NCA Colorectal Symptoms Assessment Pathway for Primary Care.

NCA Colorectal Symptoms Assessment Pathway for Primary Care. New test FIT faecal immunochemical test Guidance for investigating colorectal symptoms in primary care including IDA , Faecal Immunochemical Test (FIT) and Faecal Calprotectin. Based on NICE NG12/DG30 and York Faecal Calprotectin pathway and BSG guidance Please note that this guidance does not replace clinical judgement and should be used in conjunction with the clinical assessment and opinion of the responsible doctor(s) V28 Aims What is FIT (faecal Immunochemical Test) When to use it in the colorectal assessment pathway Some cases Collaborating to improve cancer care

Key Messages Reinforce 2ww criteria FIT is a decision support tool - not a diagnostic test For change of bowel habit, its OK to wait 3 weeks and exclude other causes, especially PPI and metformin Reinforce use of CT in some patients Reboot calprotectin by more clearly defining age group and cut-offs Collaborating to improve cancer care Sensitivity and specificity In York, their work looking symptomatic people who meet the 2ww criteria has found: Sensitivity for CRC 82% Specificity

88% Negative predictive value 99% Positive predictive value 27% Collaborating to improve cancer care What is the test? TEST Small plastic bottle containing a stick with grooved tips. Twist open twist closed The grooved tips of stick are scraped along the bowel motion so that the grooves are covered Stick is then returned to the bottle Contains buffer to preserve the sample

wet faeces unstable Test for small amount of HUMAN blood in faeces 90 95% sensitive. Decision support tool for General practice Collaborating to improve cancer care Maximum 10 days from taking the sample to be able to use it in the lab. After that the test is not reliable The poo must not get wet before taking the sample Kits are stable at room temperature but should be returned to the laboratory as soon as possible following collection. If there is delay in returning the sample, store

this in a cool dry place away from direct sunlight. FIT Process map Safety netting in primary care If no results 2 weeks after test requested - GP surgery contact patient Results in ICE GP Patient GP surgery Paper copy Local lab

Gateshead lab Results Results in OPEN net Request on ICE. Kit and info given to the patient 24 72 hours 6- 48 hours Collaborating to improve cancer care FIT Process map Safety netting in primary care If no results 2 weeks after test requested - GP surgery contact patient

Results in ICE GP Patient GP surgery Gateshead lab Results Results in OPEN net Request on ICE. Kit and info given to the patient 24 72 hours

6- 48 hours Collaborating to improve cancer care Managing risk with FIT THINK . if you didnt have a FIT test what would you have done? THIS DECISION HAS BEEN DELAYED How will you know when the result comes back? How will you know if the test has not been done? What about people with negative result? Collaborating to improve cancer care Process Safety netting Keep a waiting list in and check regularly for results Use a safety net template in EMIS/ System one Scheduled task/ task to self Do regular search through ICE for missing FIT results this needs to be activated in practice in System One and EMIS Code and search

Code: Faecal Occult Blood Requested READ Code 4791/ SNOMED ID 167666002 Search: Quantitative faecal immunochemical test - observed = result automatically coded by ICE Read Code: Xaf0H/ SNOMED ID 1049361000000101 Collaborating to improve cancer care Clinical Safety netting FIT negative means very low but not No risk of cancer Patients with abdominal pain, weight loss etc may have other GI or noncancers that would not give a positive qFiT Think CXR/ Ca125/ Urinalysis

Patients should be advised to come back to GP if they develop new symptoms or are still concerned Some people with low risk will still need routine referral if symptoms affect quality of life and have not responded to primary care management options If unsure - seek advice from secondary care Collaborating to improve cancer care FIT symptomatic Vs screening FIT is coming in for screening FIT provides ONE test but in TWO different clinical settings These applications have different

Target populations Aims Interpretation of results Potential harms Additional benefits Collaborating to improve cancer care FIT & English Bowel Cancer Screening Program All screening tests will be FIT by April 2019 Will be reported in the same way as before positive/ negative/ non-responder Tests for BCSP will have a different colour top to the tests we will use for symptomatic people in primary care Easier to use and more sensitive than the current test Estimated 7% increase in demand for screening colonoscopy Collaborating to improve cancer care

Symptomatic FIT 2015 NICE NG12 Suspected cancer: recognition & referral Occult blood in faeces = 2WW referral NICE DG30 - Offer FIT test to people with low/ medium risk sx NCA working to roll out across the region Collaborating to improve cancer care Differences between screening & symptomatic FIT Collaborating to improve cancer care Screening vs symptomatic FIT - FAQ I have just had a screening test. Why should I do this test?

This FIT test is still necessary even if you have had a normal screening result. This test is measured in a different way. Do I still have to do screening if I have had a FIT test from the GP? The screening FIT test is important for everyone over 60. More people are cured of colorectal cancer if it is detected by screening than if it is picked up in any other way What if someone has missed their bowel screening test? They can request a new test form the Hub any time. DO NOT give them one of the tests in general practice. Only use the test in general practice for

people who are symptomatic and in line with the assessment pathway. Collaborating to improve cancer care FAQs Does my patient need to follow a specific diet to undertake the qFiT? No, the qFiT only detects human blood so, unlike FoB, no change in diet is needed What is the effect of blood thinners or aspirin or NSAIDs on the use of qFiT? The patient should continue with any of these drugs whilst undertaking the qFiT test Does a qFiT recognize upper GI blood loss No the implication is that +ve qFiT does not always need an upper GI endoscopy Collaborating to improve cancer care Upsides and downsides to use of qFiT in

medium risk patients Up side: Would you rather do a stool test or have a colonoscopy? Estimated 75-80% reduction in need for colonoscopy in this medium risk patient group Reduced anxiety for patient quicker result, under their control Potential to increase capacity for screening Downside No test is 100% sensitive even colonoscopy 30-40% of patients may be non-compliant with the test May introduce more steps for GP to enact Needs safety netting If done on a lot of extremely low risk patients, could lead to increase in colonoscopy Collaborating to improve cancer care Any questions about the test? Now to put it in context

Collaborating to improve cancer care Background information Age and sex distribution for colorectal cancer - UK Men<50 1273 cases Women <50 1227 cases about 8% of cases Routes to diagnosis Relative survival estimates by presentation route and survival time, Colorectal, 20062013 from Routes to Diagnosis workbook National Cancer Intelligence website www.ncin.org/ Collaborating to improve cancer care Routes to Diagnosis screening 2WW GP

Consultant referral Emergency other Number 44 163 34 113 42 6

Percent 11% 41% 8.5% 28% 10% 1.5% 41% 36.5% Newcastle Route to first treatment 2016/17

Collaborating to improve cancer care Total 402 How to improve survival? Prevention - lifestyle Identify more people by screening Reduce emergency presentations Identify people needing 2ww referral sooner Collaborating to improve cancer care Clinical advice for the commissioning of the whole bowel cancer pathway November 2017, National Colorectal Cancer Clinical Expert group. Patients should be referred when high risk symptoms are present for three weeks before referral is made, in line with the advice given by Public Health England awareness campaigns We interpret this to mean abdominal pain and change of bowel habit not rectal bleeding or

anaemia or weight loss Collaborating to improve cancer care What NICE guidance also says . While guidelines assist the practice of healthcare professionals, they do not replace knowledge and skills These recommendations are recommendations, not requirements. Exceptions will occur and clinicians should trust their clinical experience where . It does not pertain to the specific presentation of this patient It is OK to do some watchful waiting with planned follow up if another explanation is more likely in fact new NHS commissioning guidance suggests a period of 3 weeks duration for e.g. abdo pain and ChoBH (although this would not apply to rectal bleeding or anaemia) The FIT test is NOT diagnostic it is a decision support test Collaborating to improve cancer care 2WW Criteria or High risk confirmed IDA (Men and nonmenstruating

women >40y, women >50y) New or persistent lower GI symptoms or abdominal pain for > 3 weeks Unexplained weight loss Rectal bleeding >50Y 2x Platelets >450 6 weeks apart Non-2WW <50Y Offer FIT Possible IBD/ IBS

Unexplained confirmed medium risk IDA or clinical suspicion of colorectal cancer consider CT if weight loss sx 2WW Referral Positive Fit Northern Cancer Alliance Colorectal Symptoms Assessment Pathway Negative Fit

Offer faecal calprotectin test Repeat after 4 weeks if 100 -250 Rectal Bleeding alone Safety netting in primary care Consider advice and guidance or routine referral for persistent or troublesome symptoms <100 100-250 >250

Likely IBS Routine GI referral Urgent not 2WW referral Manage in Primary Care Patients with bowel symptoms/high risk anaemia for urgent (2ww) referral Any age with rectal mass

Consider 2ww colorectal clinic referral Any age with abdominal mass or Age 40+ with abdo pain and weight loss Consider 2ww colorectal

referral and/ or contrast CT of abdomen and pelvis Age 50+ with rectal bleeding OR Age 60+ with unexplained change of bowel habit (exclude drug causes and infections first where appropriate)

Age <50 with rectal bleeding plus 1 of: abdo pain change of bowel habit weight loss iron deficiency anaemia FIT positive High risk IDA (please offer urinalysis and TTG as well) All men with confirmed IDA with low ferritin and Hb<130

Women age >50 with confirmed IDA and Hb<115 (irrespective of menopause exclude drug causes and infections) Women age 40-50 who are postmenopausal or non-menstruating (e.g. Mirena) with confirmed IDA with low ferritin and Hb<115 Consider offering urgent 2ww colorectal referral for colonoscopy or clinic depending on frailty / patient preference Collaborating to improve cancer care Consider offering urgent 2ww colorectal referral for gastroscopy and colonoscopy or clinic depending on frailty / patient preference Patients with symptoms that do not fulfil 2WW but may require routine

referral for endoscopic tests please refer by letter via electronic referral system Age<60 with significant watery diarrhoea (Bristol stool type 6 or 7) that impacts on patients life for >3-6/52 (drug and infectious causes excluded) (people 60 and older with unexplained change in bowel habit qualify for 2ww colonoscopy) Consider routine referral for colonoscopy to rule out microscopic colitis Age<50 with unexplained rectal bleeding alone (people with rectal bleeding plus abdo pain or diarrhoea or anaemia qualify for 2ww referral) Consider routine referral to colorectal team (but may not be necessary in younger people, people with single occurrence, when there is confirmed

fissure or piles or when not the presenting symptom) Collaborating to improve cancer care Medium risk lower GI symptoms Age 50+ with either of: Unexplained persistent abdominal pain alone or Unexplained documented weight loss alone Consider wide range of diagnoses consider offering FiT or routine clinic and/or CT abdomen and pelvis FiT negative FiT positive Age 50-59 with unexplained change in bowel habit

OR Age 50+ vague or chronic bowel symptoms of uncertain significance for >3/52 Age <50 suspicion of lower GI cancer Consider offering FiT to identify people needing 2WW referral FiT positive FiT negative If patients does not submit FiT within two weeks of request review in primary care If FiT ve, consider other urgent / 2ww pathways as appropriate Exclude ovarian cancer in women If FiT +ve, consider 2WW colorectal referral for clinic or straight to test

depending on frailty If FiT ve bowel cancer is unlikely. Actively monitor for any new red flags If still concerned, refer as routine to gastroenterology. Collaborating to improve cancer care Anaemia IDA (medium and low risk), isolated low ferritin and unproven IDA IDA = HB < 130g/ L ( MEN) , 115g/ L ( Women) AND confirmed by local definition which may include: Ferritin < 15 or Ferritin < 30 and low MCV or Ferritin <30 and low transferrin. Please refer to local lab guidance Medium risk Anaemia: also check tTG and urinalysis): Menstruating women <50 with confirmed IDA Without rectal bleeding

Menstruation, diet or blood donation unlikely to be the cause Low risk IDA or isolated low ferritin (also offer tTG and urinalysis) Menstruating women <50 without rectal bleeding and when menstruation, diet or blood donation is likely as the cause for either an isolated low ferritin or IDA People with low ferritin but normal Hb Over 60 Yr with unexplained anaemia without confirmed iron

deficiency Offer FIT test in primary care FiT positive Offer 2WW referral for bidirectional endoscopy. If patient does not submit FiT in 2/52, review in primary care FiT negative Treat with iron + active monitoring. Monitor ferritin and Hb and if anaemia recurs 3 months after normalising, consider routine referral to IDA clinic/ Gastroenterology. Check FIT if this has not already been done

2WW Criteria or High risk confirmed IDA (Men and nonmenstruating women >40 yr, women >50y) New or persistent lower GI symptoms or abdominal pain for > 3 weeks Unexplained weight loss Rectal bleeding <50Y >50Y Offer FIT consider CT if weight loss sx 2WW Referral

Positive Fit Northern Cancer Alliance Colorectal Symptoms Assessment Pathway Non-2WW Negative Fit Unexplained confirmed medium risk IDA or clinical suspicion of colorectal cancer Possible IBD/ IBS

Offer faecal calprotectin test Repeat after 4 weeks if 100 -250 Rectal Bleeding alone Safety netting in primary care Consider advice and guidance or routine referral for persistent or troublesome symptoms <100 100-250 >250

Likely IBS Routine GI referral Urgent not 2WW referral Manage in Primary Care What is faecal calprotectin (FCP)? Inflammatory marker released I the gut and measured in stool. Commonly raised in inflammatory bowel disease (IBD) Crohns disease and ulcerative colitis Normal in functional bowel disorders like irritable bowel syndrome (IBS)

Collaborating to improve cancer care The next slide is different to your local Process In HRW reporting for faecal calprotectin is like this: Initial test <100 Likely IBS Initial test >100 Repeat test Repeat test >100-250 Possible IBD - refer Repeat test >250 Likely IBD urgent referral This has been in place for some time and the CCG prefer to

keep this unchanged. It will not make significant difference to the pathway. Follow the report advice rather than the flow chart for this bit Collaborating to improve cancer care Low risk patients: Age <50 with unexplained change in bowel habit +/- abdo pain for >3/52 consider check Hb and coeliac antibodies Faecal Calprotectin (FC) is considered the more appropriate test in people under 50 instead of FIT IBS suspected - based on ABC (abdo pain, bloating and/or change of bowel habit) Inflammatory Bowel Disease suspected*** check faecal calprotectin (FC) and Hb FC 100-250 repeat test No further investigations usually needed

FC<100 - Including repeat <100 Monitor and manage symptomatically using IBS pathway . If FC<50 and age<50 99% confidence of IBS https://cks.nice.org.uk/irritable-bowel-syndrome#!sc enario two tests at 100-250 Offer routine referral for colonoscopy or clinic Collaborating to improve cancer care FC >250 Urgent

non-2WW referral *** - any patient with symptoms suggestive of fulminant colitis should be admitted or seen in OPC clinic urgently Summary FIT test for blood in poo People who do not meet the 2ww criteria are low risk <3% PPV People with change of bowel habit under 50 with FCP<50 have 99% likelihood of IBS REMEMBER FIT DO NOT offer qFIT to people with rectal bleeding DO NOT offer qFIT to people who already meet 2ww referral criteria

Negative FIT in the low risk group makes them very low risk. BUT not no risk and people with abdominal pain, weight loss etc may have other GI or non-GI cancers that would not give a positive FiT 1. Check urinalysis 2. CXR Safety netting in primary care Process have the results come back and been actioned? Clinical - Does this patient need anything else? 1 test but 2 different indications and different interpretation of the results

Collaborating to improve cancer care Case 1: 65 year old man with three recent episodes of rectal bleeding and feeling of prolapsing piles PR shows some blood at exit canal Which risk category is he in? Does he need additional testing or invasive investigation? Collaborating to improve cancer care Case 2: 85 year old woman with Hb of 105, MCV 80, ferritin 65, GFR normal Which risk category is she in? Does she need additional testing or invasive investigation? Collaborating to improve cancer care Case 3

40 year old man with Hb 105, ferritin 10, no GI symptoms Which risk category is he in? Does he need additional testing or invasive investigation? Collaborating to improve cancer care Case 4: 25 year old man with intermittent abdominal pain, variable bowel habit and bloating after meals. No rectal bleeding or weight loss. Which risk category is he in? Does he need additional testing or invasive investigation? What factors might trigger referral? Collaborating to improve cancer care Case 5 55 year old woman with 4 week history of profuse watery diarrhoea

On sertraline for depression for some years Which risk category is she in? Does she need additional testing or invasive investigation? Collaborating to improve cancer care Case 5 She has a FiT performed and it is negative. You give imodium to try and control symptoms and after another four weeks she still has problematic diarrhoea that has caused occassional incontinence and is making work difficult. What diagnoses need to be considered? Does she need additional invasive investigation? Collaborating to improve cancer care Case 6 25 year old woman with long term constipation complains of recent severe anal pain and rectal bleeding. PR examine is not possible due to pain Which risk category is she in?

What diagnoses need to be considered> Does she need additional testing or invasive investigation? How might you manage this? Collaborating to improve cancer care Case 7 60 year old woman presents with concern about intermittent abdominal pain for 4 months and weight loss of 1 stone. Examination does not reveal any significant finding Which risk category is she in? Does she need additional testing or invasive investigation? What diagnoses need to be considered? Collaborating to improve cancer care Case 8 60 year old woman attends with tiredness. Hb is 129, ferritin 5 Which risk category is she in?

Does she need additional testing or invasive investigation? Collaborating to improve cancer care Case 9 25 year old women presents pale and tired. Hb 95, ferritin 5. Has two children age 15 months and 4 years. Breast fed for 1 year. Periods moderate. Which risk category is she in? Does she need additional testing or invasive investigation? Collaborating to improve cancer care Case 10 74 yr man. Walks 10miles per week. Has a normal bowel screening test in August. In September he presents with rectal bleeding. He has had this intermittently for years but no sx in the last 12 noths and no change in bowel habit.

Which risk category is he in? Does he need additional testing or invasive investigation? Collaborating to improve cancer care Any Questions? Please contact your CRUK facilitator for support http://www.northerncanceralliance.nhs.uk/ https://twitter.com/northerncancer [email protected] Collaborating to improve cancer care Acknowledgements Dr Mark Welfare Gastroenterologist Northumbria Hosptials NHS Trust Mr Peter Coyne Colorectal Surgeon Newcastle Hospitals NHS Trust. NCA Colorectal Cancer Clinical Lead Dr Mel Gunn Gastroenterologist Newcastle Hospitals NHS Trust Dr John Painter Gastroenterologist Sunderland Royal Hospital NHS Trust.

NCA Upper GI Cancer Clinical Lead NCA Colorectal EAG members NCA Cancer in the Community Group members Enquiries to: Dr Katie Elliott NCA Primary Care Clinical Lead [email protected] Collaborating to improve cancer care

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