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不良反应检索过滤器的有效性:药物与医疗器械对比

Effectiveness of adverse effects search filters: drugs versus medical devices.

作者信息

Farrah Kelly, Mierzwinski-Urban Monika, Cimon Karen

出版信息

J Med Libr Assoc. 2016 Jul;104(3):221-5. doi: 10.3163/1536-5050.104.3.007.

DOI:10.3163/1536-5050.104.3.007
PMID:27366123
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4915640/
Abstract

OBJECTIVE

The study tested the performance of adverse effects search filters when searching for safety information on medical devices, procedures, and diagnostic tests in MEDLINE and Embase.

METHODS

The sensitivity of 3 filters was determined using a sample of 631 references from 131 rapid reviews related to the safety of health technologies. The references were divided into 2 sets by type of intervention: drugs and nondrug health technologies. Keyword and indexing analysis were performed on references from the nondrug testing set that 1 or more of the filters did not retrieve.

RESULTS

For all 3 filters, sensitivity was lower for nondrug health technologies (ranging from 53%-87%) than for drugs (88%-93%) in both databases. When tested on the nondrug health technologies set, sensitivity was lower in Embase (ranging from 53%-81%) than in MEDLINE (67%-87%) for all filters. Of the nondrug records that 1 or more of the filters missed, 39% of the missed MEDLINE records and 18% of the missed Embase records did not contain any indexing terms related to adverse events. Analyzing the titles and abstracts of nondrug records that were missed by any 1 filter, the most commonly used keywords related to adverse effects were: risk, complications, mortality, contamination, hemorrhage, and failure.

CONCLUSIONS

In this study, adverse effects filters were less effective at finding information about the safety of medical devices, procedures, and tests compared to information about the safety of drugs.

摘要

目的

本研究测试了在MEDLINE和Embase中搜索医疗设备、手术和诊断测试的安全信息时,不良反应搜索过滤器的性能。

方法

使用来自131篇与健康技术安全性相关的快速综述的631篇参考文献样本,确定3种过滤器的敏感性。参考文献按干预类型分为两组:药物和非药物健康技术。对非药物测试集中1个或多个过滤器未检索到的参考文献进行关键词和索引分析。

结果

在两个数据库中,对于所有3种过滤器,非药物健康技术的敏感性(53%-87%)均低于药物(88%-93%)。在非药物健康技术集上进行测试时,所有过滤器在Embase中的敏感性(53%-81%)均低于MEDLINE(67%-87%)。在1个或多个过滤器遗漏的非药物记录中,39%的MEDLINE遗漏记录和18%的Embase遗漏记录不包含任何与不良事件相关的索引词。分析任何1个过滤器遗漏的非药物记录的标题和摘要,与不良反应相关的最常用关键词为:风险、并发症、死亡率、污染、出血和故障。

结论

在本研究中,与药物安全性信息相比,不良反应过滤器在查找医疗设备、手术和测试安全性信息方面效果较差。

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本文引用的文献

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The contribution of different information sources to identify adverse effects of a medical device: a case study using a systematic review of spinal fusion.不同信息来源对识别医疗器械不良反应的贡献:一项基于脊柱融合系统评价的案例研究
Int J Technol Assess Health Care. 2014 Oct;30(4):423-9. doi: 10.1017/S0266462314000506. Epub 2014 Nov 11.
2
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Syst Rev. 2014 Oct 13;3:113. doi: 10.1186/2046-4053-3-113.
3
The performance of adverse effects search filters in MEDLINE and EMBASE.不良事件检索过滤器在 MEDLINE 和 EMBASE 中的性能。
Health Info Libr J. 2012 Jun;29(2):141-51. doi: 10.1111/j.1471-1842.2012.00980.x. Epub 2012 Mar 14.
4
Sensitivity and precision of adverse effects search filters in MEDLINE and EMBASE: a case study of fractures with thiazolidinediones.在 MEDLINE 和 EMBASE 中搜索噻唑烷二酮类药物所致骨折不良反应的检索过滤器的灵敏度和精度:一项病例研究。
Health Info Libr J. 2012 Mar;29(1):28-38. doi: 10.1111/j.1471-1842.2011.00972.x. Epub 2011 Dec 19.
5
Developing efficient search strategies to identify reports of adverse effects in MEDLINE and EMBASE.制定有效的检索策略,以识别MEDLINE和EMBASE中不良反应的报告。
Health Info Libr J. 2006 Mar;23(1):3-12. doi: 10.1111/j.1471-1842.2006.00634.x.
6
Incomplete evidence: the inadequacy of databases in tracing published adverse drug reactions in clinical trials.证据不完整:临床试验中追踪已发表药物不良反应的数据库存在不足。
BMC Med Res Methodol. 2001;1:7. doi: 10.1186/1471-2288-1-7. Epub 2001 Sep 3.