Title: EVolution of a patiEnt-REported symptom-based risk stratification sySTem to redesign the suspected Head and Neck cancer referral pathway (EVEREST-HN)
Funder: Department of Health and Social Care

Abstract: Research question Can a patient-reported symptom-based risk stratification system improve the suspected head and neck cancer (HNC) pathway? Background Patients presenting to their general practitioners with symptoms of suspected HNC may be referred to secondary care via a dedicated referral pathway for a consultation with a HNC specialist. In 2019/20, 228,482 patients were referred with suspected HNC in England: an increase from 140 to 404 patients per 100,000 population between 2009/10 and 2019/20. Currently, standard practice is to see all referrals face-to-face as the first contact. However, partly due to capacity issues, one in ten suspected HNC referrals are not seen within the two-week target and the period waiting to be seen leads to significant patient anxiety. Aims and objectives To develop and evaluate a patient-reported symptom-based risk stratification system for suspected HNC referrals which is safe, improves the patient experience, leads to faster diagnosis and optimises healthcare resource use, compared to the current system. Methods Our methodology includes six interlinked work packages to deliver our aim. WP1: To optimise a patient-reported symptom inventory for HNC and outline requirement specification for the SYmptom iNput Clinical (SYNC) system. WP2: To co-design key elements of the SYNC system, including SYNC symptom questionnaire, SYNC report and using behaviour change intervention materials to integrate the SYNC system into patient and staff s experience of existing hospital workflows. WP3: To use data from routinely collected electronic health records, linked at the patient level, to describe the suspected HNC population and their diagnostic pathway, including regional variations, and provide prognostic information for WP4 and 6. WP4: To conduct a concurrent data collection exercise and feasibility study, using the SYNC symptom questionnaire developed in WP1 and 2, alongside the prognostic data from WP3, to develop the SYNC risk stratification algorithm, agree management thresholds and recommendations by stakeholder consensus, to finalise all elements of the EVEREST-HN pathway for WP5. WP5: To conduct a cluster randomised-trial, with 6-month internal pilot, to compare the new pathway to standard care, using a non-inferiority design and primary outcome of cancer diagnosed within 62 days. WP6: To evaluate the cost-effectiveness of the new pathway. Timelines for delivery By the end of year 2, methodology and prognostic modelling for linkage of national data for suspected HNC will be complete. By the end of year 3, the re-designed pathway will be finalised for a cluster RCT. The clinical and economic effectiveness of the new pathway will have completed analysis by the end of year 6. Anticipated impact and dissemination The generic applicability of findings from this research will have a wide impact on patients, professionals and stakeholder organisations. We will disseminate to patients/public via the national press and public engagement meetings and engage with patient-facing groups, including Macmillan, Head & Neck Cancer UK and MakeSenseCampaign. We will communicate with primary and secondary care through clinical commissioning groups, our links with the BRC, BAHNO, ENTUK, BAOMS and cancer alliances. Dissemination to the scientific community will include submission to peer reviewed journals and presentation at international conferences.

Lay abstract: In healthcare, the 'head and neck' region includes the nose, mouth, throat, voice box, thyroid and salivary glands. Many patients present to their GP with symptoms affecting these areas, including hoarse voice, throat discomfort, neck lumps, mouth ulcers and difficulty swallowing. In some patients, these symptoms will be caused by a 'head and neck cancer', and so they may be referred to the hospital for an urgent specialist opinion. In the last year in England, 228,482 patients were referred with suspected head and neck cancer, making it the fifth largest group of suspected cancer referrals. After specialist assessment, the vast majority (95%) of these patients can be reassured that they are cancer-free, but about 5% of patients will be diagnosed with cancer. In referral pathways for some other suspected cancers (e.g., prostate and lung), a scan may be arranged before the patient is seen in clinic to help reach the diagnosis sooner, and reduce any anxiety that the patient may experience in this period. However, due to the various types of cancer seen within the head and neck, no single laboratory test, imaging investigation or diagnostic procedure is suitable to assess all the referrals we receive. Around one third of patients referred with suspected head and neck cancer will undergo some form of investigation but the information in the referral is often not enough to decide who may need an investigation, or which type they may need. We will work with patients and other interested parties to develop and implement a new pathway for suspected head and neck cancer referrals, based around the patient and their symptoms. In the new pathway, the hospital will make contact with the patient soon after receipt of the referral. Patients, with the help of their family and/or carers, will be asked to complete an electronic questionnaire about their symptoms using a smartphone, tablet, computer or automated phone call. Building on our previous work, we will develop a risk stratification system for head and neck cancer and based on thousands of new referrals who will be assessed as part of our development and feasibility work. The hospital specialist will then review all the information from the symptom questionnaire and the patient s individualised risk score to advise the most appropriate management, before the patient comes to hospital. Using this system, higher-risk patients may have targeted investigations arranged directly, before being seen in clinic, and lower-risk patients may avoid unnecessary investigations and hospital appointments before being reassured. We will compare this new pathway to the existing system to ensure it is safe in identifying just as many cases of cancer, while also leading to faster diagnosis, reducing patient anxiety and using healthcare resources more efficiently.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: CANCER AND NEOPLASMS