Certification Standards and Diagnostic Accuracy for Surgeon-performed Ultrasonography

NCT ID: NCT02778451

Last Updated: 2016-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ultrasonography Skills

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ultrasonography-experienced surgeons

Attending physicians and consultants in head and neck surgery using head and neck Ultrasonography on a daily basis.

Group Type OTHER

Measurement of competence

Intervention Type OTHER

This study is a psychometric validation of a generic assessment tool to evaluate ultrasonography competence among surgeons

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.

Group Type OTHER

Measurement of competence

Intervention Type OTHER

This study is a psychometric validation of a generic assessment tool to evaluate ultrasonography competence among surgeons

Interventions

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Measurement of competence

This study is a psychometric validation of a generic assessment tool to evaluate ultrasonography competence among surgeons

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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


* Medical doctor during internship

Exclusion Criteria

* experience with head and neck Ultrasonography
* experience with head and neck surgery
Minimum Eligible Age

26 Years

Maximum Eligible Age

48 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Tobias Todsen

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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H-3-2013-081

Identifier Type: -

Identifier Source: org_study_id

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