Background: 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.
Methods: 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.
Results: 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.
{"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}
<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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
背景：乳房 X 射线照相术筛查的目的是在临床症状出现之前发现乳腺癌。在乳房致密的人群中，仅靠乳房 X 光检查可能会漏诊一些癌症。有人建议在乳腺 X 射线照相术筛查的基础上增加辅助成像，以检测乳腺 X 射线照相术漏检的乳腺癌，从而减少与该疾病相关的死亡人数。我们对使用对比增强乳腺 X 线造影术、超声波、数字乳腺断层扫描（DBT）或磁共振成像（MRI）作为乳腺 X 线造影术辅助手段对致密乳房患者进行补充筛查的健康技术进行了评估，评估内容包括效果、危害、成本效益、政府资助补充筛查对预算的影响、患者和医疗服务提供者的偏好和价值观以及伦理问题：我们对 2015 年 1 月至 2021 年 10 月期间发表的临床证据进行了系统性文献检索。我们使用 Cochrane Risk of Bias 或 RoBANS 工具评估了每项纳入研究的偏倚风险，并根据建议评估、发展和评价分级（GRADE）工作组标准评估了证据的质量。我们进行了系统的经济文献综述，并从公共支付方的角度进行了终生成本效益分析。我们还分析了在安大略省由政府出资为乳房致密者提供补充筛查作为乳房 X 线照相术辅助检查的预算影响。为了明确致密型乳房补充筛查的潜在价值，我们与接受过补充筛查的致密型乳房患者进行了交谈；对定性文献进行了快速回顾；并对作为乳房 X 线照相术辅助手段的补充筛查进行了伦理分析：我们在临床证据审查中纳入了八项主要研究。没有研究对造影剂增强型乳腺 X 线照相术进行评估。非随机和随机证据（GRADE：极低至中度）表明，乳腺X线照相术加超声波的敏感性更高，特异性更低，与单独使用乳腺X线照相术相比，能发现更多癌症。乳房X线照相术加超声波检查后发生的间期癌症较少（GRADE：极低至低），但召回率几乎是单纯乳房X线照相术的两倍（GRADE：极低至中度）。低质量到极低质量的证据表明，与补充性 DBT 相比，补充性超声波更敏感，能检测出更多的癌症，并导致更多的召回。在乳房密度极高的人群中，乳房X线照相术加补充核磁共振成像与单纯乳房X线照相术相比，间期癌症的发生率更低（GRADE：高）。在非随机和随机研究中，对乳腺密度极高和乳腺密度不均的患者，在乳腺X光检查阴性后补充磁共振成像的准确性很高（GRADE：极低和中等）。在乳腺密度极高的人群中，乳腺X线造影阴性后进行核磁共振成像检查，每1,000例筛查可发现16.5例癌症（评估等级：中度），且高达9.5%的筛查对象被召回（评估等级：中度）。与对比度相关的不良事件并不常见（GRADE：中度）。没有研究报告了心理影响、乳腺癌特异性死亡率或总死亡率。我们在经济证据中纳入了九项研究，但没有一项研究结果直接适用于安大略省的情况。我们的终生成本效益分析表明，使用超声波、磁共振成像或 DBT 进行补充筛查会发现更多筛查出的癌症，减少间期癌症的数量，在生命年或质量调整生命年（QALYs）方面有小幅收益，并且与癌症管理成本的节省相关。然而，辅助筛查也增加了成像成本和假阳性病例的数量。与单纯乳腺 X 光检查相比，使用手持式超声波、核磁共振成像或 DBT 对致密乳房患者进行补充筛查的增量成本效益比（ICER）分别为每 QALY 收益 119,943 美元、314,170 美元和 212,707 美元。极致密乳房患者的 ICER 分别为每 QALY 收益 83,529 美元、101,813 美元和 142,730 美元。在敏感性分析中，单纯乳腺 X 射线照相术和乳腺 X 射线照相术加补充筛查的诊断测试敏感性对 ICER 估计值的影响最大。据估计，在未来 5 年内为乳房致密者提供手持式超声波、磁共振成像或 DBT 补充筛查的公共资金总预算影响分别为 1,500 万美元、4,100 万美元或 3,300 万美元。对于乳房密度极高的患者，相应的预算影响总额分别为 400 万美元、1000 万美元或 900 万美元。我们通过访谈和在线调查直接与 70 位参与者进行了交流，他们对安大略省乳腺致密者广泛接受补充筛查的问题提出了不同的观点。
{"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":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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}
Background: 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.
Methods: 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.
Results: 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
背景：许多 2 型糖尿病患者被归类为超重或肥胖。如果患者的 HbA1c 水平仍然高于建议的目标水平，尽管他们努力通过改变生活方式和药物疗法进行治疗，但仍可能被称为难以控制的 2 型糖尿病患者。减肥手术是指改变胃肠道的手术。对于 II 级或 III 级肥胖症患者，减肥手术可使体重大幅减轻，生活质量得到改善，死亡风险降低，2 型糖尿病得到缓解。一些证据表明，I 级肥胖症患者也有可能获得这些结果。我们对患有 I 级肥胖症和难以控制的 2 型糖尿病的成人进行了减肥手术的健康技术评估，其中包括对减肥手术的有效性、安全性、成本效益、政府资助减肥手术对预算的影响以及患者的偏好和价值观进行评估：我们进行了系统的临床文献综述。我们采用科克伦偏倚风险工具（Cochrane Risk of Bias）对随机对照试验进行评估，采用非随机干预研究偏倚风险工具（ROBINS-I）对队列研究进行评估，采用系统性综述偏倚风险工具（ROBIS）对系统性综述进行评估；我们根据建议评估、发展和评价分级工作组（GRADE）标准对证据质量进行评估。我们进行了系统的经济文献综述，并从公共支付方的角度对减肥手术与非手术常规护理进行了终生成本效用分析。我们还分析了安大略省政府资助 I 级肥胖症和难以控制的 2 型糖尿病成人减肥手术对预算的影响。为了了解减肥手术的潜在价值，我们与已经接受或正在考虑接受减肥手术的肥胖症和 2 型糖尿病患者进行了交谈：我们在临床证据审查中纳入了 14 项研究。与药物治疗相比，减肥手术可大幅提高糖尿病缓解率（GRADE：低至极低），并显著降低体重指数（GRADE：低至极低）。与药物治疗相比，减肥手术还可减少 2 型糖尿病药物的使用（评估等级：低），并可改善 I 级肥胖和难以控制的 2 型糖尿病患者的生活质量（评估等级：低）。(等级评定：低）我们的经济学证据综述包括 5 项成本效益研究；其中没有一项是在加拿大环境下进行的，4 项研究被认为部分适用于我们的研究问题。大多数研究发现，对于 I 级肥胖和 2 型糖尿病患者，减肥手术与标准护理相比具有成本效益；但是，由于临床实践、资源利用和单位成本方面的潜在差异，这些研究结果是否适用于安大略省的情况尚不确定。我们的主要经济评估发现，在终生范围内，减肥手术的成本更高（增量成本：每人 8,151 美元），但也比目前的常规护理更有效（导致每人获得 0.339 质量调整生命年[QALY]）。成本增加的原因是与手术（术前、术后和术中）相关的费用，而质量调整生命年的增加则是由于获得的生命年数。结果对减肥手术的成本以及减肥手术在减轻体重和缓解糖尿病方面的长期益处的假设很敏感。与我们交谈过的肥胖症和 2 型糖尿病患者表示，减肥手术通常被视为一种积极的治疗选择，接受过手术的患者也对其作为控制体重和糖尿病的治疗方法的价值给予了肯定：结论：对于患有一级肥胖症和难以控制的 2 型糖尿病的成年人来说，减肥手术可能比药物治疗更有临床效果和成本效益。与内科治疗相比，对 I 级肥胖和难以控制的 2 型糖尿病患者实施减肥手术可大幅提高糖尿病缓解率，大幅降低体重指数，减少 2 型糖尿病药物使用，改善生活质量。在终生范围内，减肥手术会导致成本增加和 QALY 增加。减肥手术会导致术后并发症，而接受内科治疗的患者则不会出现这些并发症。减肥手术的成本效益取决于其对肥胖相关并发症和糖尿病相关并发症的长期影响，而这可能是不确定的。
{"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}
Background: 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.
Methods: 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.
Results: 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
{"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}
Background: 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 hysterectomy (RH) for the treatment of endometrial cancer in people with obesity. Our assessment included an evaluation of the effectiveness, safety, and cost-effectiveness of RH, as well as the 5-year budget impact for the Ontario Ministry of Health of publicly funding RH. It also looked at the experiences, preferences, and values of people with endometrial cancer and obesity, as well as those of health care professionals who provide surgical treatment for endometrial cancer.
Methods: We performed a systematic literature search of the clinical evidence to identify systematic reviews and randomized controlled trials relevant to our research question. We reported the risk of bias from the 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. We also analyzed the 5-year budget impact of publicly funding RH (including total, partial, and radical procedures) for people with endometrial cancer and obesity in Ontario. To contextualize the potential value of RH for people with endometrial cancer and obesity, we spoke with people with lived experience of endometrial cancer and obesity who had undergone minimally invasive surgery (either laparoscopic hysterectomy [LH] or RH), and we spoke with gynecological cancer surgeons who perform hysterectomy.
Results: We included one systematic review in the clinical evidence review. An indirect comparison showed that conversion rates to open hysterectomy (OH) were similar for LH and RH in patients with a body mass index (BMI) ≥ 30 kg/m2 (6.5% vs. 5.5%, respectively) (GRADE: Very low). An indirect comparison within a subset of patients with a body mass index (BMI) ≥ 40 kg/m2 showed that a higher proportion of patients who underwent LH required conversion to OH compared with patients who underwent RH (7.0% vs. 3.8%, respectively) (GRADE: Very low). Rates of perioperative complications were similarly low for both LH and RH (≤ 3.5%) (GRADE: Very low). We identified two studies that met the inclusion criteria of our economic literature review. The included economic studies found RH to be more costly than OH or LH for endometrial cancer; however, because these studies were conducted in other countries, the results were not applicable to the Ontario context. Assuming a moderate increase in the volume of robotic-assisted surgeries, our reference case analysis showed that the 5-year budget impact of publicly funding RH for people with endometrial cancer
{"title":"Robotic-Assisted Hysterectomy for Endometrial Cancer in People With Obesity: 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 hysterectomy (RH) for the treatment of endometrial cancer in people with obesity. Our assessment included an evaluation of the effectiveness, safety, and cost-effectiveness of RH, as well as the 5-year budget impact for the Ontario Ministry of Health of publicly funding RH. It also looked at the experiences, preferences, and values of people with endometrial cancer and obesity, as well as those of health care professionals who provide surgical treatment for endometrial cancer.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence to identify systematic reviews and randomized controlled trials relevant to our research question. We reported the risk of bias from the 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. We also analyzed the 5-year budget impact of publicly funding RH (including total, partial, and radical procedures) for people with endometrial cancer and obesity in Ontario. To contextualize the potential value of RH for people with endometrial cancer and obesity, we spoke with people with lived experience of endometrial cancer and obesity who had undergone minimally invasive surgery (either laparoscopic hysterectomy [LH] or RH), and we spoke with gynecological cancer surgeons who perform hysterectomy.</p><p><strong>Results: </strong>We included one systematic review in the clinical evidence review. An indirect comparison showed that conversion rates to open hysterectomy (OH) were similar for LH and RH in patients with a body mass index (BMI) ≥ 30 kg/m<sup>2</sup> (6.5% vs. 5.5%, respectively) (GRADE: Very low). An indirect comparison within a subset of patients with a body mass index (BMI) ≥ 40 kg/m<sup>2</sup> showed that a higher proportion of patients who underwent LH required conversion to OH compared with patients who underwent RH (7.0% vs. 3.8%, respectively) (GRADE: Very low). Rates of perioperative complications were similarly low for both LH and RH (≤ 3.5%) (GRADE: Very low). We identified two studies that met the inclusion criteria of our economic literature review. The included economic studies found RH to be more costly than OH or LH for endometrial cancer; however, because these studies were conducted in other countries, the results were not applicable to the Ontario context. Assuming a moderate increase in the volume of robotic-assisted surgeries, our reference case analysis showed that the 5-year budget impact of publicly funding RH for people with endometrial cancer","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"23 6","pages":"1-70"},"PeriodicalIF":0.0,"publicationDate":"2023-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10656045/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138463205","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}
Background: We conducted a health technology assessment to evaluate the safety, effectiveness, and cost-effectiveness of carrier screening programs for cystic fibrosis (CF), fragile X syndrome (FXS), hemoglobinopathies and thalassemia, and spinal muscular atrophy (SMA) in people who are considering a pregnancy or who are pregnant. We also evaluated the budget impact of publicly funding carrier screening programs, and patient preferences and values.
Methods: 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 Risk of Bias Assessment tool for Non-randomized 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 conducted cost-effectiveness analyses comparing preconception or prenatal carrier screening programs to no screening. We considered four carrier screening strategies: 1) universal screening with standard panels; 2) universal screening with a hypothetical expanded panel; 3) risk-based screening with standard panels; and 4) risk-based screening with a hypothetical expanded panel. We also estimated the 5-year budget impact of publicly funding preconception or prenatal carrier screening programs for the given conditions in Ontario. To contextualize the potential value of carrier screening, we spoke with 22 people who had sought out carrier screening.
Results: We included 107 studies in the clinical evidence review. Carrier screening for CF, hemoglobinopathies and thalassemia, FXS, and SMA likely results in the identification of couples with an increased chance of having an affected pregnancy (GRADE: Moderate). Screening likely impacts reproductive decision-making (GRADE: Moderate) and may result in lower anxiety among pregnant people, although the evidence is uncertain (GRADE: Very low).We included 21 studies in the economic evidence review, but none of the study findings were directly applicable to the Ontario context. Our cost-effectiveness analyses showed that in the short term, preconception or prenatal carrier screening programs identified more at-risk pregnancies (i.e., couples that tested positive) and provided more reproductive choice options compared with no screening, but were associated with higher costs. While all screening strategies had similar values for health outcomes, when comparing all strategies together, universal screening with standard panels was the most cost-effective strategy for both preconception and prenatal periods. The incremental cost-effectiveness ratios (ICERs) of universal screening with standard panels compared with no screening in the preconception period were $29,106 per additional at-risk pregnancy detected and $367,731 per affected birth averted; the corre
{"title":"Carrier Screening Programs for Cystic Fibrosis, Fragile X Syndrome, Hemoglobinopathies and Thalassemia, and Spinal Muscular Atrophy: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>We conducted a health technology assessment to evaluate the safety, effectiveness, and cost-effectiveness of carrier screening programs for cystic fibrosis (CF), fragile X syndrome (FXS), hemoglobinopathies and thalassemia, and spinal muscular atrophy (SMA) in people who are considering a pregnancy or who are pregnant. We also evaluated the budget impact of publicly funding carrier screening programs, 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 Risk of Bias Assessment tool for Non-randomized 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 conducted cost-effectiveness analyses comparing preconception or prenatal carrier screening programs to no screening. We considered four carrier screening strategies: 1) universal screening with standard panels; 2) universal screening with a hypothetical expanded panel; 3) risk-based screening with standard panels; and 4) risk-based screening with a hypothetical expanded panel. We also estimated the 5-year budget impact of publicly funding preconception or prenatal carrier screening programs for the given conditions in Ontario. To contextualize the potential value of carrier screening, we spoke with 22 people who had sought out carrier screening.</p><p><strong>Results: </strong>We included 107 studies in the clinical evidence review. Carrier screening for CF, hemoglobinopathies and thalassemia, FXS, and SMA likely results in the identification of couples with an increased chance of having an affected pregnancy (GRADE: Moderate). Screening likely impacts reproductive decision-making (GRADE: Moderate) and may result in lower anxiety among pregnant people, although the evidence is uncertain (GRADE: Very low).We included 21 studies in the economic evidence review, but none of the study findings were directly applicable to the Ontario context. Our cost-effectiveness analyses showed that in the short term, preconception or prenatal carrier screening programs identified more at-risk pregnancies (i.e., couples that tested positive) and provided more reproductive choice options compared with no screening, but were associated with higher costs. While all screening strategies had similar values for health outcomes, when comparing all strategies together, universal screening with standard panels was the most cost-effective strategy for both preconception and prenatal periods. The incremental cost-effectiveness ratios (ICERs) of universal screening with standard panels compared with no screening in the preconception period were $29,106 per additional at-risk pregnancy detected and $367,731 per affected birth averted; the corre","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"23 4","pages":"1-398"},"PeriodicalIF":0.0,"publicationDate":"2023-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10453298/pdf/ohtas-23-4.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41215367","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}
<p><strong>Background: </strong>Pre-eclampsia is a potentially serious condition affecting up to 5% of pregnancies, most frequently after 20 weeks' gestation. Placental growth factor (PlGF)-based tests measure either the blood level of PlGF or the ratio of soluble fms-like tyrosine kinase-1 (sFlt-1) to PlGF. They are intended to complement standard clinical assessment to help diagnose pre-eclampsia in people with suspected pre-eclampsia. We conducted a health technology assessment of PlGF-based biomarker testing as an adjunct to standard clinical assessment to help diagnose pre-eclampsia in pregnant people with suspected pre-eclampsia, which included an evaluation of diagnostic accuracy, clinical utility, cost-effectiveness, the budget impact of publicly funding PlGF-based biomarker testing, and an assessment of 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 AMSTAR 2, Cochrane Risk of Bias tool, the Quality of Diagnostic Accuracy Studies 2 (QUADAS-2) 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 literature search of the economic evidence. We did not conduct a primary economic evaluation as the impact of the test on maternal and neonatal outcomes is uncertain. We also analyzed the budget impact of publicly funding PlGF-based biomarker testing in pregnant people with suspected pre-eclampsia in Ontario. To contextualize the potential value of PlGF-based biomarker testing, we spoke with people whose pregnancies had been impacted by pre-eclampsia as well as their family members.</p><p><strong>Results: </strong>We included one systematic review and one diagnostic accuracy study in the clinical evidence review. The Elecsys sFlt-1/PlGF ratio test using a test cut-off of less than 38 for ruling out pre-eclampsia within 1 week yielded a negative predictive value (NPV) of 99.2% and the DELFIA Xpress PlGF 1-2-3 test using a cut-off of 150 pg/mL or greater for ruling out pre-eclampsia within 1 week yielded a NPV of 94.8% (diagnostic GRADE: Moderate for both tests). All clinical utility outcomes were associated with uncertainties (GRADE: Low).We included 13 studies in the economic evidence review, most of which concluded that the use of PlGF-based biomarker testing resulted in cost savings. Seven studies were partially applicable to the Ontario health care setting but have some important limitations; the remaining 6 studies were not applicable. We estimated that publicly funding PlGF-based biomarker testing for people with suspected pre-eclampsia in Ontario would lead to an additional annual cost of $0.27 million in year 1 to $0.46 million in year 5, for a total additional cost of $1.83 million over 5 years.Direct engagement included 24 people who had been impacted by pre-eclampsia duri
{"title":"Placental Growth Factor (PlGF)- Based Biomarker Testing to Help Diagnose Pre-eclampsia in People With Suspected Pre-eclampsia: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Pre-eclampsia is a potentially serious condition affecting up to 5% of pregnancies, most frequently after 20 weeks' gestation. Placental growth factor (PlGF)-based tests measure either the blood level of PlGF or the ratio of soluble fms-like tyrosine kinase-1 (sFlt-1) to PlGF. They are intended to complement standard clinical assessment to help diagnose pre-eclampsia in people with suspected pre-eclampsia. We conducted a health technology assessment of PlGF-based biomarker testing as an adjunct to standard clinical assessment to help diagnose pre-eclampsia in pregnant people with suspected pre-eclampsia, which included an evaluation of diagnostic accuracy, clinical utility, cost-effectiveness, the budget impact of publicly funding PlGF-based biomarker testing, and an assessment of 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 AMSTAR 2, Cochrane Risk of Bias tool, the Quality of Diagnostic Accuracy Studies 2 (QUADAS-2) 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 literature search of the economic evidence. We did not conduct a primary economic evaluation as the impact of the test on maternal and neonatal outcomes is uncertain. We also analyzed the budget impact of publicly funding PlGF-based biomarker testing in pregnant people with suspected pre-eclampsia in Ontario. To contextualize the potential value of PlGF-based biomarker testing, we spoke with people whose pregnancies had been impacted by pre-eclampsia as well as their family members.</p><p><strong>Results: </strong>We included one systematic review and one diagnostic accuracy study in the clinical evidence review. The Elecsys sFlt-1/PlGF ratio test using a test cut-off of less than 38 for ruling out pre-eclampsia within 1 week yielded a negative predictive value (NPV) of 99.2% and the DELFIA Xpress PlGF 1-2-3 test using a cut-off of 150 pg/mL or greater for ruling out pre-eclampsia within 1 week yielded a NPV of 94.8% (diagnostic GRADE: Moderate for both tests). All clinical utility outcomes were associated with uncertainties (GRADE: Low).We included 13 studies in the economic evidence review, most of which concluded that the use of PlGF-based biomarker testing resulted in cost savings. Seven studies were partially applicable to the Ontario health care setting but have some important limitations; the remaining 6 studies were not applicable. We estimated that publicly funding PlGF-based biomarker testing for people with suspected pre-eclampsia in Ontario would lead to an additional annual cost of $0.27 million in year 1 to $0.46 million in year 5, for a total additional cost of $1.83 million over 5 years.Direct engagement included 24 people who had been impacted by pre-eclampsia duri","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"23 3","pages":"1-146"},"PeriodicalIF":0.0,"publicationDate":"2023-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10241193/pdf/ohtas-23-3.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9967354","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}
<p><strong>Background: </strong>The current standard treatment for nonpalpable breast tumours is surgical excision; however, it is nearly impossible to locate these small masses during surgery. Therefore, a marker must be implanted into the abnormal tissue under mammography or ultrasound guidance prior to surgery to guide the surgeon to the location of the tumour. Two techniques to localize nonpalpable breast tumours are currently used in Ontario: wire-guided localization and radioactive seed localization.However, these techniques have some limitations. New wire-free, nonradioactive technologies that address these limitations are now available. We conducted a health technology assessment of wire-free, nonradioactive localization techniques available in Canada that are used to localize nonpalpable breast tumours for surgical excision. This report includes an evaluation of the effectiveness, safety, and budget impact of publicly funding these techniques, as well as an evaluation 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 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 systematic economic literature search, and we analyzed the budget impact of publicly funding wire-free, nonradioactive localization techniques to guide surgical excision of nonpalpable breast tumours in Ontario. We did not conduct a primary economic evaluation because of the limited data available to use as model inputs. To contextualize the potential value of wire-free, nonradioactive localization techniques, we spoke with people who had undergone a localization procedure for the surgical excision of a nonpalpable breast tumour.</p><p><strong>Results: </strong>We included 16 studies in the clinical evidence review, of which 15 were comparative studies and one was a single-arm study. The results of our analysis of the comparative studies suggest that the re-excision rate for the wire-guided, nonradioactive devices included in this review is either lower or not different from the rate for conventional localization methods (GRADE: Moderate/Low). We found no difference in postoperative complications or operation time between the new and the conventional techniques (GRADE: Moderate). In a feasibility study of a newly developed magnetic seed device in Ontario, no patient required re-excision (GRADE: not assessed). Our economic evidence review identified two costing studies that found that wire-free, nonradioactive localization techniques were more expensive than wire-guided and radioactive seed localization. We were unable to identify any published cost-effectiveness evidence for wire-free, nonradioactive localization techniques. The annual budget impact of publicly funding wire-free, nonradioactive lo
{"title":"Wire-Free, Nonradioactive Localization Techniques to Guide Surgical Excision of Nonpalpable Breast Tumours: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>The current standard treatment for nonpalpable breast tumours is surgical excision; however, it is nearly impossible to locate these small masses during surgery. Therefore, a marker must be implanted into the abnormal tissue under mammography or ultrasound guidance prior to surgery to guide the surgeon to the location of the tumour. Two techniques to localize nonpalpable breast tumours are currently used in Ontario: wire-guided localization and radioactive seed localization.However, these techniques have some limitations. New wire-free, nonradioactive technologies that address these limitations are now available. We conducted a health technology assessment of wire-free, nonradioactive localization techniques available in Canada that are used to localize nonpalpable breast tumours for surgical excision. This report includes an evaluation of the effectiveness, safety, and budget impact of publicly funding these techniques, as well as an evaluation 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 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 systematic economic literature search, and we analyzed the budget impact of publicly funding wire-free, nonradioactive localization techniques to guide surgical excision of nonpalpable breast tumours in Ontario. We did not conduct a primary economic evaluation because of the limited data available to use as model inputs. To contextualize the potential value of wire-free, nonradioactive localization techniques, we spoke with people who had undergone a localization procedure for the surgical excision of a nonpalpable breast tumour.</p><p><strong>Results: </strong>We included 16 studies in the clinical evidence review, of which 15 were comparative studies and one was a single-arm study. The results of our analysis of the comparative studies suggest that the re-excision rate for the wire-guided, nonradioactive devices included in this review is either lower or not different from the rate for conventional localization methods (GRADE: Moderate/Low). We found no difference in postoperative complications or operation time between the new and the conventional techniques (GRADE: Moderate). In a feasibility study of a newly developed magnetic seed device in Ontario, no patient required re-excision (GRADE: not assessed). Our economic evidence review identified two costing studies that found that wire-free, nonradioactive localization techniques were more expensive than wire-guided and radioactive seed localization. We were unable to identify any published cost-effectiveness evidence for wire-free, nonradioactive localization techniques. The annual budget impact of publicly funding wire-free, nonradioactive lo","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"23 2","pages":"1-139"},"PeriodicalIF":0.0,"publicationDate":"2023-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10241192/pdf/ohtas-23-2.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9967353","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}
<p><strong>Background: </strong>A blockage to the blood vessels in the lower extremities may cause pain and discomfort. If left unmanaged, it may lead to amputation or chronic disability, such as in the form of post-thrombotic syndrome. We conducted a health technology assessment of mechanical thrombectomy (MT) devices, which are proposed to remove a blood clot, which may form in the arteries or veins of the lower legs. This evaluation considered blockages in the veins and arteries separately, and included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding MT for lower limb blockages, patient preferences and values, and clinical and health system stakeholders' perspectives.</p><p><strong>Method: </strong>We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane tool for randomized controlled trials or the risk of bias among non-randomized studies (RoBANS) tool for nonrandomized 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. We did not conduct a primary economic evaluation since the clinical evidence is highly uncertain. We also analyzed the budget impact of publicly funding MT treatment for inpatients with arterial acute limb ischemia and acute deep vein thrombosis (DVT) in the lower limb in Ontario. To contextualize the potential value of MT, we spoke with people with acute DVT. To understand the barriers and facilitators of accessing MT, we surveyed clinical and health system stakeholders to gain their perspectives.</p><p><strong>Results: </strong>We included 40 studies (3 randomized controlled trials and 37 observational studies) in the clinical evidence review. For patients who experience arterial acute limb ischemia, compared with catheter-directed thrombolysis (CDT) alone, MT has greater technical success and patency and reduced hospital length of stay, but the evidence for these outcomes is uncertain (GRADE: Very low). Mechanical thrombectomy may reduce the volume of thrombolytic medication required and CDT infusion time (a determinant for intensive care unit [ICU] need) in patients experiencing acute DVT, but it is uncertain if this is to a meaningful degree (GRADE: Moderate to Very low). It may also reduce the proportion of people who experience post-thrombotic syndrome and overall hospital length of stay, but it is uncertain (GRADE: Very low).We estimated that publicly funding MT for people with arterial acute limb ischemia in Ontario would lead to an annual cost savings of $0.17 million in year 1 to $0.14 million in year 5, for a total savings of $0.83 million over 5 years. This cost savings was mainly attributed to reduced ICU stays among people who received MT, but the results had considerable uncertainty. For the population with acute D
{"title":"Mechanical Thrombectomy for Acute and Subacute Blocked Arteries and Veins in the Lower Limbs: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>A blockage to the blood vessels in the lower extremities may cause pain and discomfort. If left unmanaged, it may lead to amputation or chronic disability, such as in the form of post-thrombotic syndrome. We conducted a health technology assessment of mechanical thrombectomy (MT) devices, which are proposed to remove a blood clot, which may form in the arteries or veins of the lower legs. This evaluation considered blockages in the veins and arteries separately, and included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding MT for lower limb blockages, patient preferences and values, and clinical and health system stakeholders' perspectives.</p><p><strong>Method: </strong>We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane tool for randomized controlled trials or the risk of bias among non-randomized studies (RoBANS) tool for nonrandomized 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. We did not conduct a primary economic evaluation since the clinical evidence is highly uncertain. We also analyzed the budget impact of publicly funding MT treatment for inpatients with arterial acute limb ischemia and acute deep vein thrombosis (DVT) in the lower limb in Ontario. To contextualize the potential value of MT, we spoke with people with acute DVT. To understand the barriers and facilitators of accessing MT, we surveyed clinical and health system stakeholders to gain their perspectives.</p><p><strong>Results: </strong>We included 40 studies (3 randomized controlled trials and 37 observational studies) in the clinical evidence review. For patients who experience arterial acute limb ischemia, compared with catheter-directed thrombolysis (CDT) alone, MT has greater technical success and patency and reduced hospital length of stay, but the evidence for these outcomes is uncertain (GRADE: Very low). Mechanical thrombectomy may reduce the volume of thrombolytic medication required and CDT infusion time (a determinant for intensive care unit [ICU] need) in patients experiencing acute DVT, but it is uncertain if this is to a meaningful degree (GRADE: Moderate to Very low). It may also reduce the proportion of people who experience post-thrombotic syndrome and overall hospital length of stay, but it is uncertain (GRADE: Very low).We estimated that publicly funding MT for people with arterial acute limb ischemia in Ontario would lead to an annual cost savings of $0.17 million in year 1 to $0.14 million in year 5, for a total savings of $0.83 million over 5 years. This cost savings was mainly attributed to reduced ICU stays among people who received MT, but the results had considerable uncertainty. For the population with acute D","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"23 1","pages":"1-244"},"PeriodicalIF":0.0,"publicationDate":"2023-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9899119/pdf/ohtas-23-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10774655","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}
Background: Ovarian cancer affects the cells of the ovaries, and epithelial cancer is the most common type of malignant ovarian cancer. The homologous recombination repair pathway enables error-free repair of DNA double-strand breaks. Damage of key genes associated with this pathway leads to homologous recombination deficiency (HRD), which results in unrepaired DNA and can lead to cancer. Tumours with HRD are believed to be sensitive to treatment with poly-adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors, such as niraparib. We conducted a health technology assessment to evaluate the clinical utility and cost-effectiveness of HRD testing to inform patient decisions about the use of niraparib maintenance therapy for patients with high-grade serous or endometrioid epithelial ovarian cancer. We also evaluated the efficacy and safety of niraparib maintenance therapy in patients with HRD or homologous recombination proficiency (HRP), the cost-effectiveness of HRD testing, the budget impact of publicly funding HRD testing, and patient preferences and values.
Methods: 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 version 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 conducted a cost-utility analysis with a 5-year time horizon from a public payer perspective. We also analyzed the budget impact of publicly funding HRD testing in people with ovarian cancer in Ontario. We performed a literature search for quantitative evidence of patient and provider preferences with respect to HRD testing and maintenance therapy with PARP inhibitors. To contextualize the potential value of HRD testing, we spoke with people with ovarian cancer.
Results: The clinical evidence review included two studies in high-grade epithelial ovarian cancer (one in patients with newly diagnosed advanced cases and one in patients with recurrent cancer). The studies evaluated niraparib maintenance therapy compared with no maintenance therapy and used HRD testing to group patients according to HRD status. Compared to placebo, niraparib maintenance therapy improved progression-free survival in patients with newly diagnosed and recurrent ovarian cancer, and in tumours with HRD or HRP (GRADE: High), but the studies did not compare the results between the HRD and HRP groups. The frequency of adverse events was higher in the niraparib group. We identified no studies that evaluated the clinical utility of HRD testing.We conducted a primary economic evaluation to evaluate the cost-effectiveness of HRD testing for people with newly diagnosed ovarian cancer in an Ontario setting. Our analysis used a 5-year time horizon. HRD
{"title":"Homologous Recombination Deficiency Testing to Inform Patient Decisions About Niraparib Maintenance Therapy for High-Grade Serous or Endometrioid Epithelial Ovarian Cancer: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Ovarian cancer affects the cells of the ovaries, and epithelial cancer is the most common type of malignant ovarian cancer. The homologous recombination repair pathway enables error-free repair of DNA double-strand breaks. Damage of key genes associated with this pathway leads to homologous recombination deficiency (HRD), which results in unrepaired DNA and can lead to cancer. Tumours with HRD are believed to be sensitive to treatment with poly-adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors, such as niraparib. We conducted a health technology assessment to evaluate the clinical utility and cost-effectiveness of HRD testing to inform patient decisions about the use of niraparib maintenance therapy for patients with high-grade serous or endometrioid epithelial ovarian cancer. We also evaluated the efficacy and safety of niraparib maintenance therapy in patients with HRD or homologous recombination proficiency (HRP), the cost-effectiveness of HRD testing, the budget impact of publicly funding HRD 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 Cochrane risk-of-bias tool for randomized trials version 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 conducted a cost-utility analysis with a 5-year time horizon from a public payer perspective. We also analyzed the budget impact of publicly funding HRD testing in people with ovarian cancer in Ontario. We performed a literature search for quantitative evidence of patient and provider preferences with respect to HRD testing and maintenance therapy with PARP inhibitors. To contextualize the potential value of HRD testing, we spoke with people with ovarian cancer.</p><p><strong>Results: </strong>The clinical evidence review included two studies in high-grade epithelial ovarian cancer (one in patients with newly diagnosed advanced cases and one in patients with recurrent cancer). The studies evaluated niraparib maintenance therapy compared with no maintenance therapy and used HRD testing to group patients according to HRD status. Compared to placebo, niraparib maintenance therapy improved progression-free survival in patients with newly diagnosed and recurrent ovarian cancer, and in tumours with HRD or HRP (GRADE: High), but the studies did not compare the results between the HRD and HRP groups. The frequency of adverse events was higher in the niraparib group. We identified no studies that evaluated the clinical utility of HRD testing.We conducted a primary economic evaluation to evaluate the cost-effectiveness of HRD testing for people with newly diagnosed ovarian cancer in an Ontario setting. Our analysis used a 5-year time horizon. HRD","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"23 5","pages":"1-188"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10453205/pdf/ohtas-23-5.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10164509","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}
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