Competency-based Assessment in Musculoskeletal Ultrasound
Primary Purpose
Musculoskeletal Diseases
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
musculoskeletal ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Musculoskeletal Diseases focused on measuring Training, Ultrasound, Medical education
Eligibility Criteria
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
Sites / Locations
- Stine Carstensen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
MSUS novices
MSUS intermediates
MSUS experts
Arm Description
Measurement of competence
Measurement of competence
Measurement of competence
Outcomes
Primary Outcome Measures
Performance score
Competence score assessed by blinded raters using a generic skills assessment scale (OSAUS).
Secondary Outcome Measures
Full Information
NCT ID
NCT05256355
First Posted
February 11, 2022
Last Updated
October 25, 2022
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT05256355
Brief Title
Competency-based Assessment in Musculoskeletal Ultrasound
Official Title
Competency-based Assessment in Musculoskeletal Ultrasound- a Validity Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases
Keywords
Training, Ultrasound, Medical education
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MSUS novices
Arm Type
Other
Arm Description
Measurement of competence
Arm Title
MSUS intermediates
Arm Type
Other
Arm Description
Measurement of competence
Arm Title
MSUS experts
Arm Type
Other
Arm Description
Measurement of competence
Intervention Type
Other
Intervention Name(s)
musculoskeletal ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Performance score
Description
Competence score assessed by blinded raters using a generic skills assessment scale (OSAUS).
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stine Maya Carstensen, MD
Organizational Affiliation
Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Copenhagen University Hospital - Rigshospitalet Glostrup, Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stine Carstensen
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
23469051
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. Epub 2013 Feb 28.
Results Reference
result
PubMed Identifier
15593176
Citation
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.
Results Reference
result
PubMed Identifier
32205568
Citation
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.
Results Reference
result
PubMed Identifier
34130348
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. No abstract available.
Results Reference
result
Learn more about this trial
Competency-based Assessment in Musculoskeletal Ultrasound
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