FIT: emerging evidence and steps towards policy development

Transcription

1 FIT: emerging evidence and steps towards policy development Cancer Alliance Data, Evidence & Analysis Service (CADEAS) Natasha Crawford Michelle Barclay 26 th February 2019

2 Today s presentation What has CADEAS been commissioned to do? How does this fit with the wider FIT programme of work? How will emerging evidence inform NHS England s position on the use of FIT in the high risk symptomatic population? The analytical steps towards policy development In-depth findings from sites later today 2

3 CADEAS The Cancer Alliance Data, Evidence and Analysis Service (CADEAS) is a partnership between NHS England & Public Health England Focus on work which adds value to the National Cancer Programme and Alliances Support, promote and spread evidence-based decision making and enable wider replication CADEAS has led a number of analytical projects to support the implementation of FIT 3

4 FIT for the NHS Screening National roll out underway NHS Long Term Plan commitment to lower screening age to 50 Screening review underway Low risk NICE DG30 guidance National roll out across Cancer Alliances Accelerated Access Collaboration programme, NHS England High risk NICE are not currently recommending the use of FIT for high risk symptomatic patients citing a lack of available evidence Test bed sites Pioneering Group Surveillance Work underway to understand whether FIT could replace 3-yearly colonoscopy for intermediate risk patients FIT for Follow-up study 4

5 CADEAS commission Appraise and synthesise the emerging evidence on the use of FIT for high risk symptomatic patients, those that would normally be referred under 2WW guidelines Inform the development of a roadmap for NHS England regarding next steps for the use of FIT to rule out cancer in this population Work is ongoing at this time 5

6 Pioneering Group The Pioneering Group is a collective of sites testing the introduction of FIT in the high-risk symptomatic population Includes both multi-site research studies and service evaluations of commissioned healthcare Liverpool Nottingham Coventry York Leicester RM Partners Croydon; UCLH Eastbourne

7 Approach taken CADEAS, together with clinical experts across NHS England, developed an overarching analytical framework to appraise evidence Structured around 6 key clinical and broader implementation questions Conversations with each Pioneering Group site Initial engagement with NICE

8 Emerging evidence 8

9 RM/ Croydon UCLHCC Liverpool Nottingham Leicester York Coventry Eastbourne Key clinical & implementation questions 1. How effective is FIT as a rule-out test for colorectal cancer (CRC)? 2. How frequently does FIT miss cancer? 3. What are appropriate cut-off levels for subgroups? 4. Impact of FIT on endoscopy services? X X X X X X X X X X X X X X X X X X X X X X X X 5. Acceptability of the test to GPs and patients? X X X 6. What barriers to implementation??? X????? 9

10 We know Clinical questions These questions are key to the work of the FIT Pioneering Group Emerging evidence that FIT may be effective in ruling out CRC in high risk symptomatic patients Publications from FIT Pioneers suggest sensitivity of 84% - 97% FIT for CRC But, cases where cancer has been missed 10

11 Clinical questions Further evidence required Comprehensive understanding of how often cancer is missed Other factors that may influence a FIT result although we do know that: Anaemia is a factor that may lead to false negatives Following introduction of FIT for screening, evidence suggests test may be influenced by some other, demographic characteristics Evidence continues to be published by Pioneering Group collectively, this will help us to ensure emerging evidence is generalisable 11

12 Endoscopy demand We know DG30: FIT at a cut-off of 10 µghb/gfaeces has the potential to rule out CRC and avoid colonoscopy in 75-80% of symptomatic patients (high and low) Anecdotal concerns that introducing FIT for low risk population will increase demand too early to know Preliminary evidence indicates FIT for high risk could significantly reduce demand Further evidence required Robust evidence of impact on endoscopy Potential impact on resources, e.g. CT colonography and flexi-sig 12

13 GP & patient acceptability We know Evidence FIT is acceptable to patients Reported in DG30, and supported by evidence gathered from FIT Pioneers sites with high return rates* Anecdotal evidence that GPs may require further training and education Further evidence required Optimal service model(s) for FIT primary care vs. secondary care Specific training support requirements to support implementation in primary care * Return rate varies across Pioneering sites due to different study designs (research studies vs. service evaluations of commissioned healthcare) 13

14 Barriers to implementation We know Uncertainty and confusion Identified by DG30: Confusion around different populations, risk groups, and thresholds compared to potential use for surveillance and screening Uncertainty of the impact on endoscopy Implementation without adequate local preparation Clarity around risk groups and pathways: how FIT could or should be used in primary and, or, secondary care 14

15 Summary and recommended next steps

16 Summary There is emerging evidence that FIT is effective at ruling out CRC in the high-risk symptomatic group But important gaps in knowledge remain: number of cancers that are missed in people who are FIT negative the appropriate cut-off levels for different subgroups the impact on endoscopy and resourcing including CTC Based on current emerging evidence we are not yet in a position to make any evidence-based recommendations on the use of FIT outside those already detailed in NICE DG30 guidance and NG12 guideline but as the Pioneering studies conclude, we anticipate having sufficient evidence to answer the questions set out in this presentation, and thus to inform NHS England s position on the use of FIT in this population

17 Recommended next steps Advice to support extraction and analysis of data to enable further understanding of the use of FIT for high risk symptomatic groups Linking and pooling of data could help to address unanswered questions but mindful of different populations studied, different types of studies Allow a period of national synthesis of evidence to comprehensively understand the risk and benefits associated with the use of FIT in this population As findings continue to be reported, newly published data and evidence should be considered 17

18 Contact details Natasha Crawford, Evidence & Evaluation Lead Analyst Michelle Barclay, Senior Analyst Thank you to the Pioneering Group and to clinical colleagues at NHS England who have supported and enabled this programme of work 18