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19/122 A cross sectional study and modelled evaluation of the performance of bowel cancer screening in England

 

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technology is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis.

Research Question:

What is the diagnostic performance of the faecal immunochemical test (FIT) used for screening at a threshold of 20 µg/g?  What is the combined diagnostic performance of FIT and bowel scope (BS) and how does the choice of FIT threshold affect the clinical and cost-effectiveness of the Bowel Scope Screening Programme (BSSP)?

  1. Interventions: Screening by FIT test with a threshold of 20 µg/g; BS screening by flexible sigmoidoscopy.
  2. Patient group:  People invited for bowel scope screening at age 55. 
  3. Setting:  NHS BSSP in England.
  4. Comparator: Colonoscopy.
  5. Study design: A cross sectional study to investigate i) the characteristics of the FIT at thresholds of 20 µg/g and above, and ii) the relative/ combined efficacy of BS and FIT at  thresholds of 20 µg/g and above. All participants should be offered a FIT test in advance of attending for their BS appointment. The person undertaking the BS should be unaware of the FIT test result.
    All participants testing positive for either test should undergo colonoscopy as per NHS Bowel Cancer Screening Programme (BCSP) protocols. Proposals should specify when the FIT result will be revealed to participants who do not attend for their BS appointment.
    The data should be modelled to generate more precise estimates of the efficacy of combination screening strategies for biannual FIT screening when BS is delivered only once, at the age of 55 as currently and if delivered at age 60 instead.
  6. Important outcomes: Characteristics and comparison of FIT test performance* at different thresholds and with BS; modelled performance of biannual FIT screening at different thresholds when combined with a single BS delivered only once at age 55 or age 60.
    Other outcomes: Cost-effectiveness of different screening strategies; FIT threshold at which the BSSP becomes cost-ineffective; detection rates of colorectal cancers and of high and low risk adenomas, recorded by location; uptake of the BS and the FIT tests; an assessment of requirements for flexible sigmoidoscopy and colonoscopy at different FIT thresholds.
  7. Minimum duration of follow-up:  Follow-up to completion of colonoscopy when either one or both of the screening tests is positive.
    Longer-term follow-up: Researchers should consider obtaining consent from participants to allow further follow up through efficient means (such as routine data) as part of a separately funded study and for use of data for future research, e.g. individualised risk -based approaches to screening.

* Test performance, e.g.  by detection rates for cancer and for high and low risk adenomas etc. 


Rationale:

In August 2018, Ministers announced that bowel cancer screening in England will start at the age of 50, rather than 60 and be offered biannually until the age of 74.  People older than this can ask to be sent a bowel screening test kit every two years.

The UK National Screening Committee, Public Health England and NHS England/ NHS Improvement are considering how this can be achieved.

In addition, in 2013 a one-off screening test, known as bowel scope was introduced in England for everyone at the age of 55.  Screening is by flexible sigmoidoscopy, roll out is still taking place and is available to the patients of approximately 55% of GP practices in England.

In 2017, the UK National Screening Committee commissioned the School of Health and Related Research (ScHARR) in Sheffield to develop a model of bowel cancer screening to explore the consequences of different FIT screening strategies and the interaction of the two screening modalities.

The model found that a screening strategy based on biannual FIT screening between the age of 50 and 74 was optimal given the available endoscopy resources, though there was insufficient data on comparative test performance at different FIT thresholds to make a recommendation about the future operation of the BSSP.
This research should provide information on FIT test performance in a screening population for different FIT thresholds and should explore the combined efficacy of the BSSP and the FIT based BCSP in combination screening strategies.
Applicants should liaise with the BSSP in Public Health England to discuss how the programme will support the delivery of the research and set out the proposed working arrangements with the programme and with ScHARR in their application.
The findings of this research should enable the UK National Screening Committee to make recommendations about the future thresholds for FIT testing in the NHS BCSP and the provision of the NHS BSSP in England.

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 on-line no later than 1pm on the 1st April 2020. Applications will be considered by the HTA Funding Committee at its meeting in May 2020.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

IMPORTANT: 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 September 2020.

Applications received electronically after 1300 hours on the due date will not be considered.

Should you have any queries please contact us:

Email:   
htacommissioning@nihr.ac.uk 

Telephone:  
Commissioning Funding Committee 02380 595510