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方法选择最佳证据,为 NICE 技术评估提供信息,该评估涉及用于治疗肝细胞癌的选择性内部放射疗法。

Methods for selecting the best evidence to inform a NICE technology appraisal on selective internal radiation therapies for hepatocellular carcinoma.

机构信息

Centre for Reviews and Dissemination, University of York, York, YO10 5DD, UK.

出版信息

Syst Rev. 2020 Aug 16;9(1):184. doi: 10.1186/s13643-020-01447-x.

Abstract

BACKGROUND

Systematic reviews of medical devices are particularly challenging as the quality of evidence tends to be more limited than evidence on pharmaceutical products. This article describes the methods used to identify, select and critically appraise the best available evidence on selective internal radiation therapy devices for treating hepatocellular carcinoma, to inform a technology appraisal for the National Institute for Health and Care Excellence.

METHODS

A comprehensive search of ten medical databases and six grey literature sources was undertaken to identify studies of three devices (TheraSphere®, SIR-Spheres® and QuiremSpheres®) for treating hepatocellular carcinoma. The large evidence base was scoped before deciding what level of evidence to include for data extraction and critical appraisal. The methodological quality of the included studies was assessed using criteria relevant to each study design.

RESULTS

Electronic searches identified 4755 records; over 1000 met eligibility criteria after screening titles and abstracts. A hierarchical process was used to scope these records, prioritising comparative studies over non-comparative studies, where available. One hundred ninety-four full papers were ordered; 64 met the eligibility criteria. For each intervention, studies were prioritised by study design and applicability to current UK practice, resulting in 20 studies subjected to critical appraisal and data extraction. Only two trials had a low overall risk of bias. In view of the poor quality of the research evidence, our technology appraisal focused on the two higher quality trials, including a thorough critique of their reliability and generalisability to current UK practice. The 18 poorer quality studies were briefly summarised; many were very small and results were often contradictory. No definitive conclusions could be drawn from the poorer quality research evidence available.

CONCLUSIONS

A systematic, pragmatic process was used to select and critically appraise the vast quantity of research evidence available in order to present the most reliable evidence on which to develop recommendations.

SYSTEMATIC REVIEW REGISTRATION

PROSPERO CRD42019128383.

摘要

背景

医疗器械的系统评价特别具有挑战性,因为证据质量往往比药物产品的证据质量更有限。本文描述了用于确定、选择和批判性评估治疗肝细胞癌的选择性内部放射治疗设备最佳可用证据的方法,为国家卫生与保健卓越研究所提供技术评估。

方法

对十个医学数据库和六个灰色文献来源进行了全面搜索,以确定治疗肝细胞癌的三种设备(TheraSphere®、SIR-Spheres®和QuiremSpheres®)的研究。在决定纳入数据提取和批判性评估的证据水平之前,对大量证据基础进行了范围界定。使用与每种研究设计相关的标准评估纳入研究的方法学质量。

结果

电子搜索确定了 4755 条记录;经过筛选标题和摘要后,有 1000 多条符合资格标准。使用层次过程对这些记录进行了范围界定,优先考虑有可比性的研究而不是非比较性的研究,只要有可用的。订购了 194 篇全文;其中 64 篇符合资格标准。对于每种干预措施,根据研究设计和对当前英国实践的适用性对研究进行了优先级排序,最终有 20 项研究进行了批判性评估和数据提取。只有两项试验的总体偏倚风险较低。鉴于研究证据质量较差,我们的技术评估侧重于两项质量较高的试验,包括对其可靠性和对当前英国实践的普遍性进行彻底的评估。对 18 项质量较差的研究进行了简要总结;许多研究规模较小,结果往往相互矛盾。无法从现有质量较差的研究证据中得出明确的结论。

结论

使用系统的、务实的方法选择和批判性评估大量可用的研究证据,以提供最可靠的证据,从而制定建议。

系统评价注册

PROSPERO CRD42019128383。

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