FIT Study

• Research type

  Research Study

• Full title

  Functional outcomes In Trauma (FIT) Study

• IRAS ID

  257064

• Contact name

  Peter Giannoudis

• Contact email

  peter.giannoudis@nhs.net

• Sponsor organisation

  Leeds Teaching Hospitals NHS Trust

• Clinicaltrials.gov Identifier

  NCT04074382

• Duration of Study in the UK

  12 years, 7 months, 1 days

• Research summary

  Why?
  There is not much information in the UK on how well patients who sustain major trauma function afterwards. Major trauma is defined as significant injuries with a calculated ‘injury severity score’ (ISS) over 15. The ISS is calculated based on how many parts of the body are injured and how badly injured these are, up to a maximum score of 75 (fatal). We feel that learning more about how these people cope afterwards, and what influences this, will allow us to improve the care we can deliver in the future, which will hopefully lead to better outcomes.

  What?
  We propose to implement the FIT (Functional outcomes In Trauma) study to assess how well patients function physically, psychologically and socially, and get back to activities of daily living, work and participation in recreational activities following major trauma.

  Who?
  Major trauma patients: 2 cohorts: prospectively, going forwards in time (from baseline to 12 months after trauma) and retrospectively, going backwards in time (patients between 1-10 years after trauma).

  Where?
  Leeds General Infirmary.

  How?
  We will do this by collecting data from questionnaires completed by patients (also known as PROMS, or Patient Reported Outcome Measures), using an online questionnaire service developed at the University of Leeds, called QTool. These will offer the participants the chance to tell us how they are doing across lots of areas, with both tick-box multiple choice questions and open-ended questions to explain how they are doing and what influences this. We will also interview a random selection of patients in further detail, to discuss how their trauma has affected them, how they found the study, how we could improve it. Afterwards we will send participants a copy of what we have learnt from the study and aim to publish it in a scientific journal.
  

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  19/YH/0427

• Date of REC Opinion

  22 May 2020

• REC opinion

  Further Information Favourable Opinion