Introduction
The aim of the (Health Technology Assessment) HTA Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.
Research Question
What is the diagnostic accuracy of different endoscopic modalities for detection of Barrett's oesophagus related neoplasia?
Patient group: Adults undergoing surveillance for Barrett’s oesophagus with no history of previous dysplasia or cancer of the oesophagus. Applicants should specify and justify their inclusion criteria. Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
Technologies: Image enhanced endoscopic surveillance techniques. Applicants should specify and justify their choice of techniques. Applications are expected that investigate multiple technologies within the study.
Comparator: Seattle protocol mapping biopsies
Setting: Secondary and tertiary care settings.
Study design: A diagnostic accuracy study with an internal pilot phase to test key processes such as recruitment and adherence. Clear stop/go criteria should be provided to inform progression from pilot to full study.
Important outcomes: Detection rates of Barrett’s oesophagus related neoplasia / histology results (low grade dysplasia, high grade dysplasia and cancer); measures of diagnostic accuracy; costs of different surveillance techniques; adverse events; patient tolerability; physician experience and preference; time to perform the procedures.
Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise. Applicants are encouraged to report recruitment and findings disaggregated by sex (and other demographic factors where relevant).
Rationale
Barrett's oesophagus (BO) is defined as an oesophagus in which any proportion of the lower part of its lining has been replaced by abnormal cells. BO is more common in men, especially in white men, and in people with a positive family history of BO. Its highest incidence is in people with gastro-oesophageal reflux disease. People with BO are at increased risk of developing cancer of the oesophagus. In fact, BO is the only known precursor lesion of oesophageal adenocarcinoma. While still relatively rare, the incidence of oesophageal cancer is rising, and survival rates are poor.
To reduce cancer rates and mortality, national and international guidelines suggest that people with BO should be offered regular endoscopic surveillance, to detect subtle early-stage lesions before they can progress to invasive adenocarcinoma. Early-stage disease may be curable through endoscopic surgery, but these lesions can be challenging to visualise.
The current reference standard for endoscopic surveillance consists of endoscopy with Seattle protocol biopsies. This protocol entails four biopsies in different quadrants of the oesophagus, taken every two centimetres within the Barrett’s oesophagus, in addition to random biopsies. However, the protocol is poorly tolerated, time-consuming, subject to sampling error, and its diagnostic accuracy is debated.
Experts in the management of BO suggest that alternative endoscopic technologies might be able to provide better tolerance and accuracy, as well as reducing endoscopy and pathology workload. Advanced imaging techniques of interest include image enhanced endoscopies, such as virtual and conventional chromoendoscopy techniques, among others. The NICE guideline committee on Barrett's oesophagus noted that these technologies have not been validated in people undergoing standard endoscopic surveillance. To address this evidence gap, a recommendation for research was made to assess the effectiveness of advanced imaging techniques for the surveillance of people with Barrett’s oesophagus.
Given the limitations of current best practice and the uncertainties expressed by experts in the field, the HTA programme wishes to fund the study outlined above to inform future practice and guidelines and to improve the patient experience. Applicants should note that applications that investigate artificial intelligence are not within the scope of this call and should apply via the researcher-led workstream.
Applications should be co-produced, demonstrating an equal partnership with service commissioners, providers and service users (or their advocates) in order to provide evidence and actionable findings of immediate utility to decision-makers and service users. Applicants may wish to consult the NIHR Learning For Involvement guidance on co-producing a research project.
Additional commissioning brief background information
A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.
Making an application
If you would like to apply for this funding opportunity, you can begin your application via the funding opportunity page.
Your application must be submitted online no later than 1pm on the 18 September 2024. Applications will be considered by the HTA Funding Committee at its meeting in November 2024.
Guidance notes and supporting information for HTA Programme applications are available.
Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in March 2025.
For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team, other than in unusual circumstances (for example, a lead from a named charity or a unique national expert in a condition).
For such exceptions, each application needs to state the case as to why the same person is included. The shared co-applicant should not divulge application details between teams, and both teams should acknowledge in their application that they are aware of the situation, and that study details have not been shared.
Should you have any queries please contact htagb@nihr.ac.uk