Cynthia Harrison-Felix

A randomized trial of modafinil for the treatment of fatigue and excessive daytime sleepiness in individuals with chronic traumatic brain injury.

BackgroundThis study examines the efficacy of modafinil in treating fatigue and excessive daytime sleepiness in individuals with traumatic brain injury (TBI). MethodsA single-center, double-blind, placebo-controlled cross-over trial, where 53 participants with TBI were randomly assigned to receive up to 400 mg of modafinil, or equal number of inactive placebo tablets. Main eligibility criteria were being at least 1 year post-TBI severe enough to require inpatient rehabilitation. The primary outcome measures were fatigue (Fatigue Severity Scale, FSS) and daytime sleepiness (Epworth Sleepiness Scale, ESS). ResultsAfter adjusting for baseline scores and period effects, there were no statistically significant differences between improvements seen with modafinil and placebo in the FSS at week 4 (–0.5 ± 1.88; P = .80) or week 10 (–1.4 ± 2.75; P = .61). For ESS, average changes were significantly greater with modafinil than placebo at week 4 (–1.2 ± 0.49; P = .02) but not at week 10 (–0.5 ± 0.87; P = .56). Modafinil was safe and well tolerated, although insomnia was reported significantly more often with modafinil than placebo (P = .03). ConclusionsWhile there were sporadic statistically significant differences identified, a clear beneficial pattern from modafinil was not seen at either week 4 or week 10 for any of the 12 outcomes. There was no consistent and persistent clinically significant difference between treatment with modafinil and placebo.

Mortality Over Four Decades After Traumatic Brain Injury Rehabilitation: A Retrospective Cohort Study

OBJECTIVE To investigate mortality, life expectancy, risk factors for death, and causes of death in persons with traumatic brain injury (TBI). DESIGN Retrospective cohort study. SETTING Used data from an inpatient rehabilitation facility, the Social Security Death Index, death certificates, and the U.S. population age-race-sex-specific and cause-specific mortality rates. PARTICIPANTS Persons with TBI (N=1678) surviving to their first anniversary of injury admitted to rehabilitation from an acute care hospital within 1 year of injury between 1961 and 2002. INTERVENTIONS Not applicable. MAIN OUTCOME MEASURES Vital status, standardized mortality ratio, life expectancy, cause of death. RESULTS Persons with TBI were 1.5 times more likely to die than persons in the general population of similar age, sex, and race, resulting in an estimated average life expectancy reduction of 4 years. Within the TBI population, the strongest independent risk factors for death after 1 year postinjury were being older, being male, having less education, having a longer hospitalization, having an earlier year of injury, and being in a vegetative state at rehabilitation discharge. After 1 year postinjury, persons with TBI were 49 times more likely to die of aspiration pneumonia, 22 times more likely to die of seizures, 4 times more likely to die of pneumonia, 3 times more likely to commit suicide, and 2.5 times more likely to die of digestive conditions than persons in the general population of similar age, sex, and race. CONCLUSIONS This study demonstrated life expectancy after TBI rehabilitation is reduced and associated with specific risk factors and causes of death.

Social communication skills in persons with post-acute traumatic brain injury: Three perspectives

Objective: To describe social communication skills problems identified by individuals with traumatic brain injury (TBI) compared to significant other (SO) and clinician ratings; and associations between these skills and participation outcome measures. Design: Cohort study. Methods: Sixty individuals with TBI ≥ 1 year post-injury were administered measures of social communication, societal participation, social integration and life satisfaction. Clinicians and SOs rated the social communication skills of the subjects. Results: Subjects were able to identify social communication skills problems, associated with lower ratings of community integration and satisfaction with life. Males reported higher scores in social communication and social integration than females. SOs and clinicians identified more social skills problems than subjects. Conclusions: Persons with TBI experience social communication skills deficits, associated with decreased societal participation and life satisfaction. Further research is needed to determine efficacy of social communication skills treatment and association with improved participation and satisfaction with life.

Mortality After Discharge From Acute Care Hospitalization With Traumatic Brain Injury: A Population-Based Study

UNLABELLED Ventura T, Harrison-Felix C, Carlson N, DiGuiseppi C, Gabella B, Brown A, DeVivo M, Whiteneck G. Mortality after discharge from acute care hospitalization with traumatic brain injury: a population-based study. OBJECTIVE To characterize mortality after acute hospitalization with traumatic brain injury (TBI) in a socioeconomically diverse population. DESIGN Population-based retrospective cohort study. SETTING Statewide TBI surveillance program. PARTICIPANTS Colorado residents with TBI discharged alive from acute hospitalization between 1998 and 2003 (N=18,998). INTERVENTIONS Not applicable. MAIN OUTCOME MEASURES Vital status at the end of the study period (December 31, 2005) and statewide population mortality rates were used to calculate all-cause and cause-specific standardized mortality ratios (SMRs) and life expectancy compared with population mortality rates. The influence of demographics, injury severity, and comorbid conditions on time until death was investigated using age-stratified Cox proportional hazards modeling. RESULTS Patients with TBI carried about 2.5 times the risk of death compared with the general population (SMR=2.47; 95% confidence interval [CI], 2.31-2.65). Life expectancy reduction averaged 6 years. SMRs were largest for deaths caused by mental/behavioral (SMR=3.84; 95% CI, 2.67-5.51) and neurologic conditions (SMR=2.79; 95% CI, 2.07-3.77) and were smaller but significantly higher than 1.0 for an array of other causes. Injury severity and older age increased mortality among young people (age <20y). However, risk factors for mortality among adults age 20 and older involved multiple domains of demographics (eg, metropolitan residence), injury-related measures (eg, falls versus vehicular incidents), and comorbidity (eg, > or =3 comorbid health conditions versus none). CONCLUSIONS TBI confers an increased risk of mortality in the months and years after hospital discharge. Although life expectancy is reduced across the population, the excess in mortality lessens as time since injury increases. Specific risk factors (eg, high injury severity, poor general health) pose an especially high threat to survival and should prompt an increased vigilance of health status, especially among younger patients.

Causes of death following 1 year postinjury among individuals with traumatic brain injury.

ObjectiveTo investigate causes of death in individuals with traumatic brain injury (TBI). DesignRetrospective cohort study. SettingUtilized data from the TBI Model Systems National Database, the Social Security Death Index, death certificates, and the US population age-race-gender-cause-specific mortality rates for 1994. PatientsTwo thousand one hundred forty individuals with TBI completing inpatient rehabilitation in 1 of 15 National Institute on Disability and Rehabilitation Research-funded TBI Model Systems of Care between 1988 and 2001, and surviving past 1 year postinjury. Main Outcome MeasuresPrimary cause of death based on the International Classification of Diseases - 9th Revision - Clinical Modification - coded death certificates. ResultsIndividuals with TBI were about 37 times more likely to die of seizures, 12 times more likely to die of septicemia, 4 times more likely to die of pneumonia, and about 3 times more likely to die of other respiratory conditions (excluding pneumonia), digestive conditions, and all external causes of injury/poisoning than were individuals in the general population of similar age, gender, and race. ConclusionLong-term follow-up of individuals with TBI should increase vigilance for, and prevention of, diagnoses frequently causing death (circulatory disorders) and diagnoses with a high relative risk of causing death in this population (seizures, septicemia, respiratory and digestive conditions, and external causes of injury).

Progress in Developing Common Data Elements for Traumatic Brain Injury Research: Version Two – The End of the Beginning

To accelerate data sharing and research on traumatic brain injury (TBI), several federal agencies have been collaborating to support the development and implementation of common data elements (CDEs). The first recommendations for CDEs were made in 2010, and were well suited for hospital-based studies of acute TBI in adults. To broaden the utility of the TBI CDEs, experts were asked to update the recommendations to make them relevant to all ages, levels of injury severity, and phases of recovery. The second version of the TBI CDEs (v.2) was organized around four major study types: 1) epidemiological research; 2) studies on acute, hospitalized patients; 3) studies of the rehabilitation for moderate/severe TBI; and 4) mild TBI/concussion research. Given the heterogeneity of TBI, only a small set of core CDEs were found to be relevant across all study types. However, within groups, a much larger set of highly relevant CDEs were identified, and these were called basic CDEs. In addition, an expanded number of supplemental CDEs were specified and recommended for use depending upon the study goals. Version 2 provides a rich data dictionary for TBI research with about 900 CDEs. Many of the CDEs overlap across the study types, which will facilitate comparisons and meta-analysis across studies. Further modifications of the CDEs should be based on evaluation of their usefulness following implementation across a range of studies.

Long-Term Disability and Survival in Traumatic Brain Injury: Results From the National Institute on Disability and Rehabilitation Research Model Systems

OBJECTIVES To document long-term survival in 1-year survivors of traumatic brain injury (TBI); to compare the use of the Disability Rating Scale (DRS) and FIM as factors in the estimation of survival probabilities; and to investigate the effect of time since injury and secular trends in mortality. DESIGN Cohort study of 1-year survivors of TBI followed up to 20 years postinjury. Statistical methods include standardized mortality ratio, Kaplan-Meier survival curve, proportional hazards regression, and person-year logistic regression. SETTING Postdischarge from rehabilitation units. PARTICIPANTS Population-based sample of persons (N=7228) who were admitted to a TBI Model Systems facility and survived at least 1 year postinjury. These persons contributed 32,505 person-years, with 537 deaths, over the 1989 to 2011 study period. INTERVENTIONS Not applicable. MAIN OUTCOME MEASURE Survival. RESULTS Survival was poorer than that of the general population (standardized mortality ratio=2.1; 95% confidence interval, 1.9-2.3). Age, sex, and functional disability were significant risk factors for mortality (P<.001). FIM- and DRS-based proportional hazards survival models had comparable predictive performance (C index: .80 vs .80; Akaike information criterion: 11,005 vs 11,015). Time since injury and current calendar year were not significant predictors of long-term survival (both P>.05). CONCLUSIONS Long-term survival prognosis in TBI depends on age, sex, and disability. FIM and DRS are useful prognostic measures with comparable statistical performance. Age- and disability-specific mortality rates in TBI have not declined over the last 20 years. A survival prognosis calculator is available online (http://www.LifeExpectancy.org/tbims.shtml).

Representativeness of the traumatic brain injury model systems national database

Objective:To determine whether the Traumatic Brain Injury Model Systems National Database (TBIMS-NDB) is representative of individuals aged 16 years and older admitted for acute, inpatient rehabilitation in the United States with a primary diagnosis of traumatic brain injury (TBI). Design:Secondary analysis of existing data sets. Setting:Acute inpatient rehabilitation facilities. Participants:Patients aged 16 years and older with a primary rehabilitation diagnosis of TBI. Main Outcome Measures:Demographic characteristics, functional status, and hospital length of stay. Results:Patients included in the TBIMS-NDB from October 2001 through December 2007 were largely representative of all individuals 16 years and older admitted for rehabilitation in the United States with a primary diagnosis of TBI. The major difference in distribution was age—the TBIMS-NDB cohort did not include as large a proportion of patients older than 65 years as were admitted for rehabilitation with a primary diagnosis of TBI in the United States. Distributional differences for age-related characteristics were observed; however, groups of patients partitioned at aged 65 years differed minimally, especially within the younger than 65 years subset. Regardless of age, the proportion of patients with a rehabilitation stay of 1 to 9 days was larger nationwide. Nationwide admissions showed an age distribution similar to patients discharged alive from acute care with moderate, severe or penetrating TBI. The proportion of patients aged 70 years and older admitted for TBI rehabilitation in the United States increased every year, a trend that was not evident in the general population, TBIMS-NDB or among TBI patients in acute care. Conclusions:These results provide substantial empirical evidence that the TBIMS-NDB is representative of patients receiving inpatient rehabilitation for TBI in the United States. Researchers utilizing the TBIMS-NDB may want to adjust statistically for the lower percentage of patients older than 65 years or those with stays less than 10 days.

Factors That Predict Acute Hospitalization Discharge Disposition for Adults With Moderate to Severe Traumatic Brain Injury

OBJECTIVE To identify factors predicting acute hospital discharge disposition after moderate to severe traumatic brain injury (TBI). DESIGN Secondary analysis of existing datasets. SETTING Acute care hospitals. PARTICIPANTS Adults hospitalized with moderate to severe TBI included in 3 large sets of archival data: (1) Centers for Disease Control and Prevention Central Nervous System Injury Surveillance database (n=15,646); (2) the National Trauma Data Bank (n=52,012); and (3) the National Study on the Costs and Outcomes of Trauma (n=1286). INTERVENTIONS None. MAIN OUTCOME MEASURE Discharge disposition from acute hospitalization to 1 of 3 postacute settings: (1) home, (2) inpatient rehabilitation, or (3) subacute settings, including nursing homes and similar facilities. RESULTS The Glasgow Coma Scale (GCS) score and length of acute hospital length of stay (LOS) accounted for 35% to 44% of the variance in discharges to home versus not home, while age and sex added from 5% to 8%, and race/ethnicity and hospitalization payment source added another 2% to 5%. When predicting discharge to rehabilitation versus subacute care for those not going home, GCS and LOS accounted for 2% to 4% of the variance, while age and sex added 7% to 31%, and race/ethnicity and payment source added 4% to 5%. Across the datasets, longer LOS, older age, and white race increased the likelihood of not being discharged home; the most consistent predictor of discharge to rehabilitation was younger age. CONCLUSIONS The decision to discharge to home a person with moderate to severe TBI appears to be based primarily on severity-related factors. In contrast, the decision to discharge to rehabilitation rather than to subacute care appears to reflect sociobiologic and socioeconomic factors; however, generalizability of these results is limited by the restricted range of potentially important variables available for analysis.

Mortality after surviving traumatic brain injury: Risks based on age groups

Objective:To assess mortality, life expectancy, risk factors, and causes of death by age groups among persons who received inpatient traumatic brain injury (TBI) rehabilitation. Design:Prospective cohort study. Setting:The TBI Model Systems. Participants:8573 individuals injured between 1988 and 2009, with survival status per December 31, 2009, determined. Interventions:Not applicable. Main Outcome Measures:Standardized mortality ratio, life expectancy, and cause of death. Results:Moderate-severe TBI increases risk of mortality compared with the general population in all age groups, with the exception of those 85 years or older at the time of injury. Teenagers to middle-aged adults are at particular risk. Risk factors for death varied by age group and included gender, marital and employment status, year and cause of injury, and level of disability. External causes of death predominate in younger groups. For the youngest male participants in the sample, longevity was reduced up to 16 years. Conclusion:Risk factors and causes of death varied considerably by age group for individuals with moderate-severe TBI who were receiving acute care rehabilitation. Moderate-severe TBI is a chronic health condition.