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下肢骨关节炎水基疗法成本效益的随机对照试验

Randomised controlled trial of the cost-effectiveness of water-based therapy for lower limb osteoarthritis.

作者信息

Cochrane T, Davey R C, Matthes Edwards S M

机构信息

Faculty of Health and Sciences, Staffordshire University, Stoke-on-Trent, UK.

出版信息

Health Technol Assess. 2005 Aug;9(31):iii-iv, ix-xi, 1-114. doi: 10.3310/hta9310.

Abstract

OBJECTIVES

To determine the efficacy of community water-based therapy for the management of lower limb osteoarthritis (OA) in older patients.

DESIGN

A pre-experimental matched-control study was used to estimate efficacy of water-based exercise treatment, to check design assumptions and delivery processes. The main study was a randomised controlled trial of the effectiveness of water-based exercise (treatment) compared with usual care (control) in older patients with hip and/or knee OA. The latter was accompanied by an economic evaluation comparing societal costs and consequences of the two treatments.

SETTING

Water exercise was delivered in public swimming pools in the UK. Physical function assessments were carried out in established laboratory settings.

PARTICIPANTS

106 patients (93 women, 13 men) over the age of 60 years with confirmed hip and/or knee OA took part in the preliminary study. A similar, but larger, group of 312 patients (196 women, 116 men) took part in the main study, randomised into control (159) and water exercise (153) groups.

INTERVENTIONS

Control group patients received usual care with quarterly semi-structured telephone interview follow-up only. The intervention in the main study lasted for 1 year, with a further follow-up period of 6 months.

MAIN OUTCOME MEASURES

Pain score on the Western Ontario and McMaster Universities OA index (WOMAC). Additional outcome measures were included to evaluate effects on quality of life, cost-effectiveness and physical function measurements.

RESULTS

Short-term efficacy of water exercise in the management of lower limb OA was confirmed, with effect sizes ranging from 0.44 [95% confidence interval (CI) 0.03 to 0.85] on WOMAC pain to 0.76 (95% CI 0.33 to 1.17) on WOMAC physical function. Of 153 patients randomised to treatment, 82 (53.5%) were estimated to have complied satisfactorily with their treatment at the 1-year point. This had declined to 28 (18%) by the end of the 6-month follow-up period, during which support for the intervention had been removed and those wishing to continue exercise had to pay their own costs for maintaining their exercise treatment. High levels of co-morbidity were recorded in both groups. Nearly two thirds of all patients had a significant other illness in addition to their OA. Fifty-four control and 53 exercise patients had hospital inpatient episodes during the study period. Water exercise remained effective in the main study but overall effect size was small, on WOMAC pain at 1 year, a reduction of about 10% in group mean pain score. This had declined, and was non-significant, at 18 months. Mean cost difference estimates showed a saving in the water exercise group of pound123--175 per patient per annum and incremental cost-effectiveness ratios ranged from pound3838 to pound5951 per quality-adjusted life-year (QALY). Net reduction in pain was achieved at a net saving of pound135--175 per patient per annum and the ceiling valuation of pound580--740 per unit of WOMAC pain reduction was favourably low.

CONCLUSIONS

Group-based exercise in water over 1 year can produce significant reduction in pain and improvement in physical function in older adults with lower limb OA, and may be a useful adjunct in the management of hip and/or knee OA. The water-exercise programme produced a favourable cost--benefit outcome, using reduction in WOMAC pain as the measure of benefit. Further research is suggested into other similar public health interventions. Investigation is also needed into how general practice can best be supported to facilitate access to participants for research trials in healthcare, as well as an examination of the infrastructure and workforce capacities for physical activity delivery and the potential extent to which healthcare may be supported in this way. More detailed research is required to develop a better understanding of the types of exercise that will work for the different biomechanical subtypes of knee and hip OA and investigation is needed on access and environmental issues for physical activity programmes for older people, from both a provider and a participant perspective, the societal costs of the different approaches to the management of OA and longer term trends in outcome measures (costs and effects).

摘要

目的

确定社区水基疗法对老年患者下肢骨关节炎(OA)的治疗效果。

设计

采用实验前匹配对照研究来评估水基运动疗法的效果,检验设计假设和实施过程。主要研究是一项随机对照试验,比较水基运动(治疗组)与常规护理(对照组)对老年髋部和/或膝部OA患者的有效性。同时进行了一项经济评估,比较两种治疗的社会成本和结果。

地点

在英国的公共游泳池进行水上运动。在既定的实验室环境中进行身体功能评估。

参与者

106名60岁以上确诊为髋部和/或膝部OA的患者(93名女性,13名男性)参与了初步研究。312名情况类似但数量更多的患者(196名女性,116名男性)参与了主要研究,随机分为对照组(159名)和水基运动组(153名)。

干预措施

对照组患者仅接受常规护理,并每季度进行一次半结构化电话随访。主要研究中的干预持续1年,另有6个月的随访期。

主要观察指标

西安大略和麦克马斯特大学OA指数(WOMAC)的疼痛评分。还纳入了其他观察指标,以评估对生活质量、成本效益和身体功能测量的影响。

结果

证实了水基运动对下肢OA治疗的短期疗效,WOMAC疼痛评分的效应大小范围为0.44[95%置信区间(CI)0.03至0.85],WOMAC身体功能评分的效应大小为0.76(95%CI 0.33至1.17)。在随机分配到治疗组的153名患者中,估计有82名(53.5%)在第1年时对治疗的依从性令人满意。到6个月随访期结束时,这一比例降至28名(18%),在此期间,干预支持已取消,希望继续锻炼的患者必须自行承担维持运动治疗的费用。两组患者的合并症发生率都很高。几乎三分之二的患者除OA外还有其他重大疾病。在研究期间,54名对照组患者和53名运动组患者有住院治疗经历。在主要研究中,水基运动仍然有效,但总体效应大小较小,在第1年时WOMAC疼痛评分方面,组平均疼痛评分降低约10%。在18个月时,这一降低幅度有所下降且无统计学意义。平均成本差异估计显示,水基运动组每名患者每年节省123 - 175英镑,增量成本效益比为每质量调整生命年(QALY)3838至5951英镑。实现了疼痛净减少,每名患者每年净节省135 - 175英镑,每减少一个单位WOMAC疼痛的最高估值为580 - 740英镑,处于较低水平。

结论

为期1年的基于小组的水上运动可显著减轻老年下肢OA患者的疼痛并改善身体功能,可能是髋部和/或膝部OA管理中的一种有用辅助手段。以WOMAC疼痛减轻作为效益衡量标准,水基运动计划产生了有利的成本效益结果。建议对其他类似的公共卫生干预措施进行进一步研究。还需要调查如何最好地支持全科医疗,以促进医疗保健研究试验的参与者招募,以及检查身体活动实施的基础设施和劳动力能力,以及这种方式可能支持医疗保健服务的潜在程度。需要进行更详细的研究,以更好地了解适用于膝部和髋部OA不同生物力学亚型的运动类型,并从提供者和参与者的角度调查老年人身体活动计划的参与机会和环境问题、OA不同管理方法的社会成本以及结果指标(成本和效果)的长期趋势。

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