Responsiveness and minimal important change of specific and generic patient-reported outcome measures for back patients: the Norwegian Neck and Back Register.

PURPOSE: To evaluate responsiveness and minimal important change (MIC) of Oswestry Disability Index (ODI), pain during activity on a numeric rating scale (NRSa) and health related quality of life (EQ-5D) based on data from the Norwegian neck and back registry (NNRR). METHODS: A total of 1617 patients who responded to NNRR follow-up after both 6 and 12 months were included in this study. Responsiveness was calculated using standardized response mean and area under the receiver operating characteristic (ROC) curve. We calculated MIC with both an anchor-based and distribution-based method. RESULTS: The condition specific ODI had best responsiveness, the more generic NRSa and EQ-5D had lower responsiveness. We found that the MIC for ODI varied from 3.0 to 9.5, from 0.4 to 2.5 for NRSa while the EQ5D varied from 0.05 to 0.12 depending on the method for calculation. CONCLUSION: In a register based back pain population, the condition specific ODI was more responsive to change than the more generic tools NRSa and EQ5D. The variations in responsiveness and MIC estimates also indicate that they should be regarded as indicative, rather than fixed estimates.

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.

Is radial extracorporeal shock wave therapy (rESWT), sham-rESWT or a standardised exercise programme in combination with advice plus customised foot orthoses more effective than advice plus customised foot orthoses alone in the treatment of plantar fasciopathy? A double-blind, randomised, sham-controlled trial.

OBJECTIVES: To assess whether radial extracorporeal shock wave therapy (rESWT), sham-rESWT or a standardised exercise programme in combination with advice plus customised foot orthoses is more effective than advice plus customised foot orthoses alone in alleviating heel pain in patients with plantar fasciopathy. METHODS: 200 patients with plantar fasciopathy were included in a four-arm, parallel-group, sham-controlled, observer-blinded, partly patient-blinded trial. At baseline, before randomisation, all patients received advice plus customised foot orthoses. Patients were randomised to rESWT (n=50), sham-rESWT (n=50), exercise (n=50) or advice plus customised foot orthoses alone (n=50). Patients in the rESWT and sham-rESWT groups received three treatments. The exercise programme comprised two exercises performed three times a week for 12 weeks, including eight supervised sessions with a physiotherapist. Patients allocated to advice plus customised foot orthoses did not receive additional treatment. The primary outcome was change in heel pain during activity in the previous week per Numeric Rating Scale (0-10) from baseline to 6-month follow-up. The outcome was collected at baseline, and 3, 6 and 12 months. RESULTS: The primary analysis showed no statistically significant between-group differences in mean change in heel pain during activity for rESWT versus advice plus customised foot orthoses (-0.02, 95% CI -1.01 to 0.96), sham-rESWT versus advice plus customised foot orthoses (0.52, 95% CI -0.49 to 1.53) and exercise versus advice plus customised foot orthoses (-0.11, 95% CI -1.11 to 0.89) at 6 months. CONCLUSION: In patients with plantar fasciopathy, there was no additional benefit of rESWT, sham-rESWT or a standardised exercise programme over advice plus customised foot orthoses in alleviating heel pain. TRIAL REGISTRATION NUMBER: NCT03472989.

Frequency and predictors of headache in the first 12 months after traumatic brain injury: results from CENTER-TBI.

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

Workplace Factors Associated With Return to Work After Mild-to-Moderate Traumatic Brain Injury.

OBJECTIVE: Sociodemographic and injury-related predictors for return to work (RTW) after mild-to-moderate traumatic brain injury (TBI) have been extensively explored. However, there is a knowledge gap regarding work-related predictors of RTW. The main aim of this study was to explore work-related predictors of work participation 6 and 12 months after mild-to-moderate TBI. SETTING: Data were collected at baseline 8 to 12 weeks after injury, and 3, 6, and 12 months after baseline, at a specialized TBI rehabilitation outpatient clinic at Oslo University Hospital, Oslo, Norway. PARTICIPANTS: Eligible patients had suffered a mild-to-moderate TBI 8 to 12 weeks previously, were employed 50% or more at time of injury, were between 18 and 60 years of age, and sick listed 50% or more at time of inclusion due to symptoms of TBI (based on the Rivermead Post-Concussion Symptoms Questionnaire). In total, 116 patients were included in a randomized controlled trial, of whom 113 were included in the 1-year analysis. DESIGN: Patients were originally included in a randomized controlled trial. There were no between-group differences in RTW after 1 year. Thus, the participants were evaluated as one cohort in this study. MAIN MEASURES: The primary outcome measure was work participation 1 year after study inclusion. Work-related predictors were chosen on the basis of previous research and expert opinion and entered into a multivariable linear regression model. The model controlled for sociodemographic and injury-related factors. RESULTS: The best-fitting model explained 25% of variation in work participation at 1 year. Significant predictors were predictability, quantitative demands and rewards (recognition) at the workplace, private or public employment, symptom burden at baseline, and sex. CONCLUSION: In this study, several work-related predictors outperformed some of the established sociodemographic and injury-related predictors of RTW after TBI, thus stressing the need for further focus and research on amendable predictors of RTW after mild-to-moderate TBI.

The reliability and validity of the Norwegian version of the Victorian Institute of Sports Assessment for gluteal tendinopathy questionnaire (VISA-G-Norwegian) for patients with greater trochanteric pain syndrome.

BACKGROUND: Greater Trochanteric Pain Syndrome (GTPS) is a common chronic musculoskeletal condition that may affect physical function, quality of life and sleep. The Victorian Institute of Sport Assessment-Gluteal questionnaire (VISA-G) has been developed as a Patient-Reported Outcome Measurement (PROM) to address pain, everyday activities, physical activities, and difficulty with weight bearing activities. The aim of the study was to test the reliability, validity and floor and ceiling effects of the Norwegian version of the VISA-G (VISA-G-Norwegian) in a population with GTPS in a specialist health care setting. METHODS: This psychometric evaluation of the VISA-G-Norwegian questionnaire were conducted with a prospective observational design. The VISA-G was translated into Norwegian following recommended guidelines. A subgroup repeated the VISA-G-Norwegian a week after the initial submission. For the reliability, the Intraclass Correlation Coefficient (ICC2.1), Standard Error of the Measurement (SEM) and the Smallest Detectable Change (SDC95%) were calculated. Internal consistency was measured using a Cronbach´s alpha. Floor and ceiling effects were evaluated, and construct validity was assessed with three a priori hypotheses. RESULTS: 78 participants were included in the study of which 47 stable participants undertook the test-retest reliability arm of the study. The ICC2.1 for the total score was 0.85 (95% CI 0.68, 0.92), SEM was 6.6 points and SDC95% 18.4 points. Cronbach`s alpha was 0.77 (95% CI 0.69, 0.84). No floor or ceiling effects were found in the total score, but ceiling effect was found in three of the eight items. For construct validity, one of the three hypotheses were confirmed. VISA-G-Norwegian correlated to the modified Harris Hip Score (mHHS), Oswestry Disability Questionnaire (ODI) and Numeric Pain Rating Scale (NPRS), 0.64, -0.75 and - 0.63 respectively. CONCLUSION: The VISA-G-Norwegian has acceptable reliability and validity, despite ceiling effect of individual items. The large SDC95% should be considered when measuring change in similar cohorts with GTPS. For a potential future version, it would be recommended to consider response options for questions with ceiling effect and the comprehensibility of question eight. TRIAL REGISTRATION: Registered at ClinicalTrials.gov the 28/02/2020 (NCT04289922).

Discrepancy between disability and reported well-being after traumatic brain injury.

BACKGROUND: Following traumatic brain injury (TBI), the clinical focus is often on disability. However, patients' perceptions of well-being can be discordant with their disability level, referred to as the 'disability paradox'. We aimed to examine the relationship between disability and health-related quality of life (HRQoL) following TBI, while taking variation in personal, injury-related and environment factors into account. METHODS: We used data from the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury study. Disability was assessed 6 months post-injury by the Glasgow Outcome Scale-Extended (GOSE). HRQoL was assessed by the SF-12v2 physical and mental component summary scores and the Quality of Life after Traumatic Brain Injury overall scale. We examined mean total and domain HRQoL scores by GOSE. We quantified variance in HRQoL explained by GOSE, personal, injury-related and environment factors with multivariable regression. RESULTS: Six-month outcome assessments were completed in 2075 patients, of whom 78% had mild TBI (Glasgow Coma Scale 13-15). Patients with severe disability had higher HRQoL than expected on the basis of GOSE alone, particularly after mild TBI. Up to 50% of patients with severe disability reported HRQoL scores within the normative range. GOSE, personal, injury-related and environment factors explained a limited amount of variance in HRQoL (up to 29%). CONCLUSION: Contrary to the idea that discrepancies are unusual, many patients with poor functional outcomes reported well-being that was at or above the boundary considered satisfactory for the normative sample. These findings challenge the idea that satisfactory HRQoL in patients with disability should be described as 'paradoxical' and question common views of what constitutes 'unfavourable' outcome.

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).

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.

"Psychometric properties of the Norwegian foot function index revised short form".

BACKGROUND: Foot disorders affect up to one quarter of the adult population. Plantar fasciopathy is a common cause of foot pain associated with decreased activity level and quality of life. Patient-reported outcome measures are important in assessing the burden of a condition as well as in research on the effects of interventions. The Foot Function Index revised short form (FFI-RS) is a region specific questionnaire frequently used in research. This study aimed to cross-culturally adapt the FFI-RS into Norwegian and to test its psychometric properties. METHODS: The FFI-RS was translated into Norwegian (FFI-RSN) following international guidelines. 139 patients with foot disorders (88% with plantar fasciopathy) were included at baseline to measure internal consistency, explorative factor analysis, construct validity and floor and ceiling effects. 54 patients were included after 1 week for test-retest reliability and smallest detectable change analyses. 100 patients were included for responsiveness and minimal important change at 3 months. RESULTS: Cronbach's alpha for internal consistency was 0.97 and factor analysis supported the use of the total score of the FFI-RSN. Two out of three predefined hypotheses were confirmed by assessing the construct validity with Spearman's correlation coefficient. Quadratic weighted Kappa for test-retest reliability showed 0.91 (95% CI 0.86-0.96) and the smallest detectable change was 6.5%. The minimal important change was 8.4% and the area under the receiver operating characteristic curve for responsiveness was 0.78 (95% CI 0.69-0.87). We found no floor or ceiling effects on the total score of the FFI-RSN. CONCLUSIONS: The present study showed excellent reliability of the FFI-RSN and supports the use of the total score of the questionnaire. Furthermore, we found the FFI-RSN to have acceptable responsiveness in relation to change in general health. Smallest detectable change, minimal important change and responsiveness were presented as novel results of the total score of the FFI-RS. FFI-RSN can be used to evaluate global foot health in clinical or research settings with Norwegian patients suffering from plantar fasciopathy. TRIAL REGISTRATION: Clinical Trials.gov NCT04207164 . Initial release 01.11.19.

The Readiness for Return to Work Scale; Does it Help in Evaluation of Return to Work?

Purpose The Readiness for Return to Work (RRTW) scale is used to evaluate workers' readiness to resume work after sick leave. Previous research has questioned the RRTW scale's constructs and stages. The aim of this study was to assess the unidimensionality of the RRTW scale and its six subscales by evaluating its fit to the Rasch model, and furthermore to assess if Rasch-based scaling would improve its predictive value, compared with the conventional use of the scale. Methods A prospective cohort study with 12 months of follow-up. Individuals (n = 397) sick-listed due to musculoskeletal, unspecified, or common mental health disorders undergoing rehabilitation were included: 191 were full-time sick-listed (not working), and 206 were part-time sick-listed (working). A Rasch analysis was applied to evaluate the measurement properties of the RRTW scale in the working and not working participants at baseline. Linear and logistic regressions were used to assess how well Rasch-based scaling predicted future work participation during the 12 months of follow-up. Results The RRTW subscales had too few items to represent underlying dimensions properly, and the items fitted poorly within the subscales. A constructed variable based on the items that fit together for not working individuals poorly predicted future work participation. The individuals' scores across stages were disordered, indicating a lack of ordered stages. Conclusions This study reveals poor measurement properties of the Norwegian version of the RRTW scale in individuals with musculoskeletal and common mental disorders, with neither the subscales nor the stages closely associated with return to work.

Post-concussion symptoms three months after mild-to-moderate TBI: characteristics of sick-listed patients referred to specialized treatment and consequences of intracranial injury.

Objective: To present pre-injury, injury-related, work-related and post-injury characteristics, and to compare patients with and without traumatic intracranial abnormalities, in a treatment-seeking sample with persistent post-concussion symptoms (PPCS) after mild-to-moderate TBI.Methods: Cross-sectional design in the context of a specialized TBI outpatient clinic. Eligible patients were aged 18-60 years, employed ≥ 50% at time of injury, and sick listed ≥ 50% at inclusion due to PPCS. Data were collected 8-12 weeks after injury through review of medical records, semi-structured interviews, questionnaires, and neuropsychological screening.Results: The study included 116 patients, of whom 60% were women, and predominantly white-collar workers in full-time positions. Ninety-four percent had a mild TBI, and 23% had intracranial abnormalities. The full sample reported high somatic, emotional, and cognitive symptom burden, and decreased health-related quality of life. Patients with normal CT/MRI results reported higher overall symptom burden, while patients with intracranial abnormalities had worse memory function.Conclusion: Injury severity and traumatic intracranial radiological findings should not be the sole ground for planning of rehabilitation service provision in patients with PPCS, as subjective complaints do not necessarily co-vary with these variables.

Pre- and in-hospital mortality for moderate-to-severe traumatic brain injuries: an analysis of the National Trauma Data Bank (2008-2014).

Objectives: This study aimed to: (1) evaluate pre- and in-hospital mortality for moderate-to-severe TBI in the U.S. by injury type (blunt vs. penetrating) and (2) estimate annual regression-adjusted mortality from 2008-2014.Methods: Data were analyzed from the National Trauma Data Bank (N=247,648). Multivariable logistic regression analyses were performed by injury type to assess changes in mortality between study periods (early period: 2008-2010; late period: 2011-2014) and to estimate annual regression-adjusted mortality. Mortality odds ratios and 95% confidence intervals were calculated.Results: Total observed mortality was 18.8%. After covariate adjustment, patients in the late period had an increased odds of prehospital mortality compared to patients in the early period for blunt (OR: 4.69; 95%CI: 4.41-4.98) and penetrating trauma (OR: 4.71; 95%CI: 4.39-5.06). In contrast, patients in the late period had a decreased odds of in-hospital mortality compared to patients in the early period for blunt (OR: 0.95; 95%CI: 0.91-0.98) and penetrating trauma (OR: 0.92; 95%CI: 0.85-0.98).Conclusions: The decreasing in-hospital mortality trend is consistent with previous literature. Additional research is warranted to validate the observed increase in prehospital mortality and to identify best practices that can improve prehospital outcomes for patients with moderate-to-severe TBI.

Marfan syndrome: Evolving organ manifestations-A 10-year follow-up study.

The age-dependent penetrance of organ manifestations in Marfan syndrome (MFS) is not known. The aims of this follow-up study were to explore how clinical features change over a 10-year period in the same Norwegian MFS cohort. In 2003-2004, we investigated 105 adults for all manifestations in the 1996 Ghent nosology. Ten years later, we performed follow-up investigations of the survivors (n = 48) who consented. Forty-six fulfilled the revised Ghent criteria. Median age: females 51 years, range 32-80 years; males 45 years, range 30-67 years. New aortic root dilatation was detected in patients up to 70 years. Ascending aortic pathology was diagnosed in 93 versus 72% at baseline. Sixty-five percent had undergone aortic surgery compared to 39% at baseline. Pulmonary trunk mean diameter had increased significantly compared to baseline. From inclusion to follow-up, two patients (three eyes) developed ectopia lentis, four developed dural ectasia, four developed scoliosis, three developed incisional or recurrent herniae, and 14 developed hindfoot deformity. No changes were found regarding protrusio acetabuli, spontaneous pneumothorax, or striae atrophicae. The study confirms that knowledge of incidence and progression of organ manifestations throughout life is important for diagnosis, treatment, and follow-up of patients with verified or suspected MFS.

Trajectory of 10-Year Neurocognitive Functioning After Moderate-Severe Traumatic Brain Injury: Early Associations and Clinical Application.

OBJECTIVE: This study aimed to explore the 10-year trajectories of neurocognitive domains after moderate-severe traumatic brain injury (TBI), to identify factors related to long-term neurocognitive functioning, and to investigate whether performance remained stable or changed over time. METHOD: Seventy-nine patients with moderate-severe TBI between the ages of 16 and 55 years were assessed at 3 months, 1, 5, and 10 years postinjury using neuropsychological tests and functional outcomes. Three hierarchical linear models were used to investigate the relationships of domain-specific neurocognitive trajectories (Memory, Executive function, and Reasoning) with injury severity, demographics, functional outcome at 3 months (Glasgow Outcome Scale-Extended) and emotional distress at 1 year (Symptom Checklist 90-Revised). RESULTS: Education, injury severity measures, functional outcome, and emotional distress were significantly associated with both Memory and Executive function. Education and emotional distress were related to Reasoning. The interaction effects between time and these predictors in predicting neurocognitive trajectories were nonsignificant. Among patients with data at 1 and 10 year follow-ups (n = 47), 94-96% exhibited stable scores on Executive function and Reasoning tasks, and 83% demonstrated stable scores on Memory tasks. Significant memory decline was presented in 11% of patients. CONCLUSIONS: The findings highlight the differential contribution of variables in their relationships with long-term neurocognitive functioning after moderate-severe TBI. Injury severity was important for Memory outcomes, whereas emotional distress influenced all neurocognitive domains. Reasoning (intellectual) abilities were relatively robust after TBI. While the majority of patients appeared to be cognitively stable beyond the first year, a small subset demonstrated a significant memory decline over time.

Health-related quality of life in Marfan syndrome: a 10-year follow-up.

BACKGROUND: Marfan syndrome, a rare hereditary connective tissue disorder caused by mutations in fibrillin-1, can affect many organ systems, especially the cardiovascular system. Previous research has paid less attention to health-related quality of life and prospective studies on this topic are needed. The aim of this study was to assess changes in health-related quality of life after 10 years in a Norwegian Marfan syndrome cohort. METHODS: Forty-seven Marfan syndrome patients ≥ 18 years were investigated for all organ manifestations in the 1996 Ghent nosology and completed the self-reported questionnaire, Short-Form-36 Health Survey, at baseline in 2003-2004 and at follow-up in 2014-2015. Paired sample t tests were performed to compare means and multiple regression analyses were performed with age, sex, new cardiovascular and new non-cardiovascular pathology as predictors. RESULTS: At 10-year follow-up: a significant decline was found in the physical domain. The mental domain was unchanged. Older age predicted a larger decline in physical health-related quality of life. None of the chosen Marfan-related variables predicted changes in any of the subscales of the Short-Form 36 Health Survey or in the physical or the mental domain. CONCLUSION: Knowledge of decline in the physical domain, not related to organ affections, may be important in the follow-up of Marfan syndrome patients.

The Family Needs Questionnaire-Revised: a Rasch analysis of measurement properties in the chronic phase after traumatic brain injury.

PURPOSE: The main aim was to evaluate the measurement properties of the Family Needs Questionnaire-Revised (FNQ-R) in family members of individuals living with severe traumatic brain injury (TBI). METHODS: A total of 309 family members of individuals with severe TBI from Colombia, Denmark, Mexico, Norway and Spain participated. Rasch analysis of the FNQ-R and its 6 subscales was conducted. RESULTS: The Rasch analysis indicated a lack of fit of the 37-item FNQ-R to one single underlying construct of needs, and less than half of the items were invariant across the countries. Misfit of single items was revealed in the Need for Health Information, Need for Emotional Support, Need for Instrumental Support, Need for Professional Support and Need for Community Support Network subscales. Fit to the Rasch model was obtained after removal of misfitting items. The Involvement in Care subscale had too few items to be adequately assessed by the Rasch approach. CONCLUSION: The FNQ-R is a well-targeted instrument for assessing the unmet needs of caregivers regarding the need for health information, emotional support, professional support and a community support network after some scoring adjustment and the removal of misfitting items. Caution should be taken when comparing responses across countries.

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.