|
BACKGROUND/RATIONALE:
This project is a prospective measurement and outcomes study of persons with severe traumatic brain injury (TBI). Severe TBI results in altered consciousness and the current state of scientific knowledge provides little insight into the course and rate of neurological recovery and the effectiveness of interventions during coma recovery. Medical and rehabilitation management during coma recovery and scientific investigations of coma recovery have been hampered by an inability to detect and measure treatment effects.
The rationale for enhancing neurobehavioral measurement and prognostication after severe TBI is based on the healthcare needs of our veterans and military service personnel as well as the needs of their family/loved ones, the chronic debilitating nature of severe TBI, preliminary evidence supporting the hypotheses and the clinical and research utility of the Disorders of Consciousness Scale (DOCS).
OBJECTIVE(S):
The purpose of this study is to enhance neurobehavioral measurement and prognostication after severe TBI. This will be done in Three Steps: (1) Enhance the Disorders of Consciousness Scale (DOCS), (2) Examine the performance characteristics of the finalized DOCS, and (3) Explore associations between the DOCS and other variables known or thought to be important to outcome prediction. The research objectives are:
Objective # 1: To shorten the Disorderso of Consciousness Scale (DOCS) from 23 items (20-30 minutes) to 15-20 items (15-20 minutes) while improving the predictive values of the DOCS; thereby enhancing clinical utility.
Objective #2: To determine what performance characteristics of the DOCS are important to predicting recovery of consciousness (ROC) and 1-year functional outcomes. The performance characteristics to be examined are: (a) Computational formulas of change, (b) Number of DOCS evaluations used for computing change, (c) Magnitude of change, and (d) Magnitude of change per units of time.
Objective #3: To determine how DOCS change, as computed from (a) through (d) above, performs as a predictor variable in a model including other variables known or thought to be important to outcome prediction.
METHODS:
This study is the third phase of a longitudinal measurement and outcomes study and it builds on previous research. Persons > = 18 years of age with severe TBI who have been unconscious for > = 28 days consecutively and are within 180 days of injury are eligible for study enrollment. 193 subjects will be enrolled and each subject will be followed for one year.
The independent variables being collected and examined for prognostic utility include the DOCS and other Neurobehavioral Variables, Injury and Lesion Characteristics, Physioloigcal Data, Etiology, Cause of Injury, Demographics, Comorbidities, Rehabilitation Services Received and indices of Injury Severity. The primary outcome is time to consciousness up to 1-year after injury and the secondary outcome is functional outcome 1-year after injury.
FINDINGS/RESULTS:
A sample of 113 is, at the time of writing this annual review report, being analyzed to compare the predictive ability of different computations of DOCS change to predict recovery and lack of recovery of consciousness. The sample is comprised largely (67%) of males with an average age at injury of 37.8 years. 78.7% of participants are white, with 90% having a high school education or higher. 19 of the 113 subjects (17%) are eligible for Veteran's Benefits. An etiology of Closed Head Injury (CHI) accounts for 71.7% of the sample, followed by, anoxic (16.8%), hemorrhagic (3.54%), aneurysm (3.54%), open head injury (2.65%) and other (1.77%). 18 subjects died within 1 year of injury (due to reasons not related to research procedures).
Predictive values positive and negative are being compared according to different DOCS measures and according to different samples. DOCS23chi indicates that DOCS measures are estimated (using Bayesian estimation procedures) when only persons with CHI (71% of sample) are included in the estimation sample. DOCS23obi indicates that DOCS measures are estimated when only persons with severe TBI due to etiologies other than CHI are included in the sample. All CHI (DOCS23) and All Other (DOCS23) indicate that all 113 persons were included in the estimation sample (for estimating DOCS measures) regardless of etiology, but CHI and All Other BI were controlled for in the logistic regression model. All DOCS measures were estimated using only the 23 items found to be reliable and valid.
The comparisons below are preliminary and are still being examined, but initial findings suggest that DOCSabs1-5 < 9 & >9 for All CHI has the most balanced predictions through the first year of injury. . That is, if a patient's DOCS measure changes by 9 DOCunits (increase or decrease) over 5 weeks then they have a 88% chance for recovering consciousness within the first 122 days of injury and a 46% chance of not recovering consciousness within 122 days of injury (4 months). These predictions remain relatively balanced at 244 days of injury (8 months) and 365 days of injury (12 months). The next step in the analysis is to compare predictive values according to whether the 9 unit change is an increase or decrease relative to no change.
During this review period there have been no findings to indicate increased risk of involvement in this protocol. There are not any additional benefits, however, families may be more interested in participating in this research knowing that they could receive some preliminary prognostic information regarding their family member's recovery of consciousness.
IMPACT:
The significance of the research is directly related to the heterogeneous nature of the course of recovery from severe TBI and to the VA's mission to provide medical care that maximizes each veteran's quality of life. This research addresses the VA's mission to provide veterans and service members with evidence based medical rehabilitation. The project will bring us one step closer to enabling evidence based medical rehabilitation in the VA. This project will develop the capacity to measure neuro-behavioral recovery in a feasible manner, measure medical and rehabilitation intervention effects and improve prognostication. Considering that veterans and military service personnel are at increased risk for TBI, the debilitating and chronic nature of severe TBI, and that medical advancements will continue to reduce mortality and increase demands for effective rehabilitation services, it is important that the VA be prepared to provide effective medical rehabilitation services and evidence based prognoses for our veterans and military service personnel.
PUBLICATIONS:
None at this time.
DRA:
Acute and Traumatic Injury, Military and Environmental Exposures
DRE:
Treatment, Diagnosis and Prognosis
Keywords:
none
MeSH Terms:
none
|
