TrUE PROMS ver1.0

• Research type

  Research Study

• Full title

  Patient Reported Outcome (PRO) Measurement of Disability in Trauma to the Upper Extremity

• IRAS ID

  183283

• Contact name

  Prakash Jayakumar

• Contact email

  prakash.jayakumar@balliol.ox.ac.uk

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  1 years, 1 months, days

• Research summary

  Trauma to the upper extremity, including fractures of the shoulder (proximal humerus or PHF) and wrist (distal radius or DRF), account for the majority of fractures involving the limbs. These injuries confer a major burden on healthcare resources and often lead to a significant impact on disability and quality of life. The inability to feed, perform personal hygiene, clothe, groom and care for oneself due to an injury, particularly involving a dominant arm, can be extremely debilitating.

  The World Health Organization (WHO) defines disability as a dynamic interaction between impairment (problems with body functions and structures), activity limitations and participation restrictions alongside environmental and personal factors. In relation to our study, it allows us to perform experimental analysis by using patient reported outcome (PRO) instruments and clinical measures to reflect impairment, psychosocial factors and symptoms such as pain, and understand their relative influence on disability.

  There is increasing evidence that disability is associated more with the subjective, psychosocial aspects of illness and pain than objective measures of impairment and pathophysiology. Studies show 1 in 5 people experiencing orthopaedic trauma meet a threshold for psychological distress. Psychological features include posttraumatic stress, pain catastrophizing, kinesiophobia, pain self-efficacy and the inability to work.

  PRO instruments containing a fixed set of questions as well as newer computer adaptive tests (CATs) will be used. CATs adapt to a patient’s response and are shown to achieve scores with greater precision and efficiency, however, studies using CATs in upper extremity trauma are lacking.

  In Summary we aim to:
  - determine the most influential factors associated with disability in PHFs and DRFs
  - determine the correlation between fixed length and CAT PRO instruments
  - define threshold scores from PRO instrument measures of disability that indicate poor outcomes based on PRO instruments measuring psychological factors and pain

• REC name

  Yorkshire & The Humber - South Yorkshire Research Ethics Committee

• REC reference

  16/YH/0017

• Date of REC Opinion

  15 Jan 2016

• REC opinion

  Favourable Opinion