Objective

Chronic venous disease is a common condition and has a significant impact on patients’ health status. Validated patient-reported outcome measures (PROMs) used to assess health status are needed to measure health status. This state-of-the-art review summarizes the current validation evidence for disease-specific PROMs for chronic venous disease and provides a framework for their use in the clinical setting.

Methods

A literature search in OVID Embase and Medline was conducted to identify relevant English-language studies of chronic venous disease that used disease-specific PROMs between January 1, 1993 to June 30, 2022. Abstracts and titles from identified studies were screened by 4 investigators, and full-text articles were subsequently screened for eligibility. Data on validation of disease-specific PROMs was abstracted from each included article. Classical test theory was used as a framework to examine a-priori defined validation criteria for content validity, reliability (construct validity, internal reliability, and test-retest reliability), responsiveness, and expansion of the validation evidence base (use in randomized controlled trials and comparative effectiveness research, cultural or linguistic translations, predictive validity, or establishing the minimal clinically important difference [MCID] threshold, defined as smallest amount an outcome or measure is perceived as a meaningful change to patients). The PROMs were categorized into three groups based on the manifestations of disease of the population for which they were developed. The overall validity of each PROM was assessed across three stages of validation including content validity (phase 1); construct validity, reliability, and responsiveness (phase 2); and expansion of the validation evidence base (phase 3).

Results

Of 2,338 unique studies screened, 112 (4.8%) studies met inclusion criteria. The 8 disease-specific PROMs identified were categorized into 3 groups: 1) overall chronic venous disease (C1-C6); 2) C1-C4; 3) C5-C6. Assessed by group, the Chronic Venous Insufficiency Questionnaire met criteria for validation at all three phases for patients with C1-C4 disease, and the Charing Cross Venous Ulcer Questionnaire met criteria for validation at all three phases for patients with C5-C6. There were no PROMs that met all criteria for validation for use in overall chronic venous disease (C1-C6).

Conclusions

Of the 8 PROMs assessed in this review, only 2 met prespecified criteria at each phase for validation. The Chronic Venous Insufficiency Questionnaire and Charing Cross Venous Ulcer Questionnaire should be considered for use in patients with chronic venous disease without venous ulcers and with venous ulcers, respectively.

中文翻译：

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静脉疾病生活质量评估的最新综述

客观的

慢性静脉疾病是一种常见病，对患者的健康状况有重大影响。需要用于评估健康状况的经过验证的患者报告结果测量（PROM）来衡量健康状况。这篇最先进的综述总结了当前针对慢性静脉疾病的疾病特异性 PROM 的验证证据，并为其在临床环境中的使用提供了框架。

方法

在 OVID Embase 和 Medline 中进行文献检索，以确定 1993 年 1 月 1 日至 2022 年 6 月 30 日期间使用疾病特异性 PROM 的慢性静脉疾病相关英文研究。已确定研究的摘要和标题由 4 名研究人员筛选，随后对全文文章进行资格筛选。从每篇纳入的文章中提取了疾病特异性 PROM 验证的数据。经典测试理论被用作框架来检查先验定义的内容有效性、可靠性（结构有效性、内部可靠性和重测可靠性）、响应性和验证证据基础扩展（用于随机对照试验）的验证标准比较有效性研究、文化或语言翻译、预测有效性或建立最小临床重要差异 [MCID] 阈值（定义为对患者有意义的变化的最小结果或测量量）。PROM 根据其开发人群的疾病表现分为三组。每个 PROM 的整体有效性在三个验证阶段进行评估，包括内容有效性（第 1 阶段）；构建有效性、可靠性和响应性（第 2 阶段）；以及扩展验证证据库（第 3 阶段）。

结果

在筛选的 2,338 项独特研究中，112 项 (4.8%) 研究符合纳入标准。确定的 8 种疾病特异性 PROM 分为 3 组：1）总体慢性静脉疾病（C1-C6）；2）C1-C4；3）C5-C6。按小组评估，慢性静脉功能不全问卷符合 C1-C4 疾病患者所有三个阶段的验证标准，查林十字静脉溃疡问卷符合 C5-C6 患者所有三个阶段的验证标准。没有 PROM 满足用于整体慢性静脉疾病 (C1-C6) 的所有验证标准。

结论

在本次审查评估的 8 个 PROM 中，只有 2 个符合每个验证阶段预先指定的标准。慢性静脉功能不全问卷和查林十字静脉溃疡问卷应分别考虑用于患有慢性静脉疾病但不伴有静脉溃疡和伴有静脉溃疡的患者。