Quality of life after brain injury-overall scale, Japanese version: assessment of reliability and validity.

This study analyzed the linguistic and psychometric validation of the Japanese version of the Quality of Life after Brain Injury-Overall Scale (QOLIBRI-OS) consisting of six items which cover several TBI-relevant domains. We hypothesized that the Japanese version has good reliability, convergent validity, and divergent validity, compared with its long version, the 37-item QOLIBRI. The QOLIBRI-OS Japanese version was forward and back-translated from the English version. In total, 129 individuals participated in this study after experiencing a traumatic brain injury and attending clinics, rehabilitation centers, and support centers in Japan. The structure of the QOLIBRI-OS was investigated by confirmatory factor analyses and compared with the QOLIBRI. Only one factor was extracted, and a model with one underlying factor had a good fit. The QOLIBRI-OS showed good-to-excellent internal consistency and test-retest reliability. The QOLIBRI-OS was positively correlated with the QOLIBRI, Short Form Health Survey-36 version 2, and Glasgow Outcome Scale Extended, and negatively correlated with the Hospital Anxiety and Depression Scale. The results suggest that the QOLIBRI-OS Japanese version is a reliable and valid tool for assessing disease-specific health-related QOL in individuals after traumatic brain injury in Japan.

Cerebrolysin after moderate to severe traumatic brain injury: prospective meta-analysis of the CAPTAIN trial series.

INTRODUCTION: This prospective meta-analysis summarizes results from the CAPTAIN trial series, evaluating the effects of Cerebrolysin for moderate-severe traumatic brain injury, as an add-on to usual care. MATERIALS AND METHODS: The study included two phase IIIb/IV prospective, randomized, double-blind, placebo-controlled clinical trials. Eligible patients with a Glasgow Coma Score (GCS) between 6 and 12 received study medication (50 mL of Cerebrolysin or physiological saline solution per day for ten days, followed by two additional treatment cycles with 10 mL per day for 10 days) in addition to usual care. The meta-analysis comprises the primary ensembles of efficacy criteria for 90, 30, and 10 days after TBI with a priori ordered hypotheses based on multivariate, directional tests. RESULTS: A total 185 patients underwent meta-analysis (mean admission GCS = 10.3, mean age = 45.3, and mean Baseline Prognostic Risk Score = 2.8). The primary endpoint, a multidimensional ensemble of functional and neuropsychological outcome scales indicated a "small-to-medium" sized effect in favor of Cerebrolysin, statistically significant at Day 30 and at Day 90 (Day 30: MWcombined = 0.60, 95%CI 0.52 to 0.66, p = 0.0156; SMD = 0.31; OR = 1.69; Day 90: MWcombined = 0.60, 95%CI 0.52 to 0.68, p = 0.0146; SMD = 0.34, OR = 1.77). Treatment groups showed comparable safety and tolerability profiles. DISCUSSION: The meta-analysis of the CAPTAIN trials confirms the safety and efficacy of Cerebrolysin after moderate-severe TBI, opening a new horizon for neurorecovery in this field. Integration of Cerebrolysin into existing guidelines should be considered after careful review of internationally applicable criteria.

Efficacy and safety of cerebrolysin in neurorecovery after moderate-severe traumatic brain injury: results from the CAPTAIN II trial.

INTRODUCTION: The objective of this trial was to evaluate the efficacy and safety of Cerebrolysin in treating patients after moderate to severe traumatic brain injury (TBI) as an adjunct to standard care protocols. The trial was designed to investigate the clinical effects of Cerebrolysin in the acute (neuroprotective) stage and during early and long-term recovery as part of a neurorestorative strategy. MATERIALS AND METHODS: The study was a phase IIIb/IV single-center, prospective, randomized, double-blind, placebo-controlled clinical trial. Eligible patients with a Glasgow Coma Score (GCS) between 7 and 12 received study medication (50 ml of Cerebrolysin or physiological saline solution per day for 10 days, followed by two additional treatment cycles with 10 ml per day for 10 days) in addition to standard care. We tested ensembles of efficacy criteria for 90, 30, and 10 days after TBI with a priori ordered hypotheses using a multivariate, directional test, to reflect the global status of patients after TBI. RESULTS: The study enrolled 142 patients, of which 139 underwent formal analysis (mean age = 47.4, mean admission GCS = 10.4, and mean Baseline Prognostic Risk Score = 2.6). The primary endpoint, a multidimensional ensemble of 13 outcome scales, indicated a "small-to-medium"-sized effect in favor of Cerebrolysin, statistically significant at day 90 (MWcombined = 0.59, 95% CI 0.52 to 0.66, P = 0.0119). Safety and tolerability observations were comparable between treatment groups. CONCLUSION: Our trial confirms previous beneficial effects of the multimodal, biological agent Cerebrolysin for overall outcome after moderate to severe TBI, as measured by a multidimensional approach. Study findings must be appraised and aggregated in conjunction with existing literature, as to improve the overall level of insight regarding therapeutic options for TBI patients. The widely used pharmacologic intervention may benefit from a large-scale observational study to map its use and to establish comparative effectiveness in real-world clinical settings.

Regeneration of Denervated Skeletal Muscles - Brunelli's CNS-PNS Paradigm.

The restoration of voluntary muscle activity in posttraumatic paraplegia in both animal experiments and other clinical applications requires reproducibility of a technically-demanding microsurgical procedure, limited by physicians' understanding of Brunelli's spinal cord grafting paradigm. The insufficient clinical investigation of the long-term benefits of the CNS-PNS graft application warrants additional inquiry. The objective of this study is to explore the potential benefits of the first replicated, graft-induced neuroregeneration of denervated skeletal muscle regarding long-term clinical outcomes and to investigate the effect of Cerebrolysin on neuromodulation. A randomized study evaluating 30 rats, approved by the National Animal Ethics Advisory Committee was performed. The medication was administered postoperatively. For 14 days, 12 rats received Cerebrolysin (serum), 11 received NaCl 0.9% (shams), and 7 were controls. For microsurgery, the lateral corticospinal tract T10 was grafted to the denervated internal obliquus abdominal muscle. On day 90, intraoperative proof of reinnervation was observed. On day 100, 15 rats were euthanized for fixation, organ removal, and extensive histology-morphology examination, and the Wei-Lachin statistical procedure was employed. After an open revision of 16 rats, 8 were CMAP positive. After intravenous Vecuronium application, two (Cerebrolysin, NaCl) out of two rats showed an incomplete compound muscle action potential (CMAP) loss due to glutamatergic and cholinergic co-transmission, while two others showed a complete loss of amplitude. Cerebrolysin medication initiated larger restored muscle fiber diameters and less scarring. FB+ neurons were not observed in the brain but were observed in the Rexed laminae. Brunelli's concept was successfully replicated, demonstrating the first graft induced existence of cholinergic and glutamatergic neurotransmission in denervated grafted muscles. Statistics of the histometric count of muscle fibers revealed larger fiber diameters after Cerebrolysin. Brunelli's CNS-PNS experimental concept is suitable to analyze graft-neuroplasticity focused on the voluntary restoration of denervated skeletal muscles in spinal cord injury. Neuroprotection by Cerebrolysin is demonstrated.

German validation of Quality of Life after Brain Injury (QOLIBRI) assessment and associated factors.

The consequences of traumatic brain injury (TBI) for health-related quality of life (HRQoL) are still poorly understood, and no TBI-specific instrument has hitherto been available. This paper describes in detail the psychometrics and validity of the German version of an internationally developed, self-rated HRQoL tool after TBI-the QOLIBRI (Quality of Life after Brain Injury). Factors associated with HRQoL, such as the impact of cognitive status and awareness, are specifically reported. One-hundred seventy-two participants after TBI were recruited from the records of acute clinics, most of whom having a Glasgow Coma Scale (GCS) 24-hour worst score and a Glasgow Outcome Scale (GOSE) score. Participants had severe (24%), moderate (11%) and mild (56%) injuries as assessed on the GCS, 3 months to 15 years post-injury. The QOLIBRI uses 37 items to measure "satisfaction" in the areas of "Cognition", "Self", "Daily Life and Autonomy", and "Social Relationships", and "feeling bothered" by "Emotions"and "Physical Problems". The scales meet standard psychometric criteria (α = .84 to .96; intra-class correlation-ICC = .72 to .91). ICCs (0.68 to 0.90) and αs (.83 to .96) were also good in a subgroup of participants with lower cognitive performance. The six-subscale structure of the international sample was reproduced for the German version using confirmatory factor analyses and Rasch analysis. Scale validity was supported by systematic relationships observed between the QOLIBRI and the GOSE, Patient Competency Rating Scale for Neurorehabilitation (PCRS-NR), Hospital Anxiety and Depression Scale (HADS), Profile of Mood States (POMS), Short Form 36 (SF-36), and Satisfaction with Life Scale (SWLS). The German QOLIBRI contains novel information not provided by other currently available measures and has good psychometric criteria. It is potentially useful for clinicians and researchers, in post-acute and rehabilitation studies, on a group and individual level.

Music and Mind: In Memoriam Professor Carlo Alberto Pagni, MD, PhD: February 13, 1931 -March 1, 2009.

Carlo Alberto Pagni, born in La Spezia, Italy, on February 13, 1931, was an eminent and respected professor of neurosurgery and chairman of the neurosurgical clinic of the University of Turin from 1980 to 2003. He died on March 1, 2009. As a professor of neurology and neurological surgery he was renowned as an expert on vascular, tumor, and functional neurosurgery. Beyond the Italian Neurosurgical Society, he was the doyen of functional neurosurgery, specializing in motor cortex stimulation for the treatment of focal dystonia, Parkinson's disease, and postictal spasticity and pain. His home was his castle, and his family was fundamental to his life. He shared with his wife, Sandra, his passion for piano playing and for their remarkable library, and together with friends, he and his wife enjoyed dinners with fine food and Barolo wines. Listening to this Grand Seigneur talking about and explaining the music of, above all, Ludwig van Beethoven, and Richard Wagner, one felt he was emotionally just "music and mind". You can imagine this from his books on music, chess, and neuroscience. Indeed, he adored playing correspondence chess worldwide. A sportsman too, he loved hiking, mountaineering, skiing, swimming, and fishing. Nature was his source for slowing down, for regenerating, and for collecting his strength for new projects and new challenges. Friends will remember Dr. Pagni as a Grand Seigneur.

Interpreting Quality of Life after Brain Injury Scores: Cross-Walk with the Short Form-36.

The Quality of Life after Brain Injury (QOLIBRI) instruments are traumatic brain injury (TBI)-specific assessments of health-related quality of life (HRQoL), with established validity and reliability. The purpose of the study is to help improve the interpretability of the two QOLIBRI summary scores (the QOLIBRI Total score and the QOLBRI Overall Scale [OS] score). An analysis was conducted of 761 patients with TBI who took part in the QOLIBRI validation studies. A cross-walk between QOLIBRI scores and the SF-36 Mental Component Summary norm-based scoring system was performed using geometric mean regression analysis. The exercise supports a previous suggestion that QOLIBRI Total scores <60 indicate low or impaired HRQoL and indicate that the corresponding score on the QOLIBRI-OS is <52. The percentage of cases in the sample that fell into the "impaired HRQoL" category was 36% for the Mental Component Summary, 38% for the QOLIBRI Total, and 39% for the QOLIBRI-OS. Relationships between the QOLIBRI scales and the Glasgow Outcome Scale-Extended (GOSE), as a measure of global function, are presented in the form of means and standard deviations that allow comparison with other studies, and data on age and sex are presented for the QOLIBRI-OS. While bearing in mind the potential imprecision of the comparison, the findings provide a framework for evaluating QOLIBRI summary scores in relation to generic HRQoL that improves their interpretability.

Quality of life in persons after traumatic brain injury as self-perceived and as perceived by the caregivers.

The primary aim of the study was to adopt QOLIBRI (quality of life after brain injury) questionnaire in a proxy version (Q-Pro), i.e., to use caregivers for comparison and to evaluate whether TBI patients' judgment corresponds to that of their caregivers since the possible self-awareness deficit of the persons with TBI. A preliminary sample of 19 outpatients with TBI and their proxies was first evaluated with the Patient Competency Rating Scale to assess patients' self-awareness; then they were evaluated with the QOLIBRI Patient version (Q-Pt) and a patient-centered version of the Q-Pro. Subsequently, 55 patients and their caregivers were evaluated using the patient-centered and the caregiver-centered Q-Pro versions. Q-Pt for assessing Quality of Life (QoL) after TBI, as patients' subjective perspective and Q-Pro to assess the QoL of patients as perceived by the caregivers. The majority of patients (62.2%) showed better self-perception of QoL than their proxies; however, patients with low self-awareness were less satisfied than patients with adequate self-awareness. Low self-awareness does not impair the ability of patients with TBI to report on satisfaction with QoL as self-perceived.

Assessment of Health-Related Quality of Life after TBI: Comparison of a Disease-Specific (QOLIBRI) with a Generic (SF-36) Instrument.

Psychosocial, emotional, and physical problems can emerge after traumatic brain injury (TBI), potentially impacting health-related quality of life (HRQoL). Until now, however, neither the discriminatory power of disease-specific (QOLIBRI) and generic (SF-36) HRQoL nor their correlates have been compared in detail. These aspects as well as some psychometric item characteristics were studied in a sample of 795 TBI survivors. The Shannon H (') index absolute informativity, as an indicator of an instrument's power to differentiate between individuals within a specific group or health state, was investigated. Psychometric performance of the two instruments was predominantly good, generally higher, and more homogenous for the QOLIBRI than for the SF-36 subscales. Notably, the SF-36 "Role Physical," "Role Emotional," and "Social Functioning" subscales showed less satisfactory discriminatory power than all other dimensions or the sum scores of both instruments. The absolute informativity of disease-specific as well as generic HRQoL instruments concerning the different groups defined by different correlates differed significantly. When the focus is on how a certain subscale or sum score differentiates between individuals in one specific dimension/health state, the QOLIBRI can be recommended as the preferable instrument.

Cerebrolysin Asian Pacific trial in acute brain injury and neurorecovery: design and methods.

Traumatic brain injury (TBI) is one of the leading causes of injury-related death. In the United States alone, an estimated 1.7 million people sustain a TBI each year, and approximately 5.3 million people live with a TBI-related disability. The direct medical costs and indirect costs such as lost productivity of TBIs totaled an estimated $76.5 billion in the U.S. in the year 2000. Improving the limited treatment options for this condition remains challenging. However, recent reports from interdisciplinary working groups (consisting primarily of neurologists, neurosurgeons, neuropsychologists, and biostatisticians) have stated that to improve TBI treatment, important methodological lessons from the past must be taken into account in future clinical research. An evaluation of the neuroprotection intervention studies conducted over the last 30 years has indicated that a limited understanding of the underlying biological concepts and methodological design flaws are the major reasons for the failure of pharmacological agents to demonstrate efficacy. Cerebrolysin is a parenterally-administered neuro-peptide preparation that acts in a manner similar to endogenous neurotrophic factors. Cerebrolysin has a favorable adverse effect profile, and several meta-analyses have suggested that Cerebrolysin is beneficial as a dementia treatment. CAPTAIN is a randomized, double-blind, placebo-controlled, multi-center, multinational trial of the effects of Cerebrolysin on neuroprotection and neurorecovery after TBI using a multidimensional ensemble of outcome scales. The CAPTAIN trial will be the first TBI trial with a 'true' multidimensional approach based on full outcome scales, while avoiding prior weaknesses, such as loss of information through "dichotomization," or unrealistic assumptions such as "normal distribution."

Consensus of clinical neurorestorative progress in patients with complete chronic spinal cord injury.

Currently, there is a lack of effective therapeutic methods to restore neurological function for chronic complete spinal cord injury (SCI) by conventional treatment. Neurorestorative strategies with positive preclinical results have been translated to the clinic, and some patients have gotten benefits and their quality of life has improved. These strategies include cell therapy, neurostimulation or neuromodulation, neuroprosthesis, neurotization or nerve bridging, and neurorehabilitation. The aim of this consensus by 31 experts from 20 countries is to show the objective evidence of clinical neurorestoration for chronic complete SCI by the mentioned neurorestorative strategies. Complete chronic SCI patients are no longer told, "nothing can be done." The clinical translation of more effective preclinical neurorestorative strategies should be encouraged as fast as possible in order to benefit patients with incurable CNS diseases. This manuscript is published as part of the International Association of Neurorestoratology (IANR) special issue of Cell Transplantation.

Coping strategies in individuals after traumatic brain injury: associations with health-related quality of life.

PURPOSE: This study investigates coping strategies after traumatic brain injury (TBI) and their associations with health-related quality of life (HRQoL). METHODS: Participants were 141 adults followed up 3 months to 15 years after TBI of all severity degrees. Coping was assessed by the Freiburg Questionnaire of Coping with Illness (FQCI) and HRQoL by the Quality of Life after Brain Injury (QOLIBRI) scale and the Short Form-36 Health Survey (SF-36). Coping dimensions were extracted by principal component analysis. Multiple linear regression analysis was used to identify predictors of coping strategies. RESULTS: Two factors for coping after TBI were extracted: Action/Distraction and Trivialisation/Resignation. The Trivialisation/Resignation strategy was negatively correlated with all aspects of HRQoL, while relationships with the Action/Distraction strategy were positive and significant for two domains. These two factors also showed significant associations with anxiety, depression, recovery, cognitive status, mood states and trauma severity. Multiple regression analysis identified recovery status as a predictor for the maladaptive Trivialisation/Resignation strategy. CONCLUSION: Two coping factors were identified, which were differentially associated with HRQoL. Maladaptive coping strategies play a particularly important role, and less reliance on such strategies is associated with better HRQoL; use of adaptive strategies should correspondingly be fostered. IMPLICATIONS FOR REHABILITATION: This study highlights the relationship of coping strategies and HRQoL after TBI. For the assessment of HRQoL a novel disease-specific instrument was applied, that provides in detail TBI-relevant aspects of well-being and HRQoL. Individuals after TBI use two main sets of coping strategies that are differentially associated with HRQoL (and clinical variables). One is adaptive and the other maladaptive for HRQoL after TBI. Maladaptive and adaptive coping strategies used by the individual should be identified and considered in rehabilitation efforts to improve HRQoL after TBI.

Self-awareness and health-related quality of life after traumatic brain injury.

OBJECTIVE: To investigate the relations among self-awareness (SA), impaired SA, and health-related quality of life (HRQOL) after traumatic brain injury (TBI). PARTICIPANTS: One hundred forty-one adults hospitalized with TBI and their significant others from a cross-sectional multicenter study. Using Glasgow Coma Scale classification, 32 participants had severe injuries, 29 moderate, 44 mild, and 25 complicated mild TBI. MEASURES: Patient Competency Rating Scale for Neurorehabilitation; Short Form-36 Health Survey; Cognitive Quality of Life; Quality Of Life after Brain Injury; Hospital Anxiety and Depression Scale; Profile of Mood States; Glasgow Outcome Scale Extended. METHOD: Patient Competency Rating Scale for Neurorehabilitation ratings made by participants and their significant others were used to assess SA and discrepancies between the 2 ratings were used to define impaired SA. RESULTS: Significant associations were identified between SA and HRQOL, anxiety, depression, and severity of injury. Participants with and without impaired SA differed in cognitive HRQOL and leisure activities. Using multiple regression, no direct predictors of SA were identified, although interaction effects were observed. CONCLUSION: After TBI, lower SA is associated with higher estimates of HRQOL, particularly in the cognitive domain. Although the associations are modest, the assessment of SA should play a role in the interpretation of reported HRQOL after TBI.

QOLIBRI overall scale: a brief index of health-related quality of life after traumatic brain injury.

BACKGROUND: The quality of life after brain injury (QOLIBRI) scale is a recently developed instrument that provides a profile of health-related quality of life (HRQoL) in domains typically affected by brain injury. However, for global assessment it is desirable to have a brief summary measure. This study examined a 6-item QOLIBRI overall scale (QOLIBRI-OS), and considered whether it could provide an index of HRQoL after traumatic brain injury (TBI). METHODS: The properties of the QOLIBRI-OS were studied in a sample of 792 participants with TBI recruited from centres in nine countries covering six languages. An examination of construct validity was undertaken on a subsample of 153 participants recruited in Germany who had been assessed on two relevant brief quality of life measures, the satisfaction with life scale and the quality of life visual analogue scale. RESULTS: The reliability of the QOLIBRI-OS was good (Cronbach's α=0.86, test-retest reliability =0.81) and similar in participants with higher and lower cognitive performance. Factor analysis indicated that the scale is unidimensional. Rasch analysis also showed a satisfactory fit with this model. The QOLIBRI-OS correlates highly with the total score from the full QOLIBRI scale (r=0.87). Moderate to strong relationships were found among the QOLIBRI-OS and the extended glasgow outcome scale, short-form-36, and hospital anxiety and depression scale (r=0.54 to -0.76). The QOLIBRI-OS showed good construct validity in the TBI group. CONCLUSIONS: The QOLIBRI-OS assesses a similar construct to the QOLIBRI total score and can be used as a brief index of HRQoL for TBI.

Unresponsive wakefulness syndrome: a new name for the vegetative state or apallic syndrome.

BACKGROUND: Some patients awaken from coma (that is, open the eyes) but remain unresponsive (that is, only showing reflex movements without response to command). This syndrome has been coined vegetative state. We here present a new name for this challenging neurological condition: unresponsive wakefulness syndrome (abbreviated UWS). DISCUSSION: Many clinicians feel uncomfortable when referring to patients as vegetative. Indeed, to most of the lay public and media vegetative state has a pejorative connotation and seems inappropriately to refer to these patients as being vegetable-like. Some political and religious groups have hence felt the need to emphasize these vulnerable patients' rights as human beings. Moreover, since its first description over 35 years ago, an increasing number of functional neuroimaging and cognitive evoked potential studies have shown that physicians should be cautious to make strong claims about awareness in some patients without behavioral responses to command. Given these concerns regarding the negative associations intrinsic to the term vegetative state as well as the diagnostic errors and their potential effect on the treatment and care for these patients (who sometimes never recover behavioral signs of consciousness but often recover to what was recently coined a minimally conscious state) we here propose to replace the name. CONCLUSION: Since after 35 years the medical community has been unsuccessful in changing the pejorative image associated with the words vegetative state, we think it would be better to change the term itself. We here offer physicians the possibility to refer to this condition as unresponsive wakefulness syndrome or UWS. As this neutral descriptive term indicates, it refers to patients showing a number of clinical signs (hence syndrome) of unresponsiveness (that is, without response to commands) in the presence of wakefulness (that is, eye opening).

Quality of life after traumatic brain injury: the clinical use of the QOLIBRI, a novel disease-specific instrument.

OBJECTIVE: To report the clinical use of the QOLIBRI, a disease-specific measure of health-related quality-of-life (HRQoL) after traumatic brain injury (TBI). METHODS: The QOLIBRI, with 37 items in six scales (cognition, self, daily life and autonomy, social relationships, emotions and physical problems) was completed by 795 patients in six languages (Finnish, German, Italian, French, English and Dutch). QOLIBRI scores were examined by variables likely to be influenced by rehabilitation interventions and included socio-demographic, functional outcome, health status and mental health variables. RESULTS: The QOLIBRI was self-completed by 73% of participants and 27% completed it in interview. It was sensitive to areas of life amenable to intervention, such as accommodation, work participation, health status (including mental health) and functional outcome. CONCLUSION: The QOLIBRI provides information about patient's subjective perception of his/her HRQoL which supplements clinical measures and measures of functional outcome. It can be applied across different populations and cultures. It allows the identification of personal needs, the prioritization of therapeutic goals and the evaluation of individual progress. It may also be useful in clinical trials and in longitudinal studies of TBI recovery.

Head injury in Germany: A population-based prospective study on epidemiology, causes, treatment and outcome of all degrees of head-injury severity in two distinct areas.

INTRODUCTION: Little is known about the ratio of mild traumatic brain injury (TBI) to moderate and severe TBI, about the time that elapses until primary care is given, about the number of patients requiring immediate surgery and about the early outcome and the costs. METHOD: In a prospective study two regions taken as model examples were investigated: the City of Hanover with its surrounding catchment area and Münster with its regions. RESULTS: From 1 March 2000 until 28 February 2001 all patients were recruited who were admitted to a hospital emergency department due to a TBI; 6783 patients (58.4% male, 41.6% female; 29.7% children < 16 years) were included; 5220 (73%) received in-hospital treatment; and 258 were given early rehabilitation. The incidence of TBI is 332 per 100 000 head of population. The GCS (Glasgow Coma Scale) or other forms of neurological examinations were performed in only 56% of all cases. According to the GCS status, 90.2% are classified as mild, 3.9% as moderate and 5.2% as severe. Intubation is given only to 76.1% of patients with severe TBI. Lethality was 1%. The predominant cause of TBI is falls, with 52.5% of all cases, while 26.3% were due to road accidents. The time elapsing between the accident event and initial examination at the hospital is less than 1 hour in 63% of all cases. X-rays were taken in 82% of all cases of TBI, with 19.3% of the patients receiving a CT scan; 58.7% of all TBI patients have additional injuries of the facial skull, 8.8% of the vertebral column, 7.2% of the thorax, 2.6% of the abdomen, 3.4% of the pelvis and 19.6% of one or more extremities. One year after the accident, 50% of all patients still required treatment even after mild TBI. CONCLUSION: It is necessary to follow the TBI guidelines, e.g. regarding intubation and neurological examination. The indication for cranial x-rays and CT should be reconsidered.

Quality of Life after Brain Injury (QOLIBRI): scale development and metric properties.

The consequences of traumatic brain injury (TBI) for health-related quality of life (HRQoL) are poorly investigated, and a TBI-specific instrument has not previously been available. The cross-cultural development of a new measure to assess HRQoL after TBI is described here. An international TBI Task Force derived a conceptual model from previous work, constructed an initial item bank of 148 items, and then reduced the item set through two successive multicenter validation studies. The first study, with eight language versions of the QOLIBRI, recruited 1528 participants with TBI, and the second with six language versions, recruited 921 participants. The data from 795 participants from the second study who had complete Glasgow Coma Scale (GCS) and Glasgow Outcome Scale (GOS) data were used to finalize the instrument. The final version of the QOLIBRI consists of 37 items in six scales (see Appendix ). Satisfaction is assessed in the areas of "Cognition," "Self," "Daily Life and Autonomy," and "Social Relationships," and feeling bothered by "Emotions," and "Physical Problems." The QOLIBRI scales meet standard psychometric criteria (internal consistency, alpha = 0.75-0.89, test-retest reliability, r(tt) = 0.78-0.85). Test-retest reliability (r(tt) = 0.68-0.87) as well as internal consistency (alpha = 0.81-0.91) were also good in a subgroup of participants with lower cognitive performance. Although there is one strong HRQoL factor, a six-scale structure explaining additional variance was validated by exploratory and confirmatory factor analyses, and with Rasch modeling. The QOLIBRI is a new cross-culturally developed instrument for assessing HRQoL after TBI that fulfills standard psychometric criteria. It is potentially useful for clinicians and researchers conducting clinical trials, for assessing the impact of rehabilitation or other interventions, and for carrying out epidemiological surveys.