PROMIS
Research type
Research Study
Full title
A cohort study to determine the minimal clinically important difference and patient acceptable symptoms state of the PROMIS Mobility Score amongst lower limb injuries in children.
IRAS ID
268677
Contact name
Chris Talbot
Contact email
Sponsor organisation
Alder Hey NHS Foundation Trust
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
This is a prospective longitudinal cohort study of paediatric lower limb trauma patients to assess progress after a lower limb fracture by calculating the minimal clinically important difference (MCID) using the PROMIS mobility questionnaire.
Patients with traumatic injuries to the ankle, tibia or femur will be recruited prospectively from outpatient fracture clinics in a single UK paediatric tertiary centre and will be asked to complete several computer adaptive tests (CATs) generating an outcome measure ranging from 8 -40 (with higher scores representing better function). A proxy report will be used for children younger than age 8 years and a self-report version will be used for children aged 8 years and older.
An anchor-based method will primarily be used and mean of slight change group from anchor based global assessment question will be calculated. The Paediatric PROMIS Mobility and an anchor question will be administered at 6 time points over a 24-week period via automated parental / guardian received text message.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0255
Date of REC Opinion
7 Aug 2019
REC opinion
Favourable Opinion