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
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
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
NCT ID
NCT02542332
First Posted
August 16, 2015
Last Updated
September 4, 2015
Sponsor
Otto Wagner Hospital
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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Schmidt R, Breyer M, Breyer-Kohansal R, Urban M, Funk GC. Do doctors understand the test characteristics of lung cancer screening? Wien Klin Wochenschr. 2018 Apr;130(7-8):238-246. doi: 10.1007/s00508-017-1305-9. Epub 2018 Jan 25.
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Are Doctors Familiar With the Test Characteristics of Lung Cancer Screening?
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