- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05384327
Development and Validation of a Theoretical Test for Chest Tube Insertion
The goal of the proposed study design is to develop and gather validity evidence of a theoretical test about cognitive skills which are important when performing Chest Tube Insertion (CTI). This study consists of two parts:
- The development of the theoretical test and its items. The test content will be based on a broad literature search, and on semi-structured interviews with content experts.
- The subsequent collection of validity evidence for this theoretical test and final selection of the test items, by testing groups that differ based on their expertise. The item analysis and observed difference in mean score between the groups will provide the validity evidence.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgium, 9000
- Ghent University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Content experts will be recruited from the departments of surgery, pulmonology, and emergency medicine of various hospitals in Flanders and the Netherlands. They must have finished their residency training and be actively involved in training of junior physicians. A maximum of six experts will be recruited, and a minimum of one physician from each department will be included.
- The novice group will attract medical students at Ghent University, within their 5th or 6th year of undergraduate training, while having no experience with CTI.
- The intermediate group will include residents of the departments of surgery, pulmonology and emergency medicine of Ghent University Hospital, within their 1st - 3rd year of residency training and must have placed less than 20 chest tubes themselves.
- The experienced group will be recruited from the departments of surgery, pulmonology, and emergency medicine of Ghent University Hospital. They must have finished the residency training in their respective fields and must have performed more than 20 CTI independently. The content experts will not be eligible for participation.
Exclusion Criteria:
- For the novice and intermediate group: having to much experience in CTI.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Interview
Content experts who will be interviewed in order to collect their opinion on theoretical knowledge.
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Interviews consist of semi-structured interviews focused on the theoretical knowledge a physician should possess before placing chest tube insertions.
|
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Other: Novices
Medical students who will complete the test
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The test contains multiple choice questions based on these interviews. Participants will complete this test. Validity evidence will be collected based on the results of this test. |
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Other: Intermediates
Junior residents (surgery, pneumology, emergency medicine) who will complete the test.
|
The test contains multiple choice questions based on these interviews. Participants will complete this test. Validity evidence will be collected based on the results of this test. |
|
Other: Experienced
Faculty members (surgery, pneumology, emergency medicine) who will complete the test.
|
The test contains multiple choice questions based on these interviews. Participants will complete this test. Validity evidence will be collected based on the results of this test. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Validity evidence for the theoretical test
Time Frame: Participants are assessed once: the score of each participant is recorded immediately after completion of the test.
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Validity evidence following Messick's framework for a new theoretical test will be collected.
The score will reflect the number of questions participants scored correctly; X/Y, where X=the number of questions answered correctly, and Y=the total number of questions.
This score can be transformed in a percentage score accordingly.
A higher score means the participant answered more questions correctly.
|
Participants are assessed once: the score of each participant is recorded immediately after completion of the test.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wouter Willaert, Prof. Dr., University Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ID 5046
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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