用于疑似前列腺癌患者的经会阴活检设备--系统综述和经济评估。

IF 3.5 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES
Inês Souto-Ribeiro, Lois Woods, Emma Maund, David Alexander Scott, Joanne Lord, Joanna Picot, Jonathan Shepherd
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引用次数: 0

摘要

背景:疑似前列腺癌患者通常会在局部麻醉的情况下接受经直肠超声引导的前列腺活检或在全身麻醉的情况下接受经会阴前列腺活检。经会阴前列腺活检通常在全身麻醉下进行,因为手术会引起疼痛。不过,最近的研究表明,在局部麻醉下进行经会阴前列腺活检可以更好地识别前列腺特定区域的癌症,并降低感染率,同时还能在门诊环境下进行。辅助经会阴前列腺局部麻醉自由操作方法的设备也可帮助从业人员进行前列腺活检:评估对疑似前列腺癌患者进行经会阴局部麻醉前列腺活检与经直肠超声引导前列腺活检和全身麻醉经会阴前列腺活检的临床有效性和成本效益,以及在局部或全身麻醉下进行经直肠超声引导前列腺活检和经会阴前列腺活检与使用网格和步进装置进行经直肠超声引导前列腺活检和使用网格和步进装置进行经会阴前列腺活检的比较。数据来源和方法:我们对比较不同前列腺活检方法的诊断率和临床效果的研究进行了系统回顾。我们使用配对分析和网络荟萃分析来汇集癌症检出率方面的证据,并对其他结果进行了结构化叙述综合。在经济评估方面,我们审查了已发表和提交的证据,并建立了一个模型来评估不同活检方法的成本效益:我们纳入了 19 项比较研究(6 项随机对照试验和 13 项观察性比较研究)和 4 项关于徒手活检设备的单臂研究。经会阴局部麻醉前列腺活检(任何方法)与经直肠超声引导前列腺活检(相对风险 1.00,95% 置信区间 0.85 至 1.18)(n = 5 项随机对照试验)相比,癌症检出率无统计学差异。18)(n = 5 项随机对照试验),与经直肠超声引导的前列腺局部麻醉相比,使用徒手装置的经直肠前列腺局部麻醉也是如此(相对风险为 1.40,95% 置信区间为 0.96 至 2.04)(n = 1 项随机对照试验)。观察性研究的荟萃分析结果与之相似。经济分析表明,与局部麻醉经直肠超声引导前列腺相比,局部麻醉经会阴前列腺可能具有成本效益(每获得质量调整生命年的增量成本低于 20,000 英镑),与全身麻醉经会阴前列腺相比,成本更低,效果也不差。对于首次活检时磁共振成像 Likert 评分为 3 分或以上的患者,与局部麻醉经直肠超声引导前列腺相比,每质量调整生命年的增量成本为 743 英镑:局限性:在检测有临床意义的前列腺癌方面,疗效证据有限。PrecisionPoint™ 经会阴入路系统(BXTAccelyon 有限公司,英国伯纳姆)有比较证据,但其他徒手设备的证据有限或没有证据。其他结果的证据也很稀少。成本效益结果对癌症检出率、并发症发生率、采用不同活检方法采集的核心样本数量以及处理这些样本的成本等不确定性非常敏感:结论:在局部麻醉下进行经会阴前列腺活检与在局部麻醉下进行经直肠超声引导前列腺活检在检测前列腺癌方面具有同等效率,但使用徒手活检设备的效果可能更好。经会阴局部麻醉的前列腺活检与尿潴留型并发症有关,而经直肠局部麻醉超声引导的前列腺活检感染率较高。与经直肠局部麻醉超声引导的前列腺活检相比,使用徒手器械进行经会阴局部麻醉的前列腺活检似乎符合常规的成本效益水平:本研究注册为 PROSPERO CRD42021266443:该奖项由国家健康与护理研究所(NIHR)证据合成计划(NIHR奖项编号:NIHR134220)资助,全文发表于《健康技术评估》第28卷第60期。如需了解更多奖项信息,请参阅 NIHR Funding and Awards 网站。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Transperineal biopsy devices in people with suspected prostate cancer - a systematic review and economic evaluation.

Background: People with suspected prostate cancer are usually offered either a local anaesthetic transrectal ultrasound-guided prostate biopsy or a general anaesthetic transperineal prostate biopsy. Transperineal prostate biopsy is often carried out under general anaesthetic due to pain caused by the procedure. However, recent studies suggest that performing local anaesthetic transperineal prostate biopsy may better identify cancer in particular regions of the prostate and reduce infection rates, while being carried out in an outpatient setting. Devices to assist with freehand methods of local anaesthetic transperineal prostate may also help practitioners performing prostate biopsies.

Objectives: To evaluate the clinical effectiveness and cost-effectiveness of local anaesthetic transperineal prostate compared to local anaesthetic transrectal ultrasound-guided prostate and general anaesthetic transperineal prostate biopsy for people with suspected prostate cancer, and local anaesthetic transperineal prostate with specific freehand devices in comparison with local anaesthetic transrectal ultrasound-guided prostate and transperineal prostate biopsy conducted with a grid and stepping device conducted under local or general anaesthetic.

Data sources and methods: We conducted a systematic review of studies comparing the diagnostic yield and clinical effectiveness of different methods for performing prostate biopsies. We used pairwise and network meta-analyses to pool evidence on cancer detection rates and structured narrative synthesis for other outcomes. For the economic evaluation, we reviewed published and submitted evidence and developed a model to assess the cost-effectiveness of the different biopsy methods.

Results: We included 19 comparative studies (6 randomised controlled trials and 13 observational comparative studies) and 4 single-arm studies of freehand devices. There were no statistically significant differences in cancer detection rates for local anaesthetic transperineal prostate (any method) compared to local anaesthetic transrectal ultrasound-guided prostate (relative risk 1.00, 95% confidence interval 0.85 to 1.18) (n = 5 randomised controlled trials), as was the case for local anaesthetic transperineal prostate with a freehand device compared to local anaesthetic transrectal ultrasound-guided prostate (relative risk 1.40, 95% confidence interval 0.96 to 2.04) (n = 1 randomised controlled trial). Results of meta-analyses of observational studies were similar. The economic analysis indicated that local anaesthetic transperineal prostate is likely to be cost-effective compared with local anaesthetic transrectal ultrasound-guided prostate (incremental cost below £20,000 per quality-adjusted life-year gained) and less costly and no less effective than general anaesthetic transperineal prostate. local anaesthetic transperineal prostate with a freehand device is likely to be the most cost-effective strategy: incremental cost versus local anaesthetic transrectal ultrasound-guided prostate of £743 per quality-adjusted life-year for people with magnetic resonance imaging Likert score of 3 or more at first biopsy.

Limitations: There is limited evidence for efficacy in detecting clinically significant prostate cancer. There is comparative evidence for the PrecisionPoint™ Transperineal Access System (BXTAccelyon Ltd, Burnham, UK) but limited or no evidence for the other freehand devices. Evidence for other outcomes is sparse. The cost-effectiveness results are sensitive to uncertainty over cancer detection rates, complication rates and the numbers of core samples taken with the different biopsy methods and the costs of processing them.

Conclusions: Transperineal prostate biopsy under local anaesthetic is equally efficient at detecting prostate cancer as transrectal ultrasound-guided prostate biopsy under local anaesthetic but it may be better with a freehand device. local anaesthetic transperineal prostate is associated with urinary retention type complications, whereas local anaesthetic transrectal ultrasound-guided prostate has a higher infection rate. local anaesthetic transperineal prostate biopsy with a freehand device appears to meet conventional levels of costeffectiveness compared with local anaesthetic transrectal ultrasound-guided prostate.

Study registration: This study is registered as PROSPERO CRD42021266443.

Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR134220) and is published in full in Health Technology Assessment Vol. 28, No. 60. See the NIHR Funding and Awards website for further award information.

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来源期刊
Health technology assessment
Health technology assessment 医学-卫生保健
CiteScore
6.90
自引率
0.00%
发文量
94
审稿时长
>12 weeks
期刊介绍: Health Technology Assessment (HTA) publishes research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS.
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