Do Degrees Matter? Rethinking Workforce Development for Youth with Intellectual Disabilities and Mental Health Challenges.

The global workforce crisis significantly impacts how evidence-based treatment is provided to youth with developmental disabilities and co-occurring mental health conditions. Addressing the workforce crisis requires re-examining the long-standing methods of selecting individuals for employment based on academic degrees. This project offers an innovative workforce development option that provides specialized training to staff with advanced education degrees and staff with less education. The participants in this study were employed in a rural area of the USA within the mental health, child welfare, and correctional industries. All participants worked with youth experiencing intellectual disabilities and mental illness. Results indicated that participants improved their knowledge of the population, demonstrated a better understanding of EBPs, and were willing to employ evidence-based approaches regardless of their education or age. Although overall attitudes toward EBPs decreased, diverging attitudes increased, suggesting a need to accommodate treatment strategies when EBP models are unavailable for special populations. Initial knowledge gaps demonstrated by those with a master's degree and those with less education disappeared after the training. This finding supports the application of innovative task-shifting options in mental health, such as diverting more sophisticated care tasks to nonprofessionally trained persons, which can reduce workforce pressure and unmet demand for care. This study demonstrates cost-effective and time-efficient methods of training staff regardless of education by relying less on specific EBP models and more on adaptation.

Benefits and Concerns regarding Use of Cannabis for Therapeutic Purposes Among People Living with Chronic Pain: A Qualitative Research Study.

OBJECTIVE: Although there is growing interest in medically authorized cannabis for chronic pain, little is known about patients' perspectives. We explored perceptions of people living with chronic pain regarding benefits and concerns surrounding their use of cannabis for therapeutic purposes. SETTING: A hospital-based clinic in Hamilton and two community-based interdisciplinary pain clinics in Burlington, Ontario, Canada. METHODS: In this qualitative descriptive study, we conducted semi-structured interviews with 13 people living with chronic pain who used cannabis therapeutically, living in Ontario, Canada. We used thematic analysis, with data collection, coding, and analysis occurring concurrently. RESULTS: People living with chronic pain reported important benefits associated with use of cannabis for therapeutic purposes, including reduced pain, improved functionality, and less risk of harms compared to prescription opioids. Most patients also acknowledged harms, such as grogginess and coughing, and there was considerable variability in patient experiences. Financial costs and stigma were identified as important barriers to use of cannabis. CONCLUSION: Evidence-based guidance that incorporates patients' values and preferences may be helpful to inform the role of cannabis in the management of chronic pain.

Motivating factors, barriers and facilitators of participation in COVID-19 clinical research: A cross-sectional survey of Canadian community intensive care units.

Only a small proportion of COVID-19 patients in Canada have been recruited into clinical research studies. One reason is that few community intensive care units (ICUs) in Canada participate in research. The objective of this study was to examine the motivating factors, barriers and facilitators to research participation amongst Canadian community ICU stakeholders. A cross-sectional online survey was distributed between May and November 2020. The survey focused on 6 domains: participant demographics, ICU characteristics, ICU research infrastructure, motivating factors, perceived barriers, and perceived facilitators. Responses were received from 73 community ICU stakeholders, representing 18 ICUs. 7/18 ICUs had a clinical research program. Participants rated their interest in pandemic research at a mean of 5.2 (Standard Deviation [SD] = 1.9) on a 7-point Likert scale from 'not interested' to 'very interested'. The strongest motivating factor for research participation was the belief that research improves clinical care and outcomes. The most significant facilitators of research involvement were the availability of an experienced research coordinator and dedicated external funding to cover start-up costs, while the most significant barriers to research involvement were a lack of start-up funding for a research coordinator and a lack of ICU research experience. Canadian Community ICU stakeholders are interested in participating in pandemic research but lack basic infrastructure, research personnel, research experience and start-up funding. Evolution of a research support model at community hospitals, where most patients receive acute care, may increase research participation and improve the generalizability of funded research in Canada.

Assessing the impact of a cannabis course on pharmacy students' understanding, beliefs and preparedness regarding medical and recreational cannabis.

BACKGROUND: With the legalization of cannabis in Canada in 2018, pharmacists are increasingly likely to encounter patients using this substance. The primary objective of this pre-post questionnaire study was to evaluate the impact of an accredited cannabis course on the understanding, beliefs, perceptions and knowledge of undergraduate PharmD students. METHODS: A 38-question, web-based survey generated in REDCap was administered to third-year PharmD students at the University of Waterloo, prior to and right after taking an accredited cannabis course. The pre- and postsurvey data were analyzed using SPSS version 25. Pearson chi-square tests were performed on questions in which answers consisted of qualitative categorical data. Two-sided t tests were performed to test the significance of mean differences of questions measuring continuous variables. RESULTS: In a class of 120 students, 110 completed the presurvey and 79 students completed the postsurvey. After the course, students were more likely to report being knowledgeable and prepared for patient encounters dealing with medical and recreational cannabis, understanding that medical cannabis should be prescribed for select (vs all) medical conditions, rating the quality of evidence as poor to moderate for medical use of cannabis, understanding that medical documents should be more prescriptive and understanding that cannabis should not be sold in pharmacies (p < 0.05). INTERPRETATION: With cannabis education a part of their curriculum, pharmacy students felt more prepared to engage patients using cannabis both medically and recreationally. Furthermore, students were more cautious regarding the potential use of cannabis therapeutically and indicated that more oversight should be in place. Can Pharm J (Ott) 2021;154:xx-xx.

Reduction in Tamoxifen Metabolites Endoxifen and N-desmethyltamoxifen With Chronic Administration of Low Dose Cannabidiol: A CYP3A4 and CYP2D6 Drug Interaction.

BACKGROUND: Cannabidiol (CBD) serves as a promising medicine, with few known adverse effects apart from the potential of drug interactions with the cytochrome P450 system. It has been hypothesized drug interactions may occur with chemotherapeutic agents, but no supporting evidence has been published to date. CASE: A 58-year-old female with a history of bilateral breast carcinoma in remission, was treated with tamoxifen for breast cancer prevention for over 6 years. CBD was instituted to treat persistent postsurgical pain, inadequately managed by alternate analgesics. It was postulated that CBD may diminish tamoxifen metabolism by CYP3A4 and 2D6 to form active metabolite endoxifen, which exerts the anticancer benefits. Endoxifen, tamoxifen, N-desmetyltamoxifen and 4-hydroxytamoxifen levels were collected while the patient chronically received CBD 40 mg/day, and after a 60-day washout. Upon discontinuation of CBD 40 mg/day, it was observed that endoxifen levels increased by 18.75% and N-desmethyltamoxifen by 9.24%, while 4-hydroxytamoxifen remained unchanged. CONCLUSION: CBD at a low dose of 40 mg/day resulted in the potential inhibition of CYP3A4 and/or CYP2D6. Patients receiving CBD and interacting chemotherapeutic drugs, such as tamoxifen, require monitoring to identify possible subtherapeutic response to treatment. Further pharmacokinetic studies are required to ascertain the dynamics of this drug interaction.

The development and efficacy of an interdisciplinary chronic pelvic pain program.

INTRODUCTION: Chronic pelvic pain (CPP) is a significant issue, and approximately 14% of women experience CPP once in their life-time. While interdisciplinary pain management is considered the gold standard of treatment, few programs offer this type of treatment in Canada. The aims of this paper were to: 1) describe the development of an interdisciplinary CPP program; and 2) demonstrate changes in patient-related outcomes after attending an interdisciplinary CPP program. METHODS: Referrals were received from community urologists and obstetricians/gynecologists, and pain physicians at the Michael G. DeGroote Pain Clinic. Patients attended an orientation session, completed an interdisciplinary assessment, and if appropriate, attended an eight-day interdisciplinary CPP program. Each day consisted of group-based pelvic floor physiotherapy, psychoeducation, goal-setting, cognitive behavioral therapy, and mindfulness. Psychometric questionnaires were completed pre- and post-program by patients, and paired sample t-tests were used to evaluate the changes in patient-related outcomes after attending the program. RESULTS: Thirty-seven female patients completed the program, and results demonstrate that the CPP program was associated with significant improvements in impact of pelvic pain on quality of life, readiness for change, and pain-related self-efficacy, as well as decreases in pain catastrophizing and fear of pain/re-injury. CONCLUSIONS: CPP is a complex condition that requires interdisciplinary management and care. The results of this study demonstrate the short-term benefits of an interdisciplinary CPP program, highlight the unique needs of women with CPP, and implicate multiple factors for programming and treatment.

Mandatory pharmacist-led education session for patients seeking medical cannabis.

OBJECTIVE: The primary objectives of this pre-post session study, was to evaluate the impact of a pharmacist-led education session on the perceived benefits and safety of cannabis among patients with chronic pain, as well as determine the influence of pharmacist education on the selection of safer cannabis products and dosage forms for medical use among patients. METHODS: A retrospective analysis of completed pre-post session questionnaires was conducted among chronic pain patients attending a mandatory education session led by a pharmacist, prior to being authorized cannabis in clinic. All questionnaire data was analyzed using SPSS v. 25. Demographic and sample characteristics were reviewed using univariate analyses. Chi-Square tests were employed to determine if the group-based education significantly affected knowledge, perception of efficacy and safety of cannabis. RESULTS: Of the 260 session participants, 203 completed pre-post session questionnaires. After the session, a majority of current cannabis users (33.8%) and cannabis naïve/past users (56.9%) reported they would use a low THC product in the future, and a majority of current users (54.5%) would use a high CBD product in the future. After education, participants were more likely to report cannabis as having the potential for addiction (chi-square =42.6, p <0.0001) and harm (chi-square =34.0, p <0.0001). CONCLUSIONS: Pharmacist counselling and education has the potential to influence patient selection and use of cannabis, from more harmful to safer products, as well as moderate the potential perceived benefits of use.

A Qualitative Exploration of the Role and Needs of Classroom Teachers in Supporting the Mental Health and Well-Being of Deaf and Hard-of-Hearing Children.

Purpose Children who are deaf and hard of hearing (DHH) face a wide array of issues that can impact their mental health and well-being. This study aimed to explore the role of schools and classroom teachers in supporting the mental health and well-being of DHH children. Method A qualitative study comprising telephone and semistructured interviews with 12 mainstream school classroom teachers who directly support the education and well-being of DHH children was conducted. Thematic analysis was used to analyze the data. Result Classroom teachers indicated they play an important role in supporting the mental health and well-being of DHH children but identified a range of constraints to providing this support. Four themes were identified: (a) "culture of professional practice," (b) "operationalized practice," (c) "constraints to practice," and (d) "solutions for constraints." Conclusions Classroom teachers play an important role in supporting the mental health and well-being of DHH children but face several constraints in their practice, including limited training and awareness and access to resources. While further research is needed, this study suggests that classroom resources and teacher professional development are needed to enhance classroom teachers' understanding of how to support the mental health and well-being of DHH children.

Evaluation of an interdisciplinary chronic pain program and predictors of readiness for change.

Background: One in five Canadians experience chronic pain, and interdisciplinary pain programs are well established as the gold standard of treatment. However, not all patients are ready to engage in interdisciplinary treatment for chronic pain. Aims: The aims of this study were to (1) first demonstrate changes in patient-related outcomes after attending a publicly funded 8-week interdisciplinary pain program and (2) evaluate pain-related predictors of readiness for change. Methods: The institution's research ethics board approved this study. One hundred twenty-nine patients completed questionnaires on the first and last day of attending the program. Paired sample t-tests were utilized to evaluate the changes in patient-related outcomes after attending the program, and linear regressions were utilized to evaluate pain-related predictors of the stages of change. Results: Postprogram, there were significant decreases in pain-related interference, fear of pain/re-injury, pain catastrophizing, and symptoms of stress, depression, and anxiety and a significant increase in wellness-focused coping and self-efficacy. Postprogram, patients also demonstrated lower scores in precontemplation and contemplation and higher scores in action and maintenance stages of readiness for change. In predicting precontemplation, fear of pain/re-injury was the sole predictor, and self-efficacy was the sole predictor of the contemplation, action, and maintenance stages. Conclusion: These results demonstrate the short-term benefits of an 8-week interdisciplinary pain program. It is suggested that preprogram interventions targeting kinesophobia for individuals who are precontemplative and self-efficacy for others may be important to facilitate patient engagement.

Contexte: Un Canadien sur cinq souffre de douleur chronique. Il est bien établi que les programmes interdisciplinaires de la douleur constituent le traitement de référence. Toutefois, ce ne sont pas tous les patients qui sont prêts à suivre un traitement interdisciplinaire pour la douleur chronique.Buts: Les buts de cette étude étaient : 1) démontrer les changements dans les résultats liés aux patients après que ces derniers aient participé à un programme interdisciplinaire de la douleur de huit semaines, financé par des fonds publics, et 2) évaluer les prédicteurs de la disposition au changement lié à la douleur.Méthodes: La commission d'éthique de la recherche de l'institution a approuvé cette étude. Cent vingt-neuf patients ont répondu à des questionnaires le premier et le dernier jour de leur participation au programme. Des tests T pour échantillons appariés ont été utilisés pour évaluer les changements dans les résultats liés aux patients après avoir participé au programme et des régressions linéaires ont été utilisées pour évaluer les prédicteurs des étapes du changement lié à la douleur.Résultats: Après le programme, des diminutions significatives ont été observées dans l'interférence liée à la douleur, la peur de la douleur ou d'une nouvelle blessure, la catastrophisation de la douleur, ainsi que dans les symptômes de stress, de dépression, et d'anxiété. Une augmentation significative des stratégies d'adaptatation axées sur le bien-être et l'efficacité personnelle a aussi été observée. Après le progamme, les patients ont aussi obtenu des scores plus faibles pour la pré-contemplation et la contemplation et des scores plus élevés pour les étapes d'action et de mantien de la disposition au changement. La peur de la douleur ou d'une nouvelle blessure était l'unique prédicteur pour la pré-contemplation et l'efficacité personnelle était l'unique prédicteur des étapes de la contemplation, de l'action et du maintien.Conclusion: Ces résultats démontrent les bienfaits à court terme d'un programme interdisciplinaire de la douleur de huit semaines. Il est suggéré que les interventions pré-programme ciblant la kinésophobie, pour les individus qui sont à l'étape de la pré-contemplation, et l'efficacité personnelle pour d'autres, peuvent être importants pour faciliter l'engagement des patients.

Use of machine learning to predict early biochemical recurrence after robot-assisted prostatectomy.

OBJECTIVES: To train and compare machine-learning algorithms with traditional regression analysis for the prediction of early biochemical recurrence after robot-assisted prostatectomy. PATIENTS AND METHODS: A prospectively collected dataset of 338 patients who underwent robot-assisted prostatectomy for localized prostate cancer was examined. We used three supervised machine-learning algorithms and 19 different training variables (demographic, clinical, imaging and operative data) in a hypothesis-free manner to build models that could predict patients with biochemical recurrence at 1 year. We also performed traditional Cox regression analysis for comparison. RESULTS: K-nearest neighbour, logistic regression and random forest classifier were used as machine-learning models. Classic Cox regression analysis had an area under the curve (AUC) of 0.865 for the prediction of biochemical recurrence. All three of our machine-learning models (K-nearest neighbour (AUC 0.903), random forest tree (AUC 0.924) and logistic regression (AUC 0.940) outperformed the conventional statistical regression model. Accuracy prediction scores for K-nearest neighbour, random forest tree and logistic regression were 0.976, 0.953 and 0.976, respectively. CONCLUSIONS: Machine-learning techniques can produce accurate disease predictability better that traditional statistical regression. These tools may prove clinically useful for the automated prediction of patients who develop early biochemical recurrence after robot-assisted prostatectomy. For these patients, appropriate individualized treatment options can improve outcomes and quality of life.

Mild Traumatic Brain Injuries Can Be Safely Managed without Neurosurgical Consultation: The End of a Neurosurgical "Nonsult".

In 2010, 2.5 million people sustained a traumatic brain injury (TBI), with an estimated 75 per cent being mild TBI. Mild TBI is defined as a Glasgow Coma Scale (GCS) of 13 to 15. Based on recent data and our institutional experience, we hypothesized that mild TBI patients, including patients on aspirin, could be safely managed by trauma surgeons without neurosurgical consultation. Trauma patients admitted to a single Level I trauma center from June 2014 through July 2015 aged 18 years or older were evaluated. Patients with a GCS ≥14, regardless of intoxication, with an epidural or subdural hematoma ≤4 mm, trace or small subarachnoid hemorrhage, and/or nondisplaced skull fracture were prospectively enrolled. The primary outcomes were needed for neurosurgical consultation and intervention. Secondary outcomes included readmission rate and neurologic morbidity and mortality rate. Of 1341 trauma admits, 77 were enrolled. No patients required neurosurgical intervention. Only 1/75 (1.3%) patients required neurosurgical consultation. Outpatient follow-up was achieved with 75/77 (97.4%) patients. No mortalities, major neurologic morbidities, or readmissions were observed (95% confidence interval 0-4%). None of the 21 patients on aspirin required neurosurgical intervention and only 1/21 (4.8%) patients required neurosurgical consultation with no mortalities observed at follow-up. Management of mild TBI can be safely accomplished by trauma surgeons without routine neurosurgical consultation. Larger multicenter prospective studies are required to evaluate our finding that this also may be safe in patients taking aspirin.

Robotic Versus Video-Assisted Thoracoscopic Lung Resection During Early Program Development.

BACKGROUND: The objective of this study is to compare robotic portal (RP) to video-assisted thoracoscopic surgery (VATS) pulmonary resections for early stage non-small cell lung cancer with respect to health care resource utilization during the first year of a robotic surgery program in thoracic oncology. METHODS: Patients who underwent anatomic lung resections using RP (n = 42) or VATS (n = 96) for early stage non-small cell lung cancer between April 2014 and March 2015 at a single institution were identified. Patient-level case costing data for hospital and home care-associated resource variables were recorded. We adopted a health care payer perspective and 30-day posthospital discharge/death time horizon. Parametric or nonparametric tests were used as appropriate and incremental cost difference using 10,000 bootstrap samples using bias-corrected and accelerated method to generate 95% confidence intervals for total cost. RESULTS: Baseline demographic and clinical characteristics were comparable between the two groups. The median total hospital cost per patient was $15,247 (95% confidence interval: $15,643 to $18,945) in the RP cohort, compared with $12,131 (95% confidence interval: $13,218 to $15,879) in the VATS cohort (n = 96; p < 0.001). Longer operating times in the RP group were the main driver of higher hospital costs. Post-hoc analysis of mean operating room time for first 20 RP procedures versus remaining 22 RP procedures found a mean difference of 71 minutes (p = 0.004), resulting in an intraoperative cost difference of $883.38 (p = 0.036). CONCLUSIONS: A micro-costing analysis demonstrates that RP pulmonary resection for early stage non-small cell lung cancer utilizes more health care resource dollars when compared with VATS during early program development, but offers similar perioperative outcomes.

Domain-specific free thiol variant characterization of an IgG1 by reversed-phase high-performance liquid chromatography mass spectrometry.

Measurement of free thiols in antibody therapeutics is important for product development and assessment of critical quality attributes. Earlier studies demonstrated fast separation of free thiol variants of IgG1 using reversed-phase high performance liquid chromatography (RP-HPLC) with diphenyl resin. Here, we report using N-tert-butylmaleimide (NtBM) alkylation followed by RP-HPLC and online mass spectrometry for rapid total and domain-specific free thiol characterization of IgG1. By increasing hydrophobicity, NtBM alkylation improves separation of free thiol variants from disulfide-linked main peak species. The unique mass shift by NtBM alkylation offers unambiguous characterization of free thiol variants by online mass spectrometry. Variant peaks separated by RP-HPLC were antibody molecules containing two NtBM-alkylated cysteines, corresponding to IgG1 containing two free thiols before alkylation. Further characterization of the collected fractions of variants by peptide mapping revealed that each variant contained unpaired cysteines located in specific IgG1 domains (CH1, CH3, VH and VL domains). Total molecular-level and domain-specific free thiol content measured by this method correlate well with orthogonal differential alkylation peptide mapping analysis, which measures free thiol level at individual cysteine residues. This method provides high throughput quantitation of total and domain-specific free thiol content in IgG1 molecules, facilitating rapid, comprehensive product and manufacturing process characterization.

In Vitro Assays for Endothelial Cell Functions Required for Angiogenesis: Proliferation, Motility, Tubular Differentiation, and Matrix Proteolysis.

This chapter deconstructs the process of angiogenesis into its component parts in order to provide simple assays to measure discrete endothelial cell functions. The techniques described will be suitable for studying stimulators and/or inhibitors of angiogenesis and determining which aspect of the process is modulated. The assays are designed to be robust and straightforward, using human umbilical vein endothelial cells, but with an option to use other sources such as microvascular endothelial cells from various tissues or lymphatic endothelial cells. It must be appreciated that such reductionist approaches cannot cover the complexity of the angiogenic process as a whole, incorporating as it does a myriad of positive and negative signals, three-dimensional interactions with host tissues and many accessory cells including fibroblasts, macrophages, pericytes and platelets. The extent to which in vitro assays predict physiological or pathological processes in vivo (e.g., wound healing, tumor angiogenesis) or surrogate techniques such as the use of Matrigel™ plugs, sponge implants, corneal assays etc remains to be determined.

Adolescent bystanders' perspectives of aggression in the online versus school environments.

Researchers' understanding of bystanders' perspectives in the cyber-environment fails to take young people's perceptions into account and remains imperfect. Interventions encouraging adolescents to help targets of cyber-aggression are therefore typically based upon traditional school-based aggression research. Twenty-four in-depth interviews with Australian 13-16 year-olds revealed two themes that reflect how young bystanders perceive differences between aggression online and at school. The physical presence theme suggests that young bystanders struggle to determine online intentions in the absence of body language, leading to hesitancy in reactions and furthermore make it easier for them to ignore online transgressions and avoid becoming involved. The authority theme indicates young bystanders perceive that, compared to the school environment, the online environment lacks clearly established rules, authority figures and formal reporting mechanisms. These differences indicate that unique strategies should be developed to encourage young bystanders to intervene in cyber-aggression situations.

Operative vs Nonoperative Management of Pediatric Blunt Pancreatic Trauma: Evaluation of the National Trauma Data Bank.

BACKGROUND: Traumatic pancreatic injury is associated with significant morbidity and mortality. We evaluated the differences in outcomes among children with blunt pancreatic injuries managed operatively and nonoperatively. STUDY DESIGN: The National Trauma Data Bank was evaluated from 2002 to 2011. Patients less than18 years of age with blunt pancreatic injuries and Abbreviated Injury Scale (AIS) scores ≥ 3 were identified. Patients were divided into nonoperative (NO), operative (O), and delayed operative (DO; operation performed 48 hours or more after admission) groups. Outcomes evaluated were total length of stay (LOS), ICU use/LOS, complications, and death. Univariate comparisons were performed using Fisher's exact and Kruskal-Wallis rank tests. Multivariable analyses were performed using robust regression and logistic regression. RESULTS: There were 424 cases analyzed. Mean (± SD) age was 10.6 ± 5.3 years, and mean Injury Severity Score (ISS) was 23.4 ± 13.4. Operative groups differed by age (p = 0.002), AIS severity (p = 0.04), and concomitant head injury (p = 0.01), but were similar with regard to sex, race, and ISS. Length of stay was significantly higher in the DO group compared with the NO or O groups; the NO group had the lowest LOS (covariate-adjusted: 18.7 days vs 11.8 days, p < 0.001 and 12.6 days, p < 0.001, respectively) and infection rates (10.2% vs 1.6% and 6.2%, respectively, p = 0.04). The ICU LOS was greatest in the DO group (vs NO, p = 0.03; O, p = 0.29), as was the likelihood of ICU use (vs NO, p = 0.02; O, p = 0.75). Groups did not differ with respect to outcomes including death (p = 0.94) and overall complication rate (p = 0.63). CONCLUSIONS: Overall, children managed nonoperatively have equivalent or better outcomes when compared with operative and delayed operative management in regard to death, overall complications, LOS, ICU LOS, and ICU use.

Preparing staff for intentional rounding: a process yielding success on a general surgical unit.

Intentional rounding is a strategicway to improve patient care through decreasing falls and hospital-acquired pressure ulcers, while increasing patient satisfaction. On the basis of literature reviews and discussions with nurses on units that pilot-tested intentional rounding, useful strategies emerged. This article will provide information about intentional rounding, a means for planning implementation, and the results of evaluating its implementation.

A prospective trial of GreenLight PVP (HPS120) versus transurethral resection of the prostate in the treatment of lower urinary tract symptoms in Ontario, Canada.

BACKGROUND: Photoselective vaporization of the prostate (PVP) is a bloodless, relatively painless alternative to transurethral resection of the prostate (TURP) for relief of lower urinary tract symptoms (LUTS) in benign prostatic hyperplasia (BPH). OBJECTIVE: We compare the effectiveness, safety and cost-effectiveness of Greenlight Laser PVP (HPS-120) and TURP. METHODS: We conducted a prospective, non-randomized trial in 3 Ontario centres from March 2008 to February 2011. Assessments were completed at baseline, 1 and 6 months following surgery at the physicians' offices and at 12 and 24 months by phone. The primary outcome was the change in International Prostate Symptoms Score (IPSS) score at 6 months versus baseline. Secondary outcomes were changes in flow rate, postvoid residual (PVR), prostate-specific antigen (PSA) and sexual health inventory for men (SHIM) scores. Adverse events, health-related quality of life (HRQoL), resource utilization and productivity losses were collected. RESULTS: Although the IPSS decreased in both arms (n = 140 for PVP and n = 24 for TURP) between baseline and 6 months, the difference in change over time between the groups was not statistically significant (p = 0.718). Other outcomes improved equally from baseline and 6 months (Qmax, SHIM, PSA and HRQoL), with only changes in PVR favouring PVP (p = 0.018). There were no statistical differences in serious adverse events. In total, 130 of 140 PVP patients were outpatients, all TURP subjects were inpatients. PVP was less costly than TURP ($3891 vs. $4863; p < 0.001) with similar quality-adjusted life years (0.448 vs. 0.441; p = 0.658). CONCLUSION: Greenlight Laser PVP (HPS-120) is a safe and cost-effective alternative to TURP for outpatient treatment of LUTS and can be completed as an outpatient with minimal blood loss.

Photoselective vaporization for the treatment of benign prostatic hyperplasia.

BACKGROUND: As an alternative to transurethral resection of the prostate (TURP), photoselective vaporization of the prostate (PVP) provides a bloodless, relatively painless relief of lower urinary tract symptoms for men with benign prostatic hyperplasia. Following a review of the evidence in 2006, the Ontario Health Technology Advisory Committee recommended that a study be conducted to evaluate PVP in Ontario. OBJECTIVES: To compare the clinical effectiveness, safety, cost-effectiveness, and budget impact of PVP compared to conventional TURP for the treatment of benign prostatic hyperplasia in Ontario. METHODS: A prospective, nonrandomized trial was conducted in 3 Ontario centres. Consenting subjects were assessed at baseline and 1, 3, and 6 months following surgery. Outcome measures included International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax), post-void residual (PVR) volume, prostate-specific antigen (PSA), health-related quality of life (HRQOL) using the EuroQol 5 Domain questionnaire, and the Sexual Health Inventory for Men (SHIM) score. Adverse events, resource utilization, and productivity losses were also assessed. Cost-effectiveness and budget impact analyses were completed using data from the study. RESULTS: Between February 2008 and August 2010, 164 subjects were enrolled in the study (n = 140 for PVP and n = 24 for TURP). Treatment outcomes were similar between the 2 groups at 6 months, with the IPSS decreasing similarly over time (P = 0.718). For other treatment outcomes (Qmax, PSA, HRQOL, SHIM) both treatments provided similar benefit over time; only changes in PVR volume favoured PVP (P = 0.018). The majority of PVP patients were managed on an outpatient basis, with only 7.1% requiring admission (all TURP subjects were inpatients). At 6 months, PVP was less costly than TURP ($3,891 versus $4,863; P = 0.001), with similar quality-adjusted life-years (0.448 versus 0.441; P = 0.658). PVP remained the most cost-effective treatment across all decision-making thresholds, with the technology costing less and providing similar clinical outcomes. Extrapolating the results to a provincial level indicated (based on an estimated case volume of 12,335 TURPs) that there is an opportunity to reallocate just over $14 million (Cdn), primarily related to the reduced need for hospital admission. LIMITATIONS: This study was nonrandomized, and the results should be interpreted with some caution, despite generally similar baseline characteristics between the 2 groups. Recruiting individuals to the TURP arm was a challenge, resulting in a size imbalance between treatment arms. CONCLUSIONS: Based on this analysis, PVP appears to be a cost-effective alternative to TURP, providing similar clinical benefit at a lower cost to the health system.