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关节镜下肩峰下减压术治疗肩峰下疼痛患者的安慰剂对照随机试验的成本效益分析。

Cost-effectiveness analysis of a placebo-controlled randomized trial evaluating the effectiveness of arthroscopic subacromial decompression in patients with subacromial shoulder pain.

机构信息

University of Oxford, Health Economics Research Centre, Nuffield Department of Population Health; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, UK.

University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, UK.

出版信息

Bone Joint J. 2019 Jan;101-B(1):55-62. doi: 10.1302/0301-620X.101B1.BJJ-2018-0555.R1.

DOI:10.1302/0301-620X.101B1.BJJ-2018-0555.R1
PMID:30601058
Abstract

AIMS

The aims of this study were to compare the use of resources, costs, and quality of life outcomes associated with subacromial decompression, arthroscopy only (placebo surgery), and no treatment for subacromial pain in the United Kingdom National Health Service (NHS), and to estimate their cost-effectiveness.

PATIENTS AND METHODS

The use of resources, costs, and quality-adjusted life-years (QALYs) were assessed in the trial at six months and one year. Results were extrapolated to two years after randomization. Differences between treatment arms, based on the intention-to-treat principle, were adjusted for covariates and missing data were handled using multiple imputation. Incremental cost-effectiveness ratios were calculated, with uncertainty around the values estimated using bootstrapping.

RESULTS

Cumulative mean QALYs/mean costs of health care service use and surgery per patient from baseline to 12 months were estimated as 0.640 (standard error (se) 0.024)/£3147 (se 166) in the decompression arm, 0.656 (se 0.020)/£2830 (se 183) in the arthroscopy only arm and 0.522 (se 0.029)/£1451 (se 151) in the no treatment arm. Statistically significant differences in cumulative QALYs and costs were found at six and 12 months for the decompression versus no treatment comparison only. The probabilities of decompression being cost-effective compared with no treatment at a willingness-to-pay threshold of £20 000 per QALY were close to 0% at six months and approximately 50% at one year, with this probability potentially increasing for the extrapolation to two years.

DISCUSSION

The evidence for cost-effectiveness at 12 months was inconclusive. Decompression could be cost-effective in the longer-term, but results of this analysis are sensitive to the assumptions made about how costs and QALYs are extrapolated beyond the follow-up of the trial.

摘要

目的

本研究旨在比较英国国家医疗服务体系(NHS)中肩峰下减压术、关节镜检查(安慰剂手术)和肩峰下疼痛无治疗三种治疗方法的资源利用、成本和生活质量结局,并评估其成本效益。

患者和方法

在试验中,分别在 6 个月和 1 年时评估资源利用、成本和质量调整生命年(QALY)。结果外推至随机分组后 2 年。根据意向治疗原则,基于协变量调整了治疗组之间的差异,并使用多重插补处理缺失数据。使用 bootstrap 法估算了增量成本效益比,并用其来评估所估计值的不确定性。

结果

从基线到 12 个月,估计每位患者的累积平均 QALY/医疗保健服务使用和手术的平均成本为减压组 0.640(标准误差(SE)0.024)/£3147(SE 166),关节镜组 0.656(SE 0.020)/£2830(SE 183),无治疗组 0.522(SE 0.029)/£1451(SE 151)。仅在减压组与无治疗组比较时,在 6 个月和 12 个月时发现 QALY 和成本的累积存在统计学显著差异。在愿意支付每 QALY 20000 英镑的阈值下,减压术与无治疗相比具有成本效益的概率在 6 个月时接近 0%,在 1 年时约为 50%,随着对 2 年的外推,这一概率可能会增加。

讨论

12 个月时的成本效益证据不确定。在长期内,减压术可能具有成本效益,但本分析的结果对如何推断试验随访期之外的成本和 QALY 非常敏感。

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