This is a feasibility study for a larger multicentre randomised controlled trial (RCT). We aim to determine the clinical effectiveness of an Artificial Intelligence (AI) decision support software (ArtiQ.Spiro) in supporting quality assessment and diagnostic performance of primary care staff in the interpretation of spirometry.
What is the reason for this study?
Lung disease is the third biggest cause of death in the UK and a major reason for hospital bed shortages in winter. Itis a national health priority in The NHS Long Term Plan for England.
Spirometry is a blowing test that measures how much air a person can breathe in and then empty their lungs. It is important for the diagnosis of common lung conditions. Sometimes it is difficult to perform good quality spirometry in the community and it can be difficult to interpret the results.
ArtiQ.Spiro is an AI software which has been developed to help with the quality assessment and interpretation of spirometry. This software has previously been tested and is currently used successfully in European hospitals. AI uses pattern recognition with the results from the breathing tests to provide a report for your GP.
We want to see whether adding the ArtiQ.Spiro AI software to spirometry can help trained staff make a quicker and a more accurate diagnosis of lung disease in primary care.
Who can take part?
We are looking to recruit participate who have been referred for a spirometry test by their GP. Participants must be ≥18 years of age and must be able to provide informed consent.
What the trial involves
Participants who wish to join the study will be asked to provide consent to take part in the study prior to their spirometry test appointment. They will also be asked to provide permission for the research team to obtain information from their electronic medical record (Primary and secondary care).
Following their spirometry test, participants will be contacted by the research team, either by phone or email, 1 week, 3 months and 6 months after their appointment.
Participants will be asked to complete two sets of questionnaires at each of the 3 contact points. These questionnaires are:
- The Euro-Qol 5-Dimensions 5-Levels (EQ5D5L) questionnaire. This, includes simple questions relating to the quality of their life, such as, mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
- The Patient Healthcare Resource Use questionnaire. This will be used to collect information about services and support they may use such as GP appointments and family support.
Participants will be randomised to one of the following groups:
Control Group: If participants are randomised to the control group, their GP will receive the spirometry report plus any additional information they would normally receive. Their GP will not receive an interpretation and quality assessment report generated by the AI software.
Intervention Group: If participants are randomised to the intervention group, their GP will receive the spirometry report plus any additional information they would normally receive plus an interpretation and quality assessment report generated by the AI software.
Randomisation will take place at the time a participant provides consent to take part in the study.
Participants may also be asked if they are willing to be interviewed by the research team, as part of a participant focus group discussions at the end of the study. If they are interested, the research team will provide them with more details about these interviews.
How to get involved
This study is currently running in some Leicester Primary Care Networks and is expected to will open to recruitment in Hillington, London in July 2023. Individuals referred by their GP practice for local spirometry in these areas will receive a copy of the study information sheet alongside their spirometry appointment letter. Individuals who consent to being contacted by the research team will receive a telephone call to discuss the study further.
Contact us to find out more
Study contact: Ethaar El-Emir, George Edwards, Gillian Doe
Contact email: rbh-tr.spiro-aid@nhs.net
Chief Investigator: Professor William Man
Research Project Information
| Specialty category | Chronic respiratory disease (including COPD, Asthma, Bronchiectasis, Interstitial Lung Disease) |
| Research title | Artificial intelligence in PRImary Care spirometry pathways for diagnosis of Lung Disease (APRIL). |
| IRAS number | 324175 |