Kelli W. Gary

Randomized controlled trials in adult traumatic brain injury

Background: To optimize strategies for achieving the effectiveness of interdisciplinary interventions, this study conducted a comprehensive literature review of all Randomized Controlled Trials (RCT) in adults with traumatic brain injury (TBI) over the past 30 years. Method: Three major databases including Medline, PsycINFO and CINAHL were searched, yielding 1176 peer reviewed publications. One hundred RCTs were included, encompassing 55 pharmacologic and non-pharmacologic acute phase trials and 45 rehabilitation and pharmacologic post-acute trials. Results: The majority of acute phase pharmacologic or non-pharmacologic trials (40/55) showed either no effect or adverse effect on TBI outcomes. Several trials involving early nutritional therapy or pre-hospital rapid intubation demonstrated significant treatment effects. The effect of decompressive craniectomy, therapeutic hypothermia and osmotic therapy remained controversial. The majority of post-acute phase trials (36/45), consisting of cognitive rehabilitation, physical rehabilitation and pharmacotherapy, produced various beneficial treatment effects. Conclusion: The data indicate that several active interventions during the acute phase of TBI are likely to be more effective than pharmacotherapy, whereas a comprehensive rehabilitation approach is preferred in post-acute phase TBI management. Great progress has been made in understanding the heterogeneous injury mechanisms as well as the complexity of medical management and rehabilitation following the recovery course of TBI.

Do racial/ethnic differences exist in post-injury outcomes after TBI? A comprehensive review of the literature

Primary objectives: (1) To describe demographic and injury characteristics that are prominent among African Americans and Hispanics with TBI; (2) To determine if racial differences exist in regard to post-injury outcomes; (3) To highlight potential causes of racial/ethnic disparities in TBI rehabilitation and post-acute services; (4) To suggest recommendations to equalize outcomes; and stimulate future TBI research. Methods and procedures: Using MEDLINE, PyschINFO, CINAHL and InfoTrac databases, 39 peer-reviewed journal articles were found that met the following inclusion criteria: research studies that reported data for African Americans and Hispanics with TBI, outcomes from both primary and secondary analyses including paediatric patients with TBI and caregivers. Main outcome and results: African Americans and Hispanics have worse functional outcomes and community integration and are less likely to receive treatment and be employed than Whites post-TBI. Emerging research detects racial and ethnic differences in marital stability, emotional/neurobehavioural complications and QOL outcomes; however, more research is needed to corroborate significant findings. African American and Hispanic caregivers express more burden, spend more time in caregiving role, have fewer needs met and use different types of coping strategies than White counterparts. Conclusion: The racial and ethnic differences noted in this literature review are an indicator that minorities are at disproportionate risk for poorer outcomes. Post-acute interventions should specifically target minorities to diminish inequities that exist.

Racial Differences in Employment Outcome After Traumatic Brain Injury at 1, 2, and 5 Years Postinjury

UNLABELLED Gary KW, Arango-Lasprilla JC, Ketchum JM, Kreutzer JS, Copolillo A, Novack TA, Jha A. Racial differences in employment outcome after traumatic brain injury at 1, 2, and 5 years postinjury. OBJECTIVES To examine racial differences in competitive employment outcomes at 1, 2, and 5 years after traumatic brain injury (TBI) and to determine whether changes in not competitive employment rates over time differ between blacks and whites with TBI after adjusting for demographic and injury characteristics. DESIGN Retrospective cohort study. SETTING Sixteen TBI Model System Centers. PARTICIPANTS Blacks (n=615) and whites (n=1407) with moderate to severe TBI. INTERVENTIONS Not applicable. MAIN OUTCOME MEASURE Employment status dichotomized as competitively employed versus not competitively employed. RESULTS After adjusting for demographic and injury characteristics, repeated-measures logistic regression indicated that (1) the odds of not being competitively employed were significantly greater for blacks than whites regardless of the follow-up year (all P<.001); (2) the odds of not being competitively employed declined significantly over time for each race (P< or =.004); and (3) changes over time in the odds of not being competitively employed versus being competitively employed were not different between blacks and whites (P=.070). In addition, age, discharge FIM and Disability Rating Scale, length of stay in acute and rehabilitation, preinjury employment, sex, education, marital status, and cause of injury were significant predictors of employment status postinjury. CONCLUSIONS Short- and long-term employment is not favorable for people with TBI regardless of race; however, blacks fare worse in employment outcomes compared with whites. Rehabilitation professionals should work to improve return to work for all persons with TBI, with special emphasis on addressing specific needs of blacks.

The Influence of Minority Status on Job Stability After Traumatic Brain Injury

To determine the influence of minority status on job stability after traumatic brain injury (TBI).

Race/ethnicity differences in satisfaction with life among persons with traumatic brain injury

OBJECTIVE To determine differences in life satisfaction at 1-year post-TBI among Caucasian, African American, Hispanic, and Asian individuals with TBI, after adjusting for covariates that significantly differ between ethnic groups and/or affect the Satisfaction with Life Scale (SWLS) at one year post-injury. DESIGN Retrospective study. SETTING Longitudinal dataset of the TBI Model Systems National Database. PARTICIPANTS 3,368 individuals with moderate to severe TBI (2478 Caucasian, 629 African American, 180 Hispanic, and 81 Asian/Pacific Islander) hospitalized between 1989 and 2005. MAIN OUTCOME MEASURES Satisfaction with Life Total score at 1 year post injury. RESULTS African Americans had 3.21 units lower SWLS scores one year post-injury than Asian/Pacific Islanders (95% CI = 0.61-5.81) and 1.99 units lower SWLS scores than Caucasians (95% CI = 0.97-3.00) after controlling for marital status, employment at admission, cause of injury, FIM at discharge, and LOS in acute care. CONCLUSIONS African Americans have poorer self-reported life satisfaction than Caucasians and Asians one year after TBI. This effect is not due to pre-injury marital or employment status, cause of injury, nor injury severity or functional status. Further research on the factors which might explain these differences is warranted, so that targeted rehabilitation programs can be designed and implemented that enhance quality of life for all individuals who have suffered a TBI.

Racial and Ethnic Disparities in Employment Outcomes for Persons With Traumatic Brain Injury: A Longitudinal Investigation 1-5 Years After Injury

To determine whether differences exist in employment rates between whites, blacks, and Hispanics with traumatic brain injury (TBI) at 1, 2, or 5 years after injury; to determine whether changes occur in postinjury employment rates over time for whites, blacks, and Hispanics; and to determine whether changes in postinjury employment rates over time are different for whites, blacks, and Hispanics.

Efficacy of a brief acute neurobehavioural intervention following traumatic brain injury: a preliminary investigation.

Primary objective: To evaluate the effectiveness of a brief acute neurobehavioural intervention, the First Steps Acute Neurobehavioural and Cognitive Intervention (FANCI), with persons who have traumatic brain injury (TBI). Research design: Prospective, controlled, repeated measures design. Methods and procedures: Seventy-two patients in acute TBI rehabilitation participated either as FANCI subjects or as control participants who watched videos to control for time and attention. Outcome measures included the Neurobehavioural Rating Scale-Revised (NRS-R), Functional Independence Measure (FIM™), a FANCI Learning Assessment (LA) and the Satisfaction with Life Scale (SWLS). Main outcomes and results: In comparison with controls, FANCI participants had significantly greater neurobehavioural (cognitive, emotional and behavioural) as well as FIM motor improvements. Significantly greater learning occurred and persisted over time for FANCI subjects as compared to controls. Pre-treatment cognitive and neurobehavioural status, length of coma and number of sessions completed were moderating variables for functional and cognitive outcomes. Conclusions: Persons with TBI can benefit from comprehensive, manualized neurobehavioural interventions, over and above standard rehabilitation care, even during the acute phase of recovery.

Differences in employment outcomes 10 years after traumatic brain injury among racial and ethnic minority groups

Employment outcomes of racial and ethnic minority groups with traumatic brain injury (TBI) have not been thoroughly examined in the research literature beyond five years. The objective of this study was to examine differences in employment outcomes 10 years after TBI among racial and ethnic minorities. Using a multi-center, nationwide database, 382 participants (194 minorities and 188 whites) with primarily moderate to severe TBI from 16 TBI Model System Centers were examined. A logistic regression model indicated that the odds of being competitively employed versus not competitively employed at 10 years follow-up were 2.370 times greater for whites as compared to minorities after adjusting for age at injury, pre-injury employment status, cause of injury, and total length of stay (LOS). In addition, the odds of being competitively employed at 10 years follow-up versus not being competitively employed ranged from being 1.485 to 2.553 greater for those who were younger, employed at injury, had shorter total LOS, and non-violent injuries, respectively. This study supports previous research illustrating that compared to whites, employment is less promising for minorities after TBI both short and long term. Recommendations are suggested to help rehabilitation professionals target the specific needs of minorities with TBI in order to address employment disparities through culturally-based interventions and service delivery.

Do racial and ethnic minority patients fare worse after SCI?: a critical review of the literature.

A number of researchers have identified differences in SCI outcomes between racial and ethnic groups, but findings have never been synthesized to give clinicians and researchers a coherent picture of the problem. The goals of the current project were to (1) conduct a critical literature review of studies specifically investigating racial and ethnic disparities in spinal cord injury care, services, and outcomes; (2) explore possible causative factors that may explain these disparities; (3) propose strategies that may reduce disparities and improve access, service, and outcomes for minority patients with SCI; and (4) generate ideas for future research in this area. A search using MEDLINE/PubMed, PsycINFO, CINAHL, and HealthSource resulted in 49 articles discussing hospital, mental health, physical functioning, employment, quality of life, and family outcomes. Results indicated that after an SCI, racial and ethnic minority groups have shorter hospital lengths of stay, higher rehospitalizations rates, higher levels of depression, more days in poor health, greater degrees of unemployment, more difficulties with mobility, lower self-reported subjective well-being and quality of life and life satisfaction, and greater risk of marital breakup. A variety of causative factors, intervention strategies, and directions for future research are presented.

Randomized Controlled Trials in Adult Traumatic Brain Injury: A Review of Compliance to CONSORT Statement

OBJECTIVE To describe the extent to which adherence to Consolidated Standards of Reporting Trials (CONSORT) statement in randomized controlled trials (RCTs) in adult traumatic brain injury (TBI) has improved over time. DATA SOURCES MEDLINE, PsycINFO, and CINAHL databases were searched from inception to September 2013. STUDY SELECTION Primary report of RCTs in adult TBI. The quality of reporting on CONSORT checklist items was examined and compared over time. Study selection was conducted by 2 researchers independently. Any disagreements were solved by discussion. DATA EXTRACTION Two reviewers independently conducted data extraction based on a set of structured data extraction forms. Data regarding the publication years, size, locations, participation centers, intervention types, intervention groups, and CONSORT checklist items were extracted from the including trials. DATA SYNTHESIS Of 105 trials reviewed, 38.1%, 5.7%, and 32.4% investigated drugs, surgical procedures, and rehabilitations as the intervention of interest, respectively. Among reports published between the 2 periods 2002 and 2010 (n=51) and 2011 and September 2013 (n=16), the median sample sizes were 99 and 118; 39.2% and 37.5% of all reports detailed implementation of the randomization process; 60.8% and 43.8% provided information on the method of allocation concealment; 56.9% and 31.3% stated how blinding was achieved; 15.7% and 43.8% reported information regarding trial registration; and only 2.0% and 6.3% stated where the full trial protocol could be accessed, all respectively. CONCLUSIONS Reporting of several important methodological aspects of RCTs conducted in adult TBI populations improved over the years; however, the quality of reporting remains below an acceptable level. The small sample sizes suggest that many RCTs are likely underpowered. Further improvement is recommended in designing and reporting RCTs.