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Hepatitis C Screening: A Health Technology Assessment. 丙型肝炎筛查:卫生技术评估。
Q1 Medicine Pub Date : 2026-01-20 eCollection Date: 2026-01-01
<p><strong>Background: </strong>Hepatitis C virus (HCV) infection causes liver inflammation that, if left untreated, can lead to scarring of the liver (cirrhosis), liver failure, liver cancer (hepatocellular carcinoma [HCC]), and death. For most people, this process usually progresses slowly, over 10 to 20 years or more, during which time the person may remain asymptomatic despite the ongoing process of liver damage. HCV screening aims to identify people with an HCV infection so that they can be linked to care and treatment. We conducted a health technology assessment of (1) one-time HCV screening for all adults in addition to risk-based HCV screening and (2) one-time HCV screening for people born between 1945 and 1975 (1945-1975 birth cohort) in addition to risk-based HCV screening, compared with risk-based HCV screening alone. This included an evaluation of effectiveness, cost-effectiveness, the budget impact of publicly funding onetime HCV screening in those populations, and patient preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Risk of Bias in Nonrandomized Studies - of Interventions (ROBINS-I) tool and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a literature search of the quantitative evidence on the preferences for HCV screening of the adult population and health care providers. We performed a systematic economic literature search and conducted a cost-utility analysis with a lifetime horizon from a public payer perspective to compare (1) one-time HCV screening for all adults plus risk-based HCV screening and (2) one-time HCV screening for the 1945-1975 birth cohort plus risk-based HCV screening, against risk-based HCV screening alone. We also analyzed the budget impact of publicly funding one-time HCV screening for all adults plus risk-based HCV screening and one-time HCV screening for the 1945-1975 birth cohort plus risk-based HCV screening in Ontario. We performed a literature search of the quantitative evidence on the preferences of adults and health care providers for HCV screening. To contextualize the potential value of expanding HCV screening, we spoke with people with HCV.</p><p><strong>Results: </strong>We included 3 observational studies in the clinical evidence review. The study findings suggest that one-time HCV screening for all adults plus risk-based HCV screening may identify more people with HCV and may result in more people with HCV linked to care compared with risk-based HCV screening alone (GRADE: Very low). No studies were identified for the assessment of one-time HCV screening for the 1945-1975 birth cohort or for the assessment of the quantitative preferences of adults and health care providers for HCV screening. One-time HCV screening for all adults plus risk-b
背景:丙型肝炎病毒(HCV)感染可引起肝脏炎症,如果不及时治疗,可导致肝脏瘢痕形成(肝硬化)、肝功能衰竭、肝癌(肝细胞癌[HCC])和死亡。对于大多数人来说,这一过程通常进展缓慢,需要10到20年或更长时间,在此期间,尽管肝损害正在进行,但患者可能没有症状。丙型肝炎病毒筛查的目的是确定丙型肝炎病毒感染者,以便将他们与护理和治疗联系起来。我们进行了一项健康技术评估:(1)除基于风险的HCV筛查外,对所有成年人进行一次性HCV筛查;(2)除基于风险的HCV筛查外,对1945-1975年出生的人(1945-1975年出生队列)进行一次性HCV筛查,与仅进行基于风险的HCV筛查进行比较。这包括对这些人群中一次性丙型肝炎筛查的有效性、成本效益、公共资助的预算影响以及患者的偏好和价值观的评估。方法:对临床证据进行系统的文献检索。我们使用非随机干预研究的偏倚风险(ROBINS-I)工具评估了每个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体的质量。我们对成人和卫生保健提供者对HCV筛查偏好的定量证据进行了文献检索。我们进行了系统的经济文献检索,并从公共付款人的角度进行了终身成本效用分析,以比较(1)所有成年人一次性丙型肝炎筛查加基于风险的丙型肝炎筛查和(2)1945-1975年出生队列一次性丙型肝炎筛查加基于风险的丙型肝炎筛查与单独基于风险的丙型肝炎筛查。我们还分析了安大略省所有成人一次性丙型肝炎筛查加基于风险的丙型肝炎筛查和1945-1975年出生队列一次性丙型肝炎筛查加基于风险的丙型肝炎筛查对预算的影响。我们对成人和卫生保健提供者对HCV筛查偏好的定量证据进行了文献检索。为了了解扩大HCV筛查的潜在价值,我们与HCV患者进行了交谈。结果:我们在临床证据综述中纳入了3项观察性研究。研究结果表明,与单独进行基于风险的HCV筛查相比,对所有成年人进行一次性HCV筛查加上基于风险的HCV筛查可能会发现更多的HCV患者,并可能导致更多的HCV患者与护理相关(GRADE: Very low)。未发现有研究评估1945-1975年出生队列的一次性丙型肝炎筛查,或评估成人和卫生保健提供者对丙型肝炎筛查的定量偏好。对所有成年人进行一次性丙型肝炎筛查加基于风险的丙型肝炎筛查,以及对1945-1975年出生队列进行一次性丙型肝炎筛查加基于风险的丙型肝炎筛查,比单独进行基于风险的丙型肝炎筛查成本更低,效果更好。对所有成年人进行一次性丙型肝炎筛查加基于风险的丙型肝炎筛查,以及对1945-1975年出生队列进行一次性丙型肝炎筛查加基于风险的丙型肝炎筛查,与单独进行基于风险的丙型肝炎筛查相比,在每个质量调整生命年(QALY)获得5万美元的支付意愿下,其成本效益为100%;在每个QALY获得10万美元的支付意愿下,其成本效益为100%。在未来5年内,安大略省所有成年人一次性丙型肝炎筛查加上基于风险的丙型肝炎筛查的公共资助的年度预算影响范围从第一年的额外2200万美元到第五年的1400万美元不等。公共资助1945-1975年出生队列的一次性丙型肝炎筛查加上安大略省未来5年基于风险的丙型肝炎筛查的年度预算影响从第一年的额外900万美元到第五年的100万美元不等。与我们交谈的丙型肝炎病毒感染者报告说,丙型肝炎病毒对他们的健康和社会福祉产生了负面影响,他们强调了与感染相关的耻辱造成的情绪困扰。结论:与单独进行基于风险的HCV筛查相比,对所有成年人进行一次性HCV筛查加上基于风险的筛查可能会发现更多的HCV患者,并可能导致更多的HCV患者与护理相关,但由于研究结果在安大略省背景下的普遍性,证据非常不确定。对所有成年人进行一次性丙型肝炎筛查加基于风险的筛查,以及对1945-1975年出生队列进行一次性丙型肝炎筛查加基于风险的筛查,都比单独进行基于风险的丙型肝炎筛查成本更低,效果更好。 我们估计,公共资助所有成年人一次性丙型肝炎筛查加上基于风险的筛查,以及安大略省1945-1975年出生队列一次性丙型肝炎筛查加上基于风险的筛查,将在未来5年内分别产生1.11亿美元和3200万美元的额外费用。丙型肝炎患者强调需要将丙型肝炎筛查扩大到传统定义的高危人群之外,以实现早期诊断和治疗。
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引用次数: 0
Renal Denervation for Uncontrolled Hypertension: A Health Technology Assessment. 未控制高血压的肾去神经:一项健康技术评估。
Q1 Medicine Pub Date : 2026-01-20 eCollection Date: 2026-01-01
<p><strong>Background: </strong>When blood pressure remains elevated despite treatment, a person is considered to have uncontrolled hypertension, which increases the risk of serious health outcomes (e.g., cardiovascular disease, stroke, kidney failure, and death) over time. Renal denervation, a minimally invasive procedure targeting sympathetic nerves in the wall of renal arteries, has emerged as a promising adjunctive treatment to standard care (e.g., health behaviour modifications and antihypertensive medications). We conducted a health technology assessment of renal denervation for adults with uncontrolled hypertension, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding renal denervation, and patient and provider preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included systematic review using the Risk of Bias in Systematic Reviews (ROBIS) tool. We performed a systematic economic literature search and conducted a cost-utility analysis with a lifetime horizon from a public payer perspective. We also analyzed the budget impact of publicly funding renal denervation in adults with uncontrolled hypertension in Ontario. To contextualize the potential value of renal denervation, we conducted a review of the quantitative evidence of patient and provider preferences and values, and we spoke with people with hypertension.</p><p><strong>Results: </strong>We included 10 systematic reviews of randomized controlled trials in our clinical evidence review, all of which showed that renal denervation statistically significantly lowered systolic blood pressure more than standard care (by a mean of 2.1-6.3 mmHg), regardless of the type of renal denervation system used, the blood pressure end points assessed, and whether people were taking antihypertensive medications at the time of the procedure. Renal denervation in addition to standard care is more effective and more expensive than standard care alone. The incremental cost-effectiveness ratio of renal denervation in addition to standard care compared with standard care alone is $121,237 per quality-adjusted life-year (QALY) gained over a lifetime horizon. The probability of renal denervation in addition to standard care being cost-effective versus standard care alone is 0% at a willingness-to-pay (WTP) of $50,000 per QALY gained, 18.02% at a WTP of $100,000 per QALY gained, and 80.50% at a WTP of $150,000 per QALY gained. The cost-effectiveness results were sensitive to changes in time horizon, assumptions about the duration of treatment effect, and the cost of the renal denervation procedure (including the cost of the renal denervation system). The annual budget impact of publicly funding renal denervation for adults with uncontrolled hypertension in Ontario over the next 5 years ranges from an additional $0.42 million in year 1 to an ad
背景:当治疗后血压仍然升高时,一个人被认为患有未控制的高血压,随着时间的推移,这增加了严重健康后果(如心血管疾病、中风、肾衰竭和死亡)的风险。肾去神经是一种针对肾动脉壁交感神经的微创手术,已成为标准护理(例如,健康行为改变和抗高血压药物)的一种有希望的辅助治疗方法。我们对未控制的高血压成人进行了肾去神经治疗的健康技术评估,包括对有效性、安全性、成本效益、公共资助肾去神经治疗的预算影响以及患者和提供者的偏好和价值观的评估。方法:对临床证据进行系统的文献检索。我们使用系统评价中的偏倚风险(ROBIS)工具评估每个纳入的系统评价的偏倚风险。我们进行了系统的经济文献检索,并从公共付款人的角度进行了终身成本效用分析。我们还分析了安大略省对未控制的高血压成人进行肾去神经支配的公共资助对预算的影响。为了了解肾去神经支配的潜在价值,我们对患者和提供者偏好和价值的定量证据进行了回顾,并与高血压患者进行了交谈。结果:在我们的临床证据回顾中,我们纳入了10项随机对照试验的系统回顾,所有这些研究都表明,与标准治疗相比,肾去神经支配能显著降低收缩压(平均降低2.1-6.3 mmHg),与使用何种肾去神经支配系统、评估的血压终点以及患者在手术时是否服用降压药物无关。除标准治疗外的肾去神经治疗比单独的标准治疗更有效,也更昂贵。与单独标准治疗相比,除标准治疗外的肾去神经治疗的增量成本-效果比在一生中每个质量调整生命年(QALY)获得121,237美元。在每个QALY获得5万美元的支付意愿(WTP)时,除标准护理外的肾去神经治疗与单独的标准护理相比具有成本效益的可能性为0%,在每个QALY获得10万美元的支付意愿(WTP)时为18.02%,在每个QALY获得15万美元的支付意愿时为80.50%。成本-效果结果对时间范围的变化、治疗效果持续时间的假设以及肾去神经支配手术的成本(包括肾去神经支配系统的成本)很敏感。在安大略省,未来5年,公共资助的成人无控制高血压肾去神经治疗的年度预算影响从第一年的42万美元到第五年的378万美元不等。我们对患者和提供者偏好和价值观的定量证据进行了回顾,发现大约30%的患者更喜欢肾去神经支配而不是药物治疗,年轻人和药物依从性差的患者更倾向于这种治疗。所有的访谈参与者都表达了对肾去神经的积极看法。与没有接受手术的人相比,接受手术的人血压更低,看医生的次数更少,心态更平静,有些人还报告说减少了药物治疗。其他人报告说,如果在其他治疗失败后,医生建议他们接受肾去神经支配。获得肾去神经支配的障碍包括对手术的认识有限和地理上的限制。结论:在我们的综述中,我们发现肾去神经治疗比标准治疗更能降低未控制高血压的成人血压,包括难治性高血压。在纳入的综述中,两组之间的安全结局或不良事件没有统计学上的显著差异。除标准治疗外的肾去神经治疗比单独的标准治疗更有效,也更昂贵。我们估计,在未来5年内,安大略省对未控制的高血压成人进行肾去神经治疗的公共资助将导致每年额外的费用在42万至378万美元之间。我们回顾了患者和提供者偏好和价值观的定量证据,以及我们直接的患者参与研究结果,强调肾去神经支配是成人高血压不受控制的潜在治疗选择。我们采访的所有人都认为肾去神经支配是有利的,特别是当其他治疗失败时。
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引用次数: 0
DNA Methylation-Based Classification for Central Nervous System Tumours: A Health Technology Assessment. 基于DNA甲基化的中枢神经系统肿瘤分类:一项健康技术评估。
Q1 Medicine Pub Date : 2025-11-06 eCollection Date: 2025-01-01
<p><strong>Background: </strong>Central nervous system (CNS) tumours occur when abnormal cells form in the tissues of the brain and/or spinal cord. Conventional testing for CNS tumour classification involves histopathological evaluation and molecular markers. More recently, DNA methylation-based classifier tests are being used as an adjunct tool in addition to conventional tests to help with CNS tumour classification. We conducted a health technology assessment of DNA methylation-based classifier tests for CNS tumours, which included an evaluation of effectiveness, cost-effectiveness, and budget impact of publicly funding DNA methylation-based classifier tests for CNS tumours. After considering the likely effects of testing on the patient experience, we determined not to perform an analysis of patient preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS) and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria.We performed a systematic economic literature search and developed a decision-analytic model to evaluate the cost-effectiveness of using DNA methylation-based classifier tests. We also analyzed the budget impact of publicly funding DNA methylation-based classifier tests. All costs were expressed in 2024 CAD.</p><p><strong>Results: </strong>We included 38 studies in the clinical evidence review. Compared with conventional testing alone, DNA methylation-based classifier tests are an adjunct tool that may improve CNS tumour classification (GRADE: Moderate). The tests may improve downstream patient outcomes, although the evidence is very uncertain (GRADE: Very low). Unclassifiable test results may increase time to treatment, but the evidence is very uncertain (GRADE: Very low).We did not identify any studies that met the inclusion criteria for our economic literature review. We estimated that there were about 716 patients with challenging diagnostic primary CNS tumours in Ontario each year. The cost of clinical-based DNA methylation profiling for CNS tumours was $1,500 per patient. The annual incremental costs of second-tier DNA methylation classifier tests (after the use of conventional test) would be $1,074,738 for all challenging diagnostic cases, and DNA methylation-based classifier tests improved the diagnosis for 195 patients. The incremental cost-effectiveness ratio (ICER; i.e., the incremental cost per case with an improvement in primary CNS tumour classification) was $5,521. Scenario analyses showed that for children aged 0 to 14 years, the ICER was reduced to $2,683. Publicly funding second-tier DNA methylation-based classifier testing for challenging diagnostic cases of primary CNS tumours would result in a budget increase of about $1 million
背景:中枢神经系统(CNS)肿瘤发生于大脑和/或脊髓组织中异常细胞的形成。中枢神经系统肿瘤分类的常规检测包括组织病理学评估和分子标记。最近,基于DNA甲基化的分类器测试被用作常规测试之外的辅助工具,以帮助中枢神经系统肿瘤分类。我们对基于DNA甲基化的CNS肿瘤分类器测试进行了健康技术评估,包括评估有效性、成本效益和公共资助的基于DNA甲基化的CNS肿瘤分类器测试的预算影响。在考虑了测试对患者体验的可能影响后,我们决定不对患者的偏好和价值观进行分析。方法:对临床证据进行系统的文献检索。我们使用非随机研究偏倚风险评估工具(RoBANS)评估每个纳入研究的偏倚风险,并根据建议评估、发展和评价分级(GRADE)工作组标准评估证据体的质量。我们进行了系统的经济文献检索,并开发了一个决策分析模型来评估使用基于DNA甲基化的分类器测试的成本效益。我们还分析了公开资助基于DNA甲基化的分类器测试的预算影响。所有费用均以2024 CAD表示。结果:我们在临床证据综述中纳入了38项研究。与传统检测相比,基于DNA甲基化的分类器测试是一种辅助工具,可以改善中枢神经系统肿瘤的分类(GRADE: Moderate)。这些检测可能改善下游患者的预后,尽管证据非常不确定(GRADE: very low)。无法分类的检测结果可能会增加治疗时间,但证据非常不确定(GRADE: very low)。我们没有发现任何符合经济文献综述纳入标准的研究。我们估计安大略省每年约有716例具有挑战性诊断的原发性中枢神经系统肿瘤患者。中枢神经系统肿瘤的临床DNA甲基化分析费用为每位患者1500美元。对于所有具有挑战性的诊断病例,二级DNA甲基化分类器测试(在使用常规测试之后)的年增量成本将为1,074,738美元,基于DNA甲基化的分类器测试改善了195例患者的诊断。增量成本-效果比(ICER,即每例原发性中枢神经系统肿瘤分类改善的增量成本)为5,521美元。情景分析显示,0至14岁儿童的综合福利费用降至2,683美元。公开资助用于原发性中枢神经系统肿瘤挑战性诊断病例的基于DNA甲基化的二级分类器测试将导致每年预算增加约100万美元,在5年内测试3,600名患者的总额外成本约为540万美元。用于资助亚群体人群(如儿童、恶性肿瘤患者)的预算增加将较小。如果将基于DNA甲基化的分类器用作所有新诊断的原发性中枢神经系统肿瘤患者的一级检测,则每年的额外资金成本约为400万美元,在最初的5年期间,总计额外资金成本约为2100万美元。结论:与常规检测相比,基于DNA甲基化的分类器测试是一种辅助工具,可以改善中枢神经系统肿瘤的分类。鉴于没有经验的支付意愿阈值来改善原发性中枢神经系统肿瘤分类,基于DNA甲基化的分类器的成本效益无法确定。公开资助用于具有挑战性的原发性中枢神经系统肿瘤诊断的基于DNA甲基化的二级分类器测试将在5年内导致总预算增加约540万美元。公共资助DNA甲基化分类器作为所有新诊断的原发性中枢神经系统肿瘤患者的一级测试,将在未来5年内导致总预算增加约2100万美元。
{"title":"DNA Methylation-Based Classification for Central Nervous System Tumours: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Central nervous system (CNS) tumours occur when abnormal cells form in the tissues of the brain and/or spinal cord. Conventional testing for CNS tumour classification involves histopathological evaluation and molecular markers. More recently, DNA methylation-based classifier tests are being used as an adjunct tool in addition to conventional tests to help with CNS tumour classification. We conducted a health technology assessment of DNA methylation-based classifier tests for CNS tumours, which included an evaluation of effectiveness, cost-effectiveness, and budget impact of publicly funding DNA methylation-based classifier tests for CNS tumours. After considering the likely effects of testing on the patient experience, we determined not to perform an analysis of patient preferences and values.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS) and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria.We performed a systematic economic literature search and developed a decision-analytic model to evaluate the cost-effectiveness of using DNA methylation-based classifier tests. We also analyzed the budget impact of publicly funding DNA methylation-based classifier tests. All costs were expressed in 2024 CAD.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;We included 38 studies in the clinical evidence review. Compared with conventional testing alone, DNA methylation-based classifier tests are an adjunct tool that may improve CNS tumour classification (GRADE: Moderate). The tests may improve downstream patient outcomes, although the evidence is very uncertain (GRADE: Very low). Unclassifiable test results may increase time to treatment, but the evidence is very uncertain (GRADE: Very low).We did not identify any studies that met the inclusion criteria for our economic literature review. We estimated that there were about 716 patients with challenging diagnostic primary CNS tumours in Ontario each year. The cost of clinical-based DNA methylation profiling for CNS tumours was $1,500 per patient. The annual incremental costs of second-tier DNA methylation classifier tests (after the use of conventional test) would be $1,074,738 for all challenging diagnostic cases, and DNA methylation-based classifier tests improved the diagnosis for 195 patients. The incremental cost-effectiveness ratio (ICER; i.e., the incremental cost per case with an improvement in primary CNS tumour classification) was $5,521. Scenario analyses showed that for children aged 0 to 14 years, the ICER was reduced to $2,683. Publicly funding second-tier DNA methylation-based classifier testing for challenging diagnostic cases of primary CNS tumours would result in a budget increase of about $1 million ","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"25 5","pages":"1-93"},"PeriodicalIF":0.0,"publicationDate":"2025-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647934/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145640283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Home-Based Heated Humidified High-Flow Therapy for Respiratory Conditions: A Health Technology Assessment. 基于家庭的加热加湿高流量呼吸疾病疗法:健康技术评估。
Q1 Medicine Pub Date : 2025-11-06 eCollection Date: 2025-01-01
<p><strong>Background: </strong>Respiratory conditions encompass a wide range of disorders that affect the lungs and other parts of the respiratory system. These conditions vary greatly in severity and impact, from mild, transient issues to chronic, life-threatening diseases. Treatment options include medications, pulmonary rehabilitation, surgery, and respiratory therapies such as mechanical ventilation, continuous positive airway pressure, bilevel positive airway pressure, conventional oxygen therapies, and heated humidified high-flow therapy (HHHFT). We conducted a health technology assessment of home-based HHHFT for (1) children with pediatric obstructive sleep apnea (OSA) who cannot tolerate conventional respiratory therapies at home, and (2) adults and children hospitalized for respiratory conditions who will need treatment at home once they are discharged and who have no at-home alternatives that offer an equivalent level of support. This assessment included an evaluation of effectiveness, safety, the budget impact of publicly funding home-based HHHFT, and patient preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence of the effectiveness and safety of home-based HHHFT for the populations described above. We performed a systematic economic literature search, but we did not conduct a primary economic evaluation because of a lack of evidence. We analyzed the budget impact of publicly funding home-based HHHFT in children with pediatric OSA and in adults and children with other respiratory conditions in Ontario. To contextualize the potential value of home-based HHHFT, we aimed to speak with adults and care partners of children in Ontario who had lived experience of respiratory conditions, including those with and without direct experience of HHHFT.</p><p><strong>Results: </strong>We did not identify any studies that met the eligibility criteria for our clinical evidence review. The estimated annual budget impact of publicly funding home-based HHHFT in Ontario over the next 5 years ranges from cost savings of $185,981 for children with pediatric OSA to an additional $2.5 million for adults and children with other respiratory conditions. We estimate that publicly funding home-based HHHFT would result in 99 fewer inpatient visits and 127 fewer outpatient visits related to pediatric OSA. It would also result in 653 inpatient days avoided for adults and children with other respiratory conditions. Due to data limitations, these budget impact estimates are highly uncertain. Care partners discussed the difficulties of caring for a child with complex care needs - particularly those of caring for a child with a tracheostomy. They shared their experiences with alternative treatment options that were ineffective in managing their child's symptoms. People with direct experience using home-based HHHFT highlighted its positive impact on their child's respiratory symptoms, improving qualit
背景:呼吸系统疾病包括影响肺部和呼吸系统其他部分的一系列疾病。这些疾病的严重程度和影响各不相同,从轻微的、短暂的问题到慢性的、危及生命的疾病。治疗方案包括药物治疗、肺康复、手术和呼吸治疗,如机械通气、持续气道正压、双水平气道正压、常规氧疗和加热湿化高流量治疗(HHHFT)。我们针对以下人群进行了一项健康技术评估:(1)患有儿童阻塞性睡眠呼吸暂停(OSA)且无法忍受常规在家呼吸治疗的儿童;(2)因呼吸疾病住院的成人和儿童,出院后需要在家治疗,且没有提供同等支持水平的家庭替代方案。该评估包括评估有效性、安全性、公共资助家庭HHHFT的预算影响以及患者的偏好和价值观。方法:我们对上述人群进行了系统的文献检索,以了解基于家庭的HHHFT的有效性和安全性的临床证据。我们进行了系统的经济文献检索,但由于缺乏证据,我们没有进行初步的经济评估。我们分析了安大略省公共资助的以家庭为基础的HHHFT对儿童OSA和成人及其他呼吸系统疾病儿童的预算影响。为了了解以家庭为基础的HHHFT的潜在价值,我们的目的是与安大略省有过呼吸系统疾病经历的儿童的成人和护理伙伴交谈,包括那些有或没有直接经历过HHHFT的儿童。结果:我们没有发现任何符合临床证据审查资格标准的研究。在未来5年,安大略省公共资助家庭HHHFT的年度预算影响范围从为儿童阻塞性睡眠呼吸暂停儿童节省185,981美元到为患有其他呼吸系统疾病的成人和儿童额外节省250万美元。我们估计,公共资助以家庭为基础的HHHFT将导致与儿童OSA相关的住院次数减少99次,门诊次数减少127次。这也将使患有其他呼吸系统疾病的成人和儿童减少653天的住院时间。由于数据的限制,这些预算影响估计高度不确定。护理伙伴讨论了照顾有复杂护理需求的儿童的困难,特别是照顾气管切开术儿童的困难。他们分享了他们在控制孩子症状方面无效的替代治疗方案的经验。有直接使用基于家庭的HHHFT经验的人强调了其对儿童呼吸道症状、改善生活质量和减少医院和专家就诊的积极影响。初始和持续的成本是获得HHHFT的最大障碍。结论:我们没有发现任何研究专门评估与我们的研究问题相关的以家庭为基础的HHHFT的相对有效性和安全性,但我们确实发现了几项在其他情况下进行的研究,证明了HHHFT的益处,包括在医院和家中使用时改善氧合,降低呼吸频率,降低OSA严重程度,减少慢性阻塞性肺疾病的急性加重。此外,HHHFT在安大略省的医院被广泛使用,通常被认为是临床有效的,是这种环境下的标准治疗。我们估计,在未来5年内,安大略省公共资助家庭HHHFT将为患有阻塞性睡眠呼吸暂停的儿童节省费用,为患有其他慢性呼吸系统疾病的成人和儿童节省250万美元的额外费用。我们估计,公共资助以家庭为基础的HHHFT将导致更少的住院就诊,更少的门诊就诊,并避免住院天数。呼吸系统疾病儿童的护理伙伴对家庭健康教育持积极态度;对许多人来说,当其他选择都失败时,它就成了一种必不可少的治疗方法。然而,费用是获得这种治疗的一个重大障碍。
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引用次数: 0
Percutaneous Vertebroplasty and Balloon Kyphoplasty for Painful Osteoporotic Vertebral Compression Fractures: A Health Technology Assessment. 经皮椎体成形术和球囊后凸成形术治疗疼痛的骨质疏松性椎体压缩性骨折:健康技术评估。
Q1 Medicine Pub Date : 2025-08-07 eCollection Date: 2025-01-01

Background: Vertebral compression fractures are among the most common types of fracture in patients with osteoporosis and they can arise during activities of daily living without any specific trauma event. For severely painful osteoporotic vertebral compression fractures (OVCFs) that do not respond to conservative treatment, minimally invasive percutaneous vertebroplasty (PVP) and percutaneous balloon kyphoplasty (PBK) may be used. We conducted a health technology assessment of PVP and PBK for people with painful OVCFs refractory to nonsurgical treatment that included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding PVP and PBK, and patient preferences and values.

Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the ROBIS tool for systematic reviews, the Cochrane Risk of Bias tool for RCTs, and the ROBINS-I tool for observational studies and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-utility analysis with a 3-year time horizon from a public payer perspective. We also analyzed the budget impact of publicly funding PVP and PBK in adults with painful OVCFs in Ontario. To contextualize the potential value of PVP and PBK, we spoke with people with OVCF.

Results: We included 10 studies in the clinical evidence review. Compared to conservative treatment (CT), there was significant (statistical and clinical) improvement in pain (up to 3 months follow-up, GRADE Low) and physical function (up to 6 months follow-up, GRADE Very low) for patients who underwent PVP. For PBK, there was significant (statistical and clinical) improvement in pain in the short term (up to 3 months follow-up, GRADE Very low) compared with CT. Overall, there were no significant differences for either PVP or PBK compared to conservative treatment for mortality, subsequent fractures or adverse events (GRADE Low to Very low). Cement leakage occurred in 4% to 39% of treated patients (PVP vs. CT, 4.0% [8/200 patients]; PVP vs. sham, 39.4% [9/99 patients]; PBK vs. CT, 4.5% [30/731 patients]) and most leakages were asymptomatic. The incremental cost-effectiveness ratio (ICER) of PVP compared with CT is $43,324 per quality-adjusted life-year (QALY) gained. The ICER of PBK compared with CT is $65,921 per QALY gained. The annual budget impact of publicly funding PVP and PBK in Ontario over the next 5 years ranges from an additional $0.5 million in Year 1 to $11.0 million in Year 5. The people we spoke to reported that their daily activities, work, social life, family relationships, and mental health were negatively impacted by OVCF. Those who underwent vertebroplasty reported a positive impact on pain relief and qu

背景:椎体压缩性骨折是骨质疏松症患者中最常见的骨折类型之一,它可以在日常生活活动中发生,没有任何特定的创伤事件。对于保守治疗无效的严重疼痛骨质疏松性椎体压缩性骨折(ovcf),可采用微创经皮椎体成形术(PVP)和经皮球囊后凸成形术(PBK)。我们对难以非手术治疗的疼痛性OVCFs患者进行了PVP和PBK的健康技术评估,包括有效性、安全性、成本效益、公共资助PVP和PBK的预算影响以及患者的偏好和价值观。方法:对临床证据进行系统的文献检索。我们使用ROBIS工具(用于系统评价)、Cochrane风险评估工具(用于随机对照试验)和ROBINS-I工具(用于观察性研究)评估每个纳入研究的偏倚风险,并根据建议评估、发展和评价分级(GRADE)工作组标准评估证据体的质量。我们进行了系统的经济文献检索,并从公共付款人的角度进行了3年时间范围的成本效用分析。我们还分析了安大略省公共资助PVP和PBK对成人疼痛性OVCFs的预算影响。为了了解PVP和PBK的潜在价值,我们采访了OVCF患者。结果:我们在临床证据综述中纳入了10项研究。与保守治疗(CT)相比,PVP患者在疼痛(长达3个月的随访,GRADE Low)和身体功能(长达6个月的随访,GRADE Very Low)方面有显著(统计学和临床)改善。对于PBK,与CT相比,在短期内(长达3个月的随访,GRADE极低)疼痛有显着(统计学和临床)改善。总的来说,与保守治疗相比,PVP或PBK在死亡率、随后的骨折或不良事件方面没有显著差异(GRADE Low至Very Low)。4% ~ 39%的患者发生骨水泥渗漏(PVP vs CT, 4.0%[8/200例];PVP vs sham, 39.4%[9/99例];PBK vs CT, 4.5%[30/731例]),且大多数渗漏无症状。PVP与CT相比,每增加质量调整生命年(QALY)的增量成本效益比(ICER)为43324美元。与CT相比,PBK的ICER为65,921美元/ QALY。在未来5年,安大略省公共资金PVP和PBK的年度预算影响范围从第一年的50万美元到第五年的1100万美元不等。我们采访的人报告说,他们的日常活动、工作、社交生活、家庭关系和心理健康都受到了OVCF的负面影响。那些接受椎体成形术的患者报告了疼痛缓解和生活质量的积极影响。结论:与保守治疗相比,一线保守治疗难治性患者和接受PVP治疗的患者在疼痛(GRADE Low)和身体功能(GRADE Very Low)方面的短期临床改善显著。同样,与保守治疗相比,接受PBK治疗的患者在疼痛方面有显着的短期临床改善(GRADE非常低)。PVP和PBK一直比CT更昂贵、更有效。我们估计,在未来5年内,公开资助安大略省的PVP和PBK将导致2800万美元的额外成本。参与者分享的见解强调了OVCF患者在管理病情方面面临的重大挑战,对日常活动、工作、社交互动和心理健康产生了显著影响。尽管存在这些挑战,但参与者强调了椎体成形术对接受手术的患者的积极结果,特别是在缓解疼痛和改善生活质量方面。
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引用次数: 0
Indocyanine Green Fluorescence Imaging for Colorectal Surgery: A Health Technology Assessment. 吲哚菁绿荧光成像用于结直肠手术:一种健康技术评估。
Q1 Medicine Pub Date : 2025-07-10 eCollection Date: 2025-01-01

Background: Both malignant and benign conditions may require colorectal surgery. Anastomotic leak is a serious potential complication, and assessing tissue perfusion at the planned site of anastomosis is critical to try to prevent leaks. The approaches used by surgeons to assess anastomotic integrity and tissue perfusion involve visual assessment of the planned resection area. Indocyanine green fluorescence imaging (ICGFI) is a technology that involves the use of a fluorescent dye and a near-infrared imaging system to allow surgeons to visualize tissue perfusion intraoperatively in real time. We conducted a health technology assessment of ICGFI in colorectal surgery, which included an evaluation of effectiveness, cost-effectiveness, the budget impact of publicly funding ICGFI for the assessment of anastomotic perfusion during colorectal surgery, and the experiences of patients undergoing colorectal cancer surgery.

Methods: We performed a systematic review of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane Risk-of-Bias Tool for randomized controlled trials (RCTs) and the Risk-of-Bias Assessment Tool for Nonrandomized Studies (RoBANS) for nonrandomized studies. We assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-effectiveness analysis comparing ICGFI with visual assessment alone for the visualization of anastomotic perfusion during colorectal surgery from a public payer perspective. We also analyzed the budget impact of publicly funding ICGFI for colorectal surgery in Ontario. To contextualize the potential value of publicly funding ICGFI for colorectal surgery, we summarized a qualitative literature rapid review conducted by the Canadian Agency for Drugs and Technologies in Health (now Canada's Drug Agency).

Results: We included 6 RCTs and 13 nonrandomized studies in the clinical evidence review. Compared with visual assessment alone, the addition of ICGFI to assess anastomotic perfusion during colorectal surgery reduced anastomotic leaks (GRADE: Low) and reoperations (GRADE: Low) and slightly reduced sepsis, but the evidence for the latter is very uncertain (GRADE: Very low to Low). ICGFI appeared to have little to no effect on hospital readmissions (GRADE: Low) or length of stay (GRADE: Low to Moderate), and its effect on mortality is very uncertain (GRADE: Very low). Our primary economic evaluation found that ICGFI is more effective and less costly than visual assessment alone and is highly likely to be cost-effective at the commonly used willingness-to-pay values of $50,000 and $100,000 per quality-adjusted life-year (QALY). The use of ICGFI could prevent 22 major anastomotic leaks per 1,000 patients undergoing colorectal surgery with anastomosis. Wit

背景:恶性和良性情况都可能需要结肠直肠手术。吻合口漏是一种严重的潜在并发症,评估计划吻合部位的组织灌注对于防止吻合口漏至关重要。外科医生用来评估吻合口完整性和组织灌注的方法包括对计划切除区域的视觉评估。吲哚菁绿荧光成像(ICGFI)是一种使用荧光染料和近红外成像系统的技术,允许外科医生在术中实时观察组织灌注。我们对ICGFI在结直肠癌手术中的应用进行了卫生技术评估,包括评估效果、成本效益、公共资助ICGFI用于结直肠癌手术中吻合口灌注评估的预算影响,以及结直肠癌手术患者的经验。方法:我们对临床证据进行了系统回顾。我们使用Cochrane随机对照试验的偏倚风险评估工具(rct)和非随机研究的偏倚风险评估工具(RoBANS)来评估每个纳入研究的偏倚风险。我们根据建议分级评估、发展和评价(GRADE)工作组标准评估了证据体的质量。我们进行了系统的经济文献检索,并进行了成本-效果分析,比较ICGFI与单独的视觉评估,从公共付款人的角度来看,结直肠手术中吻合口灌注的可视化。我们还分析了公共资助ICGFI对安大略省结直肠手术的预算影响。为了了解公共资助ICGFI用于结直肠手术的潜在价值,我们总结了由加拿大药物和卫生技术机构(现为加拿大药物管理局)进行的定性文献快速回顾。结果:我们纳入了6项随机对照试验和13项非随机研究。与单纯目视评估相比,在结直肠手术中加入ICGFI评估吻合口灌注减少了吻合口泄漏(GRADE: Low)和再手术(GRADE: Low),并略微减少了败血症,但后者的证据非常不确定(GRADE: very Low到Low)。ICGFI似乎对再入院(分级:低)或住院时间(分级:低至中等)几乎没有影响,其对死亡率的影响非常不确定(分级:非常低)。我们的主要经济评估发现,ICGFI比单独的视觉评估更有效,成本更低,并且在每个质量调整生命年(QALY)的常用支付意愿值为50,000美元和100,000美元时,极有可能具有成本效益。每1000例结直肠吻合术患者使用ICGFI可预防22例大吻合口漏。使用ICGFI, 45例患者将需要治疗以防止额外的主要吻合口漏。公开资助ICGFI评估安大略省结直肠手术吻合口灌注的年度预算影响范围从第一年的81万美元到第五年的813万美元不等,总计5年的预算影响为节省成本1,903万美元。我们确定了先前发表的快速回顾,没有发现关于ICGFI患者体验的定性文献。然而,对结直肠癌手术患者经历的定性研究发现吻合口漏和生活质量是关键的患者重要结局。在纳入的研究中,患者通常报告没有获得足够的手术结果信息,并且对癌症复发感到焦虑。我们没有进行直接的患者参与,因为该技术的目的是增强手术区域的可视化,因为预计患者的偏好和价值观将与在结直肠手术中使用ICGFI改善健康结果的潜力相一致。结论:有证据表明,与单纯目视评估相比,在结直肠手术中加入ICGFI有助于减少吻合口瘘、再手术和败血症,但可能对再入院或住院时间没有影响。ICGFI对死亡率的影响尚不清楚。ICGFI比单独的目视评估更有效,成本更低。我们估计,在安大略省,公共资助ICGFI用于结直肠手术将在未来5年内节省1903万美元的成本。未见有关ICGFI患者经历的文献。关于结肠直肠癌手术患者的偏好和价值的定性文献将吻合口渗漏和生活质量确定为关键结果,研究参与者表达了对手术结果和癌症复发的担忧。
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引用次数: 0
Magnetic Resonance-Guided Focused Ultrasound Neurosurgery for Treatment-Refractory Obsessive-Compulsive Disorder: A Health Technology Assessment. 磁共振引导聚焦超声神经外科治疗难治性强迫症:一项健康技术评估。
Q1 Medicine Pub Date : 2025-05-06 eCollection Date: 2025-01-01

Background: Obsessive-compulsive disorder (OCD) is a debilitating neuropsychiatric illness characterized by obsessions and compulsions that are distressing, impair function, and are time-consuming, especially in severe cases. Up to 40% of people with OCD have treatment-refractory OCD and experience inadequate response to multiple trials and combinations of treatments. Neurosurgery is an important treatment option for people with severe, treatment-refractory OCD but is typically invasive. Magnetic resonance-guided focused ultrasound (MRgFUS) is a noninvasive technology that is used to perform neurosurgery. We conducted a health technology assessment of MRgFUS neurosurgery for people with severe, treatment-refractory OCD, which included an evaluation of effectiveness, safety, the budget impact of publicly funding MRgFUS neurosurgery, and patient preferences and values.

Methods: We performed a systematic literature search of the clinical evidence published since 2013. We assessed the risk of bias of each included study using the Joanna Briggs Institute's Critical Appraisal Checklist for Case Series, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic literature search of the economic evidence. We estimated the 5-year budget impact of publicly funding MRgFUS neurosurgery for people with treatment-refractory OCD in Ontario. Owing to a lack of comparative clinical evidence, we did not conduct a primary economic evaluation. To contextualize the value of MRgFUS neurosurgery, we spoke to people with treatment-refractory OCD who underwent the procedure, as well as those on the waitlist.

Results: We included 2 studies in the clinical evidence review. In these small case series, MRgFUS neurosurgery led to improvements in OCD symptoms, quality of life, and patient functioning, as well as treatment response for many but not all patients (GRADE: Very low). In a minority of cases, the procedure could not be successfully performed due to skull factors (GRADE: Very low). MRgFUS neurosurgery was also found to have a favourable safety profile (GRADE: Very low). No cases of re-treatment were reported (GRADE: Very low). No studies compared MRgFUS neurosurgery with other neurosurgeries.Due to the lack of comparative clinical evidence, the cost-effectiveness of MRgFUS neurosurgery could not be determined. Our budget impact analysis found that publicly funding MRgFUS neurosurgery for people with treatment-refractory OCD in Ontario would cost an additional $1.9 million over 5 years.Patients reported the negative impacts that OCD had on their day-to-day activities, work and school, social life and family relationships, and mental health. The 6 participants who underwent MRgFUS neurosurgery commented on the positive impact that it had on their OCD symptoms, mental health, and quali

背景:强迫症(OCD)是一种使人衰弱的神经精神疾病,其特征是强迫和强迫是痛苦的,损害功能,并且耗时,特别是在严重的情况下。高达40%的强迫症患者患有难治性强迫症,并且对多次试验和联合治疗的反应不足。神经外科手术是重度难治性强迫症患者的重要治疗选择,但通常是侵入性的。磁共振引导聚焦超声(MRgFUS)是一种用于神经外科手术的非侵入性技术。我们对重度难治性强迫症患者的MRgFUS神经外科手术进行了一项健康技术评估,包括对有效性、安全性、公共资助MRgFUS神经外科手术的预算影响以及患者偏好和价值观的评估。方法:对2013年以来发表的临床证据进行系统文献检索。我们使用乔安娜布里格斯研究所的病例系列关键评估清单评估了每个纳入研究的偏倚风险,并根据建议评估、发展和评估分级(GRADE)工作组标准评估了证据体的质量。我们对经济证据进行了系统的文献检索。我们估计了安大略省对难治性强迫症患者进行MRgFUS神经外科手术的5年预算影响。由于缺乏比较临床证据,我们没有进行初步的经济评估。为了了解MRgFUS神经外科手术的价值,我们采访了接受该手术的难治性强迫症患者,以及那些在等待名单上的患者。结果:我们纳入了2项临床证据综述。在这些小病例系列中,MRgFUS神经外科手术改善了许多但不是所有患者的强迫症症状、生活质量和患者功能,以及治疗反应(GRADE: Very low)。在少数病例中,由于颅骨因素,手术不能成功进行(评分:非常低)。MRgFUS神经外科手术也具有良好的安全性(GRADE: Very low)。无再治疗病例报告(分级:非常低)。没有研究将MRgFUS神经外科手术与其他神经外科手术进行比较。由于缺乏比较的临床证据,MRgFUS神经外科手术的成本-效果无法确定。我们的预算影响分析发现,在安大略省为难治性强迫症患者提供MRgFUS神经外科手术的公共资金将在5年内额外花费190万美元。患者报告说,强迫症对他们的日常活动、工作和学习、社会生活和家庭关系以及心理健康产生了负面影响。6名接受MRgFUS神经外科手术的参与者评论了它对他们的强迫症症状、心理健康和生活质量的积极影响。结论:MRgFUS神经外科手术可能是一种有效且通常安全的治疗选择,治疗严重的难治性强迫症,但证据非常不确定。由于缺乏比较临床证据,MRgFUS神经外科手术的成本效益无法确定。在安大略省,对难治性强迫症患者进行MRgFUS神经外科手术的公共资助将在5年内导致190万美元的额外费用。患者和护理伙伴强调了强迫症对他们生活的负面影响,并强调了MRgFUS神经外科手术作为治疗难治性强迫症的治疗选择的重要性。
{"title":"Magnetic Resonance-Guided Focused Ultrasound Neurosurgery for Treatment-Refractory Obsessive-Compulsive Disorder: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Obsessive-compulsive disorder (OCD) is a debilitating neuropsychiatric illness characterized by obsessions and compulsions that are distressing, impair function, and are time-consuming, especially in severe cases. Up to 40% of people with OCD have treatment-refractory OCD and experience inadequate response to multiple trials and combinations of treatments. Neurosurgery is an important treatment option for people with severe, treatment-refractory OCD but is typically invasive. Magnetic resonance-guided focused ultrasound (MRgFUS) is a noninvasive technology that is used to perform neurosurgery. We conducted a health technology assessment of MRgFUS neurosurgery for people with severe, treatment-refractory OCD, which included an evaluation of effectiveness, safety, the budget impact of publicly funding MRgFUS neurosurgery, and patient preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence published since 2013. We assessed the risk of bias of each included study using the Joanna Briggs Institute's Critical Appraisal Checklist for Case Series, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic literature search of the economic evidence. We estimated the 5-year budget impact of publicly funding MRgFUS neurosurgery for people with treatment-refractory OCD in Ontario. Owing to a lack of comparative clinical evidence, we did not conduct a primary economic evaluation. To contextualize the value of MRgFUS neurosurgery, we spoke to people with treatment-refractory OCD who underwent the procedure, as well as those on the waitlist.</p><p><strong>Results: </strong>We included 2 studies in the clinical evidence review. In these small case series, MRgFUS neurosurgery led to improvements in OCD symptoms, quality of life, and patient functioning, as well as treatment response for many but not all patients (GRADE: Very low). In a minority of cases, the procedure could not be successfully performed due to skull factors (GRADE: Very low). MRgFUS neurosurgery was also found to have a favourable safety profile (GRADE: Very low). No cases of re-treatment were reported (GRADE: Very low). No studies compared MRgFUS neurosurgery with other neurosurgeries.Due to the lack of comparative clinical evidence, the cost-effectiveness of MRgFUS neurosurgery could not be determined. Our budget impact analysis found that publicly funding MRgFUS neurosurgery for people with treatment-refractory OCD in Ontario would cost an additional $1.9 million over 5 years.Patients reported the negative impacts that OCD had on their day-to-day activities, work and school, social life and family relationships, and mental health. The 6 participants who underwent MRgFUS neurosurgery commented on the positive impact that it had on their OCD symptoms, mental health, and quali","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"25 1","pages":"1-123"},"PeriodicalIF":0.0,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12148002/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144267557","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Noninvasive Vagus Nerve Stimulation for Cluster Headache and Migraine: A Health Technology Assessment. 无创迷走神经刺激治疗丛集性头痛和偏头痛:一项健康技术评估。
Q1 Medicine Pub Date : 2025-05-01 eCollection Date: 2025-01-01

Background: Cluster headache and migraine are 2 distinct types of primary headache that can cause substantial pain, disability, and decreased quality of life. Noninvasive vagus nerve stimulation (nVNS) is a treatment option that delivers a mild electrical stimulation to a nerve in the neck. nVNS is intended to reduce the pain and duration of a headache attack, and to prevent headaches from occurring. We conducted a health technology assessment of nVNS for the acute treatment and prevention of cluster headache or migraine, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding nVNS, and patient preferences and values.

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 quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted 2 cost-utility and cost-effectiveness analyses with a 1-year time horizon from a public payer perspective. We also analyzed the budget impact of publicly funding nVNS for people with cluster headache and migraine in Ontario. To contextualize the potential value of nVNS, we spoke with people with cluster headache and migraine.

Results: We included 8 randomized trials in the clinical evidence review (3 on cluster headache, 5 on migraine). For the acute treatment of cluster headache with nVNS, we found no statistically significant improvements in terms of overall response (pain relief), pain freedom, and duration of attacks (GRADEs: Low to Very low), or acute medication use (GRADE: Moderate). We observed little to no difference in mean pain intensity or adverse events (GRADE: Low). For the preventive treatment of cluster headache (based on 1 trial), nVNS reduced the frequency of attacks per week (GRADE: Low), improved response (GRADE: Low), reduced acute medication use (GRADE: Low), and improved quality of life (GRADE: Low to Very low). More overall adverse events were observed with nVNS, but results were uncertain (GRADE: Low). For the acute treatment of migraine (based on 1 study), nVNS improved response to treatment (i.e., pain relief; GRADE: Moderate to Low) but had little to no effect on sustained response (GRADE: Low). nVNS improved pain freedom, but the results were not statistically significant (GRADE: Moderate) and there was no difference in sustained pain freedom (GRADE: Low). There was little to no difference in mean pain intensity (GRADE: Very low) or acute medication use (GRADE: Low), and the risk of adverse events was very uncertain (GRADE: Very low). For the preventive treatment of migraine (based on 4 studies), nVNS may slightly reduce the number of headache and migraine days, but we could not exclude the possibilit

背景:丛集性头痛和偏头痛是两种不同类型的原发性头痛,可引起严重疼痛、残疾和生活质量下降。无创迷走神经刺激(nVNS)是一种对颈部神经进行轻微电刺激的治疗方法。nVNS旨在减少头痛发作的疼痛和持续时间,并防止头痛的发生。我们对nVNS用于急性治疗和预防丛集性头痛或偏头痛的卫生技术进行了评估,包括对有效性、安全性、成本效益、公共资助nVNS的预算影响以及患者偏好和价值观的评估。方法:对临床证据进行系统的文献检索。我们使用Cochrane偏倚风险工具评估每个纳入研究的偏倚风险,并根据建议评估、发展和评价分级(GRADE)工作组标准评估证据体的质量。我们进行了系统的经济文献检索,并从公共付款人的角度进行了1年时间范围内的成本效用和成本效益分析。我们还分析了安大略省公共资助nVNS对丛集性头痛和偏头痛患者的预算影响。为了了解nVNS的潜在价值,我们采访了丛集性头痛和偏头痛患者。结果:我们在临床证据综述中纳入了8项随机试验(3项针对丛集性头痛,5项针对偏头痛)。对于急性集束性头痛的nVNS治疗,我们发现在总体反应(疼痛缓解)、疼痛缓解、发作持续时间(等级:低至极低)或急性药物使用(等级:中等)方面没有统计学上显著的改善。我们观察到平均疼痛强度或不良事件几乎没有差异(GRADE: Low)。对于丛集性头痛的预防性治疗(基于1项试验),nVNS降低了每周发作的频率(GRADE: Low),改善了反应(GRADE: Low),减少了急性用药(GRADE: Low),并改善了生活质量(GRADE: Low至Very Low)。nVNS观察到更多的总体不良事件,但结果不确定(GRADE: Low)。对于偏头痛的急性治疗(基于1项研究),nVNS改善了对治疗的反应(即疼痛缓解;分级:中至低),但对持续反应几乎没有影响(分级:低)。nVNS改善了疼痛自由,但结果无统计学意义(评分:中等),持续疼痛自由无差异(评分:低)。在平均疼痛强度(GRADE:非常低)或急性药物使用(GRADE:低)方面几乎没有差异,不良事件的风险非常不确定(GRADE:非常低)。对于偏头痛的预防性治疗(基于4项研究),nVNS可能会略微减少头痛和偏头痛的天数,但我们不能排除没有效果的可能性(GRADE: Low)。nVNS在急性药物使用方面几乎没有差异(GRADE: Low),对功能状态的影响证据非常不确定(GRADE: very Low)。nVNS对不良事件的影响可能很小或没有影响,但证据非常不确定(等级:低至极低)。对于丛集性头痛的预防,nVNS加标准治疗比单独标准治疗更有效,也更昂贵。与单独标准治疗相比,nVNS加标准治疗的增量成本-效果比(ICER)为每QALY获得27338美元。在每个QALY获得5万美元的支付意愿(WTP)值时,在标准护理之外进行nVNS具有成本效益的概率为88.5%,而在每个QALY获得10万美元的WTP值时,这一概率为97%。然而,这些结果需要谨慎解释,因为根据GRADE框架,用于告知模型的临床输入是低到极低的质量。对于偏头痛的预防,除了标准治疗外,nVNS同样有效,但比单独的标准治疗更昂贵。与单独标准治疗相比,nVNS加标准治疗的ICER为每QALY获得952,116美元。nVNS在每个QALY获得的常用WTP值为50,000美元和100,000美元时不太可能具有成本效益。安大略省公共资金nVNS对集束性头痛的5年预算影响估计为急性治疗1188万美元,预防治疗992万美元。公共资助偏头痛nVNS的5年预算影响估计为急性治疗11.2亿美元,预防治疗2.7877亿美元。丛集性头痛和偏头痛患者描述了这些疾病对他们日常活动、工作、社会生活和家庭关系以及心理健康的负面影响。他们反思自己寻求适当治疗的经历。一名尝试过nVNS的参与者没有看到对他们的症状有积极的影响,但所有参与者都对尝试nVNS感兴趣。 与会者强调了集束性头痛和偏头痛的非侵入性治疗方案的重要性。结论:对于丛集性头痛或偏头痛患者,nVNS可能是一种有效且通常安全的治疗选择,但证据的确定性为极低至中等,且效果程度取决于头痛类型和治疗指征。除标准护理外,nVNS可能对预防丛集性头痛具有成本效益,但对预防偏头痛无效。我们估计,在安大略省为集丛性头痛的急性治疗提供公共资金nVNS将在5年内导致1188万美元的额外费用。为安大略省集束性头痛的预防性治疗提供公共资助的nVNS将在5年内产生992万美元的额外费用。为偏头痛的nVNS提供公共资金将导致非常高的额外费用:5年内急性治疗费用为11.2亿美元,预防性治疗费用为2.877亿美元。丛集性头痛和偏头痛患者对nVNS作为治疗和预防的非侵入性选择感兴趣。
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引用次数: 0
Interferon-Gamma Release Assay Testing for Latent Tuberculosis Infection: A Health Technology Assessment. 干扰素γ释放试验检测潜伏结核感染:卫生技术评估。
Q1 Medicine Pub Date : 2024-12-12 eCollection Date: 2024-01-01
<p><strong>Background: </strong>Many people infected with the <i>Mycobacterium tuberculosis</i> complex (the bacteria that cause tuberculosis [TB]) have an inactive stage of infection known as latent tuberculosis infection (LTBI). A person with LTBI is at risk of developing active TB. Screening for, and treating people with, LTBI is an important part of preventing adverse health outcomes, reducing the risk of reactivation and the further spread of tuberculosis in a community. We conducted a health technology assessment of interferon-gamma release assay (IGRA) for the detection of LTBI, compared to the standard tuberculin skin test (TST) to evaluate the diagnostic accuracy, cost-effectiveness, the budget impact of publicly funding, and health care provider preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence as an overview of systematic reviews. We reported the findings of the identified reviews, including their quality assessment of the body of evidence. We performed a systematic literature search of the economic evidence and included published Canadian cost-effectiveness studies. We assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We developed a probabilistic decision-tree model to estimate the incremental costs of IGRA strategies versus TST alone over 1 year in eligible population subgroups. IGRA was examined as a single test and in a sequential pathway with tuberculin skin test (TST; the test order depended on the type of population). We considered subpopulations at high risk of LTBI for whom IGRA would be preferred, as indicated by the Canadian TB Standards published in 2022 (hereinafter, the Standards); e.g., people who received a Bacille Calmette-Guérin (BCG) vaccine, such as BCG-vaccinated immigrants and people identified in contact investigations. We also considered people with comorbid conditions or who were undergoing treatments that may cause low immune function and, hence, may test incorrectly negative. We estimated the total 5-year budget impact (in 2024 CAD) for publicly funding IGRA testing in Ontario. To contextualize the potential value of IGRA, we spoke with health care providers about people requiring TB testing for LTBI. We attempted to reach out to people who had experience with IGRA or TST but did not receive any feedback.</p><p><strong>Results: </strong>We included 12 systematic reviews that included over 500 unique primary studies in the clinical evidence overview of reviews and found good evidence aligned with the uses of IGRA outlined in the Standards. This overview of reviews summarizes the existing evidence on diagnostic accuracy and the clinical utility of IGRA for LTBI. Interferon-gamma release assay was found to have good evidence as a rule-in test for LTBI due to consistently high specificity. The reviews reported slightly lower sensi
背景:许多感染结核分枝杆菌复合体(引起结核病的细菌[TB])的人有一个被称为潜伏结核感染(LTBI)的非活动性感染阶段。患有LTBI的人有发展为活动性结核病的风险。筛查和治疗LTBI患者是预防不良健康结果、降低结核病重新激活和在社区进一步传播风险的重要组成部分。我们对用于检测LTBI的干扰素- γ释放法(IGRA)进行了卫生技术评估,并与标准结核菌素皮肤试验(TST)进行了比较,以评估诊断准确性、成本效益、公共资助的预算影响以及卫生保健提供者的偏好和价值观。方法:我们对临床证据进行了系统的文献检索,作为系统综述的概述。我们报告了已确定的综述的发现,包括它们对证据体的质量评估。我们对经济证据进行了系统的文献检索,并纳入了已发表的加拿大成本效益研究。我们根据建议分级评估、发展和评价(GRADE)工作组标准评估了证据体的质量。我们开发了一个概率决策树模型来估计IGRA策略与单独TST在1年内在符合条件的人群亚组中的增量成本。IGRA作为单一试验和顺序途径与结核菌素皮肤试验(TST;测试顺序取决于种群的类型)。根据2022年发布的加拿大结核病标准(以下简称标准),我们考虑了LTBI高风险的亚人群,他们更倾向于IGRA;例如,接种过卡介苗的人,如接种过卡介苗的移民和接触者调查中确定的人。我们还考虑了患有合并症或正在接受可能导致免疫功能低下的治疗的人,因此可能会被错误地检测为阴性。我们估计了安大略省公共资助IGRA测试的5年预算影响(2024年CAD)。为了了解IGRA的潜在价值,我们与卫生保健提供者讨论了需要进行LTBI结核病检测的人。我们试图联系有IGRA或TST经验的人,但没有收到任何反馈。结果:我们在临床证据综述中纳入了12项系统综述,其中包括500多项独特的初步研究,并发现了与标准中概述的IGRA用途一致的良好证据。本综述综述了现有证据的诊断准确性和IGRA对LTBI的临床应用。由于具有一贯的高特异性,干扰素- γ释放试验被发现有很好的证据作为LTBI的常规测试。综述报告,与一般人群相比,具有潜在免疫抑制条件的人群(例如,HIV阳性或接受过器官移植的人,或正在接受癌症治疗或透析的人)的敏感性略低。然而,与TST(结核病的标准测试)相比,IGRA似乎有更少的假阳性结果,这表明在头对头比较中,两种LTBI测试均呈阳性的患者发生活动性结核病的风险差异更低。这在免疫功能低下的人群中尤为明显,在儿童和老年人(例如养老院的人)以及接受过抗结核疫苗(即卡介苗)接种的人群中也观察到。此外,IGRA可能对免疫功能低下、有TST假阴性风险的患者提供信息,因为它产生不确定的结果,表明可能需要进一步的临床研究。我们纳入了来自加拿大的5项经济研究(使用公共付款人的观点),这些研究发现IGRA,无论是作为TST后的顺序测试还是作为独立测试,对于标准中确定的高风险人群的LTBI,与单独的TST相比,都具有成本效益或节省成本。所有被回顾的研究都是高质量的,其中3项研究直接适用于安大略省的背景(GRADE:高)。因此,我们没有对安大略省进行初步的经济评估。我们的参考病例预算影响分析显示,未来5年安大略省所有被检查亚群IGRA的公共资助与额外费用相关,从299万美元(单独IGRA)到1880万美元(连续途径IGRA与TST)。这些总估计数包括某些亚群的潜在节省和其他亚群的额外费用。在针对特定人群的分析中,我们估计节省了1美元的成本。 在接种过bcg疫苗的移民或通过接触者调查发现的接种过bcg疫苗的人群中,5年内接受公共资助IGRA检测的人数达到6300万或更高(这些人仅通过TST检测容易出现假阳性结果)。这些费用的节省是由于后续评估和治疗费用的减少(由于预防LTBI重新激活)。我们发现,在免疫功能低下人群中,公共资助的IGRA检测在5年内的额外费用约为626万美元或更高,这是由于对那些先前被错误地确定为阴性的人增加了适当的医学评估。在敏感性分析中,如果我们假设LTBI在免疫功能低下人群中有很高的机会重新激活为活动性结核病,那么IGRA检测可以节省成本。我们调查的卫生保健提供者对IGRA有积极的评价,并表示它是患者首选的LTBI测试,部分原因是该测试只需要一次办公室就诊(与TST需要多次就诊相比),从而减少了交通、语言、托儿和就业安排等障碍的影响。结论:干扰素- γ释放测定检测在符合标准推荐使用的人群中具有良好的诊断准确性,并且具有成本效益或节省成本。我们估计,安大略省所有被检查人群的IGRA公共资助将导致5年内299万至1880万美元的额外费用,具体取决于该测试的使用方式。在人群特异性分析中,我们估计在符合条件的接种过bcg疫苗的移民人群或通过接触者调查确定的接种过bcg疫苗的人群中进行IGRA检测可节省163万美元或更高的成本。保健从业人员更倾向于IGRA,特别是为了支持那些可能对现有替代测试(例如TST)有困难的人。
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引用次数: 0
Peripheral Nerve Stimulation for Chronic Neuropathic Pain: A Health Technology Assessment. 外周神经刺激治疗慢性神经性疼痛:健康技术评估。
Q1 Medicine Pub Date : 2024-12-03 eCollection Date: 2024-01-01
<p><strong>Background: </strong>Chronic neuropathic pain is a major health problem that adversely affects people's physical and mental well-being, as well as their quality of life. Percutaneous peripheral nerve stimulation (PNS) may offer a minimally invasive option earlier in the treatment continuum for adults with chronic neuropathic pain that is refractory to conventional medical management. We conducted a health technology assessment of PNS for adults with chronic neuropathic pain, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding PNS, 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 controlled trials and the Risk of Bias in Non-randomized Studies - of Interventions for observational studies, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-utility analysis with a 3-year horizon from a public payer perspective. We also analyzed the budget impact of publicly funding PNS in adults with chronic neuropathic pain in Ontario. To contextualize the potential value of PNS, we spoke to people with chronic pain, and to care partners of patients with chronic pain.</p><p><strong>Results: </strong>We included 17 publications (2 randomized controlled trials and 12 nonrandomized studies) in the clinical evidence review. These studies included chronic neuropathic pain in the trunk and the upper and lower extremities. Compared with placebo controls in adults with chronic neuropathic pain that is refractory to conventional medical management, permanent PNS likely decreases pain scores, likely improves functional outcomes, and likely improves health-related quality of life, but it has little to no effect on the use of pain medications (all GRADEs: Moderate). Compared with before implantation in adults with chronic neuropathic pain, permanent PNS may decrease pain scores, may decrease the use of pain medications, may improve functional outcomes, and may improve health-related quality of life (all GRADEs: Low). Compared with placebo controls in adults with chronic postamputation pain, temporary PNS may decrease pain scores, may decrease use of pain medications, may improve functional outcomes, and may improve health-related quality of life (all GRADEs: Low). Compared with before implantation in adults with chronic postamputation pain, temporary PNS may decrease pain scores, may decrease the use of pain medications, may improve functional outcomes, and may improve health-related quality of life (all GRADEs: Low). We did not find any studies that compared permanent PNS to temporary PNS. Implantation of a PNS system is a reasonably safe p
背景:慢性神经性疼痛是影响人们身心健康和生活质量的主要健康问题。经皮周围神经刺激(PNS)可以为传统医学治疗难治性慢性神经性疼痛的成人患者提供早期治疗的微创选择。我们对成人慢性神经性疼痛患者的PNS进行了健康技术评估,包括有效性、安全性、成本效益、公共资助PNS的预算影响以及患者的偏好和价值观。方法:对临床证据进行系统的文献检索。我们使用Cochrane随机对照试验的偏倚风险工具和观察性研究的非随机干预研究的偏倚风险评估了每个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体的质量。我们进行了系统的经济文献检索,并从公共付款人的角度进行了3年的成本效用分析。我们还分析了安大略省公共资助PNS对慢性神经性疼痛成人的预算影响。为了了解PNS的潜在价值,我们采访了慢性疼痛患者,以及慢性疼痛患者的护理伙伴。结果:我们在临床证据综述中纳入了17篇出版物(2项随机对照试验和12项非随机研究)。这些研究包括躯干、上肢和下肢的慢性神经性疼痛。与安慰剂对照组相比,常规医学治疗难治性慢性神经性疼痛的成人患者,永久性PNS可能会降低疼痛评分,可能会改善功能结局,可能会改善与健康相关的生活质量,但对止痛药的使用几乎没有影响(所有等级:中度)。与植入前相比,对于患有慢性神经性疼痛的成人,永久性PNS可能会降低疼痛评分,减少止痛药的使用,改善功能结局,并可能改善与健康相关的生活质量(所有等级:低)。与安慰剂对照组相比,在患有慢性截肢后疼痛的成年人中,临时PNS可能会降低疼痛评分,可能会减少止痛药的使用,可能会改善功能结局,并可能会改善与健康相关的生活质量(所有等级:低)。与植入前相比,患有慢性截肢后疼痛的成人,临时PNS可能会降低疼痛评分,可能会减少止痛药的使用,可能会改善功能结局,并可能改善与健康相关的生活质量(所有等级:低)。我们没有发现任何比较永久性PNS和暂时性PNS的研究。植入PNS系统是一个相当安全的程序;大多数不良事件是局部的,强度轻微(等级:中至低)。每个质量调整生命年(QALY),加上标准治疗的PNS与单独标准治疗相比,增加的成本效益比为87,211美元。在每个获得的质量aly的支付意愿为5万美元时,加上标准护理的PNS与单独的标准护理相比具有成本效益的概率为1.02%,而在每个获得的质量aly的支付意愿为10万美元时,这一概率为64.88%。在未来5年,安大略省公共资助PNS的年度预算影响范围从第一年的97万美元增加到第五年的315万美元,在5年内总计为1009万美元。慢性疼痛患者及其家庭成员和护理伙伴对PNS持赞成态度。那些直接经历过永久性PNS的人认为它有效地减轻了他们的疼痛程度,对他们的生活质量和心理健康产生了积极影响。目前获取PNS的障碍包括缺乏意识、成本和地理位置。结论:在传统医学治疗难治性慢性神经性疼痛的成人患者中,永久性PNS可能改善疼痛结局、功能结局和健康相关生活质量,但与安慰剂对照组相比,对止痛药的使用几乎没有影响。临时PNS可改善疼痛结局、功能结局和与健康相关的生活质量,并可减少止痛药的使用。永久或临时PNS系统的植入是相当安全的。与单独标准护理相比,PNS加上标准护理的增量成本效益比为每获得的质量质量为87,211美元。我们估计,公共资助安大略省的PNS将在未来5年内产生1009万美元的额外费用。直接经历过永久性PNS的人谈到了它在减轻疼痛程度方面的有效性,以及对他们的生活质量和心理健康的积极影响。 获取PNS的障碍包括缺乏意识、成本和地理位置。
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引用次数: 0
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Ontario Health Technology Assessment Series
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