- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05256355
Competency-based Assessment in Musculoskeletal Ultrasound
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Glostrup, Denmark, 2600
- Stine Carstensen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Physicians working at the rheumatology departments in Denmark:
- Novices: No or little experience with MSUS (less than 100 examinations).
- Intermediates: Participated and completed at least one formal ultrasound course and more than 100 examinations (less than 1000 MSUS examinations).
- 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
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
Sponsor
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
General Publications
- Tolsgaard MG, Todsen T, Sorensen JL, Ringsted C, Lorentzen T, Ottesen B, Tabor A. International multispecialty consensus on how to evaluate ultrasound competence: a Delphi consensus survey. PLoS One. 2013;8(2):e57687. doi: 10.1371/journal.pone.0057687. Epub 2013 Feb 28.
- Brown AK, O'Connor PJ, Wakefield RJ, Roberts TE, Karim Z, Emery P. Practice, training, and assessment among experts performing musculoskeletal ultrasonography: toward the development of an international consensus of educational standards for ultrasonography for rheumatologists. Arthritis Rheum. 2004 Dec 15;51(6):1018-22. doi: 10.1002/art.20844.
- Carstensen SMD, Terslev L, Jensen MP, Ostergaard M. Future use of musculoskeletal ultrasonography and magnetic resonance imaging in rheumatoid arthritis. Curr Opin Rheumatol. 2020 May;32(3):264-272. doi: 10.1097/BOR.0000000000000709.
- Nayahangan LJ, Dietrich CF, Nielsen MB. Simulation-based training in ultrasound - where are we now? Ultraschall Med. 2021 Jun;42(3):240-244. doi: 10.1055/a-1352-5944. Epub 2021 Jun 15. No abstract available.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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