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22/168 The diagnostic accuracy of colon capsule endoscopy commissioning brief

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Published: 01 December 2022

Version: 1.0 November 2022

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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 colon capsule endoscopy compared to standard colonoscopy? 

  1. Technology: Colon capsule endoscopy. 
  2. Patient group: Patients requiring colonoscopy. Applicants should specify and justify their choice of patient group(s), e.g. symptomatic patients requiring diagnostic colonoscopy; patients requiring monitoring or surveillance; etc. Asymptomatic patients referred via the National Bowel Cancer screening programme should not be included. Applications should consider multiple patient groups and indications to be included in the study. Applications are encouraged which include recruitment from geographic/ethnic populations with high disease burden which have been historically underserved by research activity in this field. 
  3. Setting: Endoscopy services and any other suitable settings.  
  4. Comparator/Reference standard: Standard colonoscopy.  
  5. Study design: A diagnostic accuracy study (participants to undergo both tests) with an internal pilot phase to test key study processes. Clear stop/go criteria should be provided to inform progression from pilot to full trial. Applicants should consider whether blinding of assessors or randomised sequence disclosure could be applied. Applicants are encouraged to consider the deliverability of the two diagnostic tests, e.g. how the tests will be sequenced, and how the tests might be administered within minimum inconvenience to patients.  
  6. Results, and outputs: Measures of diagnostic accuracy (to be reported by indications and settings); detection rates; completion rates; capsule retention rates; other adverse events; intra- and inter-observer agreement; number of colonoscopy procedures potentially prevented by colon capsule; patient and clinician experience (including, but not limited to, acceptability; preference etc.); a model of cost-effectiveness. Subgroup analyses should be undertaken for each included patient group/indication. 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).  
  7. Minimum duration of follow-up: Until final diagnosis.
    Longer-term follow up: If appropriate, researchers should consider obtaining consent to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.

Rationale

Gastrointestinal (GI) symptoms are very common in the UK population, causing a high burden to patients, the healthcare system and society. Many patients with GI conditions require colonoscopies, e.g., for diagnosis (or rule-out) of a new condition, for surveillance of an existing one, or for monitoring treatment success. Crohn's disease, diverticular disease or diverticulitis, ulcerative colitis, and bowel cancer are among the conditions that can be diagnosed and/or monitored by colonoscopy.

Colonoscopy is also being used in colorectal cancer screening programmes. However, asymptomatic patients referred via the colon cancer screening programme are excluded from the proposed study.

Colonoscopy is a resource intensive procedure and demand for bowel examination is rising. Long waiting times are increasingly common, exacerbated by the Covid-19 pandemic. This raises concern about the sustainability of colonoscopy services, but also increased interest in, and awareness of, alternative technologies. Colonoscopy is also an invasive procedure associated with complications, so finding a less invasive option will be desirable and potentially more acceptable to patients if proven to be as good as colonoscopy.

One potential alternative to colonoscopy is colon capsule endoscopy (CCE). This procedure uses a small, pill-shaped disposable camera to examine the large bowel (colon). The patient swallows the camera, which transmits images to an external wireless data recorder. Following completion of the procedure, the data is downloaded, and the images are interpreted by specialist readers.

CCE has been available for some time but has not been established in the UK. It was recently tested in a Scottish study (ScotCap) and is currently used in a pilot programme by NHS England. Both projects are service evaluations with a focus on bowel cancer detection and a goal to potentially reduce the number of colonoscopies. However, based on previous evidence from small studies, CCE is thought to be of use in a wider range of patient groups and indications. Most studies (including the UK studies) do not formally address the diagnostic accuracy of the technology in different patient groups, indications and settings, compared to colonoscopy. There is also paucity of cost-effectiveness data comparing CCE with colonoscopy. Therefore, a cost-effectiveness analysis is also needed.

The HTA programme wishes to fund the study outlined above to inform future practice, guidelines, and patient choice. 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 wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page. To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted online no later than 1pm, 29 March 2023. Applications will be considered by the HTA Funding Committee at its meeting in May 2023.

Guidance notes and supporting information for HTA Programme applications are available.

Important: Shortlisted Stage 1 applicants will be given 8 weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in September 2023.

Applications received electronically after 1pm on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same Co-Applicant joining more than 1 competing team. There may be unusual circumstances where the same person could be included on more than 1 application e.g. a Lead from a named charity or a unique national expert in a condition.

For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared Co-Applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that 1 of their Co-Applicants is part of a competing application and that study details have not been shared. 

Should you have any queries please contact us: htacommissioning@nihr.ac.uk.