Leading Edge 2024 Issue 1

NICE DG56 vs. NICE DG30 Updates to FIT Guidance In August 2023 NICE published updated guidance on ‘Quantitative faecal immunochemical testing (FIT)’ to guide colorectal cancer pathway referral in primary care. This update expands and clarifies the previous recommendations, based on the extensive clinical evidence that has accumulated since DG30 was originally published, back in July 2017. What are the main changes? DG30 set the foundation for improving the primary care pathway for colorectal cancer, by utilising FIT in place of the guaiac faecal occult blood tests (gFOBt) for initial testing, following presentation with related symptoms. DG30 provided an overview of the diagnosis and care pathways at the time. This included referrals based on gFOBt outcomes, and identified the main problem to be addressed. DG56 has been able to utilise the huge base of clinical efficacy data and evidence, amassed since July 2017, to confirm the diagnostic accuracy of FIT, which has successfully resulted in the reduction of unnecessary colonoscopies. Additionally, with COVID-19 permanently changing the way patients engage with healthcare, FIT too has been adapted to this changed environment, to better serve the diagnostic pathway. Kayleigh Roberts, Senior Product Manager FIT, Alpha Laboratories Ltd. Original DG30 Recommendations DG30 recommended that FIT was adopted in primary care to guide referrals for suspected colorectal cancer in people without rectal bleeding who have unexplained symptoms, but who did not meet the criteria for a suspected cancer pathway (NICE NG12). Historically, the guaiac test has had low compliance and return rates and was susceptible to user errors both at initial sampling and when reading results in the lab. Utilisation of FIT meant that low-risk symptomatic patients could be triaged more effectively, addressing both clinical and cost concerns. DG56 Expanded Recommendations DG56 has expanded its recommendations to include a wider cohort of patients and symptoms. Thus, high-risk patients that wouldn’t have been offered FIT under DG30 will now be offered a FIT in conjunction with their colonoscopy referral. DG56 also states that FIT should be offered even if a patient has previously had a negative FIT result through the NHS Bowel Cancer Screening Programme, due to the differences between the threshold criteria. It also emphasises that safety netting should be put in place if a patient has a negative FIT result. This aims to prevent patients from being lost on the primary care pathway, by ensuring suitable follow-up reviews are conducted and alternative diagnostic tests are performed as necessary. The threshold for referral to a suspected cancer pathway remains unchanged at 10 micrograms of haemoglobin (Hb) per gram of faeces. DG56 reiterates that economic models still suggest a 6 Leading Edge

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