Methods of collecting traumatic brain injury outcomes
Research type
Research Study
Full title
Methods of collecting traumatic brain injury outcomes: comparing patient-reported, proxy-reported, and clinician-reported outcomes.
IRAS ID
191182
Contact name
Lindsay Horton
Contact email
Sponsor organisation
University of Stirling
Duration of Study in the UK
0 years, 10 months, 1 days
Research summary
This is a sub-study of the CENTER-TBI study, which is a large longitudinal observational study of European patients with Traumatic Brain Injury (TBI). CENTER-TBI comprises 1) A core study of approximately 5400 Traumatic Brain Injury (TBI) patients recruited via 60 centres across Europe, and 2) A registry providing basic observational data on all patients presenting with TBI (n~15000-25000). The main aim of the current study is to compare different methods of collecting information for the Glasgow Outcome Scale - Extended (GOSE), which is a popular outcome assessment for TBI. \n\nThis study will involve 100 TBI patients throughout the United Kingdom at 6 months to 2 years following head injury. Participants will be recruited primarily via the CENTER-TBI study. Participants will be recruited from three UK CENTER-TBI sites including Lothian Health Board, Cambridge University Hospital NHS Foundation Trust, and Queen Elizabeth Hospital in Birmingham. Participants will also be recruited via the NHS Lothian CENTER-TBI UK registry.\n\nThe study will compare four different methods of administering the GOSE, including 1) face-to-face structured interviews with the TBI patient, 2) structured telephone interviews with the TBI patient, 3) structured telephone interviews with a relative/caregiver, and 4) patient-reported postal questionnaires. The study will also examine the relationship between outcome on the different versions of the GOSE and self-awareness, cognition, quality of life, emotional status, injury to other parts of the body, and TBI severity. Face-to-face interviews, telephone interviews, and neurocognitive assessments will be administered by trained outcome assessors and the interviews will be audio recorded.
REC name
London - Brent Research Ethics Committee
REC reference
17/LO/0314
Date of REC Opinion
28 Feb 2017
REC opinion
Further Information Favourable Opinion