<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03264417</url>
  </required_header>
  <id_info>
    <org_study_id>S60619</org_study_id>
    <nct_id>NCT03264417</nct_id>
  </id_info>
  <brief_title>Pulmonary Function Test Study - Automated Interpretation</brief_title>
  <official_title>Pulmonary Function Test Study - Automated Interpretation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AZ Sint-Jan AV</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ziekenhuis Oost-Limburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jessa Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Onze Lieve Vrouwziekenhuis Aalst</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Universitaire de Charleroi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital St Luc, Brussels</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Universitaire Saint Pierre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Liege</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier du Luxembourg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Medical Center Nijmegen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Philipps University Marburg Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicentric study to explore variability when clinicians are intrepreting lung function&#xD;
      tests. Comparison with results of in-house built software for automatic interpretation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center non-interventional retrospective study that will use data obtained&#xD;
      from clinical routine. In the hospital, subjects with or without respiratory complaints&#xD;
      undergo subset of (or complete) pulmonary function tests if clinically indicated. Results of&#xD;
      these tests, expressed as numerical values are send to the clinical workstation (KWS) for&#xD;
      immediate clinical use. These results are subsequently being interpreted by a clinician.&#xD;
&#xD;
      A random sample of 50 lung function printouts of subjects followed at the Leuven pulmonary&#xD;
      service with a final diagnosis of a respiratory disease have been randomised. These&#xD;
      anonymized printouts will be given to different pulmonologists for examination in 18&#xD;
      different centers and compared with the interpretation of in-house developed software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Interclass correlation coëfficiënt for whole group</measure>
    <time_frame>6 months</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Interclass correlation coëfficiënt for every case</measure>
    <time_frame>6 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of physicians expressed as a percentage of correct diagnoses per case (%)</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of physicans expressed as a percentage of correct diagnoses in total group (%)</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of physicians expressed as a percentage of correct diagnoses per hospital (group) (%)</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of software expressed as a percentage of correct diagnoses in total group, per hospital and per case</measure>
    <time_frame>6 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of accuracy (% of correct diagnoses) of physicians with software</measure>
    <time_frame>6 months</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Respiratory Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with or without respiratory complaints undergo subset of (or complete) pulmonary&#xD;
        function tests&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age more than 18 years&#xD;
&#xD;
          2. Completed one or more pulmonary function tests&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Younger than 18&#xD;
&#xD;
          2. Lung transplantation, lung cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wim Janssens, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>September 3, 2018</last_update_submitted>
  <last_update_submitted_qc>September 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Wim Janssens</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03264417
org study id: S60619
nct id: NCT03264417
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
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collaborator: 
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has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Retrospective
measure: Interclass correlation coëfficiënt for whole group
time frame: 6 months
description: 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).
measure: Interclass correlation coëfficiënt for every case
time frame: 6 months
description: 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).
measure: Accuracy of physicians expressed as a percentage of correct diagnoses per case (%)
time frame: 6 months
description: 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.
measure: Accuracy of physicans expressed as a percentage of correct diagnoses in total group (%)
time frame: 6 months
description: 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.
measure: Accuracy of physicians expressed as a percentage of correct diagnoses per hospital (group) (%)
time frame: 6 months
description: 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.
measure: Accuracy of software expressed as a percentage of correct diagnoses in total group, per hospital and per case
time frame: 6 months
description: 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
measure: Comparison of accuracy (% of correct diagnoses) of physicians with software
time frame: 6 months
description: 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)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Wim Janssens, Prof. Dr.
role: Principal Investigator
affiliation: UZ Leuven
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Wim Janssens
investigator title: Prof. Dr.
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders