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Abstract Background Most of the previous studies on costs following trauma have focused solely on in-hospital costs and costs associated with the acute treatment and early rehabilitation. As a result, post-hospital costs are often neglected in the estimation of total costs. We aimed to describe service utilization and total costs for health care services, rehabilitation services, and social support in the periods 0–6 months and 7–12 months after moderate-to-severe traumatic injury. Further, we explored costs and their associations with sociodemographic, clinical and injury-related variables. Methods Data were obtained from a prospective, 12 months follow-up study of patients in all ages with moderate-to-severe traumatic injury determined by a New Injury Severity Score (NISS) > 9, admitted directly or within 72 h to the trauma referral centres in year 2020. Data on utilization of health care and rehabilitation services from the Norwegian Patient Register (NPR), the Municipal patient and user register (KPR), and the Norwegian Control and Payment of Health Reimbursements Database (KUHR) were used. Results A total of 601 patients were included, 24% with moderate and 76% with severe injuries. The overall mean total health care cost per patient in the first year after traumatic injury was 846,877 (SD 1,042,649) Norwegian Kroner (NOK). The mean total cost of rehabilitation per patient was 251,487 (SD 317,050) NOK. Most costs were attributable to secondary care in the first six months post-injury. Severely injured patients had a higher health care utilization and average cost compared to those with moderate injury. Injury severity factors were the most prominent cost drivers, and number of injuries, severe head, spine, and extremity injuries were significantly associated with higher costs during the first year following trauma. Conclusions The findings give a holistic insight into health care utilization and costs for patients across all ages with complex needs following trauma and can contribute to the planning and provision of services for this patient group.

Abstract Background Traumatic injuries, defined as physical injuries with sudden onset, are a major cause of distress and disability, with far-reaching societal consequences. A significant proportion of trauma survivors report persistent symptoms and difficulties after the injury, and studies show unmet health care needs. Self-management programs delivered in the sub-acute phase after traumatic injuries are scarcely evaluated. The aim of the present study is to evaluate the effectiveness of a self-management program (SEMPO), delivered 3–4 months after moderate-to-severe traumatic injury. Methods This study protocol describes a pragmatic randomized controlled trial (RCT) with two classical RCT arms (intervention and control) and an explorative self-selection arm. 220 patients will be recruited from Oslo University Hospital, the largest Trauma Referral Centre in Norway. Patients aged 18–72 years residing in the south-east region of Norway, admitted to the Trauma Centre directly or within 72 h after having sustained a moderate to severe traumatic injury, defined as a New Injury Severity Score > 9, having at least 2 days hospital stay, and reporting injury-related symptoms and impairment at discharge from the acute hospital will be included. Patients will be randomly assigned to either a classical RCT randomization arm (intervention or control arm) or to a self-selection arm. In the randomization arm, participants are further randomized into intervention or control group. Participants allocated to the self-selection arm will choose to partake either in the intervention or control arm. The primary outcome is the level of self-efficacy in trauma coping assessed 6 months after completion of the intervention, with a similar time point for the control group. Secondary outcomes include symptom burden, physical functioning and disability, return to work and health care utilization, health-related quality of life, and communication competency. In addition, patients will be asked to nominate one domain-related measurement as their preferred outcome measure. Discussion This RCT will determine the effect of a self-management program tailored to patients with moderate to severe physical trauma, and the self-selection arm incorporates the potential influence of patient treatment preferences on intervention results. If the intervention proves effective, cost-effectiveness and cost-utility analyses will be performed and thereby provide important information for clinicians and policy makers. Trial registration The study is registered in Clinical Trials with the identifier: NCT06305819. Registered on March 05, 2004.

Background Traumatic brain injury (TBI) is associated with an increased risk of major depressive disorder (MDD) and post-traumatic stress disorder (PTSD). We aimed to identify predictors and develop models for the prediction of depression and PTSD symptoms at 6 months post-TBI.Methods We analysed data from the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury study. We used linear regression to model the relationship between predictors and depression (Patient Health Questionnaire-9) and PTSD symptoms (PTSD Checklist for Diagnostic and Statistical Manual for Mental Health Disorders Fifth Edition). Predictors were selected based on Akaike’s Information Criterion. Additionally, we fitted logistic models for the endpoints ‘probable MDD’ and ‘probable PTSD’. We also examined the incremental prognostic value of 2–3 weeks of symptoms.Results We included 2163 adults (76% Glasgow Coma Scale=13–15). Depending on the scoring criteria, 7–18% screened positive for probable MDD and about 10% for probable PTSD. For both outcomes, the selected models included psychiatric history, employment status, sex, injury cause, alcohol intoxication and total injury severity; and for depression symptoms also preinjury health and education. The performance of the models was modest (proportion of explained variance=R2 8% and 7% for depression and PTSD, respectively). Symptoms assessed at 2–3 weeks had a large incremental prognostic value (delta R2=0.25, 95% CI 0.24 to 0.26 for depression symptoms; delta R2=0.30, 95% CI 0.29 to 0.31 for PTSD).Conclusion Preinjury characteristics, such as psychiatric history and unemployment, and injury characteristics, such as violent injury cause, can increase the risk of mental health problems after TBI. The identification of patients at risk should be guided by early screening of mental health.

ABSTRACT Background User organizations for people with disabilities in Norway work for social equality and participation, and quality of health services for people with disabilities, chronic illnesses and reduced functional capacity. Consideration of the experiences from user representatives is necessary when determining the quality and appropriateness of the rehabilitation services. Rehabilitation services constitute the provision and delivery of intangible products to maintain or improve functioning in individual patients or patient groups. Rehabilitation services can be characterized at the policy (macro), organizational (meso) and individual (micro) levels. Objectives To explore user representatives' perspectives on rehabilitation service provision and organization and how they experience the influence they exert. Methods Focus group interviews with 14 representatives nominated from 11 user organizations in Norway conducted in 2021. Two online focus groups using a semi‐structured interview guide were conducted. Data analysis was performed according to Braun and Clarke's thematic data analysis. Results Six core themes were developed when analyzing the participants' experiences and opinions regarding rehabilitation services. The themes were inter‐connected and addressed perspectives on Access to services, Integration of care, Rehabilitation team, Person centeredness, System and governance and Modes of user representation and contribution. Conclusion The user representatives revealed tension and complexity influencing the provision and organization of rehabilitation services from individual access to health policy and regulation. Empowering user representatives through training was important to fight tokenism. Filling the role of a user representative at the meso level requires the integration of personal and peer experiences at the micro level, and knowledge of health policy regulations at the macro level. Patient or Public Contribution The Norwegian Federation of Organisations of Persons with Disabilities recruited user representatives in this study. The user representatives participated in the assessment and discussion of the results of the study. The results were presented for discussion to the User panel at the Research Centre for Habilitation and Rehabilitation Models & Services (CHARM) at the University of Oslo.

Summary: Background: Post-traumatic stress disorder (PTSD) and depression are common after mild traumatic brain injury (mTBI), but their biological drivers are uncertain. We therefore explored whether polygenic risk scores (PRS) derived for PTSD and major depressive disorder (MDD) are associated with the development of cognate TBI-related phenotypes. Methods: Meta-analyses were conducted using data from two multicenter, prospective observational cohort studies of patients with mTBI: the CENTER-TBI study (ClinicalTrials.gov ID NCT02210221) in Europe (December 2014–December 2017) and the TRACK-TBI study in the US (March 2014–July 2018). In both cohorts, the most common causes of injury were road traffic accidents and falls. Primary outcomes, specifically probable PTSD and depression, were defined at 6 months post-injury using scores ≥33 on the PTSD Checklist-5 and ≥15 on the Patient Health Questionnaire-9, respectively. We calculated PTSD-PRS and MDD-PRS for patients aged ≥17 years who had a Glasgow Coma Scale score of 13–15 upon hospital arrival and assessed their association with PTSD and depression following TBI. We also evaluated the transferability of the findings in a cohort of African Americans. Findings: Overall, 11.8% (219/1869) and 6.7% (124/1869) patients were classified as having probable PTSD and depression, respectively. The PTSD-PRS was significantly associated with higher adjusted odds of PTSD in both cohorts, with a pooled odds ratio (OR) of 1.55 [95% confidence interval (CI) 1.30–1.84, p

Objective: To examine factors associated with patient satisfaction with rehabilitation services received after traumatic brain injury. Design: Cross-sectional study. Subjects/Patients: Persons with mild to severe traumatic brain injury (n = 1,375) registered in the “Oslo TBI Registry – Rehabilitation” quality register at Oslo University Hospital from 1 January 2018–31 July 2022. Methods: Sociodemographics, injury-related variables, patient-reported outcome measures, global functioning, and rehabilitation-related variables were recorded at hospital outpatient visits. The patients reported satisfaction with services received at the outpatient clinic and in primary healthcare at the final follow-up. Multivariable logistic regression models were applied to examine factors associated with patient satisfaction. Results: Of 316 patients, 83% reported satisfaction with services received at the hospital outpatient clinic. Belief in recovery (odds ratio [OR] = 2.73), shorter time to follow-up (OR = 0.39), and lower symptom burden (OR = 0.96) significantly increased satisfaction. Among 283 patients, 62% reported satisfaction with services in primary healthcare, where belief in recovery (OR = 2.90), shorter time to follow-up (OR = 0.50), higher age (OR = 1.04), and higher number of rehabilitation services received in primary healthcare (OR = 1.32) significantly increased satisfaction. Conclusion: Across service levels, the strongest associated factors for satisfaction were belief in recovery and shorter time to follow-up, suggesting that timely delivery of traumatic brain injury-related specialized services could increase overall satisfaction.

Summary: Background: The inflammatory response in patients with traumatic brain injury (TBI) offers opportunities for stratification and intervention. Previous unselected approaches to immunomodulation in patients with TBI have not improved patient outcomes. Methods: Serum and plasma samples from two prospective, multi-centre observational studies of patients with TBI were used to discover (Collaborative European NeuroTrauma Effectiveness Research [CENTER-TBI], Europe) and validate (Transforming Research and Clinical Knowledge in Traumatic Brain Injury [TRACK-TBI] Pilot, USA) individual variations in the immune response using a multiplex panel of 30 inflammatory mediators. Mediators that were associated with unfavourable outcomes (Glasgow outcome score-extended [GOS-E] ≤ 4) were used for hierarchical clustering to identify patients with similar signatures. Findings: Two clusters were identified in both the discovery and validation cohorts, termed early-inflammatory and pauci-inflammatory. The early-inflammatory phenotype had higher concentrations of interleukin-6 (IL-6), IL-15, and monocyte chemoattractant protein 1 (MCP1). Patients with the early-inflammatory phenotype were older and more likely to have an unfavourable GOS-E at 6 months. There were no differences in the baseline injury severity scores between patients in each phenotype. A combined IL-15 and MCP1 signature identified patients with the early-inflammatory phenotype in both cohorts. Inflammatory processes mediated outcomes in older patients with moderate-severe TBI. Interpretation: Our findings offer a precision medicine approach for future clinical trials of immunomodulation in patients with TBI, by using inflammatory signatures to stratify patients. Funding: CENTER-TBI study was supported by the European Union 7th Framework Programme. TRACK-TBI is supported by the National Institute of Neurological Disorders and Stroke.

Summary: Background: Traumatic brain injury is conventionally categorised as mild, moderate, or severe on the Glasgow Coma Scale (GCS). Recently developed biomarkers can provide more objective and nuanced measures of the extent of brain injury. Methods: Exposure–response relationships were investigated in 2479 patients aged ≥16 enrolled in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) prospective observational cohort study. Neurofilament protein-light (NFL), ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), and glial fibrillary acidic protein (GFAP) were assayed from serum sampled in the first 24 h; concentrations were divided into quintiles within GCS severity groups. Relationships with the Glasgow Outcome Scale-Extended were examined using modified Poisson regression including age, sex, major extracranial injury, time to sample, and log biomarker concentration as covariates. Findings: Within severity groups there were associations between biomarkers and outcomes after adjustment for covariates: GCS 13–15 and negative CT imaging (relative risks [RRs] from 1.28 to 3.72), GCS 13–15 and positive CT (1.21–2.81), GCS 9–12 (1.16–2.02), GCS 3–8 (1.09–1.94). RRs were associated with clinically important differences in expectations of prognosis. In patients with GCS 3 (RRs 1.51–1.80) percentages of unfavourable outcome were 37–51% in the lowest quintiles of biomarker levels and reached 90–94% in the highest quintiles. Similarly, for GCS 15 (RRs 1.83–3.79), the percentages were 2–4% and 19–28% in the lowest and highest biomarker quintiles, respectively. Interpretation: Conventional TBI severity classification is inadequate and underestimates heterogeneity of brain injury and associated outcomes. The adoption of circulating biomarkers can add to clinical assessment of injury severity. Funding: European Union 7th Framework program (EC grant 602150), Hannelore Kohl Stiftung, One Mind, Integra LifeSciences, Neuro-Trauma Sciences, NIHR Rosetrees Trust.

Abstract Background Huntington’s disease (HD) has substantial impact on patients and carers’ lives. Managing patients in the advanced phase of HD may be challenging to primary health care professionals. The aim of this study is to elicit health care professionals’ experiences of managing the challenges with patients with advanced HD in primary health care. Methods We did a qualitative study, collecting data from four focus group interviews with 22 primary health care professionals who had experience with caring for patients with HD in Norway. The data were analysed using a qualitative content analysis method, systematic text condensation. Results We found that health care professionals who care for patients with HD in primary health care experience challenges related to patients’ behaviour, family members and caregivers, professionals’ individual competency, and the organizational context. They conveyed that successful care and management of patients with advanced HD was dependent on individuals’ competency and “everyday tactics”, well-functioning teams, and leadership and organizational support. Conclusion In addition to individual competencies, including being personally suitable for the job, well-functioning primary care teams, and organization support and training is important for health care professionals’ ability to manage patients with advanced HD in primary health care.

Abstract 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 Background Headache is a prevalent and debilitating symptom following traumatic brain injury (TBI). Large-scale, prospective cohort studies are needed to establish long-term headache prevalence and associated factors after TBI. This study aimed to assess the frequency and severity of headache after TBI and determine whether sociodemographic factors, injury severity characteristics, and pre- and post-injury comorbidities predicted changes in headache frequency and severity during the first 12 months after injury. Methods A large patient sample from the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) prospective observational cohort study was used. Patients were stratified based on their clinical care pathway: admitted to an emergency room (ER), a ward (ADM) or an intensive care unit (ICU) in the acute phase. Headache was assessed using a single item from the Rivermead Post-Concussion Symptoms Questionnaire measured at baseline, 3, 6 and 12 months after injury. Mixed-effect logistic regression analyses were applied to investigate changes in headache frequency and associated predictors. Results A total of 2,291 patients responded to the headache item at baseline. At study enrolment, 59.3% of patients reported acute headache, with similar frequencies across all strata. Female patients and those aged up to 40 years reported a higher frequency of headache at baseline compared to males and older adults. The frequency of severe headache was highest in patients admitted to the ICU. The frequency of headache in the ER stratum decreased substantially from baseline to 3 months and remained from 3 to 6 months. Similar trajectory trends were observed in the ICU and ADM strata across 12 months. Younger age, more severe TBI, fatigue, neck pain and vision problems were among the predictors of more severe headache over time. More than 25% of patients experienced headache at 12 months after injury. Conclusions Headache is a common symptom after TBI, especially in female and younger patients. It typically decreases in the first 3 months before stabilising. However, more than a quarter of patients still experienced headache at 12 months after injury. Translational research is needed to advance the clinical decision-making process and improve targeted medical treatment for headache. Trial registration ClinicalTrials.gov NCT02210221.

Objective: To describe the needs for subacute inpatient rehabilitation and community-based healthcare services, rehabilitation, and social support in patients with moderate-to-severe traumatic injury in the first 6 months post-injury. Further, to explore associations between sociodemographic and clinical characteristics and unmet needs. Design: Multicentre prospective cohort study. Subjects: Of 601 persons (75% males), mean (standard deviation) age 47 (21) years, admitted to trauma centres in 2020 with moderate-to-severe injury, 501 patients responded at the 6-month follow-up and thus were included in the analyses. Methods: Sociodemographic and injury-related characteristics were recorded at inclusion. Estimation of needs was assessed with the Rehabilitation Complexity Scale Extended–Trauma and the Needs and Provision Complexity Scale on hospital discharge. Provision of services was recorded 6 months post-injury. Multivariable logistic regressions explored associations between baseline variables and unmet inpatient rehabilitation and community-based service needs. Results: In total, 20% exhibited unmet needs for subacute inpatient rehabilitation, compared with 60% for community-based services. Predictors for unmet community-based service needs included residing in less central areas, profound injury severity, severe head injury, and rehabilitation referral before returning home. Conclusion: Inadequate provision of healthcare and rehabilitation services, particularly in the municipalities, resulted in substantial unmet needs in the first 6 months following injury.

Abstract Background Persistent post-concussion symptoms (PPCS) affect between 34 and 46% after a mild traumatic brain injury (mTBI). Many also experience exercise intolerance. Sub-symptom threshold aerobic exercise, SSTAE (exercise at an intensity level that does not increase symptoms) is proposed as a treatment to both reduce the symptom burden and increase the exercise tolerance after the injury. It is unclear if this also applies in a more chronic phase after mTBI. Main purpose The main purpose of this study is to evaluate whether SSTAE in addition to ordinary rehabilitation will lead to clinically meaningful improvement of symptom burden, normalize exercise tolerance, increase physical activity, improve health-related quality of life, and reduce patient-specific activity limitations compared to a control group that only receives ordinary rehabilitation. Design Randomized, controlled, single-blind parallel-group study with three measurement times; T0 at baseline, T1 after the intervention and T2 six months after T1. Methods Patients between the ages of 18 and 60 with exercise intolerance and persistent PPCS (> 3 months) will be recruited to the study and randomized to two groups. All patients will receive follow-up at the outpatient TBI clinic. The intervention group will in addition receive SSTAE for 12 weeks with exercise diaries and a retest every 3 weeks for optimal dosage and progression. The Rivermead post-concussion symptoms questionnaire will be the main outcome measure. The secondary outcome measure will be a test of exercise tolerance—the Buffalo Concussion Treadmill Test. Other outcome measures include the patient-specific functional scale that measures patient-specific activity limitations, as well as outcome measures for diagnosis-specific health-related quality of life, anxiety and depression, specific symptoms such as dizziness, headache and fatigue, and physical activity. Discussion This study will add knowledge about the effect of SSTAE and whether it should be implemented in rehabilitation for the adult population with persistent PPCS after mTBI. The nested feasibility trial showed that the SSTAE intervention was safe and that the study procedures and delivery of the intervention overall were feasible. However, minor amendments to the study protocol were made prior to the commencement of the RCT. Trial registration Clinical Trials.gov, NCT05086419. Registered on September 5th, 2021.

Abstract Background Previous studies have demonstrated that the trauma population has needs for rehabilitation services that are best provided in a continuous and coordinated way. The discharge destination after acute care is the second step to ensuring quality of care. There is a lack of knowledge regarding the factors associated with the discharge destination for the overall trauma population. This paper aims to identify sociodemographic, geographical, and injury-related factors associated with discharge destination following acute care at trauma centers for patients with moderate-to-severe traumatic injuries. Methods A multicenter, population-based, prospective study was conducted with patients of all ages with traumatic injury [New Injury Severity Score (NISS) > 9] admitted within 72 h after the injury to regional trauma centers in southeastern and northern Norway over a 1-year period (2020). Results In total, 601 patients were included; a majority (76%) sustained severe injuries, and 22% were discharged directly to specialized rehabilitation. Children were primarily discharged home, and most of the patients ≥ 65 years to their local hospital. Depending on the centrality of their residence [Norwegian Centrality Index (NCI) 1–6, where 1 is most central], we found that patients residing in NCI 3–4 and 5–6 areas sustained more severe injuries than patients residing in NCI 1–2 areas. An increase in the NISS, number of injuries, or a spinal injury with an Abbreviated Injury Scale (AIS) ≥ 3 was associated with discharge to local hospitals and specialized rehabilitation than to home. Patients with an AIS ≥ 3 head injury (RRR 6.1, 95% Confidence interval 2.80–13.38) were significantly more likely to be discharged to specialized rehabilitation than patients with a less severe head injury. Age

Objective Fatigue is a common symptom in somatic and mental illness. Musculoskeletal pain and psychological distress have in turn frequently been shown to be associated with fatigue across clinical conditions and in the general population. The study aims to disentangle direct effects from those due to mere confounding from shared etiologies. Design The study used genetically informative longitudinal twin data, through a co-twin control design with an additional within-person dimension. Methods Data on fatigue, pain and distress from 2196 mono – and dizygotic twins from the Norwegian Twin Registry examined at two time points five years apart was analyzed using multilevel generalized linear regression modeling. Fatigue was regressed on pain and distress, with further controls added for confounding from genetic and stable non-shared environmental sources. Results Pain and distress had a significant impact on fatigue at genetic, stable non-shared environmental and time-varying levels, even when controlling for somatic comorbidity. Conclusion The findings indicate that a significant proportion of the association between fatigue, pain and distress is due to genetic and environmental confounding. Pain and distress exert significant, albeit smaller effects on fatigue even when controlling for genetic and stable environmental contributions, indicating direct effects. Potential etiological pathways and underlying mechanisms are discussed.

Abstract Background Despite existing guidelines for managing mild traumatic brain injury (mTBI), evidence-based treatments are still scarce and large-scale studies on the provision and impact of specific rehabilitation services are needed. This study aimed to describe the provision of rehabilitation to patients after complicated and uncomplicated mTBI and investigate factors associated with functional outcome, symptom burden, and TBI-specific health-related quality of life (HRQOL) up to six months after injury. Methods Patients (n = 1379) with mTBI from the Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI) study who reported whether they received rehabilitation services during the first six months post-injury and who participated in outcome assessments were included. Functional outcome was measured with the Glasgow Outcome Scale – Extended (GOSE), symptom burden with the Rivermead Post Concussion Symptoms Questionnaire (RPQ), and HRQOL with the Quality of Life after Brain Injury – Overall Scale (QOLIBRI-OS). We examined whether transition of care (TOC) pathways, receiving rehabilitation services, sociodemographic (incl. geographic), premorbid, and injury-related factors were associated with outcomes using regression models. For easy comparison, we estimated ordinal regression models for all outcomes where the scores were classified based on quantiles. Results Overall, 43% of patients with complicated and 20% with uncomplicated mTBI reported receiving rehabilitation services, primarily in physical and cognitive domains. Patients with complicated mTBI had lower functional level, higher symptom burden, and lower HRQOL compared to uncomplicated mTBI. Rehabilitation services at three or six months and a higher number of TOC were associated with unfavorable outcomes in all models, in addition to pre-morbid psychiatric problems. Being male and having more than 13 years of education was associated with more favorable outcomes. Sustaining major trauma was associated with unfavorable GOSE outcome, whereas living in Southern and Eastern European regions was associated with lower HRQOL. Conclusions Patients with complicated mTBI reported more unfavorable outcomes and received rehabilitation services more frequently. Receiving rehabilitation services and higher number of care transitions were indicators of injury severity and associated with unfavorable outcomes. The findings should be interpreted carefully and validated in future studies as we applied a novel analytic approach. Trial registration ClinicalTrials.gov NCT02210221.

Abstract Background Huntington’s disease (HD) is a progressive genetic neurodegenerative disease accompanied by mental and neurocognitive disabilities, which requires long-term and comprehensive treatment and care. Information on the health and economic burden of HD is scarce, but essential for conducting health economic analyses, in light of the prospect of new therapies for HD. In this study, we aim to identify values for Health-Related Quality of Life (HRQoL), describe service utilization and costs, and their associations with clinical and socio-demographic variables across all phases of HD. Methods A cross-sectional study including 86 patients across all phases of HD. Values of HRQoL were calculated based on EQ-5D-3L index scores. Additionally, health care and societal costs were estimated based on service utilization collected using the Client Service Receipt Inventory (CSRI) and data from the patients’ interviews. Total societal costs included costs of primary and secondary health care services, informal care and productivity loss of the patients. Multiple regression analyses were used to investigate associations between socio-demographic and clinical variables on HRQoL and costs. Results HRQoL values declined, while total costs increased across disease severity. Total six-month healthcare costs and total societal costs were € 18,538 and € 66,789 respectively. Healthcare and societal costs doubled from early to middle phase, and tripled from middle to advanced disease phase. Main six-month cost components for the three disease phases were informal care costs (€ 30,605) accounting for approximately half the total societal costs, and costs due to production loss (€ 18,907) being slightly higher than the total healthcare costs. Disease severity and gender were found to have the strongest effect on both values of HRQoL and costs. Conclusions Reported values of HRQoL and costs including costs for production loss may be used in modelling the cost-effectiveness of treatment for HD. Our results highlight the crucial role the informal caregivers play in the care provided to HD patients in all disease phases. Future research should focus on the estimation of productivity loss among informal caregivers.

Summary: Background: Limited evidence existed on the comparative effectiveness of decompressive craniectomy (DC) versus craniotomy for evacuation of traumatic acute subdural hematoma (ASDH) until the recently published randomised clinical trial RESCUE-ASDH. In this study, that ran concurrently, we aimed to determine current practice patterns and compare outcomes of primary DC versus craniotomy. Methods: We conducted an analysis of centre treatment preference within the prospective, multicentre, observational Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (known as CENTER-TBI) and NeuroTraumatology Quality Registry (known as Net-QuRe) studies, which enrolled patients throughout Europe and Israel (2014–2020). We included patients with an ASDH who underwent acute neurosurgical evacuation. Patients with severe pre-existing neurological disorders were excluded. In an instrumental variable analysis, we compared outcomes between centres according to treatment preference, measured by the case-mix adjusted proportion DC per centre. The primary outcome was functional outcome rated by the 6-months Glasgow Outcome Scale Extended, estimated with ordinal regression as a common odds ratio (OR), adjusted for prespecified confounders. Variation in centre preference was quantified with the median odds ratio (MOR). CENTER-TBI is registered with ClinicalTrials.gov, number NCT02210221, and the Resource Identification Portal (Research Resource Identifier SCR_015582). Findings: Between December 19, 2014 and December 17, 2017, 4559 patients with traumatic brain injury were enrolled in CENTER-TBI of whom 336 (7%) underwent acute surgery for ASDH evacuation; 91 (27%) underwent DC and 245 (63%) craniotomy. The proportion primary DC within total acute surgery cases ranged from 6 to 67% with an interquartile range (IQR) of 12–26% among 46 centres; the odds of receiving a DC for prognostically similar patients in one centre versus another randomly selected centre were trebled (adjusted median odds ratio 2.7, p

Objective: To evaluate adherence to 3 central operational recommendations for acute rehabilitation in the Norwegian trauma plan. Methods: A prospective multi-centre study of 538 adults with moderate and severe trauma with New Injury Severity Score > 9. Results: Adherence to the first recommendation, assessment by a physical medicine and rehabilitation physician within 72 h following admission to the intensive care unit (ICU) at the trauma centre, was documented for 18% of patients. Adherence to the second recommendation, early rehabilitation in the intensive care unit, was documented for 72% of those with severe trauma and ≥ 2 days ICU stay. Predictors for early rehabilitation were ICU length of stay and spinal cord injury. Adherence to the third recommendation, direct transfer of patients from acute ward to a specialized rehabilitation unit, was documented in 22% of patients, and occurred more often in those with severe trauma (26%), spinal cord injury (54%) and traumatic brain injury (39%). Being employed, having head or spinal chord injury and longer ICU stay were predictors for direct transfer to a specialized rehabilitation unit. Conclusion: Adherence to acute rehabilitation guidelines after trauma is poor. This applies to documented early assessment by a physical medicine and rehabilitation physician, and direct transfer from acute care to rehabilitation after head and extremity injuries. These findings indicate a need for more systematic integration of rehabilitation in the acute treatment phase after trauma. LAY ABSTRACT Three recommendations for acute rehabilitation in the Norwegian trauma plan were evaluated in 538 adults with moderate to severe injuries. Recommendation one: Examination by a rehabilitation physician within 72 h after hospital admission. This was documented in 18% of the patients. Recommendation two: Start of early rehabilitation in the intensive care unit. This was given to 72% of those with severe trauma. Early rehabilitation was more frequent in patients with spinal cord injury, and with long intensive care stays. Recommendation three: Patients are directly transferred from acute care in the trauma centre to specialized rehabilitation. This was followed for 22% of the patients. This happened more often in patients with severe injuries, spinal cord injury and brain injury. Being in work and longer intensive care stays increased the probability for direct transfer. Conclusion: Overall compliance with the guidelines is poor, except for early therapist rehabilitation in the intensive care unit.

Abstract Background Traumatic brain injury (TBI) represents a financial burden to the healthcare system, patients, their families and society. Rehabilitation interventions with the potential for reducing costs associated with TBI are demanded. This study evaluated the cost-effectiveness of a randomized, controlled, parallel group trial that compared the effectiveness of a combined cognitive and vocational intervention to treatment as usual (TAU) on vocational outcomes. Methods One-hundred sixteen participants with mild-to-moderate TBI were recruited from an outpatient clinic at Oslo University Hospital, Norway. They were randomized to a cognitive rehabilitation intervention (Compensatory Cognitive Training, CCT) and Supported Employment (SE) or TAU in a 1:1 ratio. Costs of CCT-SE and TAU, healthcare services, informal care and productivity loss were assessed 3, 6 and 12 months after study inclusion. Cost-effectiveness was evaluated from the difference in number of days until return to pre-injury work levels between CCT-SE and TAU and quality-adjusted life years (QALYs) derived from the EQ-5D-5L across 12 months follow-up. Cost-utility was expressed in incremental cost-effectiveness ratio (ICER). Results The mean total costs of healthcare services was € 3,281 in the CCT-SE group and € 2,300 in TAU, informal care was € 2,761 in CCT-SE and € 3,591 in TAU, and productivity loss was € 30,738 in CCT-SE and € 33,401 in TAU. Costs related to productivity loss accounted for 84% of the total costs. From a healthcare perspective, the ICER was € 56 per day earlier back to work in the CCT-SE group. Given a threshold of € 27,500 per QALY gained, adjusting for baseline difference in EQ-5D-5L index values revealed a net monetary benefit (NMB) of € -561 (0.009*27,500–979) from the healthcare perspective, indicating higher incremental costs for the CCT-SE group. From the societal perspective, the NMB was € 1,566 (0.009*27,500-(-1,319)), indicating that the CCT-SE intervention was a cost-effective alternative to TAU. Conclusions Costs associated with productivity loss accounted for the majority of costs in both groups and were lower in the CCT-SE group. The CCT-SE intervention was a cost-effective alternative to TAU when considering the societal perspective, but not from a healthcare perspective. Trial registration ClinicalTrails.gov NCT03092713 .

Abstract Background The rates of emergency neurosurgery in traumatic brain injury (TBI) patients vary between populations and trauma centers. In planning acute TBI treatment, knowledge about rates and incidence of emergency neurosurgery at the population level is of importance for organization and planning of specialized health care services. This study aimed to present incidence rates and patient characteristics for the most common TBI-related emergency neurosurgical procedures. Methods Oslo University Hospital is the only trauma center with neurosurgical services in Southeast Norway, which has a population of 3 million. We extracted prospectively collected registry data from the Oslo TBI Registry – Neurosurgery over a five-year period (2015–2019). Incidence was calculated in person-pears (crude) and age-adjusted for standard population. We conducted multivariate multivariable logistic regression models to assess variables associated with emergency neurosurgical procedures. Results A total of 2151 patients with pathological head CT scans were included. One or more emergency neurosurgical procedure was performed in 27% of patients. The crude incidence was 3.9/100,000 person-years. The age-adjusted incidences in the standard population for Europe and the world were 4.0/100,000 and 3.3/100,000, respectively. The most frequent emergency neurosurgical procedure was the insertion of an intracranial pressure monitor, followed by evacuation of the mass lesion. Male sex, road traffic accidents, severe injury (low Glasgow coma score) and CT characteristics such as midline shift and compressed/absent basal cisterns were significantly associated with an increased probability of emergency neurosurgery, while older age was associated with a decreased probability. Conclusions The incidence of emergency neurosurgery in the general population is low and reflects neurosurgery procedures performed in patients with severe injuries. Hence, emergency neurosurgery for TBIs should be centralized to major trauma centers.

This study identified workplace barriers to return-to-work (RTW) processes through a multiple case study consisting of 38 cases. Sixty-four interviews with employees with mild traumatic brain injury (TBI) and 45 interviews with their managers were conducted in 2017–2020 at T1 (1–3 months after the employees returned to work) and T2 (12–16 months after T1). Workplace barriers were associated with the organizational and psychosocial work environments, TBI knowledge, and char- acteristics of the employee. The role of management was a key aspect across all barriers. Workplace barriers often co-occurred and became increasingly important at T2. At T2, most employees increased their workload, but some still experienced unsupportive management, workplace conflicts, and a low degree of job control. The psychosocial work environment is a main area for workplace barriers. The managers’ knowledge of RTW processes and TBI-related challenges potentially reduce barriers and thereby contribute to balance the needs of the organization and the individual.

Objective: To quantify potential changes in direct referral to early specialized rehabilitation during the COVID-19 pandemic and the injury pattern of patients hospitalized with traumatic brain injury (TBI) at a level 1 trauma centre. Methods: In this registry-based study, data were retrieved from the Oslo TBI Registry-Neurosurgery and included adult patients with injury-related intracranial findings admitted to Oslo University Hospital (OUH). The study focused on a period of time when OUH was in any level of preparedness because of the COVID-19 pandemic; March 2020 to August 2021. For comparison, the study used patients hospitalized for TBI in 2018 and 2019. Results: A total of 1,310 hospitalized patients with TBI were divided into 2 groups; pre-pandemic and pandemic. Direct referral to early rehabilitation was maintained. Patient volume remained stable, and there were no differences between the groups regarding patient characteristics and acute management, although there was a significantly higher proportion of TBIs secondary to electric scooter accidents in the pandemic group. Results from univariable and multivariable logistic regression showed a multifaceted reality, but younger age, none or mild preinjury comorbidity and severe disability due to TBI at discharge from acute care remained stable strong predictors of direct referral to rehabilitation. Conclusion: For patients with moderate-severe TBI, the direct pathway to early specialized rehabilitation was maintained during 2020–21. However, the pandemic continued and the long-term impact for rehabilitation services is not yet known. LAY ABSTRACT After traumatic brain injury, early rehabilitation is important in order to achieve optimal functional outcome. The COVID-19 pandemic has put the health services under pressure, and hospitals in Norway were reorganized to be able to treat a large number of patients with COVID-19. Therefore, this study investigated to what extent the transfer to early rehabilitation has been affected and whether there have been changes in volume and characteristics of patients admitted to hospital with traumatic brain injury. In conclusion, the direct pathway to early rehabilitation was maintained during the pandemic years 2020 and 2021. Moreover, there was no change in the number of hospital admissions or patient characteristics, and acute management was maintained. However, the true long-term consequences for rehabilitation are not yet known.

ObjectiveSpine injury is highly prevalent in patients with poly-trauma, but data on the co-occurrence of spine trauma in patients with traumatic brain injury (TBI) are scarce. In this study, we used the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) database to assess the prevalence, characteristics, and outcomes of patients with TBI and a concurrent traumatic spinal injury (TSI).MethodsData from the European multi-center CENTER-TBI study were analyzed. Adult patients with TBI (≥18 years) presenting with a concomitant, isolated TSI of at least serious severity (Abbreviated Injury Scale; AIS ≥3) were included. For outcome analysis, comparison groups of TBI patients with TSI and systemic injuries (non-isolated TSI) and without TSI were created using propensity score matching. Rates of mortality, unfavorable outcomes (Glasgow Outcome Scale Extended; GOSe < 5), and full recovery (GOSe 7–8) of all patients and separately for patients with only mild TBI (mTBI) were compared between groups at 6-month follow-up.ResultsA total of 164 (4%) of the 4,254 CENTER-TBI core study patients suffered from a concomitant isolated TSI. The median age was 53 [interquartile range (IQR): 37–66] years and 71% of patients were men. mTBI was documented in 62% of cases, followed by severe TBI (26%), and spine injuries were mostly cervical (63%) or thoracic (31%). Surgical spine stabilization was performed in 19% of cases and 57% of patients were admitted to the ICU. Mortality at 6 months was 11% and only 36% of patients regained full recovery. There were no significant differences in the 6-month rates of mortality, unfavorable outcomes, or full recovery between TBI patients with and without concomitant isolated TSI. However, concomitant non-isolated TSI was associated with an unfavorable outcome and a higher mortality. In patients with mTBI, a negative association with full recovery could be observed for both concomitant isolated and non-isolated TSI.ConclusionRates of mortality, unfavorable outcomes, and full recovery in TBI patients with and without concomitant, isolated TSIs were comparable after 6 months. However, in patients with mTBI, concomitant TSI was a negative predictor for a full recovery. These findings might indicate that patients with moderate to severe TBI do not necessarily exhibit worse outcomes when having a concomitant TSI, whereas patients with mTBI might be more affected.

Objective: To identify factors related to the organization of rehabilitation services that may influence patients’ functional outcome and make recommendations for categories to be used in the reporting of rehabilitation interventions. Data Sources: A systematic review based on a search in MEDLINE indexed journals (MEDLINE [OVID], Cumulative Index of Nursing and Allied Health Literature, PsycINFO, Cochrane Central Register of Controlled Trials) until June 2019. Study Selection: In total 8587 candidate randomized controlled trials reporting on organizational factors of multidisciplinary rehabilitation interventions and their associations with functional outcome. An additional 1534 trials were identified from June 2019 to March 2021. Data Extraction: Quality evaluation was conducted by 2 independent researchers. The organizational factors were classified according to the International Classification for Service Organization in Health-related Rehabilitation 2.0. Data Synthesis: In total 80 articles fulfilled the inclusion criteria. There was a great heterogeneity in the terminology and reporting of service organization across all studies. Aspects of Settings including the Mode of Service Delivery was the most explicitly analyzed organizational category (44 studies). The importance of the integration of rehabilitation in the inpatient services was supported. Furthermore, several studies documented a lack of difference in outcome between outpatient vs inpatient service delivery. Patient Centeredness, Integration of Care, and Time and Intensity factors were also analyzed, but heterogeneity of interventions in these studies prohibited aggregation of results. Conclusions: Settings and in particular the way the services were delivered to the users influenced functional outcome. Hence, it should be compulsory to include a standardized reporting of aspects of service delivery in clinical trials. We would also advise further standardization in the description of organizational factors in rehabilitation interventions to build knowledge of effective service organization.

Abstract Background Ageing is associated with worse treatment outcome after traumatic brain injury (TBI). This association may lead to a self-fulfilling prophecy that affects treatment efficacy. The aim of the current study was to evaluate the role of treatment bias in patient outcomes by studying the intensity of diagnostic procedures, treatment, and overall 30-day mortality in different age groups of patients with TBI. Methods Included in this study was consecutively admitted patients with TBI, aged ≥ 15 years, with a cerebral CT showing intracranial signs of trauma, during the time-period between 2015–2018. Data were extracted from our prospective quality control registry for admitted TBI patients. As a measure of management intensity in different age groups, we made a composite score, where placement of intracranial pressure monitor, ventilator treatment, and evacuation of intracranial mass lesion each gave one point. Uni- and multivariate survival analyses were performed using logistic multinomial regression. Results A total of 1,571 patients with TBI fulfilled the inclusion criteria. The median age was 58 years (range 15–98), 70% were men, and 39% were ≥ 65 years. Head injury severity was mild in 706 patients (45%), moderate in 437 (28%), and severe in 428 (27%). Increasing age was associated with less management intensity, as measured using the composite score, irrespective of head injury severity. Multivariate analyses showed that the following parameters had a significant association with an increased risk of death within 30 days of trauma: increasing age, severe comorbidities, severe TBI, Rotterdam CT-score ≥ 3, and low management intensity. Conclusion The present study indicates that the management intensity of hospitalised patients with TBI decreased with advanced age and that low management intensity was associated with an increased risk of 30-day mortality. This suggests that the high mortality among elderly TBI patients may have an element of treatment bias and could in the future be limited with a more aggressive management regime.

Abstract Background The vast majority of hospital admitted patients with traumatic brain injury (TBI) will have intracranial injury identified by neuroimaging, requiring qualified staff and hospital beds. Moreover, increased pressure in health care services is expected because of an aging population. Thus, a regular evaluation of characteristics of hospital admitted patients with TBI is needed. Oslo TBI Registry – Neurosurgery prospectively register all patients with TBI identified by neuroimaging admitted to a trauma center for southeast part of Norway. The purpose of this study is to describe this patient population with respect to case load, time of admission, age, comorbidity, injury mechanism, injury characteristics, length of stay, and 30-days survival. Methods Data for 5 years was extracted from Oslo TBI Registry – Neurosurgery. Case load, time of admission, age, sex, comorbidity, injury mechanism, injury characteristics, length of stay, and 30-days survival was compiled and compared. Results From January 1st, 2015 to December 31st, 2019, 2153 consecutive patients with TBI identified by neuroimaging were registered. The admission rate of TBI of all severities has been stable year-round since 2015. Mean age was 52 years (standard deviation 25, range 0–99), and 68% were males. Comorbidities were common; 28% with pre-injury ASA score of ≥3 and 25% used antithrombotic medication. The dominating cause of injury in all ages was falls (55%) but increased with age. Upon admission, the head injury was classified as mild TBI in 46%, moderate in 28%, and severe (Glasgow coma score ≤ 8) in 26%. Case load was stable without seasonal variation. Majority of patients (68%) were admitted during evening, night or weekend. 68% was admitted to intensive care unit. Length of hospital stay was 4 days (median, interquartile range 3–9). 30-day survival for mild, moderate and severe TBI was 98, 94 and 69%, respectively. Conclusions The typical TBI patients admitted to hospital with abnormal neuroimaging were aged 50–79 years, often with significant comorbidity, and admitted outside ordinary working hours. This suggests the necessity for all-hour presence of competent health care professionals.

Abstract Background Traumatic brain injury (TBI) is often associated with life-long medical, cognitive, emotional, and behavioral changes. Although long-lasting disabilities are expected, research on effective treatment options in the chronic phase of TBI is scarce. Methods/design This study protocol describes a randomized controlled trial (RCT) aimed at evaluating the effectiveness of a goal-oriented and community-based intervention for increasing community integration, quality of life, and functional independence in the chronic phase of complicated mild to severe TBI. Participants will be recruited from Oslo University Hospital, Norway. Patients aged 18–72 years living at home with MRI/CT-verified intracranial abnormalities, a TBI diagnosis, a time since injury of ≥ 2 years, and who experience either current TBI-related problems or restrictions in community integration will be included. The 120 participants will be randomized 1:1 to either (a) an intervention group, which will receive an in-home intervention program over 4 months, or (b) a control group receiving standard care in the municipalities. The intervention will consist of six home visits and two telephone contacts with a rehabilitation professional. A SMART-goal approach will be adopted to target the individual’s self-reported TBI difficulties in everyday life. Primary outcomes will be self-reported quality of life and participation. Secondary outcomes include symptom burden, emotional functioning, and clinician-assessed global outcome and need for rehabilitation services. Outcomes will be evaluated at baseline and 4–5 and 12 months after baseline. Caregiver burden and general health will be assessed in participating family members. Goal attainment and acceptability will be evaluated in the intervention group. A process evaluation will be carried out to evaluate protocol adherence, and a cost-effectiveness analysis will be applied if the intervention is found to be effective. Discussion The current study provides an innovative approach to rehabilitation in the chronic phase of TBI evaluated using an RCT design that may inform treatment planning, health policies, and coordination of patient care. Further, the study may demonstrate new modes of establishing collaboration and knowledge transition between specialized rehabilitation facilities and local rehabilitation services that may improve patient outcomes. Trial registration ClinicalTrials.gov, NCT03545594 . Registered on June 4th, 2018.

Objective: To identify the most important categories of the International Classification of Service Organization in Rehabilitation (ICSO-R 2.0) for a minimum reporting data set. Methods: A 2-step Delphi survey was used. Rehabilitation experts from all world regions including physicians, nurses, neuropsychologists, physiotherapists, and others, were invited to participate. In the first round, all participants were asked to rate the categories and subcategories of the ICSOR 2.0 with the following criteria: Being relevant for study outcomes; Being distinctive among different rehabilitation settings; Being feasible to use and reported by objective figures or other clear characterization. All categories that were rated relevant, distinctive and feasible by more than 60% of respondents from the first round were included in the second round. Results: The most important and relevant factors for the minimum reporting set in rehabilitation services regarding the provider were: human resources, context, technical resources, quality assurance and management, location of provider, and ownership. Regarding the service delivery, the most important and relevant factors were: target group, rehabilitation team, aspect of time and intensity, setting, location of service delivery, modes of referral, facility and reporting and documentation. Conclusion: Several categories were identified, and reduction in these through discussions and iterative voting at workshops and consensus conferences is needed before finalizing the reporting set. LAY ABSTRACT A goal of this Delphi study was to identify the most important parameters of the International Classification of Service Organization in Rehabilitation (ICSO-R 2.0), to characterize rehabilitation services and identify important missing categories needed in a minimum reporting set. The most important and relevant factors for developing a minimum reporting set regarding the provider were: human resources, context, technical resources, quality assurance and management, location of provider, and ownership. Regarding service delivery the most important and relevant factors were: target group, rehabilitation team, aspect of time and intensity, setting, location of service delivery, modes of referral, facility and reporting and documentation. These factors should be discussed further, and a final set should be developed in workshops through discussion and iterative voting.

BackgroundSubstantial variance exists in outcomes after mild traumatic brain injury (MTBI), and these differences are not fully explained by injury characteristics or severity. Genetic factors are likely to play a role in this variance.ObjectivesThe aim of this study was to examine associations between the apolipoprotein (APOE)-ε4 allele and memory measures at two months post-MTBI and to evaluate whether subjective cognitive and affective symptoms were associated with APOE-ε4 status. Based on previous research, it was hypothesized that APOE-ε4 carriers would show poorer verbal memory performance compared to APOE-ε4 non-carriers.MethodsNeuropsychological data at two months post-injury and blood samples that could be used to assess APOE genotype were available for 134 patients with MTBI (mean age 39.2 years, 62% males, 37% APOE-ε4 carriers). All patients underwent computed tomography at hospital admission and magnetic resonance imaging four weeks post-injury.ResultsThe APOE-ε4 + status was associated with decreased immediate memory recall (p = 0.036; β = −0.10, 95% CI [−0.19, −0.01]). Emotional, cognitive, and everyday executive function symptoms at two months post-injury were significantly higher in APOE-ε4 carriers compared to non-carriers.ConclusionThe APOE-ε4+ allele has a negative effect on verbal memory and symptom burden two months after MTBI.

Descriptions of clinical outcomes in pediatric traumatic brain injury (pTBI) in Scandinavia are sparse. The Oslo site of the European CENTER-TBI study has performed a pTBI outcome study in a hospitalized population. The main objective was to investigate neuropsychological outcomes, self- and parent-reported symptoms associated with brain injury, and quality of life in children aged 1–15 years, 5–8 months after injury. Fifty-two children were included, and 45 completed the assessments. The sample consisted of 15.4% severe, 21.2% moderate, and 63.4% mild TBI. Subjectively experienced problems with concentration and fatigue were reported by the parents of nearly half of the children. Higher brain injury symptom load was associated with lower quality of life, but was unrelated to injury severity. Group average scores of the sample on neuropsychological testing appeared unimpaired relative to normative means aside from lower performance in working memory. However, based on an impairment index (i.e., 2 or more tests being >1.5 SD below the normative mean), the presence of weak cognitive performance was evident in as many as 45.4% of the sample. Two-thirds of the sample also showed abnormally large intraindividual variability in cognitive functioning (i.e., significant WISC-IV index discrepancies). The findings highlight the need to look beyond group averages on neuropsychological testing. Utilizing an impairment index and considering intraindividual performance variability conveyed deficits that may warrant clinical follow-up. The association of brain injury symptoms with quality of life but not injury severity emphasizes the need to consider symptoms after TBI within a biopsychosocial framework.Clinical Trial Registration:ClinicalTrials.gov; identifier: NCT02210221.

Introduction: Neurocognitive problems associated with posttraumatic stress disorder (PTSD) can interact with impairment resulting from traumatic brain injury (TBI). Research question: We aimed to identify neurocognitive problems associated with probable PTSD following TBI in a civilian sample. Material and methods: The study is part of the CENTER-TBI project (Collaborative European Neurotrauma Effectiveness Research) that aims to better characterize TBI. For this cross-sectional study, we included patients of all severities aged over 15, and a Glasgow Outcome Score Extended (GOSE) above 3. Participants were assessed at six months post-injury on the PTSD Checklist-5 (PCL-5), the Trail Making Test (TMT), the Rey Auditory Verbal Learning Test (RAVLT) and the Cambridge Neuropsychological Test Automated Battery (CANTAB). Primary analysis was a complete case analysis. Regression analyses were performed to investigate the association between the PCL-5 and cognition. Results: Of the 1134 participants included in the complete case analysis, 13.5% screened positive for PTSD. Probable PTSD was significantly associated with higher TMT-(B-A) (OR ​= ​1.35, 95% CI: 1.14–1.60, p ​

Meta-analysis of clinical trials in rehabilitation is often inconclusive, even when similar interventions are investigated. A possible reason for this is the influence of the settings in which rehabilitation services are delivered. Examples show that factors related to service organization in rehabilitation can influence study outcomes. This, in particular, is relevant, as contextual factors in rehabilitation are known to influence the participation and functioning of persons with disability. The Consolidated Statement of Reporting Trials (CONSORT) group and other initiatives published standards for reporting relevant factors for clinical trials. However, description of the rehabilitation setting of factors related to rehabilitation service provision is under-represented. Systematic reviews show that, on the one hand, these factors are scarcely reported, and only a few studies systematically evaluated the influence of factors related to service organization on rehabilitation outcomes. The International Classification of Service Organization in Rehabilitation (ICSO-R) provides a framework to systematically describe rehabilitation services. It contains 40 categories and sub-categories for the domains “provider” and “service delivery”. Therefore, it is important and relevant to develop a minimum reporting set for factors relevant to service organization for rehabilitation trials. This paper sets out a methodological approach for this purpose, including literature reviews, Delphi survey focus group discussion, and consensus conference.

Objective: Elderly patients are frequently in need of antithrombotic therapy for reducing thrombotic events. The association between antithrombotic drugs and survival after traumatic brain injury (TBI) is, nevertheless, unclear.Methods: This retrospective study included patients ≥65 years admitted to a Norwegian Level 1 trauma center with TBI identified on cerebral computed tomography (cerebral-CT) during 2014–2019. Preinjury use of antiplatelets and anticoagulants was compared to the prescription rate in the general Norwegian population. The primary outcome was 30-day mortality. Uni- and multivariate logistic regression analyses estimated the association between the use of antithrombotic drugs and mortality.Results: The study includes 832 consecutive TBI patients ≥65 years. The median age was 76 years, 58% were males, 51% had moderate or severe TBI, and 39% had multiple traumas. Preinjury use of antithrombotics was registered in 471/832 (55.6%) patients; antiplatelet therapy alone in 268, anticoagulant therapy alone in 172, and combined antiplatelet and anticoagulant therapy in 31. Antiplatelet use did not differ between the study cohort and the general Norwegian population ≥65 years (31 vs. 31%, p = 0.87). Anticoagulant therapy was used more commonly in the study cohort than in the general Norwegian population (24 vs. 19%, p = 0.04). Combined use of antiplatelet and anticoagulant therapy was significantly associated with 30-day mortality, while preinjury antiplatelet or anticoagulation treatment alone was not. No difference in 30-day mortality between patients using VKA, DOACs, or LMWH was encountered.Conclusions: In this cohort, neither antiplatelet nor anticoagulant therapy alone was associated with increased 30-day mortality. Anticoagulant use was more prevalent among TBI patients than the general population, suggesting that anticoagulation might contribute to the initiation of intracranial bleeding after blunt head trauma. Combined antiplatelet and anticoagulant therapy posed increased risk of 30-day mortality.

Objective: Secondary analysis, testing the effect on change in health-related quality of life of group-based vestibular rehabilitation in patients with mild-moderate traumatic brain injury, dizziness and -balance problems. Design: A single-blind randomized controlled trial. Subjects: A total of 65 patients aged 16–60 years with a Rivermead Post-concussion Symptoms Questionnaire dizziness score ≥2, and Dizziness Handicap Inventory score >15 points. Data collection was performed at baseline 3.5 (standard deviation (SD) 2.1) months post-injury, end of intervention, and 4.4 (SD 1.0) months after baseline. Methods: Quality of Life after Brain Injury was the main outcome. Independent variables were demographic and injury variables, Hospital Anxiety and Depression Scale, changes on the Rivermead Post-concussion Symptoms Questionnaire (RPQ3 physical and RPQ13 psychological/cognitive), and Vertigo Symptom Scale-Short Form. Results: Mean age of participants was 39.4 years (SD 13.0); 70.3% women. Predictors of change in the Quality of Life after Brain Injury were receiving the vestibular rehabilitation (p=0.049), baseline psychological distress (p=0.020), and change in RPQ3 physical (p=0.047) and RPQ13 psychological/cognitive (p=0.047). Adjusted R2 was 0.399, F=6.13, p

Aims: Knowledge regarding the most effective return to work (RTW) approaches after traumatic brain injury (TBI) is lacking. This trial aimed to compare the effectiveness of a combined cognitive and vocational intervention to treatment as usual (TAU) on RTW and work stability after TBI.Methods: We performed a parallel-group randomized controlled trial (RCT) at a TBI outpatient clinic at Oslo University Hospital (OUH), Norway. Patients with a history of mild-to-moderate TBI (n = 116) aged 18–60 were randomized (1:1) by an independent investigator to receive group-based compensatory cognitive training (CCT) and supported employment (SE) (n = 60) or TAU consisting of individualized multidisciplinary treatment (n = 56). Participants were enrolled 2–3 months post-injury. The nature of the intervention prevented blinding of patients and therapists, however, outcome assessors were blinded to group allocation. The primary outcome measure was RTW at 3 and 6 months following study inclusion. Secondary outcomes were work percentage, stability, and productivity. The present study provides results from an interim analysis from the first two planned follow ups, while subsequent publications will present results up to 12 months following study inclusion.Results: Mixed effects models showed no between-group differences in the RTW proportion, work percentage, and hours worked between CCT-SE and TAU from baseline to 6 months. A significantly higher proportion of participants in CCT-SE had returned to work at 3 months when adjusting for baseline differences. The majority of participants who were employed at 3 and 6 months were stably employed. There was a statistically significant within-group improvement on RTW proportion, hours worked and work percentage in both groups.Conclusion: The results revealed no difference between CCT-SE and TAU on work-related outcomes from baseline to 6 months. However, there was a higher RTW proportion in the CCT-SE group compared to TAU at 3 months. Future publications will assess the effectiveness of CCT-SE vs. TAU up to 12 months.Clinical Trial Registration: US National Institutes of Health ClinicalTrials.gov, identifier #NCT03092713.

Objective: To determine how health-related rehabilitation services have been described in recently pub-lished randomized clinical trials, using the International Classification System for Service Organization in Health-Related Rehabilitation (ICSO-R 2.0) as a framework. Methods: Medline was searched for English--language randomized clinical trials (RCTs) published between 1 January 2018 and 31 December 2018. RCTs were eligible if the primary goal was to provide rehabilitation services to targeted patient populations. Two authors independently screened and extracted data, and assessed the methodological quality of eligible trials. Descriptive analysis was used to compare service descriptions between eligible trials and the ICSO-R 2.0 framework (23 categories, 9 categories for provider, 14 categories for delivery). Results: Twenty-nine RCTs, with a wide range of organizational units and target groups, were included. The median number of categories reported in the provider dimension was 4 (range 3–5). The median number of categories reported in the service delivery dimension was 8 (range 6–12). None of the RCTs described all ICSO-R recommended categories. Conclusion: Descriptions of service organization in rehabilitation varied widely among recently published randomized clinical trials. Use of the framework for the classification of service organization and standardization of description of services is recommended in future RCTs, to facilitate better comparisons in service research across studies.

Abstract Background Family member’s experience and satisfaction of health care in the acute care and in-patient rehabilitation are important indicators of the quality of health care services provided to patients with severe traumatic brain injury (TBI). The objective was to assess family members’ experience of the health care provided in-hospital to patients with severe TBI, to relate experiences to family member and patient demographics, patients’ function and rehabilitation pathways. Methods Prospective national multicentre study of 122 family members of patients with severe TBI. The family experience of care questionnaire in severe traumatic brain injury (FECQ-TBI) was applied. Independent sample t-tests or analysis of variance (ANOVA) were used to compare the means between 2 or more groups. Paired samples t-tests were used to investigate differences between experience in the acute and rehabilitation phases. Results Best family members` experience were found regarding information during the acute phase, poorest scores were related to discharge. A significantly better care experience was reported in the acute phase compared with the rehabilitation phase (p

Objectives: To describe the discharge process for patients with traumatic brain injury from a trauma hospital, and patient experience and satisfaction with care transition. Furthermore, to evaluate associations between discharge process and patient satisfaction and quality of care transition. Design: Prospective-retrospective observational study. Subjects/patients: Seventy-four patients admitted to ward or intensive care unit at a trauma referral hospital within 24 h of traumatic brain injury. Methods: Baseline characteristics and discharge process variables were extracted from medical records. Patients were interviewed 6-months post-injury about their experience and satisfaction with care transition, using a visual analogue scale (VAS) and the Care Transition Measurement (CTM-3®) as outcome measures. Regression analyses were performed to investigate associations between discharge process and outcome. Results: One-third of patients were not involved in the discharge process, and information in discharge summaries was often inadequate. Patients’ involvement in care transition and co-ordination of care were significantly associated with overall satisfaction (VAS, p = 0.002 and p = 0.001, respectively) and quality of care transition (CTM-3®, p = 0.003 and p = 0.007, respectively). Patients with more severe injuries reported lower satisfaction and quality of care transition. Conclusion: Patient’s involvement in healthcare decision-making and co-ordination of care is important for self-reported satisfaction with transition and quality of care transition.

To apply the Classification of Service Organization in Rehabilitation (ICSO-R) classification of services to different target groups, include the user perspective, identify missing categories, and propose standardized descriptors for the categories from a Norwegian perspective. Expert-based consensus conferences with user involvement. Health professionals, stakeholders and users. Participants were divided into 5 panels, which applied the ICSO-R to describe the habilitation and rehabilitation services provided to children with cerebral palsy and people with Huntington’s disease, acquired brain injuries (traumatic brain injuries and stroke) and painful musculoskeletal conditions. Based on the Problem/Population, Intervention, Comparison, Outcome (PICO) framework, the services were described according to the ICSO-R. Missing categories were identified. The ICSO-R was found to be feasible and applicable for describing a variety of services provided to different target groups in Norway, but the user perspective was lacking, categories were missing, and a need for standardized description of the categories was identified. The present work supports the need to produce an updated version of the ICSO-R and to encourage national and international discussion of the framework. The ICSO-R has the potential to become a tool for the standardized assessment of rehabilitation services. For such purposes, more standardized descriptions of subcategories are necessary.

Abstract Background A considerable proportion of patients with mild to moderate traumatic brain injury (TBI) experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their capacity to return to work (RTW). Although several studies have described medical, psychological, and work-related factors that predict RTW after TBI, well-controlled intervention studies regarding RTW are scarce. Furthermore, there has traditionally been weak collaboration among health-related rehabilitation services, the labor and welfare sector, and workplaces. Methods/design This study protocol describes an innovative randomized controlled trial in which we will explore the effect of combining manualized cognitive rehabilitation (Compensatory Cognitive Training [CCT]) and supported employment (SE) on RTW and related outcomes for patients with mild to moderate TBI in real-life competitive work settings. The study will be carried out in the southeastern region of Norway and thereby be performed within the Norwegian welfare system. Patients aged 18–60 years with mild to moderate TBI who are employed in a minimum 50% position at the time of injury and sick-listed 50% or more for postconcussive symptoms 2 months postinjury will be included in the study. A comprehensive assessment of neurocognitive function, self-reported symptoms, emotional distress, coping style, and quality of life will be performed at baseline, immediately after CCT (3 months after inclusion), following the end of SE (6 months after inclusion), and 12 months following study inclusion. The primary outcome measures are the proportion of participants who have returned to work at 12-month follow-up and length of time until RTW, in addition to work stability as well as work productivity over the first year following the intervention. Secondary outcomes include changes in self-reported symptoms, emotional and cognitive function, and quality of life. Additionally, a qualitative RTW process evaluation focused on organizational challenges at the workplace will be performed. Discussion The proposed study will combine cognitive and vocational rehabilitation and explore the efficacy of increased cross-sectoral collaboration between specialized health care services and the labor and welfare system. If the intervention proves effective, the project will describe the cost-effectiveness and utility of the program and thereby provide important information for policy makers. In addition, knowledge about the RTW process for persons with TBI and their workplaces will be provided. Trial registration ClinicalTrials.gov, NCT03092713 . Registered on 10 March 2017.

Background and aims: There is a gap in knowledge regarding effective rehabilitation service delivery in the post-acute phase after traumatic brain injury (TBI). Recently, Gutenbrunner et al. proposed a classification system for health-related rehabilitation services (International Classification System for Service Organization in Health-related Rehabilitation, ICSO-R) that could be useful for contrasting and comparing rehabilitation services. The ICSO-R describes the dimensions of Provision (i.e., context of delivered services), Funding (i.e., sources of income and refunding), and Delivery (i.e., mode, structure and intensity) at the meso-level of services.We aim to:-Provide an overview of randomized, controlled trials (RCTs) with rehabilitation service relevance provided to patients with moderate and severe TBI in the post-acute phase using the ICSO-R as a framework; and-Evaluate the extent to which the provision, funding and delivery dimensions of rehabilitation services were addressed and differed between the intervention arms in these studies.Materials and methods: A systematic literature search was performed in OVID MEDLINE, EMBASE, CINHAL, PsychINFO, and CENTRAL, including multidisciplinary rehabilitation interventions with RCT designs and service relevance targeting moderate and severe TBI in the post-acute phase.Results: 23 studies with 4,644 TBI patients were included. More than two-thirds of the studies were conducted in a hospital-based rehabilitation setting. The contrast in Context between the intervention arms often co-varied with Resources. The funding of the services was explicitly described in only one study. Aspects of the Delivery dimension were described in all of the studies, and the Mode of Production, Intensity, Aspects of Time and Peer Support were contrasted in the intervention arms in several of the studies. A wide variety of outcome measures were applied often covering Body function, as well as the Activities and Participation domains of the International Classification of Functioning, Disability, and Health (ICF).Conclusion: Aspects of service organization and resources as well as delivery may clearly influence outcome of rehabilitation. Presently, lack of uniformity of data and collection methods, the heterogeneity of structures and processes of rehabilitation services, and a lack of common outcome measurements make comparisons between the studies difficult. Standardized descriptions of services by ICSO-R, offer the possibility to improve comparability in the future and thus enhance the relevance of rehabilitation studies.

Aims: Based on important predictors, global functional outcome after traumatic brain injury (TBI) may vary significantly over time. This study sought to: (1) describe changes in the Glasgow Outcome Scale–Extended (GOSE) score in survivors of moderate to severe TBI, (2) examine longitudinal GOSE trajectories up to 10 years after injury, and (3) investigate predictors of these trajectories based on socio-demographic and injury characteristics.Methods: Socio-demographic and injury characteristics of 97 TBI survivors aged 16–55 years were recorded at baseline. GOSE was used as a measure of TBI-related global outcome and assessed at 1-, 2-, 5-, and 10-year follow-ups. Hierarchical linear models were used to examine global outcomes over time and whether those outcomes could be predicted by: time, time*time, sex, age, partner relationship status, education, employment pre-injury, occupation, cause of injury, acute Glasgow Coma Scale score, length of post-traumatic amnesia (PTA), CT findings, and Injury Severity Score (ISS), as well as the interactions between each of the significant predictors and time*time.Results: Between 5- and 10-year follow-ups, 37% had deteriorated, 7% had improved, and 56% showed no change in global outcome. Better GOSE trajectories were predicted by male gender (p = 0.013), younger age (p = 0.012), employment at admission (p = 0.012), white collar occupation (p = 0.014), and shorter PTA length (p = 0.001). The time*time*occupation type interaction effect (p = 0.001) identified different trajectory slopes between survivors in white and blue collar occupations. The time*time*PTA interaction effect (p = 0.023) identified a more marked increase and subsequent decrease in functional level among survivors with longer PTA duration.Conclusion: A larger proportion of survivors experienced deterioration in GOSE scores over time, supporting the concept of TBI as a chronic health condition. Younger age, pre-injury employment, and shorter PTA duration are important prognostic factors for better long-term global outcomes, supporting the existing literature, whereas male gender and white collar occupation are vaguer as prognostic factors. This information suggests that more intensive and tailored rehabilitation programs may be required to counteract a negative global outcome development in survivors with predicted worse outcome and to meet their long-term changing needs.

Traumatic brain injury (TBI) affects the family as a whole. This study aimed to describe and compare mental health and family functioning in TBI patients and their family members, and to identify individual and family-related factors that were associated with mental health. It was conducted at an urban, specialized, TBI outpatient clinic and included 61 patients with mild to severe TBI and 63 family members. Baseline demographics and injury-related data were collected, and the participants answered standardized, self-reported questionnaires 6–18 months post-injury that assessed mental health; general health; family functioning, communication, and satisfaction; depression and anxiety; self-efficacy; resilience; and condition-specific quality of life. The patients reported significantly worse mental health, depression, resilience, self-efficacy, and general health compared with the family members. Patients and family members had similar perceptions, showing balanced family functioning, high family communication levels, and moderate family satisfaction. Factors significantly associated with mental health in patients and family members were depression, anxiety, and resilience, explaining 56% of the variance (p < 0.001). Family-related factors were not associated with mental health. The disease burden was mainly on the patients; however, the family members also reported emotional distress. Family-targeted interventions across the TBI continuum should be considered.

Purpose: To assess the feasibility of recruitment procedures and delivery of a Norwegian adaptation of a manualized cognitive intervention to a civilian sample with traumatic brain injury (TBI). Materials and methods: Six individuals received a 10-week group-based intervention (Compensatory Cognitive Training, CCT) targeting post-concussive symptom management and cognitive symptoms. Participant engagement (i.e. attendance, level of participation, ability to learn and apply strategies, and homework completion) and satisfaction were assessed by the Therapist Checklist and CCT Feedback Form. Results: All participants had a diagnosis of concussion, were enrolled on average 4 months post-injury, and were sick-listed at a range of 70–100% at the time of inclusion. Attendance across CCT sessions was 97%. Eight out of nine topics in the CCT-intervention received a rating above 3.5 on a 5-point scale (i.e. towards very helpful). The items that received the highest mean ratings were information about TBI and post-concussive symptoms, and strategies targeting fatigue, prospective memory, and memory and learning. All participants were rated as participating fully (3/6) or moderately (3/6), and most participants (5/6) attempted to apply the trained skills to real-life situations. Conclusions: The results support the feasibility of a Norwegian adaptation of the intervention for a civilian sample with TBI.

The aim of this study was to address feasibility aspects of a multidisciplinary, family-centered rehabilitation intervention for persons with traumatic brain injury and their family. The study was done in preparation of a full-scale RCT and conducted as a collaboration between specialist and municipal health-care service, with two municipal health professionals included as collaborating partners. By applying the intervention on six persons, two families, we evaluated the attendance rate, the appropriateness of the intervention’s topics, the collaboration with the municipal health professionals, and the data collection method. Predefined success-criteria were used to evaluate feasibility. The family intervention and study procedures were evaluated as feasible. Some challenges arose and were discussed prior to commencing the full-scale trial. They concerned the logistics regarding the delivery of the intervention and making appropriate adjustments to meet the families’ unique needs and facilitate participation. A pragmatic approach was considered necessary in the full-scale RCT.

Aims: To examine trajectories of employment probability up to 10 years following moderate-to-severe traumatic brain injury (TBI) and identify significant predictors from baseline socio-demographic and injury characteristics.Methods: A longitudinal observational study followed 97 individuals with moderate-to-severe TBI for their employment status up to 10 years post injury. Participants were enrolled at the Trauma Referral Center in South-Eastern Norway between 2005 and 2007. Socio-demographic and injury characteristics were recorded at baseline. Employment outcomes were assessed at 1, 2, 5, and 10 years. Hierarchical linear modeling (HLM) was used to examine employment status over time and assess the predictors of time, gender, age, relationship status, education, employment pre-injury, occupation, cause of injury, acute Glasgow Coma Scale (GCS) score, duration of post-traumatic amnesia (PTA), CT findings, and injury severity score, as well as the interaction terms between significant predictors and time.Results: The linear trajectory of employment probabilities for the full sample remained at ~50% across 1, 2, 5, and 10-years post-injury. Gender (p = 0.016), relationship status (p = 0.002), employment (p < 0.001) and occupational status at injury (p = 0.005), and GCS (p = 0.006) yielded statistically significant effects on employment probability trajectories. Male gender, those in a partnered relationship at the time of injury, individuals who had been employed at the time of injury, those in a white-collar profession, and participants with a higher acute GCS score had significantly higher overall employment probability trajectories across the four time points. The time*gender interaction term was statistically significant (p = 0.002), suggesting that employment probabilities remained fairly stable over time for men, but showed a downward trend for women. The time*employment at injury interaction term was statistically significant (p = 0.003), suggesting that employment probabilities were fairly level over time for those who were employed at injury, but showed an upward trend over time for those who had been unemployed at injury.Conclusion: Overall employment probability trajectories remained relatively stable between 1 and 10 years. Baseline socio-demographic and injury characteristics were predictive of employment trajectories. Regular follow-up is recommended for patients at risk of long-term unemployment.