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Are Doctors Familiar With the Test Characteristics of Lung Cancer Screening?

Primary Purpose

Information About the Knowledge on the Statistical Background of Lung Cancer Screening of Doctors

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
With Data
Sponsored by
Otto Wagner Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Information About the Knowledge on the Statistical Background of Lung Cancer Screening of Doctors focused on measuring lung cancer screening, statistical background

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Doctors, who were in training or had a completed specialization training in:
  • Pneumonology
  • Internal Medicine
  • Surgery
  • or Radiology

Exclusion Criteria:

  • Doctors, with a specialized training in
  • ENT
  • Pediatrics
  • Pathology and doctors who had no e-mail address were excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    With Data

    Without Data

    Arm Description

    Participants received statistical data about lung cancer screening

    Participants had no statistical data on lung cancer screening

    Outcomes

    Primary Outcome Measures

    Between-groups difference in the estimated reduction of mortality due to lung cancer screening
    Participants had 14 days to complete the survey

    Secondary Outcome Measures

    Between-groups difference prevalence of lung cancer
    Participants had 14 days to complete the survey
    Between-groups difference in sensitivity of lung cancer screening
    Participants had 14 days to complete the survey
    Between-groups difference in the frequency of a positive test result
    Participants had 14 days to complete the survey
    Between-groups difference in specificity of lung cancer screening
    Participants had 14 days to complete the survey
    Between-groups difference in positive predictive value of lung cancer screening
    Participants had 14 days to complete the survey
    Between-groups difference in the false negative rate of lung cancer screening
    Participants had 14 days to complete the survey

    Full Information

    First Posted
    August 16, 2015
    Last Updated
    September 4, 2015
    Sponsor
    Otto Wagner Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02542332
    Brief Title
    Are Doctors Familiar With the Test Characteristics of Lung Cancer Screening?
    Official Title
    Are Doctors Familiar With the Test Characteristics of Lung Cancer Screening?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Otto Wagner Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluates whether doctors are familiar with the statistical background of lung cancer screening.
    Detailed Description
    Background: Screening with low-dose CT scan can prevent three deaths due to lung cancer among 1000 high-risk individuals. However, false-positive results and radiation exposure are relevant disadvantages deserving accurate consideration. Candidates for screening can only make an autonomous decision if doctors inform them correctly about the pros and cons of the method. Therefore, this study aims to evaluate, whether doctors understand the test characteristics of lung cancer screening. Methods: In a randomized trial, 556 doctors (members of the Austrian Respiratory Society) will be invited to answer questions regarding lung cancer screening based on online case vignettes. Half of the participants will be randomized to the group 'with data' and will receive the correct solutions in advance. The group 'without data' will have to rely on prior knowledge or estimate. Primary endpoint will be the between-groups difference in the estimated number of deaths preventable by screening. Secondary endpoints will be the between-groups differences in prevalence of lung cancer, prevalence of suspicious results, sensitivity, specificity, positive-predictive value, and false negative rate. Estimations will also be compared to actual values from the literature.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Information About the Knowledge on the Statistical Background of Lung Cancer Screening of Doctors
    Keywords
    lung cancer screening, statistical background

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    556 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    With Data
    Arm Type
    Active Comparator
    Arm Description
    Participants received statistical data about lung cancer screening
    Arm Title
    Without Data
    Arm Type
    No Intervention
    Arm Description
    Participants had no statistical data on lung cancer screening
    Intervention Type
    Other
    Intervention Name(s)
    With Data
    Intervention Description
    The participants received statistical data about lung cancer screening in order to help them answer the questionaire
    Primary Outcome Measure Information:
    Title
    Between-groups difference in the estimated reduction of mortality due to lung cancer screening
    Description
    Participants had 14 days to complete the survey
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    Between-groups difference prevalence of lung cancer
    Description
    Participants had 14 days to complete the survey
    Time Frame
    14 days
    Title
    Between-groups difference in sensitivity of lung cancer screening
    Description
    Participants had 14 days to complete the survey
    Time Frame
    14 days
    Title
    Between-groups difference in the frequency of a positive test result
    Description
    Participants had 14 days to complete the survey
    Time Frame
    14 days
    Title
    Between-groups difference in specificity of lung cancer screening
    Description
    Participants had 14 days to complete the survey
    Time Frame
    14 days
    Title
    Between-groups difference in positive predictive value of lung cancer screening
    Description
    Participants had 14 days to complete the survey
    Time Frame
    14 days
    Title
    Between-groups difference in the false negative rate of lung cancer screening
    Description
    Participants had 14 days to complete the survey
    Time Frame
    14 days

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Doctors, who were in training or had a completed specialization training in: Pneumonology Internal Medicine Surgery or Radiology Exclusion Criteria: Doctors, with a specialized training in ENT Pediatrics Pathology and doctors who had no e-mail address were excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Georg-Christian Funk, Assoc.Prof.
    Organizational Affiliation
    Otto Wagner Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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