Medical complications during inpatient rehabilitation among patients with traumatic disorders of consciousness.

OBJECTIVE: To assess the incidence of medical complications in patients with recent traumatic disorders of consciousness (DOCs). DESIGN: Data on adverse events in a placebo controlled trial of amantadine hydrochloride revealed no group difference, which allowed these events to be reanalyzed descriptively as medical complications experienced by the 2 groups collectively. SETTING: Eleven clinical facilities in the United States, Denmark, and Germany with specialty rehabilitation programs for patients with DOCs. PARTICIPANTS: Patients (N=184) with nonpenetrating traumatic brain injury enrolled from acute inpatient rehabilitation programs between 4 and 16 weeks postinjury. INTERVENTIONS: Participants were randomized to receive 200 to 400mg of amantadine hydrochloride or placebo daily for 4 weeks, and followed for an additional 2 weeks. Adverse events were recorded and categorized with respect to their nature, timing, and severity. MAIN OUTCOME MEASURE: Number, type, and severity of medical complications occurring during the 6-week study interval. RESULTS: A total of 468 medical complications were documented among the patients (.40 events per week per patient). More than 80% of patients experienced at least 1 medical complication, and 41 of these were defined as serious adverse events. New medical complications declined over time in rehabilitation and were not dependent on time since injury. Hypertonia, agitation/aggression, urinary tract infection, and sleep disturbance were the most commonly reported problems. Hydrocephalus, pneumonia, gastrointestinal problems, and paroxysmal sympathetic hyperactivity were the most likely to be severe. CONCLUSIONS: Patients with DOCs have a high rate of medical complications early after injury. Many of these complications require brain injury expertise for optimal management. Active medical management appears to contribute to the reduction in new complications. An optimal system of care for DOC patients must provide expert medical management in the early weeks after injury.

Placebo-controlled trial of amantadine for severe traumatic brain injury.

BACKGROUND: Amantadine hydrochloride is one of the most commonly prescribed medications for patients with prolonged disorders of consciousness after traumatic brain injury. Preliminary studies have suggested that amantadine may promote functional recovery. METHODS: We enrolled 184 patients who were in a vegetative or minimally conscious state 4 to 16 weeks after traumatic brain injury and who were receiving inpatient rehabilitation. Patients were randomly assigned to receive amantadine or placebo for 4 weeks and were followed for 2 weeks after the treatment was discontinued. The rate of functional recovery on the Disability Rating Scale (DRS; range, 0 to 29, with higher scores indicating greater disability) was compared over the 4 weeks of treatment (primary outcome) and during the 2-week washout period with the use of mixed-effects regression models. RESULTS: During the 4-week treatment period, recovery was significantly faster in the amantadine group than in the placebo group, as measured by the DRS score (difference in slope, 0.24 points per week; P=0.007), indicating a benefit with respect to the primary outcome measure. In a prespecified subgroup analysis, the treatment effect was similar for patients in a vegetative state and those in a minimally conscious state. The rate of improvement in the amantadine group slowed during the 2 weeks after treatment (weeks 5 and 6) and was significantly slower than the rate in the placebo group (difference in slope, 0.30 points per week; P=0.02). The overall improvement in DRS scores between baseline and week 6 (2 weeks after treatment was discontinued) was similar in the two groups. There were no significant differences in the incidence of serious adverse events. CONCLUSIONS: Amantadine accelerated the pace of functional recovery during active treatment in patients with post-traumatic disorders of consciousness. (Funded by the National Institute on Disability and Rehabilitation Research; ClinicalTrials.gov number, NCT00970944.).

Tracheostomy management skills competency in physical medicine and rehabilitation residents: a method for development and assessment.

This educational unit was developed to instruct physical medicine and rehabilitation residents on tracheostomy management in non-ventilator-dependent patients and to implement an objective assessment format to measure the attainment of these skills. Thirty-one subjects participated in a 2-day didactic and hands-on workshop supervised by an attending physiatrist, certified speech pathologists, and registered nurses. Assessment tools developed for this program address the basic competencies outlined by the Accreditation Council for Graduate Medical Education. To test the success of the standardized educational module, data have been collected on an ongoing basis for a period of 6 yrs. A before-and-after multiple-choice written examination, as well as simulated patient encounters consisting of eight segments divided into four stations, was used to assess knowledge acquisition and skill achievement. Before instruction, none of the 31 participants were able to perform appropriate tracheostomy care. After the workshop, 31 of 31 (100%) successfully demonstrated clinical proficiency in every segment of the evaluation element of the educational module. Furthermore, a significant increase in knowledge was observed in the multiple-choice examination from pretest to posttest (pretest, 52.7%; posttest, 84.5%). Participation in this module resulted in substantial acquisition of knowledge and skills regarding tracheostomy management for physical medicine and rehabilitation residents.

Prophylaxis for venous thromboembolism during rehabilitation for traumatic brain injury: a multicenter observational study.

BACKGROUND: Deep venous thrombosis (DVT) is a major cause of mortality and morbidity after traumatic brain injury (TBI). There is no consensus regarding appropriate screening, prophylaxis, or treatment during acute rehabilitation. METHODS: This prospective observational study evaluated prophylactic anticoagulation during rehabilitation in patients with TBI aged 16 years or older admitted to 12 TBI Model Systems rehabilitation centers (July 2004-December 2007). After propensity score stratification within center, the odds ratio associated with incidence of symptomatic DVT or pulmonary embolism (PE) for patients who did and did not receive prophylactic anticoagulation was estimated using conditional logistic regression in patients who were not screened for DVT on rehabilitation admission or who screened negative; the analysis was repeated in these two subgroups. RESULTS: Patients with identified DVTs at rehabilitation admission (n = 266) were excluded, leaving 1,897 patients: 1,002 screened negative, 895 unscreened; 932 received prophylactic anticoagulation, and 965 did not. Symptomatic DVT/PE was detected in 32 patients (15 of 932 [1.6%] with prophylaxis, 17 of 965 [1.8%] without). After propensity score adjustment, the odds ratio (95% confidence interval) for symptomatic DVT/PE with prophylaxis versus no prophylaxis was 0.80 (0.33-1.94) in the full analytic population and 0.46 (0.12-1.84) in the screened-negative subgroup. The only probable venous thromboembolism-related death occurred in the prophylactic anticoagulation group. Fewer new/expanded intracranial hemorrhages occurred among patients who received prophylactic anticoagulation. CONCLUSIONS: Prophylactic anticoagulation during rehabilitation seemed safe for TBI patients whose physicians deemed it appropriate, but did not conclusively reduce venous thromboembolism. Given the number of DVTs present before rehabilitation, screening and prophylaxis during acute care may be more important.