The Swiss Spinal Cord Injury Cohort Study (SwiSCI) biobank: from concept to reality.

OBJECTIVES: To describe the concept, establishment and the operationalization of the biobank of the Swiss Spinal Cord Injury Cohort Study (SwiSCI), the available biosamples, and demographic and clinical characteristics of study participants. SETTING: The SwiSCI biobank is a platform for research within SwiSCI. It collects and processes serum, plasma, PBMCs, RNA, DNA, and urine from three rehabilitation centers. Samples are collected at admission to first rehabilitation and at discharge. Additionly, the biobank provides services to projects nested in SwiSCI or otherclinical trials among Spinal Cord Injury population. METHODS: Descriptive statistics were used for an overview of available biosamples, study participant characteristics, and comparison of the participating centers. RESULTS: Between the SwiSCI biobank establishment on June 27th, 2016, and October 19th, 2023, the SwiSCI Study has obtained informed consent from 524 individuals. Of these, 315 (60.1%) have agreed to donate biospecimens to the biobank. The average age of the contributors was 54 years (range: 38-65), with the majority being male (80%). Most participants suffered from traumatic injuries (66%) and were classified as paraplegic (64%). Approximately 80% presented with motor and sensory-incomplete SCI. The median Spinal Cord Independence Measure (SCIM) score was 31 (Interquartile Range: 19-58). The proportion of individuals providing paired biosamples at two distinct time points ranged from 63% (for RNA) to 65% (for urine and urine sediment). CONCLUSIONS: The SwiSCI biobank is a unique platform designed to serve as a basis for collaborative SCI research, including multi-omics approaches. The longitudinal collection of biospecimens and cryopreservation of multiple aliquots for each participant are fundamental for scrutinizing the temporal associations, ensuring research reproducibility, and achieving an adequate sample size for future investigations.

Use of professional home care in persons with spinal cord injury in Switzerland: a cross-sectional study.

BACKGROUND: Persons with spinal cord injury (SCI) living in the community often require care. The boundaries between professional home care and informal care are blurred, and it is unclear who the typical user of home care is. The objective of this study was to describe the characteristics of persons with SCI using professional home care in Switzerland, determine the frequency of home care visits, and investigate the association of sociodemographic factors, SCI-specific characteristics, secondary health conditions, and functional independence with the use of home care. METHODS: We used cross-sectional data from the 2017 community survey of the Swiss Spinal Cord Injury Cohort Study (SwiSCI). Out of 3,959 eligible individuals 1294 completed the questionnaire and were included in the analysis (response rate 33%). Using descriptive statistics, differences between home care users and non-users as well as the frequency of home care visits were investigated. The association between sociodemographic factors, SCI-specific characteristics, secondary health conditions, functional independence and the use of home care was analyzed using multivariable logistic regression. Multiple imputation was used to account for missing data. RESULTS: Of 1,294 participants, 280 (22%) used professional home care. The median weekly professional home care duration was 6 h (Q1 = 2, Q3 = 12). More home care was used in persons with lower functional independence (Odds ratio (OR) 0.30 per 10 unit decrease in the Spinal Cord Independence Measure, 95%-Confidence interval (CI) 0.24-0.37), fewer secondary health conditions (OR 0.96 per unit Spinal Cord Injury Secondary Conditions Scale, 95%-CI 0.94-0.99), tetraplegia (OR 2.77, 95%-CI 1.92-4.00), women (OR 2.42, 95%-CI 1.70-3.43), higher age (OR 1.22 per 10 years increase, 95%-CI 1.06-1.39), living alone (OR 2.48, 95%-CI 1.53-4.03), and those receiving support from an informal caregiver (OR 1.88, 95%-CI 1.27-2.77). CONCLUSIONS: This is the first study to examine the use of professional home care from the perspective of persons with SCI in Switzerland. Lower functional independence strongly predicts increased home care use. The findings showed that professional home care complements informal care and is more likely to be used by individuals with SCI who live alone, have tetraplegia, and are female.

Early Diagnosis of Late-Onset Below-Level Neuropathic Pain in an 83 Year-Old Incomplete Tetraplegic Patient: A Charcot Spinal Neuro-Arthropathy Case Report.

BACKGROUND Charcot spine (CS), also called neuropathic arthropathy, appears to be triggered by damage to the nervous system (either central or peripheral) impairing proprioception and pain/temperature sensation in the vertebral column. Therefore, the defense mechanisms of altered joints lead to a progressive degeneration of the vertebral joint and surrounding ligaments, which can provoke major spinal instability. Beyond the sensory aspects, mechanic factors are identified as risk factors. While its etiology and pathophysiology remain contested, CS represents a rare and difficult pathology to diagnose at an early stage, owing to its nonspecific clinical symptoms. The diagnosis of CS is probably still underestimated and often occurs only quite late in the disease course. CASE REPORT An 83-year-old male patient who had a history of a post-traumatic tetraplegia was diagnosed with CS after 3 years, after describing a recent progressive worsening of neuropathic pain. The diagnosis was earlier than the majority of cases described in the literature. Indeed, in a recent review, the mean time lag between the onset of neurological impairment and the diagnosis of CS was 17.3±10.8 years. CONCLUSIONS This case report demonstrates the benefits of early diagnosis of CS when confronted by the clinical and radiological criteria. Therefore, it seems important to be able to evoke this neuropathic spinal arthropathy sufficiently in time to prevent its disabling consequences in patients with spinal cord injury, in terms of quality of life and independence.

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.

Burden of Cardiovascular Risk in Individuals With Spinal Cord Injury and Its Association With Rehabilitation Outcomes: Results From the Swiss Spinal Cord Injury Cohort.

OBJECTIVES: The aims of the study are to determine the cardiovascular risk burden rehabilitation discharge and to explore the association between recovery during rehabilitation and cardiovascular disease risk profile. METHODS: We included adults without cardiovascular disease admitted for rehabilitation. We evaluated rehabilitation outcomes on admission and discharge. Cardiovascular disease risk profile was assessed by Framingham risk score, high-density lipoprotein, and fasting glucose level. RESULTS: We analyzed data from 706 participants (69.6% men) with a median age of 53.5 yrs. The median time since injury was 14 days, and the admission length was 5.2 months. Majority had paraplegia (53.3%) and motor incomplete injury (53.7%). One third of the cohort had high cardiovascular risk profile before discharge. At discharge, poorer anthropometric measures were associated with higher Framingham risk score and lower high-density lipoprotein levels. Individuals with higher forced vital capacity (>2.72 l) and peak expiratory flow (>3.4 l/min) had 0.16 mmol/l and 0.14 mmol/l higher high-density lipoprotein compared with those with lower respiratory function, respectively. Individuals with higher mobility score (>12.5) and functional independence score (>74) had 0.21 and 0.18 mmol/l higher high-density lipoprotein compared with those with lower scores. CONCLUSIONS: There is high cardiometabolic syndrome burden and cardiovascular disease risk profile upon rehabilitation discharge. Higher respiratory function, mobility, and overall independence were associated with better cardiovascular disease risk profile, although with study design limitations and short follow-up. Future studies should explore whether rehabilitation outcomes could be used to prioritize screening. TO CLAIM CME CREDITS: Complete the self-assessment activity and evaluation online at http://www.physiatry.org/JournalCME. CME OBJECTIVES: Upon reading this journal article, the reader is expected to: (1) Determine the burden of cardiometabolic disease in the early phase of spinal cord injury (SCI); (2) Differentiate the proposed SCI cutoff for high-risk obesity from the able-bodied population; and (3) Increase physicians' acuity for detecting cardiometabolic disease in their practice. LEVEL: Advanced. ACCREDITATION: The Association of Academic Physiatrists is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.The Association of Academic Physiatrists designates this Journal-based CME activity for a maximum of 1.0 AMA PRA Category 1 Credit(s) ™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

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.

Cardiometabolic risk profiling during spinal cord injury rehabilitation: A longitudinal analysis from the Swiss Spinal Cord Injury (SwiSCI) cohort.

BACKGROUND: Early screening is important in individuals with spinal cord injury (SCI) as they are deemed high risk for cardiometabolic diseases. Few studies explored changes in cardiometabolic risk profile in the early phase of the injury. Thus it remains unclear how early the cardiometabolic status deteriorates after injury. OBJECTIVE: To determine the longitudinal changes in the cardiometabolic risk profile and examine the association between injury characteristics and cardiometabolic status in subacute SCI. SETTING: Multicenter Swiss Spinal Cord Injury Cohort. PARTICIPANTS: Adults with traumatic SCI without a history of cardiovascular disease or type 2 diabetes. MAIN OUTCOME MEASURES: Blood pressure (BP), lipid profile, fasting glucose, waist circumference (WC), weight, body mass index (BMI), and Framingham risk score (FRS) were compared across time and according to the injury characteristics. RESULTS: We analyzed the data of 258 individuals with traumatic SCI (110 tetraplegia and 148 paraplegia, 122 motor complete, and 136 incomplete). The median age was 50 years (interquartile range [IQR] 32-60), with 76.4% (n = 197) of the population being male. The median rehabilitation duration was 5.5 months (IQR 3.2-7.1). At admission to rehabilitation, fully adjusted linear regression models showed higher baseline weight (ß 0.06, 95% confidence interval [CI] 0.005 to 0.11), systolic BP (ß 0.05, 95% CI 0.008 to 0.09), diastolic BP (ß 0.05, 95% CI 0.004 to 0.10), and triglycerides (ß 0.27, 95% CI 0.13 to 0.42) in paraplegia than tetraplegia. Systolic BP, diastolic BP, high-density lipoprotein cholesterol (HDL-C) levels were higher in incomplete than complete injury. In our main analysis, we observed an increase in cholesterol and HDL-C and lipid ratio when comparing the beginning and end of rehabilitation. Individuals with paraplegia had a higher increase in BMI than individuals with tetraplegia, whereas no differences in other cardiometabolic risk factors were detected when comparing motor incomplete and complete injury. Trajectories of each participant showed that the majority of individuals with SCI decreased FRS score at follow-up compared to baseline and no significant changes in the prevalence of cardiometabolic syndrome were observed. At discharge, one third of study participants were classified as moderate to high risk of cardiovascular disease (CVD), 64% were overweight, and 39.4% had cardiometabolic syndrome. CONCLUSION: We observed a modest improvement in lipid profile and FRS during the first inpatient rehabilitation hospitalization. Injury characteristics, such as level and completeness, were not associated with changes in cardiometabolic risk factors in the subacute phase of the injury. Despite this, a significant proportion of study participants remained at risk of cardiometabolic disease at discharge, suggesting that early cardiometabolic preventive strategies may be initiated as early as during the first inpatient rehabilitation hospitalization.

Early Changes in Androgen Levels in Individuals with Spinal Cord Injury: A Longitudinal SwiSCI Study.

We aimed to explore longitudinal changes in androgen levels in individuals with spinal cord injury (SCI) within initial inpatient rehabilitation stay and identify clinical/injury characteristics associated with hormone levels. Linear regression analysis was applied to explore the association between personal/injury characteristics and androgen hormones (total testosterone, free testosterone, sex hormone-binding globulin (SHBG), dehydroepiandrosterone (DHEA), and dehydroepiandrosterone sulfate (DHEA-S)) at admission to rehabilitation. Longitudinal changes in androgen levels were studied using linear mixed models. Analyses were stratified by sex and by injury type. We included 70 men and 16 women with SCI. We observed a non-linear association between age, time since injury, and androgens at baseline. At admission to initial rehabilitation, mature serum SHBG (full-length, protein form which lacks the N-terminal signaling peptide) was higher, while DHEA and DHEA-S were lower among opioid users vs. non-users. Serum levels of total testosterone and DHEA-S increased over rehabilitation period [ß 3.96 (95%CI 1.37, 6.56), p = 0.003] and [ß 1.77 (95%CI 0.73, 2.81), p = 0.01], respectively. We observed no significant changes in other androgens. Restricting our analysis to men with traumatic injury did not materially change our findings. During first inpatient rehabilitation over a median follow up of 5.6 months, we observed an increase in total testosterone and DHEA-S in men with SCI. Future studies need to explore whether these hormonal changes influence neurological and functional recovery as well as metabolic parameters during initial rehabilitation stay.

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.

Cross-cultural adaptation and validation of the French version of the Spinal Cord Injury Pain Instrument (SCIPI).

STUDY DESIGN: Cross-sectional. OBJECTIVES: To assess the reliability and validity of the French version of the Spinal Cord Injury Pain Instrument (SCIPI) and to determine its performance versus "Douleur Neuropathique 4 questions" (DN4) in diagnosing neuropathic pain (NeuP). SETTING: Clinique romande de réadaptation, spinal cord injury (SCI) center in the French-speaking part of Switzerland. METHODS: Backward and forward translation in French of the 4-item SCIPI were performed by native speakers in both languages. Thirty persons with SCI were included in the validation study. Internal consistency was measured with the Kuder-Richardson (KR-20) coefficient. Cohen's kappa coefficients were used to assess the test-retest reliability and the agreement between SCIPI and DN4. Clinical assessment was used as the reference standard to diagnose NeuP. The area under the receiver operator characteristics curve (AUROC) was used to assess the performance of diagnostic tests. RESULTS: KR-20 coefficient of internal consistency was 0.50 (95% CI 0.26, 0.74). Test-retest reliability coefficient was 0.86 (95% CI 0.76, 0.95). The best cutoff value was 2 points, resulting a sensitivity of 88% (95% CI 69%, 98%) and a specificity of 92% (95% CI 75%, 99%). SCIPI had an AUROC of 0.90 (95% CI 0.82, 0.98), which was not significantly lower than the AUROC for DN4, 0.92 (95% CI 0.85, 0.99, p = 0.56). Agreement between SCIPI and DN4 was of 0.88 (95% CI 0.77, 1.00). CONCLUSION: The French version of the SCIPI is a reliable and valid tool that can identify the presence of NeuP in an individual with SCI.

A Rasch-Based Comparison of the Functional Independence Measure and Spinal Cord Independence Measure for Outcome and Quality in the Rehabilitation of Persons with Spinal Cord Injury.

OBJECTIVE: The Functional Independence Measure (FIM™) and spinal cord injury (SCI)-specific Spinal Cord Independence Measure (SCIM) are commonly used tools for outcome measurement and quality reporting in rehabilitation. The objective of this study was to investigate the psychometric properties of FIM™ and SCIM and to equate the 2 scales. METHODS: First, content equivalence of FIM™ and SCIM was established through qualitative linking with the International Classification for Functioning, Disability and Health (ICF). Secondly, a Rasch analysis of overlapping contents determined the metric properties of the scales and provided the empirical basis for scale equating. Furthermore, a transformation table for FIM™ and SCIM was created and evaluated. SUBJECTS: Patients with SCI in Swiss inpatient rehabilitation in 2017-18. RESULTS: The ICF linking and a separate Rasch analysis of FIM™ restricted the analysis to the motor scales of FIM™ and SCIM. The Rasch analysis of these scales showed good metric properties. The co-calibration of FIM™ and SCIM motor scores was supported with good fit to the Rasch model. The operational range of SCIM is larger than for FIM™ motor scale. DISCUSSION: This study supports the advantage of using SCIM compared with FIM™ for assessing the functional independence of patients with SCI in rehabilitation.

Towards the implementation of clinical quality management at the national level: description of current types of rehabilitation services for spinal cord injury/disorder in Switzerland using an interdisciplinary consensus process.

BACKGROUND: Aligned with WHO's Global Disability Action Plan 2014-2021, the Section and Board of the European Union of Medical Specialists (UEMS-PRM) set up a plan to strengthen rehabilitation and support International Classification for Functioning, Disability and Health-based clinical quality management. Accordingly, the UEMS-PRM developed the European Framework of Rehabilitation Service Types ("European Framework"). The specifications of these service types may differ across countries and for specific application areas. AIM: The objective of this paper is to report on the development of a framework of rehabilitation service types for spinal cord injury/disorder (SCI/D) in Switzerland ("SCI/D Framework"). DESIGN: Quality improvement in healthcare. SETTING: The setting of this study was in Switzerland. POPULATION: Representatives of medical societies. METHODS: A multistage consensus process was conducted and involved representatives of national medical and rehabilitation societies recruited based on a situational analysis of existing national quality management documents. The process comprised the development of an initial framework based on the European Framework, a survey, a face-to-face consensus meeting, and a confirmatory feedback round on the version of the SCI/D Framework resulting from the meeting. RESULTS: Representatives of 12 national medical societies, one political body in rehabilitation, one national interprofessional rehabilitation society, the Swiss representative of two international rehabilitation societies and heads of four SCI/D specialized centers participated in the multistage consensus process. After the modifications based on the results of the survey, the consensus meeting and confirmatory feedback round were made, the resulting SCI/D Framework version encompassed 19 rehabilitation service types, structured in nine different clusters, of which six were subdivided into general, other specific or SCI/D-specific rehabilitation service types. CONCLUSIONS: Developing the SCI/D Framework for Switzerland was a further step toward refining existing quality criteria and national quality standards for rehabilitation and toward scaling up SCI/D rehabilitation in Switzerland. CLINICAL REHABILITATION IMPACT: The SCI/D Framework can support national efforts to address any gaps in health care provision and guide an optimal response to meet the rehabilitation needs of persons with SCI/D in Switzerland. Furthermore, the development of the SCI/D Framework illustrates an outline that can be used to develop a similar framework for other health conditions and for other countries to follow in adapting the European Framework for their own country context.

Inception cohort of the Swiss Spinal Cord Injury Cohort Study (SwiSCI): Design, participant characteristics, response rates and non-response.

OBJECTIVES: To provide a methodological reference paper for the inception cohort of the Swiss Spinal Cord Injury Cohort Study (SwiSCI), by detailing its methodological features and reporting on participant characteristics, response rates and non-response bias. DESIGN: Prospective cohort study starting in 2013 in all 4 specialized rehabilitation centres in Switzerland. SUBJECTS: Included are 655 newly diagnosed first rehabilitation patients aged ≥16 years with traumatic or non-traumatic spinal cord injury (TSCI, NTSCI). METHODS: Descriptive statistics were used to depict participant characteristics and to compare characteristics of responders and non-responders. Logistic regressions were conducted to estimate non-response bias. RESULTS: The sample consisted of 69% males, with mean age 53.5 years, 57.9% TSCI, 60.7% paraplegia and 78.8% incomplete SCI. Males and younger persons more often sustained TSCI and more severe SCI, resulting in longer duration of rehabilitation. Complete lesions were more prevalent in TSCI compared to NTSCI. The response rate was 47.5% and study participation was less likely in females, older persons, persons with lower functional independence and those with NTSCI. CONCLUSION: SwiSCI inception cohort data enable the estimation of epidemiological figures of SCI in Switzerland, and prognostic and trajectory modelling of outcomes after SCI to guide policy, service provision and clinical practice.

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.

Impact of non-formulary drugs on pharmacological prescription in hospitalised patients.

OBJECTIVES: The growing number of drugs on the market makes it necessary to adapt hospital formularies in order to ensure consistent drug coverage. The aim of this study was to evaluate the impact of the prescription of non-formulary drugs (NFD) on the therapeutic management of admitted patients. METHODS: This retrospective observational study included NFD prescriptions in patients hospitalised in a tertiary university hospital during the period 2012-2015. NFD prescriptions are displayed on the computerised medical order as a pending alert to be reviewed by the clinical pharmacists, who make a notation to the clinical course that includes a recommendation for an available therapeutic alternative when available in the hospital formulary. The degree of acceptance of the recommendation by physicians is recorded. RESULTS: Approximately 0.5% of patients hospitalised during the study period were affected by an NFD prescription. A total of 52 (9.5%) NFD were of doubtful therapeutic efficacy, five (0.9%) were non-replaceable drugs and 490 (89.4%) were prescriptions for drugs with an alternative available in the hospital formulary. The acceptance rate for the recommended alternative was 34.9% in the evaluable NFD prescriptions. No correlation was observed between the number of NFD prescriptions or the number of NFD and the availability index (drugs included in the hospital formulary in relation to the total number of drugs marketed). CONCLUSIONS: The number of patients with a NFD prescription was very low. The lack of correlation between the number of NFD or NFD prescriptions and the availability index demonstrated that the hospital formulary covers practically all therapeutic needs.

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.

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.

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.