScreening programme on 0800 924 432 for more information about the best options for you. You can also get help from the Office of the Health and Disability Commissioner. Call 0800 112 233 or visit www.hdc.org.nz For more information on the BowelScreening programme, please visit www.BowelScreeningWaitemata.co.nz call the programme on 0800 924 432 or speak to your doctor. » When will I get my results? You will receive your results within three weeks of returning your completed bowel screening kit. If you don’t receive your results within three weeks, please call 0800 924 432. » What do the results of the bowel screening test mean? If no blood is found in your sample, this means that you don’t need any further tests at this time. You will be invited back to do another bowel screening test in two years, if you still live in the Waitemata DHB area, and are still aged between 50 and 74 years. If no blood is found in your sample, it doesn’t guarantee that you don’t have bowel cancer, or that you will never develop it in the future. If you develop any signs or symptoms of bowel cancer (see page 6), it’s important you talk to your doctor. If blood is found in your sample, it doesn’t mean that you have bowel cancer. The blood may be caused by polyps, or other minor conditions such as haemorrhoids (piles). It does mean you will need a further test to find the cause of the blood. Your doctor or a nurse will contact you to discuss your results and the type of test that is right for you. When you have completed the test, just put it in the zip-lock bag provided, then into the Freepost envelope along with the signed and completed consent form. Post it as soon as possible. Keep the sample in a cool place until you post it. To prevent any postal delays, it’s best not to send it on a Friday, Saturday or Sunday. » How will I get my results? You will receive a letter with your results and information about what this means for you. You may also receive a phone call from your doctor or a nurse. 15 It’s important that you are fully informed about all aspects of bowel screening before you decide to take part in the BowelScreening programme, and do the bowel screening test. You can find more information on the BowelScreening website www.BowelScreeningWaitemata.co.nz 11 » How accurate is the test? » What is a bowel screening test? 14 » Do I have all the information I need? 10 Only a small number of people will have blood in their sample and of these, an even smaller number will be found to have bowel cancer. 76 » APPENDIX 8: PARTICIPANT INFORMATION LEAFLET ‘BOWELSCREENING – YOUR QUICK REFERENCE GUIDE’ This information will be held securely by Waitemata DHB and the Ministry of Health and only authorised people will have access to your information. This will include people who are evaluating the programme. Personal information and data are collected, stored, accessed and destroyed to a standard that complies with the Health Information Privacy Code 1994. » How do I make a complaint about the programme? » Do I have all the information I need? It’s important that you are fully informed about all aspects of bowel screening before you decide to take part in the BowelScreening programme, and do the bowel screening test. More information on bowel screening, including potential risks and benefits, is included in the booklet All About BowelScreening. You can download a copy from: www.BowelScreeningWaitemata.co.nz or phone us on 0800 924 432 and we will post a copy to you. » Who can access my information? Your doctor will be told that you are taking part in the BowelScreening programme, but will only be told the results of your tests if you agree to it. The information on your consent form and your screening results will be used by the BowelScreening programme to provide you with any necessary follow-up, including inviting you to take part in the programme again in two years. If you tell us you don’t want to take part in the programme, we will keep a record of your details to make sure that you are not invited in the future. The Code of Health and Disability Services Consumers’ Rights allows you to make a complaint in a way that is appropriate for you. If you want to make a complaint about this programme or the service you have received, you can phone the BowelScreening programme on 0800 924 432 for more information about the best options for you. You can also get help from the Office of the Health and Disability Commissioner. Call 0800 11 22 33 or visit www.hdc.org.nz For more information on the BowelScreening programme, please visit www.BowelScreeningWaitemata.co.nz or call the programme on 0800 924 432 or speak to your doctor. Information about any further assessment or treatment for bowel cancer that you may need will be collected by Waitemata DHB. For more information on the BowelScreening programme, please visit: www.BowelScreeningWaitemata.co.nz BowelScreening Your Quick reference Guide Or call the programme on 0800 924 432 Or speak to your doctor. September 2011 HP5400 5735GSL BScreen Test Brochure_Final_fa.indd 1-5 18/08/11 12:35 PM » What is a bowel screening test? This brochure is a quick guide to the BowelScreening programme. More detailed The bowel screening test is used to detect tiny traces of blood in bowel motions. These may be an early warning that something is wrong with your bowel. It doesn’t mean you have bowel cancer, but you should have a further test to find the cause of the blood. information can be found in the booklet All About BowelScreening. You can download a copy from the BowelScreening website www.BowelScreeningWaitemata.co.nz or phone us on 0800 924 432 and we will post a copy to you. » How do I complete the bowel screening test? » What is the FREE BowelScreening programme? The test is simple to do by yourself at home. BowelScreening is a free programme to check people for early signs of bowel cancer. BowelScreening is being offered to all men and women aged 50 to 74 who live in the Waitemata District Health Board (DHB) area and who are eligible for publicly funded healthcare. It is part of a four-year programme to test whether bowel screening should be introduced throughout New Zealand. Bowel screening is for people who have no obvious signs or symptoms of bowel cancer. The FREE test kit contains everything you need and comes with detailed instructions on how to use it. » Why is bowel screening important? New Zealand has one of the highest bowel cancer rates in the world. Bowel screening can help save lives by detecting bowel cancers at an early stage, when they can be treated more successfully. This is important, as there may be no warning signs or symptoms that bowel cancer is developing. People aged over 50 are more likely to develop bowel cancer, especially men. Bowel cancer is the second highest cause of cancer death in New Zealand. More than 2800 people are diagnosed with bowel cancer every year and more than 1200 die from the disease. 5735GSL BScreen Test Brochure_Final_fa.indd 6,9-10 You will need to collect a small sample from your bowel motion. To do this, just follow the instructions in the kit. Put the sample in the zip-lock bag provided and post it, along with the completed consent form, in the Freepost envelope provided. » When will I get my results? You will receive your results within three weeks of returning your completed kit. You may also receive a phone call from your doctor or a nurse. If you don’t receive your results within three weeks, please call 0800 924 432. » What do the results of the bowel screening test mean? If no blood is found in your sample, this means that you don’t need any further tests at this time. You will be invited back to do another bowel screening test in two years time, if you still live in the Waitemata DHB area, and are still aged between 50 and 74 years. If blood is found in your sample, it doesn’t mean that you have bowel cancer. It does mean you will need a further test to find the cause of the blood. Your doctor or a nurse will contact you to discuss the results and the type of test that is right for you. » What further tests might I need? The most common test used to check your bowel is a colonoscopy. A colonoscopy uses a very small camera on the end of a thin tube to examine the lining of your bowel, to see if there are any problems. » Do I need to pay for any further tests and treatment if I need them? The screening test and any follow-up tests or treatments organised through the BowelScreening programme are free. » How accurate is the test? No screening test is 100% accurate. It’s important to always watch for any symptoms of bowel cancer that may develop. Talk to your doctor if you notice: » blood in your bowel motions » a change in your normal pattern of going to the toilet that continues for several weeks (such as diarrhoea or constipation) » a feeling that your bowel doesn’t empty completely. » Who shouldn’t do the screening test? Screening is not appropriate for everyone. You shouldn’t be part of a bowel screening programme if you: » have had a colonoscopy within the last five years » are on a bowel polyp or bowel cancer surveillance programme » have had or are currently being treated for bowel cancer » have had your large bowel removed » are currently being treated for ulcerative colitis or Crohn’s Disease » are currently awaiting bowel investigations arranged by your doctor. 18/08/11 12:35 PM 77 » APPENDIX 9: PARTICIPANT INFORMATION LEAFLET ‘BOWELSCREENING – ALL CLEAR’ Personal information and data are collected, stored, accessed and destroyed to a standard that complies with the Health Information Privacy Code 1994. » If I am not satisfied with the service I have received, how do I make a complaint? The Code of Health and Disability Services Consumers’ Rights allows you to make a complaint in a way that is appropriate for you. If you want to make a complaint about this programme or the service you have received, you can phone the BowelScreening programme on 0800 924 432 for more information about the best options for you. You can also get help from the Office of the Health and Disability Commissioner. Call 0800 112 233 or visit www.hdc.org.nz For more information on the BowelScreening programme, please visit www.BowelScreeningWaitemata.co.nz call the programme on 0800 924 432 or speak to your doctor. For more information on the BowelScreening programme, please visit: www.BowelScreeningWaitemata.co.nz BowelScreening All Clear Or call the programme on 0800 924 432 AN EXPLANATION OF YOUR TEST RESULTS Or speak to your doctor. September 2011 HP5408 Your bowel screening test result shows that no blood has been found in your bowel motion. This means that you don’t need any further tests at this time. You will be invited back to do another bowel screening test in two years, if you still live in the Waitemata District Health Board area, and are still aged between 50 and 74 years. In the meantime, if you develop any signs or symptoms of bowel cancer, it is important you talk to your doctor. » How accurate is my result? » What are the symptoms of bowel cancer? Common signs and symptoms of bowel cancer may include: » a change in your normal pattern of going to the toilet that continues for several weeks (such as diarrhoea, constipation, or feeling that your bowel doesn’t empty completely) » blood in your bowel motion. Although these symptoms are usually caused by other conditions it is important to get them checked by your doctor. » Who is most at risk of bowel cancer? Bowel cancer is more common as you get older, particularly from the age of 50. It affects more men than women. You are more at risk of developing bowel cancer if: No screening test is 100% accurate. If no blood is found in your sample, it doesn’t guarantee that you don’t have bowel cancer, or that you will never develop it in the future. There is a chance that cancer can be missed if there was no bleeding from it when you did the bowel screening test. Bowel cancer may also start to slowly develop in the two years between screening tests. That’s why it’s important to have a screening test every two years and to talk to your doctor if you notice any symptoms of bowel cancer. » you have a history of a number of family members over two or three generations being affected with bowel cancer » you or a close family member have been diagnosed with bowel cancer at a young age (under 55 years) » there is concern that you and your family may have a genetic bowel cancer syndrome » you have had bowel cancer or certain types of bowel polyps » you have had extensive inflammatory bowel disease such as ulcerative colitis for more than 10 years. If you are concerned about your family history of bowel cancer or your risk of developing bowel cancer, please talk to your doctor. » How can I reduce my overall risk of cancer? » Maintain a healthy body weight. » Eat a low fat, high fibre diet with plenty of fresh fruit and vegetables. » Exercise regularly. » Avoid smoking. » Who can access my bowel screening information? Your doctor will be told that you are taking part in the BowelScreening programme, but will only be told the results of your tests if you have agreed to this. The information on your consent form and your screening results will be used by the BowelScreening programme to provide you with any necessary follow-up, including inviting you to take part in the programme again in two years. If you tell us you don’t want to take part in the programme, we will keep a record of your details to make sure that you are not invited in the future. Information about any further assessment or treatment for bowel cancer that you may need will be collected by Waitemata DHB. This information will be held securely by Waitemata DHB and the Ministry of Health and only authorised people will have access to your information. This will include people who are evaluating the programme. 78 » APPENDIX 10: PARTICIPANT INFORMATION LEAFLET ‘BOWELSCREENING – FURTHER INVESTIGATION’ » Do I have all the information I need? It’s important that you are fully informed about all aspects of bowel screening, including the screening test and any further tests you may need. You can find more information on the BowelScreening website www.BowelScreeningWaitemata.co.nz, or talk to your doctor. » Who can access my information? Information about any further assessment or treatment for bowel cancer that you may need will be collected by Waitemata DHB. This information will be held securely by Waitemata DHB and the Ministry of Health and only authorised people will have access to your information. This will include people who are evaluating the BowelScreening programme. Personal information and data are collected, stored, accessed and destroyed to a standard that complies with the Health Information Privacy Code 1994. » If I am not satisfied with the service I have received, how do I make a complaint? The Code of Health and Disability Services Consumers’ Rights allows you to make a complaint in a way that is appropriate for you. If you want to make a complaint about this programme or the service you have received, you can phone the BowelScreening programme on 0800 924 432 for more information about the best options for you. You can also get help from the Office of the Health and Disability Commissioner. Call 0800 112 233 or visit www.hdc.org.nz For more information on the BowelScreening programme, please visit www.BowelScreeningWaitemata.co.nz or call the programme on 0800 924 432 or speak to your doctor. For more information on the BowelScreening programme, please visit: www.BowelScreeningWaitemata.co.nz Or call the programme on 0800 924 432 BowelScreening Further Investigation AN EXPLANATION OF YOUR TEST RESULTS Or speak to your doctor. September 2011 HP5407 Your bowel screening test result shows that some blood has been found in your bowel motion. This does NOT mean you have bowel cancer. It does mean you will need a further test to find the cause of the blood. The blood may be caused by polyps (growths) or other minor conditions such as haemorrhoids (piles). » What happens next? Your doctor or a nurse will contact you to discuss your results and what further test you may need. They will explain what the test involves and answer any questions you may have. » How do I make an appointment for this test? If you decide to have the test, the nurse will arrange an appointment for you and will provide further information about what to do next. » What further test might I need? The most common test used to check your bowel is a colonoscopy. A colonoscopy involves a specially trained doctor putting a thin tube into your anus (bottom) to see if there are any problems with your bowel. The tube has a very small camera on the end. If the doctor sees any polyps in your bowel they will generally remove them and send them to the laboratory for testing. Removing polyps is usually painless. The polyps will be checked for any abnormal cells that might be cancerous. » Fewer than one in 100 people will be found to have cancer. » About four in 10 will have polyps which if removed may prevent cancer developing. » Will I need to stay in hospital? No. The colonoscopy is usually done as a day-patient procedure at the hospital and takes about 30 minutes. If you need a colonoscopy you will need to prepare your bowel the day before by drinking a special preparation that will give you diarrhoea. This ensures you have a clear bowel so the doctor can see any problems. Good bowel preparation is very important because it gives the doctor the best chance of finding any problems, especially small polyps. » Are there any risks from a colonoscopy? Colonoscopy is considered a safe procedure with few risks and is generally straightforward for most people. However, as with most medical procedures, there is a risk of complications. There is a very small risk that colonoscopy will cause serious bleeding, or damage or tears to your bowel and you may need an operation to fix it. Colonoscopy can detect 95 out of 100 cancers and polyps. » Will it hurt? You will be given medication that makes you very sleepy and helps to minimise any discomfort. » What happens if I miss my colonoscopy appointment? It’s very important you let us know as soon as possible if you are unable to come for your colonoscopy on the day and time arranged so we can organise another appointment for you. If you miss your appointment, or need to make another time, please phone us on 0800 924 432. » Do I need to pay for the colonoscopy, other tests or treatment? The screening test and any follow-up tests or treatments organised through the BowelScreening programme are free. » What if I am diagnosed with bowel cancer? If you are diagnosed with bowel cancer you will be referred for treatment to the hospital. The main treatment for bowel cancer is surgery. In some cases chemotherapy or radiotherapy may be recommended. » How successfully can bowel cancer be treated? People who are diagnosed with bowel cancer and receive treatment when it is at an early stage have a 90 percent chance of long term survival. If there is a delay in diagnosis and treatment, and the cancer is more advanced, it is harder to cure. Bowel screening can detect cancer early, when it can be more successfully treated. 79 » APPENDIX 11: PEOPLE AT INCREASED RISK OF BOWEL CANCER People at increased risk fall into two groups: those already identified as being at increased risk, and those identified as being at increased risk through participation in the BSP. The following table shows the criteria for categorising a person with increased risk of bowel cancer. INCREASED RISK INDIVIDUALS MODERATE RISK INDIVIDUALS Individuals with: i A family history of bowel cancer, with: • a personal history of bowel cancer • high-risk colorectal adenomas, multiple polyps • extensive inflammatory bowel disease such as ulcerative colitis for more than 10 years • one first-degree relative with bowel cancer diagnosed before the age of 55 years, or • two first-degree relatives on the same side of the family with bowel cancer diagnosed at any age HIGH RISK INDIVIDUALS A family history of: • Familial adenomatous polyposis (FAP), hereditary non-polyposis colorectal cancer (HNPCC) or other familial CRC syndromes • one first-degree relative, plus two or more first- or second-degree relatives, all on the same side of the family, with a diagnosis of CRC at any age • two first-degree relatives, or one first-degree relative plus one second-degree relatives, all on the same side of the family with a diagnosis of CRC, and one such relative diagnosed with CRC under the age of 55 years, or developed multiple bowel cancers, or developed an extracolonic tumour suggestive of HNPCC (i.e. endometrial, ovarian, stomach, small bowel, upper-renal tract, pancreas or brain) • at least one first- or second-degree relative diagnosed with CRC in association with multiple bowel polyps • a personal history of, or one firstdegree relative with, CRC diagnosed under the age of 55 years, particularly where colorectal tumour immunohistochemistry has revealed loss of protein expression for one of the mismatch repair genes (hMLH1 or hMSH2) i New Zealand Guidelines Group. Surveillance and Management of Groups at Increased Risk of Colorectal Cancer. Wellington: New Zealand Guidelines Group; 2004. 80 A significant proportion of people already at increased risk will either not know that they are at increased risk, or will know that they are and/or are not receiving the level of surveillance and monitoring currently recommended within New Zealand’s clinical guidelines for suspected cancer in primary care.ii People should be referred to the NZFGCR if familial bowel cancer is suspected (Appendix 12). Advising people to see a health professional rather than participate in screening may be a barrier for people who have poor access to primary care. On the other hand, not excluding people with symptoms suggestive of bowel cancer may give them false reassurance that a negative test means they can continue to not seek help for their symptoms, and includes people within the BSP who potentially are not at average risk of bowel cancer. To address this situation: • information regarding factors of increased risk (including a family history of bowel cancer) is included in the leaflet ‘All About BowelScreening’. People are advised to discuss risk factors with their primary care practitioner • individuals identified at increased risk of bowel cancer should not participate in the BSP • consideration should be given to the management of people, and the data associated with them, who have already had colonoscopy services outside of the public health sector. PEOPLE IDENTIFIED AS AT INCREASED RISK THROUGH SCREENING People who have high-risk adenomas or polyps detected through the BSP are no longer eligible for screening, and will be exited to a parallel programme for surveillance of people at increased risk. For these people, the clinical guidelines outline how they should be monitored on an ongoing basis (mostly with surveillance colonoscopy at specified intervalsiii). ii NZ Guidelines Group (2004) Surveillance and Management of Groups at Increased Risk of Colorectal Cancer: Wellington: NZGG iii NZ Guidelines Group (2004) Surveillance and Management of Groups at Increased Risk of Colorectal Cancer Wellington: NZGG 81 SYMPTOMS SUGGESTIVE OF BOWEL CANCER Clinical guidelines for suspected cancer in primary careiv: RECOMMENDATIONS COLORECTAL CANCER: URGENT REFERRAL (WITHIN TWO WEEKS) GRADE A person aged 40 years and older reporting rectal bleeding with a change of bowel habit towards looser stools and/or increased stool frequency persisting for 6 weeks or more should be referred urgently to a specialist* C A person aged 60 years and older with rectal bleeding persisting for 6 weeks or more without a change in bowel habit and without anal symptoms should be referred urgently to a specialist* C A person aged 60 years and older with a change in bowel habit to looser stools and/or more frequent stools persisting for 6 weeks or more without rectal bleeding should be referred urgently to a specialist* C A person presenting with a palpable rectal mass (intraluminal and not pelvic) should be referred urgently to a specialist, irrespective of age. Note that a pelvic mass outside the bowel should be referred urgently to a urologist or gynaecologist* C A man of any age with unexplained iron deficiency anaemia and a haemoglobin of 110 g/L or below, should be referred urgently to a specialist* C Unexplained iron deficiency anaemia means unrelated to other sources of blood loss, for example, non-steroidal antiinflammatory drug treatment or blood dyscrasia A non-menstruating woman with unexplained iron deficiency anaemia and a haemoglobin of 100 g/L or below, should be referred urgently to a specialist* C Unexplained iron deficiency anaemia means unrelated to other sources of blood loss, for example, non-steroidal antiinflammatory drug treatment or blood dyscrasia Grades indicate the strength of the supporting evidence, rather than the importance of the recommendations – refer to Appendix A in the guidelines for grading details. * Recommendation consistent with: Referral guidelines for suspected cancer. NICE clinical guideline 27. 2005. iv New Zealand Guidelines Group 2009. Draft Suspected cancer in primary care: Guidelines for investigation, referral and reducing ethnic disparities. Wellington: NZGG 82 GOOD PRACTICE POINTS COLORECTAL CANCER: URGENT REFERRAL (WITHIN TWO WEEKS) A person presenting with a right-sided abdominal mass should be referred urgently for a surgical opinion ü A menstruating woman with unexplained iron deficiency anaemia* and a haemoglobin of 100 g/L or below, should be referred urgently to a specialist ü * Unexplained iron deficiency anaemia means unrelated to other sources of blood loss, for example, heavy menstrual bleeding, non-steroidal anti-inflammatory drug treatment or blood dyscrasia Opinion of the Guideline Development Team, or feedback from consultation within New Zealand where no evidence is available. 83 » APPENDIX 12: NZ FAMILIAL GASTROINTESTINAL CANCER REGISTRY The NZ Familial Gastrointestinal Cancer Registry (NZFGCR) is a national Ministry of Health funded service with offices in Auckland, Wellington and Christchurch. The team consists of family history assessors, gastroenterologists, colorectal surgeons, oncologists and geneticists. The NZFGCR facilitates the identification and management of familial gastrointestinal cancer syndromes. A service for assessing individuals at increased risk of developing bowel cancer is a prerequisite to the introduction of a population bowel screening programme. WHO TO REFER TO THE NZFGCR? Individuals: • With two or more close relatives on the same side of the family with colorectal cancer (CRC) • With a personal or family history of a first-degree relative with bowel cancer diagnosed at or under the age of 50 years • With a family history of a suspected or known familial gastrointestinal cancer/polyp syndrome, e.g. familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer • Potentially at high risk for developing bowel cancer as defined in the guidelines for surveillance and management of groups at increased risk for colorectal cancer (CRC) www.nzgg.org.nz WHAT DOES THE NZFGCR DO? • Offers assessment of bowel cancer risk for people with a family history of gastrointestinal cancer • Facilitates the diagnosis of hereditary cancer by confirming the family history • Offers surveillance recommendations • Co-ordinates surveillance for high-risk families • Offers specialist management advice • Provides information for specialists and families on familial gastrointestinal cancer 84 NZFGCR CONTACT INFORMATION NATIONAL/ AUCKLAND OFFICE Auckland City Hospital PO Box 92024, Auckland 1142 Phone: 09 307 8991 Freephone: 0800 554 555 (if outside Auckland) Fax: 09 307 4978 Email: NZfamilialGIregistry@adhb.govt.nz www.bowelscreeningwaitemata.co.nz
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