Self-awareness four years after severe traumatic brain injury: discordance between the patient's and relative's complaints. Results from the PariS-TBI study.

OBJECTIVE: To evaluate the patient's awareness of his or her difficulties in the chronic phase of severe traumatic brain injury (TBI) and to determine the factors related to poor awareness. DESIGN/SETTING/SUBJECTS: This study was part of a larger prospective inception cohort study of patients with severe TBI in the Parisian region (PariS-TBI study). Intervention/Main measures: Evaluation was carried out at four years and included the Brain Injury Complaint Questionnaire (BICoQ) completed by the patient and his or her relative as well as the evaluation of impairments, disability and quality of life. RESULTS: A total of 90 patient-relative pairs were included. Lack of awareness was measured using the unawareness index that corresponded to the number of discordant results between the patient and relative in the direction of under evaluation of difficulties by the patient. The only significant relationship found with lack of awareness was the subjective burden perceived by the relative (Zarit Burden Inventory) ( r = 0.5; P < 0.00001). There was no significant relationship between lack of awareness and injury severity, pre-injury socio-demographic data, cognitive impairments, mood disorders, functional independence (Barthel index), global disability (Glasgow Outcome Scale), return to work at four years or quality of life (Quality Of Life after Brain Injury scale (QOLIBRI)). CONCLUSION: Lack of awareness four years post severe TBI was not related to the severity of the initial trauma, sociodemographic data, the severity of impairments, limitations of activity and participation, or the patient's quality of life. However, poor awareness did significantly influence the weight of the burden perceived by the relative.

Effect of Systematic Intensive Care Unit Triage on Long-term Mortality Among Critically Ill Elderly Patients in France: A Randomized Clinical Trial.

Importance: The high mortality rate in critically ill elderly patients has led to questioning of the beneficial effect of intensive care unit (ICU) admission and to a variable ICU use among this population. Objective: To determine whether a recommendation for systematic ICU admission in critically ill elderly patients reduces 6-month mortality compared with usual practice. Design, Setting, and Participants: Multicenter, cluster-randomized clinical trial of 3037 critically ill patients aged 75 years or older, free of cancer, with preserved functional status (Index of Independence in Activities of Daily Living ≥4) and nutritional status (absence of cachexia) who arrived at the emergency department of one of 24 hospitals in France between January 2012 and April 2015 and were followed up until November 2015. Interventions: Centers were randomly assigned either to use a program to promote systematic ICU admission of patients (n=1519 participants) or to follow standard practice (n=1518 participants). Main Outcomes and Measures: The primary outcome was death at 6 months. Secondary outcomes included ICU admission rate, in-hospital death, functional status, and quality of life (12-Item Short Form Health Survey, ranging from 0 to 100, with higher score representing better self-reported health) at 6 months. Results: One patient withdrew consent, leaving 3036 patients included in the trial (median age, 85 [interquartile range, 81-89] years; 1361 [45%] men). Patients in the systematic strategy group had an increased risk of death at 6 months (45% vs 39%; relative risk [RR], 1.16; 95% CI, 1.07-1.26) despite an increased ICU admission rate (61% vs 34%; RR, 1.80; 95% CI, 1.66-1.95). After adjustments for baseline characteristics, patients in the systematic strategy group were more likely to be admitted to an ICU (RR, 1.68; 95% CI, 1.54-1.82) and had a higher risk of in-hospital death (RR, 1.18; 95% CI, 1.03-1.33) but had no significant increase in risk of death at 6 months (RR, 1.05; 95% CI, 0.96-1.14). Functional status and physical quality of life at 6 months were not significantly different between groups. Conclusions and Relevance: Among critically ill elderly patients in France, a program to promote systematic ICU admission increased ICU use but did not reduce 6-month mortality. Additional research is needed to understand the decision to admit elderly patients to the ICU. Trial Registration: clinicaltrials.gov Identifier: NCT01508819.

Objective and Subjective Burden of Informal Caregivers 4 Years After a Severe Traumatic Brain Injury: Results From the PariS-TBI Study.

OBJECTIVE: Prospective assessment of informal caregiver (IC) burden 4 years after the traumatic brain injury of a relative. SETTING: Longitudinal cohort study (metropolitan Paris, France). PARTICIPANTS: Home dwelling adults (N = 98) with initially severe traumatic brain injury and their primary ICs. MAIN OUTCOME MEASURES: Informal caregiver objective burden (Resource Utilization in Dementia measuring Informal Care Time [ICT]), subjective burden (Zarit Burden Inventory), monetary self-valuation of ICT (Willingness-to-pay, Willingness-to-accept). RESULTS: Informal caregivers were women (81%) assisting men (80%) of mean age of 37 years. Fifty-five ICs reported no objective burden (ICT = 0) and no/low subjective burden (average Zarit Burden Inventory = 12.1). Forty-three ICs reported a major objective burden (average ICT = 5.6 h/d) and a moderate/severe subjective burden (average Zarit Burden Inventory = 30.3). In multivariate analyses, higher objective burden was associated with poorer Glasgow Outcome Scale-Extended scores, with more severe cognitive disorders (Neurobehavioral Rating Scale-revised) and with no coresidency status; higher subjective burden was associated with poorer Glasgow Outcome Scale-Extended scores, more Neurobehavioral Rating Scale-revised disorders, drug-alcohol abuse, and involvement in litigation. Economic valuation showed that on average, ICs did not value their ICT as free and preferred to pay a mean Willingness-to-pay = &OV0556;17 per hour to be replaced instead of being paid for providing care themselves (Willingness-to-accept = &OV0556;12). CONCLUSION: Four years after a severe traumatic brain injury, 44% of ICs experienced a heavy multidimensional burden.

Loss to Follow-Up and Social Background in an Inception Cohort of Patients With Severe Traumatic Brain Injury: Results From the PariS-TBI Study.

OBJECTIVES: To assess determinants of loss to follow-up (FU) at 2 time points of an inception traumatic brain injury (TBI) cohort. DESIGN AND PARTICIPANTS: The PariS-TBI study consecutively included 504 adults with severe TBI on the accident scene (76% male, mean age 42 years, mean Glasgow Coma Scale 5). No exclusion criteria were used. MAIN MEASURE: Loss to FU at 1 and 4 years was defined among survivors as having no outcome data other than survival status. RESULTS: Among 257 1-year survivors, 118 (47%) were lost to FU at 1 year and 98 (40%) at 4 years. Main reasons for loss to FU were impossibility to achieve contact (109 at 1 year, 52 at 4 years) and refusal to participate (respectively 5 and 24). At 1 year, individuals not working preinjury or with nonaccidental traumas were more often lost to FU in univariate and multivariable analyses. At 4 years, loss to FU was significantly associated with preinjury alcohol abuse and unemployment. Relationship with injury severity was not significant. CONCLUSIONS: Socially disadvantaged persons are underrepresented in TBI outcome research. It could result in overestimation of outcome and biased estimates of sociodemographic characteristics' effects. These persons, particularly unemployed individuals, require special attention in clinical practice.

Disability and health-related quality-of-life 4 years after a severe traumatic brain injury: A structural equation modelling analysis.

OBJECTIVES: To assess predictors and indicators of disability and quality-of-life 4 years after severe traumatic brain injury (TBI), using structural equation modelling (SEM). METHODS: The PariS-TBI study is a longitudinal multi-centre inception cohort study of 504 patients with severe TBI. Among 245 survivors, 147 patients were evaluated upon 4-year follow-up, and 85 completed the full assessment. Two outcome measures were analysed separately using SEM: the Glasgow Outcome Scale-extended (GOS-E), to measure disability, and the QOLIBRI, to assess quality-of-life. Four groups of variables were entered in the model: demographics; injury severity; mood and cognitive impairments; somatic impairments. RESULTS: The GOS-E was directly significantly related to mood and cognition, injury severity, and somatic impairments. Age and education had an indirect effect, mediated by mood/cognition or somatic deficiencies. In contrast, the only direct predictor of QOLIBRI was mood and cognition. Age and somatic impairments had an indirect influence on the QOLIBRI. CONCLUSION: Although this study should be considered as explorative, it suggests that disability and quality-of-life were directly influenced by different factors. While disability appeared to result from an interaction of a wide range of factors, quality-of-life was solely directly related to psycho-cognitive factors.

Patterns of post-acute health care utilization after a severe traumatic brain injury: Results from the PariS-TBI cohort.

OBJECTIVE: To assess brain injury services utilization and their determinants using Andersen's model. METHODS: Prospective follow-up of the PariS-TBI inception cohort. Out of 504 adults with severe traumatic brain injury (TBI), 245 survived and 147 received a 4-year outcome assessment (mean age 33 years, 80% men). Provision rates of medical, rehabilitation, social and re-entry services and their relations to patients' characteristics were assessed. RESULTS: Following acute care discharge, 78% of patients received physiotherapy, 61% speech/cognitive therapy, 50% occupational therapy, 41% psychological assistance, 63% specialized medical follow-up, 21% community re-entry assistance. Health-related need factors, in terms of TBI severity, were the main predictors of services. Provision of each therapy was significantly associated with corresponding speech, motor and psychological impairments. However, care provision did not depend on cognitive impairments and cognitive therapy was related to pre-disposing and geographical factors. Community re-entry assistance was provided to younger and more independent patients. CONCLUSIONS: These quantitative findings illustrate strengths and weaknesses of late brain injury care provision in urban France and highlight the need to improve treatment of cognitive impairments.

Ecological validity of the Dysexecutive Questionnaire: Results from the PariS-TBI study.

The Dysexecutive Questionnaire (DEX; Wilson, Pettigrew, & Teasdale, 1998 ) has been designed to assess executive dysfunctions in daily life. However, its relationships with cognitive testing, mood, and the ability to fulfil daily life demands, have not yet been systematically addressed. The objective of this study was to address these issues in a prospective four-year follow-up study of patients with severe traumatic brain injury (TBI) (PariS-TBI study). One hundred and forty seven patients were included. The DEX (self-version) showed a good internal consistency. The total DEX score was significantly inversely correlated with years of education, but did not significantly correlate with any initial injury severity measure. The DEX was significantly and positively related to cognitive deficits, as assessed with the Neurobehavioral Rating Scale-Revised (NRS-R); with mood disorders, as assessed with the Hospital Anxiety and Depression Scale (HADS); with dependency in elementary and extended activities of daily living; and with non-return to work. In multivariate analyses, cognitive and mood impairments were significantly and independently related to the total DEX score. These results suggest that the DEX is a multidetermined sensitive questionnaire to detect everyday life difficulties in patients with severe TBI at a chronic stage.

Predictors of informal care burden 1 year after a severe traumatic brain injury: results from the PariS-TBI study.

OBJECTIVE: To investigate predictors of informal care burden 1 year after a severe traumatic brain injury (TBI). PARTICIPANTS: Patients (N = 66) aged 15 years or older with severe TBI (Glasgow Coma Scale score of 8 or less) and their primary informal caregivers. SETTING: Multicenter inception cohort study over 22 months in Paris and the surrounding area (PariS-TBI study). MAIN MEASURES: Patients' preinjury characteristics; injury severity data; outcome measures at discharge from intensive care and 1 year after the injury; Dysexecutive Questionnaire; Medical Outcome Study Short Form-36; Zarit Burden Inventory. RESULTS: Among the 257 survivors at discharge from acute care, 66 patient-caregiver couples were included. Primary informal caregivers were predominantly women (73%), of middle age (age, 50 years), supporting male patients (79%), of mean age of 38 years. The majority (56%) of caregivers experienced significant burden, and 44% were at risk of depression. Caregivers' impaired health status and perceived burden significantly correlated with patients' global disability (as assessed with the Glasgow Outcome Scale-Extended) and impairments of executive functions (as assessed with the Dysexecutive Questionnaire). A focused principal component analysis suggested that disability and executive dysfunctions were independent predictors of perceived burden, whereas demographics, injury severity, and Glasgow Outcome Scale at discharge from acute care did not significantly correlate with caregiver's burden. CONCLUSION: Global handicap and impairments of executive functions are independent significant predictors of caregiver burden 1 year after TBI.

Potential for recovery between 4 and 8 years after a severe traumatic brain injury. Data from the PariS-TBI longitudinal study.

BACKGROUND: Severe traumatic brain injury (TBI) is a leading cause of complex and persistent disability. Yet, long-term change in global functioning and determinants of this change remain unclear. OBJECTIVES: This study aimed to assess change in global functioning in the long-term after severe TBI and factors associated with the change. METHODS: This was a prospective observational study of an inception cohort of adults with severe TBI in the Paris area (PariS-TBI). Outcome was assessed at 1, 4 and 8 years post-injury. For the included participants (n=257), change in global outcome between 4 and 8 years was evaluated with the Glasgow Outcome Scale Extended (GOSE) score, and its association with pre-injury, injury-related and post-injury variables was tested with univariate and multivariable analyses. RESULTS: More than half of the 73 participants evaluated at both 4 and 8 years showed global improvement (of at least one point) in GOSE score and an improvement in mood, executive function, and subjective complaints. On univariate analysis, none of the pre-injury, injury or post-injury variables were associated with GOSE score change between 4 and 8 years, except for GOSE score at 4 years (rho=-0.24, P=0.04). On multivariable analysis, probability of increased GOSE score was associated with more years of education (odds ratio 1.18 [95% confidence interval 1.02-1.37], P=0.03). The change in GOSE score was significantly correlated with change in Hospital Anxiety Depression Scale score between 4 and 8 years (rho=-0.42, P<0.001). CONCLUSIONS: Most participants with severe TBI in the present sample showed a late improvement (4 to 8 years post-injury) in global functioning. Of the socio-demographic and injury-related factors, only more years of education was associated with improvement in global functioning. Decreased anxiety and depression symptoms were associated with improved global functioning. Targeting interventions to enhance resilience may be the most effective in the long-term after severe TBI.

Employment outcome four years after a severe traumatic brain injury: results of the Paris severe traumatic brain injury study.

OBJECTIVE: To describe employment outcome four years after a severe traumatic brain injury by the assessment of individual patients' preinjury sociodemographic data, injury-related and postinjury factors. DESIGN: A prospective, multicenter inception cohort of 133 adult patients in the Paris area (France) who had received a severe traumatic brain injury were followed up postinjury at one and four years. Sociodemographic data, factors related to injury severity and one-year functional and cognitive outcomes were prospectively collected. METHODS: The main outcome measure was employment status. Potential predictors of employment status were assessed by univariate and multivariate analysis. RESULTS: At the four-year follow-up, 38% of patients were in paid employment. The following factors were independent predictors of unemployment: being unemployed or studying before traumatic brain injury, traumatic brain injury severity (i.e., a lower Glasgow Coma Scale score upon admission and a longer stay in intensive care) and a lower one-year Glasgow Outcome Scale-Extended score. CONCLUSION: This study confirmed the low rate of long-term employment amongst patients after a severe traumatic brain injury. The results illustrated the multiple determinants of employment outcome and suggested that students who had received a traumatic brain injury were particularly likely to be unemployed, thus we propose that they may require specific support to help them find work. Implications for rehabilitation Traumatic brain injury is a leading cause of persistent disablity and can associate cognitive, emotional, physical and sensory impairments, which often result in quality-of-life reduction and job loss. Predictors of post-traumatic brain injury unemployment and job loss remains unclear in the particular population of severe traumatic brain injury patients. The present study highlights the post-traumatic brain injury student population require a close follow-up and vocational rehabilitation. The study suggests that return to work post-severe traumatic brain injury is frequently unstable and workers often experience difficulties that caregivers have to consider.

Designing and conducting a cluster-randomized trial of ICU admission for the elderly patients: the ICE-CUB 2 study.

BACKGROUND: The benefit of ICU admission for elderly patients remains controversial. This report highlights the methodology, the feasibility of and the ethical and logistical constraints in designing and conducting a cluster-randomized trial of intensive care unit (ICU) admission for critically ill elderly patients. METHODS: We designed an interventional open-label cluster-randomized controlled trial in 24 centres in France. Clusters were healthcare centres with at least one emergency department (ED) and one ICU. Healthcare centres were randomly assigned either to recommend a systematic ICU admission (intervention group) or to follow standard practices regarding ICU admission (control group). Clusters were stratified by the number of ED annual visits (<44,616 or >44,616 visits), the presence or absence of a geriatric ward and the geographical area (Paris area vs other regions in France). All elderly patients (≥75 years of age) who got to the ED were assessed for eligibility. Patients were included if they had one of the pre-established critical conditions, a preserved functional status as assessed by an ADL scale ≥4 (0 = very dependent, 6 = independent), a preserved nutritional status (subjectively assessed by physicians) and without active cancer. Exclusion criteria were an ED stay >24 h, a secondary referral to the ED and refusal to participate. The primary outcome was the mortality at 6 months calculated at the individual patient level. Secondary outcomes were ICU and hospital mortality, as well as ADL scale and quality of life (as assessed by the SF-12 Health Survey) at 6 months. RESULTS: Between January 2012 and April 2015, 3036 patients were included in the trial, 1518 patients in 11 clusters allocated to intervention group and 1518 patients in 13 clusters allocated to standard care. There were 51 protocol violations. CONCLUSIONS: The ICE-CUB 2 trial was deemed feasible and ethically acceptable. The ICE-CUB 2 trial will be the first cluster-randomized trial to assess the benefits of ICU admission for selected elderly patients on long-term mortality. Trial registration Clinical trials.gov identifier: NCT01508819.

Referral to rehabilitation after severe traumatic brain injury: results from the PariS-TBI Study.

BACKGROUND: After a severe traumatic brain injury (TBI), some patients are discharged home without rehabilitation, although rehabilitation is assumed to improve outcome. OBJECTIVE: To assess factors that predict referral to rehabilitation following acute care. This study is part of a larger inception cohort study assessing the care network in the Parisian area (France). METHODS: Between July 2005 and April 2007, 504 adults with severe TBI (Glasgow Coma Scale score ≤ 8) were prospectively recruited by mobile emergency services. This study included 254 acute care survivors (80% male, median age 32 years). Data regarding demographics, injury severity, and acute care pathway were collected. The first analysis compared patients referred to a rehabilitation facility with patients discharged to a living place. The second analysis compared patients referred to a specialized neurorehabilitation (NR) facility with patients referred to nonspecialized rehabilitation. Univariate and multivariate statistics were computed. RESULTS: . In all, 162 patients (64%) were referred to rehabilitation, 115 (45%) of which were referred to NR and 47 (19%) to nonspecialized rehabilitation. The following factors were significantly predictive of nonreferral to rehabilitation: living alone, a lower income professional category, pretraumatic alcohol abuse, lower TBI severity, and transfer through a nonspecialized medical ward before discharge. Patients referred to specialized NR were significantly younger and from a higher income professional category. CONCLUSIONS: These results raise concern regarding care pathways because many patients were discharged to living places, probably without adequate assessment and management of rehabilitation needs. Injury severity and social characteristics influenced discharge destination.