2022 Alpha Laboratories Ltd Home Testing for IBD A Flexible FIT IN THIS ISSUE... Case Studies, Patient Views, Research Reports & Guidance How Technology Can Improve and Provide Personalised Patient Care 2-5 The Evolving Use of Faecal Immunochemical Testing 10-11 Patient Feedback on Home Testing Kits 6 Bespoke Patient Packs Help Support Cancer Testing Progress in the South West 12-13 IBD Therapeutic Drug Monitoring 7 How Low Can FIT Go? With Professor Callum G. Fraser 14-15 A Flexible FIT 8-9 Simple Solutions to Support Clinical Decision Making in Gastroenterology 16
2 PERSPECTIVE 2022 The merger of clinical services across Basildon, Southend and Broomfield, now forms the Mid and South Essex University Hospital Trust with a catchment population of 1.5 million. The Gastroenterology Department deals with the diagnosis and on-going management of patients with IBD. Patients who are diagnosed need regular monitoring in case of relapse/flare, to ensure ongoing effectiveness of therapy and for funding and stopping of treatments. A helpline service is operated and patients calling this often require a calprotectin test to help to guide advice and treatment. The department introduced the BÜHLMANN IBDoc® calprotectin home test in early Summer 2020. Implementation was a multidisciplinary team effort so we talked to some of the key team members about their focus on introducing new technologies to improve patient management. We also spoke to some of the patients, about their experience of using the test. Charlotte Williams, Director of Strategy “My role helps facilitate partnerships with pharma, industry and the supply chain to provide ideas, resources and intelligence that will improve the ways of operating within the NHS. Our focus in the innovation and transformation team is on supporting patient self-care and reducing unnecessary visits to hospital. Working with Dr Munuswamy we mapped the pathway and how the combination of the testing and the App interaction with the patient could achieve this. My role across the hospital group acted as the glue to bring the three clinical services together. Putting together the input from various discussions with different team members, a business case was developed to understand all the benefits and cost implications across the organisation. It was really when COVID hit that we thought about advancing the innovations. There was particular focus on those that had an impact on high risk populations where we could prevent the need to attend hospital and offer a better alternative. The IBDoc filled this requirement, and not just for the immediate crisis but it was something that we could sustain for the future as part of an existing strategy. We did a quick refresh of the documentation, a business case light approach and obviously it came out high on the impact assessment, not just during the COVID situation, but also with our future outpatient transformation programme. The Chief Finance Officer (CFO) was happy to support it, especially as the outlay has been minimal in terms of additional equipment and the nurses were quite committed to the opportunity of it too, so it wasn’t difficult to establish. The services rallied round fairly quickly to make it happen which is really to their credit. We are supporting clinicians to explore all the available options and ensure proposals are better than the current proposition. Having an executive champion within the organisation helps them get changes made without fighting through layers and layers of management.” Dr Pushpakaran Munuswamy Department Lead, Gastroenterology “Recently I gave a talk to about 50 IBD patients at the support group, on digital health and how technology can improve and provide personalised patient care for their long term conditions. This was received very well and a number of the patients expressed an interest in the new technology for monitoring of their disease, because they could see the benefits of having patient participation and taking responsibility for their care. I did some investigating, came across Alpha Laboratories and IBDoc and we rapidly progressed to a pilot. I wanted to see if this was something that patients would like and accept, as this was a big change for them. We contacted patients to be signed up on the portal and trained on using the IBDoc test– we had about 20 patients participating in this.” Laboratory Comparison The point of care team needed to establish how the IBDoc results correlate to the standard laboratory data. The calprotectin concentration is used to help make important decisions in the management of a patient so it is important that it is correct. We were conscious about making sure the lab ELISA and the IBDoc samples were at least taken on the same day. Consequently we only had 11 matched results, because of delayed samples sent to the lab, but there was no statistical difference in the results obtained (Spearman correlation was 0.795 and Pearsons correlation coefficient 0.673). Patient Acceptance Patients acceptance of the new test was almost 100% (although they were motivated patients who volunteered for the test). We now have ~ 110 patients signed up for the system and so far everyone has been really keen to try it. We haven’t had anyone refuse yet. The feedback is that patients really like the system, because of the quick result, rather than waiting weeks to find out, and they appreciate the personalised care. Obviously a big benefit for them is that we are allowing them to see the numerical results and the colour coding which is quite powerful for them in helping to understand their disease and providing reassurance. We have set the traffic lights to: <250 µg/g = Green 250 – 500 µg/g = Amber >500 µg/g = Red How Technology Can Improve and Provide Personalised Patient Care Mid and South Essex University Hospital Trust
Find out more at www.calprotectin.co.uk 3 Rapid Response From my perspective I am seeing a difference already, because we are able to escalate treatment within a day or two of asking for the calprotectin test to be done. We get the result back immediately, whereas previously there was a wait of around 4 – 6 weeks or even longer depending on when the sample was taken and the capacity in the labs. Hopefully, in the future we will see the benefits of this rapid response in terms of reduced hospitalisations and clinic visits, because patients have had timely interventions. In addition there are reduced calls to the helpline because we know the results and are able to act quickly. Cost Savings Going forward we are hoping to be able to reduce the clinic requirement for patients who are stable, because we will be using all the digital tools to remotely monitor and hopefully reduce the risk of flare up. We will be altering the natural history of the IBD which will be the most powerful thing, but it will take a few years to get the data to support this. As part of the business case we estimated some of the potential cost savings that may be realised by introducing the technology. Based on a relatively small population in one area and then extrapolating up for the CCG, the savings estimate was ~£330K. We know we need further data to support this which will take a few years to collect. More Patient Engagement The benefit of the IBDoc from the clinicians perspective is obviously the speed with which the result comes through. Personally I think there is also more engagement both with patients and within the clinical team, because you are able to follow through on a course of action quickly rather than waiting weeks in between decisions which is more frustrating. The IBDoc is very simple but with a lot of impact on patient care. IT Systems Although the user interface is very simple and straight forward, a big advantage for us would be for the hospital IT system to pull the IBDoc result into the Electronic Patient Record. If this can be achieved then people in all departments and primary care, can also access the result which will help significantly. I am hoping our hospital IT can organise this for us, but COVID has made lots of additional demands, so it may take some time. Regional Adoption The three trusts in our region (including Southend and Broomfield) amalgamated this year, so we need to operate the same pathways and services in each of the centres. At Basildon we have driven the adoption of the IBDoc because we performed the trial and have the experience. With the advent of COVID the requirement to operate more remotely became important, and so this has helped with the adoption in the other centres. We are all operating from the same IBDoc portal, but we have set it up so that we only see our own patients. The patients have a single support group now and they do talk to each other (news travels fast), so it would have been problematic not to offer the same access to the new technology. Remote Monitoring There is a move nationally towards more remote monitoring because of the huge demand for increased capacity, but by relieving some of the resource requirements we can create capacity. So, at the moment we are continuing to operate virtual clinics that were introduced during COVID and will do so for the foreseeable future. There are benefits not only for us but also for the patients in not having to attend the hospital (and find a parking space!). With remote monitoring the virtual clinics are ideal for those patients that are more stable but who we still need to stay in touch with. Before COVID we did do this for some clinics, but I certainly see it expanding. The IBDoc gives us the opportunity to monitor the patients and have the ability to intervene very early on if things start to progress so that the patients don’t have to keep coming into hospital. This ties in very much with the Topol Review published in Feb 2019 which highly recommended personalised care for long term conditions and embraces national objectives to adopt digital care. If we can implement this then it will help us to operate more targeted face to face clinics with the patients who have more complex requirements. Using the IBDoc has increased the engagement from both the patients and the clinical team, and the speed of the results really makes a big impact in decision making and patient management. It doesn’t really add more work because you save time in chasing results and additional support for patients whilst they are waiting for results. The key things are: ■ Prompt result and treatment ■ Patient engagement in long term conditions ■ Personalised treatment” Jacqueline Roscoe, IBD Nurse Specialist Jacqueline Roscoe is one of two full time IBD nurses on the Basildon site, treating patients from the surrounding areas that also include Brentwood, Thurrock, Rayleigh and Purfleet. “We treat adult patients and transitional patients, so those that are 16 – 18 years of age. For the transitional patients we have a shared care system with the specialist paediatric centres either at GOSH or Addenbrookes. Telephone Clinics They operate two telephone clinics for patients. Due to the COVID-19 pandemic capacity in these has increased to around 20 patients a week. There is also a helpline for patients taking around 10 calls and up to 50 emails a day. The nurses also run biologic pre-assessment clinics every week. There is a multidisciplinary team meeting (MDT) once a fortnight and a video capsule endoscopy service for when we want to take a closer look at the small bowel. In the initial comparisons of the IBDoc results to the lab results most data compared really well. For some results the values were quite different, but when we spoke to those patients we found that they were only sampling from one place in the stool. Once we explained they needed to sample from several different places they got better correlation. ......continued
4 PERSPECTIVE 2022 At first patients came into the clinic to be signed up, shown what to do and given the kits, but now with COVID that isn’t happening. My colleague, IBD co-ordinator, Gillian is signing the patients up on the IBDoc portal and sending the links and step by step instructions to the patient. She then packages up the kits in a padded envelope and sends them out by first class post to the patients. Initially there is a reasonable amount of work in signing up the patients for the first time, but once they are established we just need to send them a new kit each time they need a test. Easy To Use The feedback from the patients has been excellent. They found the kits very easy to use and they really like the fact that they get to see the results and that they don’t have to wait weeks for them to come through. It gives the patients a better understanding of how their disease is doing so they can see if their inflammatory markers are high or under control. This provides real peace of mind which is important. From our perspective the big benefit is how quickly we get the results back and can start to make decisions on treatment options for the patients. Patients don’t have to keeping phoning to find out if the results are available (two weeks is a long time if they are worried they are flaring). If a patient thinks something is wrong they can request a kit and easily find out if they are flaring or not, and they don’t have to come into the hospital. Even the older patients have coped really well and have embraced the new technology – the oldest patient we have on the IBDoc is 75 year old! If anything, it is some of the younger generation – the late teens that don’t seem to do quite so well. From a technology point of view this is surprising, but these patients are transitioning from paediatric to adult care, and so maybe previously their parents have dealt with things, whereas with the IBDoc it is their responsibility. If you are thinking of introducing the IBDoc into your hospital, think how it fits in with your service, and speak to your patients to see if they are willing to embrace the new technology, because a lot probably depends on your patient demographics.“ Kezia Allen, Clinical Trials and Informatics, Pathology We have always worked closely with our IBD team and this has enabled us to ensure that our assays provide them with the results they need when they need them. We had begun some work looking at IBDoc last year and the IBD team were keen for the clinical laboratory team to be involved in this. The IBD team arranged for some patients to attend a workshop hosted at the hospital where representatives from Alpha Labs along with the IBD team and myself from the lab discussed the IBDoc with the patients. Following a demonstration of the device I took the patients to try it for themselves. This was really interesting as it gave me a chance to see how the patients got on using the devices, observe any difficulties and be there to offer advice if needed. The patients found the App and the devices very easy to use and had very few questions (apart from ‘how soon can we have these as part of our standard care!’). For myself from a lab point of view (we often feel a bit of disconnect between laboratory testing and how the results are utilised in the wider healthcare setting) it was so interesting to hear how keen these patients were to be able to better manage their condition themselves at home. Following a successful pilot and with the pandemic ongoing, it became clear that getting the IBDoc devices in use would be key to help keep these IBD patients well and out of hospital during this difficult time. NEQAS Scheme We enrolled in the NEQAS faecal markers of inflammation scheme as the first user in the IBDoc group. We have been very pleased with the performance and hope that other users will enrol in the scheme as they begin using the devices for their patients. We will continue to work with the IBD team to refine the service and our use of the IBDoc portal. Vicky Munday Ulcerative Colitis Patient Vicky took part in the original IBDoc trial at Basildon. “I have done a couple of tests now with the IBDoc and I think it is brilliant, because it is just so quick. It is so much better than sending the sample to the lab because the result comes through straight away, and this time it was low so that is really reassuring. Gaining Control When you have a long term condition like IBD you put your whole treatment plan in the hands of other people, but something like IBDoc means that we can be involved and are helping. When you first get a flare up the clinical team need the results from the inflammatory markers before deciding what to do and previously this was taking too long. When you have IBD the two week wait for results seems like two months, but with the IBDoc you get the result straight away which then speeds up the treatment which can only be a good thing. The Patients’ Viewpoint I think it is brilliant.
Find out more at www.calprotectin.co.uk 5 I think that with the current situation with COVID a lot of things will become more virtual and the IBDoc will help with that. From my perspective as long as I have a plan for the next six months I am happy for appointments and testing to be virtual. There are so many people and so few resources that they are going to have to rethink how things are done – sometimes I have been to clinic to see the consultant but I have been well and ticking along fine so that space could have gone to someone with more urgent need. The opposite has also been true when I have been really poorly and have been desperate to talk to someone for advice. Once the structure is in place hopefully the clinical team will be able to prioritise better, and I think most patients will be receptive to this. Patients need the initial support with the first test, but once they have done that I can see the take up being huge, because patients really want something quick. I don’t think they could have made the test any easier to be honest – If you have been offered the chance to use the IBDoc just give it a go, taking the sample isn’t a big deal and the results come through really quickly which is all that matters. Stephen Bonnington Crohn’s Disease Patient “I was introduced to the IBDoc calprotectin test through the pilot scheme conducted at Basildon hospital and following this it has now been accepted for use throughout the trust. I have had Crohn’s Disease for 40 years and have an understanding of how important selfmanagement of IBD is and how the test can play an important part in this. However, I feel the suitability of the test will vary from patient to patient. For newer IBD patients or those yet to be diagnosed there may be a reluctance or uncertainty about carrying out this procedure. It is important that consultants / IBD nurses explain fully to those using the test what is involved, the implications of any “adverse” result and if this does happen what the follow up plan would be. For some patients a “High” result appearing in the App may cause worry if they do not understand what happens next. Watch the Video I would recommend that before taking the test all users actually watch the video shown on the website. I found this really helped me have an understanding of the procedure and helped when using the instruction sheet. I did not find the stool collection sheet particularly practical for my own bowel movements. Like many with IBD I have developed my own stool sample collection method for this test. The actual retrieving of the sample was straight forward and the instructions around what to do after that were easy to follow. When it came to obtaining the results the instructions were straight forward and even if though, as mentioned on the new website link, it can sometimes appear that it is taking a long time for the fluid to appear on the test cassette. I found the Kit and App user friendly and easy to follow. The Patient Support Website has good information both in video and the written form. The patient forum is also a great idea and can become an invaluable source for those new to using the test. Overall, I feel that there is an enormous benefit in using IBDoc for long term patients in the self management of their condition. Results can be seen straight away without the inconvenience of having to go to the hospital and then waiting for results to be sent and - treatment plans can be established more quickly. This has been particularly highlighted during the COVID-19 situation, when many patients would not want to travel to their hospital. Access to past results to look at trends is also important. Charlotte Williams adds: “It would have been nice to implement such practice sooner than we did, but certainly COVID gave us the impetus to see this through and get it signed off. Now that the IBDoc has been rolled out across the three sites within the Trust my role is to oversee the implementation and the impact of it so that we can make sure that the investment case has been achieved during the next 6 and 12 months. Also we need to make sure it is built into the planning moving forward, but once it is routine within clinical practice it will be largely handed over to the governance of the gastroenterology services.” Dr Munuswamy concludes: “It is really satisfying to know you helped introduce a technology that will benefit patients and promote personalised self-care for long term conditions which has been adopted across the Trust. The IBDoc also has the potential to transform clinical care pathways, reduce clinical admissions, reduce the need for clinic appointments and save costs by intervening quickly to stop disease progression and the requirement for more costly interventions.” BÜHLMANN IBDoc® Calprotectin helps you to better manage clinic resources and improve patient care. IBD patients can perform their own tests at home and read them using Smartphone technology: ■ Rapid quantitative calprotectin results for patient and clinic ■Helps prioritise clinic space ■Helps monitor mucosal health and predict flares ■Connect remotely with patients ■Patient involvement and reassurance See how IBDoc can help in your clinic Email: digestivedx@alphalabs.co.uk Who Needs That Valuable Clinic Space?
6 PERSPECTIVE - 2022 Following the disruption of normal paediatric inflammatory bowel disease (IBD) services during the peak of the COVID-19 pandemic, the Royal Hospital for Children in Glasgow prospectively audited the first-time use of home faecal calprotectin testing, which was then published in BMJ Open Gastroenterology. They aimed to provide an alternative to laboratory tests and to assess the value of home testing as part of their regular services going forward. Below are some of the responses form patients who took part in this audit. “I found it very interesting - as a family we hand in a lot of samples so it felt much simpler to perform the test at home. Instructions were clear and easy to follow and although we don’t see an exact figure for the calprotectin until the nurse gets back we still could see whether the result was high, medium or low, which is helpful. I assisted my son with the test but I would be confident that he could follow the steps if he had to.” “It’s a lot easier with home kit as I live 3 hour drive from the kids hospital and the sample has to be handed in at hospital here then onto Glasgow meaning the results take longer to come back. Great piece of kit.” “My son gets very anxious at hospital so this kit is perfect to keep him happy.” “It takes the pressure of our teenage son to produce a sample for a specific time! Also, going to the Hospital is not as straightforward as it used to be before COVID19. Therefore, it makes more sense to be able to do the Calprotectin test at home.” “My daughter prefers it as it’s less messy, she’s in control and it’s a more private experience.” “Previously, doing the test would have meant me collecting a kit from the GP, doing the test then physically taking it up to the hospital. The home kit is much more convenient.” “Easy to use and didn’t need to produce a sample on clinic day. Also didn’t have to go to appointment with sample as can be a little embarrassing for child.” “Saves time for health professionals and the patient.” “The video really helped to explain the process. The collection ‘sheet’ was helpful to collect the sample for the tube. The app was straightforward to use to set up the camera for reading the result.” You can view the full audit and patient feedback on the BMJ Open Gastroentrology website here: https://bmjopengastro. bmj.com/content/bmjgast/8/1/ e000631.full.pdf?with-ds=yes University Hospitals Birmingham NHS Trust also implemented the IBDoc with some of their IBD patients, in response to COVID. In a poster from ECCO 2021, Edwards et al.1 presented an improved level of compliance with calprotectin testing using the IBDoc compared with the traditional laboratory method. References 1.D Edwards, M Ibrahim, R Cooney, R Boulton, P518 Compliance with Faecal calprotectin home testing as standard during COVID-19 pandemic compared to laboratory based testing pre-COVID, Journal of Crohn’s and Colitis, Volume 15, Issue Supplement_1, May 2021, Pages S496–S497, https://doi. org/10.1093/ecco-jcc/jjab076.640 For more information on IBDoc visit: www.calprotectin.co.uk/ibdoc Patient Feedback on Home Testing Kits
Find out more at www.calprotectin.co.uk 7 IBD Therapeutic Drug Monitoring - Be in Control of Your TAT Adopt a Proactive Approach to Therapeutic Drug Monitoring for IBD Patients A UK national survey by Nigam et al., published in Frontline Gastroenterology 2021, investigated gastros’ attitudes towards therapeutic drug monitoring (TDM) of anti-TNF therapy in their inflammatory bowel disease patients. 85% of respondents said they would proactively monitor on an annual basis if the barriers were removed. The primary barrier cited was the time lag in receiving results. Rapid Testing Using the BÜHLMANN Quantum Blue system, results can be available within an hour. This enables realtime dose adjustment for infliximab and adalimumab, facilitating optimisation of treatment, minimising loss of response and side effects and saving valuable healthcare resources. Proactive Monitoring Proactive anti-TNF drug and anti-drug antibody monitoring can improve clinical outcomes through the maintenance of levels within therapeutic windows. This prevents sub-therapeutic levels which may enable low level inflammation that can cause tissue damage or trigger a flare. It also means supra-therapeutic levels can be de-escalated, minimising side effects and saving costs. Quantum Blue® Reader Quantitative results: - Infliximab 0.4 - 20µg/ml (linear up to 180µg/ml) - Adalimumab 1.3 - 35µg/ml ■ Anti-drug antibody assays available ■ Excellent correlation with the WHO infliximab standard ■ Simple bench top reader - Touch screen data entry - LIMs enabled for easy data entry and reporting ■ Ideal for use in POC: - No need to batch samples - Individually packaged single use tests to maintain quality until use - Small pack sizes available Reference Nigam GB, Nayeemuddin S, Kontopantelis E, et al. UK National Survey of Gastroenterologists’ attitudes and barriers toward therapeutic drug monitoring of anti-TNF therapy in inflammatory bowel disease. Frontline Gastroenterology 2021;12:22-29. For more information on Quantum Blue for TDM or to arrange a demonstration, please visit: www.calprotectin.co.uk/TDM Clarissa Rentsch at Alfred Health, Melbourne, Australia “This rapid test strategy has the potential to reduce patient risks and improve patient outcomes without negative cost implications” Watch the Presentation from ECCO https://youtu.be/TizubO07C1M Maria Pia Costa Santos from Hospital Beatriz Angelo, Loures, Portugal “Point of care infliximab trough levels were easy to implement into a daily practice setting. The therapeutic window was achieved in only a third of patients, in the remaining patients an immediate treatment adjustment was possible enabling a cost saving” Watch the Presentation from ECCO https://youtu.be/QNPMkaq-LD8
8 PERSPECTIVE 2022 A Flexible FIT Ensuring Services are Relevant Throughout the COVID-19 Pandemic The faecal immunochemical test (FIT) is used to identify microscopic traces of haemoglobin in faeces which is a common indicator of significant bowel disease (SBD). Primarily used in colorectal cancer (CRC) referral pathways, FIT has been in routine use across the UK for several years, aiding the assessment of symptomatic patients referred from primary care. It has also been adopted as the testing method within the national bowel screening programmes. The COVID-19 pandemic caused widespread challenges to the health service and many routine diagnostics were disrupted. As a result, the applications for FIT diversified leading to its implementation in a range of pathways; from secondary care triaging to bowel surveillance, to Vague Symptoms Pathways (VSP). The proven diagnostic efficacy, and the patientcentric nature of the associated FIT-KITs (a pack containing everything the patient needs to take and return their sample), has allowed FIT to progress naturally into these pathways. This is helping ensure patients are well-managed and resource is allocated effectively during the ongoing peaks and troughs of the pandemic. Benefits of FIT In July 2017, the National Institute of Health and Care Excellence (NICE) published its diagnostic guidance, DG30 , on the use of FIT in primary care, to help guide referral for patients with suspected colorectal cancer (CRC). As a result, the demand for FIT soared, and primary care pathways were set-up across the UK to help support the referral process. Towards the end of 2019, health services were seeing real advantages following the implementation of FIT: endoscopy waiting lists were reducing, and procedure waiting times were decreasing, resulting in better patient management. FIT was also being used more frequently in other pathways, not just primary care referral: Vague Symptoms Pathways (VSP) and Rapid Diagnostic Pathways (RDP) have been using FIT as a convenient method to gauge bowel health in individuals who may not otherwise fall into the DG30, or NG12 , pathways. Moreover, FIT has been shown to identify not only CRC, but a range of other significant bowel diseases (SBD), including inflammatory bowel disease (IBD), and high-risk adenoma (HRA) , which furthers the scope for the application of FIT in lower-GI diagnostics. Challenges of the Pandemic The advent of COVID-19 caused unprecedented disruption to a huge number of diagnostic services, threatening to undermine the work achieved so far with FIT implementation. During the initial stages of the pandemic, the risk of COVIDtransmission through faecal samples was unknown, and as all non-urgent procedures were halted, the endoscopy waiting lists increased drastically. FIT demand dropped substantially as testing was halted to allow risk-assessments and restructuring to cope with the additional strains on the NHS. Access to GPs and healthcare settings were restricted, and individuals were more reluctant to discuss symptoms with their GP for fear of having to attend the practice in person. From June 2020, laboratory analysis of FIT samples began to ramp-up, yet the pathways originally bringing in the FIT samples had changed. One of the most obvious changes was the increase in the number of samples from secondary care. Patient Triage Patients awaiting further investigation following a referral were facing extended waiting times: and, as with many SBD cases, typically the earlier the diagnosis, the better the long-term prognosis. A higher concentration of faecal haemoglobin (f-Hb) is associated with more severe disease, and therefore FIT is used to help triage patients, in conjunction with clinical suspicion, to manage the scarce endoscopy resource. It has allowed the patients with the most severe symptoms (and therefore those most at risk of severe disease) to be prioritised accordingly or assessed via other channels. Additionally, in the absence of f-Hb, the risk of severe disease is low, and these patients may often be better managed via a less invasive referral route, as colonoscopies are not without risk. Increased Test Uptake FIT and the associated FIT-KITs, have been well aligned with changes to patient’s health-seeking behaviours, increasing uptake of the test and improving sample quality. By giving patients contact-free access to a home-based sample collection kit, whether it be a COVID-19 test or a FITKIT, patients are increasingly familiar with following instructions, collecting samples, and returning them – even engaging more with follow-up and results. By reducing the fear-factor associated with faecal testing, and making the kits as user-friendly as possible, more people are engaging with the diagnostic pathway, which in turn increases the value of the test to the healthcare service. Name Date of Sample 107AIE 00000024 2021.05.31 M / F Date of Birth LOT 2m 2m Bowel surveillance
Find out more at www.faecal-immunochemical-test.co.uk 9 Further Expansion To further expand the use of FIT, healthcare decision makers are looking beyond the original DG30 and NG12 guidelines and starting to assess the value of FIT in the younger population. With the incidence of CRC on the rise in the under 50s, the test must prove valuable in yet another cohort, and early studies are showing promising results . This is yet further evidence that with well-structured pathways, and appropriate efficacy studies, it is possible for FIT to be of even more value to lower-GI diagnostics. However, it is important to use any diagnostic test with a full understanding of its limitations. Ensuring adequate safety netting is one of the most important aspects to any diagnostic service: and although FIT has a high negative predictive value for CRC (>98%) there is still a risk that cancer (or SBD) is missed. The key to further expanding FIT application is to ensure it is done safely and efficiently: monitoring patient outcomes, and ensuring the capacity challenges are resolved, not just displaced to another service. Overall, the diversification of FIT applications has been accelerated by COVID-19. By remaining cognisant of its limitations, and creating robust safety netting procedures, FIT applications will continue to diversify over the coming months. Applications in primary and secondary care, VSP and RDC, and expanding to the younger cohort, shows the true value of FIT may yet to be fully appreciated, and it is anticipated that the pathway changes will become routine and continue to help improve patient care, and resource management in the NHS for years to come. References / Sources: 1 National Institute for Health and Care Excellence (2017) Quantitative faecal immunochemical tests to guide referral for colorectal cancer in primary care. Diagnostics guidance [DG30]. [online]. Available at https://www.nice.org. uk/guidance/dg30 (Accessed 15 July 2021) 2 National Institute for Health and Care Excellence (2021) Suspected cancer: recognition and referral NICE guideline [NG12]. [online]. Available at https://www.nice.org.uk/ guidance/ng12 (Accessed 15 July 2021) 3 Strachan, J. A. and Mowat, C. (2021) The use of faecal haemoglobin in deciding which patients presenting to primary care require further investigation (and how quickly) – the FIT approach. [Online], The Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (eJIFCC). Vol. 32, No. 1, pp. 52-60. Available at https:// www.faecal-immunochemical-test. co.uk/wp/wp-content/uploads/2021/03/ ejifcc-2021-FIT-Strachan-and-Mowat. pdf (Accessed 15 July 2021) 4 D’Souza, N., Monahan, K., Benton, S. C., Wilde, L., Abulafi, M., The NICE FIT Steering Group. (2021). Finding the needle in the haystack; the diagnostic accuracy of the faecal immunochemical test for colorectal cancer in younger symptomatic patients. [Online]. Colorectal Disease. Available at https://onlinelibrary.wiley. com/doi/10.1111/codi.15786?af=R (Accessed 15 July 2021) Q. A. Q. A. Q. A. Q. A. Vague Symptoms Pathways (VSP)
10 PERSPECTIVE 2022 Recent guidance by NHS England advises the usage of FIT as shown below, for managing patients with symptoms that might be due to colorectal cancer (CRC) and to identify those most in need of urgent investigation [6]: The COVID-19 pandemic has brought many challenges for clinicians and supporting services that have driven the need to manage patients differently. With current changes in the availability of endoscopy and laboratory testing resources, new solutions have had to be developed. On the 31st December 2019, the World Health Organisation (WHO) was informed of a cluster of cases of pneumonia of unknown cause in Wuhan, China; by the second week of January it was reported that a novel coronavirus (later named SARS-CoV-2, the virus causing COVID-19) had been identified as the cause for some of these pneumonia cases. By the 11th March 2020, WHO declared COVID-19 a pandemic, the first pandemic caused by a coronavirus[1]. Due to the COVID-19 pandemic, the way in which patients are being investigated for colorectal cancer has changed; to protect both the patients and the clinical staff and due to the reallocation of some staff. Prior to COVID-19 the role of the faecal immunochemical test (FIT), in addition to screening for bowel cancer, was for the symptomatic assessment of primary care patients, as guided by NICE DG30 [2]. However, with the reduction in services available, FIT is now also being utilised for triaging patients on existing secondary care waiting lists and patients being referred under two-week-wait (2WW) pathways from Primary Care. Uptake for this has varied nationally with some areas of the UK seeing a large increase in FIT requests as the test becomes included in more pathways. On the 3rd April 2020, the British Society of Gastroenterology (BSG), supported by several key groups, published guidance on endoscopy activity during COVID-19. The Evolving Use of Faecal Immunochemical Testing - Accelerated by the COVID-19 Pandemic For urgent endoscopy or CT: (CTC or plain CT) • Early signs of a large bowel obstruction, eg. lower abdominal pain and distension. • Other NG12 specified symptoms with a FIT >100 µg Hb/g faeces who have not had a colonoscopy in the previous three years. • Symptoms deemed by specialist GI surgeons/ gastroenterologists at the point of triage, to merit urgent intervention. ! For prioritised endoscopy or colonic imaging: (CTC, plain CT or colon capsule endoscopy) • NG12 specified symptoms, with a FIT 10-100 µg Hb/g faeces. • Other NG12 specified symptoms with a FIT >100 µg Hb/g faeces who have had a colonoscopy requiring no further investigation in the previous three years. ! For patients to be safety-netted on a patient tracking list: • NG12 specified symptoms, with a FIT <10 µg Hb/g faeces. ! In this guidance the BSG recommended that all endoscopy, except emergency and essential procedures, should be ceased immediately [3]. By the end of March 2020 (the start of the pandemic lockdown period in the UK), endoscopy activity had reduced to only 5% of normal activity [4]. Rutter et al, recently published data from the National Endoscopy Database which showed that “Pre-COVID” an average of 394 colorectal cancers were detected by colonoscopy and flexible sigmoidoscopy per week, whereas during COVID this has decreased to an average of 112 cases per week [4]. In June 2020, an article in The Lancet (Gastroenterology & Hepatology by Arasaradnam et al.) for the BSG Endoscopy COVID working group, described how FIT could be used as a triage tool to guide the prioritisation of investigations. This would help in the management of the limited capacity of endoscopy departments during COVID-19, rather than being used instead of other investigations[5].
Find out more at www.calprotectin.co.uk 11 The FIT cut-offs that have been published for triaging during COVID-19 have varied between local guidance, e.g. The London Pathway involves referring only FIT-positive 2 week wait patients at a threshold over 10 µg Hb/g faeces for investigation and patients with a FIT more than 150 µg Hb/g faeces are prioritised for colonoscopy [7]. The cut-offs published recently by Scottish Government are shown below, with two published pathways for use during the pandemic and then during the subsequent recovery period [8]. Increased utilisation of FIT during the COVID-19 pandemic has allowed more focussed referral to services which are unable to operate at full capacity, whilst supporting prudent healthcare. Ongoing clinical audit of these processes and analysis of outcome measures will hopefully provide more national evidence based guidance on the use of FIT in these settings, alongside robust safety netting for FIT negative patients. References 1. World Health Organisation. 2020. Rolling updates on coronavirus disease (COVID-19). www.who.int/emergencies/diseases/novelcoronavirus-2019/events-as-they-happen 2. NICE. 2017. DG30. Quantitative faecal immunochemical tests to guide referral for colorectal cancer in primary care. 3. British Society of Gastroenterology. 2020. Endoscopy activity and COVID-19: BSG and JAG guidance – update. www.bsg.org.uk/covid-19-advice/endoscopyactivity-and-covid-19-bsg-and-jag-guidance/ 4. Rutter, M.D., Brookes, M., Lee, T.J., et al.2020. Impact of the COVID-19 pandemic on UK endoscopic activity and cancer detection: a National Endoscopy Database Analysis. doi: 10.1136/gutjnl-2020-322179 5. rasaradnam, R.P., Bhala, N., Evans, C., et al. 2020. Faecal immunohistochemical testing in the COVID-19 era: balancing risk and costs. The Lancet. Gastroenterology & hepatology; 5(8), 717–719 6. NHS Speciality guides for patient management during the coronavirus pandemic. June 2020. Clinical guide for triaging patients with lower gastrointestinal symptoms. www.england. nhs.uk/coronavirus/wp-content/uploads/ sites/52/2020/06/C0551-triaging-patientswith-lower-gi-symptoms-16-june.pdf 7. D’Souza, N. and Abulafi, M. 2020. Navigating the storm of COVID-19 for patients with suspected bowel cancer. Br J Surg;107(7): e204. doi:10.1002/bjs.11695 8. Scottish Government. July 2020. Guidance for the use of FIT in the prioritisation of patients with colorectal symptoms now and in the recovery period after COVID.. Version 1.0. www.gov.scot/ publications/coronavirus-covid-19-guidance-for-useof-fit-testing-for-patients-with-colorectal-symptoms. Colonoscopy [When local capacity allows] OR CT Abdo and Pelvis OR Colon Capsule Endoscopy Case by case discussion on investigation, take account of: • Patient Frailty • Severity and persistence of symptoms • Numerical FIT result No investigation Other than where there is significant clinical concern Colorectal Symptoms FIT and FBC ≥400 µg Hb/g faeces ≥10 to <400 µg Hb/g faeces <10 µg Hb/g faeces During Recovery Period Scotland Colorectal Symptoms FIT and FBC ≥400 µg Hb/g faeces ≥10 to <400 µg Hb/g faeces <10 µg Hb/g faeces Colonoscopy [High Priority] Colonoscopy [Intermediate Priority] OR CT Colonography If access to above still limited, consider: CT Abdo + Pelvis OR Colon Capsule Endoscopy Mode of investigation and urgency dependent on: • Patient frailty • Severity + persistence of symptoms • Numerical FIT Result No investigation Unless Iron Deficiency Anaemia or severe persistent symptoms (Urgent Suspicion of Cancer) If there is doubt about whether or not to proceed with investigation, review within 6 weeks and consider repeating the FIT
12 PERSPECTIVE 2022 Cancer is the leading cause of death in the South West. The South West Cancer Network is responsible for working with providers, commissioners and other partners in the new NHS architecture to deliver patient focused improvements in outcomes and experiences. The national cancer strategy; Achieving World Class Cancer Outcomes: A strategy for England 2015 – 2020 set an exciting vision for the transformation of cancer services to radically improve cancer outcomes and to ensure that patients can benefit from high quality modern services. There are six major themes around how this was achieved, spanning all partners involved in delivering cancer services locally. These are prevention and public health, early and earlier diagnosis, improving patient experience, support to patients living with and beyond cancer, high quality modern services and new approaches to the commissioning and provision of services. Central to delivering this agenda are the Cancer Alliances, as the delivery vehicle for implementing the strategy, meeting the challenges set out in the Five Year Forward View and the local sustainability and transformation plan. The Cancer Alliances in the South West are: Peninsula (covering Devon, Cornwall and the Isles of Scilly) and SWAG (covering Somerset, Wiltshire, Avon and Gloucestershire). In June 2018 the South West Cancer Alliance (SWCA) implemented a faecal immunochemical testing (FIT) service for occult blood. To support its diagnostic pathway for colorectal cancer (CRC), this is aimed at the early detection of CRC in patients classed as “low risk” but not “no risk” . Providing access to FIT testing for General Practice is one of a number of programmes of work aimed at increasing the proportion of cancers diagnosed at an early stage. Now, with data from over 12 months experience of the programme, the SWCA has shared some key points regarding their route to a successful service implementation. The Patient’s Perspective To facilitate the service within SWCA a complete, bespoke, FIT Patient Pack was developed, to provide all the information and materials required by patients - from how to collect their sample, correct labelling, returning their test, to when to expect the results back. Working with the SWCA, the team at Alpha Laboratories designed the patient pack to meet their requirements and necessary logistics. A stock of packs was provided directly to GPs in the region. The GPs then gave one of these, during consultations, directly to individual patients meeting the FIT testing criteria. The patient pack contains; instructions for use (IFU), the sampling device, a test request form, and a sample return mailing envelope. Patient Friendly Sampling FIT requires the patient to perform the sampling at home with the testing device. Collecting a sample with the FIT device is simple and more hygienic compared, for example, to collecting onto a guaiac faecal occult blood card, or providing a faecal sample in a pot. This patient friendly ease of use does help to increase uptake of the test. Bespoke Patient Packs Help Support Cancer Testing Progress in the South West REQUEST FORM TO BE COMPLETED BY GP FAECAL IMMUNOCHEMICAL TEST (FIT) FOR OCCULT BLOOD USE BLOCK LETTERS & BALL POINT PEN Date issued to patient: NHS NO: SPECIMEN: Faecal Sample SURNAME: INDICATIONS - MUST BE COMPLETED A REQUEST WITH NO INDICATIONS OR FROM PATIENTS <50 YEARS WILL NOT BE PROCESSED For use in people who have symptoms that could suggest colorectal cancer, but in whom a diagnosis of cancer is unlikely. Clinical indications defined by NICE in patients without rectal bleeding: Aged over 50 with: unexplained abdominal pain or weight loss Aged 50 - 60 with: changes in bowel habit or iron deficiency anaemia Aged 60 or over and have anaemia without iron deficiency FORENAME(S): MALE FEMALE Date of Birth DD MM YY If preferred use an addressograph label REQUESTED BY: Pathology Sciences Laboratory Southmead Hospital Bristol BS10 5NB Tel: 0117 414 8424 Email: Nbn-tr.nbtfit@nhs.net Website: www.nbt.nhs.uk/FIT_testing Practice Details (Code and Address) R P n a 2 Write your name and date of birth ANDthe date that the sample was taken on the label on the green bag. You may find a way that is easier for you, but make sure you catch your stool sample before it touches the water. 1 Write your name, date the sample was taken AND date of birth on the tube labels as shown here. Start Here... Date of Birth 25.07.1957 H g Name Date of Sample 999XXX 80101274 2099.12.31 M / F A. Sample 20.04.2018 Instructions continued overleaf... NB: Please write the date of sample on the green bag. Patient Instructions for Collecting Your Sample If you would like more information about FIT testing visit www.nbt.nhs.uk/FIT_testing How to Collect Your Sample BEFORE YOU BEGIN.... Your GP has asked you to complete this test. It is important that you do this as soon as possible. Once completed post the kit straight away in the stamped addressed envelope provided. 3 HOW TO CATCH THE SAMPLE It is important that your stool sample does not touch the toilet water. There are different ways to collect your sample, try: A. Several layers of folded toilet paper B. Hand inside a small plastic bag/glove C. A clean disposable container Faecal Immunochemical Test (FIT) Pack Supplied by: Lot no: 230AGD Expiry: 30/04/2019 www.alphalabs.co.uk Ŷ If you are running out of packs email: Nbn-tr.nbtfit@nhs.net to obtain more Ŷ Ensure the issuing of this collection kit is recorded in case the sample is not collected or gets lost in the post DOCTOR PLEASE NOTE : You MUST complete the request form inside this pack, including recording the date it was issued, BEFORE handing over to the patient. Business Reply Licence Number RSAC–SYBY–CLTZ North Bristol NHS Tru t Clinical Biochemistry Southmead Hospital Southmead Road Bristol BS10 5NB TAFDDDDDAFTAAFDDFFTDFTDADATDDTADAAAT HOW to Pl 1. Preparation Write your NAME and Date of Birth on the Green Plastic Bag and Device. Carefully and slowly twist and pull out the Stick Part from Main BODY. H g Name Date of Sample 999123 80101274 2021.12.31 M / F I E l 999123 2021.12.31 Name Date of Sample 80101274 Name Date of Sample 80101274 Date of Sample 80101274 M / F Date of Sampling (DD/MM/YYYY) NAME Mr Ms Date of Birth (DD/MM/YYYY) / / / /
Find out more at www.faecal-immunochemical-test.co.uk 13 One of the challenges in clinical diagnostics is the logistics of getting a quality sample from the patient to the laboratory for analysis, to minimise pre-analytical variation. Fortunately, the introduction of FIT has vastly improved the method for faecal sample collection. This is an important aspect of the process since the clinical outcomes are dependent on the ability of the assay to detect faecal haemoglobin at very low, versus undetectable concentrations. Based on extensive experience in delivering services for both screening and symptomatic programmes, Alpha Laboratories’ expertise can help support the logistics for providing FIT testing. However, patients must be clearly instructed on how to collect the stool, and how to sample it with the test device, in order to minimise any pre-analytical variability. There is also the element of the “unpleasant sample”: many patients would often prefer a blood test to a stool test simply because of the nature of the sample and how to collect it. For these reasons, the bespoke IFU was created to help people participate and encourage those who were unsure, to ask for help. The main purpose of the IFU is to; ■ Improve patient acceptance and uptake by using familiar terminology ■ Improve sampling compliance, by combining graphics and text for clarity, to reduce pre-analytical variation ■ Standardise the service to aid data collection and analysis Patient Feedback To help assess the effectiveness of the IFU, plus the patients understanding and receptiveness of the test, a short questionnaire card was also included in the patient pack. This survey method allowed patients to provide their feedback on the service, to help the SWCA ensure they are offering the best service for patients. The questionnaires focused on how user-friendly the test was, and what the patient thought of the end-to-end process. 95% of patients understood their instruction leaflet. 96% knew what to do with their sample once completed. Name Date of Sample 107AIE 00000024 2023.05.31 M / F LOT Date of Birth 20.11.2021 Amy Sample 25.07.57 95% of patients understood their instruction leaflet 96% of patients knew what to do with their sample once completed 92% reported that their GP explained the purpose of the test. This excellent response highlights that most patients found the instructions clear and were able to return the samples without issue. The SWCA also reports that the return rate of the questionnaire card was high; almost all patients who submitted a FIT sample, also included their completed questionnaire card. Primary Care Engagement To further support the service, when it was launched in 2018, Primary Care Engagement events were held. Printed guides were developed for the GPs to aid their decisionmaking process and help them understand the role of FIT in the referral pathway. Patients were also questioned on how well they felt the GP was able to help them; was the test explained, and was the onward pathway outlined to them? 92% of patients reported that their GP explained the purpose of the test. The feedback directly from primary care is also positive. With all surgeries now fully participating in the FIT referral service, it is hoped that this will continue to support the CRC pathway to ensure more cancers are found earlier. This support from primary care is vital to the success of the service. A structured service with engagement from all stakeholders is key to bringing down costs and ensuring effective use of the test – ultimately working to improve the patient experience and outcomes.
RkJQdWJsaXNoZXIy MTUyODc1Mw==