Cannabinoids and an anti-inflammatory diet for the treatment of neuropathic pain after spinal cord injury (The CATNP Study): study protocol for a randomized controlled trial.

STUDY DESIGN: Multicenter, randomized, double-blind, placebo controlled, clinical trial. OBJECTIVE: The objective of this paper is to evaluate the effectiveness of cannabinoids and an anti-inflammatory diet, alone and in combination, for the management of neuropathic pain (NP) after spinal cord injury (SCI). SETTING: Two Canadian SCI rehabilitation centers. METHODS: A sample of 144 individuals with SCI will receive either an anti-inflammatory diet, cannabinoids or a placebo for 6 weeks. Following this, a combined effect of these treatments will be evaluated for a further 6 weeks. The primary outcome measure will be the change in NP as assessed by the numeric rating scale (NRS). Secondary outcomes will include changes in inflammation, mood, sleep, spasticity, cost-effectiveness, and function. CONCLUSION: This study will assess the efficacy of an anti-inflammatory diet and cannabinoids (individually and in combination) for the treatment of NP following SCI. Results may reveal a cost-effective, side-effect free intervention strategy which could be utilized for the long-term management of NP following SCI.

Cost-Utility Analysis of Electroconvulsive Therapy and Repetitive Transcranial Magnetic Stimulation for Treatment-Resistant Depression in Ontario.

OBJECTIVES: To evaluate the cost-effectiveness of repetitive transcranial magnetic stimulation (rTMS) and electroconvulsive therapy (ECT), and combining both treatments in a stepped care pathway for patients with treatment-resistant depression (TRD) in Ontario. METHODS: A cost-utility analysis evaluated the lifetime costs and benefits to society of rTMS and ECT as first-line treatments for TRD using a Markov model, which simulates the costs and health benefits of patients over their lifetime. Health states included acute treatment, maintenance treatment, remission, and severe depression. Treatment efficacy and health utility data were extracted and synthesized from randomized controlled trials and meta-analyses evaluating these techniques. Direct costing data were obtained from national and provincial costing databases. Indirect costs were derived from government records. Scenario, threshold, and probabilistic sensitivity analyses were performed to test robustness of the results. RESULTS: rTMS dominated ECT, as it was less costly and produced better health outcomes, measured in quality-adjusted life years (QALYs), in the base case scenario. rTMS patients gained an average of 0.96 additional QALYs (equivalent to approximately 1 year in perfect health) over their lifetime with costs that were $46,094 less than ECT. rTMS remained dominant in the majority of scenario and threshold analyses. However, results from scenarios in which the model's maximum lifetime allowance of rTMS treatment courses was substantially limited, the dominance of rTMS over ECT was attenuated. The scenario that showed the highest QALY gain (1.19) and the greatest cost-savings ($46,614) was when rTMS nonresponders switched to ECT. CONCLUSION: From a societal perspective utilizing a lifetime horizon, rTMS is a cost-effective first-line treatment option for TRD relative to ECT, as it is less expensive and produces better health outcomes. The reduced side effect profile and greater patient acceptability of rTMS that allow it to be administered more times than ECT in a patient's lifetime may contribute to its cost-effectiveness.

An economic evaluation examining the cost-effectiveness of continuous diffusion of oxygen therapy for individuals with diabetic foot ulcers.

Continuous delivery of oxygen therapy has been observed to improve healing for individuals with an advanced diabetic foot ulcer (DFU). However, this intervention requires the purchasing of an oxygen delivery device and moist dressings. It is unknown whether this upfront financial investment represents good value for money. Thus the aim of this project is to evaluate the cost-effectiveness of treating advanced DFU using continuous delivery of oxygen compared with negative pressure wound therapy from the perspective of the public health care payer in Ontario, Canada. A microsimulation model was constructed with inputs from peer-reviewed journal publications and publicly available reports. The 5-year costs and quality-adjusted life-years were compared between treatment and comparator. Sensitivity analyses were conducted to evaluate the robustness of results. The model predicted that continuous delivery of oxygen would cost $4800 less compared with negative pressure wound therapy and increased quality-adjusted life years by 0.025. Lower cost and improved outcomes were observed in most scenario analyses. The results of this economic evaluation suggest that CDO therapy may reduce health care economic burden with a modest increase in quality of life outcomes. Health care decision-makers should consider the inclusion of CDO for the treatment of DFU.

A scoping review on health economics in neurosurgery for acute spine trauma.

OBJECTIVE Acute spine trauma (AST) has a relatively low incidence, but it often results in substantial individual impairments and societal economic burden resulting from the associated disability. Given the key role of neurosurgeons in the decision-making regarding operative management of individuals with AST, the authors performed a systematic search with scoping synthesis of relevant literature to review current knowledge regarding the economic burden of AST. METHODS This systematic review with scoping synthesis included original articles reporting cost-effectiveness, cost-utility, cost-benefit, cost-minimization, cost-comparison, and economic analyses related to surgical management of AST, whereby AST is defined as trauma to the spine that may result in spinal cord injury with motor, sensory, and/or autonomic impairment. The initial literature search was carried out using MEDLINE, EMBASE, CINAHL, CCTR, and PubMed. All original articles captured in the literature search and published from 1946 to September 27, 2017, were included. Search terms used were the following: (cost analysis, cost effectiveness, cost benefit, economic evaluation or economic impact) AND (spine or spinal cord) AND (surgery or surgical). RESULTS The literature search captured 5770 titles, of which 11 original studies met the inclusion/exclusion criteria. These 11 studies included 4 cost-utility analyses, 5 cost analyses that compared the cost of intervention with a comparator, and 2 studies examining direct costs without a comparator. There are a few potentially cost-saving strategies in the neurosurgical management of individuals with AST, including 1) early surgical spinal cord decompression for acute traumatic cervical spinal cord injury (or traumatic thoracolumbar fractures, traumatic cervical fractures); 2) surgical treatment of the elderly with type-II odontoid fractures, which is more costly but more effective than the nonoperative approach among individuals with age at AST between 65 and 84 years; 3) surgical treatment of traumatic thoracolumbar spine fractures, which is implicated in greater direct costs but lower general-practitioner visit costs, private expenditures, and absenteeism costs than nonsurgical management; and 4) removal of pedicle screws 1-2 years after posterior instrumented fusion for individuals with thoracolumbar burst fractures, which is more cost-effective than retaining the pedicle screws. CONCLUSIONS This scoping synthesis underscores a number of potentially cost-saving opportunities for neurosurgeons when managing patients with AST. There are significant knowledge gaps regarding the potential economic impact of therapeutic choices for AST that are commonly used by neurosurgeons.

Traumatic Cervical Spinal Cord Injury and Income and Employment Status.

Importance: Spinal cord injury (SCI) causes drastic changes to an individual's physical health that may be associated with the ability to work. Objective: To estimate the association of SCI with individual earnings and employment status using national administrative health databases linked to income tax data. Design, Setting, and Participants: This was a retrospective, national, population-based cohort study of adults who were hospitalized with cervical SCI in Canada between January 2005 and December 2017. All acute care hospitalizations for SCI of adults ages 18 to 64 years were included. A comparison group was constructed by sampling from individuals in the injured cohort. Fiscal information from their preinjury years was used for comparison. The injured cohort was matched with the comparison group based on age, sex, marital status, province of residence, self-employment status, earnings, and employment status in the year prior to injury. Data were analyzed from August 2022 to January 2023. Main outcomes and Measures: The first outcome was the change in individual annual earnings up to 5 years after injury. The change in mean yearly earnings was assessed using a linear mixed-effects differences-in-differences regression. Income values are reported in 2022 Canadian dollars (CAD $1.00 = US $0.73). The second outcome was the change in employment status up to 5 years after injury. A multivariable probit regression model was used to compare proportions of individuals employed among those who had experienced SCI and the paired comparison group of participants. Results: A total of 1630 patients with SCI (mean [SD] age, 47 [13] years; 1304 male [80.0%]) were matched to patients in a preinjury comparison group (resampled from the same 1630 patients in the SCI group). The mean (SD) of preinjury wage earnings was CAD $46 000 ($48 252). The annual decline in individual earnings was CAD $20 275 (95% CI, -$24 455 to -$16 095) in the first year after injury and CAD $20 348 (95% CI, -$24 710 to -$15 985) in the fifth year after injury. At 5 years after injury, 52% of individuals who had an injury were working compared with 79% individuals in the preinjury comparison group. SCI survivors had a decrease in employment of 17.1 percentage points (95% CI, 14.5 to 19.7 percentage points) in the first year after injury and 17.8 percentage points (14.5 to 21.1 percentage points) in the fifth year after injury. Conclusions and Relevance: In this study, SCI was associated with a decline in earnings and employment up to 5 years after injury for adults aged 18 to 64 years in Canada.

Finding the Optimal Resistance Training Intensity for Your Bones: Protocol for a Randomized Controlled Trial.

OBJECTIVE: The purpose of this trial is to evaluate the effect of twice-weekly, moderate-to-high intensity progressive resistance training (PRT) for 1 year on lumbar spine bone mineral density (BMD) in individuals with low BMD, compared to attention control. Secondary analyses will examine if resistance training improves other health outcomes; if high intensity is more effective than moderate intensity resistance training for all outcomes; the cost of intervention versus benefit; the willingness to pay; and harms. METHODS: For this study, 324 men or postmenopausal women aged ≥50 years with a femoral neck, total hip, or lumbar spine BMD T-score of ≤-1, or a Fracture Risk Assessment Tool probability of ≥20% for major osteoporotic fracture or ≥ 3% for hip fracture are being recruited to participate in a randomized controlled trial with 1:1:1 randomization. Participants will be stratified by site (3 centers) to twice-weekly, supervised PRT at moderate intensity (about 10 repetitions maximum), to high intensity PRT (≤6 repetitions maximum), or to a home posture and balance exercise program (attention control) for 1 year (resistance training to comparator allocation ratio of 2:1). The primary outcome is lumbar spine BMD via dual-energy X-ray absorptiometry. Secondary outcomes include trabecular bone score, proximal femur and total hip BMD and structure, bone-free and appendicular lean mass, physical functioning, falls, fractures, glucose metabolism, cost per life-year gained, adverse events, and quality of life. Between-group differences will be tested in intention-to-treat and per-protocol analyses using analysis of covariance, chi-square tests, or negative binomial or logistic regression, adjusting for site and baseline values. IMPACT: The Finding the Optimal Resistance Training Intensity For Your Bones trial will support decision making on resistance training for people at risk of fracture.

A systematic review of economic analyses of home-based telerehabilitation.

PURPOSE: Telerehabilitation, or the delivery of rehabilitation using information and communication technologies, may improve timely and equitable access to rehabilitation services at home. A systematic literature review was conducted of studies that formally documented the costs and effects of home-based telerehabilitation versus in-person rehabilitation across all health conditions. MATERIALS AND METHODS: Six electronic databases were searched from inception to 13 July 2021 (APA, PsycInfo, CINAHL, Embase, EmCare, Medline (Ovid), and PubMed) using a protocol developed by a medical librarian. A quality appraisal of full economic evaluation studies was conducted using the Drummond 10-point quality checklist. RESULTS: Thirty-five studies were included in this review covering various rehabilitation types and diverse populations. The majority were published in the last six years. Available evidence suggests that telerehabilitation may result in similar or lower costs as compared to in-person rehabilitation for the health care system and for patients. However, the impact of telerehabilitation on long-term clinical outcomes and health-related quality of life remains unclear. CONCLUSIONS: More high quality and robust economic evaluations exploring the short- and long-term costs and other impacts of telerehabilitation on patients, caregivers, and health care systems across all types of patient populations are still required.Implications for rehabilitationHome-based telerehabilitation may reduce barriers in access to care for individuals living in the community.Economic analyses can inform health care system decision-making by evaluating the costs and effects associated with telerehabilitation.This study found that telerehabilitation may result in similar or lower costs as in-person rehabilitation; however, its impact on health-related quality of life is unclear.

Cost-effectiveness of hydrophilic-coated urinary catheters for individuals with spinal cord injury: A systematic review.

Objective: To identify and critically evaluate the economic evaluations examining the cost-effectiveness of hydrophilic-coated vs uncoated catheters for individuals with spinal cord injury. Methods: We searched MEDLINE, the Excerpta Medica database (EMBASE), Cochrane Database of Systematic Reviews, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Emcare for studies in English and French. There were no restrictions to the year of publication. Our search strategy included the following key terms: "spinal cord injury," "catheterization," and "cost analysis." Results: The search identified 371 studies, of which eight studies met the inclusion criteria. Five studies observed hydrophilic-coated catheters to be cost-effective compared to uncoated catheters. Two studies found hydrophilic-coated catheters to be not cost-effective compared to uncoated catheters and one study estimated that hydrophilic-coated catheters reduced the long-term health-care costs compared to uncoated catheters. Conclusion: The cost-effectiveness of hydrophilic-coated catheters was dependent on the comparator used, the consideration of long-term effects, and the unit cost of treatment. Further studies are needed to explore the short-term and long-term effects of hydrophilic-coated catheter use on urinary tract infections and clarify the impact of hydrophilic-coated catheter use on long-term renal function. Overall, our critical evaluation of the literature suggests that the evidence is pointing toward hydrophilic-coated catheters being cost-effective, particularly when a societal perspective is applied.

Cost-utility analysis of transcranial direct current stimulation therapy with and without virtual illusion for neuropathic pain for adults with spinal cord injury in Canada.

OBJECTIVE: To undertake a cost-utility analysis comparing virtual illusion (VI) and transcranial direct current stimulation (tDCS) combination therapy, tDCS alone and standard pharmacological care in Ontario, Canada from a societal perspective over a three-month time horizon. DESIGN: Cost-utility analysis using Markov model methods. SETTING: Community setting in Ontario, Canada. PARTICIPANTS: Individuals with spinal cord injury and neuropathic pain (NP) resistant to pharmacological therapy. INTERVENTIONS: Virtual illusion and transcranial direct current stimulation, transcranial direct current stimulation alone and standard pharmacological therapy. OUTCOME MEASURES: Incremental costs, quality adjusted life years (QALY) and incremental cost effectiveness ratio. RESULTS: The incremental cost effectiveness ratio of VI and tDCS therapy cost is $3,396 per QALY (2020 Canadian dollars) when compared to standard care. The incremental cost per QALY of tDCS therapy alone is $33,167. VI and tDCS therapy had lower incremental costs (-$519) and higher incremental QALYs (0.026) compared to tDCS alone. From a public healthcare payer perspective, there is a 74% probability that VI and tDCS therapy and 54% probability that tDCS alone would be cost effective at a $50,000 per QALY willingness-to-pay threshold. Our findings remained relatively robust in various scenario analyses. CONCLUSION: Our findings suggest that at three-months after therapy, VI and tDCS combination therapy may be more cost effective than tDCS therapy alone. Based on conventional health technology funding thresholds, VI and tDCS combination therapy merits consideration for the treatment of NP in adults with spinal cord injuries.

Describing the current state of post-rehabilitation health system surveillance in Ontario - an invited review.

Context: Spinal cord injury (SCI) presents numerous physiological, psychosocial, and environmental complexities resulting in significant healthcare system resource demands. Objective: To describe the current health system surveillance mechanisms in Ontario, Canada and highlight gaps in health surveillance among adults with SCI across their lifespan. Methods: A review of administrative data sources capturing SCI-specific information took place via internet searching and networking among SCI rehabilitation and health services experts with emphasis on functionality, health service utilization, and quality of life data. Results: The review identified a distinct paucity of data elements specific to the health surveillance needs of individuals with SCI living in the community. The gaps identified are: (1) a lack of data usability; (2) inadequate linkage between available datasets; (3) inadequate/infrequent reporting of outcomes; (4) a lack of relevant content/patient-reported outcomes; and, (5) failure to incorporate additional data sources (e.g. Insurance datasets). Conclusion: Currently, SCI-specific health data is disproportionately weighted towards the first 3-6 months post injury with detailed data regarding pre-hospital care, acute management and rehabilitation, but little existing infrastructure supporting community-based health surveillance. Given this reality, the bolstering of meaningful community health surveillance of this population across the lifespan is needed. Addressing the identified gaps in health surveillance must inform the creation of a comprehensive community health dataset incorporating patient-reported outcome measures and enabling linkage with existing administrative and/or clinical databases. A future harmonized data surveillance strategy would, in turn, positively impact function, health services, resource utilization and health-related quality of life surveillance.