Pulmonary Function Test Study - Automated Interpretation

KU Leuven50 enrolled

Overview

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

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

Conditions

Respiratory Disease

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

UZ Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

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).

Time frame: 6 months

Secondary Outcomes

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).

Time frame: 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.

Time frame: 6 months

Accuracy of physicans expressed as a percentage of correct diagnoses in total group (%)

Time frame: 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.

Data from ClinicalTrials.gov

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