TAS::75 0888::TAS

塔斯马尼亚::75 0888::塔斯马尼亚

• 批准号: 8107931
• 负责人: CHARLES B. EATON
• 金额: $ 183.51万
• 依托单位: MEMORIAL HOSPITAL OF RHODE ISLAND
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-15 至 2015-06-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8107931
• 关键词: Accounting; Activities of Daily Living; Analgesics; Antioxidants; Arthritis; Arts; Chiropractor; Chondroitin; Chronic; Clinical; Copper; Data; Deformity; Degenerative polyarthritis; Demographic Factors; Diet; Dietary Practices; Disease; Effectiveness; Elderly; Epidemiologic Studies; Epidemiology; Equipment and supply inventories; Fishes; Food; Frequencies; Gender; Glucosamine; Health; Herb; Individual; Knee Injuries; Knee Osteoarthritis; Life Style; Measures; Mediterranean Diet; Nature; Non-Steroidal Anti-Inflammatory Agents; Obesity; Ontario; Outcome; Outcome Measure; Pain; Participant; Patient-Focused Outcomes; Patients; Pattern; Pharmaceutical Preparations; Positioning Attribute; Principal Component Analysis; Quality of life; Race; Recreation; Research Design; Rheumatoid Arthritis; Scientific Advances and Accomplishments; Severities; Sports; Statistical Methods; Structural Models; Symptoms; Testing; Time; Universities; Vitamin D; Vitamin K; Vitamins; Weight; base; biobehavior; clinically relevant; disability; follow-up; high risk; improved; improved functioning; indexing; loss of function; response; sedentary

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.

骨关节炎（OA）是关节炎的最常见形式，是一种缓慢进展的疾病，其临床特征为疼痛、畸形和功能丧失。OA是导致老年人残疾和丧失独立性的重要因素。膝关节OA与功能进行性降低相关，包括难以从坐姿变为站立位，以及活动性和进行日常生活活动的能力降低。虽然最近的科学进步已经为类风湿性关节炎产生了非常有效的疾病修饰疗法，但对于骨关节炎还不存在这样的疗法。由于疾病的慢性性质和可变的临床结局，需要更好地了解临床相关或以患者为中心的结局的各种指标之间的关系-疼痛，僵硬，功能下降，镇痛剂的使用，残疾，生活质量和综合评分，这些和其他临床相关结局。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、药理学和补充和替代（CAM）疗法来减轻OA症状、疼痛，并改善功能和生活质量。尽管CAM疗法被广泛使用，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，以评估其在改善以患者为中心的结局方面的有效性。骨关节炎倡议是一项大型流行病学研究，每年在高风险或已发生膝关节OA（通过基线时固定屈曲X线片定义）的受试者中评估多个以患者为中心的结局。此外，在基线时，评估了大量的生物行为、饮食、药理学和CAM疗法，并且在整个8年的预计随访期间，每年或每两年对这些“治疗”中的大多数进行评估。在研究生物行为、饮食、药物和CAM疗法对改善以患者为中心的膝关节骨关节炎相关结局的有效性时，在评价流行病学数据时出现了几个分析问题。首先，没有有效的复合结局指标已经开发出来，说明膝关节骨关节炎对以患者为中心的结局的全面影响。虽然已经开发了西安大略和麦克马斯特大学骨关节炎指数（WOMAC）和膝关节损伤和骨关节炎结局评分（KOOS）总结量表，但它们完全依赖于主观结局，并且高度相关，使得总结评分的价值值得怀疑。第二，基线时以患者为中心的结局较差和膝关节骨关节炎的受试者更有可能利用CAM治疗来缓解症状。这种“适应症混淆”使CAM治疗效果的潜在有益分析偏向于零，使得难以辨别它们是否有效改善膝关节OA疼痛和症状。国家的最先进的统计方法已经开发，合理有效地处理这些分析问题，并将在本项目中使用。