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Completed

NCT Number: NCT03264417

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.

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Key information

Conditions

Respiratory Disease Respiration Disorders Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age more than 18 years
  • Completed one or more pulmonary function tests

Exclusion criteria

  • Younger than 18
  • Lung transplantation, lung cancer.

Treatment and study plan

Primary outcomes

  1. 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

  1. Interclass correlation coëfficiënt for every case

    Time frame: 6 months

    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).

  2. Accuracy of physicians expressed as a percentage of correct diagnoses per case (%)

    Time frame: 6 months

    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.

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

    Time frame: 6 months

    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.

  4. Accuracy of physicians expressed as a percentage of correct diagnoses per hospital (group) (%)

    Time frame: 6 months

    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.

  5. Accuracy of software expressed as a percentage of correct diagnoses in total group, per hospital and per case

    Time frame: 6 months

    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. Comparison of accuracy (% of correct diagnoses) of physicians with software

    Time frame: 6 months

    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)

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

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

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 29, 2017
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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