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ID
Source
Brief title
Health condition
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).
Sponsors and support
Intervention
Outcome measures
Primary outcome
PROM and CRO scores to estimate MICs for PROMs and CROs.
Secondary outcome
- 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.
Background summary
Upper Extremity Injuries (UEIs) form a major problem for society. UEIs have a lot of impact on physical health, but also on work, daily activities, participation, and health care costs.
In daily clinical practice, patients’ rehabilitation outcome after suffered UEIs is objectified using clinical measurements and expert opinion-based outcomes (Clinician Reported Outcomes; CROs), e.g. grip strength, range of motion and radiological measurements. Other aspects such as pain, activity limitations, and restrictions in participating in daily life are not being taken into account by these traditional methods. Nowadays, Patient-Reported Outcome Measures (PROMs) are used more frequently to measure patient-based outcomes. Using PROMs can improve communication between patient and clinician, which might improve treatment and rehabilitation strategies.
However, for this aim it is important that scores and changes in scores can be clearly interpreted. A PROM might show a significant change over time, but this does not mean the patient will notice the difference and considers the change to be important. Little is known about how changes in scores should be interpreted. The smallest change that can be detected with a PROM, known as the Smallest Detectable Change (SDC), might not be relevant for the patient. A relevant change for patients is captured with Minimal Important Change (MIC). The MIC has been defined as ‘the smallest change in score in the construct to be measured which patients perceive as important’.
As little is known about how changes in scores should be interpreted and what is relevant change for patients, more knowledge about the MIC is recommended. In this study we want to gain more knowledge on the psychometric properties of PROMs and interpretation of change scores in CROs and PROMs in patients following UEIs. For interpretation of the effect of treatment and rehabilitation in clinical practice a ‘lean’ coreset of CROs and PROs with known MICs has been proposed.
Study objective
The aims of this study are validation of PROMs and estimating the minimal important change (MIC) for PROMs and CROs.
Study design
Baseline measurement (reference measurement before injury), 6/7 weeks after injury, 9/10 weeks after injury, 6 months after injury and 6.5 months after injury. Completing vignettes will take place between 6 and 12 months after injury.
Intervention
No intervention in treatment. Follow up with PROMs and CROs.
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9337 |
| Other | METC VUmc : 2020.02 |