Ontario Health Technology Assessment Series最新文献

{"title":"Ablative Technologies for Thyroid Nodules: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Thyroid nodules are common, but most are benign and do not require treatment. However, intervention is warranted in people who experience compressive symptoms or hyperthyroidism, or based on risk of malignancy. Ablative technologies may offer a minimally invasive option for those in whom surgery is being considered. We conducted a health technology assessment of ablative technologies for adults with symptomatic benign thyroid nodules, cystic thyroid nodules, autonomously functioning thyroid nodules (AFTNs), or small, low-risk papillary thyroid cancer, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding ablative technologies, and patient preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence to retrieve systematic reviews; we then complemented the chosen systematic reviews with a literature search to identify primary studies published from January 2022. We assessed the risk of bias of each included study using the Risk of Bias in Systematic Reviews tool for systematic reviews and the Cochrane Risk-of-Bias Tool 2 for primary studies. We assessed the quality of the body of evidence according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted cost-utility analyses with a lifetime horizon from a public payer perspective. We also analyzed the budget impact of publicly funding radiofrequency ablation (RFA) in adults with symptomatic benign thyroid nodules, AFTNs, and small, low-risk papillary thyroid cancer in Ontario. To contextualize the potential value of RFA, we spoke with people who had thyroid nodules.</p><p><strong>Results: </strong>We included 4 systematic reviews and 1 randomized controlled trial in the clinical evidence review. In patients with symptomatic benign thyroid nodules, thermal ablations (including RFA, microwave ablation, and high-intensity focused ultrasound ablation) may be as effective as surgery in reducing nodule volume and improving symptoms, and they may result in better quality of life (GRADEs: Very low to Low). In patients with cystic thyroid nodules, RFA may be as effective as ethanol ablation in reducing nodule volume and improving symptoms (GRADEs: Low). In patients with AFTNs, RFA may reduce nodule volume, improve symptoms, and normalize thyroid-stimulating hormone levels (GRADEs: Low). In patients with small, low-risk papillary thyroid cancer, thermal ablations may be as effective as surgery in terms of tumour disappearance but have a lower tumour recurrence rate; they may require less surgical time and a shorter length of hospital stay, and they may be associated with less postprocedural pain and better postprocedural quality of life than surgery (GRADEs: Low to Very low). The effectiveness of the different thermal ablations may be simil","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"26 3","pages":"1-227"},"PeriodicalIF":0.0,"publicationDate":"2026-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13268792/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148273217","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Paclitaxel-Coated Balloon Dilation for Adults With Recurrent Bulbar Urethral Stricture: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Bulbar urethral stricture is the narrowing of the bulbar segment of the urethra, which causes urinary symptoms and difficulty in voiding. Surgical urethroplasty is the gold standard treatment, but usually the first-line treatment is using either a simple (uncoated) balloon, a rigid dilator, or performing direct vision internal urethrotomy, which uses a blade or laser to make a cut in the stricture. Treatment with a balloon that is coated with paclitaxel has been offered as a second-line treatment when the stricture recurs. This health technology assessment looked at how safe, effective, and cost-effective paclitaxel-coated balloon dilation is for adults with recurrent bulbar urethral stricture. It also looked at the budget impact of publicly funding paclitaxel-coated balloon dilation and at the experiences, preferences, and values of people with bulbar urethral stricture.</p><p><strong>Methods: </strong>We performed a systematic literature search and reviewed the clinical evidence and the economic evidence. We assessed the risk of bias in the study using RoB 2 and JBI tools and the quality of the body of clinical evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We developed a probabilistic state-transition (Markov) model to conduct a cost-effectiveness analysis over the 5-year horizon from a public payer perspective. We compared urethral dilation with the paclitaxel-coated balloon catheter to usual care (i.e., endoscopic management represented by a mix of urethral dilation procedures and direct vision internal urethrotomy) for adult males with recurrent bulbar urethral strictures. We also analyzed the 5-year budget impact of publicly funding this technology in eligible adult males in Ontario. To contextualize the potential value of paclitaxel-coated balloon dilation, we aimed to speak with adults and care partners in Ontario who had lived experience with bulbar urethral strictures, including those with and without direct experience with this procedure.</p><p><strong>Results: </strong>There is currently no evidence for head-to-head comparison between paclitaxel-coated balloon dilation and direct vision internal urethrotomy (the most common treatment method for bulbar recurrent urethral stricture in Ontario) or between paclitaxel-coated balloon dilation and surgical urethroplasty (the gold standard treatment). We identified 1 randomized controlled trial that compared outcomes of treatment with paclitaxel-coated balloon with other endoscopic methods in patients with short bulbar urethral stricture (≤ 3 cm; ROBUST III trial). This trial used Kaplan-Meier analysis and reported a statistically significant difference in freedom from repeat intervention at 1 year, favouring the intervention group (GRADE: Low). However, this estimate was likely skewed by the fact that there were participants in the intervention group who failed the treatment but did","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"26 4","pages":"1-160"},"PeriodicalIF":0.0,"publicationDate":"2026-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13268791/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148273196","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hepatitis C Screening: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Hepatitis C virus (HCV) infection causes liver inflammation that, if left untreated, can lead to scarring of the liver (cirrhosis), liver failure, liver cancer (hepatocellular carcinoma [HCC]), and death. For most people, this process usually progresses slowly, over 10 to 20 years or more, during which time the person may remain asymptomatic despite the ongoing process of liver damage. HCV screening aims to identify people with an HCV infection so that they can be linked to care and treatment. We conducted a health technology assessment of (1) one-time HCV screening for all adults in addition to risk-based HCV screening and (2) one-time HCV screening for people born between 1945 and 1975 (1945-1975 birth cohort) in addition to risk-based HCV screening, compared with risk-based HCV screening alone. This included an evaluation of effectiveness, cost-effectiveness, the budget impact of publicly funding onetime HCV screening in those populations, and patient preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Risk of Bias in Nonrandomized Studies - of Interventions (ROBINS-I) tool and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a literature search of the quantitative evidence on the preferences for HCV screening of the adult population and health care providers. We performed a systematic economic literature search and conducted a cost-utility analysis with a lifetime horizon from a public payer perspective to compare (1) one-time HCV screening for all adults plus risk-based HCV screening and (2) one-time HCV screening for the 1945-1975 birth cohort plus risk-based HCV screening, against risk-based HCV screening alone. We also analyzed the budget impact of publicly funding one-time HCV screening for all adults plus risk-based HCV screening and one-time HCV screening for the 1945-1975 birth cohort plus risk-based HCV screening in Ontario. We performed a literature search of the quantitative evidence on the preferences of adults and health care providers for HCV screening. To contextualize the potential value of expanding HCV screening, we spoke with people with HCV.</p><p><strong>Results: </strong>We included 3 observational studies in the clinical evidence review. The study findings suggest that one-time HCV screening for all adults plus risk-based HCV screening may identify more people with HCV and may result in more people with HCV linked to care compared with risk-based HCV screening alone (GRADE: Very low). No studies were identified for the assessment of one-time HCV screening for the 1945-1975 birth cohort or for the assessment of the quantitative preferences of adults and health care providers for HCV screening. One-time HCV screening for all adults plus risk-b","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"26 1","pages":"1-139"},"PeriodicalIF":0.0,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12929945/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147310841","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Renal Denervation for Uncontrolled Hypertension: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>When blood pressure remains elevated despite treatment, a person is considered to have uncontrolled hypertension, which increases the risk of serious health outcomes (e.g., cardiovascular disease, stroke, kidney failure, and death) over time. Renal denervation, a minimally invasive procedure targeting sympathetic nerves in the wall of renal arteries, has emerged as a promising adjunctive treatment to standard care (e.g., health behaviour modifications and antihypertensive medications). We conducted a health technology assessment of renal denervation for adults with uncontrolled hypertension, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding renal denervation, and patient and provider preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included systematic review using the Risk of Bias in Systematic Reviews (ROBIS) tool. We performed a systematic economic literature search and conducted a cost-utility analysis with a lifetime horizon from a public payer perspective. We also analyzed the budget impact of publicly funding renal denervation in adults with uncontrolled hypertension in Ontario. To contextualize the potential value of renal denervation, we conducted a review of the quantitative evidence of patient and provider preferences and values, and we spoke with people with hypertension.</p><p><strong>Results: </strong>We included 10 systematic reviews of randomized controlled trials in our clinical evidence review, all of which showed that renal denervation statistically significantly lowered systolic blood pressure more than standard care (by a mean of 2.1-6.3 mmHg), regardless of the type of renal denervation system used, the blood pressure end points assessed, and whether people were taking antihypertensive medications at the time of the procedure. Renal denervation in addition to standard care is more effective and more expensive than standard care alone. The incremental cost-effectiveness ratio of renal denervation in addition to standard care compared with standard care alone is $121,237 per quality-adjusted life-year (QALY) gained over a lifetime horizon. The probability of renal denervation in addition to standard care being cost-effective versus standard care alone is 0% at a willingness-to-pay (WTP) of $50,000 per QALY gained, 18.02% at a WTP of $100,000 per QALY gained, and 80.50% at a WTP of $150,000 per QALY gained. The cost-effectiveness results were sensitive to changes in time horizon, assumptions about the duration of treatment effect, and the cost of the renal denervation procedure (including the cost of the renal denervation system). The annual budget impact of publicly funding renal denervation for adults with uncontrolled hypertension in Ontario over the next 5 years ranges from an additional $0.42 million in year 1 to an ad","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"26 2","pages":"1-150"},"PeriodicalIF":0.0,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12929946/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147310915","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"DNA Methylation-Based Classification for Central Nervous System Tumours: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Central nervous system (CNS) tumours occur when abnormal cells form in the tissues of the brain and/or spinal cord. Conventional testing for CNS tumour classification involves histopathological evaluation and molecular markers. More recently, DNA methylation-based classifier tests are being used as an adjunct tool in addition to conventional tests to help with CNS tumour classification. We conducted a health technology assessment of DNA methylation-based classifier tests for CNS tumours, which included an evaluation of effectiveness, cost-effectiveness, and budget impact of publicly funding DNA methylation-based classifier tests for CNS tumours. After considering the likely effects of testing on the patient experience, we determined not to perform an analysis of patient preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS) and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria.We performed a systematic economic literature search and developed a decision-analytic model to evaluate the cost-effectiveness of using DNA methylation-based classifier tests. We also analyzed the budget impact of publicly funding DNA methylation-based classifier tests. All costs were expressed in 2024 CAD.</p><p><strong>Results: </strong>We included 38 studies in the clinical evidence review. Compared with conventional testing alone, DNA methylation-based classifier tests are an adjunct tool that may improve CNS tumour classification (GRADE: Moderate). The tests may improve downstream patient outcomes, although the evidence is very uncertain (GRADE: Very low). Unclassifiable test results may increase time to treatment, but the evidence is very uncertain (GRADE: Very low).We did not identify any studies that met the inclusion criteria for our economic literature review. We estimated that there were about 716 patients with challenging diagnostic primary CNS tumours in Ontario each year. The cost of clinical-based DNA methylation profiling for CNS tumours was $1,500 per patient. The annual incremental costs of second-tier DNA methylation classifier tests (after the use of conventional test) would be $1,074,738 for all challenging diagnostic cases, and DNA methylation-based classifier tests improved the diagnosis for 195 patients. The incremental cost-effectiveness ratio (ICER; i.e., the incremental cost per case with an improvement in primary CNS tumour classification) was $5,521. Scenario analyses showed that for children aged 0 to 14 years, the ICER was reduced to $2,683. Publicly funding second-tier DNA methylation-based classifier testing for challenging diagnostic cases of primary CNS tumours would result in a budget increase of about $1 million ","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"25 5","pages":"1-93"},"PeriodicalIF":0.0,"publicationDate":"2025-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647934/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145640283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Home-Based Heated Humidified High-Flow Therapy for Respiratory Conditions: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Respiratory conditions encompass a wide range of disorders that affect the lungs and other parts of the respiratory system. These conditions vary greatly in severity and impact, from mild, transient issues to chronic, life-threatening diseases. Treatment options include medications, pulmonary rehabilitation, surgery, and respiratory therapies such as mechanical ventilation, continuous positive airway pressure, bilevel positive airway pressure, conventional oxygen therapies, and heated humidified high-flow therapy (HHHFT). We conducted a health technology assessment of home-based HHHFT for (1) children with pediatric obstructive sleep apnea (OSA) who cannot tolerate conventional respiratory therapies at home, and (2) adults and children hospitalized for respiratory conditions who will need treatment at home once they are discharged and who have no at-home alternatives that offer an equivalent level of support. This assessment included an evaluation of effectiveness, safety, the budget impact of publicly funding home-based HHHFT, and patient preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence of the effectiveness and safety of home-based HHHFT for the populations described above. We performed a systematic economic literature search, but we did not conduct a primary economic evaluation because of a lack of evidence. We analyzed the budget impact of publicly funding home-based HHHFT in children with pediatric OSA and in adults and children with other respiratory conditions in Ontario. To contextualize the potential value of home-based HHHFT, we aimed to speak with adults and care partners of children in Ontario who had lived experience of respiratory conditions, including those with and without direct experience of HHHFT.</p><p><strong>Results: </strong>We did not identify any studies that met the eligibility criteria for our clinical evidence review. The estimated annual budget impact of publicly funding home-based HHHFT in Ontario over the next 5 years ranges from cost savings of $185,981 for children with pediatric OSA to an additional $2.5 million for adults and children with other respiratory conditions. We estimate that publicly funding home-based HHHFT would result in 99 fewer inpatient visits and 127 fewer outpatient visits related to pediatric OSA. It would also result in 653 inpatient days avoided for adults and children with other respiratory conditions. Due to data limitations, these budget impact estimates are highly uncertain. Care partners discussed the difficulties of caring for a child with complex care needs - particularly those of caring for a child with a tracheostomy. They shared their experiences with alternative treatment options that were ineffective in managing their child's symptoms. People with direct experience using home-based HHHFT highlighted its positive impact on their child's respiratory symptoms, improving qualit","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"25 6","pages":"1-106"},"PeriodicalIF":0.0,"publicationDate":"2025-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647933/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145640536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Percutaneous Vertebroplasty and Balloon Kyphoplasty for Painful Osteoporotic Vertebral Compression Fractures: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Vertebral compression fractures are among the most common types of fracture in patients with osteoporosis and they can arise during activities of daily living without any specific trauma event. For severely painful osteoporotic vertebral compression fractures (OVCFs) that do not respond to conservative treatment, minimally invasive percutaneous vertebroplasty (PVP) and percutaneous balloon kyphoplasty (PBK) may be used. We conducted a health technology assessment of PVP and PBK for people with painful OVCFs refractory to nonsurgical treatment that included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding PVP and PBK, and patient preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the ROBIS tool for systematic reviews, the Cochrane Risk of Bias tool for RCTs, and the ROBINS-I tool for observational studies and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-utility analysis with a 3-year time horizon from a public payer perspective. We also analyzed the budget impact of publicly funding PVP and PBK in adults with painful OVCFs in Ontario. To contextualize the potential value of PVP and PBK, we spoke with people with OVCF.</p><p><strong>Results: </strong>We included 10 studies in the clinical evidence review. Compared to conservative treatment (CT), there was significant (statistical and clinical) improvement in pain (up to 3 months follow-up, GRADE Low) and physical function (up to 6 months follow-up, GRADE Very low) for patients who underwent PVP. For PBK, there was significant (statistical and clinical) improvement in pain in the short term (up to 3 months follow-up, GRADE Very low) compared with CT. Overall, there were no significant differences for either PVP or PBK compared to conservative treatment for mortality, subsequent fractures or adverse events (GRADE Low to Very low). Cement leakage occurred in 4% to 39% of treated patients (PVP vs. CT, 4.0% [8/200 patients]; PVP vs. sham, 39.4% [9/99 patients]; PBK vs. CT, 4.5% [30/731 patients]) and most leakages were asymptomatic. The incremental cost-effectiveness ratio (ICER) of PVP compared with CT is $43,324 per quality-adjusted life-year (QALY) gained. The ICER of PBK compared with CT is $65,921 per QALY gained. The annual budget impact of publicly funding PVP and PBK in Ontario over the next 5 years ranges from an additional $0.5 million in Year 1 to $11.0 million in Year 5. The people we spoke to reported that their daily activities, work, social life, family relationships, and mental health were negatively impacted by OVCF. Those who underwent vertebroplasty reported a positive impact on pain relief and qu","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"25 4","pages":"1-253"},"PeriodicalIF":0.0,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12425451/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145065698","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Indocyanine Green Fluorescence Imaging for Colorectal Surgery: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Both malignant and benign conditions may require colorectal surgery. Anastomotic leak is a serious potential complication, and assessing tissue perfusion at the planned site of anastomosis is critical to try to prevent leaks. The approaches used by surgeons to assess anastomotic integrity and tissue perfusion involve visual assessment of the planned resection area. Indocyanine green fluorescence imaging (ICGFI) is a technology that involves the use of a fluorescent dye and a near-infrared imaging system to allow surgeons to visualize tissue perfusion intraoperatively in real time. We conducted a health technology assessment of ICGFI in colorectal surgery, which included an evaluation of effectiveness, cost-effectiveness, the budget impact of publicly funding ICGFI for the assessment of anastomotic perfusion during colorectal surgery, and the experiences of patients undergoing colorectal cancer surgery.</p><p><strong>Methods: </strong>We performed a systematic review of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane Risk-of-Bias Tool for randomized controlled trials (RCTs) and the Risk-of-Bias Assessment Tool for Nonrandomized Studies (RoBANS) for nonrandomized studies. We assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-effectiveness analysis comparing ICGFI with visual assessment alone for the visualization of anastomotic perfusion during colorectal surgery from a public payer perspective. We also analyzed the budget impact of publicly funding ICGFI for colorectal surgery in Ontario. To contextualize the potential value of publicly funding ICGFI for colorectal surgery, we summarized a qualitative literature rapid review conducted by the Canadian Agency for Drugs and Technologies in Health (now Canada's Drug Agency).</p><p><strong>Results: </strong>We included 6 RCTs and 13 nonrandomized studies in the clinical evidence review. Compared with visual assessment alone, the addition of ICGFI to assess anastomotic perfusion during colorectal surgery reduced anastomotic leaks (GRADE: Low) and reoperations (GRADE: Low) and slightly reduced sepsis, but the evidence for the latter is very uncertain (GRADE: Very low to Low). ICGFI appeared to have little to no effect on hospital readmissions (GRADE: Low) or length of stay (GRADE: Low to Moderate), and its effect on mortality is very uncertain (GRADE: Very low). Our primary economic evaluation found that ICGFI is more effective and less costly than visual assessment alone and is highly likely to be cost-effective at the commonly used willingness-to-pay values of $50,000 and $100,000 per quality-adjusted life-year (QALY). The use of ICGFI could prevent 22 major anastomotic leaks per 1,000 patients undergoing colorectal surgery with anastomosis. Wit","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"25 3","pages":"1-124"},"PeriodicalIF":0.0,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12291517/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733726","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Magnetic Resonance-Guided Focused Ultrasound Neurosurgery for Treatment-Refractory Obsessive-Compulsive Disorder: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Obsessive-compulsive disorder (OCD) is a debilitating neuropsychiatric illness characterized by obsessions and compulsions that are distressing, impair function, and are time-consuming, especially in severe cases. Up to 40% of people with OCD have treatment-refractory OCD and experience inadequate response to multiple trials and combinations of treatments. Neurosurgery is an important treatment option for people with severe, treatment-refractory OCD but is typically invasive. Magnetic resonance-guided focused ultrasound (MRgFUS) is a noninvasive technology that is used to perform neurosurgery. We conducted a health technology assessment of MRgFUS neurosurgery for people with severe, treatment-refractory OCD, which included an evaluation of effectiveness, safety, the budget impact of publicly funding MRgFUS neurosurgery, and patient preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence published since 2013. We assessed the risk of bias of each included study using the Joanna Briggs Institute's Critical Appraisal Checklist for Case Series, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic literature search of the economic evidence. We estimated the 5-year budget impact of publicly funding MRgFUS neurosurgery for people with treatment-refractory OCD in Ontario. Owing to a lack of comparative clinical evidence, we did not conduct a primary economic evaluation. To contextualize the value of MRgFUS neurosurgery, we spoke to people with treatment-refractory OCD who underwent the procedure, as well as those on the waitlist.</p><p><strong>Results: </strong>We included 2 studies in the clinical evidence review. In these small case series, MRgFUS neurosurgery led to improvements in OCD symptoms, quality of life, and patient functioning, as well as treatment response for many but not all patients (GRADE: Very low). In a minority of cases, the procedure could not be successfully performed due to skull factors (GRADE: Very low). MRgFUS neurosurgery was also found to have a favourable safety profile (GRADE: Very low). No cases of re-treatment were reported (GRADE: Very low). No studies compared MRgFUS neurosurgery with other neurosurgeries.Due to the lack of comparative clinical evidence, the cost-effectiveness of MRgFUS neurosurgery could not be determined. Our budget impact analysis found that publicly funding MRgFUS neurosurgery for people with treatment-refractory OCD in Ontario would cost an additional $1.9 million over 5 years.Patients reported the negative impacts that OCD had on their day-to-day activities, work and school, social life and family relationships, and mental health. The 6 participants who underwent MRgFUS neurosurgery commented on the positive impact that it had on their OCD symptoms, mental health, and quali","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"25 1","pages":"1-123"},"PeriodicalIF":0.0,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12148002/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144267557","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Noninvasive Vagus Nerve Stimulation for Cluster Headache and Migraine: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Cluster headache and migraine are 2 distinct types of primary headache that can cause substantial pain, disability, and decreased quality of life. Noninvasive vagus nerve stimulation (nVNS) is a treatment option that delivers a mild electrical stimulation to a nerve in the neck. nVNS is intended to reduce the pain and duration of a headache attack, and to prevent headaches from occurring. We conducted a health technology assessment of nVNS for the acute treatment and prevention of cluster headache or migraine, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding nVNS, and patient preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane Risk of Bias tool and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted 2 cost-utility and cost-effectiveness analyses with a 1-year time horizon from a public payer perspective. We also analyzed the budget impact of publicly funding nVNS for people with cluster headache and migraine in Ontario. To contextualize the potential value of nVNS, we spoke with people with cluster headache and migraine.</p><p><strong>Results: </strong>We included 8 randomized trials in the clinical evidence review (3 on cluster headache, 5 on migraine). For the acute treatment of cluster headache with nVNS, we found no statistically significant improvements in terms of overall response (pain relief), pain freedom, and duration of attacks (GRADEs: Low to Very low), or acute medication use (GRADE: Moderate). We observed little to no difference in mean pain intensity or adverse events (GRADE: Low). For the preventive treatment of cluster headache (based on 1 trial), nVNS reduced the frequency of attacks per week (GRADE: Low), improved response (GRADE: Low), reduced acute medication use (GRADE: Low), and improved quality of life (GRADE: Low to Very low). More overall adverse events were observed with nVNS, but results were uncertain (GRADE: Low). For the acute treatment of migraine (based on 1 study), nVNS improved response to treatment (i.e., pain relief; GRADE: Moderate to Low) but had little to no effect on sustained response (GRADE: Low). nVNS improved pain freedom, but the results were not statistically significant (GRADE: Moderate) and there was no difference in sustained pain freedom (GRADE: Low). There was little to no difference in mean pain intensity (GRADE: Very low) or acute medication use (GRADE: Low), and the risk of adverse events was very uncertain (GRADE: Very low). For the preventive treatment of migraine (based on 4 studies), nVNS may slightly reduce the number of headache and migraine days, but we could not exclude the possibilit","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"25 2","pages":"1-177"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12148001/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144267558","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}