Certification Standards and Diagnostic Accuracy for Surgeon-performed Ultrasonography

May 18, 2016 updated by: Tobias Todsen, Rigshospitalet, Denmark
Ultrasonography (US) is an operator depended image modality that is difficult to reproduce and interpret by others. Competence of the US operator is crucial for reliable diagnostics but no evidence-based certification of head and neck US skills has been developed. Investigators conducted an experimental study aimed to explore diagnostic accuracy and establish validity evidence for certification standards in surgeon-performed ultrasonography.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

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

26 years to 48 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  1. Ultrasonography-experienced surgeons

    Inclusion Criteria:

    • Board certified otolaryngologist
    • Daily use of head and neck Ultrasonography
  2. Ultrasonography novices:

Inclusion Criteria:

  • Medical doctor during internship

Exclusion Criteria:

  • experience with head and neck Ultrasonography
  • experience with head and neck surgery

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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ultrasonography-experienced surgeons
Attending physicians and consultants in head and neck surgery using head and neck Ultrasonography on a daily basis.
Other: Measurement of competence
This study is a psychometric validation of a generic assessment tool to evaluate ultrasonography competence among surgeons
Other: Ultrasonography novices
Physicians participating in their one-year internship at other surgical or medical departments with no experience with head and neck US or head and neck surgery.
Other: Measurement of competence
This study is a psychometric validation of a generic assessment tool to evaluate ultrasonography competence among surgeons

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Competence score on a generic skills assessment scale (The Objective Structured Assessment of Ultrasound Skills (OSAUS))
Time Frame: up to 24 months
Performance were video-recorded Maj 25, 2013 and afterwards assessed by a consultant in diagnostic radiology and a consultant in head and neck surgery
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy assessed by a head and neck surgeon reading the ultrasonography report
Time Frame: up to 24 months
Assessed by a head and neck surgeon reading the ultrasonography report of the participating physicians from the experimental study conducted Maj 25, 2013
up to 24 months

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

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

May 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 8, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 19, 2016

Study Record Updates

Last Update Posted (Estimate)

May 19, 2016

Last Update Submitted That Met QC Criteria

May 18, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • H-3-2013-081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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