Find out more at www.faecal-immunochemical-test.co.uk 5 All data points are double-checked by the central study team. A senior clinician then checks every single colonoscopy and histopathology report. With the three layers of checks, we can be as sure as reasonably possible that the result on the system is correct. This study appears to have become multi-facetted: examining the use of FIT and its implementation and the improvement of colonoscopy/ histopathology reporting services. Are there any other branches to this study you are thinking of including? We’re working on funding for a research fellow for a number of sub-studies. One will focus on the process of sampling and pre-analytics (e.g. whether accuracy improves with multiple samples from the same or different stool). Another is the polygenic risk score; combining a faecal test with other tests such as; blood, saliva, and breath tests, to develop a broader risk score for patients and other cancer markers. Lastly, we’re also looking to qualitatively assess and improve the patient experience with FIT. You’ve worked with Sally Benton and her team in Guildford, do you have any comments on her ‘essentialism vs. consequentialism’ views? Are you finding much evidence of this with your implementation of FIT? FIT can miss some cancers, we know this. However, a large part of the project aims to prevent FIT being used indiscriminately without awareness of its limitations. This could result in more cancers being missed, and if this came to the attention of the clinicians, GPs, press or patients, the faith in FIT would be completely undermined. We’re putting a significant amount of effort into ensuring the data is as good as it can be, so NHS England can map the limitations of FIT, to provide a safe and reliable evidence base for FIT implementation. Congratulations on the 1,000 patient uptake! Is there anything specific you can attribute this increase to? A thousand is good but I’d hoped for more and we still have a few hurdles to overcome. What is your current return rate for the test? It varies greatly – between 25 and 50%. One of our main questions is, what’s limiting the uptake? Each site is different, some patients are seen in clinics, and some are triaged straight to test based on the referral letter, so there isn’t a one-size-fits-all approach. In Croydon, a triage nurse calls every patient referred for colonoscopy. In the conversation with the patient, the nurse informs them about the NICE FIT Study, and we’ve found this is a good way of introducing them to it. There is a lot of evidence from screening programmes showing that London has a significantly lower uptake than the national average – could this be a factor? I remember calling our first patient, and the call was not well received! The main question the patient asked was, “what’s in it for me?” At the time, my response could only be, “well… nothing directly!” I think this may be one of the key problems for the recruitment of patients – there is no immediate, obvious benefit to doing it as they are still referred for colonoscopy, and the FIT result does not affect their management. Do you now explain any potential future benefits to FIT when talking to patients? We do try to emphasize that based on the study data we collect, we could in the future improve the process for patients being referred with GI symptoms. Mr Abulafi was keen to develop a patient pathway tailored specifically for London. Does this come into your study? Not quite. We’re mainly looking at the diagnostic accuracy of FIT, and the sub-studies will work on ways to improve diagnostic accuracy. The positioning of FIT in primary or secondary care is being examined in other studies and service improvement projects in England and Scotland. Other sites, such as Nottingham and Leicester, have very different pathways and decision making processes. What are your thoughts on the development of a pathway? Hopefully, once the process is complete, we can combine information on diagnostic accuracy and decision making pathways from all the studies to construct an evidence based patient pathway. We are providing the diagnostic accuracy portion of the evidence base. Roughly when do you think you’ll have sufficient data for a summary on the project? The recruitment rate continues to increase so it is adaptive. With our aim to recruit the 5,500 London patients, and the additional national patients, I believe we should have some initial data by December 2018. I think there would be an interesting comparison between those inside London and those outside? Another potential study arm? Yes definitely, we’ve already seen differences in recruitment method and patient response, so yes, I think it would be valuable information. What happens with the data you collect? We will conduct a primary data analysis based on, “F-Hb depending on; age, sex, ethnicity and deprivation, and also NICE criteria on patients referral. We will then pool data with NHS England, to create a database for the safe utilisation of FIT. It has been intimated by some key opinion leaders (WAGE) that NICE was ‘wrong’ with DG30 and that FIT should not be used solely for the ‘low-risk’ patients, but all patients with GI symptoms. What are your thoughts on this? I have grounds to agree and disagree. Firstly, I do not believe these patients are necessarily low risk based on the data we’ve collected. NICE are encouraging this process using the terms ‘lowrisk’ and ‘high-risk’ for cancer. The category divisions may not be black and white– GPs may not always have time to assess for all symptoms prior to referral, so the high- and low-risk classification may be inappropriate. Previous work by our team has found that “low risk” symptoms may have a higher rate of cancer than that which has been predicted by NICE. Secondly, I do not believe there is sufficient evidence upon which the recommendations are based. We will shortly be publishing our own analysis of DG30. I worry still about the test being used without full understanding of the limitations and the safety netting requirements, and resulting in missed cancers. This could result in this great test being pulled off the table before it’s had chance to be used. Ultimately, we will hopefully use FIT for all symptomatic patients, however I think there should be a larger evidence base for the recommendations and so work is still to be done. The NICE FIT Study has a dedicated website which provides further information: www.nicefitstudy.com This information is for both clinicians and patients and provides ongoing updates on participating sites as well as recruitment numbers. Reference: 1. NICE (2017) “Quantitative faecal immunochemical tests to guide referral for colorectal cancer in primary care” Diagnostics guidance DG30. Section 4 – Evidence [Online] Available at: www.nice.org.uk/ guidance/dg30/chapter/4-Evidence We’re working on a way to make FIT as safe as possible, and identify whether it misses cancer in a predictable way. We believe in FIT, and find it a very attractive test for managing patients with GI symptoms.
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