Vila Peter M, Hullar Timothy E, Buchman Craig A, Lieu Judith E C
Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri, USA
Department of Otolaryngology-Head and Neck Surgery, Oregon Health and Science University, Portland, Oregon, USA.
Otolaryngol Head Neck Surg. 2016 Aug;155(2):238-45. doi: 10.1177/0194599816641382. Epub 2016 Apr 5.
To determine the breadth of outcome domains used in the reporting of adult cochlear implant surgery for the purpose of registry and quality measure development.
Systematic review of randomized controlled trials.
In consultation with a medical librarian, search strategies were constructed to identify randomized controlled trials studying adults undergoing cochlear implantation. MEDLINE, EMBASE, Scopus, CINAHL, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, and the Database of Abstracts of Reviews of Effects were searched from database inception to July 2015. Studies were evaluated for level of evidence and risk of bias with the Cochrane Collaboration's Risk of Bias Tool, and outcome domains were extracted from each study.
Of 4473 unique citations found, 8 studies were included in this review. All 8 trials were evidence level 1B. Risk of bias was low in 2 trials and high in the other 6. Reported outcome domains included speech perception in quiet and noise, speech tracking, quality of life, timbre perception, hearing preservation, vestibular function, electrode insertion technique, functional measures, functional imaging, fitting time, and tinnitus.
An analysis of randomized controlled trials studying cochlear implantation in adults yielded a wide spectrum of outcome domains. This is the first study to comprehensively describe the breadth of outcome domains in adult cochlear implantation. Validated instruments from these domains could be considered for potential inclusion as quality measures and registry use.
为了登记注册及制定质量指标,确定成人人工耳蜗植入手术报告中所使用的结果领域范围。
对随机对照试验的系统评价。
与医学图书馆员协商后,构建检索策略以识别研究接受人工耳蜗植入的成人的随机对照试验。检索了MEDLINE、EMBASE、Scopus、CINAHL、Cochrane系统评价数据库、Cochrane对照试验中心注册库以及循证医学数据库,检索时间从各数据库建库至2015年7月。使用Cochrane协作网的偏倚风险工具对研究进行证据水平和偏倚风险评估,并从每项研究中提取结果领域。
在检索到的4473条独特文献中,本评价纳入了8项研究。所有8项试验的证据水平均为1B级。2项试验的偏倚风险较低,另外6项试验的偏倚风险较高。报告的结果领域包括安静和噪声环境下的言语感知、言语跟踪、生活质量、音色感知、听力保留、前庭功能、电极插入技术、功能测量、功能成像、调试时间和耳鸣。
对研究成人人工耳蜗植入的随机对照试验进行分析,得出了广泛的结果领域。这是第一项全面描述成人人工耳蜗植入结果领域范围的研究。这些领域经过验证的工具可考虑作为质量指标和登记注册使用而被纳入。