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.

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.

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 .

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.

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.

Family needs at one and two years after severe traumatic brain injury: a prospective study of changes and predictors.

Objective: To assess changes in family needs between the first and second years after severe traumatic brain injury (sTBI) and to identify factors predicting unmet family needs.Design: Prospective Norwegian multicenter cohort study.Participants: The family members of 110 patients with sTBI were followed up at one year, and family members of 70 patients also at two years after trauma.Main measure: The Family Needs Questionnaire-Revised (FNQ-R).Results: Mean ratings of met family needs changed with a small decline between one year and two years post-injury on the FNQ-R subscales of Health Information and of Community Support Network. Proportions of needs met at one and two years ranged between 28% and 55%. Family needs most often met were from the Health Information subscale, and needs most often unmet were from the Emotional Support subscale. Caring for older patients, patients with more functional disabilities, female patients and being a spouse of a patient were associated with statistically significantly greater unmet family needs.Conclusion: Family members of survivors of traumatic brain injuries experience high levels of unmet needs, and rating of met needs tends to decline from one to two years post-injury. The identified predictors of unmet needs can contribute to guiding services following sTBI.

The One or the Many: Quantified Subjectivity and Aggregated Uniqueness in Qualitative Rehabilitation Research.

This article aims to identify and critically assess qualitative intervention studies of rehabilitation processes that target young adults. By applying a meta-epistemological approach inspired by the works of Michel Foucault and Julia Kristeva, we examine how the included studies present qualitative knowledge and whether they adhere to their own stated principles of qualitative knowledge. Through their stated aims and theoretical framing, the articles draw attention to individual processes of meaning making. Nonetheless, we find that the articles to a great extent emphasize frequencies of the qualitative data they present. Individual processes and experiences are subject to subdivisions and categorization and transformed into manageable objects of knowledge. In conclusion, these studies, with one important exception, contribute to self-marginalization of the knowledge they themselves promote: They undermine the uniqueness of the qualitative knowledge they proclaim by focusing on frequency and the general patterns and categories encompassing the unique.

User involvement and experiential knowledge in interprofessional rehabilitation: a grounded theory study.

BACKGROUND: User involvement is increasingly important in developing relevant health care services. The aim of this study was to contribute to a deeper understanding of user involvement and patients' experiential knowledge as recognized and incorporated into clinical practice by rehabilitation professionals. METHODS: A qualitative design using a grounded theory approach was applied. Data were collected by observations of the interprofessional meetings at two rehabilitation units treating patients with traumatic brain injury and multiple trauma and by individual semi-structured interviews with rehabilitation professionals. RESULTS: The professionals recognized and incorporated user involvement into clinical practice as formal or authentic. Formal user involvement was sometimes considered pro forma. Incorporating patient' experiential knowledge was considered a part of authentic user involvement. Possible gaps between the patients' experiential knowledge and professional expertise were recognized. Challenges included dealing with 'artifacts', sources of information external to the patients' own experiences, and addressing the patients' possibly reduced insight due to trauma. CONCLUSION: Patients' experiential knowledge was recognized as an essential component of the professionals' knowledge base. The professionals considered user involvement and patients' experiential knowledge as part of their clinical practice. Implementation of user involvement and contribution of patients' experiential knowledge could be improved by understanding the issues raised in practice, such as possible negative consequences of user involvement in form of burdening or disempowering the patients. A better understanding of the characteristics and measures of user involvement is necessary in order to be able to offer its full benefits for both the patients and the professionals.

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).

Proposed categories for reporting of service organization in rehabilitation in clinical trials: a discussion paper.

BACKGROUND: The lack of standardized reporting for crucial organizational factors in rehabilitation poses a significant barrier to understanding their impact on patient outcomes in clinical trials and meta-analyses. AIM: Based on the categories in the International Classification of Service Organization in Rehabilitation (ICSO-R 2.0), we aimed to develop reporting standards specifically for organizational factors in clinical trials. METHODS: A comprehensive two-step process was conducted. In Step 1, important categories were identified. The identification was based on previous results from a Delphi survey with international stakeholder participation, two systematic literature reviews and results from focus groups with users in Germany, Indonesia and Norway. Step 2 involved the necessary reduction of categories and the proposal of reporting specifications, achieved through two voting rounds among key researchers, stakeholders and users. RESULTS: The suggested minimum reporting set comprises Context and Setting as well as Quality assurance and management. The Context and Setting is proposed to include whether the intervention is delivered by Hospital, Community or Other service providers. The Mode of delivery is proposed to be specified as Inpatient, Outpatient, In-home, or Tele-rehabilitation. Furthermore, the Level of specialization (Primary/Secondary) and the Phase of service delivery Acute, Subacute or Long-term rehabilitation services should be reported. The Quality assurance and management should be reported as Yes or No, with the option Yes requiring description of the quality assurance applied in the methods section. CONCLUSIONS: This study proposed a compulsory and standardized reporting of organizational factors in clinical trials to facilitate the generation of scientific evidence regarding effective service provision and delivery in rehabilitation medicine. Authors are encouraged to consider the proposed reporting set to testing, criticism, and modification to enhance its applicability and robustness.

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 postacute 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-mo postinjury, 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, preinjury comorbidities, and impaired functioning. Our findings support strategies targeting younger patients, those with preinjury comorbidities, and those with higher levels of disability and provide a starting point for the development of standardized rehabilitation needs assessment and guidelines after injury.

Self-management support program delivered in the sub-acute phase after traumatic injury-study protocol for a pragmatic randomized controlled trial.

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.

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.

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.

The trajectory of physical and mental health from injury to 5 years after multiple trauma: a prospective, longitudinal cohort study.

OBJECTIVES: To describe the trajectory of physical and mental health from injury to 5 years postinjury for patients with multiple trauma, and to examine predictors of recovery of physical and mental health. DESIGN: A prospective, longitudinal cohort study with data from injury (baseline), the return home (t1), and 1 (t2), 2 (t3), and 5 (t4) years. SETTING: Hospital and community setting. PARTICIPANTS: Patients (N=105; mean age ± SD, 35.3±14.0y; age range, 18-67y; 83% men) with multiple trauma and a New Injury Severity Score (NISS) ≥16 treated at a regional trauma referral center. Mean NISS ± SD was 34.6±12.6, and mean Glasgow Coma Scale (GCS) score ± SD was 12.2±3.9. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Medical Outcomes Study 36-Item Short-Form Health Survey physical component summary (PCS) and mental component summary (MCS), injury severity parameters, and World Health Organization Disability Assessment Schedule II (WHODAS II) for activities and participation. RESULTS: The proportion with poor physical health (<40 points on the PCS) stabilized at 56% at t4 from 81% at t1. The proportion with poor mental health (<40 points on the MCS) stabilized at 31% at t4 from 43% at t1. Generalized estimating equations showed that predictors of PCS were time points of measurement (Wald, 85.50; P<.001), GCS (B=-.48, P=.004), time in hospital/rehabilitation (B=-.22, P=.001), and the rank-transformed WHODAS II subscales Getting around (B=.16, P<.001) and Participation in society (B=.06, P=.015). Predictors of MCS were time points of measurement (Wald 13.46, P=.004), sex (men/women) (B=-4.24, P=.003), education (low/high) (B=3.43, P=.019), and WHODAS II cognitive function (B=.18, P<.001) and Participation in society (B=.18, P≤.001). CONCLUSIONS: Physical and mental health over the 5 years improved with time, but was still significantly below population means. The physical and mental health status stabilized, but the recovery trajectories differed for physical and mental health. Predictors of health were personal and injury-related factors and function in a biopsychosocial perspective.

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.

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.

Returning to work after severe multiple injuries: multidimensional functioning and the trajectory from injury to work at 5 years.

BACKGROUND: The process of returning to work (RTW) after multiple injuries is lengthy. Prospective studies with follow-up times of up to 5 years are necessary but lacking. The aim of this study was to describe the trajectory of RTW and to examine the factors that predicted RTW over 5 years for patients with multiple injuries using a prospective cohort design. METHODS: One-hundred one patients aged 18 years to 67 years who had been admitted to a trauma referral center with a New Injury Severity Score >15 starting January 2002 through June 2003 were included. The follow-up rate at 5 years was 79%. Outcomes were assessed 6 weeks after discharge and at 1 year, 2 years, and 5 years postinjury. The instruments used to assess patient status were the Short Form 36, the World Health Organization Disability Assessment Schedule II cognitive subscale, a Cognitive Function Scale, and the Brief Approach/Avoidance Coping Questionnaire. Repeated measures analyses of categorical correlated data were applied. RESULTS: Patient's mean age was 34.5 years (SD, 13.5); 83% were men and 25% had a university or college education; 66% were blue-collar workers. Mean New Injury Severity Score was 35.1 (SD, 12.7). RTW rates were 28% at 1 year, 43% at 2 years, and 49% at 5 years postinjury. There were differences among patients in RTW status, and personal factors and physical and psychosocial functioning. Predictors of RTW were as follows: measurement occasion, education (high/low), coping, and physical and cognitive functioning. The proportion of unexplained variation between subjects in the models was 31% to 55%. CONCLUSION: Of the patients included in this study, 49% achieved RTW, and 23% received full disability benefits. Higher education; better physical, social, and cognitive functioning; and coping strategies all predicted RTW.

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.

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.