Osborne Richard H, Buchbinder Rachelle, Ackerman Ilana N
Centre for Rheumatic Diseases, Royal Melbourne Hospital and The University of Melbourne, Melbourne, Australia.
BMC Musculoskelet Disord. 2006 Nov 30;7:90. doi: 10.1186/1471-2474-7-90.
Patient education and self-management programs are offered in many countries to people with chronic conditions such as osteoarthritis (OA). The most well-known is the disease-specific Stanford Arthritis Self-Management Program (ASMP). While Australian and international clinical guidelines promote the concept of self-management for OA, there is currently little evidence to support the use of the ASMP. Several meta-analyses have reported that arthritis self-management programs had minimal or no effect on reducing pain and disability. However, previous studies have had methodological shortcomings including the use of outcome measures which do not accurately reflect program goals. Additionally, limited cost-effectiveness analyses have been undertaken and the cost-utility of the program has not been explored.
METHODS/DESIGN: This study is a randomised controlled trial to determine the efficacy (in terms of Health-Related Quality of Life and self-management skills) and cost-utility of a 6-week group-based Stanford ASMP for people with hip or knee OA. Six hundred participants referred to an orthopaedic surgeon or rheumatologist for hip or knee OA will be recruited from outpatient clinics at 2 public hospitals and community-based private practices within 2 private hospital settings in Victoria, Australia. Participants must be 18 years or over, fluent in English and able to attend ASMP sessions. Exclusion criteria include cognitive dysfunction, previous participation in self-management programs and placement on a waiting list for joint replacement surgery or scheduled joint replacement.Eligible, consenting participants will be randomised to an intervention group (who receive the ASMP and an arthritis self-management book) or a control group (who receive the book only). Follow-up will be at 6 weeks, 3 months and 12 months using standardised self-report measures. The primary outcome is Health-Related Quality of Life at 12 months, measured using the Assessment of Quality of Life instrument. Secondary outcome measures include the Health Education Impact Questionnaire, Western Ontario and McMaster Universities Osteoarthritis Index (pain subscale and total scores), Kessler Psychological Distress Scale and the Hip and Knee Multi-Attribute Priority Tool. Cost-utility analyses will be undertaken using administrative records and self-report data. A subgroup of 100 participants will undergo qualitative interviews to explore the broader potential impacts of the ASMP.
Using an innovative design combining both quantitative and qualitative components, this project will provide high quality data to facilitate evidence-based recommendations regarding the ASMP.
许多国家为骨关节炎(OA)等慢性病患者提供患者教育和自我管理项目。最著名的是针对特定疾病的斯坦福关节炎自我管理项目(ASMP)。虽然澳大利亚和国际临床指南提倡OA自我管理的理念,但目前几乎没有证据支持使用ASMP。几项荟萃分析报告称,关节炎自我管理项目在减轻疼痛和残疾方面效果甚微或没有效果。然而,以往的研究存在方法学上的缺陷,包括使用不能准确反映项目目标的结果指标。此外,成本效益分析有限,该项目的成本效用尚未得到探讨。
方法/设计:本研究是一项随机对照试验,旨在确定为期6周的基于小组的斯坦福ASMP对髋或膝OA患者的疗效(以健康相关生活质量和自我管理技能衡量)和成本效用。将从澳大利亚维多利亚州2家公立医院的门诊诊所和2家私立医院环境中的社区私立诊所招募600名因髋或膝OA而被转介给骨科医生或风湿病学家的参与者。参与者必须年满18岁,英语流利,能够参加ASMP课程。排除标准包括认知功能障碍、以前参加过自我管理项目以及被列入关节置换手术等候名单或计划进行关节置换。符合条件且同意参与的参与者将被随机分为干预组(接受ASMP和一本关节炎自我管理书籍)或对照组(仅接受书籍)。使用标准化的自我报告测量方法在6周、3个月和12个月时进行随访。主要结局是12个月时的健康相关生活质量,使用生活质量评估工具进行测量。次要结局指标包括健康教育影响问卷、西安大略和麦克马斯特大学骨关节炎指数(疼痛子量表和总分)、凯斯勒心理困扰量表以及髋膝多属性优先工具。将使用行政记录和自我报告数据进行成本效用分析。100名参与者的一个亚组将接受定性访谈,以探讨ASMP更广泛的潜在影响。
本项目采用结合定量和定性成分的创新设计,将提供高质量数据,以促进关于ASMP的循证建议。