Table 2.
Functional, cognitive and psychological health and quality of life.
| Domain | Outcome measures | Time points | Interview type |
|---|---|---|---|
| Screening assessment | |||
| Speech intelligibility | 3 M, 6 M*, 12 M | T, IP | |
| GOAT | 3 M, 6 M*, 12 M | T, IP | |
| Comprehensive assessment battery | |||
| Cognition (primary outcome) | NIHTB cognitive battery | 3 M, 6 M*, 12 M | IP |
| Hopkins Verbal Learning Test (HVLT) | 3 M, 6 M*, 12 M | IP | |
| Trail Making Test | 3 M, 6 M*, 12 M | IP | |
| Processing Speed Index (WAIS-IV PSI) | 3 M, 6 M*, 12 M | IP | |
| SWAPS (aka TAPS) | 3 M, 6 M*, 12 M | IP | |
| Global outcomes (secondary outcome measures) | Functional Status Examination (FSE) | 3 M, 6 M*, 12 M | T, IP |
| Revised Glasgow Outcome Scale Extended (R-GOSE) | 3 M, 6 M*, 12 M | T, IP | |
| Expanded Disability Rating Scale Post-Acute Interview (E-DRS-P) | 3 M, 6 M*, 12 M | T, IP | |
| Psychological health and quality of life (secondary outcome measures) | PROMIS PROPr Short form (PROMIS-29 profile V2.1) | 3 M, 6 M*, 12 M | T, IP, R |
| Pittsburgh Sleep Quality Index (PSQI) | 3 M, 6 M*, 12 M | T, IP, R | |
| NINDS Epilepsy Screening Questionnaire | 3 M, 6 M*, 12 M | T, IP | |
| Rivermead Post-Concussion Questionnaire (RPQ) | 3 M, 6 M*, 12 M | T, IP, R | |
| Patient health Questionnaire-9 (PHQ-9) | 3 M, 6 M*, 12 M | T, IP, R | |
| Columbia Suicide Severity Rating Scale (C-SSRS) (only required if >1 on thePHQ-9 #9) |
3 M, 6 M*, 12 M | T, IP | |
| Abbreviated assessment battery for participants who are unable to take comprehensive assessment battery | |||
| Consciousness and basic cognition | Confusion Assessment Protocol (CAP) | 3 M, 6 M*, 12 M | IP |
| Coma Recovery Scale Revised (CRS-R) | 3 M, 6 M*, 12 M | IP | |
| Global outcome | Functional Status Examination (FSE) | 3 M, 6 M*, 12 M | T |
| Revised Glasgow Outcome Scale Extended (R-GOSE) | 3 M, 6 M*, 12 M | T, IP | |
| Expanded Disability Rating Scale Post-Acute Interview (E-DRS-P) | 3 M, 6 M*, 12 M | T, IP | |
*Only for TBI group; T, telephone interview; IP, in-person interview; O, REDCap online survey.
GOAT, Galveston Orientation and Amnesia Test; NIH ToolBox- Cognitive Battery supplemented; HVLT, Hopkins Verbal Learning Test; WAIS-IV PSI, Processing Speed Index; SWAPS, Southwestern Assessment of Processing Speed; R- GOSE, Glasgow Outcome Scale Extended-Revised; FSE, Functional Status Examination; E-DRS-P Expanded Disability Rating Scale Post-Acute Interview; FIM, Functional Independence Measure; PROMIS PROPr, Patient-Reported Outcomes Measurement Information System; PSQI, Pittsburgh Sleep Quality Index; PTSD, Posttraumatic Stress Disorder; PCL-C, Checklist for Civilians; REDCap, Research Electronic Data Capture.