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In the field of pediatric traumatic brain injury (TBI), relationships between pre-injury and injury-related characteristics and post-TBI outcomes (functional recovery, post-concussion depression, anxiety) and their impact on disease-specific health-related quality of life (HRQoL) are under-investigated. Here, a multidimensional conceptual model was tested using a structural equation model (SEM). The final SEM evaluates the associations between these four latent variables. We retrospectively investigated 152 children (8–12 years) and 148 adolescents (13–17 years) after TBI at the recruiting clinics or online. The final SEM displayed a fair goodness-of-fit (SRMR = 0.09, RMSEA = 0.08 with 90% CI [0.068, 0.085], GFI = 0.87, CFI = 0.83), explaining 39% of the variance across the four latent variables and 45% of the variance in HRQoL in particular. The relationships between pre-injury and post-injury outcomes and between post-injury outcomes and TBI-specific HRQoL were moderately strong. Especially, pre-injury characteristics (children's age, sensory, cognitive, or physical impairments, neurological and chronic diseases, and parental education) may aggravate post-injury outcomes, which in turn may influence TBI-specific HRQoL negatively. Thus, the SEM comprises potential risk factors for developing negative post-injury outcomes, impacting TBI-specific HRQoL. Our findings may assist healthcare providers and parents in the management, therapy, rehabilitation, and care of pediatric individuals after TBI. [ABSTRACT FROM AUTHOR]

Traumatic brain injury (TBI) may affect the lives of the individuals concerned and their relatives negatively in many dimensions. Health-related quality of life (HRQoL) is a comprehensive and complex concept that can assess one's satisfaction with a broad range of areas of life and health. The Quality of Life after Traumatic Brain Injury (QOLIBRI) questionnaire is a TBI-specific measure for HRQoL which is used in research and health services worldwide. When evaluating self-reported HRQoL after TBI, reference values from a general population are helpful to perform clinically relevant evaluations and decisions about the condition of an affected person by comparing the patient scores with reference values. Despite the widespread use of the QOLIBRI, reference values have until now only been available for the Netherlands and the United Kingdom. The aim of this study was to validate the QOLIBRI for the general population in Italy and to provide reference values. An adapted form of the QOLIBRI was administered to 3298 Italians from a healthy general population using an online survey. Their scores were compared with those of 298 individuals post-TBI recruited within the international longitudinal observational cohort CENTER-TBI study in Italian hospitals, who completed the original questionnaire. The psychometric characteristics and the measurement invariance of the QOLIBRI were assessed. A regression analysis was performed to identify predictors relevant for HRQoL in the general population. Reference values were provided using percentiles. Measurement invariance analysis showed that the QOLIBRI captures the same HRQoL constructs in an Italian general population and Italian TBI sample from the observational Center-TBI study. Higher age, higher education and the absence of a chronic health condition were associated with higher QOLIBRI scores, suggesting better HRQoL. Reference values were provided for a general Italian population adjusted for age, sex, education and presence of chronic health conditions. We recommend using these for a better interpretation of the QOLIBRI score in clinical practice and research in Italy. [ABSTRACT FROM AUTHOR]

Background: The assessment of the impact of pediatric traumatic brain injury (TBI) on the health-related quality of life (HRQoL) of the children and adolescents affected can be ameliorated by a disease-specific instrument. Such an instrument does not yet exist. This qualitative study investigates how children and adolescents after TBI subjectively perceive their HRQoL and whether and how this differs from the perspective of individuals without a history of TBI. Methods: Eight problem-centered interviews were conducted with 11 children and adolescents around four years after mild TBI and with eight children and adolescents around three years after moderate to severe TBI. Nine problem-centered interviews were conducted with 25 participants without a history of TBI. The interviews were recorded and transcribed verbatim. The statements were assigned to inductively and deductively derived categories relevant to the HRQoL of children and adolescents after TBI and compared with those of individuals without a history of TBI. Results: The HRQoL of children and adolescents after TBI tended to display both structural and content-related differences, independently of TBI severity, on several HRQoL dimensions, in contrast to the comparison group. For example, participants after TBI reported a broader range of negative emotions (such as worry, sadness, shame, and guilt), permanent physical impairments, felt that they were treated differently from others, and perceived cognitive limitations. Conclusions: The results of this qualitative study identified HRQoL dimensions that are relevant to children and adolescents after TBI and underlined the need for the development of a disease-specific instrument. [ABSTRACT FROM AUTHOR]

Background: Pediatric traumatic brain injury (TBI) may cause a wide range of symptoms, which can negatively affect the quality of life of patients and their entire families. No internationally and simultaneously developed disease-specific instrument exists for assessing pediatric health-related quality of life (HRQoL) after TBI. The aim of the current project is to provide original material from small group interviews with individuals after TBI concerning what they state is relevant for their HRQoL. This material is required for a further study to generate items for age-adapted questionnaires assessing the TBI-specific HRQoL of children and adolescents (C&A): the QOLIBRI-Kiddy/Kid/Ado and proxy versions (Quality of Life after Brain Injury–Kiddy/Kids/Adolescents/Proxy) for individuals aged 6–17 and their parents. Methods: The semi-structured interviews were conducted with separate small groups of C&A (n = 19), divided into three age groups (5-7y, 8-12y, 13-17y), after mild, moderate, and severe TBI, and with groups of the corresponding parents (n = 26). All interviews lasted for about 60 minutes, were recorded and transcribed verbatim. The statements were investigated by qualitative analyses and sorted into categories relevant to the HRQoL of C&A after TBI. Only descriptive group comparisons but no pairwise comparisons between children and corresponding parents were performed. Results: The analyses led to 32 subcategories, which were assigned to six main theoretically based HRQoL categories. Many agreements exist between the C&A's and parents' perspectives within the main categories, however their focus on HRQoL differs, especially concerning age-related contents. Parents of the youngest participant group already focus on topics such as autonomy, whereas this only becomes relevant for C&A from the age of eight years on. Interestingly, even 5-year-old children were able to discuss their HRQoL, which indicates the importance of a self-report instrument. Conclusions: Results obtained from this qualitative study identify the content of the HRQoL dimensions important for C&A after TBI and their parents. Both, differences and similarities in the children's and the parents' views were investigated, to get a first insight in valid dimensions for the prospective questionnaires to be developed. In a future study, items for the questionnaires will be deducted from the small group interview material and psychometrically tested in C&A after TBI from Germany. This study will address whether all statements were assigned to the suitable dimensions and whether differences between C&A and parents persist. [ABSTRACT FROM AUTHOR]

Background: The German Rivermead Post-Concussion Symptoms Questionnaire (RPQ) can be used to assess post-concussion symptoms (PCS) after traumatic brain injury (TBI) in adults, adolescents, and children. Methods: In this study, we examined the psychometric properties of the German RPQ proxy version (N = 146) for children (8—12 years) after TBI at the item, total and scale score level. Construct validity was analyzed using rank correlations with the proxy-assessed Post-Concussion Symptoms Inventory (PCSI-P), the Patient Health Questionnaire 9 (PHQ-9), and the Generalized Anxiety Disorder Scale 7 (GAD-7). Furthermore, sensitivity testing was performed concerning subjects' sociodemographic and injury-related characteristics. Differential item functioning (DIF) was analyzed to assess the comparability of RPQ proxy ratings for children with those for adolescents. Results: Good internal consistency was demonstrated regarding Cronbach's α (0.81—0.90) and McDonald's ω (0.84—0.92). The factorial validity of a three-factor model was superior to the original one-factor model. Proxy ratings of the RPQ total and scale scores were strongly correlated with the PCSI-P (ϱ = 0.50—0.69), as well as moderately to strongly correlated with the PHQ-9 (ϱ = 0.49—0.65) and the GAD-7 (ϱ = 0.44—0.64). The DIF analysis revealed no relevant differences between the child and adolescent proxy versions. Conclusions: The German RPQ proxy is a psychometrically reliable and valid instrument for assessing PCS in children after TBI. Therefore, RPQ self- and proxy-ratings can be used to assess PCS in childhood as well as along the lifespan of an individual after TBI. [ABSTRACT FROM AUTHOR]

Pediatric health-related quality of life (HRQoL) as a measure of subjective wellbeing and functioning has received increasing attention over the past decade. HRQoL in children and adolescents following pediatric traumatic brain injury (pTBI) has been poorly studied, and performing adequate measurements in this population is challenging. This study compares child/adolescent and parent reports of HRQoL following pTBI using the newly developed Quality of Life after Brain Injury in Children and Adolescents (QOLIBRI-KID/ADO) questionnaire. Three hundred dyads of 8–17-year-old children/adolescents and their parents were included in the study. The parent–child agreement, estimated using intraclass correlation coefficients and Cohen's κ, displayed poor to moderate concordance. Approximately two-fifths of parents (39.3%) tended to report lower HRQoL for their children/adolescents on the total QOLIBRI-KID/ADO score. At the same time, about one-fifth (21.3%) reported higher HRQoL Total scores for their children/adolescents. The best agreement for parents rating adolescents (aged 13–17 years) was found in terms of the Total score and the Cognition and Self scale scores. To date, parent-reported HRQoL has been the preferred choice in pediatric research after TBI. However, with a parent–child disagreement of approximately 60%, our results highlight the importance of considering self-reports for children/adolescents capable of answering or completing the HRQoL measures. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Health-related quality of life (HRQOL) is an important indicator for recovery after pediatric TBI. To date, there are a few questionnaires available for assessing generic HRQOL in children and adolescents, but there are not yet any TBI-specific measures of HRQOL that are applicable to pediatric populations. The aim of the present study was to examine psychometric characteristics of the newly developed Quality of Life After Brain Injury Scale for Kids and Adolescents (QOLIBRI-KID/ADO) questionnaire capturing TBI-specific HRQOL in children and adolescents using an item response theory (IRT) framework. Children (8–12 years; n = 152) and adolescents (13–17 years; n = 148) participated in the study. The final version of the QOLIBRI-KID/ADO, comprising 35 items forming 6 scales, was investigated using the partial credit model (PCM). A scale-wise examination for unidimensionality, monotonicity, item infit and outfit, person homogeneity, and local independency was conducted. The questionnaire widely fulfilled the predefined assumptions, with a few restrictions. The newly developed QOLIBRI-KID/ADO instrument shows at least satisfactory psychometric properties according to the results of both classical test theoretical and IRT analyses. Further evidence of its applicability should be explored in the ongoing validation study by performing multidimensional IRT analyses. [ABSTRACT FROM AUTHOR]

The Quality of Life after Brain Injury (QoLIBRI) questionnaire was developed and validated to assess disease-specific health-related quality of life (HRQoL) in individuals after TBI. The present study aims to determine its longitudinal validity by assessing its responsiveness and response shift from 3 to 6 months post-injury. Analyses were based on data from the European longitudinal observational cohort Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury study. A total of 1659 individuals recovering from TBI were included in the analyses. Response shift was assessed using longitudinal measurement invariance testing within the confirmatory factor analyses framework. Responsiveness was analyzed using linear regression models that compared changes in functional recovery as measured by the Glasgow Outcome Scale–Extended (GOSE) with changes in the QoLIBRI scales from 3 to 6 months post-injury. Longitudinal tests of measurement invariance and analyses of discrepancies in practical significance indicated the absence of response shift. Changes in functional recovery status from three to six months were significantly associated with the responsiveness of the QoLIBRI scales over the same time period. The QoLIBRI can be used in longitudinal studies and is responsive to changes in an individual's functional recovery during the first 6 months after TBI. [ABSTRACT FROM AUTHOR]

Researchers have recently started evaluating whether stimulating the brain noninvasively with a weak and painless electrical current ( transcranial Electrical Stimulation , tES) enhances physiological and cognitive processes. Some studies found that tES has weak but positive effects on brain physiology, cognition, or assessment performance, which has attracted massive public interest. We present the first meta-analytic test of the hypothesis that tES in a learning phase is more effective than tES in an assessment phase. The meta-analysis included 246 effect sizes from studies on language or mathematical competence. The effect of tES was stronger when stimulation was administered during a learning phase ( d = 0.712) as compared to stimulation administered during test performance ( d = 0.207). The overall effect was stimulation-dosage specific and, as found in a previous meta-analysis, significant only for anodal stimulation and not for cathodal. The results provide evidence for the modulation of long-term synaptic plasticity by tES in the context of practically relevant learning tasks and highlight the need for more systematic evaluations of tES in educational settings. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) assesses post-concussion symptoms (PCS) after traumatic brain injury (TBI). The current study examines the applicability of self-report and proxy versions of the German RPQ in adolescents (13–17 years) after TBI. We investigated reliability and validity on the total and scale score level. Construct validity was investigated by correlations with the Post-Concussion Symptoms Inventory (PCSI-SR13), Generalized Anxiety Disorder Scale 7 (GAD-7), and Patient Health Questionnaire 9 (PHQ-9) and by hypothesis testing regarding individuals' characteristics. Intraclass correlation coefficients (ICC) assessed adolescent–proxy agreement. In total, 148 adolescents after TBI and 147 proxies completed the RPQ. Cronbach's α (0.81–0.91) and McDonald's ω (0.84–0.95) indicated good internal consistency. The three-factor structure outperformed the unidimensional model. The RPQ was strongly correlated with the PCSI-SR13 (self-report: r = 0.80; proxy: r = 0.75) and moderately–strongly with GAD-7 and PHQ-9 (self-report: r = 0.36, r = 0.35; proxy: r = 0.53, r = 0.62). Adolescent–proxy agreement was fair (ICC [2,1] = 0.44, CI95% [0.41, 0.47]). Overall, both self-report and proxy assessment forms of the German RPQ are suitable for application in adolescents after TBI. As proxy ratings tend to underestimate PCS, self-reports are preferable for evaluations. Only if a patient is unable to answer, a proxy should be used as a surrogate. [ABSTRACT FROM AUTHOR]

Assessing outcomes in multinational studies on traumatic brain injury (TBI) poses major challenges and requires relevant instruments in languages other than English. Of the 19 outcome instruments selected for use in the observational Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI) study, 17 measures lacked translations in at least one target language. To fill this gap, we aimed to develop well-translated linguistically and psychometrically validated instruments. We performed translations and linguistic validations of patient-reported measures (PROMs), clinician-reported (ClinRO), and performance-based (PerfO) outcome instruments, using forward and backward translations, reconciliations, cognitive debriefings with up to 10 participants, iterative revisions, and international harmonization with input from over 150 international collaborators. In total, 237 translations and 211 linguistic validations were carried out in up to 20 languages. Translations were evaluated at the linguistic and cultural level by coding changes when the original versions are compared with subsequent translation steps, using the output of cognitive debriefings, and using comprehension rates. The average comprehension rate per instrument varied from 88% to 98%, indicating a good quality of the translations. These outcome instruments provide a solid basis for future TBI research and clinical practice and allow the aggregation and analysis of data across different countries and languages. [ABSTRACT FROM AUTHOR]

Traumatic brain injury (TBI) may lead to impairments in various outcome domains. Since most instruments assessing these are only available in a limited number of languages, psychometrically validated translations are important for research and clinical practice. Thus, our aim was to investigate the psychometric properties of the patient-reported outcome measures (PROM) applied in the CENTER-TBI study. The study sample comprised individuals who filled in the six-months assessments (GAD-7, PHQ-9, PCL-5, RPQ, QOLIBRI/-OS, SF-36v2/-12v2). Classical psychometric characteristics were investigated and compared with those of the original English versions. The reliability was satisfactory to excellent; the instruments were comparable to each other and to the original versions. Validity analyses demonstrated medium to high correlations with well-established measures. The original factor structure was replicated by all the translations, except for the RPQ, SF-36v2/-12v2 and some language samples for the PCL-5, most probably due to the factor structure of the original instruments. The translation of one to two items of the PHQ-9, RPQ, PCL-5, and QOLIBRI in three languages could be improved in the future to enhance scoring and application at the individual level. Researchers and clinicians now have access to reliable and valid instruments to improve outcome assessment after TBI in national and international health care. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]