Arthroscopic Partial Meniscectomy for a Degenerative Meniscus Tear Is Not Cost Effective Compared With Placebo Surgery: An Economic Evaluation Based on the FIDELITY Trial Data.

IF 4.2 2区 医学 Q1 ORTHOPEDICS Clinical Orthopaedics and Related Research® Pub Date : 2024-09-01 Epub Date: 2024-05-07 DOI:10.1097/CORR.0000000000003094
Roope Kalske, Ali Kiadaliri, Raine Sihvonen, Martin Englund, Aleksandra Turkiewicz, Mika Paavola, Antti Malmivaara, Ari Itälä, Antti Joukainen, Heikki Nurmi, Pirjo Toivonen, Simo Taimela, Teppo L N Järvinen
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Abstract

Background: In patients with a degenerative tear of the medial meniscus, recent meta-analyses and systematic reviews have shown no treatment benefit of arthroscopic partial meniscectomy (APM) over conservative treatment or placebo surgery. Yet, advocates of APM still argue that APM is cost effective. Giving advocates of APM their due, we note that there is evidence from the treatment of other musculoskeletal complaints to suggest that a treatment may prove cost effective even in the absence of improvements in efficacy outcomes, as it may lead to other benefits, such as diminished productivity loss and reduced costs, and so the question of cost effectiveness needs to be answered for APM.

Questions/purposes: (1) Does APM result in lower postoperative costs compared with placebo surgery? (2) Is APM cost-effective compared with placebo surgery?

Methods: One hundred forty-six adults aged 35 to 65 years with knee symptoms consistent with a degenerative medial meniscus tear and no knee osteoarthritis according to the American College of Rheumatology clinical criteria were randomized to APM (n = 70) or placebo surgery (n = 76). In the APM and placebo surgery groups, mean age was 52 ± 7 years and 52 ± 7 years, and 60% (42 of 70) and 62% (47 of 76) of participants were men, respectively. There were no between-group differences in baseline characteristics. In both groups, a standard diagnostic arthroscopy was first performed. Thereafter, in the APM group, the torn meniscus was trimmed to solid meniscus tissue, whereas in the placebo surgery group, APM was carefully mimicked but no resection of meniscal tissue was performed; as such, surgical costs were the same in both arms and were not included in the analyses. All patients received identical postoperative care including a graduated home-based exercise program. At the 2-year follow-up, two patients were lost to follow-up, both in the placebo surgery group. Cost effectiveness over the 2-year trial period was computed as incremental net monetary benefit (INMB) for improvements in quality-adjusted life years (QALY), using both the societal (primary) and healthcare system (secondary) perspectives. To be able to consider APM cost effective, the CEA analysis should yield a positive INMB value. Nonparametric bootstrapping was used to assess uncertainty. Several one-way sensitivity analyses were also performed.

Results: APM did not deliver lower postoperative costs, nor did it convincingly improve quality of life scores when compared with placebo surgery. From a societal perspective, APM was associated with € 971 (95% CI -2013 to 4017) higher costs and 0.015 (95% CI -0.011 to 0.041) improved QALYs over 2-year follow-up compared with placebo surgery. Both differences were statistically inconclusive (a wide 95% CI that crossed the line of no difference). Using the conventional willingness to pay (WTP) threshold of € 35,000 per QALY, APM resulted in a negative INMB of € -460 (95% CI -3757 to 2698). In our analysis, APM would result in a positive INMB only when the WTP threshold rises to about € 65,000 per QALY. The wide 95% CIs suggests uncertain cost effectiveness irrespective of chosen WTP threshold.

Conclusion: The results of this study lend further support to clinical practice guidelines recommending against the use of APM in patients with a degenerative meniscus tear. Given the robustness of existing evidence demonstrating no benefit or cost effectiveness of APM over nonsurgical treatment or placebo surgery, future research is unlikely to alter this conclusion.Level of Evidence Level III, economic analysis.

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关节镜下半月板部分切除术治疗退行性半月板撕裂与安慰剂手术相比不具成本效益:基于 FIDELITY 试验数据的经济评估。
背景:对于内侧半月板退行性撕裂的患者,最近的荟萃分析和系统综述显示,关节镜下半月板部分切除术(APM)与保守治疗或安慰剂手术相比没有治疗效果。然而,APM 的拥护者仍然认为 APM 具有成本效益。我们注意到,在治疗其他肌肉骨骼疾病方面有证据表明,即使没有改善疗效,治疗也可能被证明具有成本效益,因为它可能带来其他益处,如减少生产力损失和降低成本,因此需要回答 APM 的成本效益问题。问题/目的:(1) 与安慰剂手术相比,APM 是否能降低术后成本?(2) 与安慰剂手术相比,APM 是否具有成本效益?根据美国风湿病学会的临床标准,146 名年龄在 35 岁至 65 岁之间、膝关节症状符合内侧半月板退行性撕裂且无膝关节骨关节炎的成年人被随机分配接受 APM(70 人)或安慰剂手术(76 人)。APM手术组和安慰剂手术组的平均年龄分别为52±7岁和52±7岁,男性参与者分别占60%(70人中的42人)和62%(76人中的47人)。组间基线特征无差异。两组患者均首先进行了标准诊断性关节镜检查。随后,在APM组中,撕裂的半月板被修剪为实心半月板组织,而在安慰剂手术组中,则仔细模仿APM,但不切除半月板组织;因此,两组的手术费用相同,未纳入分析。所有患者都接受了相同的术后护理,包括渐进式家庭锻炼计划。在为期两年的随访中,有两名患者失去了随访机会,均属于安慰剂手术组。2 年试验期间的成本效益是根据质量调整生命年(QALY)改善的增量净货币效益(INMB)计算得出的,采用了社会(主要)和医疗保健系统(次要)两个角度。为使 APM 具有成本效益,成本效益分析应得出正的 INMB 值。采用非参数引导法评估不确定性。此外,还进行了多项单向敏感性分析:结果:与安慰剂手术相比,APM 既没有降低术后成本,也没有令人信服地提高生活质量评分。从社会角度来看,与安慰剂手术相比,APM 在 2 年随访期间的成本增加了 971 欧元(95% CI -2013-4017),QALYs 提高了 0.015(95% CI -0.011-0.041)。这两项差异在统计学上都没有定论(95% CI 较宽,越过了无差异线)。如果采用传统的支付意愿(WTP)阈值,即每 QALY 35,000 欧元,则 APM 的 INMB 为负值 -460 欧元(95% CI -3757 - 2698)。在我们的分析中,只有当 WTP 临界值上升到每 QALY 65,000 欧元时,APM 才会带来正的 INMB。无论选择何种 WTP 临界值,较宽的 95% CI 都表明成本效益不确定:本研究的结果进一步支持了临床实践指南的建议,即在半月板退行性撕裂患者中不使用 APM。鉴于现有证据显示APM与非手术治疗或安慰剂手术相比没有益处或成本效益,未来的研究不太可能改变这一结论。
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来源期刊
CiteScore
7.00
自引率
11.90%
发文量
722
审稿时长
2.5 months
期刊介绍: Clinical Orthopaedics and Related Research® is a leading peer-reviewed journal devoted to the dissemination of new and important orthopaedic knowledge. CORR® brings readers the latest clinical and basic research, along with columns, commentaries, and interviews with authors.
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