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20/140 Faecal immunochemical test (FIT) based tools to triage patients in primary care

 

Contents

Introduction

The aim of the 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 cost effectiveness of an ‘optimal’ FIT based risk stratification tool to triage the referral of symptomatic patients to suspected colorectal cancer clinics or, to alternative management pathways?

  1. Interventions: FIT based risk stratification tools.
  2. Patient group:  Symptomatic adult patients who meet the criteria for rapid referral advised by NICE (NG12 / DG30). 
  3. Setting:  UK primary care.
  4. Study design: Research using mixed methods to include a systematic review of the diagnostic performance of risk stratification tools and quantitative FIT testing in patients who meet the NICE referral criteria.
    Informed by these findings, patient characteristics, data from recent NHS health service evaluations in primary and secondary care and other UK datasets, an ‘optimal’ risk stratification tool should be developed and then validated in an independent dataset.
    Qualitative research should identify the acceptability to clinicians and patients of different levels of risk in the tool, in the context of the alternative management pathways. A model of cost effectiveness should explore how varying the levels of risk in the tool affect the clinical and cost effectiveness of its use for the identification of colorectal cancer.
  5. Important outcomes: A validated risk stratification tool; cost effectiveness for different levels of risk; measures of diagnostic performance for colorectal cancer by FIT threshold.
    Other outcomes: Findings of the qualitative research; potential impact on 2-week wait (TWW) clinics and other NHS services; identification of other serious non-cancer pathologies. 

Rationale

NICE Guidance sets out a number of symptoms and signs that are used as criteria to guide the referral of patients from primary care to rapid assessment clinics. However, only a small proportion of the large number of people referred with bowel symptoms are found to have colorectal cancer at colonoscopy.

NICE (DG30) made research recommendations to further develop risk scores that include variables such as age, sex and symptoms to help determine pre-test probability and the use of faecal immunochemical tests (FIT) in primary care.

A more discriminating FIT based risk stratification tool to guide referral of symptomatic patients from primary care would enable practitioners to triage patients more effectively, helping ensure that people who need further investigation by colonoscopy would receive this more rapidly, while alternative management strategies and pathways are available to others.

The purpose of this research is to make use of the findings of published research, recent NHS evaluations of FIT testing and other UK datasets, to develop and validate a more effective triage tool to guide referral of patients either to the NHS 2-week wait suspected cancer clinics or, to alternative management strategies and pathways.

The model of cost effectiveness will explore how the use of the tool can be optimised to make best use of resources for patients and for the wider NHS.

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 27th January 2021. Applications will be considered by the HTA Funding Committee at its meeting in March.

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 July.

Applications received electronically after 1300 hours 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 one competing team. There may be unusual circumstances where the same person could be included on more than on application eg 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 one 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 by email: htagb@nihr.ac.uk