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首页> 外文期刊>BMJ Open >Economic evaluation within a factorial-design randomised controlled trial of exercise, manual therapy, or both interventions for osteoarthritis of the hip or knee: study protocol
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Economic evaluation within a factorial-design randomised controlled trial of exercise, manual therapy, or both interventions for osteoarthritis of the hip or knee: study protocol

机译：运动，手法治疗或两项干预的因子设计随机对照试验的经济评估：髋关节或膝关节骨关节炎：研究方案

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Introduction Clinical guidelines for the treatment of hip and knee osteoarthritis recommend non-pharmacological and non-surgical treatments. Exercise treatments are recommended as primary strategies, but specific exercise programme components have not been specified. Early evidence indicates that manual physiotherapy is effective for hip and knee osteoarthritis. The Management of Osteoarthritis (MOA) Trial was designed to evaluate the effectiveness and cost-effectiveness of physiotherapist-led, individualised exercise, manual physiotherapy and a combination of these two interventions in the treatment of adults with hip or knee osteoarthrits. This paper describes the methods that will be used to conduct the economic evaluation of these interventions within the MOA Trial. Methods and analysis This comprehensive economic evaluation will assess the incremental cost-effectiveness of physiotherapy plus usual care versus usual care alone from a societal perspective. The authors will conduct a cost-consequences analysis using end-points such as Outcomes Measures in Rheumatology Clinical Trials—Osteoarthritis Research Society International responder criteria and quality-adjusted life years. The evaluation will have a time horizon of 1?year (and so discounting will not be necessary). All costs will be reported in 2009 New Zealand dollars. The authors will address uncertainty via bootstrapping to calculate CIs for the mean incremental cost-effectiveness ratios and by performing sensitivity analyses. Ethics and dissemination Ethical approval was granted by the Lower South Regional Ethics Committee of the New Zealand Ministry of Health (ethics reference: LRS/07/11/044). All participants of the MOA Trial provided written informed consent for the capture of their healthcare costs. We will submit the results of the study for publication irrespective of outcome. Clinical trials registration number ACTRN12608000130369.
机译：简介髋关节和膝部骨关节炎的临床治疗指南建议采用非药物和非手术疗法。建议将运动疗法作为主要策略，但尚未指定特定的运动计划组成部分。早期证据表明，手动理疗对髋部和膝部骨关节炎有效。骨关节炎管理（MOA）试验旨在评估以物理治疗师为主导的个性化锻炼，手动理疗以及这两种干预措施结合治疗成人髋关节或膝关节骨关节炎的有效性和成本效益。本文介绍了将在MOA试用版中对这些干预措施进行经济评估的方法。方法和分析这项全面的经济评估将从社会角度评估物理治疗加常规治疗与常规治疗相比的增量成本效益。作者将使用诸如风湿病临床试验结果指标-骨关节炎研究学会国际响应者标准和质量调整生命年等终点进行成本后果分析。评估的时间范围为1年（因此不必进行折扣）。所有费用将以2009年新西兰元报告。作者将通过自举计算平均增量成本效益比的CI并进行敏感性分析来解决不确定性问题。道德与传播道德得到了新西兰卫生部下南地区道德委员会的批准（道德编号：LRS / 07/11/044）。 MOA试用的所有参与者均提供了书面知情同意书，以获取其医疗费用。无论结果如何，我们都会将研究结果提交发表。临床试验注册号为ACTRN12608000130369。

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