Chronic Obstructive Pulmonary Disease Respiratory
Conditions
Interventions
The study is designed so that every participant completes both the standard diagnostic test (spirometry) and the new test (N-Tidal). They will answer some questions about themselves and why they are b
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Participant is aged 35 years old or over 3. Diagnostic spirometry has been requested by their clinician where COPD is a potential diagnosis (even if it is not necessarily the most likely) Inclusion in the qualitative sub study: 1. Participants in the main study 2. Consented to be contacted regarding the sub-study
Exclusion criteria
Exclusion criteria: 1. Participants who have previously had COPD confirmed by spirometry (participants who are having repeat spirometry as part of diagnosis can be included). 2. Participants who, in the opinion of the chief investigator, or their delegate, are unlikely to comply with the requirements of the study. 3. According to the recruiting clinician, participants unable to give fully informed consent. 4. According to the recruiting clinician, participants who are acutely unwell, e.g. requiring hospitalisation 5. Patients without potential COPD i.e. COPD is extremely unlikely as a diagnosis. 6. Patients unable to breathe through their mouths e.g. tracheostomy patients. 7. Participant who have already participated in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic performance of N-Tidal Diagnose for the diagnosis of COPD measured using N-Tidal and spirometry at study visit and decided by consensus at end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Diagnostic accuracy (PPV, NPV) of N-Tidal Diagnose is measured using comparison to consensus diagnosis at end of study 2. Diagnostic accuracy (PPV, NPV) of usual care diagnosis is measured using comparison to consensus diagnosis at end of study 3. Diagnostic accuracy (sensitivity, specificity, PPV, NPV) of N-Tidal Diagnose prediction categories is measured using comparison to consensus diagnosis at end of study 4. Feasibility and acceptability to clinicians and patients is measured using Visual Analogue Score following N-Tidal and spirometry at study visit 5. Feasibility and acceptability to clinicians and patients is measured using thematic analysis of semi-structured interviews with participating clinicians and participants post-recruitment 6. Quality of primary care spirometry is measured using percentage of participants with adequate spirometry performed according to ARTP guidelines determined by independent quality assessment at end of study 7. Quality of primary care spirometry is measured using descriptive data on spirometry quality control and training procedures collected during site set-up 8. Quality of primary care spirometry is measured using thematic analysis of semi-structured interviews with participating primary care clinicians post-recruitment 9. Quality of N-Tidal Diagnose data capture is measured using percentage of participants with adequate N-Tidal Handset breath record capture sufficient to generate a diagnostic output using N-Tidal Diagnose software at study visit | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactCharlotte Latimer-Bell
Outcome results
None listed