Are you ready for the Colorectal Cancer Screening Pilot Programme?

Are you ready for the Colorectal Cancer Screening Pilot Programme? Dr Regina CHING Head, Surveillance and Epidemiology Branch Centre for Health Protection Department of Health 7 December 2014 Hong Kong Doctors Union Seminar

Outline 1. Background 2. Local burden of colorectal cancer (CRC) 3. Concept of screening 4. Screening test for CRC 5. gfobt vs ifobt(fit) 6. About FIT kits and screening interval 7. Colonoscopy for FIT positive participants 8. Update on development of pilot prgramme 9. About electronic screening registry 10.Q & A 2

1. Background 2. Local burden of colorectal cancer (CRC) 3. Concept of screening 4. Screening test for CRC 5. gfobt vs ifobt(fit) 6. About FIT kits and screening interval 7. Colonoscopy for FIT positive participants 8. Update on development of pilot prgramme 9. About electronic screening registry 10.Q & A 3

Background Cancer Expert Working Group on Cancer Prevention and Screening (CEWG) recommends individuals aged 50-75 years should consider CRC screening by either annual or biennial faecal occult blood test (FOBT); or flexible sigmoidoscopy every 5 years; or colonoscopy every 10 years 2014 Policy Address Government is developing the first ever, subsidised, population-based CRC screening programme DH, in collaboration with HA, primary care doctors and other healthcare providers First pilot on specific age groups to gather local experience from user and provider perspectives 4

Colorectal cancer (CRC) burden CRC is no. 1 cancer in 2011 4,450 new cases (overtook lung cancer) Number of total new cancer cases 4600 4300 4000 3700 3400 3100 2800 2500 Colorectum Lung 2200 Source: Hong Kong Cancer Registry, Hospital Authority Department of Health, Census and Statistics Department Year Number of annual registered colorectal cancer and lung cancer cases in Hong Kong, 1992 2011

CRC burden 2 nd killer in 2013 1,981 registered deaths (14.6% of all cancer deaths) Most people diagnosed at age 50 or above Lifetime risk before age 75-1 in 22 men; 1 in 35 women ~50% of CRC patients in stage III or IV Source: Hong Kong Cancer Registry, Hospital Authority Department of Health, Census and Statistics Department

CRC epidemiology Age-standardised incidence rates* of CRC in Hong Kong, 1983-2011 Age-standardised mortality rates* of CRC in Hong Kong, 1981-2012 Source: Hong Kong Cancer Registry, Hospital Authority Source: Department of Health Census and Statistics Department 8

CRC epidemiology Comparison of estimated age standardised incidence and mortality rates of CRC in Hong Kong and other countries, 2012 Notes: 1. For comparison purpose, the age-standardised rates for Hong Kong are calculated using the same age-standardisation method adopted by GLOBOCAN 2012, in which the age-standardised rates are calculated based on the World Standard population modified by Doll et al. (1966) from that proposed by Segi (1960), and are calculated using 10 age-groups. 2. Hong Kong data are the actual figures, while GLOBOCAN 2012 are the projected ones. The reference year of Hong Kong incidence rates is 2011, while that of GLOBOCAN 2012's is 2012. 3. Source: GLOBOCAN 2012, IARC, WHO 9

Role of Screening in 1. Primary Prevention cancer prevention 2. Secondary Prevention Early detection Screening * Screening is only part of cancer prevention * Don t forget Primary Prevention and Early Detection 11

Screening To detect early disease or risk factors for disease in large numbers of apparently healthy, asymptomatic individuals Not diagnostic - person with positive findings must be referred to doctors for diagnosis Screening can be Opportunistic (happens when an individual asks doctor for a test or offers to a patient consulting doctor for another reason) Population-based (offers systematically to all individuals without symptoms in a defined target group) 12 Source: John Last, A Dictionary of Epidemiology CEWG cancer booklets, 2013

Pitfalls of Screening Screening can lead to early diagnosis, may also falsely appear to increase time from diagnosis to death Lead time bias apparent survival of a person solely due to earlier diagnosis instead of true prolongation of life Diagnosis from screening Diagnosis in normal circumstances Death 13 Source: Report of CEWG on Cancer Prevention and Screening, Dec 2004 National Cancer Institute Cancer Screening Overview, 2014

Pitfalls of Screening Length time bias detect disproportionate no. of slowly progressive cases but miss more aggressive cases that often present in the population due to rapid progression Rapid growing (6 cases) Slow growing (6 cases) O Dx O Dx O =Time of disease onset Dx =Time when disease is clinically obvious without testing Screening Time Screening Time Source: Report of CEWG on Cancer Prevention and Screening, Dec 2004 National Cancer Institute Cancer Screening Overview, 2014 14

Pitfalls of Screening Screening can lead to early diagnosis, may also falsely appear to increase time from diagnosis to death Over-diagnosis find cancer that will go away on their own or never cause any symptoms False-positive result - person with abnormal screening result actually does not have cancer False-negative result - person with normal screening result actually does have cancer 15 Source: Report of CEWG on Cancer Prevention and Screening, Dec 2004 National Cancer Institute Cancer Screening Overview, 2014

Wilson and Jungner s classic criteria for screening Disease The condition sought should be an important health problem. There should be a recognizable latent or early symptomatic stage. The natural history of the condition, including development from latent to declared disease, should be adequately understood. Screening Test There should be a suitable test or examination The test should be acceptable to the population. Healthcare System There should be an accepted treatment for patients with recognized disease. Facilities for diagnosis and treatment should be available. There should be an agreed policy on whom to treat as patients. The cost of case finding (including diagnosis and treatment of patients diagnosed) should be economically balanced in relation to possible expenditure on medical care as a whole. Case finding should be a continuing process and not a once and for all project. Source: Wilson and Jungner Principles and practice of screening for disease. Public Health Paper No. 34. Geneva: WHO 1968 16

Screening tests for CRC 1. Faecal Occult Blood Test (FOBT) 2. Flexible Sigmoidoscopy (FS) 3. Colonoscopy 18

Evidence for Faecal Occult Blood Test (FOBT) FOBT can reduce mortality by 15-33% Sensitivity of FOBT has been reported to be 55.0-92.2% in a meta-analysis of RCTs Sensitivity and specificity of the FIT (Fecal immunochemical test) for cancer have been reported to be 65.8% - 88.2% and 89.7%-94.6% respectively FOBT, when compared with other options, is more cost-effective for population based CRC screening Source: Hardcastle, J.D et al. Lancet. 1996. Kronberg, Oet al. Lancet. 1996. Mandel, J.S. etal. New England Journal of Medicine. 1993. Tsoi KKF, et al. Alimentary Pharmacology and Therapeutics. 2008. Sharp L et al. Br J Cancer. 2012. National Cancer Institute. Colorectal Cancer Screening (PDQ ), 2004.

Evidence for Flexible sigmoidoscopy (FS) Meta-analysis of RCTs suggested FS can reduce 46% mortality from distal CRC 1 Local study using FS in detecting advanced neoplasm found a sensitivity of 77.8% and specificity of 83.9% 2 Low complication rate Only examines distal colon May miss lesions in proximal colon Source: 1. Brenner H, et al. BMJ (2014) 2. J Sung et al. (2003) 20

Evidence for colonoscopy Meta-analysis of observational studies suggested screening by colonoscopy may result in even stronger reduction in distal CRC mortality although no RCT has yet been published The only modality that allows complete bowel examination and removal of adenoma Source: Brenner H, et al. BMJ (2014) 21

FOBT as primary screening tool Currently available evidence is not conclusive on the modality that would best serve the purpose of screening in a general population FOBT is easy to administer and stool samples can be collected at home Easily prescribed by general practitioners as part of holistic primary care Overseas experience such as Australia, New Zealand and Singapore are using FOBT as the primary CRC screening tool

Types of FOBT 1. gfobt - guaiac FOBT 2. ifobt or FIT- faecal immunochemical test a) Quantitative FIT b) Qualitative FIT Taking into account healthcare infrastructure, service capacity and user acceptance, among other things, quantitative FIT appears to be an ideal screening method for use in the local primary care setting

Comparison of gfobt, qualitative FIT and quantitative FIT

Number of FIT kits and screening interval Currently NO international consensus on number of samples (1 vs 2 FIT tubes) and frequency of FIT testing (annual or biennial) for screening purpose Decision will largely be a balance of resources, operational logistics and participant convenience 27

No Country/Region Overseas No. of sample(s) & screening reference tool Interval 1 United Kingdom (NHS Bowel Cancer Screening Programme) gfobt; 2 samples from 3 different bowel movement N/A Biennial One round of FS 2 France gfobt on 3 consecutive bowel motion Biennial 3 Finland gfobt on 3 consecutive days Biennial 4 Ontario, Canada gfobt; 2 samples from 3 different bowel motions Biennial 5 Australia 2 FIT samples from two separate bowel motions Till next eligible age group 6 Italy 2 FIT from two consecutive bowel motions Biennial 7 Ireland 1 FIT Biennial 8 New Zealand 1 FIT Biennial 9 Germany FOBT (not specified) Annual Colonoscopy 10 yearly 10 Singapore 2 FIT Annual 11 Korea 1 FIT (Qualitative/ Quantitative) Annual 12 Japan 2 FIT Annual 13 China 2 FOBT Annual 14 Taiwan 1 FIT (Quantitative) Biennial 15 Thailand FIT Annual or Biennial 16 Malaysia FOBT Annual

Conclusion - FIT as screening test Quantitative FIT appears to be an ideal screening method for use in the local primary care setting 2 FIT tubes to each participant in order to catch intermittent bleeding from separate bowel motions Rescreening every 2 years 29

Colonoscopy as diagnostic test Participants with positive FIT result will be referred by the primary care doctor to receive colonoscopy for assessment and management Polyps found at colonoscopy can be removed to reduce the chance of developing CRC Potential serious complications may occur at colonoscopy such as bowel perforation (1-30 per 10000) and heavy bleeding (1-6 per 1000), but these are uncommon. Source: American Society for Gastrointestinal Endoscopy. Complications of Colonoscopy. (2011).

Proposed governance structure Food and Health Bureau Department of Health CEWG Task Force Use of FIT Colonoscopy and assessment Screening registry Promotion and publicity Primary Care Doctor (PCD) FIT lab DH centres PPP-CS HP HA RD Private S E R V I C E P R O V I D E R S NGO 33

Duty visit to Australia Experience sharing To collect experience from National Bowel Screening Programme of Australia Visited Dept. of Health of Melbourne and Canberra, private endoscopy clinic, Canberra hospital and public and private pathology laboratories in April 2014 Lessons learnt 1. Role of primary care in a screening programme 2. Data collection 3. Communication strategy 4. Quality assurance is crucial - All pathology laboratories are accredited

Lessons learnt 1. Role of primary care in screening programme Participants invited according to age on Medicare list by mail No exclusion criteria (except age), and may include ineligible persons Information giving relies heavily on information booklet Australia is considering to involve primary care practicioners to a greater extent in programme 2. Importance of data collection Manual input by staff after submission of handwritten forms from participants and health care providers labour intensive Low rate of form return due to lack of motivation or not aware of patient/ specimen was from program Poor data collection Developed Patient FU function to call patients to find that 80% of defaulters was due to missing data Australia is exploring more automated form of data input

Lessons learnt 3. Communication strategy Explanation for eligible age group to the general public needs to be clear Communication strategy would be important, other than instruction sheet e.g. cartoon video of procedure of stool collection Peer, family and primary care provider were the most trusted source of information Effective means of motivating primary care provider simple data entry and processes, financial incentives, data feedback

Local KAP (Knowledge, Awareness, Perception)) survey on CRC screening Aim: To inform policy making on a population-based CRC screening programme and formulate health promotion and education strategies Objectives: To examine public knowledge, awareness and attitude of CRC and CRC screening; public practice, intention, facilitators and barriers of having FOBT and colonoscopy Methodology: Territory-wide, cross-sectional telephone survey Conducted in April and May 2014 HK residents aged 50-75 who spoke Cantonese, Putonghua or English were interviewed 2,012 subjects were interviewed (Response rate 40%) 37

Knowledge & Awareness Respondents possessed fair knowledge of CRC Most common source of CRC screening: Newspaper, television, healthcare professional, family/friend/colleague Knowledge on FOBT & Colonoscopy as means of CRC screening 38% FOBT 12% unprompted + 26% prompted 38% 66% 38% (12% Colonoscopy unprompted + 26% prompted) 32% unprompted + 34% prompted 38

Perception, Attitude & Practice Perception & Attitude Most respondents perceived themselves having certain chance of getting CRC and need of CRC screening in future Most respondents had positive attitude towards doctor s screening recommendation 76% respondents reported they would be very likely or likely go for CRC screening if their doctors advised them Unlikely 9% Very unlikely 8% Don t know 7% Likely 28% Very likely 48% Practice Some respondents had ever had FOBT or colonoscopy. Having symptom or discomfort, tests included in body check-up package, and advised by healthcare professional were main reasons for the tests. 39

Intention Respondents had high intention of taking free FOBT offered by the Government, and very high intention of taking further assessment by colonoscopy if needed Facilitators and barriers were: Free FOBT Further colonoscopy Facilitator detection for CRC free screening perceived necessary or important test doctor s advice detection for CRC perceived necessary or important test Barrier perceived unnecessary or unimportant test not high risk groups or low chance of getting CRC perceived unnecessary or unimportant test physical discomfort or pain risk or safety cost of colonoscopy 40

Conclusion Primary care doctors play an important role in screening programme 41

Essentials of a screening programme Primary care Scientifically based protocols (FIT test and clinical management) Target well defined and most able to benefit Clearly defined screening pathway/referral Adequate facilities for testing, diagnosis and treatment Database to support call and recall, track process and outcome, monitor and evaluate operation Overall benefits overweigh harms

What does CRC screening mean for Primary Care Doctors? Keep abreast with screening evidence Practice preventive medicine and good primary care Offer FIT screening more widely to eligible persons Contribute to systematic and cost-effective population-based screening Reduce morbidity and mortality from CRC Improve population health

CRC Screening Pilot Programme Key design features 1. Primary care based; elderly care framework 2. Quality and safety assured; screening principles 3. Participant confidentiality and autonomy; opt-in 4. Acceptability, accessibility, affordability, equity 5. Ride on Electronic Health Record Sharing System (ehrss) to facilitate data sharing; CRC IT system 6. Auditing functions incorporated 7. Service monitoring and evaluation 8. 3 year pilot programme 9. Screening tool: Biennial Quantitative fecal immunochemical test (FIT); full subsidy 10. Diagnostic tool: colonoscopy, Public Private Partnership (PPP) model; partial subsidy with copayment 44

Proposed workflow 45

Inclusion criteria for FIT screening Hong Kong ID card holders with valid stay and within specified age range Eligible individuals within the target age range will be invited to screening in phases starting from the oldest age groups, extending over 3 years to the youngest within this age range (more details on next slide) Participants must first enroll in both ehrss and CRC screening pilot programme, giving consent to a primary care doctor who has enrolled in ehrss and CRC screening pilot programme to access his/her relevant clinical history 46

Target age group To offer FIT screening to individuals aged 61-70 in 2015 by phases over 3 years Year of Birth (Age in 2015) 1954 (61) 1953 (62) 1952 (63) Year 1 (2015) Year 2 (2016) Year 3 (2017) Year 1 (2015) 1951 (64) Individuals turning 68 to 70 Those born in 1945-1947 Year 2 (2016) 1950 (65) 1949 (66) 1948 (67) 1947 (68) Individuals turning 66 to 68 1946 (69) Those born in 1945-1950 1945 (70) Year 3 (2017) Eligible age group Individuals turning 63 to 66 Those born in 1945-1954 Eligible participants who have not enrolled in previous year can also enrol in subsequent years Repeat testing for previous FIT ve individuals Repeat testing for previous FIT ve individuals 47

Exclusion criteria for FIT screening Persons with symptoms of colorectal cancer Persons who have recently received colorectal cancer screening FIT screening within 2 years Colonoscopy within 10 years Persons whose medical conditions making them unlikely to benefit from screening or more prone to suffer from risks or complications of colonoscopy 48

Workload estimation 3-year biennial FIT for eligible persons CRC screening pilot programme Year 1 Year 2 Year 3 Total estimation for 3-year Projected number of participation* for FIT in person-time (30% participation rate for first time FIT participation and 10% drop off rate for repeated FIT are assumed) Positive FIT results (#4.5% for the first year, and 1.8% for subsequent years are assumed) Projected participation of Colonoscopy with +ve FIT (^88.7% for aged 63-65 and 88.6% for aged 66-70 Colonoscopy participation rate is assumed) 51,000 72,840 154,205 278,045 2,295 3,278 5,755 11,328 2,033 2,906 5,104 10,043 Adenoma (#detection rate is 27%) 549 784 1,379 2,712 Advanced neoplasms (#detection rate is 16.3%) 332 473 831 1,636 CRC (#detection rate is 2.9%) 59 85 148 292 Remarks: * Each participation will recieve 2 FIT. For each participant with negative FIT result, he/she will have next FIT 2 years later. For example, the same participant will normally have FIT on Year 1, Year 3 and Year 5 if his/her FIT results are negative on Year 1 and Year 3. # The assumption is based on the findings of the 5-year CRC screening project conducted by CUHK from May 2008 to Oct 2012. ^ The assumption is based on the survey findings on 456 community dwelling elderly aged 66-75 conducted by DH in July 2013. 49

PCD roles and responsibilities Enrol suitable persons on CRC programme Brief counselling Issue FIT kits Attend to FIT kits rejected by lab Remind patient to submit unreturned kits Inform participant of FIT result FU on FIT positive result (referral and more) Keep connected through CRC IT system

Electronic screening registry Facilitates timely, streamlined and accurate data collection and analysis Supports clinical, administrative and financial management of the Pilot Programme Riding on territory-wide electronic Health Record Sharing System (ehrss) enables participants to be served by healthcare providers comprising the primary care doctor, colonoscopist, radiologist and pathologist based on shared data Provides important reminder functions for service providers and recall functions for participants. 52

To enrol Health Care Provider (HCP) must first enroll in ehrss before joining the CRC screening programme - Enrolment procedure: 1. Provision of supporting documents (e.g. Business Registration Certificate) 2. Technical compliance for system connection For more information, please go to http://www.ehealth.gov.hk/ 53

Are we ready? Pilot programme - introduce by end 2015 Recruitment of PCDs - 4 th quarter of 2015 PCDs are encouraged to familiarise with concept of CRC screening watch out for operational details of the screening programme enroll in the CRC screening pilot programme Let s make history for Hong Kong and fight Colorectal Cancer together!

Q & A Session Information presented here is still in its draft stage. Please do not treat as final or quote!!