Clinical trial NCT03264417: Pulmonary Function Test Study - Automated Interpretation
Official title: Pulmonary Function Test Study - Automated Interpretation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Disease
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
name: AZ Sint-Jan AV
name: Ziekenhuis Oost-Limburg
name: Jessa Hospital
name: Onze Lieve Vrouwziekenhuis Aalst
name: Centre Hospitalier Universitaire de Charleroi
name: University Hospital St Luc, Brussels
name: Centre Hospitalier Universitaire Saint Pierre
name: University of Liege
name: Centre Hospitalier du Luxembourg
name: Maastricht University Medical Center
name: University Medical Center Nijmegen
name: University Medical Center Groningen
name: University Hospital, Paris
name: University Hospital, Grenoble
name: Philipps University Marburg
First posted: 2017-08-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with or without respiratory complaints undergo subset of (or complete) pulmonary function tests

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.

Eligibility criteria: Inclusion Criteria:

1. Age more than 18 years
2. Completed one or more pulmonary function tests

Exclusion Criteria:

1. Younger than 18
2. Lung transplantation, lung cancer.

Primary outcomes:
measure: Interclass correlation coëfficiënt for whole group
timeFrame: 6 months
Secondary outcomes:
measure: Interclass correlation coëfficiënt for every case
timeFrame: 6 months
measure: Accuracy of physicians expressed as a percentage of correct diagnoses per case (%)
timeFrame: 6 months
measure: Accuracy of physicans expressed as a percentage of correct diagnoses in total group (%)
timeFrame: 6 months
measure: Accuracy of physicians expressed as a percentage of correct diagnoses per hospital (group) (%)
timeFrame: 6 months
measure: Accuracy of software expressed as a percentage of correct diagnoses in total group, per hospital and per case
timeFrame: 6 months
measure: Comparison of accuracy (% of correct diagnoses) of physicians with software
timeFrame: 6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Wim Janssens, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: