Ontario Health Technology Assessment Series最新文献

Interferon-Gamma Release Assay Testing for Latent Tuberculosis Infection: A Health Technology Assessment.

Q1 Medicine

Ontario Health Technology Assessment Series

Pub Date : 2024-12-12 eCollection Date: 2024-01-01

Background: Many people infected with the Mycobacterium tuberculosis 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.Methods: 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.Results: 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

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引用次数: 0

Peripheral Nerve Stimulation for Chronic Neuropathic Pain: A Health Technology Assessment.

Q1 Medicine

Ontario Health Technology Assessment Series

Pub Date : 2024-12-03 eCollection Date: 2024-01-01

Background: 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.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 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.Results: 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

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引用次数: 0

Single-Exposure, Dual-Energy Subtraction Flat Panel X-Ray Detectors: A Health Technology Assessment. 单曝光，双能量减法平板x射线探测器：健康技术评估。

Q1 Medicine

Ontario Health Technology Assessment Series

Pub Date : 2024-11-12 eCollection Date: 2024-01-01

Background: In medicine, x-rays are used to generate images of tissues and structures inside the body. X-rays are emitted by a source device and, after passing through the body, strike a detector, which forms an image of the tissues and structures the x-rays passed through. Dual-energy subtraction (DES) x-ray systems use radiation of different energy spectra (energy levels) and the principle of differential absorption characteristics of bone and soft tissue to produce separate bone and soft tissue x-ray images, in addition to a conventional x-ray image. The aim is to minimize potential issues with anatomical overlap with conventional x-ray that may obscure some findings. Single-exposure, DES flat panel x-ray detectors produce a conventional x-ray image in addition to DES bone and soft tissue x-ray images using a single x-ray exposure. We conducted a health technology assessment of single-exposure, DES digital flat panel x-ray detectors in adults for indications such as pneumonia, pneumothorax, and pulmonary nodules, and for visualizing lines and tubes, compared with conventional x-ray. Our assessment included an evaluation of the diagnostic accuracy, the impact on diagnostic confidence, patient management and clinical outcomes, the budget impact of publicly funding the technology, and the experiences, preferences, and values of health care providers.Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the QUADAS-C 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 on the economic evidence of single-exposure, DES flat panel x-ray detectors. We did not conduct a primary economic evaluation because of limited evidence on the implications of this technology. We analyzed the budget impact of publicly funding single-exposure, DES flat panel detectors in Ontario hospitals. To contextualize the potential value of single-exposure, DES flat panel x-ray detectors, we spoke with people with expertise in diagnostic imaging, including radiologists and other health care practitioners.Results: The clinical evidence review identified 2 eligible observational studies that assessed the use of single-exposure, DES flat panel x-ray detectors to generate DES bone and soft tissue x-ray images and a conventional x-ray image. The findings of 1 study suggest an improvement in the sensitivity and specificity for the detection of pulmonary nodule calcification with the use of single-exposure, DES soft tissue and conventional x-ray images compared with using a conventional x-ray image alone (results were statistically significant for 2 out of 5 reviewers; GRADE: Low). In one study, x-ray image reviewers reported an improvement in the visibility of the tips of lines and tubes

背景：在医学上，x射线被用来产生体内组织和结构的图像。x射线由源装置发射，穿过人体后，撞击探测器，探测器形成x射线穿过的组织和结构的图像。双能减法（DES） x射线系统利用不同能谱（能级）的辐射以及骨和软组织的差分吸收特性原理，在常规x射线图像之外产生单独的骨和软组织x射线图像。目的是尽量减少潜在的问题，解剖重叠与传统x线可能掩盖一些发现。单次曝光，DES平板x射线探测器除了使用单次x射线曝光产生DES骨骼和软组织x射线图像外，还产生传统的x射线图像。与传统x线相比，我们对成人单次暴露、DES数字平板x线探测器进行了健康技术评估，用于诊断肺炎、气胸和肺结节等适应症，并用于显示线和管。我们的评估包括对诊断准确性、对诊断信心的影响、患者管理和临床结果、公共资助技术的预算影响以及卫生保健提供者的经验、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QUADAS-C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。我们对单次曝光DES平板x射线探测器的经济证据进行了系统的文献检索。由于这项技术的影响证据有限，我们没有进行初步的经济评估。我们分析了安大略省医院的单次暴露DES平板探测器的公共资助对预算的影响。为了了解单次曝光DES平板x射线探测器的潜在价值，我们采访了具有诊断成像专业知识的人员，包括放射科医生和其他医疗保健从业人员。结果：临床证据综述确定了2项符合条件的观察性研究，评估了单次暴露、DES平板x射线探测器生成DES骨骼和软组织x射线图像和常规x射线图像的使用。1项研究的结果表明，与单独使用常规x线图像相比，使用单次曝光、DES软组织和常规x线图像检测肺结节钙化的敏感性和特异性都有所提高(5名评论者中有2名结果具有统计学意义；等级:低)。在一项研究中，x射线图像审评者报告，所有患者的线和管尖端的可见性都有所改善（尽管这些都是单独使用常规x线图像时可见的），16名（57.1%）患者的诊断置信度有所提高，与单独使用常规x线图像相比，使用单次曝光、DES骨骼和软组织x线图像加常规x线图像审评图像的时间没有差异。但证据非常不确定（等级：非常低）。经济证据审查确定了1项美国环境下的成本研究。这一分析表明，采用单曝光DES x射线探测器可能会节省成本。然而，这项研究被认为不能直接适用于安大略省的情况。因此，单曝光DES平板x射线探测器的成本效益是未知的。由于关于这些检测器对诊断准确性和工作流程等短期结果以及长期成本和健康结果的影响的证据有限，我们没有进行初步的经济评估。我们的预算影响分析估计，对于一个典型的社区医院来说，购买3个探测器来改造现有的x光机将导致每个机构额外花费12,137美元。然而，该技术的下游成本和收益存在很大程度的不确定性。我们采访了20位具有x射线系统专业知识的卫生保健提供者。那些有机会在临床环境中解释由单次曝光DES探测器产生的x射线图像的人支持这项技术，并认为增加了诊断患者的信心。改造现有的x射线系统，使其与单曝光DES探测器兼容，这对操作人员来说是一个挑战，因为它不是一个无缝的过程。使用单曝光DES探测器操作改进x射线系统的人员评论了与工作流程相关的问题，包括物理规格、连接性、电池寿命和可操作性，这些都是使用的障碍。没有使用DES探测器技术经验的参与者表示，与安大略省目前使用的替代方案（如图像增强软件、新兴人工智能技术和低剂量CT扫描）相比，DES探测器技术的益处不确定。没有一个用户有使用完全集成的移动x射线系统（即不需要改装以与单次曝光DES探测器兼容的移动x射线系统）的经验。结论：与常规x线相比，使用单次曝光的DES平板x线机可能会提高检测肺结节钙化的灵敏度和特异性，但与常规x线相比，其对线和管尖端的可见性、诊断置信度和检查x线图像时间的影响证据非常不确定。证据差距包括缺乏证据证明该技术对大多数人群的使用以及我们试图评估的结果。由于有限的临床和经济证据，单次暴露的成本效益，DES平板x射线探测器目前尚不清楚。我们估计，购买3个探测器来改造现有的x光机可能会导致每个机构增加$12,137的费用。使用单曝光DES x射线探测器的用户观看并解释了所产生的图像，他们积极地评价了他们使用该技术的经验，并表示在做出诊断时增加了信心。操作改进的单次曝光DES x射线探测器的参与者评论了对他们工作流程产生负面影响的问题。目前，完全集成系统的供应商的经验尚不清楚。

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引用次数: 0

Plasma-Based Comprehensive Genomic Profiling DNA Assays for Non-Small Cell Lung Cancer: A Health Technology Assessment. 基于血浆的非小细胞肺癌的综合基因组分析：一项健康技术评估。

Q1 Medicine

Ontario Health Technology Assessment Series

Pub Date : 2024-11-07 eCollection Date: 2024-01-01

Background: Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all lung cancer cases. While some cases of NSCLC with actionable genomic alterations in the tumour cells may respond to standard therapies, they often show greater improvement with targeted therapies. The current standard of care in Ontario involves testing for actionable genomic alterations using both DNA and RNA panels via tissue testing alone. However, liquid biopsy testing may complement tissue testing by addressing some of its limitations. We conducted a health technology assessment of liquid biopsy testing using DNA panels for people with NSCLC, which included an evaluation of analytical validity, clinical validity, clinical utility, cost-effectiveness, the budget impact of publicly funding this technology, 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 QUADAS-2, QUADAS-C, ROBINS-I, and ROBINS-E 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 search and conducted a cost-utility analysis of 4 potential liquid biopsy testing strategies in which liquid biopsy testing was added to tissue testing in various ways; our model used a 20-year time horizon and was conducted from a public payer perspective. We also analyzed the budget impact of publicly funding liquid biopsy testing for people with NSCLC in Ontario. To contextualize the potential value of liquid biopsy testing, we spoke with people with NSCLC and family members and care partners of people with NSCLC.Results: We included 61 studies in the clinical evidence review. Liquid biopsy testing demonstrated a modest sensitivity in detecting actionable genomic alterations in the BRAF, EGFR, ERBB2, and KRAS genes (GRADE: Moderate to High). However, for the other genes assessed, the sensitivity was either low or uncertain (GRADE: Very Low to High). Liquid biopsy testing also showed an overall high concordance with tissue testing (GRADE: High). Further, liquid biopsy testing was found to improve partial response rates, stable disease rates, and progressive disease rates for people with NSCLC with actionable genomic alterations who were receiving matched targeted therapies (GRADE: Moderate). However, we are uncertain about the clinical validity of liquid biopsy testing in predicting prognosis with standard therapies (GRADE: Very Low). Compared with tissue testing alone, we estimate that all 4 of the potential liquid biopsy testing strategies we evaluated would be more expensive and associated with an increase in quality-adjusted life-years (QALYs). The incremental cost-effectiveness ratio (ICER) of the strategy in which liq

背景：非小细胞肺癌（NSCLC）是最常见的肺癌类型，约占所有肺癌病例的85%。虽然一些具有可操作的肿瘤细胞基因组改变的非小细胞肺癌病例可能对标准治疗有反应，但它们通常在靶向治疗中表现出更大的改善。安大略目前的护理标准包括仅通过组织检测使用DNA和RNA面板检测可操作的基因组改变。然而，液体活检检测可以通过解决组织检测的一些局限性来补充组织检测。我们对非小细胞肺癌患者使用DNA面板进行液体活检检测进行了健康技术评估，包括分析效度、临床效度、临床效用、成本效益、公共资助该技术的预算影响以及患者偏好和价值的评估。方法：对临床证据进行系统的文献检索。我们使用QUADAS-2、QUADAS-C、ROBINS-I和ROBINS-E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学文献检索，并对4种可能的液体活检检测策略进行了成本效用分析，其中液体活检检测以各种方式加入到组织检测中；我们的模型使用了20年的时间范围，并从公共付款人的角度进行了研究。我们还分析了安大略省对非小细胞肺癌患者进行液体活检检测的公共资助对预算的影响。为了了解液体活检检测的潜在价值，我们与非小细胞肺癌患者、非小细胞肺癌患者的家庭成员和护理伙伴进行了交谈。结果：临床证据回顾纳入61项研究。液体活检检测显示，在检测BRAF、EGFR、ERBB2和KRAS基因中可操作的基因组改变方面具有适度的敏感性（等级：中等至高）。然而，对于评估的其他基因，敏感性低或不确定（等级：非常低到高）。液体活检测试也显示了与组织测试的总体高度一致性（GRADE：高）。此外，液体活检检测被发现可以改善接受匹配靶向治疗的具有可操作基因组改变的NSCLC患者的部分缓解率、稳定的疾病发生率和进展性疾病发生率（GRADE: Moderate）。然而，我们不确定液体活检检测在预测标准治疗预后方面的临床有效性（GRADE: Very Low）。与单独的组织检测相比，我们估计我们评估的所有4种潜在的液体活检检测策略都将更昂贵，并且与质量调整生命年（QALYs）的增加有关。仅为组织检测组织不足（“组织不足”）的人提供液体活检检测的策略的增量成本效益比（ICER）为每额外QALY 96,738美元；ICER对其他三种策略（“组织优先”、“液体优先”和“综合”）的估计都更高，分别为147,636美元、157,267美元和173,032美元。所有4种潜在的液体活检检测策略在每个获得的QALY的支付意愿（WTP）为50,000美元时，成本效益的机会低于1%；只有组织不足策略在WTP为100,000美元/ QALY的情况下具有超过50%的成本效益。我们估计，公共资助组织不足战略的5年预算影响将达到1372万美元。公开资助其他战略将导致5年预算影响从1.1013亿美元到1.3424亿美元不等。所有访谈对象的液体活检结果均为阳性。参与者认为液体活组织检查比组织检查侵入性小，同时接受组织和液体活组织检查的参与者认为液体活组织检查的结果周转时间更快。获得液体活检检测的障碍包括缺乏意识、成本和地理位置。结论：液体活检检测在检测BRAF、EGFR、ERBB2和KRAS基因的可操作基因组改变方面具有中高灵敏度（等级：中高），但对ALK、PIK3CA、MET、RET和ROS1基因的敏感性较低（等级：低到高）。该检查与组织检查的一致性较高（87%-99%），但可能遗漏一些阳性病例。我们不确定液体活检检测在预测标准治疗预后方面的临床有效性（GRADE: Very Low）。然而，我们发现靶向治疗提高了非小细胞肺癌患者的缓解率（GRADE：中等）和生存率（GRADE：低），这些患者通过液体活检检测出可操作的基因组改变。

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引用次数: 0

Level 2 Polysomnography for the Diagnosis of Sleep Disorders: A Health Technology Assessment. 用于诊断睡眠障碍的 2 级多导睡眠图：健康技术评估》。

Q1 Medicine

Ontario Health Technology Assessment Series

Pub Date : 2024-08-20 eCollection Date: 2024-01-01

Background: It is estimated that half of Canadians have insufficient sleep, which over time is associated with poor physical and mental health. Currently, the only publicly funded option for the diagnosis of sleep disorders in Ontario is an in-person overnight sleep study, performed in a hospital or independent health facility (known as a level 1 polysomnography). Level 2 polysomnography has been proposed as an alternative that can be conducted at home for the diagnosis of suspected sleep disorders, if considered to have sufficient diagnostic accuracy. We conducted a health technology assessment of level 2 polysomnography for the diagnosis of suspected sleep disorders in adults and children, which included an evaluation of the test performance, cost-effectiveness, and budget impact of publicly funding level 2 polysomnography, and the experiences, preferences, and values of people with suspected sleep disorders.Methods: We performed a systematic literature search of the clinical evidence to identify diagnostic accuracy, test failures and subjective measures of patient preferences. We assessed the risk of bias of each included study (using the Quality Assessment of Diagnostic Accuracy Studies [QUADAS-2] tool) and the quality of the body of evidence (according to Grading of Recommendations Assessment, Development, and Evaluation [GRADE] Working Group criteria). We performed a systematic literature search of economic evidence and conducted a primary economic evaluation and budget impact analysis to determine the cost-effectiveness and additional costs of publicly funding level 2 polysomnography for adults and children with suspected sleep disorders in Ontario. To contextualize the potential value of using level 2 polysomnography, we spoke with people with sleep disorders.Results: We included 10 studies that reported on diagnostic accuracy and found level 2 polysomnography had sensitivity ranging between 0.76-1.0 and specificity ranging between 0.40-1.0 (GRADE: Moderate to Very low) when compared with level 1 polysomnography. Studies reported test failure rates from 0% to 20%, with errors present in both level 1 and level 2 tests conducted (GRADE: Very low). As well, some of these studies reported patients were found to have mixed opinions about their experiences, with more people preferring their experience with level 2 testing at home and having better quality of sleep compared with when they underwent level 1 testing (GRADE not conducted).Our primary economic evaluation showed that for adults with suspected sleep disorders, the new diagnostic pathway with level 2 polysomnography was equally effective (outcome: confirmed diagnosis at the end of the pathway) as the current practice diagnostic pathway with level 1 polysomnography. With the assumption of a lower technical fee for level 2 polysomnography, the new diagnostic pathway with level 2 polysomnography was less costly than the c

对儿童 2 级多导睡眠图进行公共资助需要在未来 5 年内增加约 00.5 万美元的成本。为了提高成本效益和预算影响估算的确定性，需要更清楚地了解该技术的使用情况、测试成本以及采用该技术的实施途径。睡眠障碍患者强调，获得诊断对于他们寻求适当的睡眠障碍治疗和改善生活是多么重要。对于许多疑似睡眠障碍患者来说，在家中进行睡眠检查比在诊所进行睡眠检查更舒适、更方便。

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引用次数: 0

Pelvic Floor Muscle Training for Stress Urinary Incontinence, Fecal Incontinence, and Pelvic Organ Prolapse: A Health Technology Assessment. 针对压力性尿失禁、大便失禁和盆腔器官脱垂的盆底肌肉训练：健康技术评估》。

Q1 Medicine

Ontario Health Technology Assessment Series

Pub Date : 2024-08-05 eCollection Date: 2024-01-01

Background: Stress urinary incontinence, fecal incontinence, and pelvic organ prolapse are common forms of pelvic floor dysfunction. Pelvic floor muscle training is used to improve pelvic floor function, through a program of exercises. We conducted a health technology assessment of pelvic floor muscle training for people with stress urinary incontinence, fecal incontinence, or pelvic organ prolapse, which included an evaluation of effectiveness, safety, and the budget impact of publicly funding pelvic floor muscle training, and patient preferences and values.Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of included studies using the ROBIS tool, for systematic reviews, and the Cochrane Risk of Bias tool, for randomized controlled trials, and we assessed the quality of the body of evidence according to Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search but did not conduct a primary economic evaluation. We also analyzed the budget impact of publicly funding pelvic floor muscle training in adults with stress urinary incontinence, fecal incontinence, and pelvic organ prolapse in Ontario. To contextualize the potential value of pelvic floor muscle training as a treatment, we spoke with people with stress urinary incontinence, fecal incontinence, and pelvic organ prolapse.Results: We included 6 studies (4 systematic reviews and 2 randomized controlled trials) in the clinical evidence review. In comparison with no treatment, pelvic floor muscle training significantly improved symptom severity and increased patient satisfaction in women with stress urinary incontinence or pelvic organ prolapse (GRADE: Moderate). For men with stress urinary incontinence after prostatectomy, pelvic floor muscle training yielded mixed results for symptom improvement (GRADE: Very low). For adults with fecal incontinence, pelvic floor muscle training did not improve symptoms in comparison with standard care (GRADE: Very low).In the economic literature review, we included 6 cost-utility analyses that had evaluated the cost-effectiveness of pelvic floor muscle training as a treatment for people with pelvic organ prolapse or urinary incontinence. We did not identify any economic studies on pelvic floor muscle training for women or men with fecal incontinence or men with pelvic organ prolapse. The analyses included in our review found that, for women with stress urinary incontinence, pelvic floor muscle training was likely cost-effective in comparison with other nonsurgical interventions. For men with urinary incontinence after prostate surgery, pelvic floor muscle training was likely not cost-effective in comparison with standard care. For women with pelvic organ prolapse, the cost-effectiveness of pelvic floor muscle training in comparison with no acti

背景：压力性尿失禁、大便失禁和盆腔器官脱垂是盆底功能障碍的常见形式。盆底肌肉训练可通过一系列练习来改善盆底功能。我们对压力性尿失禁、大便失禁或盆腔器官脱垂患者进行了盆底肌肉训练的健康技术评估，其中包括对盆底肌肉训练的有效性、安全性、公共资助对预算的影响以及患者的偏好和价值观进行评估：我们对临床证据进行了系统的文献检索。对于系统性综述，我们使用 ROBIS 工具评估了纳入研究的偏倚风险；对于随机对照试验，我们使用 Cochrane 偏倚风险工具评估了纳入研究的偏倚风险。我们进行了系统的经济学文献检索，但没有进行主要的经济学评估。我们还分析了在安大略省对患有压力性尿失禁、大便失禁和盆腔器官脱垂的成人进行盆底肌肉训练的公共资助对预算的影响。为了说明盆底肌肉训练作为一种治疗方法的潜在价值，我们与压力性尿失禁、大便失禁和盆腔器官脱垂患者进行了交谈：我们在临床证据综述中纳入了 6 项研究（4 项系统综述和 2 项随机对照试验）。与不进行治疗相比，盆底肌肉训练能明显改善压力性尿失禁或盆腔器官脱垂女性患者的症状严重程度，并提高患者满意度（GRADE：中度）。对于前列腺切除术后出现压力性尿失禁的男性患者，盆底肌肉训练在改善症状方面的效果不一（评估等级：极低）。在经济文献综述中，我们纳入了 6 项成本效益分析，这些分析评估了盆底肌肉训练作为盆腔器官脱垂或尿失禁患者治疗方法的成本效益。我们没有发现任何针对女性或男性大便失禁患者或男性盆腔器官脱垂患者进行盆底肌肉训练的经济研究。我们的综述分析发现，对于患有压力性尿失禁的女性而言，与其他非手术干预措施相比，盆底肌肉训练可能具有成本效益。对于前列腺手术后出现尿失禁的男性患者，盆底肌肉训练与标准护理相比可能不具成本效益。对于患有盆腔器官脱垂的女性患者，盆底肌肉训练与不进行积极治疗相比，其成本效益并不确定。盆底肌肉训练的平均成本约为每位患者 763 美元。对患有压力性尿失禁、大便失禁和盆腔器官脱垂的女性进行盆底肌肉训练的公共资助将在 5 年内分别产生 1.853 亿美元、2.756 亿美元和 8580 万美元的额外费用。为患有压力性尿失禁和大便失禁的男性提供骨盆底肌肉训练的公共资金将在 5 年内分别导致 1,080 万美元和 1.311 亿美元的额外费用。与我们交谈过的人都表示，压力性尿失禁、大便失禁和盆腔器官脱垂限制了他们的社交和体育活动，给他们造成了巨大的精神伤害。许多人对手术犹豫不决甚至恐惧，而大多数有过盆底肌肉训练经历的人都表示，盆底肌肉训练缓解了他们的大部分或全部症状，使他们能够恢复正常的日常活动：结论：对于患有压力性尿失禁或盆腔器官脱垂的女性而言，盆底肌肉训练可能比不治疗更有效（在症状改善和患者满意度方面）。对于前列腺切除术后患有压力性尿失禁的男性患者，盆底肌肉训练在改善症状方面的效果可能好坏参半，而对于患有大便失禁的成人患者，盆底肌肉训练对改善症状几乎没有影响。我们估计，在安大略省为患有盆底功能障碍（压力性尿失禁、大便失禁和盆腔器官脱垂）的成年人提供盆底肌肉训练的公共资金将在未来 5 年内导致预算大幅增加。患有压力性尿失禁、大便失禁和盆腔器官脱垂的人都认为这些病症对他们的社会生活和物质生活造成了负面影响，并重视盆底肌肉训练这种非手术治疗方法。

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引用次数: 0

Fractional Exhaled Nitric Oxide Testing for the Diagnosis and Management of Asthma: a Health Technology Assessment. 用于哮喘诊断和管理的分量呼出一氧化氮检测：健康技术评估。

Q1 Medicine

Ontario Health Technology Assessment Series

Pub Date : 2024-07-31 eCollection Date: 2024-01-01

Background: Asthma is a common respiratory disease characterized by airflow obstruction caused by inflammation and narrowing of the airways. Nitric oxide is a gas that is present at low levels in the lungs, but that is elevated in the presence of airway inflammation. Fractional exhaled nitric oxide (FeNO) testing may help in the diagnosis and management of asthma by measuring the amount of nitric oxide in the breath. We conducted a health technology assessment of FeNO testing for the diagnosis and management of asthma in children and adults, which included an evaluation of the accuracy, effectiveness, cost-effectiveness, the budget impact of publicly funding FeNO testing, and patient preferences and values.Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Quality Assessment of Diagnostic Accuracy Studies tool, version 2 (QUADAS-2) and of each systematic review using the Risk of Bias Assessment Tool for Systematic Reviews (ROBIS). We evaluated the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted cost-utility analyses with a 20-year time horizon from a public payer perspective. We also analyzed the budget impact of publicly funding FeNO testing in children and adults in Ontario. To contextualize the potential value of FeNO testing, we spoke with people with asthma and their care partners.Results: We included 48 primary studies assessing the diagnostic accuracy of FeNO testing and 2 reviews evaluating the effectiveness of FeNO testing for asthma management in the clinical evidence review. The use of FeNO testing for the diagnosis of asthma reported variable (~30% to 90%) sensitivities (GRADE: Very low) and consistently high (~70% to 100%) specificities (GRADE: Low) in children and adults. FeNO testing for asthma management likely reduced exacerbations in children (GRADE: Moderate) and adults (GRADE: Moderate), lowered oral corticosteroid use in children (GRADE: Moderate), and slightly improved lung function in a mixed population (GRADE: Moderate), but little to no improvement was seen in other outcomes. We found that, for asthma diagnosis, FeNO testing in addition to standard testing is cost-effective in children, with an incremental cost-effectiveness ratio (ICER) of $6,192 per quality-adjusted life-year (QALY) gained. FeNO testing is not cost-effective for asthma diagnosis in adults except when a higher FeNO cut-off is applied. For asthma management, the ICER of FeNO testing compared with standard care alone is $103,893 per QALY gained in children and $200,135 per QALY gained in adults. Publicly funding FeNO testing as an adjunct to standard testing for asthma diagnosis over the next 5 years would cost about $0.10 million to $0.

由于 FeNO 检测与其他类型的哮喘检测相似，与我们交谈过的人都不知道自己是否有过使用 FeNO 检测的经历，但他们都表示很重视 FeNO 检测的潜力，认为它能提供更多有关病情的信息，并有助于哮喘的诊断和管理。

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引用次数: 0

Sucrose Octasulfate-Impregnated Dressings for Adults With Difficult-to-Heal Noninfected Diabetic Foot Ulcers and Difficult-to-Heal Noninfected Venous Leg Ulcers: A Health Technology Assessment. 用于成人难以愈合的非感染性糖尿病足溃疡和难以愈合的非感染性静脉腿部溃疡的蔗糖八硫酸盐浸渍敷料：健康技术评估》。

Q1 Medicine

Ontario Health Technology Assessment Series

Pub Date : 2024-05-08 eCollection Date: 2024-01-01

Background: Diabetic foot ulcers and venous leg ulcers may not always heal in a timely manner despite proper wound care. Treatments that improve the healing rate of these ulcers would improve clinical outcomes for patients and may result in downstream cost savings for the health care system. We conducted a health technology assessment of sucrose octasulfate-impregnated dressings for adults with difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding sucrose octasulfate-impregnated dressings, and patient preferences and values.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 (RoB 2) and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and analyzed the budget impact of publicly funding sucrose octasulfate-impregnated dressings for adults with difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers in Ontario. We did not conduct a primary economic evaluation because there is existing evidence to approximate the cost-effectiveness of sucrose octasulfate-impregnated dressings in Ontario. We leveraged 4 previous health technology assessments to explore the perspectives and experiences of patients with diabetic foot ulcers and venous leg ulcers, as well as the perspectives and experiences of their care partners.Results: We included 3 randomized controlled trials and 2 subsequent publications of these randomized controlled trials in the clinical evidence review. Compared with dressings that do not contain sucrose octasulfate, sucrose octasulfate-impregnated dressings result in faster wound closure in patients with difficult-to-heal noninfected neuroischemic diabetic foot ulcers (GRADE: Moderate) and reduce ulcer size and improve health-related quality of life in the domains of pain/discomfort and anxiety/depression for patients with difficult-to-heal noninfected venous leg ulcers (GRADE: Moderate). The use of sucrose octasulfate-impregnated dressings with noninfected wounds is considered safe (GRADE: Moderate).The economic evidence showed that, compared with dressings that do not contain sucrose octasulfate, sucrose octasulfate-impregnated dressings are highly likely to be cost-effective for both difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers and would lead to cost savings due to faster and increased complete wound healing. The annual budget impact of publicly funding sucrose octasulfate-impregnated dressings in Ontario over the next 5 y

目前尚不清楚参与者是否有使用八硫酸蔗糖浸渍敷料的直接经验，因此我们无法从偏好和价值观的证据中得出有关这些敷料的具体结论。

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引用次数: 0

Robotic-Assisted Surgery for Rectal Cancer: An Expedited Summary of the Clinical Evidence. 机器人辅助直肠癌手术：临床证据快速摘要》。

Q1 Medicine

Ontario Health Technology Assessment Series

Pub Date : 2024-04-08 eCollection Date: 2024-01-01

Background: Rectal cancer is a disease in which cancer cells form in the rectum, which has the primary function of temporarily storing feces, controlling defecation, and maintaining continence. Surgery is the most common treatment for rectal cancer; surgical approaches include open, laparoscopic, and robotic assisted. We conducted an expedited summary of the clinical evidence for robotic-assisted surgery for rectal cancer, which included an evaluation of effectiveness and safety.

Methods: We performed a systematic literature search of the clinical evidence to retrieve systematic reviews and randomized controlled trials (RCTs). We assessed the risk of bias in the included systematic reviews using AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews, version 2), and we assessed the risk of bias in the included RCT using the Cochrane Risk-of-Bias Tool for Randomized Trials, version 1. We reported the quality of the body of evidence as evaluated in the included systematic reviews according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group criteria if it was evaluated.

Results: We included 14 studies in the clinical evidence review (12 systematic reviews and 1 RCT on robotic-assisted vs. laparoscopic rectal cancer surgery and 1 systematic review on robotic-assisted vs. open rectal cancer surgery). Compared with laparoscopic rectal cancer surgery, robotic-assisted rectal cancer surgery may result in similar overall survival; similar rates of conversion, blood transfusion, and readmission,· reduced blood loss; shorter length of stay; and improved quality of life. Compared with open rectal cancer surgery, robotic-assisted rectal cancer surgery may result in similar overall survival, reduced blood loss, and shorter length of stay.

Conclusions: Robotic-assisted rectal cancer surgery may result in similar or improved clinical outcomes compared with laparoscopic and open rectal cancer surgery.

背景：直肠癌是一种癌细胞在直肠内形成的疾病，直肠的主要功能是暂时储存粪便、控制排便和保持大小便通畅。手术是直肠癌最常见的治疗方法；手术方法包括开腹、腹腔镜和机器人辅助手术。我们对机器人辅助手术治疗直肠癌的临床证据进行了快速总结，其中包括有效性和安全性评估：我们对临床证据进行了系统的文献检索，检索了系统综述和随机对照试验（RCT）。我们使用 AMSTAR 2（评估系统性综述的测量工具，第 2 版）评估了纳入的系统性综述的偏倚风险，并使用 Cochrane Risk-of-Bias Tool for Randomized Trials，第 1 版评估了纳入的 RCT 的偏倚风险。如果对纳入的系统性综述中的证据进行了评估，我们将根据推荐、评估、发展和评价分级（GRADE）工作组的标准对证据的质量进行报告：我们在临床证据综述中纳入了 14 项研究（12 项系统综述和 1 项 RCT，涉及机器人辅助直肠癌手术与腹腔镜直肠癌手术的对比；1 项系统综述，涉及机器人辅助直肠癌手术与开腹直肠癌手术的对比）。与腹腔镜直肠癌手术相比，机器人辅助直肠癌手术可能会带来相似的总生存率；相似的转院率、输血率和再入院率；减少失血；缩短住院时间；提高生活质量。与开放式直肠癌手术相比，机器人辅助直肠癌手术可获得相似的总生存率、减少失血量和缩短住院时间：与腹腔镜直肠癌手术和开腹直肠癌手术相比，机器人辅助直肠癌手术可能会带来相似或更好的临床效果。

{"title":"Robotic-Assisted Surgery for Rectal Cancer: An Expedited Summary of the Clinical Evidence.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"Background: Rectal cancer is a disease in which cancer cells form in the rectum, which has the primary function of temporarily storing feces, controlling defecation, and maintaining continence. Surgery is the most common treatment for rectal cancer; surgical approaches include open, laparoscopic, and robotic assisted. We conducted an expedited summary of the clinical evidence for robotic-assisted surgery for rectal cancer, which included an evaluation of effectiveness and safety.Methods: We performed a systematic literature search of the clinical evidence to retrieve systematic reviews and randomized controlled trials (RCTs). We assessed the risk of bias in the included systematic reviews using AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews, version 2), and we assessed the risk of bias in the included RCT using the Cochrane Risk-of-Bias Tool for Randomized Trials, version 1. We reported the quality of the body of evidence as evaluated in the included systematic reviews according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group criteria if it was evaluated.Results: We included 14 studies in the clinical evidence review (12 systematic reviews and 1 RCT on robotic-assisted vs. laparoscopic rectal cancer surgery and 1 systematic review on robotic-assisted vs. open rectal cancer surgery). Compared with laparoscopic rectal cancer surgery, robotic-assisted rectal cancer surgery may result in similar overall survival; similar rates of conversion, blood transfusion, and readmission,· reduced blood loss; shorter length of stay; and improved quality of life. Compared with open rectal cancer surgery, robotic-assisted rectal cancer surgery may result in similar overall survival, reduced blood loss, and shorter length of stay.Conclusions: Robotic-assisted rectal cancer surgery may result in similar or improved clinical outcomes compared with laparoscopic and open rectal cancer surgery.","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"24 3","pages":"1-45"},"PeriodicalIF":0.0,"publicationDate":"2024-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11031254/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140852175","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Intrathecal Drug Delivery Systems for Cancer Pain: A Health Technology Assessment. 治疗癌症疼痛的鞘内给药系统：健康技术评估。

Q1 Medicine

Ontario Health Technology Assessment Series

Pub Date : 2024-01-11 eCollection Date: 2024-01-01

Background: Pain is a common and very distressing symptom for adults and children with cancer. Compared with other routes of delivery, infusing pain medication directly into the intrathecal space around the spinal cord may reduce the incidence of systemic side effects and allow for more rapid and effective pain relief. We conducted a health technology assessment of intrathecal drug delivery systems (IDDSs) for adults and children with cancer pain, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding IDDSs, patient preferences and values, and ethical considerations.

Methods: We performed a systematic literature search of the clinical evidence to retrieve systematic reviews, and we selected and reported results from 2 recent reviews that were relevant to our research questions. We complemented the chosen systematic reviews with a literature search to identify primary studies published after December 2020. We used the Risk of Bias in Systematic Reviews (ROBIS) tool to assess the risk of bias of each included systematic review. We assessed the quality of the body of evidence according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-effectiveness analysis comparing IDDSs with standard care (i.e., non-IDDS methods of pain management) from a public payer perspective. We also analyzed the budget impact of publicly funding IDDSs in Ontario. To contextualize the potential value of IDDSs, we spoke with patients with cancer pain and with caregivers of patients with cancer pain. We explored ethical considerations from a review of published literature on the use of IDDSs for the management of cancer pain in adults and children as well as a review of the other components of this health technology assessment to identify ethical considerations relevant to the Ontario context.

Results: We included 2 systematic reviews (1 on adults and 1 on children) in the clinical evidence review. In adults with cancer pain who have a life expectancy greater than 6 months, intrathecal drug delivery was associated with a significant reduction in pain intensity compared with before implantation up to a 1-year follow-up (GRADE: Moderate to Low). Improved pain management appeared to be maintained beyond a 4-week follow-up. IDDSs likely decrease the use of systemic opioids (GRADE: Moderate to Low). They may also improve health-related quality of life (GRADE: Low), functional outcomes (GRADE: Low), and survival (GRADE: Low to Very low). In children with cancer pain, IDDSs may reduce pain intensity, improve functional outcomes, and improve survival, but the evidence is very uncertain (all GRADEs: Very low). IDDS implantation carries certain rare risks related to mechanical errors, drug-related side effects, and surgical complication

在安大略省，与资助和实施癌痛患者 IDDS 有关的考虑因素需要明确和重点关注癌痛诊断和管理以及使用、临床吸收和提供 IDDS 疼痛管理方面的公平性和可及性。

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引用次数: 0