An Umbrella Review of Self-Management Interventions for Health Conditions With Symptom Overlap With Traumatic Brain Injury.

OBJECTIVE: To synthesize evidence for the effectiveness of self-management interventions for chronic health conditions that have symptom overlap with traumatic brain injury (TBI) in order to extract recommendations for self-management intervention in persons with TBI. DESIGN: An umbrella review of existing systematic reviews and/or meta-analyses of randomized controlled trials or nonrandomized studies targeting self-management of chronic conditions and specific outcomes relevant to persons with TBI. METHOD: A comprehensive literature search of 5 databases was conducted using PRISMA guidelines. Two independent reviewers conducted screening and data extraction using the Covidence web-based review platform. Quality assessment was conducted using criteria adapted from the Assessing the Methodological Quality of Systematic Reviews-2 (AMSTAR-2). RESULTS: A total of 26 reviews met the inclusion criteria, covering a range of chronic conditions and a range of outcomes. Seven reviews were of moderate or high quality and focused on self-management in persons with stroke, chronic pain, and psychiatric disorders with psychotic features. Self-management interventions were found to have positive effects on quality of life, self-efficacy, hope, reduction of disability, pain, relapse and rehospitalization rates, psychiatric symptoms, and occupational and social functioning. CONCLUSIONS: Findings are encouraging with regard to the effectiveness of self-management interventions in patients with symptoms similar to those of TBI. However, reviews did not address adaptation of self-management interventions for those with cognitive deficits or for populations with greater vulnerabilities, such as low education and older adults. Adaptations for TBI and its intersection with these special groups may be needed.

Race and Age-Related PSA Testing Disparities in Spinal Cord Injured Men: Analysis of National Veterans Health Administration Data.

Background: Prostate-specific antigen (PSA) testing remains controversial due to the debate about overdetection and overtreatment. Given the lack of published data regarding PSA testing rates in the population with spinal cord injury (SCI) within the US Department of Veterans Affairs (VA), there is concern for potential disparities and overtesting in this patient population. In this study, we sought to identify and evaluate national PSA testing rates in veterans with SCI. Methods: Using the VA Informatics and Computing Infrastructure Corporate Data Warehouse, we extracted PSA testing data for all individuals with a diagnosis of SCI. Testing rates were calculated, analyzed by race and age, and stratified according to published American Urological Association guideline groupings for PSA testing. Results: We identified 45,274 veterans at 129 VA medical centers with a diagnosis of SCI who had records of PSA testing in 2000 through 2017. Veterans who were only tested prior to SCI diagnosis were excluded. Final cohort data analysis included 37,243 veterans who cumulatively underwent 261,125 post-SCI PSA tests during the given time frame. Significant differences were found between African American veterans and other races veterans for all age groups (0.47 vs 0.46 tests per year, respectively, aged ≤ 39 years; 0.83 vs 0.77 tests per year, respectively, aged 40-54 years; 1.04 vs 1.00 tests per year, respectively, aged 55-69 years; and 1.08 vs 0.90 tests per year, respectively, aged ≥ 70 years; P < .001). Conclusions: Significant differences exist in rates of PSA testing in persons with SCI based on age and race. High rates of testing were found in all age groups, especially for African American veterans aged ≥ 70 years.

Identifying factors associated with acute hospital discharge dispositions in patients with moderate-to-severe traumatic brain injury.

OBJECTIVE: Identify sociodemographic, injury, and hospital-level factors associated with acute hospital discharge dispositions following acute hospitalization for moderate-to-severe traumatic brain injury (TBI) in the United States. METHODS: The 2011-2014 National Trauma Data Bank data was used, including 466 acute care hospitals and 114,736 patients ≥16 years old who survived moderate-to-severe TBI. Outcome was acute hospital discharge dispositions: home with/without care (HC), skilled nursing home/other care facility (SNF/ICF) and inpatient rehabilitation/long-term care facility (IRF). Independent variables were patients' sociodemographic, injury, and hospital-level factors. Multilevel modeling was used to assess associations and compare likelihood of discharges. RESULTS: Of all patients, 74.5%, 14.6% ,and 10.9% were discharged to HC, SNF/ICF ,and IRF, respectively. Intraclass correlation coefficients indicated that hospitals explained 14.3% and 14.8% of variations in probabilities of institution dispositions. Sociodemographic factors including older age, females, Non-Hispanic Whites, recipients of commercial insurance, and Medicare/Medicaid were significantly associated with higher institution discharges. Hospital-related factors including bed size, teaching status, trauma accreditations, and hospital locations were significantly associated with discharge dispositions. CONCLUSION: Identifying factors associated with discharge dispositions after acute hospitalization of TBI is pertinent to ensure quality of care and optimal patient outcomes. Further research into hospital-related variations in acute care discharge dispositions is recommended.

Organizational characteristics of Brain Injury Clubhouse Model programs.

OBJECTIVE: We provide an overview of the Clubhouse Model and the history and development of Brain Injury Clubhouses. We describe organizational-level characteristics associated with eight Brain Injury Clubhouses to address gaps in the literature and inform future studies or program development. METHODS: A electronic survey, the Clubhouse Profile Questionnaire (CPQ) was tailored for Brain Injury Clubhouses. The CPQ gathers program-level data that can be used to identify active ingredients of Clubhouses, understand best practices, examine, and evaluate program characteristics. The brain injury version of the CPQ was administered to a sample of eight Clubhouses affiliated with the International Brain Injury Clubhouse Association as part of a project designed to gather data on Clubhouse program characteristics and describe sociodemographic characteristics of people served by Brain Injury Clubhouses. RESULTS: CPQ data from eight Brain Injury Clubhouses was analyzed. Brain Injury Clubhouse programs in this sample served approximately 17 members per day. There was wide variability in the size, funding and funding mechanisms, and length of operation of Brain Injury Clubhouses in this study. CONCLUSIONS: Findings suggest that Brain Injury Clubhouses offer a wide range of services and supports. Additional research on the impact of Brain Injury Clubhouses is needed.

Pre- and in-hospital mortality for moderate-to-severe traumatic brain injuries: an analysis of the National Trauma Data Bank (2008-2014).

Objectives: This study aimed to: (1) evaluate pre- and in-hospital mortality for moderate-to-severe TBI in the U.S. by injury type (blunt vs. penetrating) and (2) estimate annual regression-adjusted mortality from 2008-2014.Methods: Data were analyzed from the National Trauma Data Bank (N=247,648). Multivariable logistic regression analyses were performed by injury type to assess changes in mortality between study periods (early period: 2008-2010; late period: 2011-2014) and to estimate annual regression-adjusted mortality. Mortality odds ratios and 95% confidence intervals were calculated.Results: Total observed mortality was 18.8%. After covariate adjustment, patients in the late period had an increased odds of prehospital mortality compared to patients in the early period for blunt (OR: 4.69; 95%CI: 4.41-4.98) and penetrating trauma (OR: 4.71; 95%CI: 4.39-5.06). In contrast, patients in the late period had a decreased odds of in-hospital mortality compared to patients in the early period for blunt (OR: 0.95; 95%CI: 0.91-0.98) and penetrating trauma (OR: 0.92; 95%CI: 0.85-0.98).Conclusions: The decreasing in-hospital mortality trend is consistent with previous literature. Additional research is warranted to validate the observed increase in prehospital mortality and to identify best practices that can improve prehospital outcomes for patients with moderate-to-severe TBI.

Health, wellness, and safety concerns of persons with moderate-to-severe traumatic brain injury and their family caregivers: a qualitative content analysis.

BACKGROUND: Persons with moderate-to-severe traumatic brain injury (TBI) face issues with health, wellness, and safety that affect their ability to independently manage their care, even for individuals who are ≥75% independent in activities of daily living. These issues often lead to increased family involvement in managing the person's condition after discharge home. PURPOSE: We explored health, wellness, and safety concerns after discharge home from inpatient rehabilitation from the perspectives of persons with TBI who are ≥75% independent in activities of daily living and their family caregivers. MATERIALS AND METHODS: We interviewed 27 persons with TBI and family caregivers and used conventional content analysis to analyse the data. RESULTS: Seven themes related to health, wellness, and safety encompassed participants' experience. Health themes included: (1) attempting to manage medications and (2) navigating mental health difficulties. Wellness themes included: (1) working to stay physically active, (2) dealing with sleep and sleeplessness, and (3) adjusting to changing social relationships. Safety themes were: (1) addressing mobility challenges and (2) compensating for complications with cognitive functioning. CONCLUSIONS: Findings can guide the development of tools, supports, and resources to promote health, wellness, and safety of persons with TBI as they recover after discharge home.Implications for rehabilitationFindings on numerous concerns related to health, wellness, and safety suggest the need for implementation or development and testing of tools, supports, and resources to promote health, wellness, and safety of persons with traumatic brain injury as they recover after discharge home.Our findings can be used to educate healthcare providers and increase awareness of the nuanced challenges patients and families face after discharge home.Findings can also be used by providers to educate patients and families on realistic expectations for life after discharge.

Technology and TBI: Perspectives of persons with TBI and their family caregivers on technology solutions to address health, wellness, and safety concerns.

Assistive technologies that are tailored to individuals' health, wellness, and safety concerns can help people with traumatic brain injury (TBI) and their family caregivers meet their goals. The purpose of this study was to investigate views of technology in the context of managing one's everyday life from the perspectives of persons with TBI and their family caregivers. We conducted 27 in-person, semi-structured interviews with persons with TBI (n = 15) and family caregivers (n = 12) and used conventional content analysis to analyze our data. The major themes that emerged were: 1) views of technology, 2) influence of technology on daily life, 3) desired technology solutions to address health, wellness, and safety concerns, and 4) barriers to adopting technology solutions. To address ongoing concerns, persons with TBI and family caregivers expressed a desire to have a patient portal to share information and communicate with providers, motion sensing devices to provide guidance for mobility, on-demand access to in-home rehabilitation therapy, access to a "social gym" where the persons with TBI could virtually exercise and interact with others, and technologies that help with sleep and facilitate peer support. These findings provide direction for implementation, design, or adaptation of technologies to address the concerns of this population.

Minimum Competency Recommendations for Programs That Provide Rehabilitation Services for Persons With Disorders of Consciousness: A Position Statement of the American Congress of Rehabilitation Medicine and the National Institute on Disability, Independent Living and Rehabilitation Research Traumatic Brain Injury Model Systems.

Persons who have disorders of consciousness (DoC) require care from multidisciplinary teams with specialized training and expertise in management of the complex needs of this clinical population. The recent promulgation of practice guidelines for patients with prolonged DoC by the American Academy of Neurology, American Congress of Rehabilitation Medicine (ACRM), and National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) represents a major advance in the development of care standards in this area of brain injury rehabilitation. Implementation of these practice guidelines requires explication of the minimum competencies of clinical programs providing services to persons who have DoC. The Brain Injury Interdisciplinary Special Interest Group of the ACRM, in collaboration with the Disorders of Consciousness Special Interest Group of the NIDILRR-Traumatic Brain Injury Model Systems convened a multidisciplinary panel of experts to address this need through the present position statement. Content area-specific workgroups reviewed relevant peer-reviewed literature and drafted recommendations which were then evaluated by the expert panel using a modified Delphi voting process. The process yielded 21 recommendations on the structure and process of essential services required for effective DoC-focused rehabilitation, organized into 4 categories: diagnostic and prognostic assessment (4 recommendations), treatment (11 recommendations), transitioning care/long-term care needs (5 recommendations), and management of ethical issues (1 recommendation). With few exceptions, these recommendations focus on infrastructure requirements and operating procedures for the provision of DoC-focused neurorehabilitation services across subacute and postacute settings.

Long-term employment outcomes following moderate to severe traumatic brain injury: a systematic review and meta-analysis.

Background: Returning to employment following moderate to severe traumatic brain injury (msTBI) is critical for a survivor's well-being, yet currently there are no systematic reviews that comprehensively describe employment outcomes following msTBI. The objective of this study was to systematically synthesize literature on employment outcomes following msTBI.Methods: Original studies published through April 2018 on MEDLINE/PubMed, PsychINFO, and CINAHL were eligible if the objective was to investigate employment outcomes following msTBI; outcome was measured ≥1 year; participants were ≥15; and size was ≥60. Post-injury employment prevalence and return to pre-injury level of work were summarized through meta-analysis.Results: Of 38 eligible studies, post-injury employment prevalence was most often reported (n = 35), followed by job stability (n = 6), and return to pre-injury level of work (n = 4). Overall post-injury employment prevalence was 42.2%; whereas the return-to-previous-work prevalence was 33.0%. Post-injury employment prevalence appeared to increase over time, from 34.9% at 1 year to 42.1% up to 5 years and 49.9% beyond 5 years.Conclusion: Nearly half of individuals with msTBI were employed post-injury, yet only a third returned to pre-injury level of work. Future researchers are recommended to standardize employment outcome measures to enable better comparison of outcomes across studies.

Level of Effort and 3 Hour Rule Compliance.

OBJECTIVE: To determine if patients' level of effort (LOE) in therapy sessions during traumatic brain injury (TBI) rehabilitation modifies the effect of compliance with the 3-Hour Rule of the Centers for Medicare & Medicaid Services. DESIGN: Propensity score methodology applied to the TBI Practice-Based Evidence database, consisting of multisite, prospective, longitudinal observational data. SETTING: Acute inpatient rehabilitation facilities (IRF). PARTICIPANTS: Patients (N=1820) who received their first IRF admission for TBI in the United States and were enrolled for 3- and 9-month follow-up. MAIN OUTCOME MEASURES: Participation Assessment with Recombined Tools-Objective-17, FIM Motor and Cognitive scores, Satisfaction with Life Scale, and Patient Health Questionnaire-9. RESULTS: When the full cohort was examined, no strong main effect of compliance with the 3-Hour Rule was identified and LOE did not modify the effect of compliance with the 3-Hour Rule. In contrast, LOE had a strong positive main effect on all outcomes, except depression. When the sample was stratified by level of disability, LOE modified the effect of compliance, particularly on the outcomes of participants with less severe disability. For these patients, providing 3 hours of therapy for 50% or more of therapy days in the context of low effort resulted in poorer performance on select outcome measures at discharge and up to 9 months postdischarge compared to patients with <50% of 3-hour therapy days. CONCLUSIONS: LOE is an active ingredient in inpatient TBI rehabilitation, while compliance with the 3-Hour Rule was not found to have a substantive effect on the outcomes. The results support matching time in therapy during acute TBI rehabilitation to patients' LOE in order to optimize long-term benefits on outcomes.

Practice Guideline Update Recommendations Summary: Disorders of Consciousness: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology; the American Congress of Rehabilitation Medicine; and the National Institute on Disability, Independent Living, and Rehabilitation Research.

OBJECTIVE: To update the 1995 American Academy of Neurology (AAN) practice parameter on persistent vegetative state and the 2002 case definition on minimally conscious state (MCS) and provide care recommendations for patients with prolonged disorders of consciousness (DoC). METHODS: Recommendations were based on systematic review evidence, related evidence, care principles, and inferences using a modified Delphi consensus process according to the AAN 2011 process manual, as amended. RECOMMENDATIONS: Clinicians should identify and treat confounding conditions, optimize arousal, and perform serial standardized assessments to improve diagnostic accuracy in adults and children with prolonged DoC (Level B). Clinicians should counsel families that for adults, MCS (vs vegetative state [VS]/ unresponsive wakefulness syndrome [UWS]) and traumatic (vs nontraumatic) etiology are associated with more favorable outcomes (Level B). When prognosis is poor, long-term care must be discussed (Level A), acknowledging that prognosis is not universally poor (Level B). Structural MRI, SPECT, and the Coma Recovery Scale-Revised can assist prognostication in adults (Level B); no tests are shown to improve prognostic accuracy in children. Pain always should be assessed and treated (Level B) and evidence supporting treatment approaches discussed (Level B). Clinicians should prescribe amantadine (100-200 mg bid) for adults with traumatic VS/UWS or MCS (4-16 weeks post injury) to hasten functional recovery and reduce disability early in recovery (Level B). Family counseling concerning children should acknowledge that natural history of recovery, prognosis, and treatment are not established (Level B). Recent evidence indicates that the term chronic VS/UWS should replace permanent VS, with duration specified (Level B). Additional recommendations are included.

Comprehensive Systematic Review Update Summary: Disorders of Consciousness: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology; the American Congress of Rehabilitation Medicine; and the National Institute on Disability, Independent Living, and Rehabilitation Research.

OBJECTIVE: To update the 1995 American Academy of Neurology (AAN) practice parameter on persistent vegetative state and the 2002 case definition for the minimally conscious state (MCS) by reviewing the literature on the diagnosis, natural history, prognosis, and treatment of disorders of consciousness lasting at least 28 days. METHODS: Articles were classified per the AAN evidence-based classification system. Evidence synthesis occurred through a modified Grading of Recommendations Assessment, Development and Evaluation process. Recommendations were based on evidence, related evidence, care principles, and inferences according to the AAN 2011 process manual, as amended. RESULTS: No diagnostic assessment procedure had moderate or strong evidence for use. It is possible that a positive EMG response to command, EEG reactivity to sensory stimuli, laser-evoked potentials, and the Perturbational Complexity Index can distinguish MCS from vegetative state/unresponsive wakefulness syndrome (VS/UWS). The natural history of recovery from prolonged VS/UWS is better in traumatic than nontraumatic cases. MCS is generally associated with a better prognosis than VS (conclusions of low to moderate confidence in adult populations), and traumatic injury is generally associated with a better prognosis than nontraumatic injury (conclusions of low to moderate confidence in adult and pediatric populations). Findings concerning other prognostic features are stratified by etiology of injury (traumatic vs nontraumatic) and diagnosis (VS/UWS vs MCS) with low to moderate degrees of confidence. Therapeutic evidence is sparse. Amantadine probably hastens functional recovery in patients with MCS or VS/UWS secondary to severe traumatic brain injury over 4 weeks of treatment. Recommendations are presented separately.

Comprehensive systematic review update summary: Disorders of consciousness: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology; the American Congress of Rehabilitation Medicine; and the National Institute on Disability, Independent Living, and Rehabilitation Research.

OBJECTIVE: To update the 1995 American Academy of Neurology (AAN) practice parameter on persistent vegetative state and the 2002 case definition for the minimally conscious state (MCS) by reviewing the literature on the diagnosis, natural history, prognosis, and treatment of disorders of consciousness lasting at least 28 days. METHODS: Articles were classified per the AAN evidence-based classification system. Evidence synthesis occurred through a modified Grading of Recommendations Assessment, Development and Evaluation process. Recommendations were based on evidence, related evidence, care principles, and inferences according to the AAN 2011 process manual, as amended. RESULTS: No diagnostic assessment procedure had moderate or strong evidence for use. It is possible that a positive EMG response to command, EEG reactivity to sensory stimuli, laser-evoked potentials, and the Perturbational Complexity Index can distinguish MCS from vegetative state/unresponsive wakefulness syndrome (VS/UWS). The natural history of recovery from prolonged VS/UWS is better in traumatic than nontraumatic cases. MCS is generally associated with a better prognosis than VS (conclusions of low to moderate confidence in adult populations), and traumatic injury is generally associated with a better prognosis than nontraumatic injury (conclusions of low to moderate confidence in adult and pediatric populations). Findings concerning other prognostic features are stratified by etiology of injury (traumatic vs nontraumatic) and diagnosis (VS/UWS vs MCS) with low to moderate degrees of confidence. Therapeutic evidence is sparse. Amantadine probably hastens functional recovery in patients with MCS or VS/UWS secondary to severe traumatic brain injury over 4 weeks of treatment. Recommendations are presented separately.

Practice guideline update recommendations summary: Disorders of consciousness: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology; the American Congress of Rehabilitation Medicine; and the National Institute on Disability, Independent Living, and Rehabilitation Research.

OBJECTIVE: To update the 1995 American Academy of Neurology (AAN) practice parameter on persistent vegetative state and the 2002 case definition on minimally conscious state (MCS) and provide care recommendations for patients with prolonged disorders of consciousness (DoC). METHODS: Recommendations were based on systematic review evidence, related evidence, care principles, and inferences using a modified Delphi consensus process according to the AAN 2011 process manual, as amended. RECOMMENDATIONS: Clinicians should identify and treat confounding conditions, optimize arousal, and perform serial standardized assessments to improve diagnostic accuracy in adults and children with prolonged DoC (Level B). Clinicians should counsel families that for adults, MCS (vs vegetative state [VS]/unresponsive wakefulness syndrome [UWS]) and traumatic (vs nontraumatic) etiology are associated with more favorable outcomes (Level B). When prognosis is poor, long-term care must be discussed (Level A), acknowledging that prognosis is not universally poor (Level B). Structural MRI, SPECT, and the Coma Recovery Scale-Revised can assist prognostication in adults (Level B); no tests are shown to improve prognostic accuracy in children. Pain always should be assessed and treated (Level B) and evidence supporting treatment approaches discussed (Level B). Clinicians should prescribe amantadine (100-200 mg bid) for adults with traumatic VS/UWS or MCS (4-16 weeks post injury) to hasten functional recovery and reduce disability early in recovery (Level B). Family counseling concerning children should acknowledge that natural history of recovery, prognosis, and treatment are not established (Level B). Recent evidence indicates that the term chronic VS/UWS should replace permanent VS, with duration specified (Level B). Additional recommendations are included.

Medical Symptom Validity Test Performance Following Moderate-Severe Traumatic Brain Injury: Expectations Based on Orientation Log Classification.

OBJECTIVE: This study examined performance on the Medical Symptom Validity test (MSVT) during acute rehabilitation for moderate-severe traumatic brain injury (TBI) stratified by Orientation Log (O-Log) scores. METHOD: Participants were 77 prospectively enrolled persons who sustained moderate-severe TBI and were acutely hospitalized secondary to the cognitive, medical and physical sequelae of their TBI. Participants were administered neuropsychological metrics, the O-Log and the MSVT a mean of 44 days post injury. RESULTS: Significantly lower neurocognitive test scores were observed among participants who remained in post-traumatic amnesia (O-Log scores ranging from 20 to 24) versus those who were oriented (O-Log scores ranging from 25 to 30). MSVT performance was lower among participants who remained in post-traumatic amnesia. When participants O-Log scores were unimpaired (30), performance on the MSVT was also unimpaired on immediate recognition (IR) and delayed recognition (DR). A small percentage of participants performed below MSVT interpretive expectations on CNS. As O-Log scores decreased, MSVT performance also declined on some, but not all MSVT metrics. The sample as a whole performed at or above expectations on MSVT criterion B2 (IR) = 96.6%; (DR) = 94.8%; consistency (CNS) = 92.9%; paired associate (PA) = 86.4% and delayed free recall (FR) = 46.8%. CONCLUSIONS: MSVT performance stratified by O-Log scores provides basal expectation levels for persons with acute, moderate-severe impairment in cognitive skills secondary to TBI. Our data demonstrate that persons with significant neurocognitive impairment who are oriented generally perform at or above MSVT interpretive guidelines.

Risk Factors for Institutionalization After Traumatic Brain Injury Inpatient Rehabilitation.

OBJECTIVE: To create a profile of individuals with traumatic brain injury (TBI) who received inpatient rehabilitation and were discharged to an institutional setting using characteristics measured at rehabilitation discharge. METHODS: The Traumatic Brain Injury Model Systems National Database is a prospective, multicenter, longitudinal database for people with moderate to severe TBI. We analyzed data for participants enrolled from January 2002 to June 2012 who had lived in a private residence before TBI. This cross-sectional study used logistic regression analyses to identify sociodemographic factors, lengths of stay, and cognitive and physical functioning levels that differentiated patients discharged to institutional versus private settings. RESULTS: Older age, living alone before TBI, and lower levels of function at rehabilitation discharge (independence in locomotion, bladder management, comprehension, and social interaction) were significantly associated with higher institutionalization rates and provided the best models identifying factors associated with institutionalization. Institutionalization was also associated with decreased independence in bed-chair-wheelchair transfers and increased duration of posttraumatic amnesia. CONCLUSIONS: Individuals institutionalized after inpatient rehabilitation for TBI were older, lived alone before injury, had longer posttraumatic amnesia durations, and were less independent in specific functional characteristics. Research evaluating the effect of increasing postdischarge support and improving treatment effectiveness in these functional areas is recommended.

The Safety Assessment Measure for persons with traumatic brain injury: Item pool development and content validity.

BACKGROUND: Persons with moderate to severe TBI are at increased risk for unintentional injury or harm in the home and community; however, there is currently no standard measure of safety risk they face now and in the future. OBJECTIVE: To develop comprehensive and content valid scales and item pools for assessing safety and risk for persons with moderate to severe traumatic brain injuries. METHOD: Qualitative psychometric methods for developing scales and items were used including literature review, item development and revision, focus groups with interdisciplinary rehabilitation staff (n = 26) for rating content validity, and cognitive interviewing of TBI family members (n = 9) for assuring item clarity. RESULTS: The Safety Assessment Measure is comprised of 6 primary scales - Cognitive Capacity, Visuomotor Capacity, Wheelchair Use, Risk Perception, Self-Regulation, and Compliance Failures with Safety Recommendations - in which family caregivers or clinicians rate the risk for unintentional injury or harm in adults who have sustained moderate or severe TBI. The scale item pools encompass a broad spectrum of everyday activities that pose risk in the home and community and were rated as having excellent levels of content validity. CONCLUSIONS: The Safety Assessment Measure scales and items cover a broad range of instrumental activities of daily living that can increase the risk of unintentional injuries or harm. Empirical evidence suggests that the Safety Assessment Measure items have excellent content validity. Future research should use modern psychometric methods to examine each scale unidimensionality, model fit, and precision.

Traumatic Brain Injury-Practice Based Evidence Study: Design and Patients, Centers, Treatments, and Outcomes.

OBJECTIVES: To describe study design, patients, centers, treatments, and outcomes of a traumatic brain injury (TBI) practice-based evidence (PBE) study and to evaluate the generalizability of the findings to the U.S. TBI inpatient rehabilitation population. DESIGN: Prospective, longitudinal, observational study. SETTING: Ten inpatient rehabilitation centers. PARTICIPANTS: Patients (N=2130) enrolled between October 2008 and September 2011 and admitted for inpatient rehabilitation after an index TBI injury. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Return to acute care during rehabilitation, rehabilitation length of stay, FIM at discharge, residence at discharge, and 9 months postdischarge rehospitalization, FIM, participation, and subjective well-being. RESULTS: The level of admission FIM cognitive score was found to create relatively homogeneous subgroups for the subsequent analysis of best treatment combinations. There were significant differences in patient and injury characteristics, treatments, rehabilitation course, and outcomes by admission FIM cognitive subgroups. TBI-PBE study patients were overall similar to U.S. national TBI inpatient rehabilitation populations. CONCLUSIONS: This TBI-PBE study succeeded in capturing naturally occurring variation in patients and treatments, offering opportunities to study best treatments for specific patient impairments. Subsequent articles in this issue report differences between patients and treatments and associations with outcomes in greater detail.

Institutional Variation in Traumatic Brain Injury Acute Rehabilitation Practice.

OBJECTIVE: To describe institutional variation in traumatic brain injury (TBI) inpatient rehabilitation program characteristics and evaluate to what extent patient factors and center effects explain how TBI inpatient rehabilitation services are delivered. DESIGN: Secondary analysis of a prospective, multicenter, cohort database. SETTING: TBI inpatient rehabilitation programs. PARTICIPANTS: Patients with complicated mild, moderate, or severe TBI (N=2130). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Mean minutes; number of treatment activities; use of groups in occupational therapy, physical therapy, speech therapy, therapeutic recreation, and psychology inpatient rehabilitation sessions; and weekly hours of treatment. RESULTS: A wide variation was observed between the 10 TBI programs, including census size, referral flow, payer mix, number of dedicated beds, clinician experience, and patient characteristics. At the centers with the longest weekday therapy sessions, the average session durations were 41.5 to 52.2 minutes. At centers with the shortest weekday sessions, the average session durations were approximately 30 minutes. The centers with the highest mean total weekday hours of occupational, physical, and speech therapies delivered twice as much therapy as the lowest center. Ordinary least-squares regression modeling found that center effects explained substantially more variance than patient factors for duration of therapy sessions, number of activities administered per session, use of group therapy, and amount of psychological services provided. CONCLUSIONS: This study provides preliminary evidence that there is significant institutional variation in rehabilitation practice and that center effects play a stronger role than patient factors in determining how TBI inpatient rehabilitation is delivered.