Pulmonary Function Test Study - Automated Interpretation

Respiratory Disease Clinical Trial

Official title:

Pulmonary Function Test Study - Automated Interpretation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03264417
• Other study ID #: S60619
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: September 2018
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 1, 2018
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (17)

Lead Sponsor

Collaborator

KU Leuven

AZ Sint-Jan AV, Centre Hospitalier du Luxembourg, Centre Hospitalier Universitaire de Charleroi, Centre Hospitalier Universitaire Saint Pierre, Jessa Hospital, Maastricht University Medical Center, Onze Lieve Vrouwziekenhuis Aalst, Philipps University Marburg Medical Center, University Hospital of Liege, University Hospital St Luc, Brussels, University Hospital, Ghent, University Hospital, Grenoble, University Hospital, Paris, University Medical Center Groningen, University Medical Center Nijmegen, Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interclass correlation coëfficiënt for whole group	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).	6 months
Secondary	Interclass correlation coëfficiënt for every case	Variation in preferred primary diagnosis of respiratory disease given by every physician for an individual case (selection of one diagnosis out of a fixed panel of 9 possible diagnoses).	6 months
Secondary	Accuracy of physicians expressed as a percentage of correct diagnoses per case (%)	Comparison of diagnostic labels per case provided by the physicians with gold standard diagnosis based on clinical characteristics, complete pulmonary function test data and all other investigations (CT scan, biochmestry, functional test, biopsy, etc...) needed to come to a gold standard diagnosis.	6 months
Secondary	Accuracy of physicans expressed as a percentage of correct diagnoses in total group (%)	Comparison of diagnostic labels per case provided by the physicians with gold standard diagnosis based on clinical characteristics, complete pulmonary function test data and all other investigations (CT scan, biochmestry, functional test, biopsy, etc...) needed to come to a gold standard diagnosis.	6 months
Secondary	Accuracy of physicians expressed as a percentage of correct diagnoses per hospital (group) (%)	Comparison of diagnostic labels per case provided by the group of physicians per hospital with gold standard diagnosis based on clinical characteristics, complete pulmonary function test data and all other investigations (CT scan, biochmestry, functional test, biopsy, etc...) needed to come to a gold standard diagnosis.	6 months
Secondary	Accuracy of software expressed as a percentage of correct diagnoses in total group, per hospital and per case	Comparing labels of in-house developed software for the clinical interpretation and diagnostic labeling of complete pulmonary function tests with GOLD standard based on all additional tests	6 months
Secondary	Comparison of accuracy (% of correct diagnoses) of physicians with software	Comparing the diagnostic labels provided by in-house developed software for the clinical interpretation and diagnostic labeling of complete pulmonary function tests with those of physicans (in total group, per hospital and per case)	6 months