Implementing of Population-based FOBT Screening

Transcription

1 Implementing of Population-based FOBT Screening gfobt to FIT Experience from England Prof Stephen P. Halloran

2 Guaiac FOBt Haem 2H 2 O 2 = 2H O 2 Oxidised guaiaconic acid is blue

3 Biennial Bowel Cancer Screening in the UK 1990 Trial evidence 2000 Pilot programmes 2006 Commence screening England Two yearly FOBT screen Phase year olds Phase Phase 3 55 Flexi Sig

4 England 2006 Biennial Screening for Bowel Cancer England 5 Hubs Screening Hub Activities Organisation Call & recalls (25,000 /week) Laboratory analysis Helpline (>3,000 /week) Make appointments Web-based Population Screening Served Data System (millions) 10m 13m 10m 14.6m 8m

5 Bowel Cancer Screening Colonoscopy Site Clinic Sites Southern Hub (Guildford) Screening Centres (17) Colonoscopy Site Clinic Sites Clinic Sites Quality Assurance 1. Accreditation: Centres & labs. lab staff /endoscopists Screening Activities 2. Facilities: Scope cleaning, patient facilities & privacy 3. Key Performance Explain procedures indicators: Centres monitor quality 4. Continuous Assess audit: suitability Intermediate outcomes 5. Continuous evaluation: Programme evaluation group Provide colonoscopy, CTC etc 6. Peer Review: Labs, endoscopy, pathology, etc 14.6 million

6 Bowel Cancer Screening Colonoscopy Site Clinic Sites Southern Hub (Guildford) Screening Centres (17) Colonoscopy Site Clinic Sites Clinic Sites 14.6 million

7 Screening Timeline Webbased Screening Data System Start 2 yearly Screening Cycle Day 8 Invitation Kit & Spatula Return Envelope <2 days +ve Specialist Screening Practitioner Result Clinic Screening Patient & GP Appointment Colonoscopy Letter Kit Read (1 day) <14 days <14 days Surveillance Colonoscopy Day 1 Day 29 Month 3 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 Dedicated Freephone Helpline Service (

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9 Directly age standardised incidence rate per 100,000 population 80,0 Cancer Registry Age Standardised CRC Incidence ,0 76,0 74,0 72,0 70,0 68,0 66,0 Colorectal Cancer Screening? 64,0 62,0 60, Person ASI Lower CI Upper CI

10 Have done well?

11 Why change to FIT?

12 Time for an overhaul!

13 now have the tools, to do job even better!

14 Training % Uptake 70% 65% 60% 55% 50% Gender Area deprivation FIT Pilot (England) Info. IT Finance

15 Training Target pop n - 50% of England 40,000 FIT invitations Complete in 6 months FIT Pilot (England) Info. IT Finance FIT Pilot FIT Pilot

16 Make FIT Packaging Attractive Simple to use Safe for mailing Informative Reliable

17 Moss S, Halloran SP et al Increased uptake and improved outcomes of bowel cancer screening with a faecal immunochemical test: results from a pilot study within the national screening programme in England Gut doi: /gutjnl FIT Pilot (England) Midlands & North West Hub More Deprivation Population 13.1 m gfobt Kits = 537,770 FIT Kits = 19,289 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

18 OC Sensor Diana analyser results ughb/g faeces FIT Pilot QA data 5 batches of 30 samples in both Hubs April October 2014 y=x Line of best fit y=0.997x R²= Diana 1 Wren SH result Diana 2 Lark SH result Diana1 Blackbird M&NWH Result Diana 2 Robin M&NWH result Mean OC Sensor Diana result ug Hb/g faeces

19 FIT in London Uptake & Deprivation 2014 South, Midlands & NW Pilot (IMD Index of Multiple Deprivation) 75% 70% gfobt FIT 65% 60% 55% 50% 45% 40% IMD 1 (Posh) IMD 2 IMD 3 IMD 4 IMD 5 (Poor)

20 Uptake & Deprivation 2014 South, Midlands & NW Pilot (IMD Index of Multiple Deprivation) 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)

21 gfobt in London FIT in London Uptake & Deprivation 2015 London Pilot 75% 70% gfobt FIT 65% 60% 55% 8.3% 7.7% 10.0% London 50% 45% 7.4% 9.8% 40% IMD 1 (Posh) IMD 2 IMD 3 IMD 4 IMD 5 (Poor)

22 % of Population Deprivation Index in the Two Pilot Hubs 35% 30% 25% 20% 15% Midlands & NW Hub 10% 5% 0% Southern Hub IMD 1 (Posh) IMD 2 IMD 3 IMD 4 IMD 5 (Poor) IMD n/k Mid & NW 14,0% 17,9% 18,1% 19,9% 29,7% 0,4% Southern 25,5% 21,9% 21,7% 20,1% 9,9% 0,8% (IMD Index of Multiple Deprivation) Both 20,0% 20,0% 20,0% 20,0% 19,4% 0,6%

23 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%

24 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%

25 Uptake in Incident Episodes 2014/5 South, Midlands, NW & London Pilots Both 1 5 previous participation episodes 4.2% Increase FIT gfobt Southern 4.1% Mid & NW 4.3% 82% 84% 86% 88% 90% 92%

26 Male Female Uptake by Age and Sex 2014 South, Midlands, NW Pilot All Age All Age All invitation by age and sex 10.6% FIT gfobt 45% 50% 55% 60% 65% 70% 75%

27 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%

28 12,0% % Positivity & Deprivation FIT Cut-off - 20 ug Hb/g Faeces 10,0% 8,0% 6,0% 4,0% 2,0% 0,0% IMD 1 (Posh) IMD 2 IMD 3 IMD 4 IMD 5 (Poor)

29 My age? You mean now or when we first sat down?

30 Faecal Immunochemical Test (FIT) & Positivity Thresholds adopted by National Bowel Cancer Screening Programmes (1 st October 2016) England (April 2018) Scotland (Dec. 2017) Netherlands Southern Ireland New Zealand Canada (Quebec) France Portugal Norway (pilot) Denmark Hungary Iceland (planned) Italy (North <20) Korea Malta Singapore Slovenia Spain (Catalonia)<20 Taiwan Uraguay England (pilot) Australia Lithuania (pilot) Latvia (pilot) Belgium (Flanders) Switzerland (no t Netherlands (pilot) New Zealand (pilot) Israel Austria Sweden (pilot) Predicted FIT positivity - % of participants referred for colonoscopy 12% 7.8% 5.2% 2.9% 2.1% 1.7% 1.5% Colonoscopy Capacity Problems Threshold used in the FIT pilot in England? Faecal Immunochemical Test (FIT) threshold (ug haemoglobin /g faeces)

31 Faecal Immunochemical Test (FIT) & Positivity Thresholds adopted by National Bowel Cancer Screening Programmes (1 st October 2016) England (April 2018) Scotland (Dec. 2017) Netherlands Southern Ireland New Zealand Canada (Quebec) France Portugal Norway (pilot) Denmark Hungary Iceland (planned) Italy (North <20) Korea Malta Singapore Slovenia Spain (Catalonia)<20 Taiwan Uraguay England (pilot) Australia Lithuania (pilot) Latvia (pilot) Belgium (Flanders) Switzerland (no t Netherlands (pilot) New Zealand (pilot) Israel Austria Sweden (pilot) No. of cancers missed relative to those detected using a 20ug/g threshold ,900 2,900 3,500 3,600 Colonoscopy Capacity Problems Data from 2014/5 FIT Screening Pilot in England Based on Pilot uptake and extrapolated to 2.6 million completed FIT p.a.? Faecal Immunochemical Test (FIT) threshold (ug haemoglobin /g faeces)

32 FIT & Missed Advanced Adenomas Thresholds adopted by National Bowel Cancer Screening Programmes (1 st October 2016) England (April 2018) Scotland (Dec. 2017) Netherlands Southern Ireland New Zealand Canada (Quebec) France Portugal Norway (pilot) Denmark Hungary Iceland (planned) Italy (North <20) Korea Malta Singapore Slovenia Spain (Catalonia)<20 Taiwan Uraguay England (pilot) Australia Lithuania (pilot) Latvia (pilot) Belgium (Flanders) Switzerland (no t Netherlands (pilot) New Zealand (pilot) Israel Austria Sweden (pilot) No. of missed advanced adenomas relative to those detected using a 20ug/g threshold ,000 25,000 30,000 34,000 35,000 Data from 2014/5 FIT Screening Pilot in England Based on Pilot uptake and extrapolated to 2.6 million completed FIT p.a Faecal Immunochemical Test (FIT) threshold (ug haemoglobin /g faeces)

33 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

34 Colonoscopy gfobt Normal Cancer FIT % 10.6% High-risk Adenoma Polypectomy rate increase to >64% 16.5% 23.9% more polyps in each category Intermediate-risk Adenoma Abnormal 18.6% 18.3% Low-risk Adenoma

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

36 Male Female All Registered Colorectal Cancers - % by gender July 2006 December 2014 Screen -ve - 2y interval cancer Screen +ve cancer Screen +ve Screen +ve 0,0% 10,0% 20,0% 30,0% 40,0% 50,0% 60,0% 70,0%

37 Male Female All Registered Colorectal Cancers - % by gender July 2006 December 2014 Screen -ve - 2y interval cancer Screen +ve cancer Screen +ve 33,7% Screen +ve 66,3% 0,0% 10,0% 20,0% 30,0% 40,0% 50,0% 60,0% 70,0%

38 Male Female All Registered Colorectal Cancers - % by gender July 2006 December 2014 Screen -ve - 2y interval cancer Screen +ve cancer Screen -ve 45,2% Screen +ve 33,7% Screen -ve 54,8% Screen +ve 66,3% 0,0% 10,0% 20,0% 30,0% 40,0% 50,0% 60,0% 70,0%

39 Cancers detected /5,000 male & 5,000 female participants (completed FIT) % Cancers Detection in 10,000 FIT Screened Participants (50:50 male & female) 2014 Pilot Data Expected Male Cancers detected in men Expected Female Cancers detected in women Expect 60% of cancers to be in men 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

40 Cancers detected /5,000 male & 5,000 female participants (completed FIT) % Cancers Detection in 10,000 FIT Screened Participants (50:50 male & female) 2014 Pilot Data Expected Male Cancers detected in men Expected Female Cancers detected in women Expect 60% of cancers to be in men 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

41 Cancers detected /5,000 male & 5,000 female participants (completed FIT) 25 Cancers Detection in 10,000 FIT Screened Participants (50:50 male & female) 2014 Pilot Data Cancers detected in men 20 Cancers detected in women μg 40μg 60μg 80μg 100μg 120μg 140μg 150μg 180μg 200μg gfobt FIT Concentration ug/g

42 Cancers detected /5,000 male & 5,000 female participants (completed FIT) 25 Cancers Detection in 10,000 FIT Screened Participants (50:50 male & female) 2014 Pilot Data Cancers detected in men 20 Cancers detected in women % Men (60%) 10 cancers/ 5,000 participants μg 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) 25 Cancers Detection in 10,000 FIT Screened Participants (50:50 male & female) 2014 Pilot Data Cancers detected in men 20 Cancers detected in women % Men (60%) 10 cancers/ 5,000 participants 5 40% 0 20μg 40μg 60μg 80μg 100μg 120μg 140μg 150μg 180μg 200μg gfobt FIT Concentration ug/g Women (40%) 6.7 cancers/ 5,000 participants

44 Cancers detected /5,000 male & 5,000 female participants (completed FIT) 25 Cancers Detection in 10,000 FIT Screened Participants (50:50 male & female) 2014 Pilot Data Cancers detected in men 20 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

45 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

46 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% x5.1 0,3% 0,2% x2.5 0,1% x1 0,0% FIT gfobt 140 gfobt

47 Cancer Detection Rate 0,45% Age & FIT Threshold Cancer Detection Rate 0,40% 0,35% ,30% 0,25% 0,20% 0,15% 0,10% 0,05% 0,00% FIT 20 FIT 100 FIT 150 FIT180 gfobt Age Group

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 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 Collaborators Jennifer Cooper, Nick Parsons, Sian Taylor-Phillips

50 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 invitation 4. Personalised interpretation of the FIT Screen

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53 FIT 4 Me Screening Systems

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55 Plan for sophisticated, multi-variate, FIT-based risk score Start with a simple, single FIT threshold 1. Understand impact of FIT on Volume & Complexity of colonoscopy /pathology 2. Review current colonoscopy resource Current volume current colonoscopy volume Current performance - 2 week breaches, bowel scope rollout etc) Variation between areas - Hubs and Screening Centres 3. Estimates for 2018/9?Eligible population,?fit uptake What would have been the gfobt uptake, positivity and referral rates FIT positivity and referral rates at different thresholds 4. Agree a single FIT threshold - based on OC-Sensor 5. Advise Commissioners, Centres and CEOs of likely impact of FIT in 2018/8 6. Check performance of procured FIT test against that used in the pilot.

56 Tuesday, September 26, :30 11:30 Chairs: O. Májek, S. Halloran 9:30 9:50 Faecal testing in colorectal cancer screening: state of art S. Halloran 9:50 10:00 Czech National Coordination Centre for Prevention of Serious Diseases: platform for systematic introduction of innovations to early disease detection O. Májek 10:00 10:20 Implementation of population-based faecal occult blood testing and transition to immunochemical tests: experience from England S. Halloran 10:20 10:35 Role of general practitioners in population-based colorectal cancer screening: current situation and future prospects B. Seifert 10:35 10:50 Quantitative immunochemical tests: evidence on accuracy and implementation considerations in the Czech Republic P. Kocna 10:50 11:05 Quality-assured immunochemical testing proposal for a pilot project in the Czech Republic O. Májek, Š. Suchánek 11:05 11:30 Structured discussion & wrap-up 26th Tuesday 12:00 - press conference - Thierry Ponchon could give insight into goals of UEG. SPH programme in England and how important is to have a good governance, quality assurance and political support Session title: Why do we have different levels of participation in Europe? Influence of the population type. How to tackle inequalities. Date: Wednesday, September 27 Time: 14:20 15:50

57 20% Polyp/Adenoma 18% % 2% 2% 6% 7% 9% 8% 8% England Screening Outcomes Episode /12 0% 0% 1% 17% 1 st Episode (Prevalent) 10% 17% 13% 11% Cancer detected High-risk adenoma Intermediate-risk adenoma Low-risk adenoma Abnormal finding Abnormal, no histology Normal result 28% No result 27% 31% 16% 21% 26% British Society of Gastroenterologists - Guidelines High Risk: - >=5 adenomas / > 2 cm adenoma Intermediate Risk: 3/4 small adenomas / >= 1 cm adenoma Low Risk: 1-2 <1 cm adenomas

58 20% 18% 2% 2% 2% 6% 7% 9% 8% 8% England Screening Outcomes Episode 1, /12 0% 0% 1% 17% 1 st Episode (Prevalent) 2 nd Episode (Incident) 10% 17% 13% 11% Cancer detected High-risk adenoma Intermediate-risk adenoma Low-risk adenoma Abnormal finding Abnormal, no histology Normal result 28% No result 27% 31% 16% 21% 26%

59 20% 18% 2% 2% 2% 6% 7% 9% 8% 8% England Screening Outcomes Episode 1, 2 & /12 17% 10% 11% 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%

60 Web-based Screening System Uptake and Demographics - Sept 2013 Response No Response Sept 2013

61 Positivity FIT Threshold and Positivity 2014 South, Midlands & NW Pilot 9,0% 8,0% 7.9% 7,0% 6,0% 5,0% 4,0% 3,0% 2,0% 1,0% 0,0% gfobt FIT 20 FIT 40 FIT 100 FIT 150 FIT 180 ug Haemoglobin / g Faeces

62 Positivity FIT Threshold and Positivity 2014 South, Midlands & NW Pilot 9,0% 8,0% 7.9% 7,0% 6,0% 5,0% 4,0% 3,0% 2,0% 1,0% 1.7% 1.56% 0,0% gfobt FIT 20 FIT 40 FIT 100 FIT 150 FIT 180 ug Haemoglobin / g Faeces