Psychometric properties of the Danish version of the Caregiver Burden Scale: Investigating predictors and severity of burden after stroke, spinal cord injury, or traumatic brain injury.

OBJECTIVE: To investigate (i) psychometric properties of the Danish version of the Caregiver Burden Scale, (ii) predictors of burden in caregivers of persons with stroke, spinal cord injury, or traumatic brain injury, and (iii) severity of caregiver burden, and compare level of severity of burden in caregivers of persons with stroke, spinal cord injury, or traumatic brain injury. DESIGN: Cross-sectional study. PARTICIPANTS: Pooled sample of 122 caregivers. METHODS: Psychometric properties including internal consistency, floor and ceiling effects, inter-item and item-total correlation were investigated using the Caregiver Burden Scale. Severity of burden was compared using Fisher's exact test and ANOVA, and predictors of burden were investigated using multiple linear regression models. RESULTS: The total burden score exhibited good internal consistency (α = 0.93), with no floor or ceiling effects. Longer time as a caregiver was a significant predictor of higher total score. The majority (52.2%) reported a low level of caregiver burden (below cut-off of 2.00). Mean scores on the Caregiver Burden Scale were not significantly different among caregivers across diagnostic groups. Differences were found when comparing spinal cord injury caregivers with brain injury caregivers (traumatic brain injury and stroke, collectively), χ2(2) = 6.38, p = 0.04, as spinal cord injury caregivers were more likely to report low levels of burden. CONCLUSION: Good psychometric properties were reported, and most caregivers reported a low level of burden, and longer time as a caregiver was associated with higher burden. Consequently, the Caregiver Burden Scale is a valid measure to use when measuring burden in caregivers of stroke, spinal cord injury, and traumatic brain injury patients.

Labour market participation after spinal cord injury. A register-based cohort study.

STUDY DESIGN: A register based cohort study. OBJECTIVES: To investigate labour market participation following spinal cord injury (SCI) and to describe the impact of personal and SCI characteristics. SETTING: Norway. METHODS: Persons registered with SCI in the Norwegian SCI registry 2011-2017, and matched reference individuals without SCI from the general population (named controls) were followed for up to six years after injury using national registry data on employment, education, income, and social security benefits. Main measures of labour market participation were: (1) Receiving any amount of pay for work, and (2) Receiving sickness and disability benefits. RESULTS: Among the 451 persons with SCI (aged 16-66 years and working before injury), the estimated percentages receiving pay for work and sickness and disability benefits in the sixth years after injury were 63% (95% CI 57-69) and 67% (95% CI 61-72). Corresponding percentages for the controls (n = 1791) were 91% (95% CI 90-93) for receiving pay for work and 13% (95% CI 12-15) for receiving sickness and disability benefits. Among persons with SCI, less severe neurological outcome, higher level of education, younger age at injury, and a stronger pre-injury attachment to employment (higher employment income, having an employer, less receipt of benefits), were associated with higher labour market participation. CONCLUSION: SCI substantially decreased labour market participation up to six years after injury compared to matched controls. Even if a relatively large proportion of persons with SCI remained in some degree of work activity, more than half did so in combination with receiving benefits.

The cost of providing a community-based model of care to people with spinal cord injury, and the healthcare costs and economic burden to households of spinal cord injury in Bangladesh.

DESIGN: Descriptive. SETTING: Community, Bangladesh. OBJECTIVES: To determine the costs associated with providing a community-based model of care delivered as part of the CIVIC trial to people discharged from hospital with recent spinal cord injury (SCI), and to determine the economic burden to households. METHODS: Records were kept of the costs of providing a community-based model of care to participants of the CIVIC trial. Data were also collected at discharge and 2 years post discharge to capture out-of-pocket healthcare costs over the preceding 2 years, and the number of participants suffering catastrophic health expenditure and illness-induced poverty. RESULTS: The mean cost of providing the community-based model of care to participants assigned to the intervention group (n = 204) was US$237 per participant. The mean out-of-pocket healthcare cost over the first 2 years post discharge was US$472 per participant (n = 410), and US$448 per control participant (n = 206). Median (IQR) equivalent annual household incomes prior to SCI and at 2 years post discharge were US$721 (US$452-1129) and US$464 (US$214-799), respectively. Of the 378 participants alive at 2 years, 324 (86%) had catastrophic health expenditure, and 161 of 212 participants who were not in poverty prior to injury (76%) were pushed into illness-induced poverty within 2 years of injury. CONCLUSION: The cost of providing community-based support to people with SCI for 2 years post discharge in Bangladesh is relatively inexpensive but an overwhelming majority of households rapidly experience financial catastrophe, and most fall into poverty.

Socioeconomic Consequences of Traumatic Brain Injury: A Danish Nationwide Register-Based Study.

This study examined if acquiring a traumatic brain injury (TBI) increases utilization of health care costs, increases risk of job loss for the patient and the closest relatives, and increases the risk of divorce 1 to 5 years following the injury. The study was conducted as a Danish national population-based register study with follow-up. Participants included a cohort of patients with TBI (n = 18,328) admitted to a hospital or treated in an emergency room (ER) and a matching control group (n = 89,155). For both the TBI group and the matching controls, relatives were identified, using national registers (TBI relatives: n = 25,708 and control relatives: n = 135,325). The outcome measures were utilization of health care costs (including hospital services, use of general practitioner and practicing specialists, and prescribed medication), risk of job loss, and risk of divorce among the TBI group and the control group and their relatives. Patients with TBI had significantly increased health care costs at baseline (i.e., the year before the injury) and during the following 4 years. Further, TBI relatives had a significantly higher utilization of health care costs the first and the third year after injury. The TBI group had a significant increased risk of job loss (odds ratio [OR] = 2.88; confidence interval [CI]: 2.70-3.07) and divorce (OR = 1.44; CI: 1.27-1.64) during the first 3 years following injury. In conclusion, the TBI group had significantly higher utilization of health care costs, both pre-morbidly and post-injury. Further, increased risk of job loss and divorce were found, emphasizing that the socioeconomic consequences of TBI last for years post-injury.

Gender, class, employment status and social mobility following spinal cord injury in Denmark, the Netherlands, Norway and Switzerland.

STUDY DESIGN: Cross sectional survey of 1055 persons with spinal cord injury (SCI) in Denmark, the Netherlands, Norway and Switzerland. OBJECTIVES: (1) To analyse the employment levels of people of working age with SCI, including possible gender differences. (2) To study the relevance of occupational class before SCI and its impact on employment and occupational class after SCI. SETTING: Members of national SCI consumer associations. METHODS: Employment status and social mobility after SCI was regressed on occupational class before SCI, using multinomial and binary logistic regression analysis of employment, while controlling for other explanatory variables to employment after SCI and demographic characteristics. RESULTS: Employment levels after injury were similar for men and women in each of the four nations, but Dutch women had significantly lower scores on predicted employment than Dutch men. Employment and social mobility trajectories were heavily in favour of middle-class occupations. Gender differences in employment status at the time of study primarily occurred among those in working-class occupations before SCI, with men less likely than women of being non-employed. Working-class men were significantly more likely than working-class women to retain a working-class occupation at the time of study, and although non-significant, to attain a middle-class occupation after SCI. CONCLUSION: There was little variation in employment by gender within and across countries but significant differences between working-class and middle-class occupations before and after injury. The results suggest that targeted employment measures should be particularly invested in the rehabilitation of women in working-class occupations.

A manual-based family intervention for families living with the consequences of traumatic injury to the brain or spinal cord: a study protocol of a randomized controlled trial.

BACKGROUND: Acquiring a traumatic injury constitutes a severe life change for the survivor, but also for the surrounding family. The paradigm of helping the family has primarily been on psychosocial interventions targeting caregivers. However, interventions including both survivor and caregivers should be an essential part of treatment, as the whole family's functional level and mental health can be affected. The current study protocol presents a manualized family intervention for families living with traumatic injury to the brain (TBI) or spinal cord (tSCI). The objectives are to investigate if the intervention improves quality of life (QoL) and decreases burden. It is hypothesized that the family intervention improves problem-solving strategies and family dynamics, which will reduce the burden. This may improve the caregivers' mental health, which will improve the support to the survivor and QoL. METHODS: The study is an interventional, two-arm, randomized controlled trial. During a 2-year period, a total of 132 families will be included. Participants will be recruited from East-Denmark. Inclusion criteria are (1) TBI or tSCI, (2) ≥ 18 years of age, (3) ≥ 6 months to ≤ 2 years since discharge from hospital, (4) ability to understand and read Danish, (5) cognitive abilities that enable participation, and (6) a minimum of one family member actively involved in the survivor's life. Exclusion criteria are (1) active substance abuse, (2) aphasia, (3) prior neurologic or psychiatric diagnose, and (4) history of violence. Within each disease group, families will be allocated randomly to participate in an intervention or a control group with a ratio 1:1. The intervention groups receive the family intervention consisting of eight sessions of 90 min duration. Families in the control groups receive 2 h of psychoeducation. All participants complete questionnaires on QoL, self-perceived burden, family dynamics, problem-solving strategies, mental health, and resilience at pre-intervention, post-intervention, and 6-month follow up. CONCLUSION: If the intervention is found to have effect, the study will contribute with novel knowledge on the use of a manual-based intervention including the entire family. This would be of clinical interest and would help families living with the consequences of TBI or tSCI. TRIALS REGISTRATION: ClinicalTrials.gov, NCT03814876. Retrospectively registered on 24 January 2019.

Pelvic organ prolapse and urogynecological assessment in women with spinal cord injury.

STUDY DESIGN: Observational cross-sectional study. OBJECTIVES: Due to weakened pelvic floor muscles, the risk of pelvic organ prolapse (POP) may increase after a spinal cord injury (SCI); hence, the aim of this study was to investigate the occurrence of POP after SCI and to evaluate the need for urogynecological consultations offered to women with SCI. SETTING: Clinic for Spinal Cord Injuries, Rigshospitalet, Denmark. METHODS: Women with SCI who visited our SCI-clinic during January 2013-January 2018 were offered a specialized urogynecological consultation. Any symptoms of POP, urinary/fecal incontinence, or bladder/bowel emptying problems were registered, and POP was classified according to the POP quantification system during a pelvic examination. Differences in baseline characteristics between women with POP stage 0-1 and POP stage ≥2 were investigated. RESULTS: A total of 98 women were included in the study. Fourteen women (14%) reported POP symptoms and 21 women (21%) had anatomical POP stage ≥2. The group with POP stage ≥2 had a significantly higher age, higher parity, more with vaginal delivery, and more postmenopausal women, but the groups did not differ on median time after injury, neurological level, and completeness of injury. A total of 71% experienced urinary incontinence, 27% experienced fecal incontinence, 63% experienced bladder emptying problems, and 70% experienced bowel emptying problems. Consequently, 65% received treatment. CONCLUSIONS: Women with SCI are not in increased risk of developing anatomical POP. Nonetheless, the high occurrence of other urogynecological issues and the high treatment-rate supports the need for specialized urogynecological consultations offered to women with SCI.

Protocol for process evaluation of CIVIC randomised controlled trial: Community-based InterVentions to prevent serIous Complications following spinal cord injury in Bangladesh.

INTRODUCTION: People with spinal cord injuries in low-income and middle-income countries are highly vulnerable to life-threatening complications in the period immediately after discharge from hospital. We are conducting a randomised controlled trial in Bangladesh to determine whether all-cause mortality at 2 years can be reduced if health professionals regularly ring and visit participants in their homes following discharge. We will conduct a process evaluation alongside the trial to explain the trial results and determine the feasibility of scaling this intervention up in low-income and middle-income countries if it is found to be effective. METHODS AND ANALYSIS: Our process evaluation is based on the Realist and Reach, Effectiveness, Adoption, Implementation and Maintenance frameworks. We will use a mixed methods approach that uses both qualitative and quantitative data. For example, we will audit a sample of telephone interactions between intervention participants and the healthcare professionals, and we will conduct semistructured interviews with people reflective of various interest groups. Quantitative data will also be collected to determine the number and length of interactions between the healthcare professionals and participants, the types of issues identified during each interaction and the nature of the support and advice provided by the healthcare professionals. All quantitative and qualitative data will be analysed iteratively before the final analysis of the trial results. These data will then be triangulated with the final results of the primary outcome. ETHICS AND DISSEMINATION: Ethics approval was obtained from the institutional ethics committee at the site in Bangladesh and from the University of Sydney, Australia. The study will be conducted in compliance with all stipulations of its protocol, the conditions of ethics committee approval and the relevant regulatory bodies. The results of the trial will be disseminated through publications in peer-reviewed scientific journals and presentations at scientific conferences. TRIAL REGISTRATION NUMBER: ACTRN12615000630516.

Community-based InterVentions to prevent serIous Complications (CIVIC) following spinal cord injury in Bangladesh: protocol of a randomised controlled trial.

INTRODUCTION: In low-income and middle-income countries, people with spinal cord injury (SCI) are vulnerable to life-threatening complications after they are discharged from hospital. The aim of this trial is to determine the effectiveness and cost-effectiveness of an inexpensive and sustainable model of community-based care designed to prevent and manage complications in people with SCI in Bangladesh. METHODS AND ANALYSIS: A pragmatic randomised controlled trial will be undertaken. 410 wheelchair-dependent people with recent SCI will be randomised to Intervention and Control groups shortly after discharge from hospital. Participants in the Intervention group will receive regular telephone-based care and three home visits from a health professional over the 2 years after discharge. Participants in the Control group will receive standard care, which does not involve regular contact with health professionals. The primary outcome is all-cause mortality at 2 years. Recruitment started on 12 July 2015 and the trial is expected to take 5 years to complete. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Institutional Ethics Committee at the site in Bangladesh and from the University of Sydney, Australia. The study will be conducted in compliance with all stipulations of its protocol, the conditions of ethics committee approval, the NHMRC National Statement on Ethical Conduct in Human Research (2007), the Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95) and the Bangladesh Guidance on Clinical Trial Inspection (2011). The results of the trial will be disseminated through publications in peer-reviewed scientific journals and presentations at scientific conferences. TRIAL REGISTRATION NUMBERS: ACTRN12615000630516, U1111-1171-1876.

Assessment of transmission in specific descending pathways in relation to gait and balance following spinal cord injury.

Human bipedal gait requires supraspinal control and gait is consequently severely impaired in most persons with spinal cord injury (SCI). Little is known of the contribution of lesion of specific descending pathways to the clinical manifestations of gait deficits. Here, we assessed transmission in descending pathways using imaging and electrophysiological techniques and correlated them with clinical measures of impaired gait in persons with SCI. Twenty-five persons with SCI participated in the study. Functional assessment of gait included the Walking Index for Spinal Cord Injury (WISCI), the Timed-Up and Go (TUG), the 6-Min Walking Test (6MWT), and the maximal treadmill gait speed. Balance was evaluated clinically by the Berg Balance Scale (BBS). The amplitude of tibialis anterior (TA) motor-evoked potentials (MEPs) at rest elicited by transcranial magnetic stimulation as a measure of corticospinal transmission showed a moderately good correlation with all clinical measures (r(2)~0.5), whereas the latency of the MEPs showed less good correlation (r(2)~0.35). Interestingly, the MEP amplitude was correlated to atrophy in the ventrolateral rather than the dorsolateral section of the spinal cord where the main part of the corticospinal tract is located. TA intramuscular coherence in the beta and gamma frequency range has been suggested to reflect corticospinal transmission and was, consistent with this, found to be correlated to atrophy in the dorsolateral and ventrolateral sections of the spinal cord. Coherence was found to correlate to all clinical measures to the same extent as the MEP amplitude. The latency and duration of medium-latency responses in the soleus muscle to galvanic stimulation as measures of vestibulospinal transmission showed very good correlation to BBS (r(2)=-0.8) and moderately good correlation to the assessments of gait function (r(2)~0.4). 6MWT and gait speed were correlated to atrophy of the lateral sections of the spinal cord bilaterally, whereas BBS was correlated to atrophy of both lateral and ventral sections of the spinal cord. No significant correlation was observed between the electrophysiological tests of corticospinal and vestibulospinal transmission. Combination of different electrophysiological and anatomical measures using best subset regression analysis revealed improved prediction of gait ability, especially in the case of WISCI. These findings illustrate that lesion of corticospinal and vestibulospinal pathways makes different contributions to impaired gait ability and balance following SCI and that no single electrophysiological or anatomical measure provide an optimal prediction of clinical gait and balance disability. We suggest using a combination of anatomical and electrophysiological measures when evaluating spinal cord integrity following SCI.

Assessment of a portable device for the quantitative measurement of ankle joint stiffness in spastic individuals.

OBJECTIVE: Spasticity is a common complication with neurological diseases and CNS lesions. Instrumented systems to evaluate spasticity often cannot provide an immediate result, thus limiting their clinical usefulness. In this study we investigated the accuracy and reliability of the portable Neurokinetics RA1 Ridgidity Analyzer to measure stiffness of the ankle joint in 46 controls, 14 spinal cord injured (SCI) and 23 multiple sclerosis (MS) participants. METHODS: Ankle stiffness measures were made twice by two raters, at speeds above and below the expected stretch reflex threshold. Ankle torque was measured with the portable device and a stationary torque motor. Inter- and intra-rater reliability was assessed with the intra-class correlation coefficient (ICC). RESULTS: Stiffness measures with the portable and stationary devices were significantly correlated for controls and MS participants (p < 0.01). Intra-rater reliability for the portable device ranged from 0.60-0.89 (SCI) and 0.63-0.67 (control) and inter-rater reliability ranged from 0.70-0.73 (SCI) and 0.61-0.77 (control). Ankle stiffness measures in SCI and MS participants were significantly larger than in controls for both slow (p < 0.05) and fast movements (p < 0.01), with stiffness being larger for fast compared to slow movements in SCI and MS participants (p < 0.05), but not in controls (p = 0.5). CONCLUSION: The portable device correlated well with measures obtained by a torque motor in both controls and MS participants, showed high intra- and inter-rater reliability for the SCI participants, and could easily distinguish between stiff and control ankle joints. However, the device, in its current form, may be less accurate during rapid movements when inertia contributes to stiffness and the shape of the air-filled pads did not provide a good interface with the foot. SIGNIFICANCE: This study demonstrates that a portable device can potentially be a useful diagnostic tool to obtain reliable information of stiffness for the ankle joint.