COPD Screener study V 2.0
Research type
Research Study
Full title
Evaluation of a simple COPD screener as a novel screening test for case finding for COPD in primary care
IRAS ID
140550
Contact name
Rachel Jordan
Contact email
Sponsor organisation
University of Birmingham
Research summary
COPD is widely accepted to be underdiagnosed in the UK and worldwide. There is a large drive, supported by the new COPD National Outcomes Strategy, to identify these people in order to provide them with appropriate management. However the best and most cost-effective method of “case finding” (or screening) is not known.
A COPD diagnosis requires confirmation with quality diagnostic spirometry, which is known to be difficult to perform repeatedly and accurately in primary care. It would be advantageous to identify a simple test with sufficient sensitivity and specificity, which would be easily undertaken in primary care, to reduce the numbers of people requiring referral to expensive spirometry services.
Simple COPD screeners by established manufacturers, such as the nSpire PiKo-6 and Vitalograph copd-6 and lung monitor, are smaller and far cheaper instruments than a spirometer and measure FEV1/FEV6. Initial evaluation studies suggest that it has good sensitivity and specificity in detecting newly diagnosed COPD. However, there are a number of limitations in the previous work as these studies were not performed in the UK, included patients from a variety of sources, regardless of clinical symptoms and used spirometric definitions of COPD which are known to over-diagnose. In addition, the tests were administered by GPs and nurses with only brief training, which may affect the standards of the test undertaken.
We plan therefore, using a case-control design (n=496 patients), to evaluate the sensitivity and specificity of the COPD screener (Vitalograph lung monitor) as a simple screening test for COPD in primary care, administered to people reporting respiratory symptoms, compared to the gold standard quality diagnostic spirometry.
This linked project will be incorporated into the Birmingham COPD Cohort study for which we already have ethical approval. Since the same patients would be eligible and invited for this study, it is more efficient and makes sense for patients to have the assessments at the same time. It adds little burden to patients as one assessment is replaced with the new one. During cohort assessments, an NDD spirometer is used during pre- and post-bronchodilator spirometry; this new project will introduce the use of a simple COPD screener, and will compare the findings of the COPD screener with the findings from the NDD to evaluate how good this new, cheaper test using a COPD screener is.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
14/WM/0032
Date of REC Opinion
18 Feb 2014
REC opinion
Favourable Opinion