目的:由于可用的结果测量仪器(OMIs)种类繁多,对内收肌痉挛性发声障碍(AdSD)的语音质量的治疗效果的统一评估具有挑战性。欧洲喉科学会对语音质量评估的五种测量领域进行了分类:患者报告的结果测量,感知分析,声学分析,视觉分析,和空气动力学测量。这项研究的目的是为这些领域提出一个核心结果集(COS),能够系统评估治疗对AdSD患者语音质量的影响。
方法:PubMed,Embase,和Cochrane数据库搜索2019年7月之前发表的符合条件的研究.根据基于Consensus的标准选择有效性试验中的健康测量指标/核心结果指标的方案,对结果进行了系统分析。提出的COS是基于OMI的患病率,纳入研究的质量,良好测量性能的标准,以及与其他OMI域的相关性。
结果:共纳入76篇,几乎所有的研究和OMI都被发现是中等或低质量的。报告OMI相关性的19项研究显示出相互矛盾的结果。评估现有的最佳证据,我们提出的COS包括患者报告的结局指标(语音障碍指数),感知测量(等级,粗糙度,呼吸,应变,和语音中断)和声学测量(语音中断,语音发作时间,非周期性,和多参数算法)。
结论:对评估AdSD治疗效果的OMI进行了综述。基于这篇综述,提出了统一的COS。然而,选定仪器的证据有限。建议进一步探索用于AdSD的OMI的有效性和可靠性。
OBJECTIVE: Uniform evaluation of treatment effect on the quality of voice in adductor spasmodic dysphonia (AdSD) is challenging due to the broad variety of available outcome measurement instruments (OMIs). The European Laryngological Society categorized five types of measurement domains for voice quality evaluations: patient-reported outcome measures, perceptual analyses, acoustic analyses, visual analyses, and aerodynamic measurements. The aim of this study was to propose a core outcome set (COS) for these domains, enabling systematic assessments of treatment effects on the quality of voice in patients with AdSD.
METHODS: The PubMed, Embase, and Cochrane databases were searched for eligible studies published before July 2019. The results were systematically analyzed following the protocol of the COnsensus-based Standards for the selection of health Measurement INstruments/Core Outcome Measures in Effectiveness Trials initiative. The proposed COS is based on the prevalence of OMIs, quality of the included studies, criteria for good measurement properties, and correlations to other OMI domains.
RESULTS: A total of 76 articles were included, with nearly all studies and OMIs found to be of moderate or low quality. The 19 studies that reported on the correlation of OMIs demonstrated conflicting results. Appraising the best available evidence, our proposed COS consisted of patient-reported outcome measures (voice handicap index), perceptual measurements (grade, roughness, breathiness, strain, and voice breaks) and acoustic measurements (voice breaks, voice onset time, aperiodicity, and multiparameter algorithms).
CONCLUSIONS: A
review of OMIs evaluating treatment effects in AdSD was conducted. Based on this
review, a uniform COS was proposed. However, evidence for the selected instruments was limited. Further exploration into the validity and reliability of OMIs for AdSD is recommended.