Ontario Health Technology Assessment Series最新文献

{"title":"Level 2 Polysomnography for the Diagnosis of Sleep Disorders: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>It is estimated that half of Canadians have insufficient sleep, which over time is associated with poor physical and mental health. Currently, the only publicly funded option for the diagnosis of sleep disorders in Ontario is an in-person overnight sleep study, performed in a hospital or independent health facility (known as a level 1 polysomnography). Level 2 polysomnography has been proposed as an alternative that can be conducted at home for the diagnosis of suspected sleep disorders, if considered to have sufficient diagnostic accuracy. We conducted a health technology assessment of level 2 polysomnography for the diagnosis of suspected sleep disorders in adults and children, which included an evaluation of the test performance, cost-effectiveness, and budget impact of publicly funding level 2 polysomnography, and the experiences, preferences, and values of people with suspected sleep disorders.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence to identify diagnostic accuracy, test failures and subjective measures of patient preferences. We assessed the risk of bias of each included study (using the Quality Assessment of Diagnostic Accuracy Studies [QUADAS-2] tool) and the quality of the body of evidence (according to Grading of Recommendations Assessment, Development, and Evaluation [GRADE] Working Group criteria). We performed a systematic literature search of economic evidence and conducted a primary economic evaluation and budget impact analysis to determine the cost-effectiveness and additional costs of publicly funding level 2 polysomnography for adults and children with suspected sleep disorders in Ontario. To contextualize the potential value of using level 2 polysomnography, we spoke with people with sleep disorders.</p><p><strong>Results: </strong>We included 10 studies that reported on diagnostic accuracy and found level 2 polysomnography had sensitivity ranging between 0.76-1.0 and specificity ranging between 0.40-1.0 (GRADE: Moderate to Very low) when compared with level 1 polysomnography. Studies reported test failure rates from 0% to 20%, with errors present in both level 1 and level 2 tests conducted (GRADE: Very low). As well, some of these studies reported patients were found to have mixed opinions about their experiences, with more people preferring their experience with level 2 testing at home and having better quality of sleep compared with when they underwent level 1 testing (GRADE not conducted).Our primary economic evaluation showed that for adults with suspected sleep disorders, the new diagnostic pathway with level 2 polysomnography was equally effective (outcome: confirmed diagnosis at the end of the pathway) as the current practice diagnostic pathway with level 1 polysomnography. With the assumption of a lower technical fee for level 2 polysomnography, the new diagnostic pathway with level 2 polysomnography was less costly than the c","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"24 7","pages":"1-157"},"PeriodicalIF":0.0,"publicationDate":"2024-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11450293/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142381933","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":"Pelvic Floor Muscle Training for Stress Urinary Incontinence, Fecal Incontinence, and Pelvic Organ Prolapse: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Stress urinary incontinence, fecal incontinence, and pelvic organ prolapse are common forms of pelvic floor dysfunction. Pelvic floor muscle training is used to improve pelvic floor function, through a program of exercises. We conducted a health technology assessment of pelvic floor muscle training for people with stress urinary incontinence, fecal incontinence, or pelvic organ prolapse, which included an evaluation of effectiveness, safety, and the budget impact of publicly funding pelvic floor muscle training, 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 included studies using the ROBIS tool, for systematic reviews, and the Cochrane Risk of Bias tool, for randomized controlled trials, and we assessed the quality of the body of evidence according to Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search but did not conduct a primary economic evaluation. We also analyzed the budget impact of publicly funding pelvic floor muscle training in adults with stress urinary incontinence, fecal incontinence, and pelvic organ prolapse in Ontario. To contextualize the potential value of pelvic floor muscle training as a treatment, we spoke with people with stress urinary incontinence, fecal incontinence, and pelvic organ prolapse.</p><p><strong>Results: </strong>We included 6 studies (4 systematic reviews and 2 randomized controlled trials) in the clinical evidence review. In comparison with no treatment, pelvic floor muscle training significantly improved symptom severity and increased patient satisfaction in women with stress urinary incontinence or pelvic organ prolapse (GRADE: Moderate). For men with stress urinary incontinence after prostatectomy, pelvic floor muscle training yielded mixed results for symptom improvement (GRADE: Very low). For adults with fecal incontinence, pelvic floor muscle training did not improve symptoms in comparison with standard care (GRADE: Very low).In the economic literature review, we included 6 cost-utility analyses that had evaluated the cost-effectiveness of pelvic floor muscle training as a treatment for people with pelvic organ prolapse or urinary incontinence. We did not identify any economic studies on pelvic floor muscle training for women or men with fecal incontinence or men with pelvic organ prolapse. The analyses included in our review found that, for women with stress urinary incontinence, pelvic floor muscle training was likely cost-effective in comparison with other nonsurgical interventions. For men with urinary incontinence after prostate surgery, pelvic floor muscle training was likely not cost-effective in comparison with standard care. For women with pelvic organ prolapse, the cost-effectiveness of pelvic floor muscle training in comparison with no acti","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"24 6","pages":"1-172"},"PeriodicalIF":0.0,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393479/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142297677","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":"Fractional Exhaled Nitric Oxide Testing for the Diagnosis and Management of Asthma: a Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Asthma is a common respiratory disease characterized by airflow obstruction caused by inflammation and narrowing of the airways. Nitric oxide is a gas that is present at low levels in the lungs, but that is elevated in the presence of airway inflammation. Fractional exhaled nitric oxide (FeNO) testing may help in the diagnosis and management of asthma by measuring the amount of nitric oxide in the breath. We conducted a health technology assessment of FeNO testing for the diagnosis and management of asthma in children and adults, which included an evaluation of the accuracy, effectiveness, cost-effectiveness, the budget impact of publicly funding FeNO testing, 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 Quality Assessment of Diagnostic Accuracy Studies tool, version 2 (QUADAS-2) and of each systematic review using the Risk of Bias Assessment Tool for Systematic Reviews (ROBIS). We evaluated 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 20-year time horizon from a public payer perspective. We also analyzed the budget impact of publicly funding FeNO testing in children and adults in Ontario. To contextualize the potential value of FeNO testing, we spoke with people with asthma and their care partners.</p><p><strong>Results: </strong>We included 48 primary studies assessing the diagnostic accuracy of FeNO testing and 2 reviews evaluating the effectiveness of FeNO testing for asthma management in the clinical evidence review. The use of FeNO testing for the diagnosis of asthma reported variable (~30% to 90%) sensitivities (GRADE: Very low) and consistently high (~70% to 100%) specificities (GRADE: Low) in children and adults. FeNO testing for asthma management likely reduced exacerbations in children (GRADE: Moderate) and adults (GRADE: Moderate), lowered oral corticosteroid use in children (GRADE: Moderate), and slightly improved lung function in a mixed population (GRADE: Moderate), but little to no improvement was seen in other outcomes. We found that, for asthma diagnosis, FeNO testing in addition to standard testing is cost-effective in children, with an incremental cost-effectiveness ratio (ICER) of $6,192 per quality-adjusted life-year (QALY) gained. FeNO testing is not cost-effective for asthma diagnosis in adults except when a higher FeNO cut-off is applied. For asthma management, the ICER of FeNO testing compared with standard care alone is $103,893 per QALY gained in children and $200,135 per QALY gained in adults. Publicly funding FeNO testing as an adjunct to standard testing for asthma diagnosis over the next 5 years would cost about $0.10 million to $0.","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"24 5","pages":"1-225"},"PeriodicalIF":0.0,"publicationDate":"2024-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11423898/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142355931","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":"Sucrose Octasulfate-Impregnated Dressings for Adults With Difficult-to-Heal Noninfected Diabetic Foot Ulcers and Difficult-to-Heal Noninfected Venous Leg Ulcers: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Diabetic foot ulcers and venous leg ulcers may not always heal in a timely manner despite proper wound care. Treatments that improve the healing rate of these ulcers would improve clinical outcomes for patients and may result in downstream cost savings for the health care system. We conducted a health technology assessment of sucrose octasulfate-impregnated dressings for adults with difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding sucrose octasulfate-impregnated dressings, 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 for randomized trials (RoB 2) 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 analyzed the budget impact of publicly funding sucrose octasulfate-impregnated dressings for adults with difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers in Ontario. We did not conduct a primary economic evaluation because there is existing evidence to approximate the cost-effectiveness of sucrose octasulfate-impregnated dressings in Ontario. We leveraged 4 previous health technology assessments to explore the perspectives and experiences of patients with diabetic foot ulcers and venous leg ulcers, as well as the perspectives and experiences of their care partners.</p><p><strong>Results: </strong>We included 3 randomized controlled trials and 2 subsequent publications of these randomized controlled trials in the clinical evidence review. Compared with dressings that do not contain sucrose octasulfate, sucrose octasulfate-impregnated dressings result in faster wound closure in patients with difficult-to-heal noninfected neuroischemic diabetic foot ulcers (GRADE: Moderate) and reduce ulcer size and improve health-related quality of life in the domains of pain/discomfort and anxiety/depression for patients with difficult-to-heal noninfected venous leg ulcers (GRADE: Moderate). The use of sucrose octasulfate-impregnated dressings with noninfected wounds is considered safe (GRADE: Moderate).The economic evidence showed that, compared with dressings that do not contain sucrose octasulfate, sucrose octasulfate-impregnated dressings are highly likely to be cost-effective for both difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers and would lead to cost savings due to faster and increased complete wound healing. The annual budget impact of publicly funding sucrose octasulfate-impregnated dressings in Ontario over the next 5 y","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"24 4","pages":"1-101"},"PeriodicalIF":0.0,"publicationDate":"2024-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11271442/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141789355","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":"Robotic-Assisted Surgery for Rectal Cancer: An Expedited Summary of the Clinical Evidence.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Rectal cancer is a disease in which cancer cells form in the rectum, which has the primary function of temporarily storing feces, controlling defecation, and maintaining continence. Surgery is the most common treatment for rectal cancer; surgical approaches include open, laparoscopic, and robotic assisted. We conducted an expedited summary of the clinical evidence for robotic-assisted surgery for rectal cancer, which included an evaluation of effectiveness and safety.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence to retrieve systematic reviews and randomized controlled trials (RCTs). We assessed the risk of bias in the included systematic reviews using AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews, version 2), and we assessed the risk of bias in the included RCT using the Cochrane Risk-of-Bias Tool for Randomized Trials, version 1. We reported the quality of the body of evidence as evaluated in the included systematic reviews according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group criteria if it was evaluated.</p><p><strong>Results: </strong>We included 14 studies in the clinical evidence review (12 systematic reviews and 1 RCT on robotic-assisted vs. laparoscopic rectal cancer surgery and 1 systematic review on robotic-assisted vs. open rectal cancer surgery). Compared with laparoscopic rectal cancer surgery, robotic-assisted rectal cancer surgery may result in similar overall survival; similar rates of conversion, blood transfusion, and readmission,· reduced blood loss; shorter length of stay; and improved quality of life. Compared with open rectal cancer surgery, robotic-assisted rectal cancer surgery may result in similar overall survival, reduced blood loss, and shorter length of stay.</p><p><strong>Conclusions: </strong>Robotic-assisted rectal cancer surgery may result in similar or improved clinical outcomes compared with laparoscopic and open rectal cancer surgery.</p>","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"24 3","pages":"1-45"},"PeriodicalIF":0.0,"publicationDate":"2024-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11031254/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140852175","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":"Intrathecal Drug Delivery Systems for Cancer Pain: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Pain is a common and very distressing symptom for adults and children with cancer. Compared with other routes of delivery, infusing pain medication directly into the intrathecal space around the spinal cord may reduce the incidence of systemic side effects and allow for more rapid and effective pain relief. We conducted a health technology assessment of intrathecal drug delivery systems (IDDSs) for adults and children with cancer pain, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding IDDSs, patient preferences and values, and ethical considerations.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence to retrieve systematic reviews, and we selected and reported results from 2 recent reviews that were relevant to our research questions. We complemented the chosen systematic reviews with a literature search to identify primary studies published after December 2020. We used the Risk of Bias in Systematic Reviews (ROBIS) tool to assess the risk of bias of each included systematic review. 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 IDDSs with standard care (i.e., non-IDDS methods of pain management) from a public payer perspective. We also analyzed the budget impact of publicly funding IDDSs in Ontario. To contextualize the potential value of IDDSs, we spoke with patients with cancer pain and with caregivers of patients with cancer pain. We explored ethical considerations from a review of published literature on the use of IDDSs for the management of cancer pain in adults and children as well as a review of the other components of this health technology assessment to identify ethical considerations relevant to the Ontario context.</p><p><strong>Results: </strong>We included 2 systematic reviews (1 on adults and 1 on children) in the clinical evidence review. In adults with cancer pain who have a life expectancy greater than 6 months, intrathecal drug delivery was associated with a significant reduction in pain intensity compared with before implantation up to a 1-year follow-up (GRADE: Moderate to Low). Improved pain management appeared to be maintained beyond a 4-week follow-up. IDDSs likely decrease the use of systemic opioids (GRADE: Moderate to Low). They may also improve health-related quality of life (GRADE: Low), functional outcomes (GRADE: Low), and survival (GRADE: Low to Very low). In children with cancer pain, IDDSs may reduce pain intensity, improve functional outcomes, and improve survival, but the evidence is very uncertain (all GRADEs: Very low). IDDS implantation carries certain rare risks related to mechanical errors, drug-related side effects, and surgical complication","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"24 2","pages":"1-162"},"PeriodicalIF":0.0,"publicationDate":"2024-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10855886/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139724408","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":"Minimally Invasive Bleb Surgery for Glaucoma: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Glaucoma is the term for a group of eye disorders that causes progressive damage to the optic nerve, which can lead to visual impairment and, potentially, irreversible blindness. Minimally invasive bleb surgery (MIBS) reduces eye pressure through the implantation of a device that creates a new subconjunctival outflow pathway for eye fluid drainage. MIBS is a less invasive alternative to conventional/incisional glaucoma surgery (e.g., trabeculectomy). We conducted a health technology assessment of MIBS for people with glaucoma, which included an evaluation of effectiveness, safety, the budget impact of publicly funding MIBS, 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 1.0 tool for randomized controlled trials (RCTs) and the Risk of Bias Assessment tool for Nonrandomized Studies (RoBANS) for comparative 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 conducted an economic literature search and we estimated the budget impact of publicly funding MIBS in Ontario. We did not conduct a primary economic evaluation due to the limited long-term effectiveness data. We summarized the preferences and values evidence from previous health technology assessments to understand the perspectives and experiences of patients with glaucoma.</p><p><strong>Results: </strong>We included 41 studies (2 RCTs and 39 comparative observational studies) in the clinical evidence review. MIBS may reduce intraocular pressure and the number of medications used, but we are uncertain if MIBS results in outcomes similar to trabeculectomy (GRADE: Moderate to Very low). Compared with trabeculectomy, MIBS may result in fewer follow-up visits and interventions, and adverse events (GRADE: Moderate to Very Low). MIBS may also reduce intraocular pressure and the number of antiglaucoma medications used, compared with other glaucoma treatments, but the evidence is uncertain (GRADE: Very low). Our economic evidence review identified two directly applicable studies. The results of these studies indicate that the cost-effectiveness of MIBS is highly uncertain, and the cost of glaucoma interventions are likely to vary across provinces. The annual budget impact of publicly funding MIBS in Ontario ranged from $0.11 million in year 1 to $0.67 million in year 5, for a total 5-year budget impact estimate of $1.93 million. Preferences and values evidence suggests that fear of ultimate blindness and difficulty managing medication for glaucoma led patients to explore other treatment options such as MIBS. Glaucoma patients found minimally invasive glaucoma surgery (MIGS) procedure beneficial, with minimal side effects and recovery time.</p><p><strong>Conclusions: </str","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"24 1","pages":"1-151"},"PeriodicalIF":0.0,"publicationDate":"2024-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10849035/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139708142","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":"Supplemental Screening as an Adjunct to Mammography for Breast Cancer Screening in People With Dense Breasts: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Screening with mammography aims to detect breast cancer before clinical symptoms appear. Among people with dense breasts, some cancers may be missed using mammography alone. The addition of supplemental imaging as an adjunct to screening mammography has been suggested to detect breast cancers missed on mammography, potentially reducing the number of deaths associated with the disease. We conducted a health technology assessment of supplemental screening with contrast-enhanced mammography, ultrasound, digital breast tomosynthesis (DBT), or magnetic resonance imaging (MRI) as an adjunct to mammography for people with dense breasts, which included an evaluation of effectiveness, harms, cost-effectiveness, the budget impact of publicly funding supplemental screening, the preferences and values of patients and health care providers, and ethical issues.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We performed a systematic literature search of the clinical evidence published from January 2015 to October 2021. We assessed the risk of bias of each included study using the Cochrane Risk of Bias or RoBANS tools, 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 review and conducted cost-effectiveness analyses with a lifetime horizon from a public payer perspective. We also analyzed the budget impact of publicly funding supplemental screening as an adjunct to mammography for people with dense breasts in Ontario. To contextualize the potential value of supplemental screening for dense breasts, we spoke with people with dense breasts who had undergone supplemental screening; performed a rapid review of the qualitative literature; and conducted an ethical analysis of supplemental screening as an adjunct to mammography.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;We included eight primary studies in the clinical evidence review. No studies evaluated contrast-enhanced mammography. Nonrandomized and randomized evidence (GRADE: Very low to Moderate) suggests that mammography plus ultrasound was more sensitive and less specific, and detected more cancers compared to mammography alone. Fewer interval cancers occurred after mammography plus ultrasound (GRADE: Very low to Low), but recall rates were nearly double that of mammography alone (GRADE: Very low to Moderate). Evidence of Low to Very low quality suggested that compared with supplemental DBT, supplemental ultrasound was more sensitive, detected more cancers, and led to more recalls. Among people with extremely dense breasts, fewer interval cancers occurred after mammography plus supplemental MRI compared to mammography alone (GRADE: High). Supplemental MRI after negative mammography was highly accurate in people with extremely dense breasts and heterogeneously dense breasts in nonrandomized and randomized studies (GRADE: Very Low and Moderate). In people","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"23 9","pages":"1-293"},"PeriodicalIF":0.0,"publicationDate":"2023-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11445669/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142373060","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":"Bariatric Surgery for Adults With Class I Obesity and Difficult-to-Manage Type 2 Diabetes: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Many individuals with type 2 diabetes are classified as either overweight or obese. A patient may be described as having difficult-to-manage type 2 diabetes if their HbA1c levels remain above recommended target levels, despite efforts to treat it with lifestyle changes and pharmacotherapy. Bariatric surgery refers to procedures that modify the gastrointestinal tract. In patients with class II or III obesity, bariatric surgery has resulted in substantial weight loss, improved quality of life, reduced mortality risk, and resolution of type 2 diabetes. There is some evidence suggesting these outcomes may also be possible for patients with class I obesity as well. We conducted a health technology assessment of bariatric surgery for adults with class I obesity and difficult-to-manage type 2 diabetes, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding bariatric surgery, and patient preferences and values.</p><p><strong>Methods: </strong>We performed a systematic clinical literature review. We assessed the risk of bias of each included study, using the Cochrane Risk of Bias tool for randomized controlled trials, the Risk of Bias in Non-randomized Studies - of Interventions (ROBINS-I) tool for cohort studies, and the Risk of Bias in Systematic Reviews (ROBIS) tool for systematic reviews; 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 review and conducted a cost-utility analysis of bariatric surgery in comparison with nonsurgical usual care over a lifetime horizon from a public payer perspective. We also analyzed the budget impact of publicly funding bariatric surgery for adults with class I obesity and difficult-to-manage type 2 diabetes in Ontario. To contextualize the potential value of bariatric surgery, we spoke with people with obesity and type 2 diabetes who had undergone or were considering this procedure.</p><p><strong>Results: </strong>We included 14 studies in the clinical evidence review. There were large increases in diabetes remission rates (GRADE: Low to Very low) and large reductions in body mass index (GRADE: Low to Very low) with bariatric surgery than with medical management. Bariatric surgery may also reduce the use of medications for type 2 diabetes (GRADE: Low) and may improve quality of life for people with class I obesity and difficult-to-manage type 2 diabetes compared with medical management. (GRADE: Low)Our economic evidence review included 5 cost-effectiveness studies; none were conducted in a Canadian setting, and 4 were considered partially applicable to our research question. Most studies found bariatric surgery to be cost-effective compared to standard care for patients with class I obesity and type 2 diabetes; however, the applicability of these results to the Ontario co","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"23 8","pages":"1-151"},"PeriodicalIF":0.0,"publicationDate":"2023-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10732121/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138832074","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":"Robotic-Assisted Partial Nephrectomy for Kidney Cancer: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Robotic-assisted surgery has been used in Ontario hospitals for over a decade, but there is no public funding for the robotic systems or the disposables required to perform robotic-assisted surgeries (\"robotics disposables\"). We conducted a health technology assessment of robotic-assisted partial nephrectomy for the treatment of kidney cancer (RAPN). Nephrectomy may be radical (the surgical removal of an entire kidney, nearby adrenal gland and lymph nodes, and other surrounding tissue) or partial (the surgical removal of part of a kidney or a kidney tumour). Partial nephrectomy is the gold standard surgical treatment for early kidney cancer. Our assessment included an evaluation of the effectiveness, safety, and cost-effectiveness of RAPN, as well as the 5-year budget impact for the Ontario Ministry of Health of publicly funding RAPN. It also looked at the experiences, preferences, and values of people with kidney cancer, as well as those of health care professionals who provide surgical treatment for kidney cancer.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence to retrieve systematic reviews and selected and reported results from five reviews that were recent and relevant to our research questions. We used the Risk of Bias in Systematic Reviews (ROBIS) tool to assess the risk of bias of each included systematic review. We assessed the quality of the body of evidence reported in the selected reviews according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search. We also analyzed the 5-year budget impact of publicly funding robotics disposables for RAPN for people with kidney cancer in Ontario. To contextualize the potential value of RAPN for people with kidney cancer, we spoke with people with lived experience of kidney cancer who had undergone either open or robotic-assisted nephrectomy, and we spoke with urologic surgeons who perform nephrectomy.</p><p><strong>Results: </strong>We included five systematic reviews in the clinical evidence review. Low-quality evidence from observational studies suggests that compared with open or laparoscopic partial nephrectomy, RAPN may decrease estimated blood loss, shorten length of hospital stay, and reduce complications (All GRADEs: Low). We identified five studies that met the inclusion criteria of our economic literature review. Most included economic studies found robotic-assisted surgical procedures to be more costly than open and laparoscopic procedures; however, the results from these studies were not applicable to the Ontario context. Assuming a moderate increase in the volume of RAPN procedures, our reference case analysis showed that the 5-year budget impact of publicly funding RAPN for people with kidney cancer would be $1.58 million. The budget impact analysis results were sensitive to surgical volume and t","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"23 7","pages":"1-77"},"PeriodicalIF":0.0,"publicationDate":"2023-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10656046/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138463206","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}