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一种用于有症状髋病的年轻、活跃患者的自我管理生活质量结局测量工具的开发和验证:国际髋关节结局工具(iHOT-33)。

The Development and validation of a self-administered quality-of-life outcome measure for young, active patients with symptomatic hip disease: the International Hip Outcome Tool (iHOT-33).

机构信息

University of Calgary Sport Medicine Centre, Calgary, Alberta, Canada.

出版信息

Arthroscopy. 2012 May;28(5):595-605; quiz 606-10.e1. doi: 10.1016/j.arthro.2012.03.013.

DOI:10.1016/j.arthro.2012.03.013
PMID:22542433
Abstract

PURPOSE

The purpose of this study was to develop a self-administered evaluative tool to measure health-related quality of life in young, active patients with hip disorders.

METHODS

This outcome measure was developed for active patients (aged 18 to 60 years, Tegner activity level ≥ 4) presenting with a variety of symptomatic hip conditions. This multicenter study recruited patients from international hip arthroscopy and arthroplasty surgeon practices. The outcome was created using a process of item generation (51 patients), item reduction (150 patients), and pretesting (31 patients). The questionnaire was tested for test-retest reliability (123 patients); face, content, and construct validity (51 patients); and responsiveness over a 6-month period in post-arthroscopy patients (27 patients).

RESULTS

Initially, 146 items were identified. This number was reduced to 60 through item reduction, and the items were categorized into 4 domains: (1) symptoms and functional limitations; (2) sports and recreational physical activities; (3) job-related concerns; and (4) social, emotional, and lifestyle concerns. The items were then formatted using a visual analog scale. Test-retest reliability showed Pearson correlations greater than 0.80 for 33 of the 60 questions. The intraclass correlation statistic was 0.78, and the Cronbach α was .99. Face validity and content validity were ensured during development, and construct validity was shown with a correlation of 0.81 to the Non-Arthritic Hip Score. Responsiveness was shown with a paired t test (P ≤ .01), effect size of 2.0, standardized response mean of 1.7, responsiveness ratio of 6.7, and minimal clinically important difference of 6 points.

CONCLUSIONS

We have developed a new quality-of-life patient-reported outcome measure, the 33-item International Hip Outcome Tool (iHOT-33). This questionnaire uses a visual analog scale response format designed for computer self-administration by young, active patients with hip pathology. Its development has followed the most rigorous methodology involving a very large number of patients. The iHOT-33 has been shown to be reliable; shows face, content, and construct validity; and is highly responsive to clinical change. In our opinion the iHOT-33 can be used as a primary outcome measure for prospective patient evaluation and randomized clinical trials.

摘要

目的

本研究旨在开发一种自评工具,用于评估患有髋关节疾病的年轻、活跃患者的健康相关生活质量。

方法

该结局测量工具适用于患有各种髋关节症状的年轻(18 岁至 60 岁)、活跃(Tegner 活动水平≥4)患者。该多中心研究招募了来自国际髋关节关节镜和关节置换外科医生的患者。该结果通过生成项目(51 例患者)、项目缩减(150 例患者)和预测试(31 例患者)的过程创建。问卷的测试包括重测信度(123 例患者)、表面效度、内容效度和结构效度(51 例患者),以及关节镜术后 6 个月的反应性(27 例患者)。

结果

最初确定了 146 个项目。通过项目缩减,将数量减少到 60 个,然后将项目分为 4 个领域:(1)症状和功能限制;(2)运动和娱乐性体育活动;(3)与工作相关的问题;(4)社会、情感和生活方式问题。然后,这些项目采用视觉模拟量表的格式。33 个问题中的 30 个问题的重测信度表现出大于 0.80 的 Pearson 相关系数。组内相关统计量为 0.78,Cronbach α 为 0.99。在开发过程中确保了表面效度和内容效度,与非关节炎髋关节评分的相关性为 0.81,表明结构效度。通过配对 t 检验(P≤0.01)显示出反应性,效应量为 2.0,标准化反应均值为 1.7,反应比为 6.7,最小临床重要差异为 6 分。

结论

我们开发了一种新的健康相关生活质量患者报告结局测量工具,即 33 项国际髋关节结局工具(iHOT-33)。该问卷使用视觉模拟量表响应格式,专为有髋关节病变的年轻、活跃患者的计算机自我管理而设计。其开发遵循了最严格的方法,涉及大量患者。iHOT-33 已被证明具有可靠性;表现出表面效度、内容效度和结构效度;并且对临床变化高度敏感。我们认为,iHOT-33 可作为前瞻性患者评估和随机临床试验的主要结局测量指标。

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