Summary
N-Tidal Diagnose, a product from Tidal Sense, is a point-of-care diagnostic medical device (2a EU MDR CE-marked expected clearance Q1/Q2 2025) that can be used in the primary care pathway to identify and diagnose patients with Chronic Obstructive Pulmonary Disease (COPD). The quick and simple test aims to support earlier initiation of appropriate treatment by enabling diagnosis at a GP surgery.
Staff need only ten minutes training to use the device which performs real-time shape analysis of breath waveforms to provide highly sensitive quantification of lung function based on just 75 seconds of relaxed breathing. This analysis combined with an AI diagnostic platform interprets the data and provides a COPD diagnosis in real time. The device aims to reduce referrals into secondary care spirometry services. Results are available within five minutes of the test being carried out.
Health Innovation Oxford and Thames Valley (HIOTV) conducted a feasibility study and engaged with key stakeholders in the NHS COPD diagnostic pathway to assess the clinical need, perceived potential benefits, acceptability and barriers to adoption of the device.
What is the challenge?
COPD is a lung condition characterised by chronic respiratory symptoms that cause persistent, often progressive, airflow obstruction. Approximately 1.4 million people aged 40 years or over in England have a diagnosis of COPD with a further 500,000 undiagnosed. Diagnosis of COPD is the crucial first step in effective management of the disease.
The prevalence and severity of COPD increases with age and the earlier a diagnosis the better the long-term health outcomes. Despite this, most people are not diagnosed until they are in their fifties. Patients with suspected COPD are referred for spirometry testing for confirmation. However, currently patients may not receive a prompt diagnosis due to delays in receiving testing as there is a substantial bottleneck for this diagnostic test. This results in longer wait times for patients and increased burden on specialist or secondary care centres.
What did we do?
HIOTV performed a feasibility study using the lean assessment process (LAP) methodology to gain insights into the perceived usefulness, potential clinical benefits, acceptability and barriers to adoption of the device. Thirteen key clinical and commissioning stakeholders working in the COPD diagnostic pathway across five NHS trusts were interviewed according to the LAP methodology. The potential impact of the device in the primary and secondary care setting was also assessed. Responses were thematically analysed and combined with human factor tools to provide a comprehensive report on the device’s potential utility and benefit.
What has been achieved?
The feasibility study showed a strong stakeholder interest in the device’s potential as a COPD diagnostic support tool. Stakeholders agreed that there is an unmet need for a point-of-care COPD diagnostic device for early identification of people with suspected COPD in the primary care setting. Key potential benefits identified by stakeholders included a reduced burden on secondary care referrals and providing earlier diagnosis, leading to earlier treatment and improved patient outcomes. Recommendations to overcome any barriers to adoption have been given.
What next?
HIOTV will continue to collaborate closely with Tidal Sense to explore opportunities within the respiratory space and develop a real-world evidence generation programme involving health economics to support eventual commercialisation plans.
Contact
Lauren Hudson, Project Manager lauren.hudson@healthinnovationoxford.org