通过与视频辅助肺叶切除术（VATS-Lobectomy）相比较，确定机器人辅助肺叶切除术（RPL-4）在成本效益和改善早期非小细胞肺癌（NSCLC）患者的健康效用方面是否具有优势。公共资助医疗机构普遍存在对RPL-4采用的障碍，包括高质量前瞻性试验的缺乏和机器人手术的高价格的感知。患者在加拿大、美国和法国的多中心、随机对照试验中进行了盲评，以1:1的比例随机分组为RPL-4组和VATS-Lobectomy组。应用EQ-5D-5L评估基线和术后第1天、第3、第7、第12周以及第6和第12个月的健康效用。使用标准方法跟踪直接和间接成本。采用表面无关回归法估计成本效应，根据基线健康效用进行调整。使用多元插补的链式方程生成10000个引导样本来计算增量成本效益比。经过筛选的406名患者中，有186名随机分组，并在最终符合条件审核后分析了164名患者（RPL-4组：n=81；VATS-Lobectomy组：n=83）。12个月的随访完全率达到94.51%（155/164）。中位年龄为68岁（60-74岁）。两组在体重指数、合并症、肺功能、吸烟状况、基线健康效用和肿瘤特征方面没有显著差异。12周的健康效用评分为RPL-4组为0.85（0.10），VATS-Lobectomy组为0.80（0.19）（P=0.02）。RPL-4组的淋巴结采样显著多于VATS-Lobectomy组[10(8-13) vs 8(5-10)；P=0.003]。在12个月时，RPL-4的每增加一个QALY的成本为14,925.62美元（95% CI 6,843.69美元至23,007.56美元）。RAVAL试验的初步结果表明，与VATS-Lobectomy相比，RPL-4具有相当的短期患者报告的健康效用得分，并且具有成本效益。版权所有©2023 Wolters Kluwer Health，Inc. 保留所有权利。

Determine if robotic-assisted lobectomy (RPL-4) is cost-effective and offers improved patient-reported health utility for patients with early-stage NSCLC when compared to video-assisted lobectomy (VATS-Lobectomy).Barriers against the adoption of RPL-4 in publicly-funded healthcare include the paucity of high-quality prospective trials and the perceived high cost of robotic surgery.Patients were enrolled in a blinded, multi-centered, RCT in Canada, the USA, and France, and were randomized 1:1 to either RPL-4 or VATS-Lobectomy. EQ-5D-5L was administered at baseline and post-operative 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. Incremental cost effectiveness ratio was generated by 10,000 bootstrap samples with multivariate imputation by chained equations.Of 406 patients screened, 186 were randomized, and 164 analyzed after final eligibility review (RPL-4:n=81; VATS-Lobectomy:n=83). Twelve-month follow-up was completed by 94.51%(155/164) of participants. 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/QALY of RPL-4 was $14,925.62(95% CI $6,843.69,$23,007.56) at 12-months.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 to VATS-Lobectomy.Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.