Development and Validation of a Theoretical Test for Chest Tube Insertion

May 8, 2023 updated by: University Ghent

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

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Interviews consist of semi-structured interviews focused on the theoretical knowledge a physician should possess before placing chest tube insertions.
Other: Novices
Medical students 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: 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.
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Wouter Willaert, Prof. Dr., University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2022

Primary Completion (Actual)

April 18, 2023

Study Completion (Actual)

April 18, 2023

Study Registration Dates

First Submitted

May 13, 2022

First Submitted That Met QC Criteria

May 18, 2022

First Posted (Actual)

May 20, 2022

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ID 5046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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