Methodology:
A focus group of five senior clinicians agreed that structured remote
assessment could be performed, for new referrals, using the latest
iteration of the risk calculator. It was agreed that those who were at
high risk should be triaged for further assessment and the low risk
referrals undergo a deferred assessment until later in the pandemic or
when capacity became available. It was also considered appropriate for
follow up patients to be asked if they had developed any new and
specific symptoms since their previous consultation, allowing data from
the 2018 audit to risk stratify this group to inform decisions regarding
future management.
The project looked to collect data on clinician choice and patient
preference and did not mandate treatment according to set protocols.
Accordingly, the project was deemed to be a service evaluation and did
not constitute research (http://www.hra-decisiontools.org.uk/research/)
The project was developed in collaboration with INTEGRATE. Through
lending its support, and using its network to promote the project, all
UK head and neck cancer centres were approached to consider
participation. Further advertising was delivered through emails from ENT
UK and the Association of Otolaryngologists in Training (AOT;
www.aotent.org).
Designing the project in this way presented a number of challenges that
the data collection strategy that needed to be overcome.
- A need for immediate feedback to the clinician triaging the patient,
and so the data must be entered directly into a computer interface
- A need for a complete dataset to give valid results, again mandating a
computer interface for data validation
- A need for follow-up data to be collected at six months to see if
patients subsequently develop cancer, and so patient identifiable data
must be used in some capacity
- A need for rapid deployment of the project to ensure the
newly-implemented service to appropriately evaluated, and so formal
applications for sponsorship or ethics may be too slow to achieve.
- However, to comply with data governance regulations, patient
identifiable information should not leave the institution and, if it
were to, it must be handled with appropriate standards and practices
to maintain confidentiality. Further, formal consent may be required
from the patient for their data to be used in this way.
The solution developed was a customised Excel Data Tool ((Microsoft.
Excel for Mac. Redmond, Washington, USA: Microsoft Corporation; 2018).
This was made freely available for download at
www.entintegrate.co.uk, alongside
a user guide, protocol and registration link for the project. Dates and
hospital numbers may be entered into the Spreadsheet, which is stored on
the hospital computer system, in line with local data governance
regulations for handling patient identifiable data. Data entry is mostly
limited to drop down lists and the decision aid only provides
information if all required fields are completed. Clinician preference,
patient choice and the immediate triage outcome can be recorded.
Subsequently, the patient ID can be used to obtain the cancer status at
six months follow up to complete the dataset.
At this point, the spreadsheet can be anonymised by removing the site,
the date of triage (if recorded) and the patient ID. Anonymous data only
is then submitted to the project management team who then apply
sequential study IDs for further analysis. Using these methods, the data
held by the project management team has high levels of data completeness
but is not traceable back to any individual centre or individual
patient.
Figure 1 summarises the remote triaging process in a flow chart for new
referrals and follow up patients, along with a recommended script to
advise the patient on the outcome of the triaging process.
We intend for the service evaluation to continue for as long as
telephone triage is being utilised in this patient group. It is
anticipated the period of disruption/telephone triage may last for at
least six months. The outcome of presence/absence of cancer diagnosis at
a minimum of six months will be treated as gold standard, and measures
of diagnostic efficacy of the remote triaging system will be analysed,
including a descriptive analysis. This will allow external validation of
the HAN-RC V2 in a pan-UK or even a global suspected head and neck
cancer referral population. Moreover, a detailed assessment of the false
negatives will be carried out to investigate the potential scope for
further refinement of the calculator.