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Transformation of diagnostic pathways for COPD in primary care using N-Tidal: introducing the CORMORANT programme (ID 564)

Ashdown HF, Lambert G, Margerison E, Fleming S, Turner PJ, Goodman A, Kitov A, Patel A, Campbell L, Glogowska M, Wolstenholme J, Butler CC, Hayward GN

University of Oxford

Funding: This study is funded by the National Institute for Health and Care Research (NIHR) through an NIHR i4i Challenge award. HA, PJT, MG, JW, CB & GNH receive funding from the NIHR HealthTech Research Centre in Community Healthcare at Oxford Health NHS Foundation Trust. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

Abstract

Aim:

Prompt COPD diagnosis is essential for optimal management and treatment. Spirometry is the existing diagnostic standard, but is difficult for patients, time-consuming, and requires specialist training to perform and interpret. Delivery of primary care spirometry in the UK is struggling to meet demand, leaving many individuals undiagnosed.

TidalSense has developed an easy-to-use device and accompanying AI-derived algorithm, N-Tidal Diagnose™, which uses CO2 waveforms during relaxed tidal breathing to assess probability of COPD.

Further evidence is needed to assess whether N-Tidal could be a replacement or triage tool to spirometry for primary care COPD diagnosis.

Methods:

The CORMORANT programme has been funded through NIHR Invention For Innovation (i4i) as a collaboration between industry, academia, patients and the NHS. Commencing in July 2024, we have three programmes of work planned:

(1) A UK-wide survey and qualitative interviews with clinicians and stakeholders will map existing COPD diagnostic pathways and evaluate potential NHS adoption of N-Tidal. A national survey and focus groups will investigate patient priorities for community respiratory diagnostics.
(2) A UK-wide multi-centre observational study will assess the diagnostic performance of N-Tidal compared to spirometry. 500 participants who are undergoing spirometry for suspected COPD will have N-Tidal in addition. We hope to recruit patients from multiple sites, including GP practices and diagnostic hubs, to incorporate diversity of geography, deprivation and existing care models. A nested qualitative study will evaluate real-life experiences of using N-Tidal.
(3) Data from (1) and (2) will be used to map diagnostic pathways, resource use, and NHS impact, to develop health economic models which assess clinical and cost-effectiveness of reshaped pathways involving N-Tidal.

Patient and public involvement, led by Asthma+Lung-UK, will inform all aspects of the programme. At the conference, we hope to share programme details and receive feedback and expressions of interest from potential recruiting sites.

Conflicts of interest: HFA, SF, PJT, MG, JW, CB, GNH are employees of the University of Oxford. They receive no payments or support from TidalSense, and will retain ownership and governance of research data.
AP is a shareholder of TidalSense Limited. GL, EM and AK are employees of TidalSense Limited.
AG is an employee of Asthma+Lung-UK.
LC is our PPI co-investigator.

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