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使用电诱发复合动作电位进行人工耳蜗植入调试:系统评价。

Use of Electrically Evoked Compound Action Potentials for Cochlear Implant Fitting: A Systematic Review.

机构信息

ENT Department, Leiden University Medical Center, Leiden, The Netherlands.

Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.

出版信息

Ear Hear. 2018 May/Jun;39(3):401-411. doi: 10.1097/AUD.0000000000000495.

Abstract

OBJECTIVES

The electrically evoked compound action potential (eCAP) is widely used in the clinic as an objective measure to assess cochlear implant functionality. During the past decade, there has been increasing interest in applying eCAPs for fitting of cochlear implants. Several studies have shown that eCAP-based fitting can potentially replace time-consuming behavioral fitting procedures, especially in young children. However, a closer look to all available literature revealed that there is no clear consensus on the validity of this fitting procedure. This study evaluated the validity of eCAP-based fitting of cochlear implant recipients based on a systematic review of the recent literature.

DESIGN

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses were used to search the PubMed, Web of Science, and Cochrane Library databases. The term "eCAP" was combined with "cochlear implants," "thresholds," and "levels," in addition to a range of related terms. Finally, 32 studies met the inclusion criteria. These studies were evaluated on the risk of bias and, when possible, compared by meta-analysis.

RESULTS

Almost all assessed studies suffered from some form of risk of bias. Twenty-nine of the studies based their conclusion on a group correlation instead of individual subject correlations (analytical bias); 14 studies were unclear about randomization or blinding (outcome assessment bias); 9 studies provided no clear description of the populations used, for example, prelingually or postlingually implanted subjects (selection bias); and 4 studies had a high rate of loss (>10%) for patients or electrodes (attrition bias). Meta-analysis of these studies revealed a weak pooled correlation between eCAP thresholds and both behavioral T- and C-levels (r = 0.58 and r = 0.61, respectively).

CONCLUSIONS

This review shows that the majority of the assessed studies suffered from substantial shortcomings in study design and statistical analysis. Meta-analysis showed that there is only weak evidence to support the use of eCAP data for cochlear implant fitting purposes; eCAP thresholds are an equally weak predictor for both T- and C-levels. Based on this review, it can be concluded that research on eCAP-based fitting needs a profound reflection on study design and analysis to draw well-grounded conclusions about the validity of eCAP-based fitting of cochlear implant recipients.

摘要

目的

电诱发复合动作电位(eCAP)被广泛应用于临床,作为评估人工耳蜗功能的客观指标。在过去的十年中,人们对 eCAP 用于人工耳蜗植入的适配越来越感兴趣。一些研究表明,基于 eCAP 的适配有可能替代耗时的行为适配程序,尤其是在儿童中。然而,仔细研究所有可用的文献表明,对于这种适配程序的有效性尚无明确共识。本研究通过对近期文献的系统回顾,评估基于 eCAP 的人工耳蜗植入受者适配的有效性。

设计

本研究使用系统评价和荟萃分析的首选报告项目,在 PubMed、Web of Science 和 Cochrane Library 数据库中进行检索。将“eCAP”与“人工耳蜗”、“阈值”和“级别”结合使用,并结合了一系列相关术语。最终,有 32 项研究符合纳入标准。这些研究评估了偏倚风险,并在可能的情况下进行荟萃分析比较。

结果

几乎所有评估的研究都存在某种形式的偏倚风险。29 项研究基于组间相关性而非个体受试者相关性得出结论(分析偏倚);14 项研究对随机化或盲法不明确(结局评估偏倚);9 项研究未对使用的人群进行明确描述,例如,术前或术后植入的受试者(选择偏倚);4 项研究患者或电极的失访率( attrition bias)较高(>10%)。对这些研究的荟萃分析显示,eCAP 阈值与行为 T 级和 C 级之间存在较弱的总体相关性(r = 0.58 和 r = 0.61)。

结论

本综述表明,评估的大多数研究在研究设计和统计分析方面存在明显的缺陷。荟萃分析显示,只有微弱的证据支持将 eCAP 数据用于人工耳蜗适配目的;eCAP 阈值是 T 级和 C 级的弱预测因子。基于本综述,可以得出结论,关于基于 eCAP 的适配的研究需要对研究设计和分析进行深刻反思,以便就基于 eCAP 的人工耳蜗植入受者适配的有效性得出有充分依据的结论。

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