Gastroenterology Today Summer 2021

Gastroenterology Today Summer 2021 Gastroenterology Today Summer 2021

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FEATURE ENCOURAGING UPTAKE OF FAECAL IMMUNOCHEMICAL TESTS (FIT) IN ASSESSMENT OF PATIENTS WITH LOWER BOWEL SYMPTOMS Keywords: Faecal immunochemical test (FIT), COVID-19, bespoke, FIT-KIT, triaging, endoscopy, waiting time. Abstract GASTROENTEROLOGY TODAY - SUMMER 2021 6 In April 2020, all non-urgent endoscopy procedures were suspended due to the COVID-19 pandemic. Consequently, those referred for colorectal cancer (CRC) investigation in England under the NG12 1 and DG30 2 guidelines faced increasing waiting times. It became necessary to triage these patients to allocate resources effectively. However, the pandemic makes patient contact challenging, reducing the number of face-toface consultations to minimise the spread of COVID-19. Faecal immunochemical tests (FIT) offer a unique solution since the process can be managed “contact free”, reducing risk to patients and health workers. Faecal sample collection by patients is still novel, compared to other sample collection methods such as for blood tests. However, patients are often reluctant to handle faecal samples. A solution must, therefore, have a patient-centred approach to encourage sample collection and return, while ensuring good quality samples for analysis. The answer lies in the provision of bespoke patient literature. Trust and Health Board specific leaflets with local phone numbers, QR-codes, barcodes, and clear visuals, with non-clinical instructional text, provide much needed support to FIT pathways which, in turn, has aided the management of endoscopy waiting lists. The bespoke leaflets result in noticeable increases in return rates, and the quality of samples received by laboratories are also much improved. The onset of the COVID-19 pandemic caused widespread disruption to many clinical diagnostic pathways. Already overburdened endoscopy services faced considerable reductions, resulting in fewer procedures and, in consequence, fewer diagnoses of colorectal cancer (CRC) and other significant bowel diseases. CRC is highly treatable if detected in its early stages 3 and long-term quality of life is much improved following successful treatment. However, the waiting times for endoscopy have resulted, and still are resulting, in concerning delays to diagnosis 4 . Therefore, a supporting pathway is a necessary prerequisite to alleviate pressure on the service and prioritise those with the most severe symptoms for further investigation. Use of FIT It is widely appreciated that FIT is the ideal tool to use, not only to continue supporting the existing primary care pathways, as guided by NICE NG12 1 and DG30, 2 but also for use in secondary care and triaging patients on waiting lists. National guidelines published in both England 5 and Scotland 6 outline how FIT can be used to support CRC referrals in the pandemic, by using higher faecal haemoglobin concentration (f-Hb) thresholds than that recommended originally for the low-risk cohort under DG30. 2 The f-Hb is proportional to the risk of severe disease and has been proven to be a valuable marker even in those referred with rectal bleeding 7 , suggesting that FIT is suitable in both high- and low-risk patient groups. This is further supported by recent diagnostic accuracy studies, highlighting that the negative predictive value (NPV) for CRC is over 98.9% 8 even when using a high threshold of 150 µg Hb/g faeces. Other possible thresholds for investigation have been very recently documented in detail 9 . However, ubiquitous use of FIT in the triage for further investigation of patients presenting with symptoms is still relatively novel in terms of sample collection and logistics, so, while technically FIT is a suitable test, its application must be carefully managed to ensure the issues with overburdened services are resolved, and not just relocated. Managing Remote Sample Collection GP consultations dropped by 30% between the end of March and end of May 2020 10 , and primary care is the most common starting point for referral for patients with suspected CRC. With this decrease, there was concern surrounding the use of FIT and how well clinical pathways could be supported. To address this, innovative logistics strategies were required because good engagement is a key driver to motivating patients to collect and sample faeces and return these samples for analysis. Since telephone and video consultations increased sharply, it was considered that the FIT sample collection device and instructions for use, could be posted out to the patient, as well as being collectable at the GP surgery. After the sample is collected by the patient, the device is either posted back to the laboratory or dropped off at the GP surgery for onward transport. These approaches make the complete process between consultation and the generation of a result “contact free” and therefore considerably reduces the risk of spreading COVID-19. With the sample collection, handling, transport, and other logistics now in place, encouraging correct use is clearly a vital consideration. Maximising Uptake With such reliance on samples collected by patients, uptake is vital. With faecal samples, there are the associated “fear” and “disgust” factors which deter some patients from collecting the sample, in spite of the

FEATURE simple, easy to use, hygienic FIT sample collection devices. However, bespoke instruction for use (IFU) leaflets have been hugely influential in increasing uptake and improving sample quality. Such IFU are based around core sampling requirements but adapted to suit the specific clinical pathway adopted by Trusts and Health Boards. With local contact numbers, bar-codes, and detailed pathway information, patients are made to feel included in the diagnostic process and are provided with the tools to complete the sample collection successfully or talk to a knowledgeable professional should they have any questions. IFU have evolved over time, after initially being used in primary care, FIT is now being used in a more diverse range of patients, 11 so the detail must be regularly reviewed to ensure suitability. Usability studies, consultation events, focus groups and feedback from cancer charities all could contribute to the design and production of these IFU to maximise the inclusivity of the process. The design and application of sample collection devices are suited to patient-based sampling and, although the attributes will not be discussed in detail here, research has been conducted on the efficacy of FIT in the hands of patients, 12,13 , proving them suitable for this application. Additionally, the IFU provide supporting information such as tips for collecting the faeces prior to using the device, which helps familiarise using faeces as a sample and helps break some of the barriers to the sampling process. It also helps reduce contamination risk in terms of the faecal sample, and the sample collection device. FIT for All The last, and possibly most critical, barrier to uptake, is ensuring the IFU are suitable for a range of patient groups. With FIT now being used in a diverse range of patients, the bespoke literature must be as inclusive as possible, ensuring patients can understand and follow the instructions. As discussed above, the use of simple colourful pictures or diagrams and text help those with visual impairments, or those for whom English is not a primary language, and the additional information provided, such as phone numbers, links to videos and websites, provide more routes for patients to access help should this be required. It is important to consider that a FIT device should not be simply handed to a patient with no advice: as part of the safety-netting process, FIT should be provided following a discussion with the patient. Large, full-colour pictures with accompanying text provide patients with user-friendly guidelines on the collection of faeces, using the sample collection device to take the sample, and then how to return it for analysis. Additional information should be provided on the clinical pathway, why the test has been requested, and who to contact if the patient has questions. These personalised aspects reduce the unpleasantness associated with faecal sample collection. Their introduction has resulted in an increase in return rate facilitating a service to maximise impact and alleviate some waiting times. Quality Samples Any pathway involving a patient collected sample must yield samples suitable for analysis. With FIT, there has been much scrutiny over the use of a patient utilised sample collection device and the possible impact on the laboratory result and, therefore, on patient outcome. The primary consideration here is that FIT should never be used in isolation and should be a tool applied in conjunction with clinical suspicion and adjunct tests including the full blood count and iron studies when appropriate, to further reduce the risk of missing CRC, particularly in complex patients on waiting lists. 11 Concerns around patient sampling include over-sampling, undersampling (or even, not sampling at all and providing an unused device for testing). Contaminating the faeces prior to sampling with, for example, menstrual blood and toilet cleaners can also be an issue. To ensure continued relevance in the pathway, IFU are continuously reviewed. Involvement with patients, key opinion leaders, and feedback from laboratories all contribute to the ongoing improvement programmes. Ensuring fidelity to the Trust or Health Board’s specific clinical pathway helps the laboratories manage the samples effectively, reducing the risk of overburdening the analytical capability. Feedback is positive, with many reports showing over 90% of patients have been able to follow the IFU and use the device as intended. 14 Logistics The initiation of the use of FIT following the design of an IFU includes the logistics: some encourage the GP surgery to hold stock of the FIT-KITs (device, plus IFU, plus return envelope) so distribution is managed on a local level, whereas others (particularly those with electronic test requesting) have a centralised location from which the FIT-KITs are distributed. Both models work for their respective users, with stock management and logistics managed in a similar way to other consumables, slotting into already proven processes. Sample return logistics are also well studied. Originally, postal return services, similar to the methods used in the bowel screening programmes conducted in all four nations of the UK, was preferred, reducing the footfall in GP surgeries, and giving patients a quick and convenient sample return method. The ambient temperature stability of any haemoglobin present after collection of faeces means a postal return service would be a suitable route for sample returns. However, due to cost implications, the return of samples via the GP surgery is becoming more popular, negating the postage costs. Samples can be efficiently and effectively returned to the laboratory with other types of specimens via existing transport services. There has been no reduction GASTROENTEROLOGY TODAY - SUMMER 2021 7

FEATURE<br />

ENCOURAGING UPTAKE OF FAECAL<br />

IMMUNOCHEMICAL TESTS (FIT) IN ASSESSMENT<br />

OF PATIENTS WITH LOWER BOWEL SYMPTOMS<br />

Keywords: Faecal immunochemical test (FIT), COVID-19, bespoke, FIT-KIT, triaging, endoscopy, waiting time.<br />

Abstract<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2021</strong><br />

6<br />

In April 2020, all non-urgent endoscopy procedures were<br />

suspended due to the COVID-19 pandemic. Consequently,<br />

those referred for colorectal cancer (CRC) investigation in<br />

England under the NG12 1 and DG30 2 guidelines faced increasing<br />

waiting times. It became necessary to triage these patients to<br />

allocate resources effectively. However, the pandemic makes<br />

patient contact challenging, reducing the number of face-toface<br />

consultations to minimise the spread of COVID-19. Faecal<br />

immunochemical tests (FIT) offer a unique solution since the<br />

process can be managed “contact free”, reducing risk to patients<br />

and health workers. Faecal sample collection by patients is still<br />

novel, compared to other sample collection methods such as<br />

for blood tests. However, patients are often reluctant to handle<br />

faecal samples. A solution must, therefore, have a patient-centred<br />

approach to encourage sample collection and return, while<br />

ensuring good quality samples for analysis. The answer lies<br />

in the provision of bespoke patient literature. Trust and Health<br />

Board specific leaflets with local phone numbers, QR-codes,<br />

barcodes, and clear visuals, with non-clinical instructional text,<br />

provide much needed support to FIT pathways which, in turn, has<br />

aided the management of endoscopy waiting lists. The bespoke<br />

leaflets result in noticeable increases in return rates, and the<br />

quality of samples received by laboratories are also much<br />

improved.<br />

The onset of the COVID-19 pandemic caused widespread disruption to<br />

many clinical diagnostic pathways. Already overburdened endoscopy<br />

services faced considerable reductions, resulting in fewer procedures<br />

and, in consequence, fewer diagnoses of colorectal cancer (CRC) and<br />

other significant bowel diseases. CRC is highly treatable if detected in<br />

its early stages 3 and long-term quality of life is much improved following<br />

successful treatment. However, the waiting times for endoscopy have<br />

resulted, and still are resulting, in concerning delays to diagnosis 4 .<br />

Therefore, a supporting pathway is a necessary prerequisite to alleviate<br />

pressure on the service and prioritise those with the most severe<br />

symptoms for further investigation.<br />

Use of FIT<br />

It is widely appreciated that FIT is the ideal tool to use, not only to<br />

continue supporting the existing primary care pathways, as guided by<br />

NICE NG12 1 and DG30, 2 but also for use in secondary care and triaging<br />

patients on waiting lists. National guidelines published in both England 5<br />

and Scotland 6 outline how FIT can be used to support CRC referrals in<br />

the pandemic, by using higher faecal haemoglobin concentration (f-Hb)<br />

thresholds than that recommended originally for the low-risk cohort<br />

under DG30. 2<br />

The f-Hb is proportional to the risk of severe disease and has been<br />

proven to be a valuable marker even in those referred with rectal<br />

bleeding 7 , suggesting that FIT is suitable in both high- and low-risk<br />

patient groups. This is further supported by recent diagnostic accuracy<br />

studies, highlighting that the negative predictive value (NPV) for CRC<br />

is over 98.9% 8 even when using a high threshold of 150 µg Hb/g<br />

faeces. Other possible thresholds for investigation have been very<br />

recently documented in detail 9 . However, ubiquitous use of FIT in the<br />

triage for further investigation of patients presenting with symptoms<br />

is still relatively novel in terms of sample collection and logistics, so,<br />

while technically FIT is a suitable test, its application must be carefully<br />

managed to ensure the issues with overburdened services are resolved,<br />

and not just relocated.<br />

Managing Remote Sample Collection<br />

GP consultations dropped by 30% between the end of March and end<br />

of May 2020 10 , and primary care is the most common starting point<br />

for referral for patients with suspected CRC. With this decrease, there<br />

was concern surrounding the use of FIT and how well clinical pathways<br />

could be supported. To address this, innovative logistics strategies<br />

were required because good engagement is a key driver to motivating<br />

patients to collect and sample faeces and return these samples for<br />

analysis. Since telephone and video consultations increased sharply, it<br />

was considered that the FIT sample collection device and instructions<br />

for use, could be posted out to the patient, as well as being collectable<br />

at the GP surgery. After the sample is collected by the patient, the<br />

device is either posted back to the laboratory or dropped off at the GP<br />

surgery for onward transport. These approaches make the complete<br />

process between consultation and the generation of a result “contact<br />

free” and therefore considerably reduces the risk of spreading<br />

COVID-19. With the sample collection, handling, transport, and<br />

other logistics now in place, encouraging correct use is clearly a vital<br />

consideration.<br />

Maximising Uptake<br />

With such reliance on samples collected by patients, uptake is vital. With<br />

faecal samples, there are the associated “fear” and “disgust” factors<br />

which deter some patients from collecting the sample, in spite of the

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