The purpose of this study is to complete the third and final phase of PRO instrumentdevelopment, cross-sectional field-testing of the LIMB-Q. The field-test data will be analyzedto identify the subsets of items for each scale that represent the best…
ID
Source
Brief title
Condition
- Bone and joint injuries
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Scores on the LIMB-Q
Secondary outcome
scores on the ED-5Q and PROMIS physical functional score
Background summary
Severe lower extrem¡ty trauma can be life changing for patients. Treatment
options include
immediate amputation, delayed amputation after attempts at reconstruction, and
successful
limb-salvage. However, successful limb salvage often requires multiple
operations, with a
high rate of complications. Alternatively, amputation results in a permanent
loss of limb and
reliance on a prosthetic for ambulation. From a patient perspective, it remains
unclear how
outcomes compare between reconstruction and amputation, as there is no
patient-reported
outcome (PRO) instrument designed for limb threatening lower extremity injuries
to collect
this data. PRO instruments are rating scales that measure concepts of interest
(COl) relevant
to patients such as symptoms, appearance, function and health-related
quality-of-life (QOL)
by asking patients directly. ln order to measure COI important to patients with
a limbthreatening
lower extremity injury, a well-defined, valid, reliable and responsive PRO
instrument is needed.
The LIMB-Q is currently being developed to meet this need.
The first two phases of LIMB-Q development have been completed at Duke using
rigorous, international PRO instrument
development standards.
Study objective
The purpose of this study is to complete the third and final phase of PRO
instrument
development, cross-sectional field-testing of the LIMB-Q. The field-test data
will be analyzed
to identify the subsets of items for each scale that represent the best
indicators of outcome
based on their performance against a standardized set of psychometric criteria.
Once this is
completed, we anticipate that the LIMB-Q will provide meaningful, precise and
reliable
feedback on important patient-centered outcomes with the potential for
widespread use in
both clinical and research settings.
Study design
Cross-sectional
Study burden and risks
No risks are associated with this study. The main burden is the time it takes
to complete these questionnaires. The outcomes of these questionnaires will be
used to improve the care for these patients.
Wake Forest Rd Ste 202
Raleigh NC 27609
US
Wake Forest Rd Ste 202
Raleigh NC 27609
US
Listed location countries
Age
Inclusion criteria
Had a reconstrution or amputation for a severe lower extremity trauma, in the
last 20 years, aged 18 years or older, fluent in Dutch or english
Exclusion criteria
aged <18 years, not fluent in Dutch or English
Design
Recruitment
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 |
|---|---|
| CCMO | NL75275.078.20 |