TAS::75 0888::TAS

骨关节炎(OA)是最常见的关节炎形式，是一种进展缓慢的疾病，临床特征是疼痛、畸形和功能丧失。老年失能和丧失独立性是造成老年人残疾和丧失独立性的一个重要因素。膝关节骨性关节炎与功能的进行性下降有关，包括从坐姿到站姿的转换困难，以及活动能力和日常生活活动能力的下降。虽然最近的科学进步已经为类风湿性关节炎产生了高效的疾病修正疗法，但对于骨性关节炎还没有这样的疗法。由于疾病的慢性性质和不同的临床结果，需要更好地了解各种临床相关或以患者为中心的结果指标之间的关系-疼痛、僵硬、功能减退、止痛剂的使用、残疾、生活质量以及考虑这些和其他临床相关结果的综合评分。由于其慢性性质和缺乏有效的疾病改善疗法，患者使用一系列生物行为、饮食、药物和补充和替代(CAM)疗法来减轻OA症状、疼痛，并改善功能和生活质量。尽管它们被广泛使用，但相对较少的CAM疗法已经通过适当的研究设计进行了充分的测试，以评估它们在改善以患者为中心的结果方面的有效性。骨性关节炎计划是一项大型流行病学研究，每年对高危或已经发生膝骨性关节炎的患者进行多项以患者为中心的结果评估，根据基线固定屈曲X线片的定义。此外，在基线时，对大量的生物行为、饮食、药物和CAM疗法进行了评估，并在8年的计划随访中每年或每两年对这些“治疗”进行一次评估。在研究生物行为疗法、饮食疗法、药理学疗法和CAM疗法在改善与膝关节骨关节炎相关的以患者为中心的结果方面的有效性时，在评估流行病学数据时会出现几个分析问题。首先，还没有开发出能够解释膝骨性关节炎对以患者为中心的结果的全部影响的有效的综合结果测量方法。虽然西安大略大学和麦克马斯特大学的骨关节炎指数(WOMAC)和膝关节损伤和骨关节炎结果评分(KOOS)摘要量表已经开发出来，但它们完全依赖主观结果，并且高度相互关联，使得摘要评分的价值值得怀疑。第二，基线水平的受试者S以患者为中心的预后更差，膝骨性关节炎更有可能使用CAM疗法来试图缓解症状。这种“指征混淆”偏向于对CAM疗法潜在益处的分析偏向于无效，使得很难辨别它们是否对改善膝骨性关节炎的疼痛和症状有效。最先进的统计方法已经被开发出来，合理有效地处理这些分析问题，并将在这个项目中使用。

Osteoarthritis (OA), the most common form of arthritis, is a slowly progressing disease characterized clinically by pain, deformity, and loss of function. OA is a significant contributor to disability and loss of independence among the elderly. Knee OA is associated with a progressive reduction in function, including difficulty in changing from the sitting to the standing position, and a decrease in mobility and in the ability to carry out activities of daily living. While recent scientific advances have yielded highly effective disease-modifying therapies for rheumatoid arthritis, no such therapies exist for osteoarthritis. Because of the chronic nature of the disease and variable clinical outcomes, a better understanding of the relationship between various measures of clinically relevant or patient-centered outcomes - pain, stiffness, reduced function, use of analgesics, disability, quality of life and composite scores accounting for these and other clinically relevant outcomes are needed. Due to its chronic nature and the lack of effective disease modifying therapies a range of biobehavioral, dietary, pharmacologic and complementary and alternative (CAM) therapies are used by patients to reduce OA symptoms, pain, and improve function and quality of life. Despite their wide use, relatively few CAM therapies have been tested adequately with appropriate study designs to assess their effectiveness in improving patient-centered outcomes. The Osteoarthritis Initiative is large epidemiologic study with multiple patient-centered outcomes assessed yearly in subjects at high risk or having already developed knee OA as defined by fixed flexion radiographs at baseline. In addition at baseline, a large inventory of biobehavioral, dietary, pharmacologic and CAM therapies was assessed and most of these "treatments" are assessed either yearly or every two years throughout 8 years of projected follow-up. When studying the effectiveness of biobehavioral, dietary, pharmacologic and CAM therapies on improving patient centered outcomes related to knee osteoarthritis several analytic issues arise when evaluating epidemiological data. First no validated composite outcome measure has been developed that accounts for the full impact of knee osteoarthritis on patient-centered outcomes. While Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) and Knee Injury and Osteoarthritis Outcomes Score (KOOS) summary scales have been developed they rely exclusively on subjective outcomes, and are highly inter-correlated making a summary score of questionable value. Second, participant s at baseline with worse patient-centered outcomes and knee osteoarthritis are more likely to utilize CAM therapies in an attempt to alleviate symptoms. This "confounding by indication" biases analyses of the potential beneficial of CAM therapies effects towards the null, making it difficult to discern whether they are effective for improvement of knee OA pain and symptoms. State-of-the art statistical methods have been developed that deal reasonably effectively with these analytic issues and will be employed in this project.