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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05256355
Other study ID # 2022-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date June 30, 2022

Study information

Verified date October 2022
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 30, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
musculoskeletal ultrasound
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.

Locations

Country Name City State
Denmark Stine Carstensen Glostrup

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

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 ultrasonograp — View Citation

Carstensen SMD, Terslev L, Jensen MP, Østergaard 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. Review. — View Citation

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. — View Citation

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. Ep — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Performance score Competence score assessed by blinded raters using a generic skills assessment scale (OSAUS). Up to 12 months
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