Work Package 2

The overall aims of this work are to assess the feasibility and practical implementation steps of introducing Cytosponge - TFF3 as a triage test for endoscopy to identify Barrett’s oesophagus, early cancer and other oesophageal conditions. This work seeks to recruit patients and collect data to re-design and evaluate the clinical pathway such that we systematically identify those at risk, perform a simple test to inform who needs endoscopy and in so doing rationalise the use of long-term PPI medication. Due to the cost-effectiveness of Cytosponge™ -TFF3 compared with endoscopy these changes will likely result in an economic benefit to the NHS, a social benefit for early detection of a lethal cancer and a reduction in over-use of PPI medication.

 

Professor Fitzgerald’s team will explore a number of options for Cytosponge clinics in both primary and secondary care settings. The team will build on the evidence achieved to date and move towards Cytosponge rollout, assessing the feasibility and practical implementation steps required to introduce the Cytosponge - TFF3 as a triage test for endoscopy to identify Barrett’s oesophagus, early cancer and other oesophageal conditions.

 

The development of clinical pathways for cytosponge in primary and secondary care involves consideration of two key behavioural science issues – uptake and patient experience. Preliminary scoping work, as well as analysis of qualitative and quantitative BEST3 trial data, suggests that patient experience is very high overall. The initial plan to develop an eHealth tool to improve experience has therefore been modified since the application was submitted. The teams led by Professor Fitzgerald and Dr Waller will investigate feasibility of a patient app for use in clinical care to enhance how patients experience the Cytosponge test for improved patient outcomes. The work led by Dr Waller aims to ensure that any app meets patient and provider needs and is acceptable to patients. This will be done by interviewing patients and providers about the content and format of the proposed app, and gather views on the feasibility and acceptability of providing this app.

 

Patient experience will be further examined with analyses of BEST3 survey data (in collaboration with the Sasieni team) to better understand the small group of patients with very negative experiences. Dr Waller’s team will now focus on better understanding prospective acceptability and reasons for refusal to take part in the study. Given that well over two-thirds of patients in BEST3 found swallowing the sponge more comfortable than expected, and over half found pulling up the sponge more comfortable than expected, there may be ways of optimizing communication about the procedure to make expectations more realistic and address barriers to taking part.

  

Professor Sasieni’s team will support the development of an operating model for a nurse-led Cytosponge clinic. They aim to identify any concerns raised by general practitioners (GPs) around different aspect of this model and how to address them. A round table discussion with academic GPs, GPs who took part in BEST3 and Gastroenterologist will be carried out to discuss any concerns and the currently proposed clinical pathway for these Cytosponge clinics. They will furthermore support recruitment to Cytosponge clinics by providing a monthly report. Lastly, they will analyse BEST3 patient experience data to identify any patient or delivery characteristics as predictors of negative patient experience.

 

WP2 will utilise the findings from the risk stratification in WP1 to invite at-risk patients for further investigation using Cytosponge via a nurse-led clinic. This potentially raises issues concerning the uptake of the test by professionals and attitudes of patients that are invited. Dr Hall's team will explore specific regulatory challenges in more detail including the potential legal and regulatory challenges relating to information provision, obtaining consent and associated with compliance with relevant data processing legislation (GDPR and the Data Protection Act 2018). These will include exploring the implications for consent discussions (including the impact of the case on informing about risks); inputting to materials which could be used to support interactions between health professionals and patients, and specific challenges associated with compliance with the GDPR, if the invitation for testing were to be based on solely automated decisions in future. These include consideration of the requirements for information provision, transparency (GDPR Articles 5, 13-15 and Article 22 of the GDPR). Finally, this element will address how these implications might differ depending on whether the activity is screening, surveillance, risk stratification case finding or diagnosis/clinical care.

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Professor Hippisley-Cox’s team will develop and implement a web-based tool to assist physicians with decision making of specialist referrals

 

Professor Rees’ team will provide context review and structured interviews in order to inform the application of the Newcastle ENDOPREM to use in cytosponge. This will cover context review, interview stage, transcription, analysis of results, adaptation of Newcastle ENDOPREM and will result in the ENDOPREM then being available for use to measure patient experience of Cytosponge. This work will be undertaken from August to December 2020. Although the work will not be funded by DELTA it will feed into the DELTA Deliverables.

 

CUH will collaborate with Professor Fitzgerald’s team to ensure all ethical and regulatory approvals and contractual obligations are met throughout the project.