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Cytosponge is an exciting novel technology for oesophageal pathology diagnosis. Uses include screening for Barrett’s oesophagus, Barrett’s surveillance and triage of patients with chronic reflux symptoms. Cytosponge performs well in Barrett’s oesophagus diagnosis, with a specificity of >92% and sensitivity of 80% in intention-to-treat analyses in a case–control study.1 Furthermore, a cluster-randomised controlled trial demonstrated that offering Cytosponge to individuals with chronic reflux increased Barrett’s diagnoses by over 10 times compared with usual care.2
The need to reduce the burden on endoscopy services (exacerbated by the COVID-19 pandemic) expedited the pilot implementation of Cytosponge into national care pathways. Cytosponge can prioritise upper gastrointestinal (GI) endoscopy with high sensitivity and specificity for high grade dysplasia and early cancer.3 UK policy-makers strongly support real-world implementation studies with independent evaluation.
Patient experience is a crucial marker of quality of GI procedures and impacts patient attendance and reattendance. All patient-reported experience measures should be patient centred; derived from and completed by patients.4 Previous GI endoscopy patient experience questionnaires were often developed by clinicians with little or no patient input, typically focused only on comfort and were recorded by healthcare professionals. The Newcastle ENDOPREM was developed using robust methodology; in-depth patient interviews identified key areas, followed by iterative question development, cognitive interviews and field testing with psychometric property analysis.5 6 It is validated for use in patients undergoing GI endoscopy and CT colonography.
Previous Cytosponge studies used a simple analogue scale and anxiety questionnaires. The procedure itself was acceptable to patients, comparing favourably to endoscopy.7 Qualitative interviews highlighted that not all aspects of the procedure are equally acceptable. We sought to adapt the Newcastle ENDOPREM to provide a robust patient experience measure of Cytosponge.
In terms of content validity, the ENDOPREM underwent context review with clinicians and healthcare workers familiar with the Cytosponge procedure. Face and content validity was then explored through semi-structured interviews with 19 diverse patients who had undergone Cytosponge (age 37–80, 13 male). Using a talk-aloud approach, participants completed the Newcastle ENDOPREM question by question, and provided comments on redundant items or areas of experience which were not covered. The questionnaire was then modified, with redundant items removed and additional items inserted. The finalised questionnaire is now an adapted version of the ENDOPREM suitable for use in the Cytosponge population.
Novel technologies such as Cytosponge have the potential to revolutionise reflux and Barrett’s pathways providing an accessible, office-based triage to endoscopy. It is crucial that patients are the central focus of innovation and development and measuring patient experience is essential to achieve that. The Newcastle ENDOPREM’s benefits over simple satisfaction surveys are that it covers all aspects of patient experience and, given it has been adapted from an established patient reported experience measure, can be used to compare experience of different tests, as well as identify specific aspects of the pathway which may require improvement. The adapted Newcastle ENDOPREM provides a robust, patient-derived method of measuring patient experience of Cytosponge and is now available for use in wider evaluation of the Cytosponge.
This tool is also available online at: https://colospeed.uk
Patient consent for publication
This study involves human participants and was approved by East of England Cambridge East Research Ethics Committee. REC reference: 20/EE/0141IRAS No: 283505. Participants gave informed consent to participate in the study before taking part.
Funding was received from Innovate UK.
LS and CJR are joint senior authors.
Contributors CR, RCF, LS and LJN conceived and designed the study. ID-B and JD undertook participant recruitment. JD undertook qualitative interviews. JD, LS and LJN undertook qualitative analysis. JD, LS, LJN and CR adapted PREM according to analysis. All authors contributed to this letter.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests LJN, LS and CR have received grant funding from Medtronic. LS and CR have received grant funding from 3D Matrix solutions. CJR has received grant funding from ARC medical, Norgine and Olympus medical. He was an expert witness for ARC medical and Olympus medical. RCF is named on patents related to Cytosponge and associated assays that have been licensed to Covidien (now Medtronic). RCF is a founder and <8% shareholder of Cyted Ltd. ID-B and JD have no conflicts to declare.
Provenance and peer review Not commissioned; internally peer reviewed.
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