Reasons for Initiation and Discontinuation of Pharmacological Therapies for Osteoporosis in Veterans with Spinal Cord Injury and Disorders.

INTRODUCTION: Medications for osteoporosis have not been reported to reduce fracture rates in patients with spinal cord injury and disorders (SCI/D), yet these medications are still prescribed. Clinical decision-making underscoring the initiation and discontinuation of osteoporosis medications in SCI/D remains poorly understood. METHODOLOGY: Veterans with a SCI/D with at least one prescription for an osteoporosis medication (bisphosphonate, calcitonin, denosumab, raloxifene, and teriparatide) who received healthcare within Veterans Affairs (VA) from 2005 to 2015 were identified using VA administrative databases. A 10% subsample of Veterans was selected for electronic health record review. RESULTS: Two hundred and sixty-seven Veterans with 330 prescriptions underwent electronic health record review. Bisphosphonates were the most frequently prescribed medication for osteoporosis (n = 223, 67.6%). Of the 187 Veterans with prescriptions for prevention or treatment of osteoporosis, the primary reason for initiation was Dual Energy X-ray Absorptiometry (DXA) scan with osteopenia or osteoporosis (n = 119, 63.6% of Veterans), primarily at the hip (81.0% of DXAs). The majority (79.0%) of DXAs were "screening tests," with SCI/D being the sole reason for the scan. Fractures (n = 51, 27.3%) and fall risk concerns (n = 29, 15.5%) were other major reasons for initiation. On average, oral bisphosphonates were filled for <3 yr, with medication-related side effects (n = 23, 15.8% of bisphosphonates discontinued), predominately gastrointestinal (n = 17, 73.9% of reported side effects), the most common reason for discontinuation. Drug holidays occurred in 14.3% of 35 oral bisphosphonates used for ≥5 yr. No cases of osteonecrosis of the jaw were found. There was one case of an atypical femoral fracture which could not be confirmed. CONCLUSIONS: The decision to initiate pharmacological therapies in SCI/D is primarily based on osteopenia or osteoporosis at the hip by screening DXAs. Gastrointestinal side effects are the major reason for discontinuation of oral bisphosphonates. New therapies for osteoporosis in SCI/D are needed.

Factors influencing providers' decisions on management of bone health in people with spinal cord injury.

STUDY DESIGN: Survey. OBJECTIVES: Managing osteoporosis in persons with chronic spinal cord injury (SCI) is difficult as little evidence exists regarding effective strategies. We examined the effect of key factors on providers' bone health management decisions in persons with SCI. SETTING: USA. METHODS: Providers reviewed blocks of 9 hypothetical cases that varied on four factors: osteoporosis, osteopenia, or normal bone mineral density using dual-energy X-ray absorptiometry (DXA); DXA region of interest (lumbar spine, hip, knee), prior lower extremity fracture; and no or limited ambulation. They indicated how likely they would recommend pharmacological management, what treatment(s) they would recommend, and whether they would request another DXA before treatment. RESULTS: Eighty-two healthcare providers completed the survey. Treatment recommendations for bisphosphonates and Vitamin D/calcium supplements, respectively, were more likely if there was a prior fracture (OR: 2.65, 95%CI: 1.76-3.99, p < 0.0001; OR: 2.96, 95%CI: 1.40-6.26, p = 0.004) and if a DXA scan found osteopenia (OR: 2.23, 95%CI: 1.41-3.54, p = 0.001; OR: 6.56, 95%CI: 2.71-15.85, p < 0.0001) or osteoporosis (OR: 12.08, 95%CI: 7.09-20.57, p < 0.0001; OR: 4.54, 95%CI: 2.08-9.90, p < 0.0001). Another DXA scan was more likely to be requested if there was a prior fracture (OR: 1.75, 95%CI: 1.10-2.78, p = 0.02) but less likely if the person was nonambulatory (OR: 0.41, 95%: 0.19-0.90, p = 0.03). CONCLUSIONS: Prior fracture and DXA findings influenced treatment recommendations for bone health management in SCI. Reliance on lumbar spine scans to determine bone loss and treatment identifies a knowledge gap for which future education is required.

Exoskeletal-Assisted Walking in Veterans With Paralysis: A Randomized Clinical Trial.

Importance: Robotic exoskeletons leverage technology that assists people with spinal cord injury (SCI) to walk. The efficacy of home and community exoskeletal use has not been studied in a randomized clinical trial (RCT). Objective: To examine whether use of a wheelchair plus an exoskeleton compared with use of only a wheelchair led to clinically meaningful net improvements in patient-reported outcomes for mental and physical health. Design, Setting, and Participants: This RCT of veterans with SCI was conducted at 15 Veterans Affairs medical centers in the US from September 6, 2016, to September 27, 2021. Data analysis was performed from March 10, 2022, to June 20, 2024. Interventions: Participants were randomized (1:1) to standard of care (SOC) wheelchair use or SOC plus at-will use of a US Food and Drug Administration (FDA)-cleared exoskeletal-assisted walking (EAW) device for 4 months in the home and community. Main Outcomes and Measures: Two primary outcomes were studied: 4.0-point or greater improvement in the mental component summary score on the Veterans RAND 36-Item Health Survey (MCS/VR-36) and 10% improvement in the total T score of the Spinal Cord Injury-Quality of Life (SCI-QOL) physical and medical health domain and reported as the proportion who achieved clinically meaningful changes. The primary outcomes were measured at baseline, post randomization after advanced EAW training sessions, and at 2 months and 4 months (primary end point) in the intervention period. Device usage, reasons for not using, and adverse events were collected. Results: A total of 161 veterans with SCI were randomized to the EAW (n = 78) or SOC (n = 83) group; 151 (94%) were male, the median age was 47 (IQR, 35-56) years, and median time since SCI was 7.3 (IQR, 0.5 to 46.5) years. The difference in proportion of successes between the EAW and SOC groups on the MCS/VR-36 (12 of 78 [15.4%] vs 14 of 83 [16.9%]; relative risk, 0.91; 95% CI, 0.45-1.85) and SCI-QOL physical and medical health domain (10 of 78 [12.8%] vs 11 of 83 [13.3%]; relative risk, 0.97; 95% CI, 0.44-2.15) was not statistically different. Device use was lower than expected (mean [SD] distance, 1.53 [0.02] miles per month), primarily due to the FDA-mandated companion being unavailable 43.9% of the time (177 of 403 instances). Two EAW-related foot fractures and 9 unrelated fractures (mostly during wheelchair transfers) were reported. Conclusions and Relevance: In this RCT of veterans with SCI, the lack of improved outcomes with EAW device use may have been related to the relatively low device usage. Solutions for companion requirements and user-friendly technological adaptations should be considered for improved personal use of these devices. Trial Registration: ClinicalTrials.gov Identifier: NCT02658656.

Delayed and unmet need for medical care among publicly insured adults with disabilities.

BACKGROUND: While Medicaid is an important source of insurance coverage for persons with disabilities, barriers remain to accessing care for this population. OBJECTIVES: This study addresses 3 research questions: (1) do adults with disabilities experience greater unmet need/delayed care?; (2) do barriers related to cost, providers, or structure vary by disability status?; and (3) do barriers mediate the relationship between disability and access to care? RESEARCH DESIGN: Data were obtained from a 2008 stratified random sample of Minnesota Health Care Program's nonelderly adult enrollees (n=1880). The survey was administered by mail, with a telephone follow-up for nonresponders. MEASURES: Disability is defined by self-report. Access to care is measured by reported delayed and unmet need for medical care within the past year. Respondents were asked about their experiences with a variety of cost-related, provider-related, and structural barriers to care. RESULTS: Respondents with a disability were more likely to experience delayed (40%) and unmet need (23%) for medical care than persons without disabilities (24% and 10%, respectively). Persons with disabilities also reported multiple barriers to health care, especially structural barriers, such as making a timely appointment and accessing transportation (74% vs. 59%). The greater likelihood of facing a structural barrier partially explained increased risk of delayed or unmet care among adults with disabilities. CONCLUSIONS: Disparities in access to health care based on disability status remain even for persons who have insurance. These disparities deserve further research and policy attention to better address the particular needs of this population.

Life satisfaction and life values in people with spinal cord injury living in three Asian countries: a multicultural study.

OBJECTIVE: To compare the differences in life satisfaction and life values among people with spinal cord injury (SCI) living in three economically similar Asian countries: India, Vietnam, and Sri Lanka. DESIGN: Cross-sectional and comparative investigation using the unified questionnaire. SETTING: Indian Spinal Injuries Centre in New Delhi (India), Spinal Cord Rehabilitation Department of the Bach Mai Hospital in Hanoi (Vietnam), and Foundation for the Rehabilitation of the Disabled in Colombo (Sri Lanka). PARTICIPANTS: Two hundred and thirty-seven people with SCI using a wheelchair; 79 from India, 92 from Vietnam, and 66 from Sri Lanka. OUTCOME MEASURES: Life Satisfaction Questionnaire, Chinese Value Survey. RESULTS: People with SCI in Vietnam had significantly higher general life satisfaction than participants in India and Sri Lanka. Significant differences were identified in several demographic and life situation variables among the three Asian countries. With regard to "Traditional", "Universal", and "Personal" life values significant differences among three participating countries were identified in all domains. No significant relationships were identified between life satisfaction and life values for people with SCI in India, Vietnam, or Sri Lanka. CONCLUSION: It could be presumed that particular demographic and life situation variables are more powerful factors of life satisfaction following SCI than the dominant culture of a country expressed by life values.

Spinal cord injury providers' perspectives on managing sublesional osteoporosis.

Objective: Persons with spinal cord injuries (SCI) experience rapid sublesional bone loss following injury (1, 3). Evidence on preventing/managing osteoporosis in SCI is lacking. This project examined how providers manage bone loss in SCI. Design: Telephone interviews with SCI providers. Setting: VA SCI centers and clinics. Participants: Veterans Administration SCI centers and clinics were categorized on their average number of dual-energy X-ray absorptiometry (DXA) scans (FY2014-2016). Twelve SCI providers from high and low DXA-ordering sites were interviewed. Questions included osteoporosis screening/diagnosis, prevention/treatment strategies, secondary causes of osteoporosis, and osteoporotic fracture complications. Interviews were audio-recorded, transcribed, and analyzed. Results: Providers described a lack of standardized guidelines for managing osteoporosis in SCI. They most often screened for osteoporosis using DXA when: (1) considering use of a new device or activity, (2) for patients with a history of fracture. Some providers assumed that non-ambulatory SCI patients already have osteoporosis so infrequently ordered DXAs. Assessment of secondary causes of osteoporosis was uncommon. Fracture prevention strategies identified included weight-bearing and engaging in activities like adaptive sports. Vitamin D and calcium were frequently prescribed as a result of deficiencies identified during lab testing. Providers seldom prescribed FDA-approved medications for osteoporosis. Post-fracture complications encountered included nonunion/malunion and compartment syndrome. Providers indicated that patients often experienced psychological stress, anxiety and depression following fractures. Conclusion: Providers described a lack of evidence for screening and management of patients with SCI and osteoporosis. Future efforts should include developing evidence-informed guidelines to aid providers in osteoporosis management.

Epidemiology of hospital-acquired infections in veterans with spinal cord injury and disorder.

OBJECTIVE: To describe the epidemiology of hospital-acquired infections (HAIs) in veterans with spinal cord injury and disorder (SCI&D). DESIGN: Retrospective medical record review. SETTING: Midwestern Department of Veterans Affairs spinal cord injury center. PARTICIPANTS: A total of 226 patients with SCI&D hospitalized at least once during a 2-year period (October 1, 2001, through September 30, 2003). RESULTS: A total of 549 hospitalizations were included in the analysis (mean duration of hospitalization, 33.7 days); an HAI occurred during 182 (33.2%) of these hospitalizations. A total of 657 HAIs occurred during 18,517 patient-days in the hospital (incidence rate, 35.5 HAIs per 1,000 patient-days). Almost half of the 226 patients had at least 1 HAI; the mean number of HAIs among these patients was 6.0 HAIs per patient. The most common HAIs were urinary tract infection (164 [25.0%] of the 657 HAIs; incidence rate, 8.9 cases per 1,000 patient-days), bloodstream infection (111 [16.9%]; incidence rate, 6.0 cases per 1,000 patient-days), and bone and joint infection (103 [15.7%]; incidence rate, 5.6 cases per 1,000 patient-days). The most common culture isolates were gram-positive bacteria (1,082 [45.6%] of 2,307 isolates), including Staphylococcus aureus, and gram-negative bacteria (1,033 [43.6%] of isolates), including Pseudomonas aeruginosa. Multivariable regression demonstrated that predictors of HAI were longer length of hospital stay (P=.002), community-acquired infection (P=.007), and use of a urinary invasive device (P=.01) or respiratory invasive device (P=.04). CONCLUSIONS: The overall incidence of HAIs in persons with SCI&D was higher than that reported for other populations, confirming the increased risk of HAI in persons with spinal cord injury. The increased risk associated with longer length of stay and with community-acquired infection suggests that strategies are needed to reduce the duration of hospitalization and to effectively treat community-acquired infection, to decrease infection rates. There is significant room for improvement in reducing the incidence of HAIs in this population.

Development and testing of a vaccination message targeted to persons with spinal cord injuries and disorders.

BACKGROUND/OBJECTIVE: Individuals with spinal cord injuries and disorders (SCI&D) are at high-risk of complications and death after influenza and pneumonia. Respiratory vaccinations are effective in reducing infection and complications. The aim of this study was to test the feasibility and effectiveness of a multimedia educational message developed using a strong theoretical basis and targeted consumer input to modify negative perceptions, increase knowledge, and positively influence intentions and beliefs regarding respiratory vaccinations. METHODS: Veterans with SCI&D (n = 36) completed a pretest questionnaire, viewed the message, and, after a clinic visit, completed a posttest questionnaire. Mean differences were examined using paired t tests. Providers (n = 25) were surveyed about the content, comprehension, and reception of the message; response frequencies were examined. RESULTS: Respondents showed positive changes in beliefs from pre- to posttest on multiple items related to knowledge, severity, and self efficacy and response efficacy. There were no changes in perception of personal susceptibility to these diseases. Most providers were in favor of using the message in this population. CONCLUSIONS: A brief theory-based multimedia intervention is a feasible way to improve knowledge and attitudes about respiratory vaccinations in high-risk populations.

Investigation of soft-tissue stiffness alteration in denervated human tissue using an ultrasound indentation system.

BACKGROUND/OBJECTIVE: Differences in soft-tissue stiffness may provide for a quantitative assessment and detection technique for pressure ulcers or deep-tissue injury. An ultrasound indentation system may provide a relatively convenient, simple, and noninvasive method for quantitative measurement of changes in soft-tissue stiffness in vivo. METHODS: The Tissue Ultrasound Palpation System (TUPS) was used to quantitatively measure changes in soft-tissue stiffness at different anatomical locations within and between able-bodied persons and individuals with chronic spinal cord injury (SCI). The stiffness of soft tissue was measured at the ischial tuberosity, greater trochanter, posterior midthigh, and biceps brachii. Additionally, soft-tissue thickness and soft-tissue deformation were also measured. RESULTS: Significant differences in soft-tissue stiffness were observed within the various anatomical locations tested, in both the able-bodied and SCI groups. Differences in soft-tissue stiffness were also observed between the 2 groups. Participants with SCI had significantly softer tissue in their buttock-thigh area. CONCLUSIONS: TUPS is a clinically feasible technology that can reliably and effectively detect changes in soft-tissue stiffness. The study has provided a better understanding of the tissue mechanical response to external loading, specifically in the SCI population, suggesting the use of tissue stiffness as a parameter to detect and assess pressure-related soft-tissue injury.

Long-term outcomes from nosocomial infections in persons with spinal cord injuries and disorders.

BACKGROUND: Nosocomial infection may contribute to poor long-term consequences in persons who have spinal cord injuries and disorders (SCI&D). METHODS: This is a cohort study of individuals who had SCI&D and were hospitalized at least once during 2002. They were followed for 3 years to assess inpatient (IP) admissions, total IP length of stay (LOS), outpatient (OP) visits, and mortality. Count data models and a Cox proportional hazards model were used to assess the relationship between previous infection and subsequent IP and OP use and long-term mortality, respectively. RESULTS: Of persons who had SCI&D, 59% had at least one nosocomial infection. Multivariable regression indicated that veterans who had SCI&D had more IP admissions (b = 0.405; P < .0001) and longer IP LOS (b = 0.843; P < .0001) if they had a previous infection; however, infection status was not a predictor of future OP visits. Survival time was lower (913.93 versus 1034.75 days, P = .004) in the infection group. Death rate was higher in the nosocomial infection group (30.11% versus 10.77%; P = .004), but the association did not achieve significance in the Cox proportional hazards model (P = .12). CONCLUSIONS: Nosocomial infections have serious subsequent consequences that result in future hospitalization and shorter survival. Efforts to prevent nosocomial infections are needed to reduce long-term adverse effects in persons who have SCI&D.