NCT05256355

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

1 month

First QC Date

February 11, 2022

Last Update Submit

October 25, 2022

Conditions

Keywords

TrainingUltrasoundMedical education

Outcome Measures

Primary Outcomes (1)

  • Performance score

    Competence score assessed by blinded raters using a generic skills assessment scale (OSAUS).

    Up to 12 months

Study Arms (3)

MSUS novices

OTHER

Measurement of competence

Other: musculoskeletal ultrasound

MSUS intermediates

OTHER

Measurement of competence

Other: musculoskeletal ultrasound

MSUS experts

OTHER

Measurement of competence

Other: musculoskeletal ultrasound

Interventions

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.

MSUS expertsMSUS intermediatesMSUS novices

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stine Carstensen

Glostrup Municipality, 2600, Denmark

Location

Related Publications (5)

  • 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.

  • Carstensen SMD, Just SA, Pfeiffer-Jensen M, Ostergaard M, Konge L, Terslev L. Solid validity evidence for two tools assessing competences in musculoskeletal ultrasound: a validity study. Rheumatology (Oxford). 2024 Mar 1;63(3):765-771. doi: 10.1093/rheumatology/kead286.

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD fellow, Principal investigator

Study Record Dates

First Submitted

February 11, 2022

First Posted

February 25, 2022

Study Start

May 1, 2022

Primary Completion

June 1, 2022

Study Completion

June 30, 2022

Last Updated

October 27, 2022

Record last verified: 2022-10

Locations