WOMAC: a 20-year experiential review of a patient-centered self-reported health status questionnaire.
WOMAC: a 20-year experiential review of a patient-centered self-reported health status questionnaire.
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WOMAC：以患者为中心的自我报告健康状况调查问卷的 20 年经验回顾。
作者：
N. Bellamy
2473 肌肉骨骼医学临床研究和临床实践的一个关键要素是评估单独或组合使用的干预措施的治疗效果。在临床研究和临床实践环境中，可靠性、有效性和响应性是健康状况测量工具的基本属性，而在后者中，简洁性、简单性和易于评分被认为非常重要1,2。 1981 年之前，风湿病学中髋关节和膝关节骨关节炎 (OA) 的疼痛、僵硬和身体残疾的量化测量程序多种多样，并且在内容、格式和尺度方面缺乏标准化3。此外，健康状况调查问卷只有极少数语言版本，大多数情况下都是用英语编写并翻译成几种欧洲语言。 1981 年的挑战是针对髋关节和膝关节 OA 建立标准化的疾病特异性患者相关自我报告健康状况调查问卷。 1982 年，我有机会在完成硕士论文的过程中描述了名为西安大略和麦克马斯特 (WOMAC) 骨关节炎指数 4 的健康状况调查问卷的开发。二十年后，WOMAC 指数得到了广泛验证，并以 60 多种替代语言形式进行了翻译和语言验证。在大多数替代语言形式中，它都有 Likert (LK) 和视觉模拟 (VA) 缩放格式。关于 WOMAC 在验证研究、与其他健康状况测量的比较研究以及其在各种临床研究和临床实践环境中的应用，有数百次引用（完整手稿、摘要、评论）。 WOMAC 指数的想法源自与 Watson Buchanan 教授的简短讨论，在这次对话中，我在选择论文主题以解决临床测量中未满足的需求时征求了他的建议。虽然这个想法的提出只花了 12 个月的时间，但验证和实施却耗费了接下来 15 年的大部分时间。 1996 年至 1999 年间，该指数经历了重大改进，这一过程在 1999 年至今得到了巩固，并产生了 3.1 系列 WOMAC 调查问卷。该指数的 WOMAC LK3.1 和 WOMAC VA3.1 版本现已广泛使用，特别是在评估制药和生物技术环境中的功效时。 WOMAC指数的成功在很大程度上与6个因素有关：（1）患者广泛参与项目清单的制定6。这也许是最重要的，因为它是一种减少家长作风潜在影响的方法，并将项目内容锚定到与患者相关的疾病经历的各个方面，因此他们可以与之相关。 (2) 评估指数不同临床测量特性的大量研究的进行，包括评估有效性、可靠性和响应性的分析、评估 LK 与 VA 缩放比例的比较研究、盲法与知情陈述、跟踪信号项与完整指数使用、参数与非参数分析以及时间范围变化 5。 (3) 使用基于串联向前和向后翻译过程以及后续语言验证的标准操作程序，开发和语言验证 WOMAC VA3.1 和 WOMAC LK3.1 的多种替代语言形式。 (4) 继续研究和开发内容和管理问题，包括 WOMAC 在电话访谈中的应用 7 以及鼠标驱动的光标和触摸屏电子数据捕获格式 8,9。 (5) 将WOMAC纳入国际骨关节炎研究学会(OARSI)临床试验指南，作为OA10结果测量的相关指标； (6) 以所需的缩放格式、替代语言形式和学术、商业和临床应用的管理格式提供 WOMAC 索引，并提供持续的用户支持。 WOMAC 的发展并非没有挑战。 WOMAC 3.1 指数的跨文化适应是一个复杂的过程，美国加利福尼亚州帕洛阿尔托的 Health Outcomes Group 承担了主要责任，并应用其标准操作程序来开发语言上有效的高质量替代语言形式。考虑到 OA 的全球性和生活方式的多样性，北美或欧洲开发的仪器的优势可能会令人担忧。因此，令人欣慰的是，WOMAC 指数在其全球应用中保持了良好的表现。因此，虽然可能反映了对全球多样性的有限看法，但该指数似乎利用了社论中存在的共性
2473 A key element in clinical research and clinical practice in musculoskeletal medicine is the evaluation of the therapeutic benefit of interventions used either singularly or in combination. In both clinical research and clinical practice environments, reliability, validity, and responsiveness are essential attributes of health status measurement tools, and in the latter brevity, simplicity, and ease of scoring are regarded with high importance1,2. Prior to 1981, measurement procedures for quantifying pain, stiffness, and physical disability in hip and knee osteoarthritis (OA) in rheumatology were diverse and lacked standardization in content, format, and scaling3. Further, health status questionnaires were available in very few languages, most often having been developed in English and translated into a few European languages. The challenge in 1981 was to build a standardized diseasespecific patient-relevant self-reported health status questionnaire for hip and knee OA. In 1982, I had the opportunity in the course of completing an MSc thesis to describe the development of a health status questionnaire termed the Western Ontario and McMaster (WOMAC) Osteoarthritis Index4. Twenty years later, the WOMAC Index has been extensively validated and has been translated and linguistically validated in over 60 alternative-language forms. In the majority of alternative-language forms it is available in both Likert (LK) and visual analog (VA) scaling formats. There are several hundred citations (full manuscripts, abstracts, reviews) to the use of WOMAC in validation studies, comparative studies against other health status measures, and in its application in various clinical research and clinical practice settings5. The idea for the WOMAC index evolved from a brief discussion with Professor Watson Buchanan, a conversation in which I sought his advice in selecting a thesis topic that would address an unmet need in clinical measurement. While development of the idea took only 12 months, the validation and implementation was to consume much of the next 15 years. Between 1996 and 1999 the Index underwent significant refinement, a process that has been consolidated between 1999 and the present, and has resulted in the 3.1 series of WOMAC questionnaires. The WOMAC LK3.1 and WOMAC VA3.1 versions of the Index are now extensively used, particularly in assessing efficacy in pharmaceutical and biotechnology environments. The success of the WOMAC index is in large part related to 6 factors: (1) Extensive patient involvement in the development of the item inventory6. This is perhaps the most important since it is an approach that reduces the potential influence of paternalism, and anchors the item content into aspects of the disease experience that are relevant to patients, and to which they can therefore relate. (2) The conduct of numerous studies evaluating different clinimetric properties of the Index, including analyses evaluating validity, reliability, and responsiveness, comparative studies assessing LK versus VA scaling, blind versus informed presentation, tracking signal items versus complete index usage, parametric versus non-parametric analyses and time frame variations5. (3) The development and linguistic validation of numerous alternative-language forms of WOMAC VA3.1 and WOMAC LK3.1 using a standard operating procedure based on tandem forward and backward translation processes and subsequent linguistic validation5. (4) Continued research and development into content and administration issues including the application of WOMAC in telephone interviews7 as well as mouse driven cursor and touch screen electronic data capture formats8,9. (5) The incorporation of WOMAC into Osteoarthritis Research Society International (OARSI) clinical trials guidelines as an index relevant to outcome measurement in OA10; and (6) the provision of the WOMAC Index, in the required scaling format, alternative-language form, and administration format for academic, commercial, and clinical applications, and ongoing user support. The development of WOMAC has not been without its challenges. Trans-cultural adaptation of the WOMAC 3.1 Index has been a complex process for which Health Outcomes Group, Palo Alto, California, USA, have taken primary responsibility and in which they have applied their standard operating procedures to develop linguistically valid alternative-language forms of extremely high quality. The preponderance of instruments developed in either North America or Europe might be viewed with concern given the global nature of OA and diversity of lifestyles. It is gratifying, therefore, that the performance of the WOMAC Index has been maintained in its global applications. Thus, while potentially reflecting a restricted view of global diversity, the Index nevertheless appears to tap into the commonalities that exist in the Editorial