Minimal Clinically Important Difference for the Rasch Neuropsychiatric Inventory Irritability and Aggression Scale for Traumatic Brain Injury

Objective To determine the minimal clinically important difference (MCID) for a Rasch measure derived from the Irritability/Lability and Agitation/Aggression subscales of the Neuropsychiatric Inventory (NPI)—the Rasch NPI Irritability and Aggression Scale for Traumatic Brain Injury (NPI-TBI-IA). Design Distribution-based statistical methods were applied to retrospective data to determine candidates for the MCID. These candidates were evaluated by anchoring the NPI-TBI-IA to Global Impression of Change (GIC) ratings by participants, significant others, and a supervising physician. Setting Postacute rehabilitation outpatient clinic. Participants 274 cases with observer ratings; 232 cases with self-ratings by participants with moderate-severe TBI at least 6 months postinjury. Interventions Not applicable. Main Outcome Measure NPI-TBI-IA. Results For observer ratings on the NPI-TBI-IA, anchored comparisons found an improvement of 0.5 SD was associated with at least minimal general improvement on GIC by a significant majority (69%–80%); 0.5 SD improvement on participant NPI-TBI-IA self-ratings was also associated with at least minimal improvement on the GIC by a substantial majority (77%–83%). The percentage indicating significant global improvement did not increase markedly on most ratings at higher levels of improvement on the NPI-TBI-IA. Conclusions A 0.5 SD improvement on the NPI-TBI-IA indicates the MCID for both observer and participant ratings on this measure

Behavioral Recovery and Early Decision Making in Patients with Prolonged Disturbance in Consciousness after Traumatic Brain Injury

The extent of behavioral recovery that occurs in patients with traumatic disorders of consciousness (DoC) following discharge from the acute care setting has been under-studied and increases the risk of overly pessimistic outcome prediction. The aim of this observational cohort study was to systematically track behavioral and functional recovery in patients with prolonged traumatic DoC following discharge from the acute care setting. Standardized behavioral data were acquired from 95 patients in a minimally conscious (MCS) or vegetative state (VS) recruited from 11 clinic sites and randomly assigned to the placebo arm of a previously completed prospective clinical trial. Patients were followed for 6 weeks by blinded observers to determine frequency of recovery of six target behaviors associated with functional status. The Coma Recovery Scale-Revised and Disability Rating Scale were used to track reemergence of target behaviors and assess degree of functional disability, respectively. Twenty percent (95% confidence interval [CI]: 13-30%) of participants (mean age 37.2; median 47 days post-injury; 69 men) recovered all six target behaviors within the 6 week observation period. The odds of recovering a specific target behavior were 3.2 (95% CI: 1.2-8.1) to 7.8 (95% CI: 2.7-23.0) times higher for patients in MCS than for those in VS. Patients with preserved language function ("MCS+") recovered the most behaviors (p ≤ 0.002) and had the least disability (p ≤ 0.002) at follow-up. These findings suggest that recovery of high-level behaviors underpinning functional independence is common in patients with prolonged traumatic DoC. Clinicians involved in early prognostic counseling should recognize that failure to emerge from traumatic DoC before 28 days does not necessarily portend unfavorable outcome

Contextualized Treatment in Traumatic Brain Injury Inpatient Rehabilitation: Effects on Outcomes During the First Year after Discharge

Objective To evaluate the effect of providing a greater percentage of therapy as contextualized treatment on acute traumatic brain injury (TBI) rehabilitation outcomes. Design Propensity score methods are applied to the TBI-Practice-Based Evidence (TBI-PBE) database, a database consisting of multi-site, prospective, longitudinal observational data. Setting Acute inpatient rehabilitation. Participants Patients enrolled in the TBI-PBE study (n=1843), aged 14 years or older, who sustained a severe, moderate, or complicated mild TBI, receiving their first IRF admission in the US, and consented to follow-up 3 and 9 months post discharge from inpatient rehabilitation. Interventions Not applicable. Main Outcome Measures Participation Assessment with Recombined Tools-Objective- -17, FIMTM Motor and Cognitive scores, Satisfaction with Life Scale and Patient Health Questionnaire-9. Results Increasing the percentage of contextualized treatment during inpatient TBI rehabilitation leads to better outcomes, specifically in regard to community participation. Conclusions Increasing the proportion of treatment provided in the context of real-life activities appears to have a beneficial impact on outcome. Although the effect sizes are small, the results are consistent with other studies supporting functional-based interventions effecting better outcomes. Furthermore, any positive findings, regardless of size or strength, are endorsed as important by consumers (survivors of TBI). While the findings do not imply that decontextualized treatment should not be used, when the therapy goal can be addressed with either approach, the findings suggest that better outcomes may result if the contextualized approach is used

Impact of Level of Effort on the Effects of Compliance with the 3-Hour Rule

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 (TBI-PBE) database, consisting of multi-site, prospective, longitudinal observational data. Setting Acute inpatient rehabilitation facilities (IRF). Participants Patients (n=1820) who received their first IRF admission for TBI in the US and were enrolled for 3 and 9 month follow-up. Main Outcome Measures Participation Assessment with Recombined Tools-Objective-17, FIMTM 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%+ of therapy days in the context of low effort resulted in poorer performance on select outcome measures at discharge and up to 9 months post discharge compared to patients with <50% of 3-hr 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 impact 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

Rasch Analysis, Dimensionality, and Scoring of the Neuropsychiatric Inventory Irritability and Aggression Subscales in Individuals With Traumatic Brain Injury

Objectives To develop, for versions completed by individuals with traumatic brain injury (TBI) and an observer, a more precise metric for the Neuropsychiatric Inventory (NPI) Irritability and Aggression subscales using all behavioral item ratings for use with individuals with TBI and to address the dimensionality of the represented behavioral domains. Design Rasch and confirmatory factor analyses of retrospective baseline NPI data from 3 treatment studies. Setting Postacute rehabilitation clinic. Participants NPI records (N = 525) consisting of observer ratings (n = 287) and self-ratings (n = 238) by participants with complicated mild, moderate, or severe TBI at least 6 months postinjury. Interventions Not applicable. Main Outcome Measures Frequency and severity ratings from NPI Irritability/Lability and Agitation/Aggression subscales. Results Confirmatory factor analyses of both observer and participant ratings showed good fit for either a 1-factor or a 2-factor solution. Consistent with this, the Rasch model also fit the data well with aggression items indicating the more severe end of the construct and irritability items populating the milder end. Conclusions Irritability and aggression appear to represent different levels of severity of a single construct. The derived Rasch metric offers a measure of this construct based on responses to all specific items that is appropriate for parametric statistical analysis and may be useful in research and clinical assessments of individuals with TBI

Social Competence Treatment after Traumatic Brain Injury: A Multicenter, Randomized, Controlled Trial of Interactive Group Treatment versus Non-Interactive Treatment

Objective To evaluate the effectiveness of a replicable group treatment program for improving social competence after traumatic brain injury (TBI). Design Multicenter randomized controlled trial comparing two methods of conducting a social competency skills program, an interactive group format versus a classroom lecture. Setting Community and Veteran rehabilitation centers. Participants 179 civilian, military, and veteran adults with TBI and social competence difficulties, at least 6 months post-injury. Experimental Intervention Thirteen weekly group interactive sessions (1.5 hours) with structured and facilitated group interactions to improve social competence. Alternative (Control) Intervention Thirteen traditional classroom sessions using the same curriculum with brief supplemental individual sessions but without structured group interaction. Primary Outcome Measure Profile of Pragmatic Impairment in Communication (PPIC), an objective behavioral rating of social communication impairments following TBI. Secondary Outcomes LaTrobe Communication Questionnaire (LCQ), Goal Attainment Scale (GAS), Satisfaction with Life Scale (SWLS), Post-Traumatic Stress Disorder Checklist – (PCL-C), Brief Symptom Inventory 18 (BSI-18), Scale of Perceived Social Self Efficacy (PSSE). Results Social competence goals (GAS) were achieved and maintained for most participants regardless of treatment method. Significant improvements in the primary outcome (PPIC) and two of the secondary outcomes (LCQ and BSI) were seen immediately post-treatment and at 3 months post-treatment in the AT arm only, however these improvements were not significantly different between the GIST and AT arms. Similar trends were observed for PSSE and PCL-C. Conclusions Social competence skills improved for persons with TBI in both treatment conditions. The group interactive format was not found to be a superior method of treatment delivery in this study

Mortality following Traumatic Brain Injury among Individuals Unable to Follow Commands at the Time of Rehabilitation Admission: A National Institute on Disability and Rehabilitation Research Traumatic Brain Injury Model Systems Study

Severe traumatic brain injury (TBI) has been associated with increased mortality. This study characterizes long-term mortality, life expectancy, causes of death, and risk factors for death among patients admitted within the National Institute on Disability and Rehabilitation Research (NIDRR) TBI Model Systems Programs (TBIMS) who lack command following at the time of admission for inpatient TBI rehabilitation. Of the 8084 persons enrolled from 1988 and 2009, 387 from 20 centers met study criteria. Individuals with moderate to severe TBI who received inpatient rehabilitation were 2.2 times more likely to die than individuals in the U.S. general population of similar age, gender, and race, with an average life expectancy (LE) reduction of 6.6 years. The subset of individuals who were unable to follow commands on admission to rehabilitation was 6.9 times more likely to die, with an average LE reduction of 12.2 years. Relative to the U.S. general population matched for age, gender, and race/ethnicity, these non–command following individuals were more than four times more likely to die of circulatory conditions, 44 times more likely to die of pneumonia, and 38 times more likely to die of aspiration pneumonia. The subset of individuals with TBI who are unable to follow commands upon admission to inpatient rehabilitation are at a significantly increased risk of death when compared with the U.S. general population and compared with all individuals with moderate to severe TBI receiving inpatient rehabilitation. Respiratory causes of death predominate, compared with the general population

Prevalence of suicidal behaviour following traumatic brain injury: Longitudinal follow-up data from the NIDRR Traumatic Brain Injury Model Systems

Objective: This study utilized the Traumatic Brain Injury Model Systems (TBIMS) National Database to examine the prevalence of depression and suicidal behaviour in a large cohort of patients who sustained moderate-to-severe TBI. Method: Participants presented to a TBIMS acute care hospital within 72 hours of injury and received acute care and comprehensive rehabilitation in a TBIMS designated brain injury inpatient rehabilitation programme. Depression and suicidal ideation were measured with the Patient Health Questionnaire (PHQ-9). Self-reported suicide attempts during the past year were recorded at each follow-up examination, at 1, 2, 3, 10, 15 and 20 years post-injury. Results: Throughout the 20 years of follow-up, rates of depression ranged from 24.8–28.1%, suicidal ideation ranged from 7.0–10.1% and suicide attempts (past year) ranged from 0.8–1.7%. Participants who endorsed depression and/or suicidal behaviour at year 1 demonstrated consistently elevated rates of depression and suicidal behaviour 5 years after TBI. Conclusion: Compared to the general population, individuals with TBI are at greater risk for depression and suicidal behaviour many years after TBI. The significant psychiatric symptoms evidenced by individuals with TBI highlight the need for routine screening and mental health treatment in this population

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

Reductions in Alexithymia and Emotion Dysregulation After Training Emotional Self-Awareness Following Traumatic Brain Injury: A Phase I Trial

OBJECTIVES: To examine the acceptability and initial efficacy of an emotional self-awareness treatment at reducing alexithymia and emotion dysregulation in participants with traumatic brain injury (TBI). SETTING: An outpatient rehabilitation hospital. PARTICIPANTS: Seventeen adults with moderate to severe TBI and alexithymia. Time postinjury ranged 1 to 33 years. DESIGN: Within subject design, with 3 assessment times: baseline, posttest, and 2-month follow-up. INTERVENTION: Eight lessons incorporated psychoeducational information and skill-building exercises teaching emotional vocabulary, labeling, and differentiating self-emotions; interoceptive awareness; and distinguishing emotions from thoughts, actions, and sensations. MEASURES: Toronto Alexithymia Scale-20 (TAS-20); Levels of Emotional Awareness Scale (LEAS); Trait Anxiety Inventory (TAI); Patient Health Questionnaire-9 (PHQ-9); State-Trait Anger Expression Inventory (STAXI); Difficulty With Emotion Regulation Scale (DERS); and Positive and Negative Affect Scale (PANAS). RESULTS: Thirteen participants completed the treatment. Repeated-measures analysis of variance revealed changes on the TAS-20 (P = .003), LEAS (P < .001), TAI (P = .014), STAXI (P = .015), DERS (P = .020), and positive affect (P < .005). Paired t tests indicated significant baseline to posttest improvements on these measures. Gains were maintained at follow-up for the TAS, LEAS, and positive affect. Treatment satisfaction was high. CONCLUSION: This is the first study published on treating alexithymia post-TBI. Positive changes were identified for emotional self-awareness and emotion regulation; some changes were maintained several months posttreatment. Findings justify advancing to the next investigational phase for this novel intervention