Eligibility

Persons are considered eligible if they meet the case definition of TBI.

Definition of TBI

TBI is defined as damage to brain tissue caused by an external mechanical force as evidenced by medically documented loss of consciousness or post traumatic amnesia (PTA) due to brain trauma or by objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination. Penetrating wounds fitting definition listed above are included.

This definition of TBI excludes several conditions when criteria above are not met: Lacerations or contusions of the face, eye, or scalp, without other criteria listed above; Fractures of skull or facial bones, without criteria listed above; Primary anoxic, inflammatory, toxic, or metabolic encephalopathies which are not complications of head trauma; Brain infarction (ischemic stroke); Intracranial hemorrhage (hemorrhagic stroke) without associated trauma; Airway obstruction (e.g., near - drowning, throat swelling, choking, strangulation, or crush injuries to the chest); Seizure disorders (Grand mal, etc.); Intracranial surgery; Neoplasms

The Inclusion Criteria for the TBIMS NDB are:

  1. fitting the above definition;
  2. meeting at least one of the following criteria for moderate to severe TBI:
    • PTA > 24 hours
    • Trauma related intracranial neuroimaging abnormalities
    • Loss of consciousness exceeding 30 minutes (unless due to sedation or intoxication)
    • GCS in the emergency department of less than 13 (unless due to intubation, sedation,or intoxication);
  3. who are age 16 or older at the time of injury;
  4. presenting to the TBIMS’s acute care hospital within 72 hours of injury;
  5. must receive both acute hospital care and comprehensive rehabilitation in a designated brain injury inpatient rehabilitation program within the TBIMS. Comprehensive rehabilitation must occur in a hospital, rehabilitation unit, rehabilitation hospital, hospital-based skilled nursing facility, skilled nursing facility, or long-term acute care hospital that meets the following criteria:
    • Medical and rehabilitation care are supervised on a regular basis by a physician affiliated with the TBIMS
    • 24-hour nursing care is provided to the patient
    • PT, OT, Speech, Rehabilitation Psychology/Clinical Neuropsychology, and family support/education are provided in an integrated, team approach with the expectation of further gain.
    • Regardless the setting in which it is constituted, a comprehensive rehabilitation program operates in a manner consistent with (a) CARF standards for brain injury inpatient rehabilitation and/or (b) Medicare requirements for inpatient rehabilitation.
    • If a TBIMS’s comprehensive rehabilitation program co-exists with programming that does not meet the above criteria, the TBIMS must explicitly define its methodology for establishing the dates of admission and discharge from comprehensive rehabilitation that will be reported to the TBIMS Data and Statistical Center (NDSC). These dates will represent the period of time during which CARF and/or Medicare criteria are met. This period may include interruptions during which the criteria are not met for medical reasons but after which a rehabilitation programming meeting CARF and/or Medicare criteria is resumed.
    • All data required by the National Database are accessible and transferable to the NDSC with appropriate informed consent;
  6. who understand and provide informed consent to participate or, if unable, family or legally authorized representative understands and provides informed consent for the patient.

Randomized Demographics

The TBIMS uses established criteria to determine eligibility for enrollment and participation in the TBIMS National Database (NDB). Since inception, it has been the expectation that TBIMS centers approach every eligible subject for enrollment in the NDB. However, beginning on January 1, 2020, it is expected that through randomization of eligible cases a center will have a target of 35 cases per year. This procedures that will take place for all centers, providing them with a sampling strategy that maintains the representativeness of their sample of subjects.