A Longitudinal Investigation of Alexithymia as a Predictor of Empathy, Emotional Functioning, Resilience, and Life Satisfaction Two Years after Brain Injury.

OBJECTIVE: To examine the unique contribution of alexithymia at 1 year after traumatic brain injury (TBI) to the prospective prediction of emotional and social health outcomes at 2 years post-injury. DESIGN: Multicenter, longitudinal cohort study. SETTING: Data were collected during Year 1 and Year 2 post-injury follow-up interviews across four TBI Model System (TBIMS) centers. PARTICIPANTS: Persons with TBI (N = 175; 134 men and 41 women) who had English fluency and were capable of providing self-report data. MAIN OUTCOME MEASURE: Primary independent variable was the Toronto Alexithymia Scale-20. Outcome measures included the Interpersonal Reactivity Index, National Institute of Health Toolbox Emotion Battery Anger, Difficulty with Emotion Regulation Scale, Connor-Davidson Resilience Scale, Posttraumatic Stress Disorder Checklist-Civilian, Satisfaction With Life Scale, General Anxiety Disorder-7, Patient Health Questionnaire-9, suicidal ideation, and problematic substance use. RESULTS: Simple adjusted models demonstrated that after controlling for the specific outcome at Year 1, TAS-20 scores significantly predicted Year 2 scores for perspective taking, physical aggression, emotion dysregulation, resilience, anxiety, depression, and suicidal ideation. All of these predictive findings except for physical aggression were maintained in the fully adjusted models that also controlled for age, sex, education level, number of prior TBIs, and motor and cognitive functioning. CONCLUSIONS: Compared to those with lower alexithymia scores, persons with TBI who had higher alexithymia scores at 1-year post-injury reported poorer emotional health at 2 years after TBI, even after controlling for Year 1 outcome scores, sociodemographics, and injury-related factors. These results support the need to assess for elevated alexithymia and to provide interventions targeting alexithymia early in the TBI recovery process.

The Effects of Repetitive Head Impact Exposure on Mental Health Symptoms Following Traumatic Brain Injury.

OBJECTIVE: This study aimed to characterize the types and timing of repetitive head impact (RHI) exposures in individuals with moderate to severe traumatic brain injury (TBI) and to examine the effects of RHI exposures on mental health outcomes. SETTING: TBI Model Systems National Database. PARTICIPANTS: 447 patients with moderate to severe TBI who reported RHI exposure between 2015 and 2022. DESIGN: Secondary data analysis. MAIN MEASURES: RHI exposures reported on the Ohio State University TBI Identification Method (OSU TBI-ID) were characterized by exposure category, duration, and timing relative to the index TBI. Mental health outcomes were evaluated at the 5-year follow-up assessment using the Patient Health Questionnaire-9 (PHQ-9) for depression symptoms and the Generalized Anxiety Disorder-7 (GAD-7) for anxiety symptoms. RESULTS: The majority of RHI exposures were sports-related (61.1%), followed by other causes (20.8%; including falls), repetitive violence/assault (18.8%), and military exposures (6.7%). Males predominantly reported sports and military exposures, while a larger proportion of females reported violence and falls. Sports exposures were most common before the index TBI, while exposures from falls and violence/abuse were most common after TBI. RHI exposures occurring after the index TBI were associated with higher levels of depression (ß = 5.05; 95% CI, 1.59-8.50) and anxiety (ß = 4.53; 95% CI, 1.02-8.05) symptoms than exposures before the index TBI. CONCLUSION: The findings emphasize the need to consider RHI exposures and their interaction with TBI when assessing mental health outcomes. Understanding the prevalence and challenges associated with RHI post-TBI can inform targeted interventions and improve the well-being of individuals with TBI. Preventive measures and ongoing care should be implemented to address the risks posed by RHI, particularly in individuals with prior TBI, especially surrounding fall and violence/abuse prevention.

Assessing the benefits and risks of amantadine for irritability and aggression after traumatic brain injury.

OBJECTIVE: To quantify the benefits versus harms of amantadine in the treatment of irritability and aggression following traumatic brain injury. METHODS: Secondary outcome data from a randomized controlled multisite trial of amantadine 100 mg twice daily were used to calculate number-needed-to-treat (NNT). Given prior findings of positive clinician-perceived effects and low incidence of adverse events, we hypothesized low number-needed-to-treat for benefit (NNTB; high benefit) and high number-needed-to-treat for harm (NNTH; low risk) based on the clinician ratings, supporting the use of amantadine in clinical practice. Specifically, NNTB values were calculated using number of individuals with improvement on the Clinician Global Impressions-Global Improvement scale (GI). NNTB values were computed using number of individuals with worsening on the GI and experiencing serious and any adverse events. RESULTS: Based on clinician ratings, on average for every six patients treated with amantadine rather than placebo, one extra patient would be expected to improve (NNTB = 6.4; 95% confidence interval [CI]: [3.3-76.8]). More participants in the placebo group worsened than in the amantadine group, but the result was not statistically significant (NNTH = -92.4; 95% CI: [NNTB -32.9 to infinity to NNTH -19.2]). The amantadine and placebo groups did not differ on the numbers of adverse events experienced during the trial. CONCLUSION: Clinician ratings suggest modest benefit of amantadine 100 mg twice daily with low risk to appropriately selected patients with adequate renal clearance. Thus, amantadine should be considered a treatment option for the experienced brain injury clinician. These data may support treatment decisions when a pharmaceutical agent is being considered to control irritability/aggression.

Implementing traumatic brain injury screening in behavioral health treatment settings: results of an explanatory sequential mixed-methods investigation.

BACKGROUND: Traumatic brain injury (TBI) is a complex condition common among individuals treated in behavioral healthcare, but TBI screening has not been adopted in these settings which can affect optimal clinical decision-making. Integrating evidence-based practices that address complex health comorbidities into behavioral healthcare settings remains understudied in implementation science, limited by few studies using theory-driven hypotheses to disentangle relationships between proximal and medial indicators on distal implementation outcomes. Grounded in the Theory of Planned Behavior, we examined providers' attitudes, perceived behavioral control (PBC), subjective norms, and intentions to adopt The Ohio State University TBI Identification Method (OSU TBI-ID) in behavioral healthcare settings. METHODS: We used an explanatory sequential mixed-methods design. In Phase I, 215 providers from 25 organizations in the USA completed training introducing the OSU TBI-ID, followed by a survey assessing attitudes, PBC, norms, and intentions to screen for TBI. After 1 month, providers completed another survey assessing the number of TBI screens conducted. Data were analyzed using structural equation modeling (SEM) with logistic regressions. In Phase II, 20 providers were purposively selected for semi-structured interviews to expand on SEM results. Qualitative data were analyzed using thematic analysis, integrated with quantitative results, and combined into joint displays. RESULTS: Only 25% (55/215) of providers adopted TBI screening, which was driven by motivations to trial the intervention. Providers who reported more favorable attitudes (OR: 0.67, p < .001) and greater subjective norms (OR: 0.12, p < .001) toward TBI screening demonstrated increased odds of intention to screen, which resulted in greater TBI screening adoption (OR: 0.30; p < .01). PBC did not affect intentions or adoption. Providers explained that although TBI screening can improve diagnostic and clinical decision-making, they discussed that additional training, leadership engagement, and state-level mandates are needed to increase the widespread, systematic uptake of TBI screening. CONCLUSIONS: This study advances implementation science by using theory-driven hypothesis testing to disentangle proximal and medial indicators at the provider level on TBI screening adoption. Our mixed-methods approach added in-depth contextualization and illuminated additional multilevel determinants affecting intervention adoption, which guides a more precise selection of implementation strategies.

Traumatic brain injury as a chronic disease: insights from the United States Traumatic Brain Injury Model Systems Research Program.

Traumatic brain injury (TBI) is a global health priority, associated with substantial burden. Historically conceptualised as an injury event with finite recovery, TBI is now recognised as a chronic condition that can affect multiple domains of health and function, some of which might deteriorate over time. Many people who have had a TBI remain moderately to severely disabled at 5 years, are rehospitalised up to 10 years post-injury, and have a reduced lifespan relative to the general population. Understanding TBI as a chronic disease process can be highly informative for optimising care, which has traditionally focused on acute care. Chronic brain injury care models must be informed by a holistic understanding of long-term outcomes and the factors that can affect how care needs evolve over time. The United States Traumatic Brain Injury Model Systems of Care follows up individuals with moderate-to-severe TBI for over 30 years, allowing characterisation of the chronic (2-30 years or more post injury) functional, cognitive, behavioural, and social sequelae experienced by individuals who have had a moderate-to-severe TBI and the implications for their health and quality of life. Older age, social determinants of health, and lower acute functional status are associated with post-recovery deterioration, while younger age and greater functional independence are associated with risky health behaviours, including substance misuse and re-injury. Systematically collected data on long-term outcomes across multiple domains of health and function are needed worldwide to inform the development of models for chronic disease management, including the proactive surveillance of commonly experienced health and functional challenges.

Perceived care partner burden at 1-year post-injury and associations with emotional awareness, functioning, and empathy after TBI: A TBI model systems study.

BACKGROUND: People with traumatic brain injury (TBI) can lack awareness of their own emotions and often have problems with emotion dysregulation, affective disorders, and empathy deficits. These impairments are known to impact psychosocial behaviors and may contribute to the burden experienced by care partners of individuals with TBI. OBJECTIVE: To examine the associations of emotional awareness, emotional functioning, and empathy among participants with TBI with care partner burden. METHOD: This multisite, cross-sectional, observational study used data from 90 dyads (participants with TBI and their care partner) 1-year post-injury. Participants with TBI completed the Difficulty with Emotional Regulation Scale (DERS; Awareness, Clarity, Goals, Impulse, Nonacceptance, and Strategies subscales); PTSD Checklist-Civilian Version; NIH Toolbox Anger-Affect, Hostility and Aggression Subdomains; PHQ-9; GAD-7; and the Interpersonal Reactivity Index (empathic concern and perspective taking subscales). Care partners completed the Zarit Burden Inventory (ZBI) and provided demographic information. RESULTS: Care partners were predominately female (77%), and most were either a spouse/partner (55.2%) or parent (34.4%). In an unadjusted model that included assessments of emotional awareness, emotional functioning, and empathy of the participant with TBI, the DERS-Awareness and NIH-Hostility subscales accounted for a significant amount of variance associated with care partner burden. These findings persisted after adjusting for care partner age, relationship, education, and the functional status of the participant with TBI (ß= 0.493 and ß= 0.328, respectively). CONCLUSION: These findings suggest that high levels of hostility and low emotional self-awareness can significantly affect the burden felt by TBI care partners.

Examining the Evidence From Single-Case Experimental Designs to Treat Challenging Behaviors Following Moderate to Severe Traumatic Brain Injury.

OBJECTIVE: To evaluate evidence on the effectiveness of behavioral interventions using single-case experimental design (SCED) methodology and to identify behavioral interventions with sufficient evidence for possible inclusion in the development of guidelines for the management of challenging behaviors in adults following moderate to severe traumatic brain injury (TBI). METHODS: As a subinvestigation of a larger systematic review process designed to identify evidence for guidelines development, the current review focused on studies using SCED methodology applied to persons with challenging behaviors following moderate to severe TBI. Articles were identified from a search of the published literature through January 2021, identifying studies in CINAHL, Cochrane Database of Systematic Reviews, EMBASE, MEDLINE/Ovid, and PsycINFO. Articles meeting inclusion criteria were assessed for design rigor to allow for effect size determination. The identified cases were then critically appraised using the RoBiNT (Risk-of-Bias in N-of-1 Trails) Scale to determine strength of evidence for causal inference. RESULTS: Thirty-four studies met inclusion criteria, with a total of 44 cases evaluated for effect of the treatment intervention on defined target behaviors. Seventeen cases had effect sizes rated as large, 22 cases as medium, 3 cases as small, and 3 as no effect. An observed trend was for large and medium effect sizes to be associated with lower RoBiNT Scale internal validity scores. Randomization, blinded provider and assessor, and assessment of treatment adherence were the internal validity items unlikely to meet criteria. CONCLUSIONS: SCED methodology was found to produce large and medium effect sizes for behavioral interventions targeting challenging behaviors following moderate to severe TBI. However, the strength of the evidence is limited because of weaknesses in study designs. Most of the studies failed to meet established internal validity criteria designed to reduce risk of bias in SCED studies as such rigor is difficult to establish or often not practical in clinical settings. Suggestions and recommendations are outlined for improving the quality of published cases using SCED methodology, which, in turn, will improve credibility of evidence and better inform the development of treatment guidelines for behavior regulation.

Traumatic Brain Injury Rehabilitation Outcome Prediction Using Machine Learning Methods.

Objective: To investigate the performance of machine learning (ML) methods for predicting outcomes from inpatient rehabilitation for subjects with TBI using a dataset with a large number of predictor variables. Our second objective was to identify top predictive features selected by the ML models for each outcome and to validate the interpretability of the models. Design: Secondary analysis using computational modeling of relationships between patients, injury and treatment activities and 6 outcomes, applied to the large multi-site, prospective, longitudinal observational dataset collected during the traumatic brain injury inpatient rehabilitation study. Setting: Acute inpatient rehabilitation. Participants: 1946 patients aged 14 years or older, who sustained a severe, moderate, or complicated mild TBI, and were admitted to 1 of 9 US inpatient rehabilitation sites between 2008 and 2011 (N=1946). Main Outcome Measures: Rehabilitation length of stay, discharge to home, FIM cognitive and FIM motor at discharge and at 9-months post discharge. Results: Advanced ML models, specifically gradient boosting tree model, performed consistently better than all other models, including classical linear regression models. Top ranked predictive features were identified for each of the 6 outcome variables. Level of effort, days to rehabilitation admission, age at rehabilitation admission, and advanced mobility activities were the most frequently top ranked predictive features. The highest-ranking predictive feature differed across the specific outcome variable. Conclusions: Identifying patient, injury, and rehabilitation treatment variables that are predictive of better outcomes will contribute to cost-effective care delivery and guide evidence-based clinical practice. ML methods can contribute to these efforts.

Lifetime history of TBI with loss of consciousness and disability among Appalachian and rural residents: 2016-2019 Ohio BRFSS.

BACKGROUND: While lifetime history of traumatic brain injury (TBI) is associated with increased risk of disabilities, little is known about disability and TBI among Appalachian and other rural residents. This study aimed to examine if the relationship between lifetime history of TBI with loss of consciousness (LOC) and disability differs by location of living (Appalachian vs. non-Appalachian; rural vs. urban). METHODS: We obtained data on lifetime history of TBI with LOC, location of living, and six sources of disability (auditory, visual, cognitive, mobility, self-care related, and independent living-related impairments) from the 2016-2019 Ohio Behavioral Risk Factor Surveillance System. We modeled the disability outcomes with Appalachian living (or rural living), lifetime history of TBI with LOC, and their interaction as independent variables. RESULTS: Of the 16,941 respondents included, 16.9% had a lifetime history of TBI with LOC, 19.5% were Appalachian residents and 22.9% were rural residents. Among Appalachian residents, 56.1% lived in a rural area. Appalachian (ARR = 1.92; 95%CI = 1.71-2.13) and rural residents (ARR = 1.87; 95%CI = 1.69-2.06) who had a lifetime history of TBI with LOC were at greater risk for having any disability compared to non-Appalachian and urban residents without lifetime history of TBI with LOC, respectively. CONCLUSIONS: Appalachian and rural living and lifetime history of TBI with LOC are risk factors for disability. Future research and health policies should address mechanisms for this risk as well as access to healthcare services following a TBI among Appalachian and rural residents.

Implementing traumatic brain injury screening in behavioral healthcare: protocol for a prospective mixed methods study.

BACKGROUND: Characteristics of both individuals and innovations are foundational determinants to the adoption of evidenced-based practices (EBPs). However, our understanding about what drives EBP adoption is limited by few studies examining relationships among implementation determinants and implementation outcomes through theory-driven hypothesis testing. Therefore, drawing on the Theory of Planned Behavior and Diffusion of Innovations Theory, this study will disentangle relationships between provider characteristics and innovation factors on the early adoption of the Ohio State University Traumatic Brain Injury Identification Method (OSU TBI-ID) in behavioral health settings. METHODS: This study will utilize an explanatory sequential mixed methods design. In Phase I (quantitative), Time 1, we will investigate behavioral health providers (N = 200) attitudes, perceived behavioral control, subjective norms, and intentions to screen for TBI upon completion of a video module introducing the OSU TBI-ID. At Time 2, we will examine the number of TBI screens conducted over the previous month, as well as the feasibility, appropriateness, and acceptability of using the OSU TBI-ID in practice. Structural equation modeling will be used to determine whether provider characteristics predict TBI screening intentions, and whether intentions mediate actual TBI screening behaviors. We will then test whether feasibility, appropriateness, and acceptability of the OSU TBI-ID moderates the relationship between intentions and TBI screening behaviors. In Phase II (qualitative), we will develop an interview guide using results from Phase I and will conduct semi-structured interviews with providers (N = 20) to assess contextual determinants of TBI screening adoption. Qualitative data will be thematically analyzed using sensitizing concepts from the Consolidated Framework for Implementation Research and integrated with the quantitative results using a joint display. DISCUSSION: This mixed methods study capitalizes on two theory-driven hypotheses bridging proximal (e.g., screening intent) to distal (actual behaviors) implementation outcomes and will contextualize these results qualitatively to advance our understanding about why TBI screening adoption has failed to translate to the behavioral healthcare context. Results of this study will offer insights into what is driving TBI screening adoption so that implementation strategies can be selected with greater precision to improve the adoption, sustainment, and scale-up of TBI screening in behavioral healthcare.

Rural-Urban Differences in Behavioral Outcomes among Adults with Lifetime History of Traumatic Brain Injury with Loss of Consciousness: 2016-2019 Ohio BRFSS.

This study examined if the associations between lifetime history of traumatic brain injury (TBI) with loss of consciousness (LOC) and unhealthy alcohol use or mental health problems differ by location of living (rural vs. urban). The lifetime history data of TBI with LOC, location of living, unhealthy alcohol use (binge drinking, heavy drinking), and mental health problems (depression diagnosis, number of poor mental health days) were sourced from the 2016, 2017, 2018, and 2019 Ohio Behavioral Risk Factory Surveillance Surveys, and the final sample included 16,941 respondents. We conducted multivariable logistic regressions to determine the odds ratios for each of the five outcomes between individuals living in rural vs. urban areas and between individuals with vs. without a lifetime history of TBI with LOC. No interaction between location of living and lifetime history of TBI with LOC was observed for any outcomes, indicating rurality did not modify these relationships. Living in a rural area was associated with decreased binge drinking or heavy drinking but not mental health outcomes. Lifetime history of TBI with LOC was associated with an increased risk of binge drinking, heavy drinking, depression diagnoses, and poor general mental health, regardless of location of living. Our findings support the need for TBI screenings as part of mental health intake evaluations and behavioral health screenings. Though rurality was not associated with mental health outcomes, rural areas may have limited access to quality mental health care. Therefore, future research should address access to mental health services following TBI among rural residents.

Who Moves After SCI? Individual, Health, and Neighborhood Predictors of Residential Mobility Among Participants in the National Spinal Cord Injury Model Systems Database.

OBJECTIVE: To investigate residential mobility among community-living adults with spinal cord injury (SCI) and the individual, health, and neighborhood factors associated with the propensity to relocate. DESIGN: Retrospective analysis of data from the National SCI Model Systems (SCIMS) Database collected between 2006 and 2018 and linked with the American Community Survey 5-year estimates. SETTING: Community. INTERVENTIONS: Not applicable. PARTICIPANTS: People with traumatic SCI (N=4599) who participated in 2 waves of follow-up and had residential geographic identifiers at the census tract level. MAIN OUTCOME MEASURES: Moving was a binary measure reflecting change in residential locations over a 5-year interval. Move distance distinguished nonmovers from local movers (different tracts within the same county) and long-distance movers (to different county or state). Move quality included 4 categories: stayed/low poverty tract, stayed/high poverty tract, moved/low poverty tract, and moved/high poverty tract. RESULTS: One in 4 people moved within a 5-year interval (n=1175). Of the movers, 55% relocated to a different census tract within the same county and 45% relocated to a different county or state. Thirty-five percent of all movers relocated to a high poverty census tract. Racial and ethnic minorities, people from low-income households, and younger adults were more likely to move, move locally, and relocate to a high poverty neighborhood. High poverty and racial/ethnic segregation in the origin neighborhood predicted an increased risk for remaining in or moving to a high poverty neighborhood. CONCLUSIONS: Although people with SCI relocated at a lower rate than has been reported in the general population, moving was a frequent occurrence postinjury. People from vulnerable groups were more likely to remain in or relocate to socioeconomically disadvantaged neighborhoods, thus increasing the risk for health disparities and poorer long-term outcomes among minorities and people from low-income households. These findings inform policy makers' considerations of housing, health care, and employment initiatives for individuals with SCI and other chronic disabilities.

Comparative effectiveness of a brief intervention for alcohol misuse following traumatic brain injury: A randomized controlled trial.

PURPOSE/OBJECTIVE: Compare the effects of an adapted Screening, Education, and Brief Intervention (Adapted SBI) for alcohol misuse following traumatic brain injury (TBI) to a Screening and Education with Attention Control (SEA) condition. STUDY DESIGN: A single-masked, parallel group, randomized controlled trial was conducted with 58 participants who were 18 and older, sustained a TBI requiring inpatient rehabilitation, had a history of alcohol misuse, were English-speaking, cleared posttraumatic amnesia, were free of language impairments precluding participation in the intervention, and who provided informed consent. Outcomes were collected at 3, 6, and 12 months postdischarge. The primary outcome was drinks per week at 12 months postdischarge. RESULTS: Participants in both conditions reduced alcohol use following their injury. The number of drinks per week at 12 months did not differ between the treatment conditions; the number of drinks consumed across the entire sample was very low (median = 0). A lower percentage of participants in the Adapted SBI condition resumed alcohol use by 12 months postdischarge (32% vs. 62% in the SEA condition, p < .05). No significant differences were found on other outcomes (binging, facts recalled about the negative effects of alcohol, drug use). The inclusion of a booster session did not appear to alter the intervention effects. The interventions did not impact other healthy behaviors, however healthy eating and stress management practices were associated with abstaining from alcohol use at the 12-month follow-up. CONCLUSIONS/IMPLICATIONS: While alcohol misuse generally declines postinjury, by 12 months postdischarge many individuals resume alcohol use. Adapted SBI may slow the resumption of alcohol use. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Do state supports for persons with brain injury affect outcomes in the 5 Years following acute rehabilitation?

While a substantial literature has examined the effects of individual and family-level factors on outcomes following traumatic brain injury (TBI), minimal attention has been directed to the potential influence of the larger environmental context on outcomes. The purpose of the current study was to investigate the effects of state-level resources and supports as an environmental factor influencing long-term outcomes from TBI using data from the TBI Model Systems. We examined the effects of U.S. state supports that specifically target people with TBI (federal funding for state brain injury programs, per capita revenue generated by brain injury trust funds, and expenditures for brain injury specific Medicaid waivers) and one measure of the relative quality of a state's Long-Term Services and Supports (LTSS) for all people with disabilities. The primary hypothesis was that community participation, global functioning, and life satisfaction will be higher on average among people with TBI living in states with more brain injury specific programs and resources and better LTSS. The results of multilevel and fixed-effects modeling indicated that state supports have a small but significant impact on participation and life satisfaction. The most consistent finding indicated that states with better LTSS had higher levels of community participation and life satisfaction on average for people with TBI over and above individual-level differences and fluctuations in these outcomes over time. There was some indication that more brain injury specific supports also result in better participation in the community. These findings deserve replication and extension to include other environmental factors, particularly community level characteristics, that might affect outcomes from TBI.

Quasi-Contextualized Speech Treatment in Traumatic Brain Injury Inpatient Rehabilitation: Effects on Outcomes During the First Year After Discharge.

OBJECTIVE: To evaluate the effect of providing quasi-contextualized speech therapy, defined as metacognitive, compensatory, or strategy training applied to cognitive and language impairments to facilitate the performance of future real-life activities, on functional outcomes up to 1 year following traumatic brain injury (TBI). SETTING: Acute inpatient rehabilitation. PARTICIPANTS: Patients enrolled during the TBI-Practice-Based Evidence (TBI-PBE) study (n = 1760), aged 14 years or older, who sustained a severe, moderate, or complicated mild TBI, received speech therapy in acute inpatient rehabilitation at one of 9 US sites, and consented to follow-up 3 and 9 months postdischarge from inpatient rehabilitation. DESIGN: Propensity score methods applied to a database consisting of multisite, prospective, longitudinal observational data. MAIN MEASURES: Participation Assessment with Recombined Tools-Objective-17, FIM Motor and Cognitive scores, Satisfaction With Life Scale, and Patient Health Questionnaire-9. RESULTS: When at least 5% of therapy time employed quasi-contextualized treatment, participants reported better community participation during the year following discharge. Quasi-contextualized treatment was also associated with better motor and cognitive function at discharge and during the year after discharge. The benefit, however, may be dependent upon a balance of rehabilitation time that relied on contextualized treatment. CONCLUSIONS: The use of quasi-contextualized treatment may improve outcomes. Care should be taken, however, to not provide quasi-contextualized treatment at the expense of contextualized treatment.

Improving transition from inpatient rehabilitation following traumatic brain injury: Protocol for the BRITE pragmatic comparative effectiveness trial.

Moderate to severe traumatic brain injury (TBI) is a common cause of long-term disability. Due to challenges that include inconsistent access to follow-up care, persons with TBI being discharged from inpatient rehabilitation facilities (IRFs) are at risk for rehospitalization, poor reintegration into the community, family stress, and other unfavorable outcomes resulting from unmet needs. In a six-center randomized pragmatic comparative effectiveness study, the BRITE trial (Brain Injury Rehabilitation: Improving the Transition Experience, ClinicalTrials.govNCT03422276), we compare the effectiveness of two existing methods for transition from IRF to community living or long-term nursing care. The Rehabilitation Discharge Plan (RDP) includes patient/family education and referrals for continued care. The Rehabilitation Transition Plan (RTP) provides RDP plus individualized, manualized care management via phone or videoconference, for 6 months. Nine hundred patients will be randomized (1:1) to RDP or RTP, with caregivers also invited to participate and contribute caregiver-reported outcomes. Extensive stakeholder input, including active participation of persons with TBI and their families, has informed all aspects of trial design and implementation planning. We hypothesize that RTP will result in better patient- and caregiver-reported outcomes (societal participation, quality of life, caregiver well-being) and more efficient use of healthcare resources at 6-months (primary outcome) and 12-months post-discharge, compared to RDP alone. Planned analyses will explore which participants benefit most from each transition model. With few exclusion criteria and other pragmatic features, the findings of this trial are expected to have a broad impact on improving transitions from inpatient TBI rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03422276.

Patterns of Functional Change Five to Ten Years after Moderate-Severe Traumatic Brain Injury.

This study aims to characterize the patterns of functional change experienced between 5 and 10 years after moderate-severe traumatic brain injury (TBI). The study included TBI Model Systems national database participants (N = 372) at six sites who experienced TBI, received inpatient rehabilitation, and were followed at 5 and 10 years post-TBI. Outcome measures included self- or proxy-reported Functional Independence Measure (FIMTM) structured interview at 5 and 10 years post-TBI and domain change indices (DCIs) at 10 years to assess subjective change over the previous 5 years. When all seven FIM and subjective DCI subscales were considered together, 69% reported improvement in at least one subscale and 41% reported decline in at least one subscale; 51% reported more domains improved than declined, and 20% reported more domains declined than improved. Age at injury, post-traumatic amnesia duration, FIM, and depression and anxiety at year 5 were associated with FIM change and DCI measures. Although most persons with moderate-severe TBI do not experience widespread change from year 5 to 10 on individual FIM subscales or perceived domain-specific subscales, the vast majority do report change in one or more domains, with more improvement than decline and more change in subjective DCI than in FIM. Clinicians and researchers should be alert to the possibility of both positive and deleterious changes many years after TBI.

Reinjury After Moderate to Severe TBI: Rates and Risk Factors in the NIDILRR Traumatic Brain Injury Model Systems.

OBJECTIVES: To compare characteristics of those who do and do not sustain subsequent traumatic brain injuries (TBIs) following index TBI and to identify reinjury risk factors. DESIGN: Secondary data analysis of an ongoing longitudinal cohort study. SETTING: TBI Model Systems Centers. PARTICIPANTS: In total, 11 353 individuals aged 16+ years. MAIN OUTCOME MEASURES: Ohio State University TBI Identification Method. RESULTS: In total, 7.9% of individuals reported sustaining a TBI post-index TBI. Twenty percent of reinjuries occurred within a year of the index TBI. Reinjury risk followed an approximate U-shaped distribution such that risk was higher in the first year, declined 2 to 10 years postinjury, and then increased after 10 years. A multivariable Weibull model identified predictors of reinjury: younger (<29 years) and middle-aged and older (50+ years) age at index TBI relative to middle age, pre-index TBI, pre-index alcohol and illicit drug use, incarceration history, and less severe index TBI. CONCLUSIONS: A subset of individuals who receive inpatient rehabilitation for TBI are at an increased risk for reinjury, and an injury-prone phenotype may be characterized by engagement in risk behaviors. Factors associated with reinjury risk may differ for younger versus middle-aged and older adults. Findings underscore the need for empirically informed risk stratification models to identify TBI survivors at risk for reinjury.

Mining reported adverse events induced by potential opioid-drug interactions.

OBJECTIVE: Opioid-based analgesia is routinely used in clinical practice for the management of pain and alleviation of suffering at the end of life. It is well-known that opioid-based medications can be highly addictive, promoting not only abuse but also life-threatening overdoses. The scope of opioid-related adverse events (AEs) beyond these well-known effects remains poorly described. This exploratory analysis investigates potential AEs from drug-drug interactions between opioid and nonopioid medications (ODIs). MATERIALS AND METHODS: In this study, we conduct an initial exploration of the association between ODIs and severe AEs using millions of AE reports available in FDA Adverse Event Reporting System (FAERS). The odds ratio (OR)-based analysis and visualization are proposed for single drugs and pairwise ODIs to identify associations between AEs and ODIs of interest. Moreover, the multilabel (multi-AE) learning models are employed to evaluate the feasibility of AE prediction of polypharmacy. RESULTS: The top 12 most prescribed opioids in the FAERS are identified. The OR-based analysis identifies a diverse set of AEs associated with individual opioids. Moreover, the results indicate many ODIs can increase the risk of severe AEs dramatically. The area under the curve values of multilabel learning models of ODIs for oxycodone varied between 0.81 and 0.88 for 5 severe AEs. CONCLUSIONS: The proposed data analysis and visualization are useful for mining FAERS data to identify novel polypharmacy associated AEs, as shown for ODIs. This approach was successful in recapitulating known drug interactions and also identified new opioid-specific AEs that could impact prescribing practices.

Comparison of Diagnostic Sleep Studies in Hospitalized Neurorehabilitation Patients With Moderate to Severe Traumatic Brain Injury.

BACKGROUND: OSA is prevalent during a time of critical neural repair after traumatic brain injury (TBI). The diagnostic utility of existing sleep studies is needed to inform clinical management during acute recovery from TBI. RESEARCH QUESTION: This study aimed to evaluate the non-inferiority and diagnostic accuracy of a portable level 3 sleep study relative to level 1 polysomnography in hospitalized neurorehabilitation patients with TBI. STUDY DESIGN AND METHODS: This is a prospective clinical trial conducted at six TBI Model System study sites between May 2017 and February 2019. Of 896 admissions, 449 were screened and eligible for the trial, with 345 consented. Additional screening left 263 eligible for and completing simultaneous administration of both level 1 and level 3 sleep studies, with final analyses completed on 214 (median age = 42 years; ED Glasgow Coma Scale = 6; time to polysomnography [PSG] = 52 days). RESULTS: Agreement was moderate to strong (weighted kappa = 0.78, 95% CI, 0.72-0.83) with the misclassification commonly occurring with mild sleep apnea due to underestimation of apnea hypopnea index (AHI). Most of those with moderate to severe sleep apnea were correctly classified (n = 54/72). Non-inferiority was not demonstrated: the minimum tolerable specificity of 0.5 was achieved across all AHI cutoff scores (lower confidence limits [LCL] range, 0.807-0.943), but the minimum tolerable sensitivity of 0.8 was not (LCL range, 0.665-0.764). INTERPRETATION: Although the non-inferiority of level 3 portable diagnostic testing relative to level 1 was not established, strong agreement was seen across sleep apnea indexes. Most of those with moderate to severe sleep apnea were correctly identified; however, there was risk of misclassification with level 3 sleep studies underestimating disease severity for those with moderate to severe AHI and disease presence for those with mild AHI during early TBI neurorehabilitation.