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Clinical relevance of Clinician and Patient Reported Outcome Measures in patients with upper extremity injuries by determining Minimal Important Change (COMIC)

Clinical relevance of Clinician and Patient Reported Outcome Measures in patients with upper extremity injuries by determining Minimal Important Change (COMIC)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON22661
Enrollment
400
Registered
2021-03-12
Start date
2021-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper extremity injury: clavicle fracture, AC luxation, shoulder dislocation, humerus fracture (proximal, shaft and distal), elbow dislocation, radius fracture (proximal, shaft, distal), ulna fracture (olecranon, shaft, distal), carpal fractures and dislocations, metacarpal fractures and dislocations, finger fractures and dislocations (proximal falanx, midfalanx, distal falanx, PIP, DIP, MCP).

Interventions

No intervention in treatment. Follow up with PROMs and CROs.

Sponsors

Amsterdam UMC, location VUmc
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with UEI (uni- or bilateral), thus; patients will be included <1 week after injury. 2. Age of 18 years or older. (3. Extra inclusion criterium for patients suffering hand/wrist injury: unilateral injury)

Exclusion criteria

Exclusion criteria: 1. No sufficient command of the Dutch language. 2. Patients with UE disorders; longer existing complaints (>1 week). (3. Extra exclusion criterium for patients suffering hand/wrist injury: bilateral injury)

Design outcomes

Primary

MeasureTime frame
PROM and CRO scores to estimate MICs for PROMs and CROs.

Secondary

MeasureTime frame
- PROM and CRO scores to validate PROMs. - Estimating the MIC for the PROMIS UE v2.0 item bank by using the vignettes method. Development and validation of the required vignettes.

Contacts

Public ContactSuus van Bruggen

Amsterdam UMC, location VUmc

s.vanbruggen@amsterdamumc.nl0622562194

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)