23/34 Screening for COPD during the targeted lung health check commissioning brief

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

Does screening the targeted lung health check (TLHC) population for chronic obstructive pulmonary disease (COPD) improve subsequent health outcomes, and is it cost effective?

1. Target group: Adults invited for NHS targeted lung health checks (TLHC). Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
2. Technology: Offer of screening for COPD by spirometry. 
3. Comparator: No offer of screening for COPD. 
4. Important outcomes: Patient centred health outcomes related to COPD, applicants to define and justify, but likely to include one or more of (mortality; symptoms, impaired health-related quality of life, exercise intolerance, exacerbations, hospitalisation, weight loss, etc); adverse events; rates of treatment with inhaled pharmacotherapy; pulmonary rehabilitation referral; adherence to protocols by GPS and patients; acceptability; cost effectiveness. 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, plus other demographic factors where relevant.
5. Setting: Any appropriate setting.
6. Study design: A randomised controlled trial with an internal pilot phase to test key trial processes such as recruitment and adherence. Clear stop and go criteria should be provided to inform progression from pilot to full trial. A process evaluation should also be considered to examine implementation processes. There are several points in the pathway when spirometry might be offered: at the initial invite, at the triage point (where the risk assessment for low dose CT (LDCT) takes place) and when the CT scan is being done. Applicants will need to describe and explain at which point the offer and test will be offered and done, and describe how the test will be carried out, and by whom. Applicants might consider whether a design utilising multiple randomisation points in the pathway might be possible. Applicants will need to explain the subsequent care pathway for COPD screen positive individuals, that is, whether patient management is to be initiated by or at the spirometry screening appointment or whether this will be referred back to the patients GP to initiate and subsequently manage, and will need to describe the mechanisms which will drive adherence to protocols by GPs and patients and how this will be monitored.
7. Minimum duration of follow-up: Applicants to define and justify.
   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

Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disease due to airflow obstruction that is most commonly caused by exposure to cigarette smoke. It is a leading cause of morbidity and mortality globally and often leads to hospitalisation.

While there are clear criteria and processes in place for diagnosis of COPD involving spirometry-based lung function tests these are generally only considered when patients present with one or more of a number of respiratory symptoms.

Whether early identification of COPD in individuals who are asymptomatic improves outcomes is unknown. Screening of those without symptoms and no risk factors is not recommended but for those with risk factors such as current or former smoking, has been proposed.

The Targeted Lung Health Check (TLHC) programme has been established in several regions of England and is likely to be extended across the UK. Offered to all current or former smokers this provides a brief risk assessment and offer of subsequent CT scan for those deemed at highest risk of potential lung cancer.

Early studies in the THLC and other similar screening programmes have demonstrated significant numbers of previously undiagnosed cases of COPD when spirometry has been added to the lung health check. Finding patients with COPD is one thing, doing something once identified is another. Indeed, there is no high-quality evidence that early diagnosis leads to early treatment and subsequent improved outcomes. Early treatment improves respiratory symptoms and reduces exacerbations and, therefore, may reduce rapid lung function decline and mortality, but this can only be fully determined in a high-quality trial by randomising to spirometry or no spirometry and whether this makes significant difference to subsequent management and related health outcomes.

For the avoidance of doubt, research which aims to demonstrate that screening for COPD is acceptable and simply finds more patients with COPD will not be sufficient. The aim of this call is to assess whether having found patients in this high-risk population with COPD using spirometry, this has more advantages than disadvantages, and cost effectively, by assessing subsequent COPD and other health related patient outcomes.

To support the ambitions of NIHR’s Best Research for Best Health: the next chapter, NIHR strongly encourages the inclusion of nurses, midwives and allied health professionals within well-developed research teams responding to this call, to increase the building of nurse, midwife and allied health professional-related research activity, capacity and capability across the professions. Depending on the level of experience, this could be through the role of lead applicant, as joint co-applicant supported by detailed mentoring plans submitted with the application, or as a co-applicant member of the research team. Through this activity, NIHR aims to support nurses, midwives and allied health professionals to become future research leaders and release the potential to lead, use, deliver and participate in research as a part of their job.

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

Your application must be submitted on-line no later than 1pm on 26 July 2023. Applications will be considered by the HTA Funding Committee at its meeting in September.

HTA Programme Stage 1 guidance notes are available, alongside supporting information for applicants.

Please note that 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 January 2024.

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 one competing team. There may be unusual circumstances where the same person could be included on more than on application, 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. 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 htacommissioning@nihr.ac.uk.