The Intersectional Impact of Cost-Related Non-Adherence and Depression: A Cross-Sectional Analysis of the Canadian Community Health Survey by Sex, Race, and Indigeneity.

We evaluated the relationship between cost-related non-adherence (CRNA) and depressive symptoms. Pooling data from the 2015, 2016, 2018, and 2019 annual Canadian Community Health Survey, we analyzed the relationship between CRNA and moderate to severe depressive symptoms, assessed by the Patient Health Questionnaire (PHQ-9). Among the sample, 4.9% experienced CRNA and 6.8% experienced moderate to severe depressive symptoms. Respondents who reported CRNA had 1.51 (95% confidence interval [CI], 1.51-1.52) greater odds of experiencing moderate to severe depressive symptoms. Stratified analysis by sex and race showed the association between CRNA and depressive symptoms was greatest among racialized males (aOR: 1.83, 95% CI: 1.81- 1.85). Stratified analysis by sex and Indigeneity showed this association was greatest for Indigenous males (aOR: 2.16, 95% CI: 2.10-2.22). Forgoing prescribed medications due to cost is associated with more severe depressive symptoms among Canadians, particularly racialized and Indigenous males.

Amphetamine-Related Emergency Department Visits in Ontario, Canada, 2003-2020.

OBJECTIVES: Despite unregulated amphetamine use increasing, there are limited data on related emergency department (ED) visits in Canada. Our primary objective was to examine trends in amphetamine-related ED visits over time in Ontario, including by age and sex. Secondary objectives were to examine whether patient characteristics were associated with ED revisit within 6 months. METHODS: Using administrative claims and census data, we calculated annual patient- and encounter-based rates of amphetamine-related ED visits from 2003 to 2020 among individuals 18+ years of age. We also performed a retrospective cohort study of individuals with amphetamine-related ED visits between 2019 and 2020 to determine whether select factors were associated with ED revisit within 6 months. Multivariable logistic regression modelling was used to measure associations. RESULTS: The population-based rate of amphetamine-related ED visits increased nearly 15-fold between 2003 (1.9/100,000 Ontarians) and 2020 (27.9/100,000 Ontarians). Seventy-five percent of individuals returned to the ED for any reason within 6 months. Psychosis and use of other substances were both independently associated with ED revisit for any reason within 6 months (psychosis: AOR = 1.54, 95% CI = 1.30-1.83; other substances: AOR = 1.84, 95% CI = 1.57-2.15), whereas having a primary care physician was negatively associated with ED revisit (AOR = 0.77, 95% CI = 0.60-0.98). CONCLUSIONS: Increasing rates of amphetamine-related ED visits in Ontario are cause for concern. Diagnoses of psychosis and the use of other substances may serve to identify individuals who are most likely to benefit from both primary and substance-specific care.

International surveillance study in acute spinal cord injury confirms viability of multinational clinical trials.

BACKGROUND: The epidemiological international landscape of traumatic spinal cord injury (SCI) has evolved over the last decades along with given inherent differences in acute care and rehabilitation across countries and jurisdictions. However, to what extent these differences may influence neurological and functional recovery as well as the integrity of international trials is unclear. The latter also relates to historical clinical data that are exploited to inform clinical trial design and as potential comparative data. METHODS: Epidemiological and clinical data of individuals with traumatic and ischemic SCI enrolled in the European Multi-Center Study about Spinal Cord Injury (EMSCI) were analyzed. Mixed-effect models were employed to account for the longitudinal nature of the data, efficiently handle missing data, and adjust for covariates. The primary outcomes comprised demographics/injury characteristics and standard scores to quantify neurological (i.e., motor and sensory scores examined according to the International Standards for the Neurological Classification of Spinal Cord Injury) and functional recovery (walking function). We externally validated our findings leveraging data from a completed North American landmark clinical trial. RESULTS: A total of 4601 patients with acute SCI were included. Over the course of 20 years, the ratio of male to female patients remained stable at 3:1, while the distribution of age at injury significantly shifted from unimodal (2001/02) to bimodal distribution (2019). The proportional distribution of injury severities and levels remained stable with the largest percentages of motor complete injuries. Both, the rate and pattern of neurological and functional recovery, remained unchanged throughout the surveillance period despite the increasing age at injury. The findings related to recovery profiles were confirmed by an external validation cohort (n=791). Lastly, we built an open-access and online surveillance platform ("Neurosurveillance") to interactively exploit the study results and beyond. CONCLUSIONS: Despite some epidemiological changes and considerable advances in clinical management and rehabilitation, the neurological and functional recovery following SCI has remained stable over the last two decades. Our study, including a newly created open-access and online surveillance tool, constitutes an unparalleled resource to inform clinical practice and implementation of forthcoming clinical trials targeting neural repair and plasticity in acute spinal cord injury.

16-year trends in asthma hospital admissions in Canada.

BACKGROUND: Asthma hospitalizations declined rapidly in many parts of the world, including Canada, in the 1990s and early 2000s. OBJECTIVE: To examine whether the declining trend of asthma hospitalizations persisted in recent years in Canada. METHODS: Using the Canadian comprehensive nationwide hospitalization data (2002-2017), we identified hospital admissions with the main International Classification of Diseases codes for asthma. We analyzed sex-specific age-standardized trends in annual hospitalization rates among pediatric (< 19 years) and adult (19+ years) patients. We used change-point analysis to evaluate any substantial changes in the trends in the sex-age groups. RESULTS: There were 254,672 asthma-related hospital admissions (59% pediatric, 50% female) during the study period. Among children, age-adjusted annual rates per 100,000 decreased by 55% in females (152-69) and by 60% in males (270-108) from 2002 to 2017. Among adults, the rates decreased by 59% in both sexes (females: 61-25; males: 27-11). Change-point analysis indicated a substantial plateauing of the annual rate in both pediatric (from -15.3 [females] and -25.8 [males] before 2010 to -0.6 [females] and -0.8 [males] after 2010) and adult (from -5.4 [females] and -2.6 [males] before 2008 to -0.6 [females] and -0.2 [males] after 2008) groups. CONCLUSION: After a substantial decline in hospital admissions for acute asthma, there has been minimal further decline since 2010 for children and 2008 for adults. In addition to adhering to the contemporary standards of asthma care, novel, disruptive strategies are likely needed to further reduce the burden of asthma.

A systematic, concept-based method of developing the exposure measure for drug safety and effectiveness studies.

PURPOSE: In drug safety and effectiveness studies based on secondary data, the choice of an appropriate exposure measure for a given outcome can be challenging. Different measures of exposure can yield different estimates of treatment effect and safety. There is a knowledge gap with respect to developing and refining measures of drug exposure, to ensure that the exposure measure addresses the study question and is suitable for statistical analysis. METHODS: We present a transparent, step-by-step approach to the development of drug exposure measures involving secondary data. This approach would be of interest to students and investigators with initial training in pharmacoepidemiology. We illustrate the approach using a study about Parkinson's disease. RESULTS: We described the exposure specifications according to the study question. Next, we refined the exposure measure by linking it to knowledge about four major concepts in drug safety and effectiveness studies: drug use patterns, duration, timing, and dose. We then used this knowledge to guide the ultimate choice of exposure measure: time-varying, cumulative 6-month exposure to tamsulosin (a drug used to treat prostate hyperplasia). CONCLUSIONS: The proposed approach links exposure specifications to four major concepts in drug safety and effectiveness studies. Formulating subject-matter knowledge about these major concepts provides an avenue to develop the rationale and specifications for the exposure measure.

Readmission Following Hospitalization for Traumatic Brain Injury: A Nationwide Study.

OBJECTIVE: To determine whether sociodemographic and clinical factors were associated with nonelective readmission within 30 days of hospitalization for traumatic brain injury (TBI). Secondary objectives were to examine the effects of TBI severity on readmission and characterize primary reasons for readmission. SETTING: Hospitalized patients in the United States, using the 2014 Nationwide Readmission Database. PARTICIPANTS: All patients hospitalized with a primary diagnosis of TBI between January 1, 2014, and November 30, 2014. We excluded patients (1) with a missing or invalid length of stay or admission date, (2) who were nonresidents, and 3) who died during their index hospitalization. DESIGN: Observational study; cohort study. MAIN MEASURES: Survey weighting was used to compute national estimates of TBI hospitalization and nonelective 30-day readmission. Associations between sociodemographic and clinical factors with readmission were assessed using unconditional logistic regression with and without adjustment for suspected confounders. RESULTS: There were 135 542 individuals who were hospitalized for TBI; 8.9% of patients were readmitted within 30 days of discharge. Age (strongest association for 65-74 years vs 18-24 years: adjusted odds ratio [AOR], 2.57; 95% CI: 2.02-3.27), documentation of a fall (AOR, 1.24; 95% CI: 1.13-1.35), and intentional self-injury (AOR, 3.13; 95% CI: 1.88-5.21) at the index admission were positively associated with readmission. Conversely, history of a motor vehicle (AOR, 0.69; 95% CI: 0.62-0.78) or cycling (AOR, 0.56; 95% CI: 0.40-0.77) accident was negatively associated with readmission. Females were also less likely to be readmitted following hospitalization for a TBI (AOR, 0.87; 95% CI: 0.82-0.92). CONCLUSIONS: Many sociodemographic and clinical factors were found to be associated with acute readmission following hospitalizations for TBI. Future studies are needed to determine the extent to which readmissions following TBI hospitalizations are preventable.

National survey of mental health and suicidal thoughts in people with spinal cord injury.

STUDY DESIGN: Retrospective cross-sectional epidemiological study. OBJECTIVES: Previous studies have quantified longitudinal psychological morbidity in individuals with spinal cord injury (SCI) relative to uninjured individuals. However, there is limited information regarding how lifestyle and socioeconomic factors are associated with mental health conditions in individuals with SCI. This study aims to quantify and compare mental health and suicidal thoughts in people with and without SCI, and examine the associations between mental health, suicidal thoughts, sex, age, lifestyle, and socioeconomic factors. SETTING: Canada. METHODS: The 2010 Canadian Community Health Survey (n > 40,000) was used, which includes several measures assessing mental health and suicidal thoughts. Bivariate and multivariate logistic regressions were performed and odds ratios with corresponding 95% confidence intervals were estimated. Sensitivity analyses were performed to evaluate the effect of covariates on reported effect sizes. RESULTS: People with SCI had higher odds of having mood (3.6) and anxiety disorders (2.5), suicidal thoughts (2.3), self-perceived stress (1.9), and depression (4.4); in addition to lower odds of having good self-perceived mental health (0.24) and satisfaction with life (0.25). These differences persisted after adjusting for age, sex, lifestyle, and socioeconomic factors. Lower household income, fruit and vegetable consumption, and physical activity levels, and increased smoking use were associated with poorer mental health in individuals with SCI. CONCLUSIONS: Mental health is poorer in those with SCI when compared with the general population. Those with SCI exhibit a unique profile of lifestyle and socioeconomic factors that are associated with poorer mental health and increased suicidal thoughts.

Tardive neurotoxicity of anticholinergic drugs: A review.

The cholinergic system is a complex neurotransmitter system with functional involvement at multiple levels of the nervous system including the cerebral cortex, spinal cord, autonomic nervous system, and neuromuscular junction. Anticholinergic medications are among the most prescribed medications, making up one-third to one-half of all medications prescribed for seniors. Recent evidence has linked long-term use of anticholinergic medications and dementia. Emerging evidence implicates the cholinergic system in the regulation of cerebral vasculature as well as neuroinflammation, suggesting that anticholinergic medications may contribute to absolute risk and progression of neurodegenerative diseases. In this review, we explore the involvement of the cholinergic system in various neurodegenerative diseases and the possible detrimental effects of anticholinergic medications on the onset and progression of these disorders. We identified references by searching the PubMed and Cochrane database between January 1990 and September 2019 for English-language animal and human studies including randomized clinical trials (RCTs), meta-analyses, systematic reviews, and observational studies. In addition, we conducted a manual search of reference lists from retrieved studies. Long-term anticholinergic medication exposure may have detrimental consequences beyond well-documented short-term cognitive effects, through a variety of mechanisms either directly impacting cholinergic neurotransmission or through receptors expressed on the vasculature or immune cells, providing a pathophysiological framework for complex interactions across the entire neuroaxis.

Evaluation of cardiovascular disease risk in individuals with chronic spinal cord injury.

STUDY DESIGN: Multicentre, cross-sectional study. OBJECTIVES: To identify which markers of obesity, injury characteristics and autonomic function variables are related to cardiovascular disease (CVD) risk after spinal cord injury (SCI), and establish cut-points for detection and risk management. SETTING: Eight SCI rehabilitation centres in the Netherlands. METHODS: Individuals (n = 257) with a traumatic, chronic (≥10 years) SCI, with age at injury between 18 and 35 years, completed a self-report questionnaire and a one-day visit to a rehabilitation centre for testing. Three anthropometric measures were tested: body mass index (BMI); waist circumference (WC); and waist-to-height ratio (WHtR). Injury characteristics included: American Spinal Injury Association impairment scale (AIS); duration of injury (DOI); and neurological level of injury (LOI). Cardiovascular autonomic function was assessed from peak heart rate during maximal exercise (HRpeak). Systolic arterial pressure (SAP) and aerobic capacity (VO2peak) were also determined. CVD risk was calculated using the Framingham risk score (FRS). RESULTS: All anthropometric variables were associated with FRS, with WC showing the strongest correlation (r = 0.41, p < 0.001) and greatest area under the curve (0.73) for 10-year CVD risk (%). WC, DOI, SAP, HRpeak, LOI, and VO2peak (variable importance: 0.81, 1.0, 0.98, 0.98, 0.66, 0.68, respectively) were important predictive variables for 10-year CVD risk in individuals with SCI. CONCLUSIONS: We confirm that WC is a simple, practical measure of CVD risk, and along with DOI and markers of cardiovascular autonomic function, plays a role in the increased CVD risk following SCI.

Ecological fallacy as a novel risk factor for poor translation in neuroscience research: A systematic review and simulation study.

BACKGROUND: Translational neuroscience is largely concerned with establishing causal links between biological processes and functional outcomes. Exciting new methods have emerged and top-tier biomedical journals are placing increasingly high demand for experiments that link outcomes. One pitfall to making these connections is the "ecological fallacy"-establishing a relationship between outcomes based on aggregate (averaged) results (a distinct issue from correlation vs causation). METHODS: To showcase the ecological fallacy, we first used simulated data to define and demonstrate the problem. Next, we performed a systematic review to determine the prevalence of the fallacy in top-tier biomedical journals (Science, Nature Medicine, Neuron, Nature, Nature Neuroscience, Cell). Based on our own research interests and specializations, we specifically focused on recent publications in the area of spinal cord injury and regenerative medicine. RESULTS: Of the articles reviewed which examined a relationship between central nervous system regeneration and a behavioural outcome, 100% (21/21) were subject to possible ecological fallacy. CONCLUSIONS: Ecological fallacy is highly prevalent in neuroscience research and could partially account for translation failures in this field. Reporting guidelines for in vivo experiments should include subject-level correlation analyses for the primary outcomes.

Prediction of autonomic dysreflexia during urodynamics: a prospective cohort study.

BACKGROUND: Autonomic dysreflexia is a severe and potentially life-threatening condition in patients with spinal cord injury, as it can lead to myocardial ischemia, brain hemorrhage, or even death. Urodynamic investigation is the gold standard to assess neurogenic lower urinary tract dysfunction due to spinal cord injury and reveal crucial pathological findings, such as neurogenic detrusor overactivity. However, neurogenic detrusor overactivity and urodynamic investigation are known to be leading triggers of autonomic dysreflexia. Therefore, we aimed to determine predictors of autonomic dysreflexia in individuals with spinal cord injury during urodynamic investigation. METHODS: This prospective cohort study included 300 patients with spinal cord injuries and complete datasets of continuous non-invasive cardiovascular monitoring, recorded during same session repeat urodynamic investigation. We used logistic regression to reveal predictors of autonomic dysreflexia during urodynamic investigation. RESULTS: We found that level of injury and presence of neurogenic detrusor overactivity were the only two independent significant predictors for autonomic dysreflexia during urodynamic investigation. A lesion at spinal segment T6 or above (odds ratio (OR) 5.5, 95% CI 3.2-9.4) compared to one at T7 or below, and presence of neurogenic detrusor overactivity (OR 2.7, 95% confidence interval (CI) 1.4-4.9) were associated with a significant increased odds of autonomic dysreflexia during urodynamic investigation. Both odds persisted after adjustment for age, sex, and completeness and stage of injury (adjusted OR (AOR) 6.6, 95% CI 3.8-11.7, and AOR 2.2, 95% CI 1.1-4.5, respectively). Further stratification by lesion level showed level-dependent significantly increased adjusted odds of autonomic dysreflexia, i.e., from C1-C4 (AOR 16.2, 95% CI 5.9-57.9) to T4-T6 (AOR 2.6, 95% CI 1.3-5.2), compared to lesions at T7 or below. CONCLUSIONS: In patients with neurogenic lower urinary tract dysfunction due to spinal cord injury, autonomic dysreflexia is independently predicted by lesion level and presence of neurogenic detrusor overactivity. Considering the health risks associated with autonomic dysreflexia, such as seizures, stroke, retinal bleeding, or even death, we recommend both continuous cardiovascular monitoring during urodynamic investigation in all spinal cord-injured patients with emphasis on those with cervical lesions, and appropriate neurogenic detrusor overactivity treatment to reduce the probability of potentially life-threatening complications. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01293110 .

Prevalence of chronic pain among individuals with neurological conditions.

BACKGROUND: The prevalence of pain among people with a variety of individual neurological conditions has been estimated. However, information is limited about chronic pain among people with neurological conditions overall, and about the conditions for which chronic pain is most prevalent. To fill these information gaps, a common method of pain assessment is required. DATA AND METHODS: The data are from the Survey on Living with Neurological Conditions in Canada, a cross-sectional national survey. Based on self-reports, chronic pain was assessed for 16 neurological conditions. Multivariable logistic regression was used to produce odds ratios and 95% confidence intervals (CIs). RESULTS: Close to 1.5 million individuals aged 15 or older who lived in private households reported having been diagnosed with a neurological condition. The overall prevalence of chronic pain for the 16 neurological conditions combined was 36% (95% CI: 31% to 42%). The odds of chronic pain were significantly elevated among individuals with spinal cord trauma. DISCUSSION: Chronic pain is highly prevalent among people with neurological conditions, particularly those with spinal cord trauma. These results suggest a need to target health services and direct research to improved pain management, and thereby reduce the burden of neurological disease.

Five-Year Incidence of Amyotrophic Lateral Sclerosis in British Columbia (2010-2015).

BACKGROUND: Amyotrophic lateral sclerosis (ALS) is a fatal degenerative neurological disease with significant effects on quality of life. International studies continue to provide consistent incidence values, though complete case ascertainment remains a challenge. The Canadian population has been understudied, and there are currently no quantitative data on the incidence of ALS in British Columbia (BC). The objectives of this study were to determine the five-year incidence rates of ALS in BC and to characterize the demographic patterns of the disease. METHODS: The capture-recapture method was employed to estimate ALS incidence over a five-year period (2010-2015). Two sources were used to identify ALS cases: one database from an ALS medical centre and another from a not-for-profit ALS organization. RESULTS: During this time period, there were 690 incident cases within the two sources. The capture-recapture method estimated 57 unobserved cases, corresponding to a crude five-year incidence rate of 3.29 cases per 100,000 (CI 95%=3.05-3.53). The mean age of diagnosis was 64.6 (CI 95%=59.7-69.4), with 63.5 (CI 95%=56.9-70.1) for men and 65.7 (CI 95%=58.6-72.7) for women. There was a slight male preponderance in incidence, with a 1.05:1 ratio to females. Peak numbers in incidence occurred between the ages of 70 and 79. CONCLUSIONS: The incidence of ALS in BC was found to be consistent with international findings though nominally higher than that in other Canadian provinces to date.

Neuropathic pain, depression, and cardiovascular disease: a national multicenter study.

BACKGROUND: Individuals with spinal cord injury (SCI) have a more than twofold increased risk of heart disease and stroke compared with able-bodied individuals. The increased risk appears to be in excess of the risk conferred by several well-established risk factors, including diabetes, hypertension, and sex. This raises the question whether other factors, secondary to SCI, are also contributing to the development of cardiovascular disease (CVD). Two potential factors associated with SCI and CVD are pain and depression. Both are frequently reported among individuals with SCI, develop in the acute stages of injury, and are commonly described as severe. Therefore, the primary aim of this study was to examine the relationship between pain (and types of pain) and depression with CVD among individuals with SCI. METHODS: A total of 1,493 individuals (referred sample) with chronic SCI participated in a self-report cross-sectional multicenter Canada-wide survey from 2011-2012 (mean age ± standard deviation: 49.6 ± 13.9 years). RESULTS: After adjustment for age, sex, and injury characteristics, neuropathic pain and depression were significantly and independently associated with CVD (adjusted odds ratio and 95% confidence interval: 2.27 (1.21, 4.60) for neuropathic pain; 4.07 (2.10, 7.87) for depression). In contrast to neuropathic pain, non-neuropathic pain was not significantly associated with CVD (p = 0.13). CONCLUSION: In conclusion, these data illustrate important interrelationships between secondary complications following SCI, as well as raise the possibility of neuropathic pain (versus nociceptive pain) as a novel and emerging risk factor for CVD.

Transitional care clinics for patients discharged from hospital without a primary care provider: A systematic review.

BACKGROUND: The transition from hospital to home is a high-risk period. Timely follow-up care is essential to reducing avoidable harms such as adverse drug events, yet may be unattainable for patients who lack attachment to a primary care provider. Transitional care clinics (TCCs) have been proposed as a measure to improve health outcomes for patients discharged from hospital without an established provider. In this systematic review, we compared outcomes for unattached patients seen in TCCs after hospital discharge relative to care as usual. METHODS: We searched the following bibliographic databases for articles published on or before August 12, 2022: MEDLINE, Cumulative Index to Nursing and Allied Health Literature, Cochrane Database of Systematic Reviews, PsycINFO, and Web of Science. Five studies were identified that examined the effects of a dedicated postdischarge clinic on emergency department (ED) visits, readmissions, and/or mortality within 90 days of discharge for patients with no attachment to a primary care provider. RESULTS: Studies were heterogeneous in design and quality; all were from urban centers within the United States. Four of the five studies reported a reduction in either the number of ED visits or readmissions in patients seen in a TCC following hospitalization. CONCLUSIONS: TCCs may be effective in reducing hospital contacts in the period following hospital discharge in patients with no established primary care provider. Further studies are required to evaluate the health benefits attributable to the implementation of TCCs across a broad range of practice contexts, as well as the cost implications of this model.

Sex differences in heart disease prevalence among individuals with spinal cord injury: A population-based study.

CONTEXT/OBJECTIVE: The risk for cardiovascular disease is amplified following spinal cord injury, but whether risk differs between the sexes remains unknown. Here, we evaluated sex differences in the prevalence of heart disease among individuals with spinal cord injury, and compared sex differences with able-bodied individuals. DESIGN: The design was a cross-sectional study. Multivariable logistic regression analysis was conducted, using inverse probability weighting to account for the sampling method and to adjust for confounders. SETTING: Canada. PARTICIPANTS: Individuals who participated in the national Canadian Community Health Survey. INTERVENTIONS: Not applicable. OUTCOME MEASURES: Self-reported heart disease. RESULTS: Among 354 individuals with spinal cord injury, the weighted prevalence of self-reported heart disease was 22.9% in males and 8.7% in females, with an inverse-probability weighted odds ratio of 3.44 (95% CI 1.70-6.95) for males versus females. Among 60,605 able-bodied individuals, the prevalence of self-reported heart disease was 5.8% in males and 4.0% in females, with an inverse probability weighted odds ratio of 1.62 (95% CI 1.50-1.75) for males versus females. The effect of male sex on increasing heart disease prevalence was about two times higher among individuals with spinal cord injury than able-bodied individuals (relative difference in inverse probability weighted odds ratios = 2.12, 95% CI 1.08-4.51). CONCLUSION: Males with spinal cord injury exhibit a significantly higher prevalence of heart disease, compared with females with spinal cord injury. Moreover, relative to able-bodied individuals, spinal cord injury amplifies sex-related differences in heart disease. Overall, this work will inform targeted cardiovascular prevention strategies, and may also inform a better understanding of cardiovascular disease progression in both able-bodied and individuals with spinal cord injury.

Perspectives on Data Sharing in Persons With Spinal Cord Injury.

Open data sharing of clinical research aims to improve transparency and support novel scientific discoveries. There are also risks, including participant identification and the potential for stigmatization. The perspectives of persons participating in research are needed to inform open data-sharing policies. The aim of the current study was to determine perspectives on data sharing in persons with spinal cord injury (SCI), including risks and benefits, and types of data people are most willing to share. A secondary aim was to examine predictors of willingness to share data. Persons with SCIs in the United States and Canada completed a survey developed and disseminated through various channels, including our community partner, the North American Spinal Cord Injury Consortium. The study collected data from 232 participants, with 52.2% from Canada and 42.2% from the United States, and the majority completed the survey in English. Most participants had previously participated in research and had been living with an SCI for ≥5 years. Overall, most participants reported that the potential benefits of data sharing outweighed the negatives, with persons with SCI seen as the most trustworthy partners for data sharing. The highest levels of concern were that information could be stolen and companies might use the information for marketing purposes. Persons with SCI were generally supportive of data sharing for research purposes. Clinical trials should consider including a statement on open data sharing in informed consents to better acknowledge the contribution of research participants in future studies.

Pharmacological management of acute spinal cord injury: a longitudinal multi-cohort observational study.

Multiple types and classes of medications are administered in the acute management of traumatic spinal cord injury. Prior clinical studies and evidence from animal models suggest that several of these medications could modify (i.e., enhance or impede) neurological recovery. We aimed to systematically determine the types of medications commonly administered, alone or in combination, in the transition from acute to subacute spinal cord injury. For that purpose, type, class, dosage, timing, and reason for administration were extracted from two large spinal cord injury datasets. Descriptive statistics were used to describe the medications administered within the first 60 days after spinal cord injury. Across 2040 individuals with spinal cord injury, 775 unique medications were administered within the two months after injury. On average, patients enrolled in a clinical trial were administered 9.9 ± 4.9 (range 0-34), 14.3 ± 6.3 (range 1-40), 18.6 ± 8.2 (range 0-58), and 21.5 ± 9.7 (range 0-59) medications within the first 7, 14, 30, and 60 days post-injury, respectively. Those enrolled in an observational study were administered on average 1.7 ± 1.7 (range 0-11), 3.7 ± 3.7 (range 0-24), 8.5 ± 6.3 (range 0-42), and 13.5 ± 8.3 (range 0-52) medications within the first 7, 14, 30, and 60 days post-injury, respectively. Polypharmacy was commonplace (up to 43 medications per day per patient). Approximately 10% of medications were administered acutely as prophylaxis (e.g., against the development of pain or infections). To our knowledge, this was the first time acute pharmacological practices have been comprehensively examined after spinal cord injury. Our study revealed a high degree of polypharmacy in the acute stages of spinal cord injury, raising the potential to impact neurological recovery. All results can be interactively explored on the RXSCI web site ( https://jutzelec.shinyapps.io/RxSCI/ ) and GitHub repository ( https://github.com/jutzca/Acute-Pharmacological-Treatment-in-SCI/ ).

Race-based reporting and participation of Black individuals in registered pain clinical trials, United States, 2000 to 2019.

ABSTRACT: There are numerous, well-established racial disparities in the management of pain. The degree to which these are evident at the stage of conducting clinical trials is unknown. To address this knowledge gap, we examined race-based reporting, participation of Black individuals, and the factors associated with reporting and participation in pain clinical trials in the United States. Data were extracted from Clinicaltrials.gov and published articles. One thousand two hundred trials met our inclusion criteria; 482 (40.2%) reported participant race. More recent, publicly funded, and larger trials were more likely to report race. Of 82,468 participants included in pain clinical trials that reported race, 15,101 were Black individuals (18.3%). Participation of Black individuals was significantly associated with pain type (ß = +27% in cardiovascular disease pain compared with acute pain, P < 0.05), study population (ß = +33% and +7% in pain in minoritized populations and women, respectively, compared with general population, P < 0.05), pain intervention (ß = +7.5% for trials of opioid interventions compared with nonopioid interventions, P < 0.05), and a diverse team of investigators (ß = +8.0% for studies incorporating a visible non-White investigator compared with those that did not, P < 0.05). Our results indicate that representation of Black participants in pain clinical trials generally aligns with national demographics in the United States. Increased representation corresponds with health conditions more prevalent among Black individuals (eg, cardiovascular disease) and with a diverse study team composition. Despite these encouraging results, less than half of pain trials reported race, which introduces potential publication bias and limits external validity.