10-kHz High-Frequency Spinal Cord Stimulation for Adults With Chronic Noncancer Pain: A Health Technology Assessment.

Q1 Medicine
Ontario Health Technology Assessment Series Pub Date : 2020-03-06 eCollection Date: 2020-01-01
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引用次数: 0

Abstract

Background: Chronic pain is costly for patients and for the health care system. It negatively affects people's physical, emotional, social, and mental health. We conducted a health technology assessment of 10-kHz high-frequency spinal cord stimulation (SCS) in adults with chronic noncancer pain that was refractory to medical management, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding 10-kHz high-frequency SCS, 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 and ROBINS-I 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. We analyzed the 5-year budget impact of publicly funding 10-kHz high-frequency SCS in Ontario for adults with chronic noncancer pain who had already tried other available SCS therapies (up to 1.2 kHz). To contextualize the potential value of 10-kHz high-frequency SCS, we spoke with people who had chronic noncancer pain.

Results: We included 5 studies (7 publications) in the clinical evidence review. Overall, 10-kHz high-frequency SCS likely provides reductions in pain intensity and functional disability, and improvements in quality of life in people with chronic noncancer pain (GRADE: Moderate). As well, patients may reduce their opioid consumption with 10-kHz high-frequency SCS (GRADE: Low). The two included economic evaluations found that 10-kHz high-frequency SCS was cost-saving compared with conventional SCS, but neither was applicable to the Ontario context. Owing to limited evidence about the effectiveness of 10-kHz high-frequency SCS in people who have first tried and failed SCS at lower frequencies (up to 1.2 kHz), we did not conduct a cost-effectiveness analysis comparing this pathway of care and 10-kHz high-frequency SCS for Ontario. Publicly funding 10-kHz high-frequency SCS (using the Freedom SCS system) in Ontario over the next 5 years would lead to a total net cost savings of $0.73 million (ranging from about $0.10 million in year 1 to about $0.21 million in year 5). However, if the province outsourced this therapy using the Senza HF10 SCS system, the total 5-year budget impact would be about $8.76 million. The people we spoke with who had chronic noncancer pain reported that their pain had a substantial negative impact on their activities and emotional well-being. Their direct knowledge of different pain therapies allowed them to provide context and comparisons when they discussed the impact of SCS on their chronic pain.

Conclusions: For adults with chronic noncancer pain that was refractory to medical management, 10-kHz high-frequency SCS was effective in relieving pain, reducing disability, and improving quality of life. Because there was limited evidence about the effectiveness of 10-kHz high-frequency SCS in people who had first tried and failed SCS at lower frequencies (up to 1.2 kHz), we were unable to determine whether 10-kHz high-frequency SCS is cost-effective in the Ontario context. We estimate that publicly funding 10-kHz high-frequency SCS in Ontario would result in cost savings of about $0.10 million to $0.21 million per year, for a potential total 5-year net cost savings of about $0.73 million. Although people with chronic noncancer pain knew little about SCS before they received it, they reported that it reduced their level of chronic pain, leading to improvements in function and their ability to perform activities of daily living.

10 kHz 高频脊髓刺激治疗成人慢性非癌性疼痛:健康技术评估。
背景:慢性疼痛对患者和医疗保健系统来说代价高昂。它对人们的身体、情绪、社交和心理健康造成了负面影响。我们对10千赫兹高频脊髓刺激(SCS)治疗药物治疗难治的慢性非癌症疼痛成人患者进行了健康技术评估,其中包括对有效性、安全性、成本效益、10千赫兹高频SCS公共资助对预算的影响以及患者的偏好和价值进行评估:我们对临床证据进行了系统的文献检索。我们使用 Cochrane Risk of Bias 和 ROBINS-I 工具评估了每项纳入研究的偏倚风险,并根据建议评估、发展和评价分级(GRADE)工作组标准评估了证据的质量。我们进行了系统的经济文献检索。我们分析了安大略省政府资助 10 kHz 高频 SCS 对已尝试过其他 SCS疗法(最高 1.2 kHz)的慢性非癌性疼痛成人患者 5 年预算的影响。为了了解 10 kHz 高频 SCS 的潜在价值,我们与慢性非癌症疼痛患者进行了交谈:我们在临床证据审查中纳入了 5 项研究(7 篇论文)。总体而言,10 千赫兹高频自律神经刺激疗法可能会减轻慢性非癌症疼痛患者的疼痛强度和功能障碍,并改善其生活质量(GRADE:中度)。此外,患者使用 10 kHz 高频 SCS 可能会减少阿片类药物的用量(等级评定:低)。纳入的两项经济评估发现,与传统的 SCS 相比,10 千赫高频 SCS 可以节约成本,但这两项评估均不适用于安大略省的情况。由于有关 10 kHz 高频 SCS 对首次尝试低频(最高 1.2 kHz)SCS 但失败者的有效性的证据有限,我们没有对安大略省的这一护理途径和 10 kHz 高频 SCS 进行成本效益分析比较。未来 5 年,安大略省对 10 千赫兹高频 SCS(使用 Freedom SCS 系统)进行公共资助,将总共净节省 73 万美元的成本(从第 1 年的约 10 万美元到第 5 年的约 21 万美元不等)。但是,如果该省使用 Senza HF10 SCS 系统外包这种疗法,5 年的预算影响总额将达到约 876 万美元。与我们交谈过的慢性非癌症疼痛患者表示,疼痛对他们的活动和情绪产生了很大的负面影响。他们对不同疼痛疗法的直接了解使他们在讨论 SCS 对其慢性疼痛的影响时能够提供背景情况并进行比较:结论:对于药物治疗无效的慢性非癌症疼痛成人患者,10 千赫高频 SCS 能有效缓解疼痛、减少残疾并改善生活质量。由于有关 10 kHz 高频 SCS 对首次尝试低频(最高 1.2 kHz)SCS 但失败者的有效性的证据有限,我们无法确定 10 kHz 高频 SCS 在安大略省是否具有成本效益。我们估计,在安大略省公开资助 10 千赫高频 SCS 每年可节省约 10 万至 21 万加元的成本,5 年的净成本节省总额可能约为 73 万加元。尽管慢性非癌性疼痛患者在接受 SCS 治疗前对其知之甚少,但他们报告称,SCS 治疗降低了他们的慢性疼痛程度,从而改善了他们的功能和日常生活能力。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Ontario Health Technology Assessment Series
Ontario Health Technology Assessment Series Medicine-Medicine (miscellaneous)
CiteScore
4.60
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