Measure | Source (Instrument) | Instrument psychometrics/measurement properties | Frequency | Groups | |
Transitional factors | Age Insurance status Gender | Medical Record Review (Patient Enrolment Form) | Day 0 | 1, 2, 3, 4 | |
Education Income Pre-existing conditions | Self/Family Report (Patient Enrolment Form, Elixhauser) | Day 0 Day 3 (or as early as able to obtain information reliably) | 3, 4 1, 2 | ||
New onset illness or injury | Self/Family Report on Patient Data Form-Follow up visit | Day 7 1, 3, 6 months | 1, 2 1, 2, 3, 4 | ||
Social support | MOS Social Support Survey47 | α>0.91 | Day 0 Day 3 (or when able to obtain reliable information) | 3, 4 1, 2 | |
Pathology: injury | Injury Type Location Mechanism Severity | Medical record (GCS, IISS,48 Injury Mechanism E-code,49 Head CT findings) Confirm with Trauma Registry (Patient Enrolment Form) | Day 0 | 1,2 | |
Inflammatory markers Interleukin (IL)−1 beta IL-2, IL-4, IL-5, IL-6, Ll-7, IL-10, IL-12, IL-13, GM-CSF, TNF-alpha, leptin, fractalkine | Plasma (Multiplex Bead based assay) | Day 0, 3, 7 1, 3 and 6 months (Day 3, 7 and 3 month for TBI groups only*) | 1, 2, 3, 4 | ||
Cellular immune response (IFN-γ secretion in response to PHA or LPS) | PBMCs (ELISpot assay) | Inter-rater reliability in pilot >0.92; test retest reliability >0.90 | Day 0, 3, 7 1, 3 and 6 months (Day 3, 7 and 3 month for TBI groups only*) | 1, 2, 3, 4 | |
Impairment: symptoms | Symptom presence and burden | RPQ50 | Rho=0.67 at 3 months postinjury; 0.56 at 6 months. Test-retest reliability 0.8950 | Day 0 Day 7 1, 3, 6 months | 3, 4 1,2 1, 2, 3, 4 |
BSI-1851 | Test-retest in patients with TBI 0.57–0.67 on the subscales; Internal consistency reported to be α=0.75–0.9151 | ||||
Neuropsychological impairment | RAVLT52 | Internal reliability high with reported α>0.9; test retest good.52–54 | Day 0 Day 7 3, 6 months (3 month for TBI group only*) | 3, 4 1, 2 1, 2, 3, 4 | |
TMT52 | Inter-rater reliability is reported as 0.94 for Part A and 0.90 for Part B55 | ||||
Processing Speed Index from Wechsler Adult Intelligence Scale56 | High internal consistency (0.8–0.89). Good test-retest reliability52 | ||||
Functional limitation disability | Functional change postinjury disability | Functional Independence Measure57 | Construct and predictive validity demonstrated in patients with TBI. Inter-rater reliability of the FIM is reported to be >0.90; >0.90 test-retest reliability57 | Day 0 Day 7 1, 3, 6 months | 3, 4 1, 2 1, 2, 3, 4 |
GOS-E58 | Inter-rater reliability of the GOS-E is reported to be 0.78 with a weighted kappa of.8558 | 3, 6 months | 1, 2, 3, 4 | ||
Quality of life | Health-related quality of life | Self-Report (MOS Short Form-36v2 Acute Recall)59 | Reliability of the SF-36 reported to be 0.92 and 0.88 for the subscales.59 60 In patients with mild TBI, α 0.83–0.91 reported61 | Day 0 Day 7 1, 3, 6 months | 3, 4 1, 2 1, 2, 3, 4 |
SWLS62 | Internal consistency exceeds 0.80; Test-retest reliability 0.82–0.8963 | Day 0 Day 7 1, 3, 6 months | 3, 4 1, 2 1, 2, 3, 4 |
Group 1: Older mild TBI; Group 2: Younger mild TBI; Group 3: Older non-injured control; Group 4: Younger non-injured control.
*For non-injured control, no 3-day visit, phone visit only at 3-month visit to reduce burden and increase subject retention based on pilot work.
BSI-18, Brief Symptom Inventory-18; GCS, Glasgow Coma Scale;GOS-E, Glasgow Outcome Scale-Extended; ISS, Injury Severity Score; LPS, lipopolysaccharide; PHA, phytohemagglutinin; RAVLT, Rey Auditory Verbal Learning Test; RPQ, Rivermead Postconcussion Symptom Questionnaire; SWLS, Satisfaction with Life Scale; TMT, Trail Making Test.