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机器人肺叶切除术具有成本效益,并可提供与电视辅助肺叶切除术相当的健康效用评分:RAVAL 试验的早期结果。

Robotic Lobectomy Is Cost-effective and Provides Comparable Health Utility Scores to Video-assisted Lobectomy: Early Results of the RAVAL Trial.

机构信息

Department of Surgery, Division of Thoracic Surgery, McMaster University, Hamilton, ON, Canada.

Department of Surgery, Division of Thoracic Surgery, Rouen Normandy University, Rouen Cedex, France.

出版信息

Ann Surg. 2023 Dec 1;278(6):841-849. doi: 10.1097/SLA.0000000000006073. Epub 2023 Aug 8.

Abstract

OBJECTIVE

The aim of this study was to determine if robotic-assisted lobectomy (RPL-4) is cost-effective and offers improved patient-reported health utility for patients with early-stage non-small cell lung cancer when compared with video-assisted thoracic surgery lobectomy (VATS-lobectomy).

BACKGROUND

Barriers against the adoption of RPL-4 in publicly funded health care include the paucity of high-quality prospective trials and the perceived high cost of robotic surgery.

METHODS

Patients were enrolled in a blinded, multicentered, randomized controlled trial in Canada, the United States, and France, and were randomized 1:1 to either RPL-4 or VATS-lobectomy. EuroQol 5 Dimension 5 Level (EQ-5D-5L) was administered at baseline and postoperative day 1; weeks 3, 7, 12; and months 6 and 12. Direct and indirect costs were tracked using standard methods. Seemingly Unrelated Regression was applied to estimate the cost effect, adjusting for baseline health utility. The incremental cost-effectiveness ratio was generated by 10,000 bootstrap samples with multivariate imputation by chained equations.

RESULTS

Of 406 patients screened, 186 were randomized, and 164 analyzed after the final eligibility review (RPL-4: n=81; VATS-lobectomy: n=83). Twelve-month follow-up was completed by 94.51% (155/164) of participants. The median age was 68 (60-74). There were no significant differences in body mass index, comorbidity, pulmonary function, smoking status, baseline health utility, or tumor characteristics between arms. The mean 12-week health utility score was 0.85 (0.10) for RPL-4 and 0.80 (0.19) for VATS-lobectomy ( P =0.02). Significantly more lymph nodes were sampled [10 (8-13) vs 8 (5-10); P =0.003] in the RPL-4 arm. The incremental cost/quality-adjusted life year of RPL-4 was $14,925.62 (95% CI: $6843.69, $23,007.56) at 12 months.

CONCLUSION

Early results of the RAVAL trial suggest that RPL-4 is cost-effective and associated with comparable short-term patient-reported health utility scores when compared with VATS-lobectomy.

摘要

目的

本研究旨在确定与电视辅助胸腔镜手术肺叶切除术(VATS-肺叶切除术)相比,对于早期非小细胞肺癌患者,机器人辅助肺叶切除术(RPL-4)在成本效益方面是否具有优势,以及能否改善患者报告的健康效用。

背景

在公共资助的医疗保健中采用 RPL-4 的障碍包括高质量前瞻性试验的缺乏,以及对机器人手术高成本的认知。

方法

患者在加拿大、美国和法国参加了一项盲法、多中心、随机对照试验,并按 1:1 比例随机分配至 RPL-4 或 VATS-肺叶切除术组。在基线和术后第 1 天、第 3 周、第 7 周、第 12 周以及第 6 个月和第 12 个月进行 EuroQol 5 维度 5 级量表(EQ-5D-5L)评估。使用标准方法跟踪直接和间接成本。采用似乎不相关回归来估计调整基线健康效用后的成本效果。通过 10,000 次 bootstrap 抽样和多变量链方程插补生成增量成本效益比。

结果

在筛选的 406 名患者中,有 186 名进行了随机分组,在最终资格审查后对 164 名患者进行了分析(RPL-4:n=81;VATS-肺叶切除术:n=83)。164 名患者中有 155 名(94.51%)完成了 12 个月的随访。中位年龄为 68(60-74)岁。两组间的体重指数、合并症、肺功能、吸烟状况、基线健康效用或肿瘤特征均无显著差异。RPL-4 组的 12 周健康效用平均得分为 0.85(0.10),VATS-肺叶切除术组为 0.80(0.19)(P=0.02)。RPL-4 组的淋巴结取样数显著更多[10(8-13)个 vs 8(5-10)个;P=0.003]。RPL-4 在 12 个月时的增量成本/质量调整生命年为 14,925.62 美元(95%CI:6843.69 美元,23,007.56 美元)。

结论

RAVAL 试验的早期结果表明,与 VATS-肺叶切除术相比,RPL-4 在成本效益方面具有优势,并且与短期患者报告的健康效用评分相当。

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