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反流症状评分短版的制定与验证:反流症状评分-12。

Development and Validation of the Short Version of the Reflux Symptom Score: Reflux Symptom Score-12.

机构信息

Research Committee of the Young Otolaryngologists, International Federations of ORL Societies, Paris, France.

Department of Human Anatomy and Experimental Oncology, School of Medicine, UMONS Research Institute for Health Sciences and Technology, University of Mons, Mons, Belgium.

出版信息

Otolaryngol Head Neck Surg. 2021 Jan;164(1):166-174. doi: 10.1177/0194599820941003. Epub 2020 Jul 21.

DOI:10.1177/0194599820941003
PMID:32689876
Abstract

OBJECTIVE

To develop and validate a short version of the Reflux Symptom Score-the 12-question Reflux Symptom Score-12 (RSS-12)-for patients with laryngopharyngeal reflux disease (LPR).

STUDY DESIGN

Prospective study.

SETTING

Multicenter academic hospitals.

METHODS

Patients with LPR diagnosed via multichannel intraluminal impedance pH monitoring were enrolled from 3 European hospitals. Healthy individuals completed the study. Individuals completed the Reflux Symptom Score, Reflux Symptom Index (RSI), and Voice Handicap Index (VHI) at baseline and 3 months posttreatment. The Reflux Symptom Score was completed twice within a 7-day period to assess test-retest reliability. Cronbach's α was used for assessing internal consistency. The RSS-12 was developed and validity assessed through a comparison of the RSS-12, RSI, and VHI. Responsiveness to change was evaluated through the pre- to posttreatment evolution of the RSS-12 total score. Receiver operating characteristic analysis was used to determine the RSS-12 threshold that is suggestive of LPR.

RESULTS

The RSS-12 was characterized by high test-retest reliability ( = 0.956) and adequate internal consistency reliability (α = 0.739). The RSS-12 was significantly correlated with the RSI ( = 0.845), suggesting high external validity. The RSS-12 total and item scores were significantly higher in patients with LPR as compared with healthy individuals ( = .001), supporting high internal validity. RSS-12, VHI, and RSI significantly improved throughout treatment. Regarding the receiver operating characteristic curve, an RSS-12 score >11 is suggestive of LPR, exhibiting a sensitivity of 94.5% and a specificity of 86.2%.

CONCLUSION

The RSS-12 is a shorter, reliable, and valid self-administered patient-reported outcome measure questionnaire that can be used in the outpatient setting to suggest and monitor LPR.

摘要

目的

为喉咽反流病(LPR)患者开发并验证反流症状评分的简短版本-12 项反流症状评分-12(RSS-12)。

研究设计

前瞻性研究。

设置

多中心学术医院。

方法

通过多通道腔内阻抗 pH 监测诊断为 LPR 的患者从 3 家欧洲医院招募。健康个体完成了这项研究。个体在基线和治疗后 3 个月完成反流症状评分、反流症状指数(RSI)和嗓音障碍指数(VHI)。在 7 天内完成两次反流症状评分以评估测试-重测信度。Cronbach's α 用于评估内部一致性。通过比较 RSS-12、RSI 和 VHI 来开发和评估 RSS-12 的有效性。通过 RSS-12 总分在治疗前后的演变来评估对变化的反应能力。使用接收者操作特征分析来确定提示 LPR 的 RSS-12 阈值。

结果

RSS-12 的测试-重测可靠性高( = 0.956),内部一致性可靠性适中(α = 0.739)。RSS-12 与 RSI 显著相关( = 0.845),表明具有较高的外部有效性。与健康个体相比,LPR 患者的 RSS-12 总分和条目得分明显更高( = 0.001),支持较高的内部有效性。RSS-12、VHI 和 RSI 在整个治疗过程中均显著改善。关于接收者操作特征曲线,RSS-12 评分 >11 提示 LPR,具有 94.5%的敏感性和 86.2%的特异性。

结论

RSS-12 是一种简短、可靠且有效的自我管理的患者报告结局测量问卷,可用于门诊环境中提示和监测 LPR。

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