Musculoskeletal Diseases Clinical Trial
Official title:
Competency-based Assessment in Musculoskeletal Ultrasound- a Validity Study
| 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 |
| Verified date | October 2022 |
| Source | Rigshospitalet, Denmark |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Stine Carstensen | Glostrup |
| Lead Sponsor | Collaborator |
|---|---|
| Rigshospitalet, Denmark |
Denmark,
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
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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