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.
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.