Pulmonary Function Test Study - Automated Interpretation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- KU Leuven
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Interclass correlation coëfficiënt for whole group
Study Overview
Brief Summary
A multicentric study to explore variability when clinicians are intrepreting lung function tests. Comparison with results of in-house built software for automatic interpretation.
Detailed Description
This is a multi-center non-interventional retrospective study that will use data obtained from clinical routine. In the hospital, subjects with or without respiratory complaints undergo subset of (or complete) pulmonary function tests if clinically indicated. Results of these tests, expressed as numerical values are send to the clinical workstation (KWS) for immediate clinical use. These results are subsequently being interpreted by a clinician.
A random sample of 50 lung function printouts of subjects followed at the Leuven pulmonary service with a final diagnosis of a respiratory disease have been randomised. These anonymized printouts will be given to different pulmonologists for examination in 18 different centers and compared with the interpretation of in-house developed software.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age more than 18 years
- •Completed one or more pulmonary function tests
Exclusion Criteria
- •Younger than 18
- •Lung transplantation, lung cancer.
Outcomes
Primary Outcomes
Interclass correlation coëfficiënt for whole group
Time Frame: 6 months
Variation in preferred primary diagnosis of respiratory disease given by every physician for every case (selection of one diagnosis out of a fixed panel of 9 possible diagnoses).
Secondary Outcomes
- Accuracy of software expressed as a percentage of correct diagnoses in total group, per hospital and per case(6 months)
- Interclass correlation coëfficiënt for every case(6 months)
- Accuracy of physicians expressed as a percentage of correct diagnoses per case (%)(6 months)
- Accuracy of physicans expressed as a percentage of correct diagnoses in total group (%)(6 months)
- Accuracy of physicians expressed as a percentage of correct diagnoses per hospital (group) (%)(6 months)
- Comparison of accuracy (% of correct diagnoses) of physicians with software(6 months)
Investigators
Wim Janssens
Prof. Dr.
KU Leuven