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多汗症疾病严重程度测量——腋窝:项目内容的概念化与开发

The Hyperhidrosis Disease Severity Measure-Axillary: Conceptualization and Development of Item Content.

作者信息

Kirsch Brandon M, Burke Laurie, Hobart Jeremy, Angulo David, Walker Patricia S

出版信息

J Drugs Dermatol. 2018 Jul 1;17(7):707-714.

PMID:30005091
Abstract

INTRODUCTION

Patients with primary axillary hyperhidrosis (AHH) suffer from a variety of symptoms. Improved patient-reported outcome (PRO) measures are needed to better assess and categorize the severity of AHH symptoms experienced by patients because the widely used Hyperhidrosis Disease Severity Scale (HDSS) is a single-item measure that cannot capture the broad scope of disease impact.

METHODS

The Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) was developed for determining the severity of excessive sweating in patients with primary focal AHH based on face-to-face concept elicitation interviews with 58 AHH patients, a literature review, and expert clinical input. Two waves of face-to-face cognitive interviews (n=26 and n=27) were conducted to evaluate HDSM-Ax clarity and relevance. Additional interviews (n=5) were conducted to confirm content. Adding Rasch Measurement Theory (RMT) analyses allowed for an iterative streamlined approach to documenting content validity and other cross-sectional measurement properties of the new HDSM-Ax measurement.

RESULTS

The 11-item HDSM-Ax PRO scale (0-4 scale per item; 0-44 total scale) represents an AHH symptom range of 0 (no sweating) to 44 (worst possible sweating). Content validity of the HDSM-Ax was documented by showing that chronologically-grouped interviews demonstrated saturation in AHH symptom severity concepts. Cognitive debriefing interviews provided evidence that item content is complete, comprehensible, meaningful, and relevant. RMT-based exploration indicated that targeting of the HDSM-Ax was adequate, suggesting good matching between items and persons; item fit was adequate, suggesting a clinically cohesive scale; and items appeared to be stable between subgroups, thereby supporting a summary score.

CONCLUSIONS

The HDSM-Ax is a well-developed measure of AHH severity based on patient-reported signs and symptoms. It is a superior measure to the HDSS and can be used in clinical research and clinical practice to quantify changes in symptom severity in response to treatment. J Drugs Dermatol. 2018;17(7):707-714.

摘要

引言

原发性腋窝多汗症(AHH)患者会出现多种症状。由于广泛使用的多汗症疾病严重程度量表(HDSS)是一项单一指标测量方法,无法涵盖疾病影响的广泛范围,因此需要改进患者报告结局(PRO)测量方法,以更好地评估和分类患者所经历的AHH症状的严重程度。

方法

多汗症疾病严重程度测量-腋窝(HDSM-Ax)是基于对58例AHH患者进行面对面概念激发访谈、文献综述和专家临床意见而开发的,用于确定原发性局灶性AHH患者出汗过多的严重程度。进行了两轮面对面认知访谈(分别为26例和27例)以评估HDSM-Ax的清晰度和相关性。还进行了额外的访谈(5例)以确认内容。添加拉施测量理论(RMT)分析允许采用迭代简化方法来记录新HDSM-Ax测量的内容效度和其他横断面测量属性。

结果

11项HDSM-Ax PRO量表(每项0-4分;总分0-44分)代表了AHH症状范围从0(无出汗)到44(可能的最严重出汗)。通过显示按时间顺序分组的访谈在AHH症状严重程度概念上达到饱和,证明了HDSM-Ax的内容效度。认知反馈访谈提供了证据,表明项目内容完整、可理解、有意义且相关。基于RMT的探索表明,HDSM-Ax的针对性足够,表明项目与人群之间匹配良好;项目拟合度足够,表明量表具有临床连贯性;并且项目在亚组之间似乎稳定,从而支持汇总得分。

结论

HDSM-Ax是一种基于患者报告的体征和症状的成熟的AHH严重程度测量方法。它是比HDSS更好的测量方法,可用于临床研究和临床实践中,以量化症状严重程度随治疗的变化。《药物皮肤病学杂志》。2018年;17(7):707-714。

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