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基于锚定和分布方法确定的中文版耳鸣问卷的最小临床重要差异。

Minimal clinically important difference for the Mandarin version of the Tinnitus Questionnaire determined via anchor-based and distribution-based methods.

机构信息

Department of Otolaryngology-Head and Neck Surgery, Hearing Center/Hearing and Speech Science Laboratory, West China Hospital of Sichuan University, 37 Guo Xue Lane, Chengdu, 610041, Sichuan, People's Republic of China.

West China Hospital/West China Medical School, Sichuan University, Chengdu, Sichuan, People's Republic of China.

出版信息

Health Qual Life Outcomes. 2022 Nov 30;20(1):157. doi: 10.1186/s12955-022-02072-z.

Abstract

BACKGROUND

The previous study showed that the Mandarin Tinnitus Questionnaire (MTQ) has satisfactory reliability and validity. We have also completed the classification of the severity of tinnitus based on MTQ scores. In clinical studies, efficacy is often judged by whether results are statistically significant; however, statistical significance does not necessarily equate to clinical significance, whereas the minimum clinically important difference (MCID) of the scale does. In the following project, we will explore the MCID of the MTQ.

METHODS

We recruited participants aged 18 years and above who sought treatment for primary or secondary tinnitus at the Otorhinolaryngology Department of the Hearing Center of West China Hospital, Sichuan University from September 2020 to September 2021. The participants had to undergo the following four assessments of tinnitus severity: doctor evaluation, self-report, the MTQ, and the visual analog scale (VAS), all at baseline and at the follow-up. The MCIDs of the MTQ were established via anchor-based and distribution-based methods. The anchor method used the VAS and self-reported clinical impression as anchors and defined the treatment effectiveness by mean/median and receiver operating characteristic (ROC) curve, while methods of effect size (ES), standard error of measurement (SEM), and reliability change index (RCI) were used in distribution-based methods.

RESULTS

A total of 115 patients were investigated in this study, 57.4% of whom were women. The average age was 43.2 ± 13.20 years. The average MTQ and VAS scores at baseline were 31.3 ± 14.90 and 5.03 ± 2.24, respectively, while the average MTQ and VAS scores at follow-up were 15.9 ± 11.70 and 3.58 ± 2.48, respectively. Moreover, in terms of self-reported clinical impressions, 19 patients indicated that they were cured (16.5%), 24 that it was much better (20.9%), 63 that there was no change (54.8%), and 9 that it was much worse (7.8%). The MCIDs for the change in total MTQ ranged from 6.29 to 19.00, those for improvement from 1.09 to 22.75, and those for deterioration from 3.50 to 7.64.

CONCLUSION

We selected an absolute value of 7.5 as the MCID for the MTQ score. An increase in MTQ score more than 7.5 was considered aggravation of tinnitus, and a decrease in MTQ score more than 7.5 was considered a reduction in tinnitus.

摘要

背景

先前的研究表明,普通话耳鸣问卷(MTQ)具有令人满意的信度和效度。我们已经完成了基于 MTQ 分数的耳鸣严重程度分类。在临床研究中,疗效通常通过结果是否具有统计学意义来判断;然而,统计学意义并不一定等同于临床意义,而量表的最小临床重要差异(MCID)则是。在以下项目中,我们将探讨 MTQ 的 MCID。

方法

我们招募了 2020 年 9 月至 2021 年 9 月在四川大学华西医院听力中心耳鼻喉科因原发性或继发性耳鸣就诊的年龄在 18 岁及以上的参与者。参与者必须接受以下四项耳鸣严重程度评估:医生评估、自我报告、MTQ 和视觉模拟量表(VAS),所有评估均在基线和随访时进行。MTQ 的 MCIDs 通过锚定和分布两种方法确定。锚定法使用 VAS 和自我报告的临床印象作为锚定点,通过均值/中位数和接收器工作特征(ROC)曲线来定义治疗效果,而效应量(ES)、测量误差标准(SEM)和可靠性变化指数(RCI)方法则用于分布法。

结果

本研究共调查了 115 名患者,其中 57.4%为女性。平均年龄为 43.2±13.20 岁。基线时 MTQ 和 VAS 的平均评分分别为 31.3±14.90 和 5.03±2.24,随访时 MTQ 和 VAS 的平均评分分别为 15.9±11.70 和 3.58±2.48。此外,就自我报告的临床印象而言,19 名患者表示已治愈(16.5%),24 名患者表示明显好转(20.9%),63 名患者表示无变化(54.8%),9 名患者表示恶化(7.8%)。总 MTQ 变化的 MCID 范围为 6.29 至 19.00,改善的 MCID 范围为 1.09 至 22.75,恶化的 MCID 范围为 3.50 至 7.64。

结论

我们选择 7.5 的绝对值作为 MTQ 评分的 MCID。MTQ 评分增加超过 7.5 被认为是耳鸣加重,MTQ 评分减少超过 7.5 被认为是耳鸣减轻。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc6f/9710156/ad238f15c994/12955_2022_2072_Fig1_HTML.jpg

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