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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.

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 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.

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 .

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.

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.

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.

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.

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.