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Adapting a 2-week-wait colorectal service in the pandemic using the quantitative faecal immunochemical test

08 April 2021
Volume 30 · Issue 7

Abstract

The coronavirus pandemic has brought about an economic and healthcare crisis. This has resulted in delays in virtually all areas of patient care and has forced clinicians to review and adapt their processes, in order to ensure patients continue to have access to timely and effective services. In the author's local Trust, this manifested in altered protocols, developed in order to maintain patient and staff safety while conducting invasive and potentially virus-spreading investigations. A new (temporary) standard operating procedure was developed in conjunction with Cancer Alliance South West to introduce the quantitative faecal immunochemical test (qFIT) as an indicator for diagnostic testing after the majority of diagnostic services were suspended or drastically reduced. Patients would then have their investigation(s) deferred on the basis of a negative result (<10 mcg Hb/g). This cohort (n=120) were revisited once diagnostic services were resumed and referred for CT examination. Audits carried out on the data showed that nine cancers had been identified in the negative qFIT population (lung, prostate, breast, bladder, small bowel carcinoid, oesophageal and three occurrences of caecal carcinoma. This article provides an overview of the experiences and outcomes of a colorectal 2-week-wait service in response to this global pandemic and how this experience will shape the service in the future.

Since October 2014 the colorectal 2-week-wait service at the authors' acute Trust has been a nurse-led service and has demonstrated high levels of patient satisfaction (Cock and Kent, 2017). Before 2014, patients referred on the 2-week-wait pathway by their primary care specialist were seen on an ad hoc basis by junior medical staff in a geographically blind fashion (resulting in many patients travelling excessive numbers of miles around the county). Frequently, the waiting time to be seen was at the 14-day limit, and this prompted the change in service provision. Originally the team began with three permanent members; however, an increased patient demand (from 1500 patients in 2015 to 4600 patients in 2019) has seen this rise to five full-time staff, with a further four in the process of training.

Since implementing a nurse-led service, the waiting time has consistently been kept below 5 days. Not only does the nursing team undertake the patient assessments, but the nurses also review all the results from the booked investigations and determine whether a patient can be discharged back to their GP or requires additional care. Results are checked within 4 days of reporting, meaning that patients do not have to wait an extended period of time before receiving potentially sensitive results (Bromley and Cock, 2019).

Currently the team consists of six fully trained practitioners plus four in training who have undergone or are undergoing further education in clinical examination and history taking, plus a rigorous in-house training programme devised and overseen by the colorectal consultant nurse and the gastrointestinal specialty lead. Each nurse undergoes a supervisory period where they are trained and then observed and monitored for consistency and adherence to guidelines. Once competent in face-to-face assessments, further training is provided so that they can undertake the relatively new format of telephone assessments, which arguably require a greater level of skill (Guttman et al, 2018).

The outbreak of the global COVID-19 pandemic forced a different perspective on urgent care (Cutler, 2020), and clinical service leads were required to consider suitable alternatives for maintaining a 2-week-wait service while ensuring that patients were not subjected to increased risk of contracting the virus by being brought into an acute Trust unnecessarily.

Simply limiting face-to-face interactions with frontline staff meant the overall risk of transmission would be decreased (Murray, 2020) and so, at the end of March 2020, just before the nationwide lockdown was implemented by the Government, the 2-week-wait service was altered to purely telephone delivery.

In the following weeks, and because the virus responsible for COVID-19 is highly transmissible, the population was advised to stay at home and to avoid all non-essential travel (Cabinet Office, 2020) and therefore the move to telephone-only clinics enabled the service to continue to run when many others were forced to stop, as specialist staff were redeployed to cover acute services such as the wards and emergency departments or forced to shield at home themselves. The staffing for the 2-week-wait service was reduced from six specialist nurses (who had multifaceted roles and conducted two clinics a week each) to three full-time colorectal specialist nurses who delivered the service remotely from home.

Remote working has been integral to the bowel 2-week-wait service since April 2018, when an experienced member of the team moved a significant distance for their partner's work. In the business and finance sector, it is not uncommon to have an entire workforce working from a remote location and, although it does come with its own set of unique challenges (such as, suitable management to maintain effectiveness and productivity), there are numerous benefits to this, for both employer and employee (Felstead and Henseke, 2017). These include reduced time commuting (thereby reducing the environmental impact), reduced funds spent on travel (financial benefit to employee), minimising the need for parking spaces (always contentious and difficult in highly populated areas), and in this instance, the retention of a valued worker. Furthermore, in the wake of the pandemic, remote working may continue to be an integral part of future workforce systems.

As this was already working practice, the remaining two team members were able to seamlessly step into the role of remote worker, thus minimising the impact of COVID-19 on the 2-week-wait service and its patients.

There was no deviation from the national NG12 guidance for referral (National Institute for Health and Care Excellence, (NICE), 2017a) and, in the first few weeks, the referral rate of approximately 86 patients a week continued unchanged. However, patients themselves were much more reluctant to attend the hospital for investigations and this led to a small number being discharged (at their own request) back to the GP for re-referral if symptoms persisted or worsened.

A multitude of meetings followed, with endoscopy and radiology either stopping certain services altogether (gastroscopy, computed tomography (CT) pneumocolon) or dramatically reducing what they were able to deliver. This was further impacted by the infection control measures that were implemented to ensure that the departments were sufficiently cleaned between cases and that additional personal protective equipment (PPE) was used (Royal College of Radiologists, 2020).

One of the main changes was the implementation of quantitative faecal immunochemical testing (qFIT) as a first-line test prior to investigation within the colorectal 2-week-wait target. The test is designed to detect blood in stool samples that is not visible macroscopically. It specifically recognises haemoglobin and is more sensitive than the previously used faecal occult blood (FOB) test (NICE, 2017b). Research has shown that the application of such a test, with a view to triaging symptomatic patients, means that there can be some assurance that limited resources (in terms of radiology and endoscopy) are being utilised appropriately (Cheshire and Merseyside Endoscopy Network, 2020) during the COVID-19 pandemic.

Studies have previously been carried out to determine the credibility of employing qFIT as a way of ruling out invasive tests in symptomatic patients (D'Souza et al, 2019) and consensus seems to indicate that this is the way forward, in terms of both patient safety and sustainability. At the local Trust, this data led to the implementation of the COVID-19 algorithm (Figure 1) for all patients without overt rectal bleeding, a rectal/abdominal mass or iron-deficiency anaemia outside of the British Society of Gastroenterology (Goddard et al, 2011) guidelines for the management of iron-deficiency anaemia range (haemoglobin (Hb) <110 g/litre in women; <120 g/litre in men and ferritin <30 mcg/litre) in men and women.

Figure 1. COVID-19 algorithm for colorectal 2-week-wait service at the Royal Cornwall Hospital

The agreement reached between the Trust and the Cancer Alliance South West was that all patients with a qFIT <20 mcg Hb/g would be discharged without test back to their GP to be re-referred after the pandemic if symptoms persisted. There were several discussions among the multidisciplinary team regarding whether it was appropriate to keep these patients on a pending list to be phoned and reviewed at a later stage. However, it was felt that the safest process would be for the GP to retain responsibility for each patient's care and letters were sent to both the patient and GP to advise the patient to contact the GP if symptoms persisted or worsened. Patients with positive qFIT results would be booked for a bowel-clearing test, specifically colonoscopy or CT enema (Faux et al, 2020).

Although CT virtual colonoscopy (CT pneumocolon) is the gold standard test for CT imaging of the bowel (Zaleska-Dorobisz et al, 2014) the radiology department at the local Trust was unable to facilitate these types of CT scans during the COVID-19 pandemic because of a lack of staff and capacity. The only bowel-specific CT imaging available was therefore a CT enema.

At the beginning of June 2020, with services restarting, and a greater capacity for diagnostics, the decision was made to lower the reference range of qFIT to 10 mcg Hb/g. A qFIT has been used to categorise patients in a ‘low risk but not no risk’ group as part of a South West research project running over the previous 2 years, while other areas in the country have studied qFIT testing within the NG12 symptomatic group (Chapman et al, 2020). The test does not categorically identify the presence (or absence) of a cancer but in terms of offering bowel-specific testing, there is little impact on clinical investigative demand when comparing qFIT results >10 mcg Hb/g with qFIT >20 mcg Hb/g (Faux et al, 2020).

Concurrently, the acute Trust was seeking to implement a non-site-specific (NSS) pathway, for those who did not necessarily meet the criteria under the bowel 2-week-wait parameters. Although it was understood that, in the presence of a negative qFIT, a patient's risk of having a colorectal cancer is thought to be low (<0.2–1.1*), the qFIT algorithm was altered to include this cohort and all patients with a qFIT <10 mcg Hb/g were booked for a plain CT of abdomen and pelvis (AP) to exclude non-bowel pathology. In the presence of weight loss the CT was extended to include the thorax (TAP).

An audit was carried out over a 4-week period; 41 patients were booked for a CT (24 CT-TAP and 17 CT-AP), and within this cohort there were four cancers identified (see Table 1). Worryingly, despite the negative qFIT test, three of the cancers reported were advanced colorectal cancers (7*), in stark comparison with Digby et al (2017) who had a cancer detection rate of 0.4*, although it is worth noting that their cohort was significantly larger (n=227). Furthermore, the Digby et al (2017) study was looking purely at colorectal pathology and did not explore extra-colonic cancers. Therefore, although the three colorectal cancers would have been identified, the five non-colorectal cancers in Table 2 would have gone undiagnosed.


Table 1. Cancers in the qFIT<10 mcg Hb/g cohort
Demographics Referral criteria qFIT value Diagnosis Symptoms
56-year-old man IDA (Hb 167 g/L Ferritin: 12.5 mcg/L) <2 mcg Hb/g Oesophageal cancer Nausea, weight loss and low ferritin
79-year-old woman Weight loss and abdominal pain 3 mcg Hb/g Obstructing caecal cancer Variable bowel habit with weight loss and pain
81-year-old man Weight loss and pain 5 mcg Hb/g Caecal cancer with liver and peritoneal metastases No change in bowel habit
64-year-old man Weight loss and pain <2 mcg Hb/g Obstructing caecal cancer with lung and peritoneal metastases Firmer less frequent stool, weight loss

Key: g=gram; Hb=haemoglobin; IDA=iron-deficiency anaemia; L=litre; mcg=microgram


Table 2. Original qFIT<20 mcg Hb/g previously discharged cohort
Demographics Referral criteria qFIT value Diagnosis Symptoms
78-year-old woman Looser stools <2 mcg Hb/g Lung cancer Looser more frequent stools and weight loss
66-year-old man Looser stools <2 mcg Hb/g Prostate cancer Looser more frequent stools
51-year-old woman Looser stools 5 mcg Hb/g Breast cancer Looser more frequent stools, painful defecation and weight loss
80-year-old man Looser stools <2 mcg Hb/g Bladder cancer Looser more frequent stools only
77-year-old man Weight loss and abdominal pain <2 mcg Hb/g Carcinoid tumour Looser more frequent stool, weight loss and abdominal pain

Key: g=gram; Hb=haemoglobin; mcg=microgram

Based on this information, and a 9.8* cancer pick-up rate within this cohort, the decision was made to review the cohort of patients previously discharged back to their GP with a qFIT of <20 mcg Hb/g. All 79 patients were offered either a CT-TAP or CT-AP dependent on symptoms.

  • 45 patients: CT-AP
  • 27 patients: CT-TAP
  • 2 patients: admitted with obstruction
  • 5 patients had been booked via an alternative route for a bowel-clearing investigation

This cohort identified a further five cancers (see Table 2) of variable origin (6.3*).

The combined cohort of all patients identified during the COVID-19 pandemic (6 April to 1 July 2020) through the authors' colorectal 2-week-wait service with a qFIT<10 consists of 120 patients with a cancer detection rate of 7.5* (n=9). This data has been shared with the Cancer Alliance South West to shape the care of colorectal 2-week-wait patients throughout the wider community.

It is too early at this stage to report the data on the effects of the COVID-19 pandemic on colorectal cancer presentation, but it is strongly believed that people are presenting at a more advanced stage. This could be due to a reluctance to seek medical attention through fear of contracting the virus, resulting in only those with severe or worsening symptoms attending. Additionally, bowel cancer screening (with the primary aim of diagnosing cancer earlier) has been on hold locally for several months. This ‘collateral damage’ is mirrored and already being demonstrated in other specialty areas, such as cardiac and stroke care (Masroor, 2020).

The clinic will continue to carry out colonic-specific investigations for patients with a qFIT >10 but we have made a revision to our standard operating procedure, which dictates that a qFIT must be performed for all patients without overt rectal bleeding or an anal/rectal mass prior to referral by their GP to the service (patients with overt rectal bleeding or an anal/rectal mass will be referred directly to the 2-week-wait service—no change in practice). Any patient with a qFIT <10 can then be referred by their GP via the NSS pathway for further review, with a view to streamlining the referrals process and increasing the probability of the patient undergoing investigation by the correct specialty.

Telephone consultations were used effectively before the COVID-19 pandemic, and proved invaluable throughout it, therefore there is no clinical reason why, as a team, we will not continue to take this method forward. We were originally working to strict inclusion/exclusion criteria with regard to telephone consultations (<80 years of age, World Health Organization status 2 or less (NICE, 2007), normal rectal examination), which understandably had to be relaxed during the period of enforced self-isolation. Thus far, the data have not indicated that there has been any detrimental effect on patients who would previously have had a face-to-face appointment, and patients themselves have reported increased satisfaction at not needing to attend an acute Trust during this time. The clinic staff will of course monitor this and be prepared to revise the new guidelines as the global situation and patient requirement dictates.

In conclusion, COVID-19 has brought with it a need to change and adapt the service to ensure that safe and effective care can continue. By reviewing and assessing outcomes and data, clinic staff have been able to implement changes efficiently and ensure that our patients receive the most up-to-date and evidence-based care possible. With the ongoing COVID-19 pandemic and the changes that will continue to be required, the team will ensure that continued monitoring and reviewing of the data is integral to planning the service.

KEY POINTS

  • The COVID-19 pandemic brought about the need for changes within existing healthcare services
  • The colorectal 2-week service was reviewed and modified to ensure that patients referred from primary care would be managed in a safe and timely manner during the pandemic
  • The use of quantitative faecal immunochemical testing (qFIT) to triage patients and prioritise investigations, utilised an existing and effective, if underused, laboratory test
  • Auditing of practice and efficacy brought about a revision of the new protocols and the development of a non-site-specific pathway
  • The service was formally reviewed and the decision made to bring new qFIT protocols into post-COVID-19 practice, rather than reverting to the previous standard

CPD reflective questions

  • Think about changes that have been made within your service area. Do you think these are an improvement on previous practice?
  • What positive changes have you seen that only came about as a result of the COVID-19 pandemic?
  • Have you needed to collaborate with other services or hospitals, as a direct result of the pandemic, where you might not have previously? Think about the benefits and disadvantages of this