Therapy In Canada Research Articles

The use of focal therapy for the treatment of prostate cancer in Canada: Where are we, how did we get here, and where are we going?

Focal therapy is an emerging treatment for localized prostate cancer. The objectives of this review were to: 1) review how focal therapies are regulated and approved; 2) summarize the scope and quality of the literature regarding safety, efficacy, and side-effects; and 3) outline ongoing clinical trials of focal therapy in Canada. Using the PRISMA framework for scoping reviews, we searched PubMed, Embase, and Cochrane from 2021-2024, complementing Hopstaken et al's search up functional and oncologic outcomes. Additionally, we examined the FDA database for regulatory details and ongoing trials in Canada via ClinicalTrial.gov. FDA approval for prostate tissue ablation was granted to high-intensity focused ultrasound (HIFU) in 2015 via the de novo pathway; other therapies followed the 510(k) route, citing equivalence to predicate devices. Most studies are in early stages, primarily single-arm, prospective cohort designs. Oncologic outcomes like cancer detection and survival rates, alongside functional data, such as adverse events and erectile function, were assessed. Recurrence-free survival at 48 months ranged from 58-92%, pad-free rates were greater than 95%, and rates of new-onset erectile dysfunction were variable, ranging from no change to 50%. Rates of serious adverse events (SAEs) were low, ranging from 0-14%. Three Canadian clinical trials are actively enrolling participants, and five private clinics were found offering private HIFU, irreversible electroporation (IRE), or transurethral ultrasound ablation (TULSA). Focal therapy technologies have gained regulatory approval for prostate tissue ablation, and, aside from provincial support for cryoablation in Alberta, are available to Canadians through private payment or clinical trials. Many studies demonstrate promising cancer control and impressive functional outcomes but are limited by their short followup and lack of comparator group. Clinical trial or registry participation should be prioritized to ensure an evidence-based integration into current prostate cancer treatment approaches.

S71 - Association Between Ongoing Illicit Fentanyl Use and Risk for Non-Fatal Overdose Among Patients Treated With Opioid Agonist Therapy in Canada

S71 - Association Between Ongoing Illicit Fentanyl Use and Risk for Non-Fatal Overdose Among Patients Treated With Opioid Agonist Therapy in Canada

Review of CAR T-Cell Therapy in Multiple Myeloma: A Canadian Perspective.

Multiple myeloma (MM) is an incurable plasma cell malignancy. In the context of the current standard of care therapies in Canada, outcomes among patients with relapsed/refractory multiple myeloma (RRMM), particularly those with triple-class (or more) refractory disease remain poor. Immunotherapies have significantly changed the treatment landscape of MM. Since 2021, two BCMA-targeting CAR T-cell therapy products have been approved for RRMM-namely Idecabtagene vicleucel (Ide-cel) (ABECMA®) and Ciltacabtagene autoleucel (Cilta-cel) (CARVYKTI®), both of which are available in the US and Europe. Although they have shown unprecedented efficacy in RRMM, their clinical and logistical limitations must be acknowledged. MM CAR T-cell therapy is likely to be approved in Canada soon. Therefore, it is timely that we review the latest evidence for commercially available CAR T-cell therapy in multiple myeloma, with a focus on its relevance and impact in the Canadian setting. There will be challenges to access and strategies must be in place to ensure equitable care for all Canadians with MM. Alongside haematologists working in the immune effector cell therapy programs, providers in the community will also play a role in the ongoing monitoring and management of long-term side effects including opportunistic infections and late neurotoxicity.

0604 Substantial Cost Savings with Novel Oral Appliance O2Vent Optima Compared to CPAP Therapy in Canada

0604 Substantial Cost Savings with Novel Oral Appliance O2Vent Optima Compared to CPAP Therapy in Canada

Lessons learned from the Canadian Fabry Disease Initiative for future risk-sharing and managed access agreements for pharmaceutical and advanced therapies in Canada

Risk sharing agreements (RSAs) and managed access agreements have emerged as tools to overcome evidentiary uncertainty and contain costs of pharmaceuticals; however, Canada has relatively little experience with these health policy instruments. This article describes one of the few examples of national RSAs. Enzyme replacement therapies (ERT) were introduced in Canada to treat Fabry disease in the early 2000s through an RSA. Based on qualitative interviews with key participating actors, this article explains how this RSA ensured continuity of treatment for patients already on ERT, and collected robust real-world evidence to secure treatment for future Fabry patients. We show the importance of partnerships, collaborations, and active patient communities in establishing RSAs, as well as the critical role of robust registries for the collection, storage, and use of that real-world data. In doing so, this paper points to reasons that explain the relative dearth of RSAs in Canada, which can be resource (both human and finance) intensive and are difficult to broker in a federalist health system. Through these findings, policy lessons are developed concerning the need for technological and governance platforms on how RSA in Canada can be more effectively supported going forward in a broader move towards “social pharmaceutical innovation”.

Providing Insights into the Challenges of Implementing Activity-Based Therapy in Canada: A Comparative Analysis Using Focus Group Interviews with Key Interest Groups.

Activity-based therapy (ABT) has emerged as a therapeutic approach that may promote neurorecovery and reduce secondary complications in people living with spinal cord injury or disease (SCI/D). In spite of the numerous health benefits, adoption of ABT into practice has been limited across the Canadian care continuum. This study aimed to understand the challenges of implementing ABT in Canada for people living with SCI/D through the perspectives of key interest groups. Researchers, hospital therapists, community trainers, administrators, persons living with SCI/D, and advocates, funders, and policy experts who had knowledge of and/or experience with ABT participated in focus group interviews to share their perspectives on the barriers to ABT practice. Interviews were analyzed using conventional content analysis followed by a comparative analysis across groups. The 48 participants identified six key challenges: (1) challenge of gaps in knowledge/training, (2) challenge of standardizing ABT, (3) challenge of determining the optimal timing of ABT, (4) challenge of defining, characterizing, and achieving high dosage and intensity, (5) challenge of funding ABT, and (6) challenge of measuring participation and performance in ABT. A comparative analysis found some challenges were emphasized by certain groups, such as the cost of ABT for persons with SCI/D, lack of education and training in ABT for therapists and trainers, minimal evidence to develop guidelines for researchers and advocates, and funding ABT programs for administrators. Participants highlighted several challenges that limit ABT practice. Strategies to address these challenges will support successful implementation of ABT in Canada.

Is Canada Prepared for the Surge of Dementia?

What Was the Question?
 
 How can health policy decision-makers prepare for the potential future use of new and emerging treatments for Alzheimer disease (AD) and other dementias?
 
 What Did We Do?
 
 We identified emerging technologies for early diagnosis.
 We assessed the infrastructural capacity to deliver amyloid-targeted therapy in Canada, including the availability of PET-CT imaging equipment for confirming treatment eligibility, access to MRI units for monitoring treatment side effects, and IV infusion clinics for administering the treatment.
 We engaged with clinicians who treat people with dementia, researchers involved with dementia-related health research, and people with dementia and their caregivers.
 
 What Did We Find?
 
 There are several emerging diagnostic technologies — including blood, imaging, saliva, and ocular tests, and artificial intelligence algorithms — that could diagnose AD in its early stages more easily and quickly.
 The availability of PET-CT and MRI units, radiopharmaceuticals, and cyclotrons is currently not sufficient to accommodate the implementation of amyloid-targeted therapies in Canada.
 People living with dementia described barriers to accessing adequate, appropriate, and equitable care. Clinicians and researchers said that access to timely and reliable diagnosis must be improved.
 
 What Does This Mean?
 
 Our work highlights recent advances in AD diagnosis and treatment, related health system gaps in terms of accessing diagnostic testing and treatment, and the unmet needs of people living with dementia and their caregivers.
 It is important that health systems prepare for the potential surge in the number of people with dementia who might need additional diagnostic tests, treatments, monitoring, and models of care.

Disease Characteristics and Outcomes of 504 Young Patients Diagnosed with Multiple Myeloma Treated with Modern Therapies in Canada

Background:Multiple myeloma (MM) mostly affects older adults. Although representing around 10% of all cases, patients ≤ 50 years old suffer from the highest number of years lost due to their disease. MM in young patients occurs during their most productive years of life, resulting in a significantly higher personal, familial, professional, and economic burden. Young MM patients are currently underrepresented in clinical trials due to small numbers overshadowed in cohorts of older patients. Their disease characteristics and outcomes following modern treatments remain poorly understood (Tanguay M et al., Current Oncol 2023). The purpose of this study is to report disease characteristics, treatments, and outcomes of young MM patients treated in Canada. Methods:This is a retrospective study using the Canadian Myeloma Research Group Database, which is a repository of real-world patient data reflecting 17 of the major MM academic centers across Canada. All patients 18-50 years old with newly diagnosed MM between January 1, 2010 and July 1, 2022 were included. High-risk (HR) cytogenetics were defined as either del17p, t(4;14) or t(14;16). Survival analyses were performed using the Kaplan-Meier method. Results:Among the 6,604 patients newly diagnosed with MM during the study period, 504 (7.6%) were aged between 18-50 years, and included in this analysis. Within this young group, 87 (17.3%) were 18-40 years old and 417 (82.7%) were between 41-50 years. MM was diagnosed in 301 (59.7%) patients between 2010 to 2015, and in 203 (40.3%) patients between 2016 to 2022. The median age at diagnosis was 45.9 years (range 25.6 to 50). Male patients represented 57.7% of the cohort. IgG was the most common isotype in 251 (49.8%) cases, while 115 (22.8%) patients had light chain disease. In 375 patients with available data, 16% were R-ISS 1, 73.1% R-ISS 2, and 10.9% R-ISS 3. Lytic lesions, elevated creatinine, anemia, hypercalcemia, and high LDH were respectively present in 46.8%, 15.5%, 44%, 18.8%, and 18.7% of patients. HR cytogenetics were present in 23.7% of patients, with del17p in 11.5%, t(4;14) in 14.9%, and t(14;16) in 5.1%; while 1q+ and del1p were detected in 27.9% and 15.3%, respectively. Twelve (2.4%) patients were diagnosed with plasma cell leukemia. First-line treatment was proteasome inhibitor (PI)-based in 462 (91.7 %) and immunomodulatory (IMiD) agent-based in 7 (1.4 %); 18 (3.6%) received both a PI and an IMiD and 17 (3.4%) were treated with other modalities. Among all patients, 453 (89.9%) underwent autologous stem cell transplant (ASCT) during their disease course. Some patients did not receive ASCT for the following reasons: early death before ASCT in 10 (2%) cases, lost to follow-up prior to ASCT in 13 (2.6%) cases, deemed ineligible for ASCT or patient declined in 24 (4.8%) cases, and participation in a clinical trial not involving ASCT in 1 (0.2%) case. Out of the entire cohort, allogeneic-SCT (allo-SCT) was performed in only 11 patients (2.2%), including 3 (0.6%) who received allo-SCT alone without ASCT. Among patients who received maintenance post ASCT, 93.6% were treated with a lenalidomide-based regimen. Median duration of the different maintenance treatments was 21.2 months. With a median follow-up of 51.9 months (range 0.9 to 154), median PFS (progression-free survival) was 55.4 months (95% CI 49.1-70.2), while median OS (overall survival) was not reached. The 5-year OS and PFS were 78% (95% CI 74-82) and 48% (95% CI 43-53), respectively, whereas the 10-year OS and PFS were 64% (95% CI 58-71) and 28% (95% CI 22-35), respectively (Figure 1a). Median PFS for patients with any HR cytogenetics was 37.9 months (95% CI 29.6-62.8) vs 64.5 months (95% CI 50.6-80.7) for patients with standard-risk cytogenetics (p=0.004) (Figure 1b). We observed no difference in disease characteristics, treatments, and outcomes after comparing cohorts aged 18-40 years old vs 41-50 years old. Conclusions: This is among the largest real-world cohorts of young MM patients ≤ 50 years old treated with modern therapies ever reported. Most patients were R-ISS 2 (73.1%), 23.7% had known HR cytogenetics, and the majority (91.7%) received a PI-based first-line treatment. Outcomes of specific subgroups are under analysis and will be presented. Although the OS was not yet reached in this young population, the median PFS of only 55.4 months highlights the urgent need to develop more effective treatments to induce deeper and more durable responses.

Twice-Weekly Outpatient Rehabilitation Intervention for Young Children With Spinal Muscular Atrophy Treated With Genetic-Based Therapies: Protocol for a Feasibility Study

Background Spinal muscular atrophy (SMA) is a progressive neuromuscular disorder that causes muscle weakness and is the leading genetic cause of infant mortality worldwide. While no definitive cure exists, the approval of 3 genetic-based therapies in Canada since 2018 has led to significant improvements in muscle function for children with SMA. With that, there are no evidence-based rehabilitation interventions and minimal evidence on the combined effects of genetic-based therapies and rehabilitation. Objective This protocol describes the methodology to assess the feasibility of a twice-weekly outpatient rehabilitation intervention focusing on gross and fine motor function to inform the methodology and sample size of a definitive clinical trial. Methods We will conduct a single-center nonrandomized pilot and feasibility trial to explore an outpatient rehabilitation intervention for children aged 6 months to 3 years with SMA treated with genetic-based therapies. Participation in the study will occur over a 25-week period, with a baseline assessment visit followed by a 12-week intervention period and a 12-week nonintervention period. The rehabilitation intervention comprises weekly physical and occupational therapy for 11 weeks. Assessments will occur at baseline (week 0), end of intervention or early withdrawal (week 12), and follow-up (week 24). Predetermined feasibility indicators will evaluate study feasibility across process (recruitment rates, eligibility criteria, adherence rates, retention rates, questionnaire suitability, and acceptability), resource (time, implementation, and execution), management (materials and data), and scientific (safety, tolerability, and preliminary efficacy) domains. Results This project was funded in March 2022, and data will be collected between March 2023 and December 2023. Data analysis will occur between January 2024 and March 2024, with publication expected in the fall of 2024. The protocol for the feasibility trial will be considered successful if it meets the success criteria set out for the feasibility indicators. Indicators of specific interest include all process indicators, as well as time. Exploratory indicators will be reported. Pragmatically, the results of the feasibility trial will inform changes to the protocol and the start-up of a definitive multisite trial. Conclusions This novel twice-weekly outpatient rehabilitation intervention will be the first step toward filling the need for an evidence-based rehabilitation intervention for children with SMA treated with genetic-based therapies. It is expected that consistent and intensive rehabilitation therapy will augment functional gains being observed in this population. In the future, a definitive trial will measure the efficacy of the intervention. Trial Registration ClinicalTrials.gov NCT05638750; https://clinicaltrials.gov/study/NCT05638750 International Registered Report Identifier (IRRID) DERR1-10.2196/46363

Utilization of Opioid Agonist Therapies in Canada


 Canada continues to experience an opioid crisis that has had a devastating impact on public health, highlighting the importance of management strategies for opioid use disorder (OUD). Several opioid agonist therapies (OATs) for the management of OUD are available in Canada, including recent approvals of new brand name drugs and generic versions of widely used OATs.
 Coverage criteria for OATs are comparable across public drug plans in Canada. Methadone hydrochloride (HCL) and the combination of buprenorphine HCL and naloxone HCL (buprenorphine HCL-naloxone HCL) are typically listed as regular or open benefits; generics for these 2 medications have been available since 2020 and 2013, respectively. Sublocade and Probuphine — long-acting buprenorphine preparations approved by Health Canada in 2018 — have varied coverage that is often dependent on prior therapy requirement.
 The annual number of public claims for OATs decreased by 19.5% from 2018 to 2022. The market share of claims during this period was dominated by methadone HCL and buprenorphine HCL-naloxone HCL, with an increase in claims market share for buprenorphine over time (starting in 2020) and a negligible contribution by buprenorphine HCL. Additionally, in a subanalysis on the number of OAT claimants, the results did not indicate a decrease in individual beneficiaries for these medications; therefore, the decrease in OAT claims was likely driven by increased usage of OATs that require fewer claims per patient, as opposed to decreased OAT use in the population.
 Despite the decrease in annual OAT claims during the analysis period, total OAT expenditures increased every year, with a 67.0% increase from 2018 to 2022 (5-year total of $307 million). The increase was initially driven by buprenorphine HCL-naloxone HCL, which increased from $27 million (58.9% of OAT expenditures) in 2018 to $39 million (67.2% of OAT expenditures) in 2019. Thereafter, expenditures for buprenorphine drove overall OAT cost increases from 2020 onward, accounting for $22 million (28.2% of OAT expenditures) in 2022. In contrast, methadone HCL accounted for a decreasing proportion of expenditures each year ($19 million or 41.1% of OAT expenditures in 2018 to $16 million or 21.0% of OAT expenditures in 2022), despite having the greatest proportion of claims throughout the study period.
 The availability of new OAT formulations and generic versions of existing products, as well as other notable regulatory policy changes (e.g., Health Canada’s removal of the need for an exemption to prescribe methadone HCL) and reimbursement decisions (e.g., positive reimbursement recommendations from CADTH for the newer branded OATs, Sublocade and Probuphine), impacted the observed utilization and expenditure patterns, and will likely continue to influence decision-making, particularly where coverage has recently changed or has yet to change to reflect the evolving landscape. If the utilization of injectable buprenorphine (Sublocade) continues at the rate observed in this analysis, it will likely continue to drive increases in OAT expenditures; Sublocade has several patents and the earliest patent expiry is not until 2031, so generic versions of this formulation will likely not be available for several more years. Overall, the findings of this analysis may help to inform jurisdictions in funding decisions regarding OATs for the treatment of OUD.

Real-world Evidence for Impact of Opioid Agonist Therapy on Nonfatal Overdose in Patients with Opioid Use Disorder during the COVID-19 Pandemic.

The primary objectives of this study were to describe the demographics and clinical characteristics of patients who were treated with buprenorphine extended-release versus buprenorphine-naloxone sublingual tablets versus methadone in a real-world setting and to evaluate the difference in nonfatal overdose events between treatment cohorts. This study was a retrospective chart review of patients with opioid use disorder initiating opioid agonist therapy in Canada during the outset of the COVID-19 pandemic (March 11, 2020 to October 31, 2021). Three treatment cohorts were defined by the initial prescribed opioid agonist therapy regimen: buprenorphine extended-release, buprenorphine-naloxone sublingual tablets, and methadone. Baseline characteristics, as well as treatment status, overdose events, and substance use 6 months after treatment initiation were collected using a standardized form. Nine clinics provided data on 379 patient cases. The incidence rate (number of events per 100 person-years) for a self-reported nonfatal overdose was 46.8 (n = 18), 19.3 (n = 10), and 1.7 (n = 1) in the methadone, buprenorphine-naloxone sublingual tablets, and buprenorphine extended-release cohorts, respectively. The risk-adjusted difference for the proportion of patients with nonfatal overdose was 8.59% (95% confidence interval, 3.10-14.08%; P = 0.0022) for methadone versus buprenorphine extended-release and 6.51% (95% confidence interval, 1.46-11.56%; P = 0.0115) for buprenorphine-naloxone sublingual tablets versus buprenorphine extended-release. Buprenorphine extended-release was associated with lower rates of nonfatal overdose events compared with daily opioid agonist therapy. Given the limitations of this naturalistic, retrospective design, further prospective studies are needed to validate these findings and demonstrate the potential for long-acting opioid agonist therapy in addressing the opioid crisis.

Survey of the quality and origins of websites on penile low-intensity shockwave therapy in Canada.

The aim of this study was to establish the quality of patient-facing websites advertising low-intensity shockwave therapy (LISWT) for erectile dysfunction (ED) and Peyronie's disease (PD) patients in Canada. Canadian websites offering LIWST for ED or PD were identified using online web searches. The characteristics of these websites were reviewed, along with examining the presence of HONCode certification, assigning a brief DISCERN score (a tool designed to evaluate health information online) and readability scores. We also examined the LIWST technology advertised, as well as benefits of LIWST cited by the websites. Twenty-five unique websites linked to 46 clinics were identified and reviewed. Twenty-four percent of websites were run by a urologist. Other specialties offering LISWT included general practitioners, anesthesiologists, naturopaths, nurse practitioners, physiotherapists, and registered massage therapists. Twenty-four percent of the websites advertised the use of a focused shockwave generator. Forty percent of the websites had peer-reviewed references. The average brief DISCERN score was 14 (standard deviation 3.4). There was no association between the physician-or non-physician-led websites and the use of peer-reviewed references, readability scores, the number of clinic locations, or higher brief discern scores. LISWT is readily advertised online for ED and PD patients in Canada; however, only a minority use a focused shockwave generator. There is a wide diversity of practitioners offering LISWT. Websites offering LISWT are generally of poor quality and do not provide adequate information for patients to make educated treatment decisions.

P.013 Patient preferences for selection of preventive migraine therapies in Canada: results from a discrete choice experiment

Background: This study assessed the importance of mode of administration relative to other treatment attributes when selecting a preventive migraine therapy. Methods: Cross-sectional study among Canadian adults diagnosed with migraine with ≥5 monthly migraine days and tried ≥2 prescription migraine treatments (any kind/duration). Preferences for treatments varying in the following attributes were evaluated via a discrete choice experiment: speed of efficacy (effective in 24hr/1wk/3mo), duration of efficacy (wears off never/1wk/2 wks before next dose), mode of administration (infusion/auto-injection/cranial injections), administration setting (clinic/home), and administration frequency (1mo/3mo). Attribute-level preference weights were estimated using Hierarchical Bayes modeling. Results: Of 200 respondents, 142 experienced episodic migraine and 58 experienced chronic migraine. Preference weights confirmed that respondents’ most preferred treatments were those that provided fast and long-lasting efficacy (effective in 24hr = 0.59; wears off never = 1.07) and were offered via infusion (0.58) or auto-injection (0.47) over intracranial injection (-1.04). Respondents reported being moderately willing to receive infusions in either a home or clinic setting (1-6 Likert scale from “not at all” to extremely” willing). Conclusions: Second to speed and duration of efficacy, respondents were most concerned with mode of administration when selecting their preferred migraine preventive, suggesting that physicians should consider patient preferences in treatment decision-making.

P.084 The Canadian Neuromuscular Disease Registry: a national spinal muscular atrophy registry for real world evidence

Background: Patient registries are an effective tool in tracking the natural history of rare diseases as well as post-marketing surveillance of novel therapies. The Canadian Neuromuscular Disease Registry (CNDR) is a pan-neuromuscular disease registry that prospectively collects Spinal Muscular Atrophy (SMA)-specific data in 28 clinics across Canada. The objective of this study is to describe real-world data from the CNDR-SMA patient population. Methods: We report cross-sectional data from Canadian SMA patients. Patients were included in analysis if they were active (alive and with follow-up within 24 months). Results: Of 171 SMA patients included in analyses, 37% currently use non-invasive ventilation, 2% invasive ventilation, and 61% no ventilation support. Feeding tubes are used by 27% of patients. and 28% of patients have a history of scoliosis surgery. Of the 171 patients, 137 have had disease-modifying therapy: 96 on nusinersen, 22 on risdiplam, and 19 on onasemnogene abeparvovec (OA). Median (min,max) years of age at therapy initiation was 7 (0,54), 20.5 (5,53), and 1 (0,6), respectively. At therapy initiation, functional status was 32% non-sitters, 38% sitters, and 30% walkers. Conclusions: The CNDR captures a comprehensive SMA dataset that prospectively evaluates real-world data, supporting post-marketing surveillance of novel therapies in Canada.

MP76-01 MID-TERM EVALUATION OF IMPACT ON STORAGE AND OBSTRUCTIVE SYMPTOMS WITH REZŪM: OUTCOMES OF A LARGE, MULTI-CENTER, PROSPECTIVE REGISTRY OF REZŪM WATER VAPOR THERAPY BENIGN PROSTATIC ENLARGEMENT

You have accessJournal of UrologyCME1 Apr 2023MP76-01 MID-TERM EVALUATION OF IMPACT ON STORAGE AND OBSTRUCTIVE SYMPTOMS WITH REZŪM: OUTCOMES OF A LARGE, MULTI-CENTER, PROSPECTIVE REGISTRY OF REZŪM WATER VAPOR THERAPY BENIGN PROSTATIC ENLARGEMENT Kevin C. Zorn, Naeem Bhojani, Bilal Chughtai, and Dean Elterman Kevin C. ZornKevin C. Zorn More articles by this author , Naeem BhojaniNaeem Bhojani More articles by this author , Bilal ChughtaiBilal Chughtai More articles by this author , and Dean EltermanDean Elterman More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003350.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Rezūm convective water vapor ablation is a minimally invasive procedure to treat benign prostatic tissue. Herein, we report a prospective, multi-center results of the largest cohort of prostates treated with Rezum in Canada to address mid-term outcomes on IPSS storage and obstructive voiding symptoms. METHODS: A prospective registry was established for Rezūm therapy in Canada (2019) at two high-volume centers. All patients had baseline medical and BPH history documented along with uroflowmetry (Qmax and PVR), and validated questionnaires (IPSS, IPSS QoL, BPHII, IIEF-15, MSHQ-EjD function and bother). Sub-category IPSS-V and IPSS-S were evaluated for the entire cohort, men in retention and those with prostate volume >80 cc vs <80 cc and median lobe vs non-median lobe. IPSS-S was calculated by summing question 1 (incomplete emptying), question 3 (intermittency), question 5 (weak stream), and question 6 (straining to void). IPSS-V was calculated by summing question 2 (frequency), question 4 (urgency), and question 7 (nocturia). RESULTS: 345 men (mean age of 67.4, were treated with Rezūm from April 2019 to October 2022. The mean prostate volume was 72.3 cc (range 17-271) and 64% had a median lobe. 85 patients had prior episode of urinary. Mean number of injections was 10.1(range 2-28). Mean duration of procedure was 3.7 minutes (range 1-13). Mean duration of post-procedure catheterization was 9.8 days. IPSS-S reduced from a baseline score of 9.4 to 8.4 (10%), 6.1 (35%), 4.9 (48%), 4.8 (49%), 4.6 (51%), 4.3 (54%) at 1, 3, 6, 12, 24 and 36 months respectively. Comparatively, IPSS-V reduced from a baseline of 12.7 to 7.7 (39%), 4.1 (67%), 4.3 (66%), 4.3 (66%), 4.6 (64%), 3.7 (70%) at 1, 3, 6, 12, 24 and 35 months respectively. Outcomes were similar among subgroup analysis of men with baseline retention, men with prostate volume >80 cc or those with median lobe (all p>0.05). CONCLUSIONS: Rezum therapy is safe, effective, quick, out-patient, office-based procedure for prostate glands over a wide range of volumes with equally significant improvements in storage and voiding symptoms regardless of prostate volume, median lobe status and baseline urinary retention. Source of Funding: No © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1090 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kevin C. Zorn More articles by this author Naeem Bhojani More articles by this author Bilal Chughtai More articles by this author Dean Elterman More articles by this author Expand All Advertisement PDF downloadLoading ...

Proton Therapy in Canada: Toward Universal Access and Health Equity With a Publicly Funded Facility

Proton beam therapy (PBT) is utilized worldwide in the treatment of pediatric cancers and many cancers in adults as accumulating clinical evidence indicates dosimetric and toxicity advantages. However, Canada is the only G8 country without an operating clinical PBT facility. Access to out-of-country PBT referrals, adjudicated by individual provincial governments, varies across the country. The lack of domestic capacity for PBT, variability in public funding nationwide, and the anticipated future demand for PBT suggest unmet needs for health equity in Canadian cancer care. This article outlines the current state of access to PBT across Canadian provinces, domains of health inequities among those receiving PBT, and strategies for addressing health inequity in PBT, in the context of ongoing planning for a Canadian publicly funded facility. The lessons learned from the Canadian experience may be applicable to other jurisdictions seeking to improve fair, equitable access to PBT.

A survey of minimally invasive surfactant therapy in Canada.

IntroductionMinimally invasive surfactant therapy (MIST) can be used to treat neonatal respiratory distress syndrome in neonatal intensive care units (NICUs). Clinical and institutional variances in MIST utilization persist globally with little published research regarding MIST utilization in Canada. Therefore, the objective of this study was to survey MIST utilization in NICUs in Canada.MethodsAn online survey was emailed to the 33 participating centres of Canadian Neonatal NetworkTM (CNN) Evidence-based Practice for Improving Quality (EPIQ) Lung Health Group (LHG). Site demographics and surfactant therapy procedural details were categorically collected. Free text and multiple-choice questions were utilized to capture perceived barriers and individual preferences for MIST use.ResultsTwenty-eight of 33 participating members of the CNN EPIQ-LHG completed the survey between April 2021 and October 2021 (85%); 17/28 (61%) respondents reported ongoing MIST utilization at their center. Most centers that used MIST techniques administered bovine lipid extract surfactant (68%), commonly using angiocatheters (47%) and purpose-built catheters (41%). MIST was widely used for patients at 26–33 weeks gestational age (88%). Nine centres had never used MIST (32%), and 3 indicated a plan to implement MIST within the next 2 years. Common barriers to MIST use included lack of consensus amongst clinicians (78%), lack of training (56%), and lack of experience with MIST (56%).ConclusionWhile MIST is being increasingly used in Canadian NICUs, universal use is yet to be seen. Clinician inexperience and lack of consensus, formal training, and local guidelines contribute to underutilization of MIST. Training workshops, country-wide data collection, and uniform operating protocols are needed to standardize practice.

The Cost Effectiveness of Axicabtagene Ciloleucel Versus Best Supportive Care in the Treatment of Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma (LBCL) After Two or More Lines of Systemic Therapy in Canada.

Axicabtagene ciloleucel (axi-cel) received marketing authorisation in Canada for the treatment of relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, and the clinical and economic value of axi-cel to patients and the healthcare system should be examined. The objective of this analysis is to determine, from societal and public healthcare payer perspectives, the cost effectiveness of axi-cel versus best supportive care for patients with relapsed or refractory large B-cell lymphoma in Canada. A pharmacoeconomic model was developed and populated with clinical data derived from the ZUMA-1 and SCHOLAR-1 studies using a propensity score-matched comparison. A partitioned survival mixture-cure modelling approach was taken to characterise the potential curative effect of axi-cel therapy in large B-cell lymphoma. Healthcare resource utilisation and adverse event data were based on results from ZUMA-1, and utility values were derived from ZUMA-1 data supplemented with published literature. Costs (in 2021 Canadian dollars) were taken from publicly available Canadian cost databases and published literature. Benefits and costs were discounted at 1.5% per year, and sensitivity analyses were conducted to assess the robustness of the results. In the base case, axi-cel generated an incremental 6.2 life-years compared to best supportive care, corresponding to 4.6 additional quality-adjusted life-years, and was associated with $606,010 in additional costs. The incremental cost-utility ratio was $132,747 per quality-adjusted life-year gained compared with best supportive care from a societal perspective ($106,392 per quality-adjusted life-year gained from a public healthcare payer perspective). Key drivers of the analysis included progression-free survival and overall survival values for axi-cel. The results of this analysis suggest that axi-cel may be considered a cost-effective allocation of resources compared with best supportive care for the treatment of adult patients with relapsed or refractory large B-cell lymphoma in Canada.

Indigenous Peoples and Occupational Therapy in Canada: A scoping review.

Background. Calls to Action outlined by the Truth and Reconciliation Commission (TRC) necessitate critical reflection and urgent action to improve occupational therapy with Indigenous Peoples in Canada. Purpose. This scoping review aims to synthesize the literature related to Indigenous Peoples and occupational therapy practice, research, and education in Canada, and appraise empirical research using adapted Indigenous Health Research criteria. Method. A scoping review was conducted across published academic and grey literature with additional appraisal of empirical studies. Findings. A total of 6 themes emerged from 47 articles spanning from 1970 to 2020: recognizing colonial history, responding to the TRC, participating in personal and professional reflection, identifying Western ideologies, engaging in partnership in practice, and recognizing social and systemic barriers. Empirical studies met appraisal criteria inconsistently. Implications. To meaningfully engage in reconciliation, the profession of occupational therapy must generate Indigenous-led and relevant research, critically transform curricula, and address tensions between themes in practice.

Large, Multi-Center, Prospective Registry of Rezūm Water Vapor Therapy for Benign Prostatic Hyperplasia

ObjectiveTo illustrate the role of Rezūm convective water vapor ablation for treatment of lower urinary tract symptoms secondary to Benign prostatic hyperplasia. MethodsA prospective registry was established for Rezūm therapy in Canada at two high-volume centers. All patients had baseline medical and Benign prostatic hyperplasia history documented, along with uroflowmetry and validated questionnaires up to 12 months post-surgery. Results229 patients (mean age 67.3 years), including 83 with prostate volumes ≥80 mL, were treated from April 2019 to December 2020. The mean prostate volume was 71.5 mL (range 20-160 mL) and 55% had a median lobe. The mean number of injections was 11 (range: 4-28) and mean procedural length was 4.8 minutes (range: 1.5-14). The mean duration of postprocedure catheterization was 9.8 days. International Prostate Symptom Scores improved from baseline by 29%, 53%, and 59% at 1, 3, and 12 months, respectively. International Prostate Symptom Scores quality of life improved from baseline by 30%, 50%, and 67% at 1, 3, and 12 months, respectively. Qmax improved by 60% at 3 months and 74% at 12 months. Post-void residual volume improved by 51% and 61% at 3 and 12 months, respectively. No statistically significant changes were seen in International Index of Erectile Function-15 or Male Sexual Health Questionnaire for Ejaculatory Dysfunction scores. No Clavien-Dindo events ≥Grade III occurred. ConclusionRezūm therapy is a safe, effective, and quick outpatient procedure for prostate glands over a wide range of volumes. Clinically significant improvements are seen in all validated questionnaires. Objective maximum flow measures improved, while erectile and ejaculatory function remains preserved.