Competency-based Assessment in Musculoskeletal Ultrasound

October 25, 2022 updated by: Stine Maya Dreier Carstensen, Rigshospitalet, Denmark

Competency-based Assessment in Musculoskeletal Ultrasound- a Validity Study

Early diagnosis and rapid treatment initiation are of most importance to prevent joint damage in patients with arthritis. Musculoskeletal ultrasound (MSUS) is becoming an integrated part of rheumatology routine care and is more sensitive than clinical examination for detecting synovitis even in the early stage of disease.

However, MSUS is highly operator dependent and competences are needed to ensure correct image interpretation. Traditionally competences are evaluated on how many examinations the trainees have performed, but the gold standard has now shifted towards competency-based education where objective assessment tools are the key element. A previous study has developed a scale for assessment of ultrasound competence, The Objective Structured Assessment of Ultrasound skills (OSAUS). Although expert consensus supports evidence of content validity of the assessment instrument, it is not known if the OSAUS scale can discriminate differences in performance scores between different levels of MSUS experience in rheumatology in a reliable way.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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

      • Glostrup, Denmark, 2600
        • Stine Carstensen

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Physicians working at the rheumatology departments in Denmark:

    1. Novices: No or little experience with MSUS (less than 100 examinations).
    2. Intermediates: Participated and completed at least one formal ultrasound course and more than 100 examinations (less than 1000 MSUS examinations).
    3. Physicians with a long experience in MSUS doing the procedure almost daily and providing teaching and/or research within this field (more than 1000 examinations).

Exclusion Criteria:

  • No informed consent
  • Novices/Intermediates: extensive experience in MSUS

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: MSUS novices
Measurement of competence
The participants will perform four MSUS examinations which are all videorecorded. All videos will be rated by two blinded raters using the OSAUS assessment tool.
OTHER: MSUS intermediates
Measurement of competence
The participants will perform four MSUS examinations which are all videorecorded. All videos will be rated by two blinded raters using the OSAUS assessment tool.
OTHER: MSUS experts
Measurement of competence
The participants will perform four MSUS examinations which are all videorecorded. All videos will be rated by two blinded raters using the OSAUS assessment tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance score
Time Frame: Up to 12 months
Competence score assessed by blinded raters using a generic skills assessment scale (OSAUS).
Up to 12 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Stine Maya Carstensen, MD, Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Copenhagen University Hospital - Rigshospitalet Glostrup, Copenhagen, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 1, 2022

Primary Completion (ACTUAL)

June 1, 2022

Study Completion (ACTUAL)

June 30, 2022

Study Registration Dates

First Submitted

February 11, 2022

First Submitted That Met QC Criteria

February 24, 2022

First Posted (ACTUAL)

February 25, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-002

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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