Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
To evaluate whether an artificial intelligence decision support software (ArtiQ.Spiro) improves the diagnostic accuracy of spirometry interpreted by primary care clinicians, as measured by Clinician Diagnostic Accuracy (vs Reference Standard).
This is a randomised controlled study to evaluate the effects of AI support software on the performance of primary care clinicians in the interpretation of spirometry. Clinicians will be provided with a clinical dataset of 50 entirely anonymous, previously recorded real-world spirometry records to interpret and will be asked to complete specific questions about diagnosis and quality assessment. The records will be randomly selected from a database comprising spirometry records from 1122 patients undergoing spirometry in primary care and community -based respiratory clinics in Hillingdon borough between 2015-2018.
Participating clinicians will be allocated at random to receive either spirometry records alone or spirometry records with the addition of an AI spirometry interpretation eport. The clinical spirometry records will be de-identified (name, date of birth, address, postcode, occupation, GP, medications data removed), by a member of the clinical care team.
Study participants (participating clinicians) will independently examine the same 50 spirometry records through an online platform. For each spirometry record, the primary care clinician participant will answer questions about technical quality, pattern interpretation, preferred diagnosis, differential diagnosis and self-rated confidence with these answers.
The study statistician will be blinded to treatment allocation up to completion of analysis and interpretation.
The reference standards for spirometry technical quality and pattern interpretation will be made by a senior experienced respiratory physiologist but without access to AI report.
The reference standard for diagnosis will be made by a panel of three respiratory specialists from the clinical care team with access to medical notes and results of relevant investigations but without access to AI report.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants to report 50 spirometry records alone | |
| Intervention | Experimental | Participants report the same 50 spirometry records provided in the control arm with an artificial intelligence-powered spirometry interpretation report |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Intelligence-powered Spirometry Interpretation Report | Other | A report generated by artificial intelligence powered software that assessed technical quality of spirometry and estimates the diagnostic probability of six categories: COPD/Asthma/ILD/ Normal/Other obstructive/Other Unidentified |
| Measure | Description | Time Frame |
|---|---|---|
| Preferred Diagnostic Performance | A correct case is where the preferred diagnosis matches the reference final diagnosis. Units will be percentage of total cases that are correct. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Pattern interpretation | A correct case is where the participants' selected pattern matches the reference pattern. Options are: Normal, Airflow obstruction, Possible restriction or non-specific pattern, Possible Mixed Disorder. Units will be percentage of total cases that are correct. | Six months |
| Differential diagnostic performance |
Not provided
Inclusion Criteria:
Exclusion Criteria:
1. Clinicians who have completed specialist training in respiratory medicine and recognised by the General Medical Council with a right to practise as a NHS consultant in respiratory medicine
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ethaar El-Emir, PhD | Contact | 01895 823737 | 85952 | e.el-emir@rbht.nhs.uk |
| George Edwards, MSc | Contact | 01895 823737 | G.Edwards2@rbht.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| William Man | Royal Brompton & Harefield Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brompton & Harefield Hospitals | Recruiting | Uxbridge | UB9 6JH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38950987 | Derived | Doe G, El-Emir E, Edwards GD, Topalovic M, Evans RA, Russell R, Sylvester KP, Van Orshoven K, Sunjaya AP, Scott DA, Prevost AT, Harvey J, Taylor SJ, Hopkinson NS, Kon SS, Jarrold I, Spain N, Banya W, Man WD. Comparing performance of primary care clinicians in the interpretation of SPIROmetry with or without Artificial Intelligence Decision support software (SPIRO-AID): a protocol for a randomised controlled trial. BMJ Open. 2024 Jul 1;14(6):e086736. doi: 10.1136/bmjopen-2024-086736. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
A correct case is where the preferred or differential diagnosis matches the reference final diagnosis. Units will be percentage of total cases that are correct. |
| Six months |
| Quality assessment performance | A correct case is where the participant's quality grade matches the reference quality grade. Options are: Acceptable (Grade A/B) or Not Acceptable (Grades C/D/E/F/U). Units will be percentage of total cases that are correct. | Six months |
| Pattern interpretation self-rated confidence | Pattern interpretation self-rated confidence will be measured on a visual analogue scale (0-10) where 0 = not confident at all; 10= very confident) | Six months |
| Diagnostic self-rated confidence | Diagnostic self-rated confidence will be measured on a visual analogue scale (0-10) where 0 = not confident at all; 10= very confident) | Six months |
| Quality Assessment self-rated confidence | Quality Assessment self-rated confidence will be measured on a visual analogue scale (0-10) where is 0 = not confident at all; 10= very confident) | Six months |