Asthma-Dx-PC: A platform for investigating novel diagnostic techniques to improve asthma diagnosis in primary care: study protocol (ID 569)

Ashdown HF, Daines L, Fleming S, Cook J, Ukwatte U, Wanat M, Rasbach R, Smith N, Ritchie G, Gamlen L, Turner PJ, Talbot N, Rahman N, Petousi N, Robbins P, and Hayward GN

University of Oxford

Funding: This study is funded through an Asthma+Lung-UK Diagnosis Pump Priming Grant (DPP23\49).
HFA, PJT, UU, NR & 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:

Asthma diagnosis mostly takes place in primary care, but there is considerable over- or under-diagnosis due to lack of definitive tests. Existing measures of airway obstruction, such as spirometry, are difficult to perform and often discordant with other clinical disease measures or fail to detect variable or subtle disease.

Development of novel technologies is a key interest area for the health technology industry, patient organisations and the NHS. These include computer-based algorithms using AI-based consultation analysis, novel physiological techniques and blood/breath biomarkers for diagnosis and disease phenotyping.

We aim to establish an asthma diagnostics platform to evaluate new technologies alongside existing combinations of tests, recruiting in a real-world primary care setting.

Method:
Asthma-Dx-PC, funded by Asthma+Lung-UK, has been established under the umbrella of the new NIHR Community HealthTech Research Centre, initially as a pilot of 100 participants to conduct process evaluation of the study design, but extending and expanding in future. We will recruit patients presenting to their GP with suspected asthma. They will undergo diagnostic assessment using existing tests, but in addition will have an audio-recorded consultation and a panel of novel diagnostic and physiological tests. They will also have home monitoring using existing techniques (peak flow) alongside novel digital home testing. Diagnostic accuracy of individual and combinations of tests will be compared to a reference standard diagnosis, assessed by a blinded expert panel following UK asthma diagnosis guidance. Survey and qualitative methods will evaluate patients’ views on test acceptability. Process evaluation including patients’, clinicians’ and innovators’ views will assess feasibility and acceptability of this novel study design.

Conclusions:
Innovations in asthma diagnostics have potential to diagnose asthma earlier and more accurately, guide optimal treatment and help patients and clinicians monitor treatment outcomes, but need to be prioritised and supported in evidence generation and evaluation of implementation potential.

Conflicts of interest: Novel diagnostic test companies are providing devices for the study free-of-charge, but will not be involved in collection, analysis or interpretation or data.
GR & PR hold patents through Oxford University Innovation, a wholly owned subsidiary of the University of Oxford, relating to the background IP for the physiology (lung heterogeneity) assessment.

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