Gastroenterology Today Summer 2021

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
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