Needs for community-based rehabilitation services and support 12 months after moderate and severe physical traumatic injuries: a brief report.

ABSTRACT: Patients with physical traumatic injuries frequently require long-term rehabilitation services. To strengthen rehabilitation services in the post-acute phase, we need to assess characteristics of this population and their healthcare and rehabilitation needs in the community. This brief report summarizes the frequency of unmet rehabilitation needs in community-based rehabilitation during the first year after moderate and severe trauma. Additionally, the associations between sociodemographic, injury severity factors and unmet needs were examined. Data from a prospective multicenter cohort study of patients with moderate and severe trauma (New Injury Severity Score > 9) of all ages discharged alive from two regional trauma centers in 2020 were used. Needs were estimated using the Needs and Provision Complexity Scale. Overall, 46% of patients had unmet needs at 12 months post-injury, particularly related to the provision of rehabilitation services, specialist follow-ups, and social and family support. The probability of unmet needs was associated with age, pre-injury comorbidities, and impaired functioning. Our findings support strategies targeting younger patients, those with pre-injury comorbidities, and those with higher levels of disability and provide a starting point for the development of standardized rehabilitation needs assessment and guidelines following injury.

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).

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.

Sub-symptom threshold aerobic exercise for patients with persisting post-concussion symptoms and exercise intolerance after mild traumatic brain injury - a study protocol with a nested feasibility study for a randomized controlled trial.

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.

Associations between protective resources and family functioning after traumatic brain injury: A cross-sectional study using a structural equation modeling approach.

BACKGROUND: A strength-based approach in the rehabilitation after traumatic brain injury (TBI) is recommended for patients and their families. However, further exploration of the complexity of individual and family factors is needed. OBJECTIVE: To explore the associations between individual protective resources in patients and family members and the overall family functioning using a strength-based approach. METHODS: Secondary analysis of data collected at baseline in a randomized controlled trial. Structural equation modeling with two latent constructs and six observed variables was performed. Outcome measures included the Resilience Scale for Adults, the Mental Component Summary (SF-36), the General Self-Efficacy Scale, and the Family Adaptability and Cohesion Evaluation Scale-IV. RESULTS: Hundred and twenty-two participants (60 patients, 62 family members) with a mean age of 43 years were included at a median of 11 months post-injury. The final model demonstrated a strong covariance (coefficient = 0.61) between the latent Protective construct and Family functioning. Model-fit statistics indicated an acceptable fit to the data. CONCLUSION: Higher levels of protective resources (resilience, self-efficacy, and mental HRQL) were positively associated with family functioning. These resources should be further assessed in patients and their families, to identify factors that can be strengthened through TBI rehabilitation intervention.

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.

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.

Development of a Minimum Reporting Set of Contextual Factors for Rehabilitation Studies: A Delphi Study.

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.

Cost-effectiveness analysis of combined cognitive and vocational rehabilitation in patients with mild-to-moderate TBI: results from a randomized controlled trial.

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 .

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.

Rehabilitation Goals and Effects of Goal Achievement on Outcome Following an Adapted Physical Activity-Based Rehabilitation Intervention.

PURPOSE: To explore the goal-setting process carried out at a rehabilitation facility providing adapted physical activity, by 1) identifying goals set by individuals with chronic disabilities, 2) comparing these goals to the negotiated goals set in collaboration with the rehabilitation team and 3) assessing goal achievement and its association with self-reported functioning after 12 months. METHODS: A prospective observational study where adults (18-67 years) admitted to Beitostølen Healthsports Centre (n=151) reported mental and physical functioning measured by the Medical Outcomes Study 12-item Short-Form Health Survey (SF-12) administered at baseline (eight weeks before rehabilitation), admission, discharge and follow-up 12 months after rehabilitation. The participants provided their individual goals for rehabilitation in the admission questionnaire. Individual goals were compared to negotiated goals set by the participants and the rehabilitation team together as part of the goal-setting process at the facility. The goals were linked to The International Classification of Functioning, Disability and Health (ICF) for comparison. Goal achievement was assessed on a 10-point numeric rating scale (NRS) in the discharge questionnaire. The association between SF-12 physical and mental functioning at long-term follow-up and goal achievement was explored. RESULTS: The 293 individual goals and the 407 negotiated goals were most frequently linked to the ICF-component Body Functions. When comparing negotiated to individual goals, negotiated goals were more frequently linked to activities and participation. Goals to wide to be linked to the ICF were less frequent. For 76% of the participants, content of individual goals was captured in negotiated goals. Goal achievement with NRS scores ≥9 points was reported by 66% of the included participants. Goal achievement was a significant predictor for long-term mental functioning (p=0.04). CONCLUSION: Collaboration between participants and health professionals resulted in more specific goals directed towards the activities and participation component. Goal achievement predicted long-term mental functioning following rehabilitation.

Towards standardized reporting of service organization in rehabilitation for clinical trials.

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.

Effect of vestibular rehabilitation on change in health-related quality of life in patients with dizziness and balance problems after traumatic brain injury: A randomized controlled trial.

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<0.001. CONCLUSION: There was an effect in favour of the intervention group in improvement in health-related quality of life. Changes on the Rivermead Post-concussion Symptoms Questionnaire were also associated with change on the Quality of Life after Brain Injury.

The effectiveness of a family-centred intervention after traumatic brain injury: A pragmatic randomised controlled trial.

OBJECTIVES: To determine the effectiveness of a family-centred intervention for patients with traumatic brain injury and family members. DESIGN: Open-labelled, two-armed randomised controlled trial. SETTINGS: Outpatient clinic and family residences. PARTICIPANTS: Sixty-one patients (33 women) with traumatic brain injury, with mean (SD) age 43.8 (12.2), and 63 family members (33 women), with mean (SD) age 42.6 (11.3), were assign to intervention (n = 30 families) and control group (n = 31 families). INTERVENTION: An eight-session single-family intervention to improve individual and family functioning. OUTCOME MEASURES: Self-reported questionnaires at start-of-treatment, median (IQR) 11.4 (8.4, 15.9) months post-injury, and at two follow-ups, 2.7 (2.3, 3.8) and 9.2 (8.2, 9.9) months after start-of-treatment. Primary outcome measures were the SF-36 Mental Component Summary (MCS) and Caregiver Burden Scale (CGB). Secondary outcome measures were the Family Adaptability and Cohesion Evaluation Scale (FACES) and Quality of Life after Brain Injury Questionnaire (QOLIBRI). Group differences were analysed with linear mixed-model analysis for repeated measurements. RESULTS: No significant between-group differences were found. The intervention group significantly improved on the MCS, the CGB and FACES in the treatment period, whereas the controls did not. The mean (SD) MCS change in the treatment period was 2.4 (1.1) points P = 0.028 in the intervention group. Mean (SE) MCS scores were 47.9 (1.26) and 47.3 (1.27) in the intervention and control group at last follow-up. CONCLUSIONS: Receiving an eight-session family intervention, in addition to specialised rehabilitation for the patients, was not superior to rehabilitation at a specialised traumatic brain injury outpatient clinic.

Effectiveness of Combining Compensatory Cognitive Training and Vocational Intervention vs. Treatment as Usual on Return to Work Following Mild-to-Moderate Traumatic Brain Injury: Interim Analysis at 3 and 6 Month Follow-Up.

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.

Mental Health and Family Functioning in Patients and Their Family Members after Traumatic Brain Injury: A Cross-Sectional Study.

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.

Description of health-related rehabilitation service provision and delivery in randomized controlled trials: A topic review.

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.

Long-term follow-up of use of therapy services for patients with moderate-to-severe traumatic brain injury.

OBJECTIVES: To examine the probabilities and baseline predictors of the use of physical therapy, occupational therapy and speech therapy over a period of 10 years after traumatic brain injury. DESIGN: Longitudinal prospective follow-up at 1, 2, 5 and 10 years after traumatic brain injury. PARTICIPANTS: A total of 97 patients with moderate-to-severe traumatic brain injury recruited from Oslo University Hospital, Norway, during acute hospital admission in 2005-2007. METHODS: Socio-demographics and injury characteristics were recorded at baseline. Use of physical therapy, occupational therapy and speech therapy were recorded at follow-ups. Hierarchical linear modelling was applied to examine service use probabilities across the 4 time-points. RESULTS: Service use decreased substantially over time, with physical therapy being the main service utilized at the 10-year follow-up (physical therapy 16%, occupational therapy 1%, speech therapy 3%). Use of services was related to severity of injury (CT head severity scores and post-traumatic amnesia), female sex, and pre-injury employment. In addition, in this sample, time since injury was associated with use of occupational therapy and speech therapy. CONCLUSION: This study presents a novel model for the long-term probability of use of physical therapy, occupational therapy and speech therapy following traumatic brain injury. The use of services was much lower than the expected problem profile of severe traumatic brain injuries, suggesting an insufficient long-term provision of traditional traumatic brain injury rehabilitation services.

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.

Associations between shoulder pain and functioning on the ICF checklist and the disabilities of the arm, shoulder, and hand scale - a cross-sectional study.

Purpose: The association between patients' shoulder pain and functioning according to the International Classification of Functioning, Disability, and Health (ICF), and outcome on a condition specific patient reported outcome measure (PROM), has not been studied. The aim was to investigate how the most common problems on the ICF checklist were associated with shoulder function and disability.Materials and methods: In a cross-sectional design 164 patients ≥ 18 years with chronic shoulder pain were included. The ICF checklist, the Disability of the Arm, Shoulder, and Hand (DASH) outcome measure and the Self-Report Comorbidity Questionnaire were used. A hierarchical regression model tested categories for functioning on the ICF checklist associated with disability on the DASH.Results: Mean age was 46.5 years, 54% were women. 85% had had the shoulder pain longer than 6 months. Mean DASH score was 33.2 points (SD 17.1). Adjusted R2 was 0.67. Older age, being woman and having a lower education explained 22% of the variance on the DASH. The body functions bodily pain, mobility of joints and energy and drive function explained 30% of the variance, and the activities and participation problems lifting and carrying objects, washing oneself and recreation and leisure explained an additional 13%.Conclusions: The shoulder disability was multi-dimensional and comprised body functions and activities and participation. And 67% of the variance in the DASH score was explained.Implications for rehabilitationPersistent shoulder pain results in multi-dimensional disability calling for a broader assessment of function.A biopsychosocial approach to shoulder pain and disability is recommended.Functioning assessed on the ICF checklist can be applied in the assessment of chronic shoulder pain as it contributes to the understanding of self-reported disability on a region specific outcome measure.