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
Is it feasible to conduct a study to examine the diagnostic performance of low-dose chest CT in the assessment of patients with symptoms that may suggest lung cancer?
- Technology: Low-dose chest CT.
- Patient group: People presenting to primary care with symptoms that may suggest lung cancer (as defined by NICE guideline NG12).
- Setting: General practice referral to imaging facilities.
- Comparator: Chest X-ray.
- Study design: A feasibility study to determine whether future diagnostic research is possible, and if appropriate, a value of information study.
- Outcomes and outputs: Feasibility; deliverability; and implementability of the study findings across the NHS; including (but not limited to): NHS imaging capacity; impact on other healthcare services (e.g. resulting from further investigations and treatments, including those from incidental findings); acceptability to clinicians, service providers, commissioners, and patients (and their carers where appropriate); value of information of a future full study. If adequate, key parameters of a potential future study.
Rationale
Lung cancer is the third most common cancer in the UK, with more than 48,000 new cases annually. It is also the most common cause of cancer death in the UK. Early symptoms are usually non-specific, which makes it difficult to detect lung cancer at early stages. However, disease and treatment outcomes, including survival rates, depend on the stage of the cancer when it was diagnosed. Currently, most people with lung cancer in the UK are diagnosed at late disease stages, resulting in lower survival rates compared to most European countries.
In order to improve early diagnosis, NICE has developed a guideline (NG12) that aims to enable GPs to identify people with symptoms that may suggest cancer. The guideline outlines appropriate investigations in primary care, and selection of people to refer for a specialist opinion. In patients presenting with symptoms associated with lung cancer, the guideline recommends that a chest X-ray should be performed in the first instance.
However, the diagnostic accuracy of chest X-ray is debated, with recent studies suggesting that chest X-ray could miss one in five lung cancers (false-negative results). This could result in delayed diagnosis and treatment, potentially affecting patient outcomes.
Low-dose computed tomography (CT) has been discussed as a possible alternative to chest X-ray. The technology is already being used in lung cancer screening trials, where it showed high diagnostic accuracy in detecting lung cancer, but low-dose CT is not currently used in symptomatic NHS patients (e.g., those seen in primary care for suspicious chest symptoms). Because of its high sensitivity, low-dose CT is believed to return more incidental findings than chest X-ray (e.g., lung nodules) that could lead to additional investigations and potentially unnecessary treatments, thereby causing harm and distress to patients.
As the NICE guideline is based on a very low threshold, the risk of most patients' symptoms representing cancer is very low. Chest X-rays are currently the most common X-ray investigations in primary care. Therefore, the choice of initial imaging technology for the investigation of chest symptoms is likely to affect many patients and could have significant implications for patients and for the NHS.
The HTA programme is interested in commissioning research:
- to evaluate the feasibility and deliverability of a future diagnostic study of low-dose CT vs. chest X-ray in patients with symptoms that may suggest lung cancer, seen in primary care;
- to assess the implementability of study findings across the NHS; and
to undertake a value of information study if the above criteria are successfully demonstrated.
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 25 January 2023. Applications will be considered by the HTA Funding Committee at its meeting in March 2023.
Guidance notes and supporting information for HTA Programme applications are available.
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 2023.
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 at htagb@nihr.ac.uk.