Comparability of (post-concussion) symptoms across time in individuals after traumatic brain injury: results from the CENTER-TBI study

Post-concussion symptoms often occur after TBI, persist and cause disabilities. The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is widely used in this population, but little is known about the comparability of the symptoms over time, i.e., longitudinal measurement invariance (MI). The objectives of this study were to analyze the longitudinal MI of RPQ symptoms from three to twelve months after TBI and to find factors related to RPQ symptoms. The study involved 1023 individuals after TBI who took part in the Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI) study and completed the RPQ at three, six and twelve months postinjury. Longitudinal confirmatory factor analysis showed that the three-factor structure (somatic, emotional and cognitive) remains stable within one year after TBI. Linear mixed models revealed that sex, injury cause and prior psychiatric problems were related to the RPQ three-factor structure as well as to the RPQ total score. The study strengthens evidence for the RPQ’s factorial structure stability within one year after TBI and identifies sex, injury cause and prior psychiatric problems as important factors that may help clinicians to prevent future complications of symptomatology after TBI.CENTER-TBI was supported by the European Union 7th Framework program (EC grant 602150). Additional funding was obtained from the Hannelore Kohl Stiftung (Germany), from OneMind (USA) and from Integra LifeSciences Corporation (USA). The funders of the study had no role in study design, data collection, data analysis, data interpretation or writing of the report

Reference Values for the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) from General Population Samples in the United Kingdom, Italy, and The Netherlands

After traumatic brain injury (TBI), individuals may experience short- or long-term health burdens, often referred to as post-concussion symptoms (PCS). The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is one of the commonly used instruments to assess self-reported PCS. To date, no reference values for RPQ have been provided, although they are crucial for clinical practice when evaluating a patient’s health status relative to a comparable healthy population. Therefore, the aim of this study is to provide reference values for the United Kingdom, the Netherlands, and Italy. A total of 11,759 individuals (50.3% women) from representative general population samples participated in an online survey (4646 individuals from the UK, 3564 from the Netherlands, and 3549 from Italy). The factorial structure of the RPQ was examined using confirmatory factor analysis (CFA), and results from the general population samples were compared with those from respective TBI samples recruited within the international CENTER-TBI study using multigroup CFA. Reference values were stratified by sex, health status, age, and education using percentiles. The three-factorial model outperformed the one-factorial structure. The general population samples were largely comparable to the corresponding TBI samples, except for items such as dizziness, vision, and sensory sensitivity, which can be considered more TBI-specific. Because of the significant differences between the general population samples, we provided reference values for the total score and for the somatic, emotional, and cognitive scales for each country separately. The reference values provided can now be used in clinical practice and research. Future studies should obtain stratified reference values for other countries and languages to improve accuracy in the diagnosis and treatment of symptom burden after TBI

Pediatric Health-Related Quality of Life:A Structural Equation Modeling Approach

Objectives: One of the most referenced theoretical frameworks to measure Health Related Quality of Life (HRQoL) is the Wilson and Cleary framework. With some adaptions this framework has been validated in the adult population, but has not been tested in pediatric populations. Our goal was to empirically investigate it in children.Methods: The contributory factors to Health Related Quality of Life that we included were symptom status (presence of chronic disease or hospitalizations), functional status (developmental status), developmental aspects of the individual (social-emotional) behavior, and characteristics of the social environment (socioeconomic status and area of education). Structural equation modeling was used to assess the measurement structure of the model in 214 German children (3-5 years old) participating in a follow-up study that investigates pediatric health outcomes.Results: Model fit was chi(2) = 5.5; df = 6; p = 0.48; SRMR = 0.01. The variance explained of Health Related Quality of Life was 15%. Health Related Quality of Life was affected by the area education (i.e. where kindergartens were located) and development status. Developmental status was affected by the area of education, socioeconomic status and individual behavior. Symptoms did not affect the model.Conclusions: The goodness of fit and the overall variance explained were good. However, the results between children' and adults' tests differed and denote a conceptual gap between adult and children measures. Indeed, there is a lot of variety in pediatric Health Related Quality of Life measures, which represents a lack of a common definition of pediatric Health Related Quality of Life. We recommend that researchers invest time in the development of pediatric Health Related Quality of Life theory and theory based evaluations.</p

Frequency of fatigue and its changes in the first 6 months after traumatic brain injury : results from the CENTER-TBI study

Background Fatigue is one of the most commonly reported subjective symptoms following traumatic brain injury (TBI). The aims were to assess frequency of fatigue over the first 6 months after TBI, and examine whether fatigue changes could be predicted by demographic characteristics, injury severity and comorbidities. Methods Patients with acute TBI admitted to 65 trauma centers were enrolled in the study Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI). Subjective fatigue was measured by single item on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ), administered at baseline, three and 6 months postinjury. Patients were categorized by clinical care pathway: admitted to an emergency room (ER), a ward (ADM) or an intensive care unit (ICU). Injury severity, preinjury somatic- and psychiatric conditions, depressive and sleep problems were registered at baseline. For prediction of fatigue changes, descriptive statistics and mixed effect logistic regression analysis are reported. Results Fatigue was experienced by 47% of patients at baseline, 48% at 3 months and 46% at 6 months. Patients admitted to ICU had a higher probability of experiencing fatigue than those in ER and ADM strata. Females and individuals with lower age, higher education, more severe intracranial injury, preinjury somatic and psychiatric conditions, sleep disturbance and feeling depressed postinjury had a higher probability of fatigue. Conclusion A high and stable frequency of fatigue was found during the first 6 months after TBI. Specific socio-demographic factors, comorbidities and injury severity characteristics were predictors of fatigue in this study.Peer reviewe

Outcome assessment after traumatic brain injury - Authors' reply

First paragraph: We thank Thomas McMillan and colleagues for their thoughtful comments on assessment of outcomes, with many of which we fully agree. As with many outcome assessments in traumatic brain injury (TBI), the Glasgow Outcome Scale (GOS) is open to a wide variety of influences other than brain injury: factors related to acute TBI appear to explain at best 35% of the variance.1 The predictors, moderators, and mediators of outcome after TBI are incompletely understood. There is thus much progress to be made in identifying confounding covariates for the effects of interventions. The current approach has many strengths, as pointed out by McMillan and colleagues. However, the GOS as originally proposed was quickly recognised to have limitations, and consequently has been adapted and improved over the years. The Extended Glasgow Outcome Scale (GOSE) structured interview was originally intended to help standardise assessment of outcomes, but there is still work to be done

Sensitivity of outcome instruments in a priori selected patient groups after traumatic brain injury:Results from the CENTER-TBI study

Traumatic brain injury (TBI) can negatively impact patients' lives on many dimensions. Multiple instruments are available for evaluating TBI outcomes, but it is still unclear which instruments are the most sensitive for that purpose. This study examines the sensitivity of nine outcome instruments in terms of their ability to discriminate within and between specific patient groups, selected a priori as identified from the literature, at three different time points within a year after TBI (i.e., 3, 6, and 12 months post injury). The sensitivity of the instruments to sociodemographic (sex, age, education), premorbid (psychological health status), and injury-related (clinical care pathways, TBI and extracranial injury severity) factors was assessed by means of cross-sectional multivariate Wei-Lachin analyses. The Glasgow Outcome Scale Extended (GOSE)-the standard in the field of TBI for measuring functional recovery-demonstrated the highest sensitivity in most group comparisons. However, as single functional scale, it may not be able to reflect the multidimensional nature of the outcome. Therefore, the GOSE was used as a reference for further sensitivity analyses on more specific outcome scales, addressing further potential deficits following TBI. The physical component summary score (PCS) of the generic health-related quality of life (HRQOL) instruments (SF-36v2/-12v2) and the TBI-specific HRQOL instruments (QOLIBRI/-OS) were most sensitive in distinguishing recovery after TBI across all time points and patient groups, followed by the RPQ assessing post-concussion symptoms and the PHQ-9 measuring depression. The SF-36v2/-12v2 mental component summary score and the GAD-7 measuring anxiety were less sensitive in several group comparisons. The assessment of the functional recovery status combined with generic HRQOL (the PCS of the SF-12v2), disease-specific HRQOL (QOLIBRI-OS), and post-concussion symptoms (RPQ) can provide a sensitive, comprehensive, yet time-efficient evaluation of the health status of individuals after TBI in different patient groups.</p

Health-related quality of life after traumatic brain injury: deriving value sets for the QOLIBRI-OS for Italy, The Netherlands and The United Kingdom

PurposeThe Quality of Life after Brain Injury overall scale (QOLIBRI-OS) measures health-related quality of life (HRQoL) after traumatic brain injury (TBI). The aim of this study was to derive value sets for the QOLIBRI-OS in three European countries, which will allow calculation of utility scores for TBI health states. Methods A QOLIBRI-OS value set was derived by using discrete choice experiments (DCEs) and visual analogue scales (VAS) in general population samples from the Netherlands, United Kingdom and Italy. A three-stage procedure was used: (1) A selection of health states, covering the entire spectrum of severity, was defined; (2) General population samples performed the health state valuation task using a web-based survey with three VAS questions and an at random selection of sixteen DCEs; (3) DCEs were analysed using a conditional logistic regression and were then anchored on the VAS data. Utility scores for QOLIBRI-OS health states were generated resulting in estimates for all potential health states. Results The questionnaire was completed by 13,623 respondents. The biggest weight increase for all attributes is seen from "slightly" to "not at all satisfied", resulting in the largest impact on HRQoL. "Not at all satisfied with how brain is working" should receive the greatest weight in utility calculations in all three countries. Conclusion By transforming the QOLIBRI-OS into utility scores, we enabled the application in economic evaluations and in summary measures of population health, which may be used to inform decision-makers on the best interventions and strategies for TBI patients.</p

Reference Values of the QOLIBRI from General Population Samples in the United Kingdom and The Netherlands

The Quality of Life after Traumatic Brain Injury (QOLIBRI) instrument is an internationally validated patient-reported outcome measure for assessing disease-specific health-related quality of life (HRQoL) in individuals after traumatic brain injury (TBI). However, no reference values for general populations are available yet for use in clinical practice and research in the field of TBI. The aim of the present study was, therefore, to establish these reference values for the United Kingdom (UK) and the Netherlands (NL). For this purpose, an online survey with a reworded version of the QOLIBRI for general populations was used to collect data on 4403 individuals in the UK and 3399 in the NL. This QOLIBRI version was validated by inspecting descriptive statistics, psychometric criteria, and comparability of the translations to the original version. In particular, measurement invariance (MI) was tested to examine whether the items of the instrument were understood in the same way by different individuals in the general population samples and in the TBI sample across the two countries, which is necessary in order to establish reference values. In the general population samples, the reworded QOLIBRI displayed good psychometric properties, including MI across countries and in the non-TBI and TBI samples. Therefore, differences in the QOLIBRI scores can be attributed to real differences in HRQoL. Individuals with and without a chronic health condition did differ significantly, with the latter reporting lower HRQoL. In conclusion, we provided reference values for healthy individuals and individuals with at least one chronic condition from general population samples in the UK and the NL. These can be used in the interpretation of disease-specific HRQoL assessments after TBI applying the QOLIBRI on the individual level in clinical as well as research contexts

Frequency of fatigue and its changes in the first 6 months after traumatic brain injury: results from the CENTER-TBI study.

BACKGROUND: Fatigue is one of the most commonly reported subjective symptoms following traumatic brain injury (TBI). The aims were to assess frequency of fatigue over the first 6 months after TBI, and examine whether fatigue changes could be predicted by demographic characteristics, injury severity and comorbidities. METHODS: Patients with acute TBI admitted to 65 trauma centers were enrolled in the study Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI). Subjective fatigue was measured by single item on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ), administered at baseline, three and 6 months postinjury. Patients were categorized by clinical care pathway: admitted to an emergency room (ER), a ward (ADM) or an intensive care unit (ICU). Injury severity, preinjury somatic- and psychiatric conditions, depressive and sleep problems were registered at baseline. For prediction of fatigue changes, descriptive statistics and mixed effect logistic regression analysis are reported. RESULTS: Fatigue was experienced by 47% of patients at baseline, 48% at 3 months and 46% at 6 months. Patients admitted to ICU had a higher probability of experiencing fatigue than those in ER and ADM strata. Females and individuals with lower age, higher education, more severe intracranial injury, preinjury somatic and psychiatric conditions, sleep disturbance and feeling depressed postinjury had a higher probability of fatigue. CONCLUSION: A high and stable frequency of fatigue was found during the first 6 months after TBI. Specific socio-demographic factors, comorbidities and injury severity characteristics were predictors of fatigue in this study

Quality of life after brain injury in children and adolescents (QOLIBRI-KID/ADO)-The first disease-specific self-report questionnaire after traumatic brain injury

The subjective impact of the consequences of pediatric traumatic brain injury (pTBI) on different life dimensions should be assessed multidimensionally and as sensitively as possible using a disease-specific health-related quality of life (HRQoL) instrument. The development and psychometrics of the first such self-report questionnaire for children and adolescents after TBI are reported here. Focus group interviews with children, adolescents, and their parents, cognitive debriefing, item pool generation and reduction using Delphi expert panels were performed. The resulting version was psychometrically tested on 300 individuals aged 8–17 years. After item reduction based on factor analyses, differential item functioning, reliability, and validity were investigated. The final 35 items were associated with six scales (Cognition, Self, Daily Life and Autonomy, Social Relationships, Emotions, Physical Problems). Internal consistency and construct validity were satisfactory. Health-related Quality of life (HRQoL) was significantly lower in older and in female participants, as well as those with cognitive disabilities, anxiety, depression and post-concussion symptoms, than in comparative groups. The new QOLIBRI-KID/ADO is a comprehensive, multidimensional, reliable, and valid instrument, comparable in content and items to the QOLIBRI adult version. Therefore, disease-specific HRQoL can now be measured across the lifespan and may support the amelioration of treatment, care, rehabilitation, and daily life of children and adolescents after TBI.This research was funded by Dr. Senckenbergische Stiftung/Clementine Kinderhospital Dr. Christ‘sche Stiftungen (Germany), and Uniscientia Stiftung (Switzerland)