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

    christalbot@doctors.org.uk

  • 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