Pulmonary Function Test Study - Automated Interpretation

A multicentric study to explore variability when clinicians are intrepreting lung function tests. Comparison with results of in-house built software for automatic interpretation.

Study Overview

• Status: Completed
• Conditions: Respiratory Disease

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with or without respiratory complaints undergo subset of (or complete) pulmonary function tests

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: University Medical Center Groningen; Maastricht University Medical Center; University of Liege; Jessa Hospital; University Hospital, Ghent; University Hospital, Grenoble; AZ Sint-Jan AV; Ziekenhuis Oost-Limburg; Philipps University Marburg Medical Center; University Hospital, Paris; Centre Hospitalier Universitaire Saint Pierre; University Medical Center Nijmegen; Onze Lieve Vrouwziekenhuis Aalst; Centre Hospitalier du Luxembourg; Centre Hospitalier Universitaire de Charleroi; University Hospital St Luc, Brussels
• Investigators: Principal Investigator: Wim Janssens, Prof. Dr., UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): December 30, 2017
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 3, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: S60619

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No