Incidence and Risk Factors of Pneumonia in Individuals With Acute Spinal Cord Injury: A Multi-national, Multi-center, Prospective Cohort Study.

OBJECTIVE: To describe the occurrence of pneumonia in individuals with acute spinal cord injury (SCI) and identify its key predictors. DESIGN: Multi-centric, longitudinal cohort study. SETTING: 10 specialized SCI rehabilitation units in Europe and Australia. PARTICIPANTS: Eligible were 902 men and women with acute SCI, aged 18 years or older, with cervical or thoracic lesions and not dependent on 24-hour mechanical ventilation; 503 participated in the study (N=503). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: We assessed demographics and lesion related parameters at study entry, and any pneumonia events throughout inpatient rehabilitation. Respiratory function, decubitus, and urinary tract infections were assessed at 1, 3, and 6 months post injury as well as at discharge from inpatient rehabilitation. Time to event (pneumonia) analyses were done using the Kaplan-Meier method, and potential predictors for pneumonia were analyzed with multivariable survival models. RESULTS: Five hundred three patients with SCI were included, with 70 experiencing at least 1 pneumonia event. 11 participants experienced 2 or more events during inpatient rehabilitation. Most events occurred very early after injury, with a median of 6 days. Pneumonia risk was associated with tetraplegia (hazard ratio [HR]=1.78; 95% confidence interval [CI] 1.00-3.17) and traumatic etiology (HR=3.75; 95% CI 1.30-10.8) American Spinal Injury Impairment Scale (AIS) A (HR=5.30; 95% CI 2.28-12.31), B (HR=4.38; 95% CI 1.77-10.83), or C (HR=4.09; 95% CI 1.71-9.81) lesions. For every 10 cmH2O increase in inspiratory muscle strength, pneumonia risk was reduced by 13% (HR=0.87; 95% CI 0.78-0.97). CONCLUSION: Pneumonia is a major complication after SCI with the highest incidence very early after injury. Individuals with traumatic or AIS A, B, or C tetraplegia are at highest risk for pneumonia.

Urodynamics Are Essential to Predict the Risk for Upper Urinary Tract Damage after Acute Spinal Cord Injury.

We used clinical parameters to develop a prediction model for the occurrence of urodynamic risk factors for upper urinary tract (UUT) damage during the first year after acute spinal cord injury (SCI). A total of 97 patients underwent urodynamic investigation at 1, 3, 6, and 12 months after acute SCI, within the framework of a population-based longitudinal study at a single university SCI center. Candidate predictors included demographic characteristics and neurological and functional statuses 1 month after SCI. Outcomes included urodynamic risk factors for UUT damage: detrusor overactivity combined with detrusor sphincter dyssynergia, maximum storage detrusor pressure (pDetmax) ≥ 40 cmH2O, bladder compliance < 20 mL/cmH2O, and vesicoureteral reflux. Multivariable logistic regression was used for the prediction model development and internal validation, using the area under the receiver operating curve (aROC) to assess model discrimination. Two models showed fair discrimination for pDetmax ≥ 40 cmH2O: (i) upper extremity motor score and sex, aROC 0.79 (95% CI: 0.69-0.89), C-statistic 0.78 (95% CI: 0.69-0.87), and (ii) neurological level, American Spinal Injury Association Impairment Scale grade, and sex, aROC 0.78 (95% CI: 0.68-0.89), C-statistic 0.76 (95% CI: 0.68-0.85). We identified two models that provided fair predictive values for urodynamic risk factors of UUT damage during the first year after SCI. Pending external validation, these models may be useful for clinical trial planning, although less so for individual-level patient management. Therefore, urodynamics remains essential for reliably identifying patients at risk of UUT damage.

Unplanned hospital admissions due to secondary health conditions after spinal cord injury: a population-based description of determinants of length of stay.

STUDY DESIGN: Population-based prospective study. OBJECTIVES: To provide a population-based description of length of stay (LOS) and person-related risk factors following unplanned hospital admission due to a secondary health condition (SHC) in persons with spinal cord injury (SCI). SETTING: Specialized SCI hospital and rehabilitation center in Switzerland. METHODS: Descriptive analysis of LOS using routine clinical data of persons with SCI, who were acutely hospitalized between 01.01.2017-30.06.2018. Multivariable regression analysis was used to derive marginal predictions of LOS by acute SHCs and person characteristics. RESULTS: The study included 183 persons, 83% were male, and the median age was 57 years (interquartile range, IQR, 49-67 years). SCI cause was traumatic in 160 (88.4%) cases, 92 (50.3%) were persons with tetraplegia, 147 (80.3%) were classified as motor complete lesions (American Spinal Injury Association Impairment Scale (AIS) A or B) and median time since injury (TSI) was 24 (IQR 13-34) years. Median LOS was 19 (IQR 9-39) days, varying from 74 (IQR 39-92) days for pressure ulcers, 13 (IQR 8-24) days for urinary tract infections (UTI), to 27 (IQR 18-47) days for fractures. LOS was prolonged in persons with multiple co-morbidities or those developing complications during hospitalization. Sex, SCI etiology and lesion level were not associated with LOS. CONCLUSIONS: This population-based description identified substantial variation in LOS between acute SHCs and clinical complications as the main, potentially modifiable, person-related risk factors for extended hospital stay.

Temporal development of unfavourable urodynamic parameters during the first year after spinal cord injury.

OBJECTIVES: To describe the temporal development of and risk factors for the occurrence of unfavourable urodynamic parameters during the first year after spinal cord injury (SCI). PATIENTS AND METHODS: This population-based longitudinal study used data from 97 adult patients with a single-event traumatic or ischaemic SCI who underwent video-urodynamic investigation (UDI) at a university SCI centre. The first occurrences of unfavourable urodynamic parameters (detrusor overactivity combined with detrusor sphincter dyssynergia [DO-DSD], maximum storage detrusor pressure ≥40 cmH2 O, bladder compliance <20 mL/cmH2 O, vesico-ureteric reflux [VUR] and any unfavourable parameter [composite outcome]) were evaluated using time-to-event analysis. RESULTS: The majority of the population (87/97 [90%]) had at least one unfavourable urodynamic parameter. Most unfavourable urodynamic parameters were initially identified during the 1- or 3-month UDI, including 92% of the DO-DSD (78/85), 82% of the maximum storage pressure ≥40 cmH2 O (31/38), and 100% of the VUR (seven of seven) observations. No low bladder compliance was observed. The risk of DO-DSD was elevated in patients with thoracic SCI compared to those with lumbar SCI (adjusted hazard ratio [aHR] 2.38, 95% confidence interval [CI] 1.16-4.89). Risk of maximum storage detrusor pressure ≥40 cmH2 O was higher in males than females (aHR 8.33, 95% CI 2.51-27.66), in patients with a cervical SCI compared to those with lumbar SCI (aHR 14.89, 95% CI 3.28-67.55), and in patients with AIS Grade B or C compared to AIS Grade D SCI (aHR 6.17, 95% CI 1.78-21.39). No risk factors were identified for the composite outcome of any unfavourable urodynamic parameter. CONCLUSIONS: The first UDI should take place within 3 months after SCI as to facilitate early diagnosis of unfavourable urodynamic parameters and timely treatment. Neuro-urological guidelines and individualised management strategies for patients with SCI may be strengthened by considering sex and SCI characteristics in the scheduling of UDIs.

Sex differences in urological management during spinal cord injury rehabilitation: results from a prospective multicenter longitudinal cohort study.

STUDY DESIGN: Prospective, multicenter, longitudinal cohort study. OBJECTIVES: To describe female-male differences in first-line urological management during spinal cord injury (SCI) rehabilitation. SETTING: Inpatient specialized post-acute SCI rehabilitation in Switzerland. METHODS: Data on bladder storage medication (antimuscarinic and beta-3 agonist) use, suprapubic catheter placement, demographic and SCI characteristics was collected within 40 days of SCI and at rehabilitation discharge from May 2013-September 2021. Prevalence and indicators of bladder storage medication and suprapubic catheter use at discharge were investigated with sex-stratified descriptive and logistic regression analyses. RESULTS: In 748 patients (219 females, 29%), bladder storage medication use at discharge had a prevalence of 24% (95% CI: 18-29%) for females and 30% (95% CI: 26-34%) for males and was indicated by cervical AIS grade A, B, C and traumatic SCI in both sexes. Thoracic AIS grade A, B, C SCI (males), and lumbar/sacral AIS grade A, B, C SCI (females) predicted higher odds of bladder storage medication use (SCI characteristic*sex interaction, p < 0.01). Prevalence of suprapubic catheter use at discharge was 22% (95% CI: 17-28%) for females and 17% (95% CI: 14-20%) for males. Suprapubic catheter use was indicated by cervical AIS grade A, B, C SCI, and age >60 in both sexes. Females with thoracic grade A, B, C SCI tended to have higher odds of suprapubic catheter use (SCI characteristic*sex interaction, p = 0.013). CONCLUSIONS: We identified sex differences in urological management especially in persons with AIS grade C or higher sub-cervical SCI. There is scope for well-powered, female-specific research in SCI in order to understand the underlying mechanisms and support patient-tailored management.

Neurogenic Lower Urinary Tract Dysfunction in the First Year After Spinal Cord Injury: A Descriptive Study of Urodynamic Findings.

PURPOSE: We aimed to provide a real-world description of neurogenic lower urinary tract dysfunction within the first year after spinal cord injury with a focus on unfavorable urodynamic parameters that are associated with urological morbidity. MATERIALS AND METHODS: Urodynamic investigations from 97 patients with traumatic or ischemic acute spinal cord injury and managed according to the European Association of Urology Guidelines on Neuro-Urology were analyzed at a single university spinal cord injury center at 1 month, 3 months, 6 months, and 12 months after injury. Unfavorable urodynamic parameters were defined as detrusor overactivity in combination with detrusor sphincter dyssynergia, maximum storage detrusor pressure of 40 cm H2O or higher, bladder compliance less than 20 mL/cm H2O, and vesicoureteral reflux of any grade. RESULTS: One or more unfavorable urodynamic parameter was observed in 87 out of 97 patients (90%) within the first year after spinal cord injury. Eighty-eight percent of the patients showed detrusor overactivity with detrusor sphincter dyssynergia, 39% a maximum storage detrusor pressure of 40 cm H2O or higher, and 7% vesicoureteral reflux. No patient developed a low-compliance bladder. CONCLUSIONS: Using a standardized urodynamic follow-up schedule, we found unfavorable urodynamic parameters in a majority of the population within the first year after spinal cord injury. As early treatment based on urodynamic findings might reduce the risk of deterioration of upper and lower urinary tract function, thereby improving long-term outcomes, there is need for further research regarding recommendations for a urodynamic follow-up schedule during the first year after spinal cord injury.

Untangling the role of social relationships in the association between caregiver burden and caregiver health: an observational study exploring three coping models of the stress process paradigm.

BACKGROUND: Caregivers health is often at risk due to the detrimental effects of caregiver burden. It is therefore vital to identify strategies and resources, which ensure the safeguarding of caregivers' health, whilst also enabling caregivers to continue providing high quality long-term care to care-receivers. The objective of this study is therefore to examine the moderating and mediating role of different social relationship constructs (social networks, social support, relationship quality, and loneliness) in the relationship between subjective caregiver burden and health, by exploring different coping models of the stress process paradigm, namely the stress buffering, social deterioration and counteractive models. METHODS: Longitudinal survey data from 133 couples of caregiving romantic partners and persons with spinal cord injury, living in Switzerland were used. We employed multivariable regression analysis with the inclusion of interaction terms to explore moderation effects of social relationships (i.e. stress buffering model), and path analysis to explore mediation effects (i.e. social deterioration vs. counteractive model) of social relationships on the association between subjective caregiver burden and health. Health was operationalised using the following outcomes: mental health, vitality, bodily pain and general health. RESULTS: Social support and relationship quality were found to buffer the negative effects of subjective caregiver burden on mental health. Mediating effects of social relationships were observed for mental health (indirect effect -0.25, -0.42- -0.08) and vitality (indirect effect -0.20, -0.37- -0.03), providing support for the deterioration model. Loneliness was found to be a particularly important construct on the pathway from caregiver burden to health. CONCLUSION: Our study highlights the potential of social support and relationship quality to override the negative consequences of caregiver burden on mental health and vitality. Our evidence thus supports the advance of interventions that seek to improve qualitative aspects of social relationships, especially in caregivers experiencing a high subjective caregiver burden.

Urological Management at Discharge from Acute Spinal Cord Injury Rehabilitation: A Descriptive Analysis from a Population-based Prospective Cohort.

Background: There is limited epidemiological evidence describing contemporary neuro-urological management of persons with acute spinal cord injury (SCI). Objective: To describe neurogenic lower urinary tract dysfunction (NLUTD) management at discharge from SCI rehabilitation. Design setting and participants: The population-based Swiss Spinal Cord Injury (SwiSCI) cohort study prospectively collected data from 602 adults undergoing specialized postacute SCI rehabilitation from 2013 to 2020. The management strategy was based on the European Association of Urology (EAU) Guidelines on Neuro-Urology. Outcome measurements and statistical analysis: Data were collected at discharge using the International SCI Lower Urinary Tract Function Basic Data Set. Multivariable logistic regression adjusting for demographics, SCI characteristics, and center, with inverse probability weighting accounting for sampling bias, was used to produce prevalence estimates and identify predictors of lower urinary tract symptoms (LUTS) and NLUTD management outcomes. Results and limitations: At discharge (median time after SCI: 5.0 mo [Q1-Q3: 3.0-7.2]), the prevalence of LUTS or managed NLUTD was 82% (95% confidence interval [CI]: 79-85%). SCI completeness was the main predictor of LUTS and managed NLUTD. The risk of urinary incontinence was elevated in females (odds ratio 1.98 [95% CI: 1.18-3.32]) and with complete lesions (odds ratio 4.71 [95% CI: 2.52-8.81]). Voiding dysfunction was most commonly managed with intermittent catheterization (prevalence 39% [95% CI: 35-42%]), followed by indwelling catheterization (prevalence 22% [95% CI: 18-25%]). The prevalence of antimuscarinic or mirabegron use was 29% (95% CI: 26-33%). Urodynamic and renal function data were not collected. Conclusions: Our population-based description of urological management in Swiss SCI centers utilizing the EAU Guidelines on Neuro-Urology may be used as a reference for evaluation in other settings. Data further indicate a need for sex-specific neuro-urological management research. Patient summary: At discharge from spinal cord injury (SCI) rehabilitation, a majority of patients have lower urinary tract problems, especially those with complete SCI. Women have a higher risk of urinary incontinence.

Vitamin D supplementation in chronic spinal cord injury (VitD-SCI): study protocol for a randomised controlled trial.

INTRODUCTION: Vitamin D insufficiency, a vitamin D status or serum 25(OH)D concentration of ≤75 nmol/L, is highly prevalent in individuals with a spinal cord injury (SCI). Vitamin D is important for the functioning of the musculoskeletal, immune and respiratory systems, which are relevant determinants of secondary health conditions in SCI. An insufficiency should be treated with vitamin D supplementation. However, there is a lack of evidence regarding the optimal dosage and duration of vitamin D supplementation for individualised and long-term management of the vitamin D status in the context of SCI. This paper presents the protocol for the vitamin D supplementation in chronic spinal cord injury (VitD-SCI) trial that aims to investigate the effect of a 12-month intake of vitamin D supplementation on vitamin D status as well as on several secondary parameters among individuals with a chronic SCI. METHODS AND ANALYSES: The VitD-SCI trial is a randomised, placebo-controlled, double-blinded, parallel-group, superiority trial, conducted at the Swiss Paraplegic Centre. A total of 45 participants living with an SCI for at least 3 years (chronic SCI) and a vitamin D insufficiency at the first study visit, will be randomly assigned to one of three intervention groups. Participants receive either a monthly dosage of 24 000 IU or 48 000 IU vitamin D or a placebo for 12 months. Measurements taking place every 3 months include the assessment of vitamin D status (primary outcome) as well as bone mineral density, handgrip strength, fatigue, mood, pain and pressure injuries (secondary outcomes). Safety and tolerance of vitamin D supplementation will also be evaluated. ETHICS AND DISSEMINATION: The Swiss Ethics Committee for Northwest/Central Switzerland (EKNZ, 2020-01493) and the Swiss Agency for Therapeutic Products (Swissmedic, 2020DR3150) approved this study. Findings will be disseminated through peer-reviewed publications. TRIAL REGISTRATION NUMBERS: NCT04652544 and SNCTP000004032.

Labor market participation of individuals with spinal cord injury living in Switzerland: determinants of between-person differences and counterfactual evaluation of their instrumental value for policy.

STUDY DESIGN: Longitudinal, population-based survey. OBJECTIVE: To examine determinants of between-person differences in labor market participation of individuals with spinal cord injury (SCI) living in Switzerland and their potential importance for policy. SETTING: Community. METHODS: Longitudinal information on labor market participation (i.e., paid work or not) was obtained from 1198 and 1035 individuals of working-age participating in the 2012 and 2017 SwiSCI community survey, respectively. Determinants of between-person variation in labor market participation were examined using mixed effects logistic regression, controlling for within-person variation. Employment rates were predicted using counterfactual data for modifiable determinants. RESULTS: The employment rate was 56% for the 2012 and 61% for the 2017 survey. Labor market participation was affected mostly by static (sex, nationality, SCI severity), temporal (age), dynamic (education level, functional independence, chronic pain), and policy-related (general pension, disability pension level) determinants. Counterfactual (what-if) predictions indicated the highest improvement of employment rates for strategies that increase functional independence (up to 6% increase), foster education (5%), reduce chronic pain (2%), or promote a shift to partial disability pensions (15%). CONCLUSIONS: Between-person variation in labor market participation of persons with SCI is influenced by various temporal, static, dynamic, and policy-related determinants. Our results suggest that policy strategies aimed at enhancing the employment rate of the Swiss SCI population may particularly invest in programs promoting functional independence, education, and partial pension levels that are more adequate for ensuring sustainable employment.

Detecting subgroups in social participation among individuals living with spinal cord injury: a longitudinal analysis of community survey data.

STUDY DESIGN: Longitudinal community survey. OBJECTIVES: To determine subgroups in social participation of individuals living with spinal cord injury (SCI). SETTING: Community. METHODS: Data were collected in 2012 and 2017 as part of the community survey of the Swiss Spinal Cord Injury cohort. Participation was assessed using the 33-item Utrecht Scale of Evaluation of Rehabilitation-Participation evaluating frequency of, restrictions in and satisfaction with productive, leisure, and social activities. Linear mixed-effects model trees were used to distinguish subgroups in participation associated with sociodemographic and lesion characteristics. RESULTS: In all, 3079 observations were used for the analysis, of which 1549 originated from Survey 2012, 1530 from Survey 2017, and 761 from both surveys. Participants were mostly male (2012: 71.5%; 2017: 71.2%), aged on average 50 years (2012: 52.3; 2017: 56.5), with an incomplete paraplegia (2012: 37.5%; 2017: 41.8%) of traumatic origin (2012: 84.7%; 2017: 79.3%). There was limited within-person variation in participation over the 5-year period. Participation varied with age, SCI severity, education, financial strain, number of self-reported health conditions (SHCs), and disability pension level. Among modifiable parameters, the number of SHCs and disability pension level emerged as the most frequent partitioning variables, while education was most informative for participation in productive, leisure, and social activities. CONCLUSIONS: Long-term rehabilitation management and clinical practice should target people most prone to decreased participation in major life domains. Our study indicates that the alleviation of SHCs, engagement in further education, or adjusting disability pension level are promising areas to improve participation of persons living with SCI.

Perceived sleep problems after spinal cord injury: Results from a community-based survey in Switzerland.

Objective: To investigate the burden of sleep problems within the Spinal Cord injured (SCI) community with respect to the general population (GP) in Switzerland. The study further explored potential predictors for receiving treatment for sleep problems after SCI.Design: Cross-sectional study.Setting: SCI community in Switzerland.Participants: Individuals diagnosed with an SCI, aged 16 years or older that permanently reside in Switzerland (N = 1549).Interventions: Not applicable.Outcome measures: Perceived sleep problems within the SCI community and GP. For those with sleep problems and SCI, an indicator for having received treatment was measured.Results: 58.8% of survey participants indicated having a sleep problem; 69.4% of those with a sleep problem did not indicate receiving treatment. Amongst people living with an SCI, individuals between the ages of 46-60 years (adjusted Odds Ratio, OR = 3.07; 95% CI 1.54-6.16), participants reporting severe financial hardship (OR = 2.90; 95% CI) 1.69-4.96, and those that indicated having pain (OR = 5.62; 95% CI 3.52-8.98) were more likely to have a chronic sleep problem. In comparison to the Swiss GP, the prevalence of having a sleep problem was 18% higher among persons with SCI, with the largest discrepancy for males with paraplegia between the ages of 46-60 years (Prevalence ratio, PR = 1.28; 95% CI, 1.21-1.36).Conclusion: Individuals with SCI experience more sleep problems compared to the Swiss GP. Findings from this study suggest that clinical screening for sleep issues targeting high risk groups is needed to reduce the large prevalence of non-treatment in individuals with SCI.

Etiology-specific variation in survival following non-traumatic spinal cord injury: a causal inference approach using data from a population-based cohort.

STUDY DESIGN: Observational, population-based cohort study. OBJECTIVES: To evaluate the origin and contribution to excess of survival differences following non-traumatic spinal cord injury (NTSCI) using etiology as proxy for variation in underlying health condition. SETTING: Specialized rehabilitation centers in Switzerland. METHODS: Medical record data collected by the Swiss Spinal Cord Injury cohort (SwiSCI) study were linked with mortality information from the Swiss National Cohort. Considering contemporary theory and empirical evidence, a directed acyclic graph (DAG) was developed to formally evaluate causal differences among NTSCI etiologies, relative to traumatic SCI (TSCI). Statistical inference was contingent on hazard ratios (HRs) and marginal survival differences, derived using flexible parametric modeling. RESULTS: 3643 individuals (NTSCI = 1357; TSCI = 2286) diagnosed with SCI between 1990 and 2011 were included, contributing a cumulative 41,344 person-years and 1323 deaths. Test statistics confirmed DAG-dataset consistency. As compared to TSCI, mortality was elevated in all NTSCI etiological groups; malignant etiologies had the highest HRs (10; 95% CI, 8.0 to 14) followed by infection (2.6; 1.8 to 3.6) and vascular (2.5; 2.0 to 3.2) etiology groups. At the attained age of 55, the estimated reduction in survival among non-malignant etiologies was 9.4% (5.8 to 13) at 5 years and 17% (11 to 23) at 20 years. CONCLUSIONS: Causal differences in survival among NTSCI etiological groups are likely a result of chronic variation in health conditions. This study supports the development of long-term interdisciplinary management and policy for individuals with NTSCI, specific to etiology.

Self-reports of treatment for secondary health conditions: results from a longitudinal community survey in spinal cord injury.

STUDY DESIGN: Longitudinal community survey. OBJECTIVES: To describe the treatment for secondary health conditions as reported by individuals living with spinal cord injury (SCI) and to identify potential predictors of treatment. SETTING: Community (people with SCI living in Switzerland). METHODS: Data on the frequency, severity, and treatment of 14 common health conditions (HCs) in the past three months were collected in two surveys by the Swiss Spinal Cord Injury (SwiSCI) cohort study, in 2012 and 2017. Variation in treatment was analyzed using descriptive statistics, by survey period and severity of HC. Conditional multilevel random-effects logistic regression was used to describe differences in self-reported treatment with respect to sociodemographic and socioeconomic factors in addition to SCI characteristics and severity and number of HCs. RESULTS: Severe or chronic autonomic dysreflexia and sleep problems showed in the self-report as the HCs with the lowest occurrence/frequency of treatment. Across all HCs, higher age, shorter time since injury, the total number of HCs, and level of severity were associated with a higher propensity for reporting treatment. Individuals with severe financial difficulties additionally had 1.40 greater odds of receiving treatment (95% CI 1.09-1.80). CONCLUSIONS: This study identified systematic differences in the report of HCs and their treatment within the Swiss SCI community. This study thus provides a basis to guide future research on identifying targets of intervention for long-term clinical management of SCI.

Optimizing clinical trial design using prospective cohort study data: a case study in neuro-urology.

STUDY DESIGN: Simulations using data from a prospective cohort study. OBJECTIVES: To illustrate how prospective cohort data can be employed in randomized controlled trial (RCT) planning to assess feasibility and operational challenges, using TASCI (Transcutaneous tibial nerve stimulation in patients with Acute Spinal Cord Injury to prevent neurogenic detrusor overactivity: a nationwide randomized, sham-controlled, double-blind clinical trial) as a case study. SETTING: Spinal cord injury (SCI) rehabilitation centers in Switzerland. METHODS: TASCI is nested in the multicenter Swiss Spinal Cord Injury Cohort Study (SwiSCI), which prospectively includes patients with acute SCI. In simulations, data from 640 patients, collected by SwiSCI, were used to investigate different scenarios of patient eligibility and study consent, as well as the performance of the randomization list. Descriptive analysis was used to describe the population of interest and the simulation results; multivariable logistic regression analysis was performed to identify predictors of discharge within the TASCI intervention time period. RESULTS: The recruitment target of 114 patients is obtainable within the originally envisioned 3-year time period under the most favorable recruitment scenario examined. The distribution of the primary prognostic factor produced imbalance in the randomization lists and informed further discussion of the cut-off values used in stratification. Influxes of patients resulted in overlapping intervention periods for multiple participants, which guided resource allocation. Early discharge was related to the primary prognostic factor and study center, but is only anticipated in about 8% of participants. CONCLUSIONS: Prospective cohort data are a very valuable resource for planning RCTs.

Respiratory function and respiratory complications in spinal cord injury: protocol for a prospective, multicentre cohort study in high-income countries.

INTRODUCTION: Pneumonia is one of the leading complications and causes of death after a spinal cord injury (SCI). After a cervical or thoracic lesion, impairment of the respiratory muscles decreases respiratory function, which increases the risk of respiratory complications. Pneumonia substantially reduces patient's quality of life, may prolong inpatient rehabilitation time, increase healthcare costs or at worse, lead to early death. Respiratory function and coughing can be improved through various interventions after SCI, but the available evidence as to which aspect of respiratory care should be optimised is inconclusive. Furthermore, ability of respiratory function parameters to predict pneumonia risk is insufficiently established. This paper details the protocol for a large-scale, multicentre research project that aims to evaluate the ability of parameters of respiratory function to predict and understand variation in inpatient risk of pneumonia in SCI. METHODS AND ANALYSIS: RESCOM, a prospective cohort study, began recruitment in October 2016 across 10 SCI rehabilitation centres from Australia, Austria, Germany, the Netherlands and Switzerland. Inpatients with acute SCI, with complete or incomplete cervical or thoracic lesions, 18 years or older and not/no more dependent on 24-hour mechanical ventilation within the first 3 months after injury are eligible for inclusion. The target sample size is 500 participants. The primary outcome is an occurrence of pneumonia; secondary outcomes include pneumonia-related mortality and quality of life. We will use the longitudinal data for prognostic models on inpatient pneumonia risk factors. ETHICS AND DISSEMINATION: The study has been reviewed and approved by all local ethics committees of all participating centres. Study results will be disseminated to the scientific community through peer-reviewed journals and conference presentations, to the SCI community, other stakeholders and via social media, newsletters and engagement activities. TRIAL REGISTRATION DETAILS: ClinicalTrials.gov NCT02891096.

TASCI-transcutaneous tibial nerve stimulation in patients with acute spinal cord injury to prevent neurogenic detrusor overactivity: protocol for a nationwide, randomised, sham-controlled, double-blind clinical trial.

INTRODUCTION: Neurogenic lower urinary tract dysfunction (NLUTD), including neurogenic detrusor overactivity (NDO) and detrusor sphincter dyssynergia, is one of the most frequent and devastating sequelae of spinal cord injury (SCI), as it can lead to urinary incontinence and secondary damage such as renal failure. Transcutaneous tibial nerve stimulation (TTNS) is a promising, non-invasive neuromodulatory intervention that may prevent the emergence of the C-fibre evoked bladder reflexes that are thought to cause NDO. This paper presents the protocol for TTNS in acute SCI (TASCI), which will evaluate the efficacy of TTNS in preventing NDO. Furthermore, TASCI will provide insight into the mechanisms underlying TTNS, and the course of NLUTD development after SCI. METHODS AND ANALYSIS: TASCI is a nationwide, randomised, sham-controlled, double-blind clinical trial, conducted at all four SCI centres in Switzerland. The longitudinal design includes a baseline assessment period 5-39 days after acute SCI and follow-up assessments occurring 3, 6 and 12 months after SCI. A planned 114 participants will be randomised into verum or sham TTNS groups (1:1 ratio), stratified on study centre and lower extremity motor score. TTNS is performed for 30 min/day, 5 days/week, for 6-9 weeks starting within 40 days after SCI. The primary outcome is the occurrence of NDO jeopardising the upper urinary tract at 1 year after SCI, assessed by urodynamic investigation. Secondary outcome measures assess bladder and bowel function and symptoms, sexual function, neurological structure and function, functional independence, quality of life, as well as changes in biomarkers in the urine, blood, stool and bladder tissue. Safety of TTNS is the tertiary outcome. ETHICS AND DISSEMINATION: TASCI is approved by the Swiss Ethics Committee for Northwest/Central Switzerland, the Swiss Ethics Committee Vaud and the Swiss Ethics Committee Zürich (#2019-00074). Findings will be disseminated through peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT03965299.

Attrition from specialised rehabilitation associated with an elevated mortality risk: results from a vital status tracing study in Swiss spinal cord injured patients.

INTRODUCTION: Study drop-out and attrition from treating clinics is common among persons with chronic health conditions. However, if attrition is associated with adverse health outcomes, it may bias or mislead inferences for health policy and resource allocation. METHODS: This retrospective cohort study uses data attained through the Swiss Spinal Cord Injury (SwiSCI) cohort study on persons with spinal cord injury (SCI). Vital status (VS) was ascertained either through clinic medical records (MRs) or through municipalities in a secondary tracing effort. Flexible parametric survival models were used to investigate risk factors for going lost to clinic (LTC) and the association of LTC with subsequent risk of mortality. RESULTS: 1924 individuals were included in the tracing study; for 1608 of these cases, contemporary VS was initially checked in the MRs. VS was ascertained for 704 cases of the 1608 cases initially checked in MRs; of the remaining cases (n=904), nearly 90% were identified in municipalities (n=804). LTC was associated with a nearly fourfold higher risk of mortality (HR=3.62; 95% CI 2.18 to 6.02) among persons with traumatic SCI. Extended driving time (ie, less than 30 min compared with 30 min and longer to reach the nearest specialised rehabilitation facility) was associated with an increased risk of mortality (HR=1.51, 95% CI 1.02 to 2.22) for individuals with non-traumatic SCI. CONCLUSION: The differential risk of LTC according to sociodemographic and SCI lesion characteristics underscores the importance of accounting for attrition in cohort studies on chronic disease populations requiring long-term care. In addition, given the associated risk of mortality, LTC is an issue of concern to clinicians and policy makers aiming to optimise the long-term survival of community-dwelling individuals with traumatic SCI. Future studies are necessary to verify whether it is possible to improve survival prospects of individuals LTC through more persistent outreach and targeted care.

Failed reciprocity in social exchange and wellbeing: evidence from a longitudinal dyadic study in the disability setting.

Objectives: Failed reciprocity at work and in partnerships was shown to adversely affect wellbeing in general populations, but evidence in disability settings is widely lacking. We explore the effects of failed reciprocity on wellbeing and the impact of the partners' perception of reciprocity on wellbeing in persons with a physical disability and their partners.Design: We use longitudinal dyadic data from the pro-WELL study, a Swiss survey of persons with spinal cord injury (SCI) and their partners (n = 246). Two-level mixed-models with random effects for persons and repeated measures were applied.Main outcome measures: Cognitive wellbeing was measured with the Satisfaction with Life Scale and affective wellbeing with the Positive and Negative Affect Scale short-form.Results: Failed reciprocity at work and in the partnership was associated with all indicators of wellbeing in persons with SCI and with cognitive wellbeing and negative affect in caregiving partners. Life satisfaction of caregiving partners and positive affect of persons with SCI was lower if the partner perceived the partnership as non-reciprocal.Conclusion: Negative associations of failed reciprocity with wellbeing are not restricted to general populations but equally apply to the disability setting and dyadic analyses reveal the importance of the partners' perception of partnership reciprocity for wellbeing.

Is informal caregiving at odds with optimal health behaviour? A cross-sectional analysis in the caregiving partners of persons with spinal cord injury.

BACKGROUND: The intricate relationship between caregiving and health may to some extent be determined by the burden and restrictions imposed on informal caregivers, and the impact these experiences have on health behaviours. It is assumed that a positive caregiver experience leads to health promoting behaviours in caregivers, whereas a negative experience induces the opposite. The objective of this study is to test these assumptions and to investigate the association between the caregiver experience and health behaviours in the caregiving partners of persons with severe physical impairment, due to spinal cord injury. METHODS: Cross-sectional survey data from 133 couples of caregiving partners and persons with spinal cord injury living in Switzerland was used. We employed multivariable regression to evaluate the associations of the caregiver experience (objective and subjective caregiver burden, and satisfaction with caregiving) with health behaviours (physical activity, fruit and vegetable consumption, alcohol consumption, smoking, and sleep duration). RESULTS: The most robust associations were found between subjective caregiver burden and health behaviours, whereby caregivers reporting a higher burden reported less physical activity (Incidence Rate Ratio [IRR]:0.41; 95% CI 0.35-0.49), more alcohol consumption (IRR: 1.46; 1.20-1.77), greater smoking intensity (IRR: 1.29; 0.95-1.73), and a higher likelihood of insufficient sleep duration (Odds Ratio [OR]: 4.98; 1.58-15.74). Caregivers, who reported high objective burden, i.e. invested long hours in caregiving, were more prone to partake in health adverse behaviours, in particular greater alcohol consumption. Results also suggested that caregivers who were satisfied in their role and who received social support in caregiving were more likely to be physically active. CONCLUSION: Caregivers suffering from high emotional and time burden may benefit from both practical and psychological support. This support may release resources enabling individuals to partake in health promoting behaviours, or to develop coping strategies to better deal with the burden of caregiving.