Colorectal cancer screening in England

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1 Colorectal cancer screening in England critical analysis Prof Stephen P. Halloran

2 Participation Rate 57% All Screens (1.9% +ve) 52% Prevalent 1 st Screen (age 60 years) 36% Prevalent Screen (2.2% +ve) 86% Incident Screen (1.7% +ve)

3 Bowel Cancer Screening Programme Design Implementation Strengths and Weaknesses Performance Changes /Enhancements Future Breast Cancer Cervical Cancer Bowel Cancer Looking Listening Learning Leading

4 England Biennial Screening for Bowel Cancer Evidence lead Published pilots (gfobt) Additional pilot in UK setting UK pilot(s) 1m people Principles followed Population-based Minimise barriers to participation Centralise & uniform processes Single IT system Minimum no. of screening labs Comprehensive Quality Assurance Key performance indicators Frequent monitoring with teeth!

5 England Biennial Screening for Bowel Cancer 1 England July 2006 Guaiac FOBT two yearly Phase year olds Phase Phase ? Phased Roll-out Dependent upon evidence of Capacity Quality Opt-in if age>74 Scotland 2007 Wales 2008 N. Ireland 2010 S. Ireland million

6 England Biennial Screening for Bowel Cancer 2 England 5 Hubs 5 Screening Hubs - Stroke of Genius! Volume of activity QA monitoring (adequate pop n) Cost effective & efficient Population Served (millions) 10m 13m 14.6m 10m 8m

7 England Biennial Screening for Bowel Cancer 3 Hub s Roles Helpline Essential service! Lab Quality Assurance Appointments on day of test result England 5 Hubs Population Served (millions) Screening Hub Activities Organisation (invitations etc) Call & recalls (25,000 /week) Laboratory analysis Helpline (>3,000 /week) Makes initial appointment 13m 10m Web-based IT System 10m 8m Single database Access to all 14.6m Hubs, Centres, & Pathology

8 England Biennial Screening for SC SC SC Bowel Cancer3 SC SC SC SC Southern Hub (Guildford) SC SC SC SC Colonoscopy Site Screening Centres (17) Colonoscopy Site Clinic Sites Clinic Sites Clinic Sites SC SC SC SC SC Screening Centre Activities Explain procedures Assess suitability Provide colonoscopy, CTC etc 14.6 million

9 Quality Assurance list Quality Assurance 1. Accreditation: Centres & labs. lab staff /endoscopists 2. Facilities: Scope cleaning, patient facilities & privacy 3. Key Performance indicators: Centres monitor quality 4. Continuous audit: Intermediate outcomes 5. Continuous evaluation: Programme evaluation group 6. Regular multidiscipline inspections : labs clinics etc Screening Centre Activities Explain procedures Assess suitability Provide colonoscopy, CTC etc 7. Peer Review: Labs, endoscopy, pathology, etc Endoscopy Global Rating Scale Joint Advisory Group (JAG) Accreditation Global Rating Scale Web-based assessment tool. Assesses quality of endoscopy. Joint Advisory Group (JAG) Accreditation - formal recognition Endoscopy service competent. Measured against endoscopy Global Rating Scale Standards

10 England Biennial Screening 4 for NHS database Bowel Cancer Assigns an NHS number System knows Current GP Practice Current address Date of birth Postal check of address NHS Register Birth registered in UK Register with a GP Practice Accident have NHS treatment Eligibility for screening? Bowel Cancer Screening Database (BCSS) Updated overnight from NHS database with Change GP & home address Newly eligible Deaths If eligible - automatic invitation! 60th Birth day

11 England Biennial Screening for Bowel Cancer 5 1. Day 1 Pre-invitation to be screened 2. Day 8 gfobt kit by default (Free return post) 3. Day 30 Reminder 4. and then a. No 3m repeat invitation in 2 years b. Test normal repeat in 2 years c. Test abnormal The Hub i. Makes clinic appointment (< 14 days time) ii. Notify GP (first class mail) d. Specialist Screening Practitioner Assess for colonoscopy e. Colonoscopy GP informed by letter /IT message of all critical steps invite, participation, test outcome, colonoscopy outcome & surveillance

12 Start 2 yearly Screening Cycle Day 1 Invitation Kit & Spatula Return Envelope Day 8 <2 days Screening Timeline Very Slick Process +ve SSP Result Hub responsible until participant arrives at SSP appointment Clinic Screening Patient People & GPnot lost or forgotten! All critical steps Appointment monitored and reviewed Colonoscopy GP Letter Letter Kit Read 1 day <14 days <14 days D29 M3 Surveillance Colonoscopy 2 Years Pre-Invitation At Screening Due Date Kit Returned -ve Result Patient letter & GP letter /e-message Reminder Letter No Response GP Letter/ E-Comms Next Pre-Invitation Freephone Helpline (

13 Easy access to Information Access to Information Emphasis on reaching everyone! Special arrangements for Prisoners Military personnel Major challenges to reach those with - Dementia Learning difficulties Blindness Available in 21 Languages Large Print Version British Sign Language

14 % CRC Screening Uptake Colorectal Cancer Screening Relationship between %Uptake and primarily care involvement For highest uptake Distribute kits centrally! 5 4 Opportunistic & Decentralised Primarily Care Test Distribution Centralised Invitations 0 0

15 Screening Invitations 7,000 Smoothing Profile St Elsewhere (22/08/2012) 6,000 5,000 4,000 3,000 Total Invitations Smoothed Invitations 2,000 1,000 0

16 Bowel Cancer Screening Programme critical analysis Design Implementation Strengths and Weaknesses Performance Challenges Future Coverage Participation Quality

17 GL4 6DX GL5 4EX GL2 4NF GL50 3ED GL1 5JJ GL4 4SH GL20 5RF GL50 4DP GL20 5QQ GL5 1UY GL8 8AA GL54 1EQ GL15 4RS GL56 0LA GL52 6HS GL5 4BH GL7 1RF GL2 0AJ GL6 0DQ GL7 1US GL6 9JF K81085 K81611 K81086 K81075 K81633 K81043 K81056 K81101 K81084 K81647 K81067 K81078 K81102 K81059 K81074 K81100 K81041 K81069 K81055 K81057 K81070 K81605 Bowel Cancer Screening Programme % Uptake Cheltenham & Gloucester Berkshire GP Practice Code GP Practice Code

18 Uptake and Demographics - Sept 2013 Uptake and Demographics Population Total 14.4 million Target 2.3 million Response No Response

19 Uptake and Demographics - Sept 2013 Uptake and demographics 2 Population Total 14.4 million Target 2.3 million Response No Response

20 Uptake and demographics 3 Uptake By Postcode Sector Bowel Cancer Screening Programme S. Hub Response No Response

21 Bowel Cancer Screening Programme S. Hub Bowel Cancer Screening Programme Uptake By Postcode Sector S. Hub Response No Response

22 %Uptake in Portsmouth Response No Response 66.4% 33.9%

23 % Uptake Relationship to Socioeconomic Status First 2.6 million Invitation Collaborative Research (BCSP - UCL Study) Male Female Poor Posh von Wagner C, Baio G, Raine R et al. (2011) Int J Epidemiol 40,

24 % Uptake 80 % Uptake FOBT kits First 2.6 million invitations in England Gender Age Area ethnic diversity Area deprivation von Wagner C, Baio G, Raine R et al. (2011) Int J Epidemiol 40,

25 % Uptake % Uptake FOBT kits First 2.6 million invitations in England Gender Age Area ethnic diversity Area deprivation von Wagner C, Baio G, Raine R et al. (2011) Int J Epidemiol 40,

26 % Uptake % Uptake - gfobt Screening (Southern Hub - Population year) % Uptake in all invited % Uptake following previous acceptance 61% Uptake % Uptake following previous refusal Date Sept 2006 April

27 1 st Invitation 2 nd Invitation 3 rd Invitation Very Poor Adherence Poor Adherence Full Adherence % Uptake - 3 Episodes (E1, E2 & E3) BCSP Southern Hub Colorectal cancer screening uptake over three biennial invitation rounds in the English bowel cancer screening programme. Lo SH, Halloran et al Gut Adherence to screening? 70% 1 of 3 61% 2 of 3 44% 3 of st Episode 2nd Episode 3rd Episode At least once At least twice At least 3 times

28 20% 18% 17% 2% 2% 2% 6% 7% 9% 8% 8% 10% 11% England Screening Outcomes Episode 1, 2 & /12 Cancer detected High-risk adenoma 0% 0% 1% 1 st Episode (Prevalent) 2 nd Episode (Incident) 17% 13% Intermediate-risk adenoma Low-risk adenoma Abnormal finding Abnormal, no histology 3 rd Episode (Incident) 28% Normal result No result 27% 31% 16% 21% 26% Polypectomy Rate 48%

29 Proportion of CR cancers diagnosed in women Proportion of colorectal cancers that occur in women (C18-C ) Source: cruk.org/cancerstats 70% 60% 50% 40% 60:40 split Men:Women 30% 20% 10% 0% Age Range (years)

30 Bowel Cancer Screening Programme Design Implementation Strengths and Weaknesses Performance Changes /Enhancements Future FIT FIT threshold Resource Surveillance Primary care FIT

31 FIT measure of Faecal Haemoglobin Concentration FIT Concentration relates to disease severity Outcome Mean FIT Conc. ug Hb /g faeces Positives at 20 ug /g Cut-off Endoscopic Classification Mean FIT Conc. ug Hb /g faeces +ve at 20 ug /g Cut-off Normal 10 (1-20) 6.9% All adenoma 14 (4-23) 9.3% Adv. adenoma 81 (37-125) 34.5% Histology LGD % HGD % Size < 10 mm % Cancer 170 (89-252) OC-SENSA MICRO 84.6% 10 mm % Number < 3 adenoma % 3 adenoma %

32 In good company Faecal Immunochemical Test European guidelines for quality assurance in colorectal cancer screening and diagnosis. Chapter 4. Faecal occult blood testing. Endoscopy 2012; 44 (S 03):SE65-SE87

33 Midlands & North West Hub More Deprivation Population 13.1 m gfobt Kits = 537,770 FIT Kits = 19,289 FIT Pilot (England) Both Hubs Population 27.8 m gfobt Kits = 1,126,087 FIT Kits = 40,930 Southern Hub Less Deprivation Population 14.7 m gfobt Kits = 588,317 FIT Kits = 21,641 FIT Pilot FIT Pilot

34 FIT packagingmake FIT Packaging Attractive Simple to use Safe for mailing Informative Reliable

35 Uptake & Deprivation 2014 South, Midlands & NW Pilot Index of Multiple Deprivation (IMD) 75% gfobt 70% 65% 6.7% 6.0% 6.8% FIT 60% 8.0% 55% 50% 7.9% 45% 40% IMD 1 (Posh) IMD 2 IMD 3 IMD 4 IMD 5 (Poor)

36 Uptake at First Invitation 2014/5 South, Midlands, NW & London Pilots Both 1 st invitation (mostly 60 year old subjects) FIT gfobt 10.9% Increase Southern 9.7% 38.6% London 52.4% 14.4% Increase Mid & NW 12.2% 40% 45% 50% 55% 60% 65%

37 Uptake in Prevalent Episodes 2014/5 South, Midlands, NW & London Pilots Both 1 5 invitations but no previous response FIT gfobt 11.6% Increase Southern Mid & NW 11.3% 11.8% London 9.7% 19.5% Uptake doubles! 0% 5% 10% 15% 20% 25% 30%

38 Uptake & All Episodes 2014 South, Midlands, NW Pilot Both 0 5 previous screening invitations 7.1% Increase FIT gfobt Southern Mid & NW 7.3% 7.0% 290,000 Additional screens each year! 50% 55% 60% 65% 70%

39 gfobt FIT 180 FIT 150 FIT 100 FIT 40 FIT 20 Normal 17.5% 4.0% 8.3% Colonoscopy Cancer 10.1% 14.0% High-risk Adenoma Intermediate-risk Adenoma Abnormal 30.6% 19.5% Low-risk Adenoma

40 Threshold in England

41 Threshold in England 2

42 Cancers detected /5,000 male & 5,000 female participants (completed FIT) Cancers Detection in 10,000 FIT Screened in 10,000 Participants FIT 60% Screened Participants Expect 60% of cancers to be in men (50:50 male & female) 2014 Pilot Data Expected Male Cancers detected in men Expected Female Cancers detected in women 10 40% 5 0 Expect 40% of cancers to be in women 20μg 40μg 60μg 80μg 100μg 120μg 140μg 150μg 180μg 200μg gfobt FIT Concentration ug/g

43 Cancers detected /5,000 male & 5,000 female participants (completed FIT) Cancers Detection in 10,000 FIT Screened in 10,000 Participants FIT (50:50 male & female) 2014 Pilot Data Screened Participants 2 Cancers detected in men Cancers detected in women % 40% Men FIT Threshold 180ug/g Positivity = 2.0% PPV = 12.6% 0 Women FIT Threshold 60ug/g Positivity = 2.8% PPV = 5.1% 20μg 40μg 60μg 80μg 100μg 120μg 140μg 150μg 180μg 200μg gfobt FIT Concentration ug/g

44 FIRST PREVALENT INCIDENT FIRST PREVALENT INCIDENT FIRST PREVALENT INCIDENT FIRST PREVALENT INCIDENT FIRST PREVALENT INCIDENT FIRST PREVALENT INCIDENT FIRST PREVALENT INCIDENT FIRST PREVALENT INCIDENT FIRST PREVALENT INCIDENT FIRST PREVALENT INCIDENT FIRST PREVALENT INCIDENT % Cancer Detection Rate Screen Episode & FIT threshold Cancer Detection Rate 0.6% First Invitation (60 year olds) No response to previous invitations Participated previously 0.5% 0.4% 0.3% 0.2% 0.1% 0.0% FIT gfobt gfobt

45 Cancer Detection Rate 0.45% 0.40% 0.35% Age & FIT Threshold Cancer Detection Rate Age & FIT Threshold Cancer Detection Rate % 0.25% 0.20% 0.15% 0.10% 0.05% 0.00% FIT 20 FIT 100 FIT 150 FIT180 gfobt Age Group

46 21% 12% 12% 8%

47 70% Ulcerative colitis Crohn's colitis 22-33% Type II diabetes 33% Gallstones 33-41% 25% Metabolic syndrome Family history of colon cancer Ethnicity (Ashkenazi Jew) Personal cancer history - (colon, rectum, ovary, endometrium, or breast)

48 The Future of Quantitative FIT Multivariate Risk Scores Quantitative FIT concentration Age & Sex Multivariate Bowel Cancer Risk Score Better Screening! PPV Cost Effectiveness Colonoscopy Referrals Screening history Indices of Deprivation Postcode Medical History IBD, Crohns, DM, etc Family History 1 st and 2 nd deg. relatives Life style Smoking, exercise, diet, obesity

49 Collaborators Developed a Multivariable Risk Prediction Model Jennifer Cooper, Nick Parsons, Sian Taylor-Phillips Developed a Multivariable Risk Prediction Model Logistic linear regression Artificial neural networks Machine learning So far neural networks in the lead. Marked increase in detection of advanced adenomas Better Screening! PPV Cost Effectiveness Colonoscopy Referrals Risk-adjusted colorectal cancer screening using the FIT and routine screening data: development of a risk prediction model Jennifer Cooper et al British Journal of Cancer (2017), 1 9 doi: / bjc

50 Risk-adjusted screening results Neural Network Approach Conventional FIT Only Approach Collaborators Jennifer Cooper, Nick Parsons, Sian Taylor-Phillips Better Screening! PPV Cost Effectiveness Colonoscopy Referrals Risk-adjusted colorectal cancer screening using the FIT and routine screening data: development of a risk prediction model Jennifer Cooper et al British Journal of Cancer (2017), 1 9 doi: / bjc

51 FIT An opportunity to personalise population-based screening? Better Screening by - focusing on individuals...as well as on populations? Personalising population-based screening 1. Intelligent use of FIT data 2. Incorporate personal risk 3. Personalised interpretation of the FIT Screen 4. Personalised invitation?

52 Personalized screening Context sensitive answers Personal Bowel Screening Account Mrs Dawn P. Harlequin BCSP No. **** *** 7843 Preferred Language? English Your Personal Screening Record 1. Next Screen: March/April Last Screen: 18/03/2014 Normal Result 3. Previous Screen: 14/02/2012 Not Received 4. Previous Screen: 14/02/2010 Normal Result Screening Information Kiosk Text Video Audio Why screen for colon cancer? How to collect your sample Understand your result What happens at clinic appointments?

53 Personalized screening 2 Personal Bowel Screening Account Mrs Dawn P. Harlequin BCSP No. **** *** 7843 Preferred Language? English Sample Received By the Hub Sample Tested By the Hub Result in the Post Click for Details SSP Clinic Appointment 02/01/ /01/ /01/ /01/2015

54 Personalized screening 3 Personal Bowel Screening Account Mrs Dawn P. Harlequin BCSP No. **** *** 7843 Preferred Language? English Two way communication as well? A replacement FIT kit? My FIT kit will be delayed because I m going on holiday? Change my appointment date? I have decided not do do bowel scope screening?

55 FIT Screening needs to join the 4 Personalised Me Medicine band Screening wagon Systems

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