Which innovations can improve timeliness of investigations and address the backlog in endoscopy for patients with potential symptoms of upper and lower Gastrointestinal (GI) cancers? (preprint)

TOPLINE SUMMARY What is a Rapid Review? Our rapid reviews use a variation of the systematic review approach, abbreviating or omitting some components to generate the evidence to inform stakeholders promptly whilst maintaining attention to bias. They follow the methodological recommendations and minimum standards for conducting and reporting rapid reviews, including a structured protocol, systematic search, screening, data extraction, critical appraisal, and evidence synthesis to answer a specific question and identify key research gaps. They take 1-2 months, depending on the breadth and complexity of the research topic/ question(s), extent of the evidence base, and type of analysis required for synthesis. Background / Aim of Rapid Review Many patients were not able to access routine diagnostic care through 2020/21 because of extraordinary pressures on the NHS due to COVID-19 and the UK national lockdowns. For some patients this can have serious short and long-term consequences to their health and life expectancy. The NHS has limited resources and is looking for new ways to meet many demands and patient needs. This Rapid Review Report aims to answer the question “Which innovations can be used to accelerate the patients’ journey through the endoscopic cancer diagnosis pathway?” The report highlights evidence of innovations and new ways to improve the timeliness of access to endoscopy and to address the backlog of unmet need for patients who have waited a long time for such tests and investigations by selecting those at highest for prioritisation. It does not evaluate in terms of effectiveness on clinical outcomes. Key Findings Extent of the evidence base ▪ Nine papers were included in the rapid review in total. ▪ Two reviews were identified. One review examined the novel colon capsule endoscopy (CCE) procedure and the second review summarised the effects of COVID-19 on colorectal cancer (CRC) screening, the potential long-term? outcomes, and ways to adapt CRC screening during the COVID-19 pandemic. ▪ Seven primary studies assessed innovations for the diagnosis of Gastrointestinal (GI) cancers. Five of these studies examined faecal immunochemical testing (FIT) for prioritising patients for further testing. ▪ Two studies reported pathways/innovations to triage patients e.g. from primary care. These methods of triage used interventions such as Cytosponge for oesophageal symptoms. Recency of the evidence base ▪ Of the primary studies, one was published in 2020 and six were published in 2021. Of the reviews, one was published in 2020 and one in 2021. Evidence of effectiveness ▪ The five studies investigating FIT found that it could help prioritise patients for further testing and improve targeting of high-risk patients. ▪ One review proposed CCE may offer a useful solution for investigating colorectal patients to reduce the need for some endoscopies following the pandemic. ▪ One review found a shift from current CRC screening and surveillance practices towards an individualized approach based on risk factors, could result in the allocation of resources to people with higher risks and prevent inappropriate use of healthcare resources for those with lower risks. Best quality evidence ▪ All studies were quality appraised using the relevant JBI checklist. Five studies were of low to moderate quality. Policy Implications ▪ Increased use of faecal immunochemical testing (FIT) could reduce the endoscopy backlog and save NHS resources if those with low FIT scores can be excluded from further testing. ▪ Policy in Wales supports prioritisation of potential gastrointestinal cancer patients for endoscopy using FIT test scores (NHS Wales 2021) although local implementation currently varies, so it is not yet fully utilised. The FIT test gives results which could be utilised by healthcare professionals to prioritise those who are most in need of urgent diagnosis. The viability of this method to prioritise those in greatest need of being referred for diagnosis through endoscopy is proven (though safety-netting is still required), and the FIT test is part of the diagnostic pathway already in Wales. It will be important to ensure all areas of Wales have equal access to the use of FIT testing for this purpose, and that clinical guidelines are harmonised and adhered to throughout Wales. ▪ Innovations to reduce backlog and speed up time to diagnosis should be explored including: ○ Triage in primary care settings such as GP surgeries using innovations such as the cytosponge for oesophageal symptoms (e.g. reflux). ○ Direct referral from primary care settings to specialist investigation, without the need for prior additional referrals in secondary care. Strength of Evidence ▪ The evidence presented in this review is recent, however with small samples (di Pietro et al., 2020), short-term follow up periods (Sagar et al., 2020) and assumptions required for modelling studies (Loveday et al., 2021). This reduces the generalisability and confidence of conclusions. The confidence in the strength of evidence about FIT testing is rated as ‘low-moderate confidence’. Cytosponge evidence is rated ‘low confidence’. Review team and stakeholder involvement This Rapid Review is being conducted as part of the Wales COVID-19 Evidence Centre Work Programme. The above question was developed in consultation with Cancer Research UK’s identified research gaps and with Professor Tom Crosby OBE. Professor Crosby is a Consultant Oncologist, National Cancer Clinical Director for Wales and Clinical Lead for Transforming Cancer Services and acted as the expert stakeholder for this review. The search questions were identified as a priority during the Cancer/COVID-19 Research Summit hosted by Cancer Research UK (CRUK), Public Health England (PHE) and the National Cancer Research Institute (NCRI). The stakeholder group supporting the review work here is Cancer Research Wales.

Protocol for a Feasibility study incorporating a Randomised Pilot Trial with an Embedded Process Evaluation and Feasibility Economic Analysis of ThinkCancer!: A primary care intervention to expedite cancer diagnosis in Wales (preprint)

ABSTRACT Background Relative to the rest of Europe, the UK has relatively poor cancer outcomes, with late diagnosis and a slow referral process being major contributors. General practitioners (GPs) are often faced with patients presenting with a multitude of non-specific symptoms that could be cancer. Safety netting can be used to manage diagnostic uncertainty by ensuring patients with vague symptoms are appropriately monitored, which is now even more crucial due to the ongoing Covid-19 pandemic and its major impact on cancer referrals. The ThinkCancer! Workshop is an educational behaviour change intervention aimed at the whole general practice team, designed to improve primary care approaches to ensure timely diagnosis of cancer. The workshop will consist of teaching and awareness sessions, the appointment of a Safety Netting Champion and the development of a bespoke Safety Netting Plan, and has been adapted so it can be delivered remotely. This study aims to assess the feasibility of the ThinkCancer! Intervention for a future definitive randomised controlled trial. Methods The ThinkCancer! study is a randomised, multisite feasibility trial, with an embedded process evaluation and feasibility economic analysis. Twenty-three to 30 general practices will be recruited across Wales, randomised in a ratio of 2:1 of intervention versus control who will follow usual care. The workshop will be delivered by a GP educator and will be adapted iteratively throughout the trial period. Baseline practice characteristics will be collected via questionnaire. We will also collect Primary Care Intervals (PCI), Two Week Wait (2WW) referral rates, conversion rates and detection rates at baseline and six months post-randomisation. Participant feedback, researcher reflections and economic costings will be collected following each workshop. A process evaluation will assess implementation using an adapted Normalisation Measure Development (NoMAD) questionnaire and qualitative interviews. An economic feasibility analysis will inform a future economic evaluation. Discussion This study will allow us to test and further develop a novel evidenced-based complex intervention aimed at general practice teams to expedite the diagnosis of cancer in primary care. The results from this study will inform the future design of a full-scale definitive phase III trial. Trial registratio intended registry: clinicaltrials.gov