FIT Testing update Patricia McLarnon We cant have the image of the ‘shaking hands’. Not NHE E format

Introduction oduction FIT testing was implemented in primary care across the South West region 2018 - 600 practices FIT was introduced for symptomatic patients who were classed as “low risk, but not no risk” of having colorectal cancer. These are patients who have unexplained symptoms, but did not previously meet the criteria for a suspected cancer referral pathway (amounting to a risk of cancer less than 3%). The first South West evaluation of the data showed, the test has a positive predictive value PPV of 6.2%. This suggests that the risk of cancer in the +ve FIT group is 6.2% -which is more than double the NICE threshold of 3% for a 2ww referral (in NICE NG12). Text

FIT- Results in SWAG SWAG 17% 3761 620 43 24** Locality Positive Rate (average) Tests received (June 2018 to March 2019) Number of Positive tests (June 2018 to March 2019) Number of cancers detected to date (June 2018 to March 2019) No of cancers detected that are stage 1 or 2 SWAG 17% 3761 620 43 24** *Due to waiting times, not all data is available. Incomplete data set from Swindon and no results from North Bristol however, even with incomplete data PPV is still 7% **Not all have staging yet (Glos 7 and Bath may have a few more) Interestingly Gloucester (and North Devon for Peninsula) are identifying a high number of stage 1 – more so that other trusts. We might need to explore this further.

Difference in positivity rates between SWAG and Peninsula The positivity rate in SWAG is consistently higher than in the Peninsula. The reasons for this are not yet known.   Region 2018 2019 Total July–Aug Aug–Sept Sept–Oct Oct-Nov Nov-Dec Dec-Jan Jan-Feb Feb-Mar Mar-April April-May Samples received SWAG 357 375 454 470 509 484 595 517 766 572 5099 Positive 51 58 85 75 91 84 87 89 141 850 % positive 16% 15% 19% 18% 17% Peninsula 325 378 366 374 318 373 508 596 4121 36 38 42 56 48 67 88 551 10% 12% 11% 14% 13%

FIT uptake in SWAG- Uptake of the test is variable across the region CRUK Facilitators CCG % of practices NOT using FIT % of practices who have sent <10 FIT referrals % of practices who have sent >10 FIT referrals BNSSG 2% (2) 29% (24) 69% (58) BaNES 0% (0) 57% (13) 43% (10) Gloucestershire 6% (5) 30% (24) 64% (51) Somerset 22% (15) 57% (38) 21% (14) Wiltshire 6% (3) 31% (15) 63% (30)

Use of FIT testing and Electronic reporting Locality Number of GP practices No samples sent % no samples Electronic reporting % electronic reporting % of those using service BANES   23 0% 16 70% Bristol 42 1 2% 100% Gloucestershire 80 5 6% 7% North Somerset 17 15 88% 94% Somerset 67 14 21% 29 43% 55% South Gloucestershire 25 Wiltshire 48 3 36 75% 80%

GP Education & Experience of FIT To implement the test in primary care an education toolkit was produced including GP guidance (issued May 2018), a website: https://www.nbt.nhs.uk/severn-pathology/pathology-services/clinical-biochemistry/fit-testing and an online video: https://youtu.be/zb1o8ykvS6U This has been distributed to all GPs and practice staff through GP engagement events, via CCGS and additionally, with the kits. To gather detailed feedback from GPs, CR-UK conducted visits to GP Practices across the two alliances and an online survey was conducted the results of which are shown below – 19 responses Emergent trends are being fed back into the programme as targeted improvements. For example safety netting is being improved by supporting the use of read codes for test requests. Questions Yes No I have issued a Faecal Immunochemical Test (FIT) to a patient? 74% 26%   Agree Disagree The guidance I received about the test was sufficient 84% 16% The referral criteria for this test are clear to me 17% 5% I feel confident explaining and issuing this test I am satisfied that I have appropriate safety netting measures in place 63% 37% A negative FIT result will enable me to reassure patients when in the past a referral was needed.

Patient Information and Experience of FIT Patients are provided with information on how to use FIT in the pack they receive from their GP. A survey was included in the pack to ascertain user experience, the results are tabled below. Feedback has been very positive. Patient Survey Results (SWAG only) – 178 Responses About the consultation with your GP   Disagree Agree The GP explained the purpose of the test 10% (15) 90% (134) The GP clearly explained how to use the test 15% (24) 85% (143) The GP clearly explained what would happen when the results come back 16% (28) 84% (137) Using the FIT KIT I understood the test instructions 4% (7) 96% (162) I found it easy to collect my sample 16% (19) 84% (151) I knew what to do with my sample afterwards 3% (5) 97% (162) Further patient information is under development including a video, and leaflet to support GP’s advising patients.

FIT and Secondary Care One of the challenges in launching this test was that there was little supporting data to suggest how it might impact on secondary care. There was concern that it might increase demand on an already constrained service. However, the results of a local audit (Devon) suggested that patients in this cohort were being referred for routine investigations and that the new test should therefore reduce the number of patients undergoing an invasive test unnecessarily. Referral rates into secondary care have been carefully monitored and no notable impact has been seen in the data submissions from providers or raised by clinicians. An in depth audit is being carried out as part of the evaluation programme to understand what happens to FIT negative patients, and when FIT positive patients aren’t referred as well as understand the diagnostic tests this cohort receive. We are now doing a follow up audit to understand what happened to the negative fit patients – did they get referred anyway? How are they managed? Results from this will be available by September. Crucially  through – following feedback through SSG’s, - none of the clinicians have experienced a hike in referral rates due to FIT - that they’ve raised with us.  

Future commissioning of the test Cancer Alliance funding of this test will conclude in March 2020, thereafter it will need to be commissioned by CCG’s. As this is a new test, the project team are embarking on a robust programme of monitoring and evaluation to support commission decision making. This will conclude in January 2021 but an early insights paper will be available in time for the commissioning service planning rounds commencing in September 2019. The evaluation is being commissioned from the DISCOVERY Team, at Exeter University who are assessing the diagnostic performance of the test and health economics. To be robust, the evaluation must include 3500 patients (this is the volume of patients that received a FIT test between July & December 2018). To measure false negatives we need to assess whether any of those 3500 patients went on to develop Cancer within 12 months of their test. This is why the final (publishable) evaluation will not be available until January 2020.

Future commissioning of the test NICE published further guidance in July 2017 (DG30) which encourages the use of the test for any patient with abdominal symptoms who doesn’t fit the NG12 2WW criteria. However, at the moment the Peninsula and SWAG Cancer Alliances are only offering the test to the cohort previously referred to in NG12. The Cancer Alliances will make recommendations on this in its commissioning support paper available for September 2019. Estimated running costs are anticipated to be less than £10 per test total revenue can be estimated from the figures per CCG above.