Perspective 2020

GASTROENTEROLOGY CLINICAL SUPPLEMENT 2020 Alpha Laboratories Ltd COVID-19: Accelerating Evolution in Gastroenterology Diagnostics IN THIS ISSUE ...Case Studies, Patient Views, Research Reports, Guidance South West Cancer Alliances - HSJ Awards recognition for Faecal Immunochemical Testing Implementation 2 Things you only know if… Your partner has a chronic illness 6 Bespoke Patient Packs - Facilitating Remote Patient Sampling 3 Big Changes to IBD Clinics - During the COVID-19 Pandemic 7 The Evolving Use of Faecal Immunochemical Testing Accelerated by the COVID-19 Pandemic 4-5 Digital Health - How Technology Can Improve and Provide Personalised Patient Care 8-11

PERSPECTIVE 2020 2 Alastair McLellan Editor HSJ Cancer Care Initiative of the Year Implementation of Symptomatic Faecal Immunochemical Testing in the South West South West Cancer Alliances FINALIST Success in the South West – Congratulations for Cancer Care Initiatives In 2018, the South West Cancer Alliances (SWCA) began a pilot for the use of faecal immunochemical testing (FIT) in primary care. The programme was led by the SWCA (Peninsula and Somerset, Wiltshire, Avon and Gloucestershire Clinical Advisory Groups -SWAG) working in partnership with 7 Clinical Commissioning Groups (CCGs), 14 Trusts, GP Cancer Leads, Cancer Research-UK (CR-UK), Exeter Pathology Service, Severn Pathology Service and the DISCOVERY Team at the University of Exeter. The aim was to provide access to FIT for over 600 General Practices, serving a population of approximately 4.5 million across the South West. Following the successful pilot, the full service was implemented the following year. FIT has proven a valuable resource, not just for colorectal cancer (CRC) referral pathways in primary care, but also for triaging in secondary care. With changes to endoscopy services due to the COVID-19 pandemic, FIT has been instrumental in supporting these pathways, and getting patients access to the right services. Another exciting development for the team, was the announcement of their selection as finalists in the HSJ (Health Services Journal) Value Awards 2020. The Value Awards focus on the NHS, and public sector groups who have made exceptional progress on cancer care and prevention. The South West Cancer Alliances were listed, among only seven others, as finalists in the “Cancer Care Initiative of the Year” category! This is a fantastic achievement, showcasing the hard work of all involved, and provides a brilliant model for successful FIT implementation. We would like to congratulate all those involved with the project. The Peninsula Cancer Alliance team produced a video about FIT and its implementation in the South West. You can view this at: As the global coronavirus pandemic persists, adjustments are being made across gastroenterology services to ensure the best patient care can be delivered under the cicumstances. The impact and challenges have been huge. In June 2020 the British Society of Gastroenterology reported on the redeployment of Gastroenterologists to other duties, the reduction in the volume of endoscopy, with 21% doing 2 week waits, 11% urgent cases and 5% routine cases. Only 47% had access to trained endoscopy nursing staff for emergency/essential endoscopies. Of those still doing clinics, on average they were doing 57% of their normal number. The majority were doing telephone or video clinics, although only 11% had access to video consultations. 56% of referrals not seen were being collated by the administration team to be seen postCOVID, implying that a significant proportion are at risk of being potentially missed or triaged using different criteria. There is a large backlog of clinic and endoscopy cases and concern that a proportion of patients will have a delayed diagnosis of cancer and poor outcomes for benign disease. This issue of Leading Edge explores how evolutions in gastroenterology diagnostics are helping to support the response to these problems, by offering methods for remote patient testing and non-invasive triage. The benefits of faecal immunochemical testing expanding into secondary care is explored and case studies from Basildon and Glasgow share real life examples of rapid implementation of calprotectin home testing, accelerated by demands of the pandemic.

Find out more about FIT at 3 Bespoke Patient Packs Facilitating Remote Patient Sampling When the COVID-19 pandemic brought endoscopy services to a stand-still, diagnosis and treatment pathways for suspected colorectal cancer (CRC) were presented with a host of new challenges. With only urgent and essential procedures to be performed, it was vital to ensure individuals on waiting lists were triaged appropriately, and those in the most urgent need of assessment, were prioritised. Faecal Immunochemical Testing (FIT) posed a valuable resource for this new pathway and has been widely implemented for triaging in secondary care. This, however, is only part of the problem in terms of diagnosing CRC quickly. Face-to Face GP Appointments Decreased by 30% During the start of the pandemic, individuals were less likely to visit their GP. NHS Digital (2020) reported face-to-face GP appointments decreased by 30% in May 2020, compared to the same time last year. This is a staggering number of people who may be choosing not to visit their GP, as the fear of COVID-19 outweighs the fear of the cause behind their symptoms. Phone Consultations Increase Fortunately, phone-consultations increased from 14% of all appointments in February 2020, to 48% in May 2020. Phoneconsultation, although safer in terms of reducing possible exposure to COVID-19, still presents a challenge in terms of collecting samples from patients, or performing physical examinations (for example, a digital rectal exam (DRE)). To facilitate this change in GP appointment access, FIT has evolved. FIT Patient Packs Patient Packs have been in use by many trusts for some time, for the referral of patients from Primary Care. Patient Packs are bespoke sampling kits that the GP or hospital can send directly to patients. They enable the sample for the FIT test to be taken at home, and returned either via the post to the laboratory, or to the GP office. The packs reduce the amount of face-to-face contact: helping to keep people safe during the pandemic. The bespoke instruction leaflets direct the patient through their pathway: how to take the test, advice on collecting their sample, and instructions on how to return the completed kit. By rolling out the Patient Packs into both primary and secondary care, FIT has been instrumental in reducing endoscopy waiting lists by increasing patient access. The packs can be customised for secondary care, primary care, Vague Symptoms Pathways (VSPs), or Rapid Diagnostics Centres (RDCs) – making sure the pack guides the patient accurately on their pathway and outlining what they can expect in terms of follow-up. Communication with patients is key for continued compliance: the packs can be used to help guide patients on safety netting services, highlight what other diagnostic services are currently offered, or what to do if they remain concerned following their test result. A well-structured, patient-centric approach is key to maximising the benefits of FIT in these difficult times. If you would like additional information on Patient Packs, or to discuss how the Packs can improve your service, please contact us. References NHS Digital (2020) “Appointments in General Practice May 2020” Appointments in General Practice. [online] Available at: data-and-information/publications/statistical/ appointments-in-general-practice/may-2020 (Accessed 03 August 2020) H g Name Date of Sample 999123 80101274 2021.12.31 M / F Amy Sample Date of Sampling (DD/MM/YYYY) / / NAME Mr Ms Date of Birth (DD/MM/YYYY) / / 25 07 1957 20 04 2018 Amy Sample H g Name Date of Sample 999123 80101274 2021.12.31 M / F Amy Sample H g Name Date of Sample 999123 80101274 2021.12.31 M / F Amy Sample H g Name Date of Sample 999123 80101274 2021.12.31 M / F Amy Sample H g999123 2021.12.31 Name Date of Sample 2021.12.31 Name Date of Sample Name Date of Sample Date of Sample 80101274 Date of Sample 80101274 Amy Sample Amy Sample M / Date of Sample Amy Sample Amy Sample Amy Sample Amy Sample Amy Sample M / Amy Sample M / Amy Sample Amy Sample Amy Sample Amy Sample Amy Sample Amy Sample M / M / F Amy Sample Amy Sample Amy Sample Amy Sample Amy Sample Amy Sample Amy Sample Amy Sample

4 PERSPECTIVE 2020 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 about FIT at 5 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). 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. 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. coronavirus/wp-content/uploads/sites/52/2020/06/ C0551-triaging-patients-with-lower-gi-symptoms16-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. 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 During COVID-19 Pandemic Scotland 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

6 PERSPECTIVE 2020 In this humbling account, Rose Stanley, wife of long term Crohn’s sufferer Lee, shares her experiences of how, together, they tackle the daily challenges of living with the disease. It reminds us of why efficient monitoring, to help individuals manage the condition themselves, is so important. “I’ve been with my husband for twenty eight years and he’s been ‘sick’ for twenty seven and a half of them and life is not dissimilar to what everyone has experienced during lockdown. Specifically, short notice cancellations, you can’t do what you want when you want and you are often having to put other people’s health before your own! When you make your wedding vows, like when you listen to the small print in an advert you agree to ‘in sickness and in health’ but you rarely comprehend what that actually means. Even if you think you know what you’re signing up to. Lee and I married on our tenth anniversary, by which time he already had two major operations for Crohn’s disease. I thought I knew what I was dealing with. It didn’t put me off. I didn’t have a second thought about the commitment I was taking on. If you’ve ever loved, you’ll know what it’s like to want to walk the ends of the earth for your partner. Ever the optimist, our quests to find a cure have seen us chasing the world’s leading doctors in Australia and America, trying all sorts of mad cap diets, even experimenting with worms! At times it’s been like a scene from ‘Lorenzo’s oil’ in our house. And the money. It costs a lot to be sick. Prescriptions, supplements, probiotics, consultant fees, hospital parking fees, healthy eating, loss of income. It’s a financial burden not to be underestimated. What I didn’t comprehend though was the daily toil on the mind. Both our minds. Dust yourself off and start again. That’s tiring. When you have to do it weekly or even daily. Its always two steps forward, one step back. Crohn’s disease is a hidden illness and an embarrassing illness so people stop asking you about it too. It’s probably made us stronger, we’re fairly indestructible. When you watch someone in so much pain or stand by helplessly thinking they’re going to die, it kinda focuses you on what’s important. That the kids have a loving dad, that I have a loving husband. We rarely row and when we do we resolve it quickly. It seems pointless expending the energy that we need to save for other more significant matters. And I admire him so much for the fight, for the resistance to what seems at times like torture, for the times he leads a business meeting with a head full of fog and a stomach full of cramps. My own job sees me working with all types of people and in the past I’ve found myself standing on a stage or doing an interview, evangelising about the positive change the business makes with young people, whilst flicking glances at my phone in case I need to get back early if there’s a problem. And, jokingly Lee points out on a regular basis that I’d be nothing without him! And I agree. Not just because of the slack he has picked up over the years in home care and childcare, but also because ironically, so many career decisions have been made as a result of putting my family first. I didn’t necessarily choose to do a lot of the things I’ve done, they just fitted with what my family needed from me, be that hard fast cash or just flexible hours. But not least, because when it all gets overwhelming he’s there, solid in his support to pick up the pieces. I’m definitely no saint. I feel sorry for us a lot. I wistfully watch as friends travel and socialise, as not being able to travel is what I find the hardest. I can’t even pretend I haven’t thought ‘Well! now you know what I feel like!’ when everyone else’s trips got cancelled at short notice this summer due to the pandemic. But I am grateful. As ridiculous as it sounds I’m grateful for all the beautiful things people do when you least expect it. A kind text, a knowing nod, an offer of support. And for the ever present rock, that is my family, my wonderful family and friends support network. Living with illness is humbling and insightful. You realise everyone’s got their challenges to deal with and you’ll often have no idea. Unless you ask.” Lee writes a regular blog that includes accounts of his experience of using the BÜHLMANN IBDoc® calprotectin home test: Things you only know if… Your partner has a chronic illness: Rose Stanley Rose and Lee managing to have a good time at a wedding last year.   Life is not dissimilar to what everyone has experienced during lock-down.

Find out more at 7 Big Changes to IBD Clinics During the COVID-19 Pandemic In May 2020 results of a global survey1, on the views of patients with inflammatory bowel disease during the COVID-19 pandemic, were published in The Lancet online. The data showed that 74% of IBD patients were afraid to go to the hospital or IBD centre for a gastroenterological consultation. A UK survey conducted by Kennedy et al.2 during the initial stages of the pandemic, evaluated the challenges presented to IBD services and the adaptations required to meet these challenges. It revealed that key tools for monitoring and managing IBD patients were removed or restricted. ■ 35% reported all IBD related endoscopy activity had been cancelled, but most reported significant reduction in availability ■ In addition 27% locations reported no access to faecal calprotectin, whilst a further 32% reported reduced access They also reported a significant reduction in staffing resources for the IBD team. 94% reported an increase in IBD advice line contact. [Figure 1]. Face-to-face consultations in outpatients, non-emergency endoscopies and elective IBD had been significantly curtailed. There was an increased uptake of telemedicine, virtual multidisciplinary team meetings and non-invasive monitoring of patients. ■ 62% reported patient initiated cancellation of some infusions (~10%) due to: □ Self-isolation due to COVID symptoms □ Fears and concerns about therapies ■ 86% substituted face to face clinics with telephone consultations 11% substituted face to face clinics with video consultations The study concluded that despite these unprecedented and challenging times, opportunities were presented from the rapid adaptation of models of service delivery. Some of these are likely to also be suitable in a post-COVID-19 world, bringing positive changes in IBD services resulting from this difficult time. What will IBD Care look like in the ‘New Normal’? A further survey conducted by Charlie Lees, Consultant Gastroenterologist at the Western General Hospital, shows the changes in how IBD clinics have been operating before and during the COVID pandemic and what is anticipated moving forward: [Figure 2] The view is that face-to-face consultations will reduce to about 50% in the future. A small proportion of respondents had been using home faecal calprotectin tests (including IBDoc®). The publication noted: “Of those that haven’t [used home calprotectin testing], the overwhelming majority replied that this is something they are interested in adopting.” Implications of Recurrent SARS-CoV-2 Outbreaks for IBD Management Segal and Moss published a review in Frontline Gastroenterology4 in June 2020 summarising the changes in IBD clinical practice that will be required during the ‘post-peak’ phase of viral pandemics. They state “The ability to detect deteriorations in disease and react remotely will be important: ■ IBD Apps for recording symptoms ■ Faecal calprotectin should be incorporated into remote monitoring, ideally using home kits for sample acquisition” They also concluded that: “Faecal calprotectin should replace endoscopy as a means to confirm mucosal healing or assess symptom relapse in most cases” References 1. Views of patients with inflammatory bowel disease on the COVID-19 pandemic: a global survey. July 2020 PIIS2468-1253(20)30151-5.pdf 2. Kennedy NA, et al. Organisational changes and challenges for inflammatory bowel disease services in the UK during the COVID-19 pandemic. Frontline Gastroenterology 2020;0:1–8. doi:10.1136/flgastro-2020-101520 3. Lees CW et al. Innovation in Inflammatory Bowel Disease Care During the COVID-19 Pandemic: Results of a Global Telemedicine Survey by the International Organization for the Study of Inflammatory Bowel Disease, Gastro Journal, May 28, 2020, 4. Segal JP, Moss AC. Implications of recurrent SARSCoV-2 outbreaks for IBD management, Frontline Gastroenterology. 2020;0:1–6. doi:10.1136/flgastro-2020-101531 Figure 1 - Change in inflammatory bowel disease advice line calls during the COVID-19 era.2 Figure 2 - Stacked bar chart showing proportion of inflammatory bowel disease (IBD) clinics that were conducted face-to-face, by telephone and by video consultation before the coronavirus disease-19 (COVID-19) (top), during the COVID-19 pandemic (middle), and anticipated proportions after COVID-19 (bottom). 2

8 PERSPECTIVE 2020 The recent 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 has been 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 Digital Health - How Technology Can Improve and Provide Personalised Patient Care Mid and South Essex University Hospital Trust

Find out more at 9 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

10 PERSPECTIVE 2020 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 11 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 selfcare 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.” Who Needs That Valuable Clinic Space? 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:

40 Parham Drive, Eastleigh, Hampshire, SO50 4NU, UK Tel: 023 8048 3000 | Email: Web: Registered in England 1215816 Calprotectin Testing Make more informed clinical decisions without waiting for lab results. The future for IBD Care: ■IBDoc® Home Tests Supporting remote patient monitoring and virtual clinics ■Quantum Blue® for Point of Care Helps triage patients in clinic giving results in a rapid time frame (15 minutes) Faecal Immunochemical Testing Triage patients within the colorectal cancer pathway ■Complete customised FIT ‘Patient Packs’ ■Include everything the patient requires to take their sample safely at home and return it to the laboratory. Find out more at Simple Solutions to Support Clinical Decision Making in Gastroenterology For more information, to discuss your requirements or organise an evaluation please contact: H g Name Date of Sample 999123 80101274 2021.12.31 M / F 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. 999123 2021.12.31 Name Date of Sample 80101274 2021.12.31 Name Date of Sample 80101274 Date of Sample Date of Sampling (DD/MM/YYYY) NAME Mr Ms Date of Birth (DD/MM/YYYY) / / / / Faecal I munochemical Testing Triage patients within the colorectal cancer pathway to better manage colonoscopy resources. ■Complete customised FIT ‘Patient Packs’ ■Include everything the patient requires to take their sample safely at home and return it to the laboratory. If undelivered please return to 40 Parham Drive, Eastleigh, Hampshire, SO50 4NU