Lubeck D P, Gause D, Schein J R, Prebil L E, Potter L P
University of California, San Francisco 94143, USA.
Qual Life Res. 1999;8(1-2):121-9. doi: 10.1023/a:1026429012353.
Onychomycosis is a common nail disorder associated with pain, discomfort and varying degrees of physical impairment and loss of dexterity. Psychological and social limitations result from reactions of others to visible impairment. The goal of this research is to validate a questionnaire to measure the impact of toenail onychomycosis on health-related quality of life (HRQoL). One hundred and fifty onychomycosis patients were enrolled in an observational study at eight sites in the US. Attending physicians reported information on clinical status at enrolment. Patients completed a questionnaire covering HRQoL that included general and disease-specific items measuring the impact of onychomycosis on activities and appearance, plus problems and symptoms associated with toenail infection. The subscales of the instrument showed high internal consistency reliability (range = 0.63-0.95). Construct validity reflected the close association of physical functioning scores with onychomycosis impairment. Test-Retest reliability was good to excellent for all scales (ICC = 0.52-0.89). Discriminant validity was evidenced by persons who are younger and female reporting worse disease-specific HRQoL. Responsiveness to clinical change was noted for all disease-specific scale scores for improved patients. This instrument has demonstrated reliability, validity and responsiveness for use in observational and clinical studies of toenail onychomycosis patients. Data indicate that onychomycosis patients report significant pain and discomfort reflecting the need for HRQoL measurement.
甲癣是一种常见的指甲疾病，会导致疼痛、不适以及不同程度的身体功能受损和灵活性丧失。他人对明显损伤的反应会导致心理和社会限制。本研究的目的是验证一份问卷，以衡量趾甲甲癣对健康相关生活质量（HRQoL）的影响。150名甲癣患者在美国的8个地点参与了一项观察性研究。主治医生报告了入组时的临床状况信息。患者完成了一份涵盖HRQoL的问卷，其中包括一般项目和疾病特异性项目，用于测量甲癣对活动和外观的影响，以及与趾甲感染相关的问题和症状。该工具的子量表显示出较高的内部一致性信度（范围 = 0.63 - 0.95）。结构效度反映了身体功能得分与甲癣损伤之间的密切关联。所有量表的重测信度良好至优秀（组内相关系数 = 0.52 - 0.89）。年轻女性报告的疾病特异性HRQoL较差，证明了区分效度。改善患者的所有疾病特异性量表得分均显示出对临床变化的反应性。该工具已证明在趾甲甲癣患者的观察性和临床研究中具有可靠性、有效性和反应性。数据表明，甲癣患者报告了明显的疼痛和不适，这反映了对HRQoL测量的需求。
