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OpenTrials
Completed

NCT Number: NCT02778451

Certification Standards and Diagnostic Accuracy for Surgeon-performed Ultrasonography

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.

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Key information

Conditions

Ultrasonography Skills

Age range

26 year–48 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Ultrasonography-experienced surgeons

Inclusion criteria

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

Inclusion criteria

  • Medical doctor during internship

Exclusion criteria

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

Treatment and study plan

Measurement of competence

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 19, 2016
Registry last updated
May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.