Process evaluation of a complex intervention evaluating the effectiveness of home-based rehabilitation in the chronic phase of traumatic brain injury.

PURPOSE: To perform a process evaluation of a randomized controlled trial (RCT) evaluating a manualized intervention aiming to ameliorate long-term symptoms of traumatic brain injury (TBI) by assessing implementation fidelity, delivery context and acceptability of the intervention. METHODS: Data from 60 participants were collected during recruitment, intervention delivery and outcome data collection in the RCT. Enrollment records, logs and checklists documented the delivery of the intervention (implementation fidelity) and the collaboration with family members and outside collaborators (delivery context). Attendance-rate, self-reported acceptability and willingness to participate in future studies were used to assess the acceptability of the intervention. RESULTS: The main elements and dose of the intervention were delivered as intended with an excellent adherence to the manual items. Family members co-participated in the intervention for 39 (65%) of the participants. Outside collaborators were contacted for 32 (53%) of the participants. Acceptability scores were high for participants, family members and therapists. CONCLUSIONS: The intervention was successfully delivered with high acceptability. This process evaluation informs researchers, clinicians and stakeholders about important factors influencing the outcomes of the intervention that should be considered in clinical implementation of rehabilitation interventions. TRIAL REGISTRATION: Pre-registered 4th of June 2018 at clinicaltrials.gov (NCT03545594).

Validity of the Norwegian Version of the Needs and Provision Complexity Scale (NPCS) in Patients with Traumatic Brain Injury and Atraumatic Subarachnoid Hemorrhage.

There is a lack of validated measures in Scandinavian languages to track healthcare service needs and delivery for patients with neurological disabilities. The aim of the present study was to validate the Norwegian version of the clinician and patient Needs and Provision Complexity Scale (NPCS) Needs and Gets. Data on the NPCS from 60 adult patients with traumatic brain injury or atraumatic subarachnoid hemorrhage and symptoms lasting >5 months were assessed for inter-rater/test-retest reliability and agreement, as well as concurrent validity with the Neurological Impairment Scale (NIS), the Functional Independence Measure (FIM), and the Community Integration Questionnaire (CIQ). The clinician NPCS showed good-excellent inter-rater reliability, and the patient NPCS demonstrated good-excellent test-retest reliability. Absolute agreement was moderate-excellent across all clinician and patient items. Concurrent validity was significant, with large correlations between clinician NPCS-Needs and the NIS and FIM total scores, and small-medium correlations between the clinician and patient NPCS-Gets and the NIS and FIM total scores. There were no significant correlations between the NPCS and the CIQ. The study findings support the use of the Norwegian version of the NPCS to assess met and unmet healthcare and support needs for Norwegian-speaking adults with neurological disabilities.

The Participation Assessment with Recombined Tools-Objective (PART-O): measurement properties of the Norwegian version after traumatic brain injury.

OBJECTIVE: To translate and evaluate the validity of the Participation Assessment with Recombined Tools-Objective (PART-O) in a Norwegian context. METHODS: One hundred and twenty persons with TBI with verified intracranial lesions and persistent symptoms lasting more than 2 years, included in a randomized controlled trial, rated their participation using the PART-O at baseline. The PART-O with its three subscales (Productivity, Out and About, and Social Relations) was translated to Norwegian. Descriptive statistics, Cronbach's alpha, Rasch analysis, and correlation analysis were applied. RESULTS: The Rasch analysis indicated a unidimensional construct of PART-O and its subscales (χ2 < 12.69, p > 0.28). The internal consistency was moderate (Cronbach's alpha 0.48-0.52) and there was a need to reduce scaling options for most of the items. The Out and About and Productivity subscales had considerable floor effects. PART-O showed moderate positive correlation to TBI-related quality of life and global functioning. CONCLUSIONS: PART-O and its subscales reflect unidimensional aspects of participation. In the present Norwegian TBI population the original scaling of PART-O was too detailed for all subscales. The floor effects and suboptimal targeting between items and subjects participation level of the Out and About subscale is a matter of concern.

Participation in the Chronic Phase after Traumatic Brain Injury: Variations and Key Predictors.

Participation is of major importance for individuals with traumatic brain injury (TBI). This study evaluates participation over a period of one year among persons with TBI in the chronic phase and explores sociodemographic, psychological, and environmental predictors of levels and trajectories of participation. One hundred and twenty home-living survivors of TBI with persistent injury-related consequences at least two years post-injury who participated in a goal-oriented randomized trial were assessed at baseline and after four and twelve months. Linear mixed-effects model analysis was applied to evaluate height, trajectory slope, and predictors of the Participation Assessment with the Recombined Tools-Objective (PART-O) total score and the subscales Productivity, Social Relations, and Being Out and About. Being married, having a higher education, and having good global functioning predicted more frequent participation. Education, executive- and global functions predicted Productivity, while age and being married predicted Social Relations. Participating in the study during the COVID-19 pandemic had a negative impact on Productivity. Participation was relatively stable over 12 months, with a slight decline, but may be influenced by demographic factors and functional consequences. Rehabilitation services should particularly focus on people with TBI living alone with lower levels of global and executive function.

Children's, parents', and teachers' experiences of the feasibility of a telerehabilitation intervention for children with acquired brain injury in the chronic phase - a qualitative study of acceptability and participation in the Child In Context Intervention (CICI).

BACKGROUND: This is a qualitative feasibility study of the Child in Context Intervention (CICI). The CICI is an individualized, goal-oriented and home-based tele-rehabilitation intervention which targets everyday functioning of children (6-16 years) with acquired brain injury in the chronic stage, and their families, one year or more after insult, who have ongoing challenges (physical, cognitive, behavioral, social and/or psychological). The aim of this study is to better understand how children, parents and teachers experienced participation and acceptability; to develop knowledge about the mechanisms of change, and to explore how the CICI was tailored to the context. METHODS: Six families and schools participated in the intervention, which comprised seven tele-rehabilitation sessions in which the child and parent participated, one in-person parent seminar and four digital school meetings. A multidisciplinary team delivered the intervention to 23 participants over a 4- to 5-month period. The intervention involved psychoeducation about targeted acquired brain injury-related problems, such as fatigue, pain, or social challenges. All but one consented to participate in the current digital interview study. The data were analyzed using content analysis. RESULTS: The experience of participation and acceptability varied among the children. Attendance was consistently high; the child participants felt mostly listened to and could influence goal setting and strategies. However, engaging and motivating the child participants proved somewhat challenging. The parents found the CICI rewarding, useful and relevant. However, they had different experiences regarding which intervention component they perceived as most helpful. Some argued in favor of the 'whole intervention', while others highlighted new knowledge, SMART goals or the school collaboration. The teachers found the intervention acceptable and useful but wanted a better meeting plan. They had difficulties in finding time for meetings, emphasized the involvement of school leaders, and appreciated the digital format. CONCLUSIONS: Overall, the intervention was perceived as acceptable, and the participants felt that the various intervention components contributed to improvements. The CICI's flexibility facilitated tailoring to different contexts based on the children's functional level. The digital format saved time and provided flexibility regarding the amount of attendance but limited full participation from children with more severe cognitive impairments. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04186182.

Effect of an Individually Tailored and Home-Based Intervention in the Chronic Phase of Traumatic Brain Injury: A Randomized Clinical Trial.

Importance: Traumatic brain injury (TBI) can cause long-lasting and heterogeneous difficulties that require an individually tailored approach to rehabilitation. However, high-quality studies of treatment options in the chronic phase of TBI are lacking. Objective: To evaluate the effect of a home-based, individualized, and goal-oriented rehabilitation intervention in the chronic phase of TBI. Design, Setting, and Participants: This study was an intention-to-treat parallel-group assessor-blinded randomized clinical trial with 1:1 randomization to an intervention or control group. Participants included adults in southeastern Norway who had sustained a TBI more than 2 years earlier, lived at home, and had ongoing TBI-related difficulties. A population-based sample of 555 individuals were invited, and 120 were included. Participants were assessed at baseline, 4 months, and 12 months after inclusion. Specialized rehabilitation therapists provided the intervention in patients' homes or via video conference and telephone. Data collection was conducted between June 5, 2018, and December 14, 2021. Interventions: The intervention group received an 8-session individually tailored and goal-oriented rehabilitation program over 4 months. The control group received usual care in their municipality. Main Outcomes and Measures: Preestablished primary outcomes were disease-specific health-related quality of life (HRQOL; measured by the Quality of Life After Brain Injury [QOLIBRI] overall scale) and social participation (measured by the Participation Assessment With Recombined Tools-Objective [PART-O] social subscale). Preestablished secondary outcomes included generic HRQOL (measured by the EuroQol 5-dimension 5-level [EQ-5D-5L] questionnaire), difficulty with TBI-related problem management (target outcomes; mean severity calculated across 3 main self-identified problem areas that were individually measured using a 4-point Likert scale), TBI symptoms (measured by the Rivermead Post Concussion Symptoms Questionnaire [RPQ]), psychological distress (depression and anxiety; measured by the Patient Health Questionnaire 9-item scale and the Generalized Anxiety Disorder 7-item scale [GAD-7], respectively), and functional competency (measured by the Patient Competency Rating Scale). Results: Among 120 participants in the chronic phase of TBI, the median (IQR) age was 47.5 (31.0-55.8) years, and the median (IQR) time since injury was 4 (3-6) years; 85 (70.8%) were male. A total of 60 participants were randomized to the intervention group, and 60 were randomized to the control group. Between baseline and 12 months, no significant between-group effects were found for the primary outcomes of disease-specific HRQOL (QOLIBRI overall scale score: 2.82; 97.5% CI, -3.23 to 8.88; P = .30) or social participation (PART-O social subscale score: 0.12; 97.5% CI, -0.14 to 0.38; P = .29). At 12 months, the intervention group (n = 57) had significantly higher generic HRQOL (EQ-5D-5L score: 0.05; 95% CI, 0.002-0.10; P = .04) and fewer symptoms of TBI (RPQ total score: -3.54; 95% CI, -6.94 to -0.14; P = .04) and anxiety (GAD-7 score: -1.39; 95% CI, -2.60 to -0.19; P = .02) compared with the control group (n = 55). At 4 months only, the intervention group (n = 59) had significantly less difficulty managing TBI-related problems (target outcomes mean severity score: -0.46, 95% CI, -0.76 to -0.15; P = .003) compared with the control group (n = 59). No adverse events were reported. Conclusions and Relevance: In this study, no significant results were observed for the primary outcomes of disease-specific HRQOL or social participation. However, the intervention group reported improvements in secondary outcomes (generic HRQOL and symptoms of TBI and anxiety) that were maintained at 12-month follow-up. These findings suggest that rehabilitation interventions could help patients even in the chronic phase of TBI. Trial Registration: ClinicalTrials.gov Identifier: NCT03545594.

Investigating survival, quality of life and cognition in PROton versus photon therapy for IDH-mutated diffuse grade 2 and 3 GLIOmas (PRO-GLIO): a randomised controlled trial in Norway and Sweden.

INTRODUCTION: The use of proton therapy increases globally despite a lack of randomised controlled trials demonstrating its efficacy and safety. Proton therapy enables sparing of non-neoplastic tissue from radiation. This is principally beneficial and holds promise of reduced long-term side effects. However, the sparing of seemingly non-cancerous tissue is not necessarily positive for isocitrate dehydrogenase (IDH)-mutated diffuse gliomas grade 2-3, which have a diffuse growth pattern. With their relatively good prognosis, yet incurable nature, therapy needs to be delicately balanced to achieve a maximal survival benefit combined with an optimised quality of life. METHODS AND ANALYSIS: PRO-GLIO (PROton versus photon therapy in IDH-mutated diffuse grade 2 and 3 GLIOmas) is an open-label, multicentre, randomised phase III non-inferiority study. 224 patients aged 18-65 years with IDH-mutated diffuse gliomas grade 2-3 from Norway and Sweden will be randomised 1:1 to radiotherapy delivered with protons (experimental arm) or photons (standard arm). First intervention-free survival at 2 years is the primary endpoint. Key secondary endpoints are fatigue and cognitive impairment, both at 2 years. Additional secondary outcomes include several survival measures, health-related quality of life parameters and health economy endpoints. ETHICS AND DISSEMINATION: To implement proton therapy as part of standard of care for patients with IDH-mutated diffuse gliomas grade 2-3, it should be deemed safe. With its randomised controlled design testing proton versus photon therapy, PRO-GLIO will provide important information for this patient population concerning safety, cognition, fatigue and other quality of life parameters. As proton therapy is considerably more costly than its photon counterpart, cost-effectiveness will also be evaluated. PRO-GLIO is approved by ethical committees in Norway (Regional Committee for Medical & Health Research Ethics) and Sweden (The Swedish Ethical Review Authority) and patient inclusion has commenced. Trial results will be published in international peer-reviewed journals, relevant conferences, national and international meetings and expert forums. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT05190172).

Rehabilitation and outcomes after complicated vs uncomplicated mild TBI: results from the CENTER-TBI study.

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.

Feasibility and Acceptability of a Complex Telerehabilitation Intervention for Pediatric Acquired Brain Injury: The Child in Context Intervention (CICI).

The current study is a feasibility study of a randomized controlled trial (RCT): the Child in Context Intervention (CICI). The CICI study is an individualized, goal-oriented and home-based intervention conducted mainly through videoconference. It targets children with ongoing challenges (physical, cognitive, behavioral, social and/or psychological) after acquired brain injury (ABI) and their families at least one year post injury. The CICI feasibility study included six children aged 11-16 years with verified ABI-diagnosis, their families and their schools. The aim was to evaluate the feasibility of the intervention components, child and parent perceptions of usefulness and relevance of the intervention as well as the assessment protocol through a priori defined criteria. Overall, the families and therapists rated the intervention as feasible and acceptable, including the videoconference treatment delivery. However, the burden of assessment was too high. The SMART-goal approach was rated as useful, and goal attainment was high. The parents' ratings of acceptability of the intervention were somewhat higher than the children's. In conclusion, the CICI protocol proved feasible and acceptable to families, schools and therapists. The assessment burden was reduced, and adjustments in primary outcomes were made for the definitive RCT.

Goal Attainment in an Individually Tailored and Home-Based Intervention in the Chronic Phase after Traumatic Brain Injury.

Traumatic brain injury (TBI) is a heterogeneous condition with long-term consequences for individuals and families. Goal-oriented rehabilitation is often applied, but there is scarce knowledge regarding types of goals and goal attainment. This study describes goal attainment in persons in the chronic phase of TBI who have received an individualized, SMART goal-oriented and home-based intervention, compares goal attainment in different functional domains, and examines indicators of goal attainment. Goal attainment scaling (GAS) was recorded in the intervention group (n = 59) at the final session. The goal attainment was high, with 93.3% increased goal attainment across all goals at the final session. The level of goal attainment was comparable across domains (cognitive, physical/somatic, emotional, social). Gender, anxiety symptoms, self-reported executive dysfunction, and therapy expectations were indicators of goal attainment. These results indicate a potential for the high level of goal attainment in the chronic phase of TBI. Tailoring of rehabilitation to address individual needs for home-dwelling persons with TBI in the chronic phase represents an important area of future research.

Rehabilitation for children with chronic acquired brain injury in the Child in Context Intervention (CICI) study: study protocol for a randomized controlled trial.

BACKGROUND: Pediatric acquired brain injury (pABI) is associated with long-term cognitive, behavioral, social, and emotional problems, which may affect the quality of life, school, and family functioning. Yet, there is a lack of evidence-based community-centered rehabilitation programs for chronic pABI and these children do not systematically receive comprehensive rehabilitation. The Child In Context Intervention (CICI) study is a pragmatic randomized controlled trial (RCT) for children with chronic pABI, which aims to evaluate the effectiveness of an individualized and goal-oriented intervention targeting everyday functioning of the child and family. METHODS: Children aged 6-16 years with MRI/CT-verified intracranial abnormalities will be included in the CICI study if they have persistent self- or parent-reported cognitive, emotional, and/or behavioral challenges 1 year or more after insult and attend school regularly. A total of 70 families will be randomized 1:1 to an intervention or a control group. The intervention consists of seven family sessions, one parent seminar, and four school sessions delivered over approximately 6 months. The parent seminar will be held in person, and the other sessions will mainly be video based. The children's and families' self-reported major challenges in everyday life will be targeted using SMART goals. Evidence-based strategies, when available, will be applied to achieve the goals, combined with psychoeducation. Goal attainment scaling (GAS) will be used to evaluate goal attainment. Data is collected at baseline and after approximately 6 and 9 months. External assessors are blinded to group allocation. Primary outcomes are parent-reported brain injury symptoms in children and parenting self-efficacy at 9 months of follow-up. Secondary outcomes include child-reported brain injury symptoms, quality of life, executive functioning in daily life, parent emotional symptoms, family functioning, and unmet family health care needs. A process evaluation will be conducted. DISCUSSION: The current study provides an innovative approach to rehabilitation for children in the chronic phase of ABI and their families. This complex intervention may contribute to the development of evidence-based, high-quality rehabilitation for a large patient group, which is underrepresented in clinical research. It may also improve collaboration between specialized rehabilitation facilities, schools, and local health care services. Inclusion for the trial started in April 2021. TRIAL REGISTRATION: ClinicalTrials.gov NCT04798859 . Registered on March 15, 2021.

Community-Based Interventions After Acquired Brain Injury-A Systematic Review of Intervention Types and Their Effectiveness.

OBJECTIVES: Comprehensive review of existing types and effectiveness of community-based interventions delivered to adults (mean age 18-65 years) with long-lasting (≥6 months) difficulties following acquired brain injury (ABI). DESIGN: Systematic review of controlled intervention studies published until February 2021. MAIN MEASURES: Systematic searches in databases (MEDLINE, PsycINFO, Database of Abstracts of Reviews of Effects [Cochrane Library], and Cochrane Central Register of Controlled Trials [Cochrane Library]) and inclusion of English peer-reviewed full-text articles; randomized or controlled community-based intervention studies; sample size of 20 or more participants; and 3 or more intervention sessions. Two reviewers independently extracted data for the synthesis and assessed the methodological quality. Data extraction included study characteristics, demographics of participants, content and dose of intervention, outcome measures, and findings. RESULT: The search returned 7386 publications, of which 49 eligible studies were included, revealing a diverse range of community-based interventions and a myriad of outcome measures applied for assessing functional capacities, participation, and quality of life in the chronic phase of ABI. Intervention types encompassed 14 holistic, 23 physical, and 12 specific interventions. A large heterogeneity regarding intervention frequency and intensity was found. Meta-analyses performed on the holistic, physical, and specific interventions did not indicate any significant pooled effects but showed highly variable effects between individuals, both in persons with traumatic and nontraumatic brain injuries. CONCLUSIONS: Because of lack of pooled effects within types of community-based interventions, specific evidence-based recommendations within holistic, physical, and specific interventions designed to mitigate long-lasting ABI problems cannot be made. This review highlights the need for future studies to address methodological issues concerning larger sample size, lack of clear description interventions and comparator, missing reports of effects in change scores, need for consistent use of recommended outcome measures, and investigating the wide variety in intervention responsiveness among participants with ABI. Systematic review registration: PROSPERO (CRD42019124949).

A pilot study of cognitive remediation in remitted major depressive disorder patients.

Major depressive disorder (MDD) is associated with working memory (WM) impairments. These deficits often persist following remission and are associated with rumination, a recognized risk factor for depression relapse. The efficacy of WM-targeted cognitive remediation as a potential relapse prevention tool has not been investigated. The present pilot study aimed to investigate the feasibility, acceptability, and cognitive benefits of a WM-targeted cognitive remediation program in remitted depression. Twenty-eight MDD participants in remission were recruited. The intervention consisted of twenty-five 30-40-minute training sessions, coupled with weekly coaching, administered over a 5-week period. Before and after the intervention, a battery of objective neuropsychological tests and self-report measures was administered. Key outcomes were WM, inhibition and rumination. Acceptability of the intervention was observed, with 83% showing high motivation, along with WM gains for all completers (n = 18, 64% of recruited participants). The cognitive remediation selectively improved targeted WM functions, as measured by objective tests. This did not translate into self-reported improvements in everyday WM or inhibition. However, all but one completer achieved at least one personal goal related to WM and 44% achieved two or, the maximum possible, three such goals. For remitters whose WM was significantly enhanced after the intervention, the cognitive remediation also decreased dysphoric-mood related rumination. The successful pilot testing of the WM-targeted intervention supports the conduct of a fully powered randomized controlled trial as a relapse prevention approach in remitted MDD.

Patient-Reported Problem Areas in Chronic Traumatic Brain Injury.

OBJECTIVE: The aims of this study were to (1) assess self-reported main problem areas reported by patients with traumatic brain injury (TBI) and their family members in the chronic phase, and (2) compare the self-prioritized problems with difficulties captured by questionnaires and neuropsychological screening through linking to the International Classification of Functioning, Disability and Health (ICF). SETTING: Outpatient clinic at the Oslo University Hospital, Norway. PARTICIPANTS: In total, 120 patients with TBI were recruited, of whom, 78 had a participating family member. Eligibility criteria were a clinical TBI diagnosis with verified intracranial injury, living at home, aged 18 to 72 years, 2 years or more postinjury, and experiencing perceived TBI-related difficulties, reduced physical and mental health, or difficulties with participation in everyday life. Patients with severe psychiatric or neurological disorders or inability to participate in goal-setting processes were excluded. DESIGN: Cross-sectional. MAIN MEASURES: Target Outcomes, that is, 3 main TBI-related problem areas reported by patients and family members, collected in a semistructured interview; standardized questionnaires of TBI-related symptoms, anxiety, depression, functioning, and health-related quality of life; neuropsychological screening battery. RESULTS: Target Outcomes were related to cognitive, physical, emotional, and social difficulties. Target Outcomes were linked to 12 chapters and 112 distinct categories in the ICF, while standardized measures only covered 10 chapters and 28 categories. Some aspects of post-TBI adjustment were found to be insufficiently covered by the ICF classification, such as identity issues, lack of meaningful activities, and feeling lonely. CONCLUSION: The Target Outcomes approach is a useful assessment method in a population with chronic TBI. The standardized questionnaires capture the spectrum of problems, whereas the Target Outcomes approach captures the prioritized individual problems hindering everyday life after TBI. While the standardized measures are an irreplaceable part of the assessment, Target Outcomes ensures patient involvement and may help clinicians better tailor relevant rehabilitation efforts.

Unmet Rehabilitation Needs after Traumatic Brain Injury across Europe: Results from the CENTER-TBI Study.

This study aims to assess rehabilitation needs and provision of rehabilitation services for individuals with moderate-to-severe disability and investigate factors influencing the probability of receiving rehabilitation within six months after traumatic brain injury (TBI). Overall, the analyses included 1206 individuals enrolled in the CENTER-TBI study with severe-to-moderate disability. Impairments in five outcome domains (daily life activities, physical, cognition, speech/language, and psychological) and the use of respective rehabilitation services (occupational therapy, physiotherapy, cognitive and speech therapies, and psychological counselling) were recorded. Sociodemographic and injury-related factors were used to investigate the probability of receiving rehabilitation. Physiotherapy was the most frequently provided rehabilitation service, followed by speech and occupational therapy. Psychological counselling was the least frequently accessed service. The probability of receiving a rehabilitative intervention increased for individuals with greater brain injury severity (odds ratio (OR) 1.75, CI 95%: 1.27-2.42), physical (OR 1.92, CI 95%: 1.21-3.05) and cognitive problems (OR 4.00, CI 95%: 2.34-6.83) but decreased for individuals reporting psychological problems (OR 0.57, CI 95%: 1.21-3.05). The study results emphasize the need for more extensive prescription of rehabilitation services for individuals with disability. Moreover, targeted rehabilitation programs, which aim to improve outcomes, should specifically involve psychological services to meet the needs of individuals recovering from TBI.

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

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

Care transitions in the first 6months following traumatic brain injury: Lessons from the CENTER-TBI study.

BACKGROUND: No large international studies have investigated care transitions during or after acute hospitalisations for traumatic brain injury (TBI). OBJECTIVES: To characterise various TBI-care pathways and the number of associated transitions during the first 6 months after TBI and to assess the impact of these on functional TBI outcome controlled for demographic and injury-related factors. METHODS: This was a cohort study of patients with TBI admitted to various trauma centres enrolled in the Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI) study. Number of transitions and specific care pathways were identified. Multiple logistic regression analyses were used to assess the impact of number of transitions and care pathways on functional outcome at 6 months post-injury as assessed by the Glasgow Outcome Scale-Extended (GOSE). RESULTS: In total, 3133 patients survived the acute TBI-care pathway and had at least one documented in-hospital transition at 6-month follow-up. The median number of transitions was 3 (interquartile range 2-3). The number of transitions did not predict functional outcome at 6 months (odds ratio 1.08, 95% confidence interval 1.09-1.18; P=0.063). A total of 378 different care pathways were identified; 8 were identical for at least 100 patients and characterized as "common pathways". Five of these common care pathways predicted better functional outcomes at 6 months, and the remaining 3 pathways were unrelated to outcome. In both models, increased age, violence as the cause of injury, pre-injury presence of systemic disease, both intracranial and overall injury severity, and regions of Southern/Eastern Europe were associated with unfavourable functional outcomes at 6 months. CONCLUSIONS: A high number of different and complex care pathways was found for patients with TBI, particularly those with severe injuries. This high number and variety of care pathway possibilities indicates a need for standardisation and development of "common data elements for TBI care pathways" for future studies. STUDY REGISTRATION: ClinicalTrials.gov NCT02210221.

Traumatic brain injury-needs and treatment options in the chronic phase: Study protocol for a randomized controlled community-based intervention.

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.